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Roncadelle Operations srl Massimo Rossi Quality & Regulatory Manager Via Renolda 10 Castel Mella (Brescia), Lombardia 25030 Italy Re: K221981 Trade/Device Name: SafeR Syringe and SafeR Sting Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: MEG, FMI, FMF Dated: November 16, 2022 Received: December 1, 2022 Dear Massimo Rossi: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov

statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the...

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 SafeR Syringe and SafeR Sting SafeR® is an automatically Retractable Safety Syringe, it is intended to provide a safe, accurate and reliable method for the aspiration of fluids and for the injection of fluids immediately after filling. It is intended to be used for the administration of medications (intramuscular (IM), intradermal (ID) and subcutaneous (SC)). SafeR® system is provided in 2 separate parts: SafeR Syringe and the needle group SafeR Sting. Before...

510(k) Summary K221981 The following information is provided in accordance with 21 CFR 807.92 for the Premarket 510(k) Summary: 1. Submitter Information Company: Roncadelle Operations srl Via Renolda 10 Castel Mella (Brescia), Lombardia 25030 Italy Telephone: + 39 030 672 4322 Massimo Rossi Quality & Regulatory Manager Roncadelle Operations srl Via Renolda 10 Castel Mella (Brescia), Lombardia 25030 Italy Telephone: + 39 030 672 4322 massimo.rossi@roncadelle-operations.com Date Summary Prepared: 2. Device Name and Classification Trade Name: SafeR Syringe and SafeR Sting Common Name: Safety...

4. Indication for use SafeR® is an automatically Retractable Safety Syringe, it is intended to provide a safe, accurate and reliable method for the aspiration of fluids and for the injection of fluids immediately after filling. It is intended to be used for the administration of medications (intramuscular (IM), intradermal (ID) and subcutaneous (SC)). SafeR® system is provided in 2 separate parts: SafeR Syringe and the needle group SafeR Sting. Before use, the end user needs to assemble syringe and needle group. The syringe, once assembled with his needle, incorporates a passive safety...

6. Substantial Equivalence Comparison Substantial Equivalence Table Primary Predicate Device: Proposed Device: SafeR Syringe WTF SECURA SYRINGE and SafeR Sting AND NEEDLE (K132120) SafeR® (SafeR Syringe and SafeR Sting) is an automatically Retractable Safety Syringe, it is intended to provide a safe, accurate and reliable method for the aspiration of fluids and for the injection of fluids immediately after filling. It is intended to be used for the administration of medications (intramuscular (IM), intradermal (ID) and subcutaneous (SC)). The syringe, once assembled with its needle,...

for SafeR® is an automatically Retractable Safety Syringe, it is intended to provide a safe, accurate and reliable method for the aspiration of fluids and for the injection of fluids immediately after filling. It is intended to be used for the administration of medications (intramuscular (IM), intradermal (ID) and subcutaneous (SC)). SafeR® system is provided in 2 separate parts: SafeR Syringe and the needle group SafeR Sting. Before use, the end user needs to assemble syringe and needle group. The syringe, once assembled with his needle, incorporates a passive safety mechanism which...

Syringe Volume SafeR Syringe and SafeR Sting 1/2/2.25/3/5 ml Similar (the proposed device has syringe volumes 1/2/2.25/3/5 ml that fall within the volume range of the predicate device (1/2.5/3/5/10 ml) Syringe Design Piston Syringe (Syringe Antistick) Syringe Design: Piston Syringe Same with hypodermic single lumen (Syringe Antistick) with needle hypodermic single lumen needle Needle Design Tip Type: Tri-Beveled Tip Needle tip configuration: Regular point Needle Design: Tri-Beveled Tip Needle hub luer lock connector. Needle & syringe separable Needle hub luer lock connector. Needle &...