(216 days)
The Automatically Retractable Safety Syringe is used for aspiration of fluids from vials and a variety of fluid injections into the human body through subcutaneous and muscle.
It has a detachable needle with a dedicated fitting. The Automatically Retractable Safety Syringe contains an inner mechanism used to allow the needle to be retracted inside the plunger of the syringe after the operator's thumb force released. After activation the needle is fully contained inside the syringe guarding against accidental needle sticks during normal handling and disposal of the used needle/syringe combination.
Automatically Retractable Safety Syringe
The provided document is a 510(k) clearance letter from the FDA for the "Automatically Retractable Safety Syringe". It describes the indications for use and states that the device is substantially equivalent to legally marketed predicate devices. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any of the other specific details requested in your prompt.
Therefore, I cannot provide the requested information based on the text provided. This document is a regulatory approval, not a technical study report.
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Zhejiang Lingyang Medical Apparatus Co., Ltd. % Olivia Meng Regulatory Affairs Manager Guangzhou Osmunda Medical Device Technical Service Co., Ltd. 9th Floor, R&D Building, No.26 Qinglan Street, Panyu District Guangzhou, Guangdong 510006 China
Re: K213077
Trade/Device Name: Automatically Retractable Safety Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: MEG. FMF. FMI Dated: March 28, 2022 Received: March 31, 2022
Dear Olivia Meng:
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
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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 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 quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for CAPT Alan Stevens Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K213077
Device Name
Automatically Retractable Safety Syringe
Indications for Use (Describe)
The Automatically Retractable Safety Syringe is used for aspiration of fluids from vials and a variety of fluid injections into the human body through subcutaneous and muscle.
It has a detachable needle with a dedicated fitting. The Automatically Retractable Safety Syringe contains an inner mechanism used to allow the needle to be retracted inside the plunger of the syringe after the operator's thumb force released. After activation the needle is fully contained inside the syringe guarding against accidental needle sticks during normal handling and disposal of the used needle/syringe combination.
| Type of Use (Select one or both , as applicable) | |
|---|---|
| ---------------------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).