The Automatically Retractable Safety Syringes with Fixed Needle (Iml, 3ml, 10ml with 30G, 29G, 27G, 26G, 25G, 24G, 23G, 22G, 21G, or 20G) is a sterile, single-use, disposable and non-reusable, retractable safety syringe which is intended to provide a safe and reliable method for intramuscular and subcutaneous injection of medication into a patient.

Device Description

The Automatically Retractable Safety Syringes with Fixed Needle devices are piston syringes, intended for medical purposes and consist of a calibrated hollow barrel and a movable plunger. The syringe works like a conventional hypodermic syringe except that the contaminated needle is retracted inside the syringe immediately after patient injection. The needle retracting mechanism is activated by a spring action mechanism after injection is completed. The exposed needle remains safely inside the empty syringe barrel for disposal. The Automatically Retractable Safety Syringes with Fixed Needle are sterile, single use, disposable and non-reusable.

AI/ML Overview

This document is a 510(k) premarket notification for an "Automatically Retractable Safety Syringe with Fixed Needle". It is primarily focused on demonstrating substantial equivalence to a predicate device rather than presenting a study of the device's performance against specific acceptance criteria in the context of an AI/algorithm-driven device.

Therefore, many of the requested categories related to AI/algorithm performance studies (like sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance, training set details) are not applicable to this type of regulatory submission for a physical medical device.

However, I can extract information related to "acceptance criteria" through the lens of performance testing conducted to show substantial equivalence.

Here's a breakdown of the available information:

1. Table of acceptance criteria and the reported device performance

The document does not provide a table of explicit, quantitative "acceptance criteria" and their corresponding "reported device performance" values in the format typically seen for algorithm validation. Instead, it refers to general performance testing to demonstrate substantial equivalence.

Acceptance Criteria Category (Implied)	Reported Device Performance
Design Verification	Test results concluded that the modified device passed appropriately.
Design Validation	Test results concluded that the modified device passed appropriately.
Biocompatibility	Test results concluded that the modified device passed appropriately.
Sterilization	Test results concluded that the modified device passed appropriately.
Substantial Equivalence	Product performance is substantially equivalent to the predicate device due to no changes in product performance specifications or device functional technology.

Explanation of "Acceptance Criteria" in this context: For a physical medical device like a syringe seeking 510(k) clearance, "acceptance criteria" are typically defined by recognized standards (e.g., ISO standards for syringes, biocompatibility standards) and the internal design specifications of the manufacturer. The document states that testing was done "appropriately for design verification, design validation, biocompatibility and sterilization," implying that the device met these established criteria without specifying the exact numerical thresholds.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified in the document. The document mentions "performance testing" but does not detail the number of units tested.
Data Provenance: Not specified. It's likely the testing was conducted by the manufacturer, Shantou Wealy Medical Instrument Co. Ltd, in China, given their location. The nature of the testing (design verification, biocompatibility, etc.) suggests it would be prospective testing of newly manufactured devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This device is a physical medical instrument, not an AI/algorithm-driven diagnostic device that would require expert-established ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not an AI/algorithm study requiring adjudication of diagnostic outputs.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/algorithm-driven device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable in the AI/algorithm sense. For a physical device, "ground truth" would be established by objective measurements against engineering specifications and relevant ISO/ASTM standards (e.g., fluid delivery accuracy, plunger force, needle retraction force, material biocompatibility test results). The document refers to "test results" concluding the device passed these standards.

8. The sample size for the training set

Not applicable. There is no AI/algorithm training set for this physical device.

9. How the ground truth for the training set was established

Not applicable. There is no AI/algorithm training set for this physical device.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 19,2014

Shantou Wealy Medical Instrument Company Limited Ms. Charmaine Henderson Regulatory Consultant 570 Silverado Drive Lafayette, CA 94549

Re: K141640

Trade/Device Name: Automatically Retractable Safety Syringe with Fixed Needle (1ml, 3ml, 10ml) Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: August 25, 2014 Received: August 29, 2014

Dear Ms. Henderson:

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. 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.

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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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Susan Runco DDS, MA

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K141640

Device Name

Device Name
Automatically Retractable Safety Syringe with Fixed Needle (Iml, 3ml, 10ml with 30G, 29G, 27G, 23G, 23G, 21G, or 20G)

Indications for Use (Describe)

Indically Retractable Safety Syringe with Fixed Needle (Iml, 3ml, 10ml with 30G, 29G, 27G, 26G, 25G, 24G, 23G, 22G, 21G, or 20G) is a sterile, single-use, disposable and non-reusable, retractable safety syringe which is intended to provide a safe and reliable method for intramuscular and subcutaneous injection of medication into a patient.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary Shantou Wealy Medical Instrument Co. Ltd Automatically Retractable Safety Syringes with Fixed Needle

Date of Summary Preparation: May 2, 2014

Submitter: Shantou Wealy Medical Instrument Co, Ltd North Jin Huan Road Shantou, Guangdong, China 515064 Tel: +86-754-88218123 Fax: +86-754-82121654
Establishment Registration Number: 3005202235

Company Contact:	Charmaine Henderson
	Regulatory Affairs Consultant
	Office: 925.212.5264
	Email: crhinlaf@gmail.com

Trade name: Automatically Retractable Safety Syringes with Fixed Needle (1ml, 3ml, 10ml)
Device name (Common Name): Piston syringe

Device Classification: Class II

Product Code: MEG

Regulation Number:

Requlation Description: piston syringe

Predicate Device:

Shantou Wealy Medical Instrument Co. Ltd Automatically Retractable Safety Syringes with Fixed Needle (5 ml) 510(k) K113587 Concurrence date: February 24, 2012

General Device Description:

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Indications for Use:

The Automatically Retractable Safety Syringes with Fixed Needle devices are indicated for use where a safe and reliable method for intramuscular and subcutaneous injection of medication in a patient is desired.

Summary of Technological Characteristics:

The modified Automatically Retractable Safety Syringes with Fixed Needle share the same technological characteristics as its predicate device. The characteristics include the same design, same syringe type, same materials, same principle of operation, same safety features, and same intended use.

Summary of Performance Testing:

The modified Automatically Retractable Safety Syringes with Fixed Needle (1ml, 3ml and 10 ml) devices are substantially equivalent to the predicate device in design, materials, function and intended use. The performance testing of the modified Automatically Retractable Safety Syringes with Fixed Needle devices were reviewed and tested appropriately for design verification, design validation, biocompatibility and sterilization. The test results concluded that the modified Automatically Retractable Safety Syringes with Fixed Needle devices (1ml, 3ml and 10 ml) are substantially equivalent to the predicate device; Automatically Retractable Safety Syringes with Fixed Needle (5ml).

Substantial Equivalence:

Shantou Wealy Medical Instrument Co, Ltd considers the modified Automatically Retractable Safety Syringes with Fixed Needle (1ml, 3ml, and 10ml) product performance to be substantially equivalent to its predicate device, Automatically Retractable Safety Syringes with Fixed Needle (5ml) because there are no changes to the product performance specifications or device functional technology.

Regulation Number and Section

§ 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).