The Push-On Needle is a sterile, non-pyrogenic, single-use, pen needle designed for use with a compatible auto-injector. The Push-On Needle consists of a 30GX 8 mm stainless steel cannula, plastic hub, plastic shield and a protective sealing paper. The assembled Push-On Needle has a circular hub design that clicks and attaches to a cartridge retainer ridge of an auto-injector. Push-On Needle is used by peeling the sealing paper, thus exposing the non-patient end of the needle and pushing this end up against the auto-injector nozzle, and then attaching the needle hub to the auto injector nozzle. The needle shield can be pulled off making the Push-On Needle ready to use.

AI/ML Overview

The provided text describes the Push-On Needle, a sterile, single-use hypodermic needle intended for use with a compatible auto-injector for fluid injections.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Device Performance/Standard Met
Performance:	Meets requirements outlined in ISO 7864 and ISO 9626. Additional tests included (paper seal) peel resistance (ASTM F2824) and (needle) cover (i.e., shield) pull-off force (internal standard).
Biocompatibility:	Materials successfully passed testing as outlined in ISO 10993-1 for devices categorized as External Communicating Devices, Circulating Blood, Limited Exposure.
Sterilization:	Assured by a validated sterilization method qualified in accordance with AAMI TIR 33:2005. Needles are sterilized by gamma irradiation and have a Sterility Assurance Level (SAL) of 10⁻⁶.
Shelf-life:	Performed in accordance with ISO 11607-1:2006.

2. Sample Sizes Used for the Test Set and Data Provenance:

The document does not specify the sample sizes used for the individual performance, biocompatibility, sterilization, or shelf-life tests. It also does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective, although regulatory submissions for new devices typically involve prospective testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:

This information is not provided in the document. The device's substantial equivalence is primarily based on meeting established international and internal performance standards, not on expert-adjudicated ground truth in a clinical context.

4. Adjudication Method for the Test Set:

This information is not provided. The testing described is largely objective measurement against specified standards, rather than subjective interpretation requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted and is not relevant for this type of device. This device is a hypodermic needle, and its effectiveness is determined by its physical and material properties meeting safety and performance standards, not by human reader interpretation of images or data. Therefore, an effect size of human readers improving with or without AI assistance is not applicable.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:

A standalone performance study was not explicitly mentioned in the context of an algorithm. However, the performance and safety data presented (e.g., ISO 7864, ISO 9626, ASTM F2824, ISO 10993-1, AAMI TIR 33:2005, ISO 11607-1:2006) describe the "algorithm only" or device-only performance without human interaction during the actual functioning of the device for its intended purpose.

7. Type of Ground Truth Used:

The "ground truth" for the device's performance is based on established international and industry standards. For example:

Performance: ISO 7864 (Sterile hypodermic needles for single use), ISO 9626 (Stainless steel needle tubing for the manufacture of medical devices -- Requirements and test methods), ASTM F2824 (Standard Test Method for Determining Peel Resistance of Medical and Surgical Adhesive Tapes and Dressings to Skin), and an internal standard for shield pull-off force.
Biocompatibility: ISO 10993-1 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process).
Sterilization: AAMI TIR 33:2005 (Sterilization of health care products — Radiation — Guidance on the method for validating a sterility assurance level of 10⁻⁶).
Shelf-life: ISO 11607-1:2006 (Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems).

These standards define the objective and measurable criteria that the device must meet.

8. Sample Size for the Training Set:

This information is not applicable as the Push-On Needle is a physical medical device (hypodermic needle), not an AI algorithm or software that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

This question is not applicable for the same reason as point 8; there is no training set for a physical hypodermic needle.

Summary

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KI20191

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ട. 510(k) Summary (21 CFR 807.92(a))

Date Prepared: January 7, 2012

MAY 2 3 2012

Submitted By: 5.1

Julia Yeh Director Corporate Quality & Regulatory Affair

Scandinavian Health Limited (SHL) No. 136 Kuo Sheng 2nd Street Taoyuan City, Taiwan 330, R.O.C

Phone: +1-240-367-5200 Fax: +1-800-887-6260

Name of Device: 5.2

Product name: Push-On Needle Sterile disposable hypodermic needle Common name: 880.5570 Regulation number: Needle, Hypodermic, Single Lumen Classification name: Class II Class: Product code: FMI

5.3 Predicate Devices:

NovoTwist® 30G×8 mm needle, Device name: K093109 510(k) number: Feel Fine® Insulin Pen Needle Device name: 510(k) number: K080904

Substantial Equivalence 5.4

The Push-On Needle is substantially equivalent to the Feel Fine® Insulin Pen Needle and NovoTwist® needle. Proof of substantial equivalence is supported by the attached documentation.

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SHIL GROUP

ર્સ્ડ Device Description

ર્સ્ડ્ Intended Use

The Push-On Needle is intended for the hypodermic injection of fluids into the body when attached to a compatible auto-injector.

Technological Characteristics 5.7

The Push-On Needle has similar technological characteristics as the Feel Fine® Insulin Pen Needle and NovoTwist® needle. Minimal differences between the devices do not raise any significant new issues regarding safety and effectiveness.

Performance and Safety Data 5.8

The Push-On Needle has been designed and tested to meet requirements of voluntary standards and FDA guidance documents applicable to the subject device and predicate devices. Results of non-clinical testing support the substantial equivalence of Push-On Needle to the named predicate devices.

Performance Testing:

The Push-On Needle has met the requirements outlined in ISO 7864 and ISO 9626. Additional performance tests included (paper seal) peel resistance (ASTM F2824) and (needle) cover (i.e. shield) pull off force (internal standard).

Biocompatibility Testing:

The materials of Push-On Needle have successfully passed testing as outlined in ISO 10993-1 for devices categorized as External Communicating Devices, Circulating Blood, Limited Exposure.

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Sterilization and Shelf-life Testing:

The sterility of Push-On Needle is assured by using a validated sterilization method qualified in accordance with AAMI TIR 33:2005. The needles are sterilized by gamma irradiation and have a sterility assurance level (SAL) of 100.

The shelf-life testing of Push-On Needle has been performed in accordance with ISO 11607-1:2006

Clinical Data

No clinical tests are required.

ર્સ્ત્રેન્ડ Conclusion

The intended use, principle of operation, technology, materials, performance of Push-On Needle and the predicate devices, K093109 and K080904, are essentially the same. The minor differences between the devices do not raise any significant issues of safety or efficacy.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Ms. Sharlin Yeh Vice President Scandinavian Health Limited (SHL) No. 136 Kuo Sheng 2nd Street Taoyuan City, 330 Taiwan

MAY 2 3 2012

Re: K120191

Trade/Device Name: Push-On Needle 30GX 8mm Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: May 16, 2012 Received: May 17, 2012

Dear Ms. Yeh:

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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Page 2 - Ms. Yeh

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Anthony D. Watson, B.S., M.S., M.B.A.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K120191

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Indications for Use

510(k) Number (if known): Not available

Device Name: Push-On Needle 30G×8 mm

Indications for Use:

Push-On Needle is intended for hypodermic injection of fluids into the body when attached to a compatible auto injector.

Prescription Use ____________ AND/OR (Part 21 CFR 801 Subpart D)

Over-the-Counter Use_ V (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Richard C. Chapman
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K120191

Regulation Number and Section

§ 880.5570 Hypodermic single lumen needle.

(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).