PUSH-ON NEEDLE 30GX8MM

K120191 · Scandinavian Health Limited · FMI · May 23, 2012 · General Hospital

Device Facts

• Record ID: K120191
• Device Name: PUSH-ON NEEDLE 30GX8MM
• Applicant: Scandinavian Health Limited
• Product Code: FMI · General Hospital
• Decision Date: May 23, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Push-On Needle is a sterile, single-use, pen needle for hypodermic fluid injection. Device consists of 30G x 8 mm stainless steel cannula, plastic hub, plastic shield, and protective sealing paper. Operation involves peeling sealing paper, pushing non-patient end against auto-injector nozzle, and attaching hub to nozzle; shield is removed prior to use. Circular hub design clicks onto cartridge retainer ridge of compatible auto-injectors. Used in clinical or home settings by patients or healthcare providers. Benefits include secure attachment to auto-injectors for fluid delivery.

Clinical Evidence

No clinical data provided; substantial equivalence supported by bench testing including ISO 7864, ISO 9626, ASTM F2824 (peel resistance), and internal pull-off force testing. Biocompatibility verified per ISO 10993-1.

Technological Characteristics

30G x 8 mm stainless steel cannula; plastic hub and shield. Circular hub design for auto-injector attachment. Sterilized via gamma irradiation (AAMI TIR 33:2005). Biocompatibility per ISO 10993-1. Performance standards: ISO 7864, ISO 9626, ASTM F2824.

Indications for Use

Indicated for hypodermic injection of fluids into the body via compatible auto-injector. No specific patient population, age, or disease state restrictions provided.

Regulatory Classification

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.

Predicate Devices

• NovoTwist® 30G×8 mm needle (K093109)
• Feel Fine® Insulin Pen Needle (K080904)

Submission Summary (Full Text)

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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: [phone] Fax: [phone]

### 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

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.

#### 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

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.

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 [phone] or [phone] 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

Image /page/5/Picture/1 description: The image shows the logo for SHL GROUP. The logo consists of a stylized graphic to the left of the text "SHL GROUP". The graphic appears to be a stylized representation of a mechanical or engineering component. The text is in a bold, sans-serif font.

# 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