CLICKFINE PEN NEEDLE

K102108 · Ypsomed AG · FMI · Nov 23, 2010 · General Hospital

Device Facts

• Record ID: K102108
• Device Name: CLICKFINE PEN NEEDLE
• Applicant: Ypsomed AG
• Product Code: FMI · General Hospital
• Decision Date: Nov 23, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Ypsomed Clickfine Pen Needles are intended for the hypodermic injection of fluids into the body when attached to an injection pen.

Device Story

Clickfine Pen Needles are sterile, single-use, non-pyrogenic hypodermic needles; designed for attachment to commercially available pen-injectors. Operation involves snapping the hub onto the pen-injector, puncturing the drug reservoir port, removing protective caps, and inserting the needle into the injection site. The pen-injector delivers the fluid; the needle is then removed and discarded. Used in clinical or home settings by patients or healthcare providers for fluid administration. Benefits include safe, standardized delivery of prescribed medications.

Clinical Evidence

Bench testing only. Compliance with ISO 11608-2, ISO 9626, ISO 7864, and ISO 10993-1 standards confirmed. Puncture resistance and sterile barrier seal integrity were verified as equivalent to the unmodified device.

Technological Characteristics

Single-use, sterile, non-pyrogenic hypodermic needle. Materials comply with ISO 9626 (stainless steel tubing) and ISO 10993-1 (biocompatibility). Designed for use with standard pen-injectors per ISO 11608-2. No electronic components or software.

Indications for Use

Indicated for hypodermic injection of fluids into the body via an injection pen for patients requiring such therapy.

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

• Disetronic Penfine Injection Pen Needles (K994197)

Submission Summary (Full Text)

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## Summary of Safety and Effectiveness

NOV 2 3 2010

## "510(K) SUMMARY"

| Submitted By/<br>Contact Person: | Dr. Manfred Mäder |
|----------------------------------|-----------------------------------------|
| | Senior Vice President |
| | Quality Management & Regulatory Affairs |
| | Ypsomed AG |
| | Brunnmattstrasse 6 |
| | CH - 3401 Burgdorf |
| | Switzerland |
| | Tel. [phone] |
| | Fax [phone] |
| | E-mail: [e-mail] |

Date Prepared: August 20, 2010

- Clickfine Pen Needle Trade/Proprietary Name: 7.1
- 7.2 Common/Usual Name:

Injection Pen Needle

- 7.3 Classification Name:
Hypodermic single lumen needle

- 7.4 Classification: FDA has classified Hypodermic single lumen needles in Class II. Final Order was published in the Federal Register on October 21, 1980 after review by the General Hospital and Personal Use Devices Classification Panel.
Panel: 80 Procode: FMI

- 7.5 Purpose of Submission: To establish the substantial equivalence of the modified Y psomed Clickfine Pen Needles to the Disetronic Penfine Insulin Injection Pen Needles.
Substantial Equivalence: The Ypsomed Clickfine Pen Needles are substantially equivalent to the Disetronic Penfine Injection Pen Needles (K994197). The equivalence is supported by the attached documentation.

- 7.6 Device Description
The Yosomed Clickfine Pen Needles are sterile, non-pyrogenic, single use needles designed to be used with commercially available pen-injectors for the administration of prescribed fluids. Each needle is individually packaged in a sealed protective container with a peel tab. The pen needles are used by peeling back the peel tab and snapping the hub onto the threaded end of the pen injector. The back end of the cannula punctures the rubber injection port of the drug reservoir in the pen-injector. The outer protective cap is then removed. The inner protective cap will remain over

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the needle until the insulin is ready to be injected. When the injection is needed, the inner protective cap is removed and the needle is inserted into the chosen site. The pen-injector automatically delivers the fluid through the needle. The protective cap is replaced and the needle is then removed, safely discarded and replaced with a new needle.

- 7.7 Intended Use
The intended use of the modified device remains the same as the predicate device (Disetronic Penfine Injection Pen Needles, K994197):

The Ypsomed Clickfine Pen Needles are intended for the hypodermic injection of fluids into the body when attached to an injection pen.

### 7.8 Technological Characteristics The technological characteristics have not changed.

- 7.9 Performance and Safety Data
Y psomed has performed the relevant assessments specified in the following international and internal standards and protocols and confirmed compliance of the modified devices and equivalence to the predicate devices.

The Clickfine Pen Needles have met the requirements of the relevant sections of the following standards:

- ISO 11608-2:2000 Pen-injectors for medical use -- Part 2: Needles Requirements . and test methods
- ISO 9626:1991/Amd.1:2001 Stainless steel needle tubing for the manufacture of . medical devices
- ISO 7864:1993 Sterile hypodermic needles for single use .
- ISO 10993-1:2003 Biological evaluation of medical devices Part 1: Evaluation . and testing
- . Puncture resistance of outer cap - Equivalent to Unmodified Device
- Seal Integrity of Sterile barrier Equivalent to Unmodified Device ●

The verifications have shown evidence that the Clickfine Pen Needles meet the acceptance criteria of these standards. Based on the results it can be concluded that the device performance and safety are acceptable for the product.

#### 7.10 Conclusion

Ypsomed AG concludes based on the information presented that the modified product is substantially equivalent to the current product legally marketed in the USA.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular fashion around the symbol. The logo is black and white and appears to be a scanned image.

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

Mr. Manfred Mader Senior Vice President Quality Management & Regulatory Affairs YPSOMED AG Brunnmattstrasse 6 Burgdorf Switzerland CH-3401

NOV 2 3 2010

Re: K102108

Trade/Device Name: Clickfine Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: October 27, 2010 Received: November 4, 2010

Dear Mr. Mader:

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- Mr. Mader

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 vours.

Sincerely, yours,

Hiens J. Roberts

for

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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# Indications for Use

NOV 2 3 2010

510(k) Number (if known):

Device Name:

Indications For Use:

Clickfine Pen Needle

K102108

The Clickfine pen needle is intended for the hypodermic injection of fluids into the body when attached to an injection pen.

.

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

Over-The-Counter Use (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)

ion (ODE)

Ald C. Chape 11/22/20

(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K102108