COOL.CLICK 2

K060819 · Medical House Products Limited · KZE · Jun 16, 2006 · General Hospital

Device Facts

• Record ID: K060819
• Device Name: COOL.CLICK 2
• Applicant: Medical House Products Limited
• Product Code: KZE · General Hospital
• Decision Date: Jun 16, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5430
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The cool.click 2™ Needle-free Growth Hormone Delivery System is indicated for the administration of Serono's growth hormone drug products and is intended for home use by patients authorized by their physicians to self-inject.

Device Story

Needle-free jet injector for subcutaneous delivery of Serono growth hormone. Device uses spring-loaded piston to force liquid drug through small nozzle aperture at high speed, creating high-pressure stream that penetrates skin. Intended for home use by patients authorized by physicians. Includes digital display to provide accurate information to users. Replaces needle-based injection; benefits patient by eliminating needle use.

Clinical Evidence

Bench testing only. Extensive design verification, functional, and performance testing conducted to demonstrate safety and effectiveness.

Technological Characteristics

Non-electrically powered fluid injector. Spring-actuated piston mechanism. Includes digital display. Needle-free delivery via high-pressure stream.

Indications for Use

Indicated for patients prescribed Serono growth hormone drug products for self-injection in a home setting.

Regulatory Classification

Identification

A nonelectrically powered fluid injector is a nonelectrically powered device used by a health care provider to give a hypodermic injection by means of a narrow, high velocity jet of fluid which can penetrate the surface of the skin and deliver the fluid to the body. It may be used for mass inoculations.

Predicate Devices

• cool.click (K050734)
• Serojet (K003908)
• Clicker (K994384)
• Reconstitution Kit & Vial Connector (K010623)

Submission Summary (Full Text)

{0}------------------------------------------------

JUN 1 6 2006

K060819

Page 1 of 2

*The Medical House*

| | Medical House Products Limited | |
|-------------------------|--------------------------------|----------------------------------|
| Pre-market Notification | | Revision No :01 |
| Product: cool.click 2™ | Section 5.0<br>510(k) Summary | Effective Date:<br>22 March 2006 |

# 510(k) Summary [As required by 21 CFR 907.92(a)]

### A. Submitter Information:

| Submitter: | Medical House Products Limited<br>199, Newhall Road<br>Sheffield, S9 2QJ<br>United Kingdom |
|------------|--------------------------------------------------------------------------------------------|
|------------|--------------------------------------------------------------------------------------------|

| Contact person: | Rose Y Guang |
|-----------------|--------------------------------------------------|
| | Quality Assurance and Regulatory Affairs Manager |
| E-mail: | [e-mail] |
| Phone: | ([phone] |
| Fax: | ([phone] |

Date: March 22 2006

### B. Device Information

Trade/Proprietary Name: cool.click 2™

Common Name: Needle-free Injector, Jet Injector

Classification Name: Jet Injector, Non-Electrically Powered Fluid Injector

- Predicate Devices: cool.click K050734 Serojet K003908 Clicker K994384 Reconstitution Kit & Vial Connector K010623
- cool.click 2™ is a needle-free delivery device for Serono Device Description: growth hormone products. The device delivers the drug product by firing a jet of liquid directly through the skin to the subcutaneous region. The jet is created via a powerful spring acting on a piston inside the nozzle and the liquid is forced out through a small aperture at high speed, creating a very fine, high pressure stream of drug that penetrates the skin.

5-1.

{1}------------------------------------------------

K060819 Page 2042

| The Medical House | Medical House Products Limited | |
|-------------------------|--------------------------------|----------------------------------|
| Pre-market Notification | | Revision No :01 |
| Product: cool.click 21M | Section 5.0<br>510(k) Summary | Effective Date:<br>22 March 2006 |

Intended Use: The cool.click 2™ Needle-free Growth Hormone Delivery System is indicated for the administration of Serono's growth hormone drug products and is intended for home use by patients authorized by their physicians to self-inject.

## C. Comparison of Required technological characteristics:

cool.click 2™ Needle-Free Growth Hormone Delivery System applies the same technological characteristics as the predicated devices. It is designed similarly to the devices that are currently marked in the U. S.

The key difference of the cool.click 2™ Needle-Free Growth Hormone Delivery System is it has a digital display to provide more clear and accurate information to users.

Due to the technological identity and the same indications for use of cool.click 2™ Needle-Free Growth Hormone Delivery System and predicated devices, no additional safety items were identified.

## D. Summary and conclusion of performance tests:

Extensive design verification, functional and performance testing have been conducted. The information provided in this premarket notification demonstrates that the cool.click 2TM Needle-Free Growth Hormone Delivery System is safe and effective for the intended use and is substantially equivalent to the legally marketed predicate devices.

{2}------------------------------------------------

| | The Medical House Products Limited | | |
|-------------------------|-----------------------------------------------------------|----------------------------------|--|
| Pre-market Notification | <b>Section 4.0</b><br><b>Indication for Use Statement</b> | Revision No :01 | |
| Product: cool.click 2™ | | Effective Date:<br>22 March 2006 | |

510(k) Number: K060819

Device Name: cool.click 2TM Needle-free Growth Hormone Delivery System

Indications for Use:

The cool.click 2™ Needle-free Growth Hormone Delivery System is indicated for the administration of Serono's growth hormone drug products and is intended for home use by patients authorized by their physicians to self-inject.

X Prescription Use (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its wing. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

JUN 1 6 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Rose Y. Guang Quality Assurance & Regulatory Affairs Manager Medical House Products Limited 199 Newhall Road Sheffield, United Kingdom S9 2QJ

Re: K060819

Trade/Device Name: Cool.Click 2 Needle-Free Growth Hormone Delivery System Regulation Number: 880.5430 Regulation Name: Nonelectrically Powered Fluid Injector Regulatory Class: II Product Code: KZE Dated: March 22, 2006 Received: March 27, 2006

Dear Ms. Guang:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

{4}------------------------------------------------

### Page 2 - Ms. Guang

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

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone] Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

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

Enclosure

{5}------------------------------------------------

*The Medical House*
**Medical House Products Limited**

| Pre-market Notification |
|---------------------------------------------|
| Product: cool.click 2™ |
| Section 4.0<br>Indication for Use Statement |

| Revision No | :01 |
|-----------------|---------------|
| Effective Date: | 22 March 2006 |

510(k) Number:

Device Name: cool.click 2TM Needle-free Growth Hormone Delivery System

Indications for Use:

The cool.click 2™ Needle-free Growth Hormone Delivery System is indicated for the administration of Serono's growth hormone drug products and is intended for home use by patients authorized by their physicians to self-inject.

X Prescription Use (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anton Vons

1-6-6 11) of Anesthesiology, General Hospital, on Control, Dental Devices

< 460816