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 Description

cool.click 2™ is a needle-free delivery device for Serono 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. 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.

AI/ML Overview

The provided text is a 510(k) summary for the cool.click 2™ Needle-free Growth Hormone Delivery System, a medical device. It does not describe a study involving an algorithm, AI, or human readers, nor does it provide detailed acceptance criteria and performance data in the way a clinical study report for an AI-powered device would.

Therefore, many of the requested items, such as multi-reader multi-case studies, standalone algorithm performance, number of experts, and training set details, cannot be extracted from this document, as they are not relevant to a traditional medical device submission like a needle-free injector.

However, I can extract the information that is present:

1. Table of Acceptance Criteria and Reported Device Performance:

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

This statement serves as the general acceptance criteria and performance summary. However, specific numerical acceptance criteria (e.g., "must achieve X% accuracy") and their corresponding reported values are not detailed in this summary. Instead, the focus is on demonstrating substantial equivalence to predicate devices, implying that if it performs comparably to already approved devices, it meets the required safety and effectiveness standards.

2. Sample size used for the test set and the data provenance:

Sample size: Not specified.
Data provenance: Not specified (e.g., country of origin, retrospective/prospective). The testing would have been conducted as part of the device's design verification and validation, likely under controlled conditions by the manufacturer, Medical House Products Limited (United Kingdom).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable/Not specified. For a simple mechanical device like a needle-free injector, "ground truth" established by human experts in the context of diagnostic interpretation is not relevant. The testing would involve engineering and functional performance evaluations.

4. Adjudication method for the test set:

Not applicable/Not specified. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations, which is not relevant for this type of device testing.

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:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic tools or systems where human interpretation is involved. The cool.click 2™ is a mechanical drug delivery device.

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

No, a standalone algorithm performance evaluation was not done. This device does not feature an algorithm or AI component.

7. The type of ground truth used:

Not applicable in the context of an AI device. For this mechanical device, "ground truth" would relate to engineering specifications, performance against established standards (e.g., injection force, volume accuracy, sterility, durability), and safety parameters as defined during the design and testing phases. The document does not specify the exact nature of these "truths" but confirms "Extensive design verification, functional and performance testing have been conducted."

8. The sample size for the training set:

Not applicable. This device does not use machine learning or AI, and therefore does not have a "training set."

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

Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

Summary

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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 5.0510(k) Summary	Effective Date:22 March 2006

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

A. Submitter Information:

Submitter:	Medical House Products Limited199, Newhall RoadSheffield, S9 2QJUnited Kingdom
------------	--------------------------------------------------------------------------------------------

Contact person:	Rose Y Guang
	Quality Assurance and Regulatory Affairs Manager
E-mail:	rguang@themedicalhouse.com
Phone:	(+44) 1142619011
Fax:	(+44) 1142431597

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.

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K060819 Page 2042

The Medical House	Medical House Products Limited
Pre-market Notification		Revision No :01
Product: cool.click 21M	Section 5.0510(k) Summary	Effective Date: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.

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

510(k) Number: K060819

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

Indications for Use:

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)

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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.

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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 (240) 276-0115 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 (800) 638-2041 or (301) 443-6597 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

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The Medical House
Medical House Products Limited

Pre-market Notification
Product: cool.click 2™
Section 4.0Indication 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:

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

Regulation Number and Section

§ 880.5430 Nonelectrically powered fluid injector.

(a)
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.(b)
Classification. Class II (performance standards).