The Juniper CLN1 Dermal Cooling Device is intended for use as a skin cooling device to minimize pain and thermal injury during laser and dermatological treatments. Alternative uses include skin cooling as a local anesthetic for procedures that induce minor local discomfort. The Juniper CLN1 Dermal Cooling Device can also provide localized thermal therapy (hot or cold) to minimize pain for post traumatic and / or post surgical pain and to temporarily relieve minor aches and pains and muscle spasms. The optional massage function can also be used for the relief of minor muscle aches, pain, and spasm and for the improvement in local circulation and temporary reduction in the appearance of cellulite.

The Juniper Medical Coupling Gels 400 and 600 facilitate thermal contact of Juniper Dermal Cooling Devices with a patient's skin by mitigating minor variances in device-toskin contact.

Device Description

The Juniper CLN1 Dermal Cooling Device is a thermoelectric cooling and heating device that applies controlled cooling or heating to a treatment site. The device also includes the option of electrically powered massage.

AI/ML Overview

The provided text describes the Juniper CLN1 Dermal Cooling Device and its associated coupling gels. However, it does not contain specific acceptance criteria, detailed study results with performance metrics, or information about sample sizes for test/training sets, expert qualifications, or adjudication methods.

The document is a 510(k) summary for premarket notification, which primarily focuses on demonstrating substantial equivalence to predicate devices, rather than detailed performance studies with hard acceptance criteria.

Therefore, I cannot fully answer your request based on the provided input. I will extract the information that is available.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not explicitly stated in the document. The general principle is "functional equivalence" to predicate devices.	Functionality: "Testing confirms that the Juniper CLN1 Dermal Cooling Device system can be used in an equivalent manner to the predicate devices." Safety (Gels): "The Juniper Medical Coupling Gels 400 and 600 can be safely applied to the skin prior to use with Juniper Dermal Cooling Devices."

The study essentially aimed to prove that the device is "functionally equivalent" and can be "safely applied" to skin, rather than meeting specific quantifiable performance metrics like sensitivity, specificity, or temperature ranges.

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

Sample Size (Test Set): Not specified. The document states "bench testing" was conducted but provides no details on sample size for the device or the gels.
Data Provenance: Not specified. The testing is referred to as "bench testing." No information is given about the origin of any data (e.g., country of origin, retrospective or prospective).

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

Not applicable. This type of device (skin cooling/heating, massage) does not typically involve expert-established ground truth in the way medical imaging or diagnostic AI devices do. The testing described is "bench testing" for functional equivalence and safety.

4. Adjudication method for the test set

Not applicable. There is no mention of expert review or adjudication for the testing described.

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 is not applicable to this type of device. This device is a physical cooling/heating/massage device, not an AI diagnostic or assistance tool.

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

Not applicable. This is not an algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not explicitly stated, but the "ground truth" or reference standard for "functional equivalence" and "safety" would likely come from established engineering specifications for heating/cooling and materials safety for the gels, referenced against the predicate devices. This would involve physicochemical testing and perhaps some basic human factors/skin irritation testing for the gels, rather than medical ground truth like pathology or expert consensus.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" as it is not an AI/machine learning device.

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

Not applicable. This device does not involve a "training set" or its associated ground truth establishment.

Summary of what the document does say about the study:

The study performed was "bench testing."
The purpose of the testing was to demonstrate "functional equivalence" to predicate devices.
Testing confirmed the device system "can be used in an equivalent manner" to predicate devices.
Testing confirmed the coupling gels "can be safely applied to the skin."
The basis for substantial equivalence determination included "A technological comparison and bench testing."

Summary

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SECTION 5. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

K072/52

న. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

APPLICANT	Juniper Medical, Inc.4698 Willow RoadPleasanton, CA 94588	SEP - 7 2007
TRADE NAME:	Juniper Cooling Device
COMMON NAME:	Skin Refrigerant
CLASSIFICATIONNAME:	Laser instrument, surgical, powered
DEVICECLASSIFICATION:	Class II, 21 CFR §878.4810
PRODUCT CODE	79 GEX - laser instrument, surgical, powered89 IOL - pack, hot or cold, water circulating89 ISA - massager, therapeutic, electric
PREDICATE DEVICE:	The Juniper CLN1 Dermal Cooling Device is substantiallyequivalent in intended use and mechanism of action to theJuniper Cooling Device (K060407), the Juniper CoolingDevice XTRA (K063715), and the MediSeb's ElfCarethermal therapy device for both hot and cold applications(K023231). The device is also substantially equivalent tothe Cynosure Triactive Therapeutic massager (K030876).Also included in this submission are the Juniper MedicalCoupling Gels 400 and 600. The gels are substantiallyequivalent in intended use and mechanism of action to thecoupling gel provided with the Juniper Cooling Device.

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

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SECTION 5. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

INDICATION FOR USE:

The Juniper Medical Coupling Gels 400 and 600 facilitate thermal contact of Juniper Dermal Cooling Devices with a patient's skin by mitigating minor variances in device-toskin contact.

TECHNICAL CHARACTERISTICS:

The Juniper CLN1 Dermal Cooling Device is a thermoelectric cooling and heating device that applies controlled cooling or heating to a treatment site. The optional massage feature uses electrically powered vibration.

PERFORMANCE DATA:

Testing confirms that the Juniper CLN1 Dermal Cooling Device system can be used in an equivalent manner to the predicate devices. The Juniper Medical Coupling Gels 400 and 600 can be safely applied to the skin prior to use with Juniper Dermal Cooling Devices.

BASIS FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE:

The indications for use for the Juniper CLN1 Dermal Cooling Device system are the same as for the predicate devices cited in this application. A technological comparison and bench testing demonstrate that the Juniper CLN1 Dermal Cooling Device system and the Juniper Medical Coupling Gels 400 and 600 are functionally equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three curved lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Juniper Medical, Inc. % Mr. Donald V. Johnson 4698 Willow Road Pleasanton, CA 94588

Re: K072152

Trade/Device Name: Juniper Cooling Device Regulation Number: 21 CFR 890.5720 Regulation Name: Water circulating hot or cold pack Regulatory Class: II Product Code: ILO Dated: August 1. 2007 Received: August 6, 2007

SEP - 7 2007

Dear Mr. Johnson:

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.

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 (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.

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Page 2 - Mr. Donald V. Johnson

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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/g0pport/index.html.

Sincerely yours,

For

Mark N. Melkerson
Director
Division of General, Restorative
and Neurological Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

"Sincerely yours,
For Peter
DEPUTY DIRECTOR
9/6/07"

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Device Name: Juniper CLN1 Dermal Cooling Device

Indications for Use:

The Juniper CLN1 Dermal Cooling Device is intended for use as a skin cooling device to minimize pain and thermal injury during laser and dermatological treatments. Alternative uses include skin cooling as a local anesthetic for procedures that induce minor local discomfort. The Juniper CLN1 Dermal Cooling Device can also provide localized thermal therapy (hot or cold) to minimize pain for post traumatic and / or post nurgical pain and to temporarily relieve minor aches and pains and muscle spasms. The optional massage function can also be used for the relief of minor muscle aches, pain, and spam and for the improvement in local circulation and temporary reduction in the appeapance of cellulite.

The Juniper Medical Coupling Gels 400 and 600 facilitate thermal contact of Juniper Dermal Cooling Devices with a patient's skin by mitigating minor variances in device-toskin contact.

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)

(Division Sign-Off)
Division of General, Restorative and Neurological Devices

510(k) Number	K072152
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Juniper Medical, Inc. Juniper CLN1 Dermal Cooling Device

CONFIDENTIAL

Regulation Number and Section

§ 890.5720 Water circulating hot or cold pack.

(a)
Identification. A water circulating hot or cold pack is a device intended for medical purposes that operates by pumping heated or chilled water through a plastic bag and that provides hot or cold therapy for body surfaces.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.