JUNIPER CLN1 DERMAL COOLING DEVICE

K072152 · Juniper Medical, Inc. · ILO · Sep 7, 2007 · Physical Medicine

Device Facts

• Record ID: K072152
• Device Name: JUNIPER CLN1 DERMAL COOLING DEVICE
• Applicant: Juniper Medical, Inc.
• Product Code: ILO · Physical Medicine
• Decision Date: Sep 7, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5720
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 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 Story

The Juniper CLN1 Dermal Cooling Device is a thermoelectric system providing controlled heating or cooling to a treatment site, with an optional electrically powered vibration/massage function. It is used in clinical settings to manage pain and thermal injury during dermatological procedures or for therapeutic relief of muscle aches and spasms. The device includes coupling gels (400 and 600) to ensure thermal contact between the applicator and the patient's skin. Operators (clinicians) apply the device to the skin surface; the thermal output provides immediate cooling or heating to modulate pain or tissue temperature. The massage function is used to improve local circulation and temporarily reduce cellulite appearance. The device benefits patients by reducing discomfort during laser treatments and providing non-pharmacological pain relief for post-surgical or post-traumatic conditions.

Clinical Evidence

Bench testing only. No clinical data provided. Testing confirmed the system performs in an equivalent manner to predicate devices and that coupling gels are safe for skin application.

Technological Characteristics

Thermoelectric cooling/heating system; electrically powered vibration for massage. Includes coupling gels for thermal interface. Device is a powered surgical/therapeutic instrument.

Indications for Use

Indicated for patients requiring skin cooling to minimize pain/thermal injury during laser/dermatological procedures, local anesthesia for minor discomfort, or localized thermal therapy (hot/cold) for post-traumatic/post-surgical pain, minor aches, pains, and muscle spasms. Optional massage indicated for relief of minor muscle aches/pain/spasms, improvement of local circulation, and temporary reduction in cellulite appearance.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Juniper Cooling Device (K060407)
• Juniper Cooling Device XTRA (K063715)
• MediSeb's ElfCare thermal therapy device (K023231)
• Cynosure Triactive Therapeutic massager (K030876)

Submission Summary (Full Text)

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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.<br>4698 Willow Road<br>Pleasanton, CA 94588 | SEP - 7 2007 |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| TRADE NAME: | Juniper Cooling Device | |
| COMMON NAME: | Skin Refrigerant | |
| CLASSIFICATION<br>NAME: | Laser instrument, surgical, powered | |
| DEVICE<br>CLASSIFICATION: | Class II, 21 CFR §878.4810 | |
| PRODUCT CODE | 79 GEX - laser instrument, surgical, powered<br>89 IOL - pack, hot or cold, water circulating<br>89 ISA - massager, therapeutic, electric | |
| PREDICATE DEVICE: | The Juniper CLN1 Dermal Cooling Device is substantially<br>equivalent in intended use and mechanism of action to the<br>Juniper Cooling Device (K060407), the Juniper Cooling<br>Device XTRA (K063715), and the MediSeb's ElfCare<br>thermal therapy device for both hot and cold applications<br>(K023231). The device is also substantially equivalent to<br>the Cynosure Triactive Therapeutic massager (K030876).<br>Also included in this submission are the Juniper Medical<br>Coupling Gels 400 and 600. The gels are substantially<br>equivalent in intended use and mechanism of action to the<br>coupling gel provided with the Juniper Cooling Device. | |

# DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

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.

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

## INDICATION 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 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.

### 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 [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 toll-free number [phone] or [phone] 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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4. 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) | |
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| Division of General, Restorative and Neurological Devices | |

| 510(k) Number | k072152 |
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Juniper Medical, Inc. Juniper CLN1 Dermal Cooling Device

CONFIDENTIAL