Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The provided text does not mention AI, ML, deep learning, neural networks, or any related concepts. The device description and intended use are purely focused on physical cooling, heating, and massage functions.

Therapeutic

Yes
The device is described as providing localized thermal therapy to minimize pain, relieve aches, pains, and muscle spasms, and improve circulation, all of which are therapeutic functions.

Diagnostic

No
The device is described as a cooling device and thermal therapy device, with functions to minimize pain, relieve aches, and improve circulation. There is no mention of it being used to identify or diagnose any medical condition.

SaMD (Software as a Medical Device)

No

The device description is not found, but the intended use and predicate devices clearly indicate a physical cooling device and associated gel, not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, the Juniper Cooling Device XTRA is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly describes a device that applies thermal therapy (cooling and heating) and massage directly to the skin for pain relief, minimizing thermal injury during procedures, and improving local circulation. This is a physical therapy/treatment device, not a diagnostic device.
Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, tissue) or to provide information about a patient's health status based on such analysis.
Device Description (Not Found): While the description is missing, the intended use is the primary indicator of whether a device is an IVD.
No Mention of IVD-related terms: The document does not contain any terms typically associated with IVDs, such as "in vitro," "diagnostic," "assay," "reagent," "sample analysis," etc.

In summary, the Juniper Cooling Device XTRA is a therapeutic device that interacts directly with the patient's body for treatment and comfort, not a device used to perform tests on samples outside the body for diagnostic purposes.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Juniper Cooling Device XTRA 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 Cooling Device XTRA 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 Gel facilitates thermal contact of the Juniper Cooling Device XTRA with a patient's skin by mitigating minor variances in device-to-skin contact.

Product codes (comma separated list FDA assigned to the subject device)

GEX, IOL, ISA

Device Description

Not Found

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K060407, K023231, K030876

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K05170, K961222

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.

Summary

0

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

K 063715

5. 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.
7139 Koll Center Parkway, Suite 300
Pleasanton, CA 94566 | | | | | FEB 05 2007 |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|-------------|
| TRADE NAME: | Juniper Cooling Device | | | | | |
| COMMON NAME: | Skin Refrigerant | | | | | |
| CLASSIFICATION
NAME: | Laser instrument, surgical, powered | | | | | |
| DEVICE
CLASSIFICATION: | Class II, 21 CFR §878.4810 | | | | | |
| PRODUCT CODE | 79 GEX - laser instrument, surgical, powered
89 IOL - pack, hot or cold, water circulating
89 ISA - massager, therapeutic, electric | | | | | |
| PREDICATE DEVICE: | The Juniper Cooling Device XTRA is substantially
equivalent in intended use and mechanism of action to the
Juniper Cooling Device (K060407) and the MediSeb's
ElfCare thermal therapy device for both hot and cold
applications (K023231, cleared on April 4th, 2003). The
device is also substantially equivalent to the Cynosure
Triactive Therapeutic massager (K030876). Also included
in this submission is the Juniper Medical Coupling Gel,
which is intended to be supplied as an optional consumable
supply. The gel is substantially equivalent in intended use
and mechanism of action to the coupling fluid provided
optionally with the Thermage ThermaCool System
(K05170), and is substantially equivalent in composition to
Pharmaceutical Innovation's Eyron Gel (K961222) | | | | | |

SUBSTANTIALLY EQUIVALENT TO:

The Juniper Cooling Device XTRA is substantially equivalent in intended use and mechanism of action to the Juniper Cooling Device (K060407) and the MediSeb's ElfCare thermal therapy device for both hot and cold applications (K023231, cleared on April 44, 2003). The device is also substantially equivalent to the Cynosure Triactive Therapeutic massager (K030876). Also included in this submission is the Juniper Medical Coupling Gel, which is intended to be supplied as an optional consumable

1

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a simple, clean design.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Juniper Medical, Inc. % Mr. Don Johnson Vice President, Regulatory, Clinical & Quality Affairs 7139 Koll Center Parkway Suite 300 Pleasanton, California 94566

FEB 5 2007

Re: K063715

Trade/Device Name: Juniper Cooling Device XTRA Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX, ILO, ISA Dated: December 13, 2006 Received: December 14, 2006

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

2

Page 2 – Mr. Don Johnson

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.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson

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

Enclosure

3

SECTION 4.

INDICATIONS FOR USE STATEMENT

510(k) Number (if known): 长 063715

Device Name: Juniper Cooling Device XTRA

Indications for Use:

The Juniper Cooling Device XTRA 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 Cooling Device XTRA 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 Gel facilitates thermal contact of the Juniper Cooling Device XTRA with a patient's skin by mitigating minor variances in device-to-skin contact.

-------------------------------------------------	---	--------	------------------------------------------------	--

(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, Page of

and Neurological Devices

510(k) Number: K063716

Juniper Medical, Inc. Juniper Cooling Device XTRA

CONFIDENTIAL

Tradiitonal 510(k) Page 16 of 187