(35 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The device description focuses on thermoelectric cooling/heating and massage functions.
Yes.
The device's intended uses explicitly state it is for minimizing pain, temporary relief of minor aches and pains, and muscle spasms, and improvement in local circulation, which are therapeutic applications.
No
The device is described as a skin cooling and heating device for pain minimization, thermal injury prevention, and localized thermal therapy. It does not perform any diagnostic functions.
No
The device description explicitly states it is a "thermoelectric cooling and heating device" and includes an "electrically powered massage" function, indicating it is a hardware device.
Based on the provided information, the Juniper CLN1 Dermal Cooling Device is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes the device's function as a skin cooling and heating device for pain management, thermal therapy, and massage. These are all applications that interact directly with the patient's body surface.
- Device Description: The description confirms it's a thermoelectric device applying controlled temperature and optional massage to a treatment site.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening. The device's function is entirely external and therapeutic/comfort-based.
Therefore, the Juniper CLN1 Dermal Cooling Device falls under the category of a therapeutic or physical medicine device, not an in vitro diagnostic device.
N/A
Intended Use / 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 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-to-skin contact.
Product codes (comma separated list FDA assigned to the subject device)
79 GEX, 89 IOL, 89 ISA
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.
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)
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.
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, K063715, 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.
Not Found
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
§ 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.
0
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 Road
Pleasanton, CA 94588 | SEP - 7 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 CLN1 Dermal Cooling Device is substantially
equivalent in intended use and mechanism of action to the
Juniper Cooling Device (K060407), the Juniper Cooling
Device XTRA (K063715), and the MediSeb's ElfCare
thermal therapy device for both hot and cold applications
(K023231). The device is also substantially equivalent to
the Cynosure Triactive Therapeutic massager (K030876).
Also included in this submission are the Juniper Medical
Coupling Gels 400 and 600. The gels are substantially
equivalent in intended use and mechanism of action to the
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.
1
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.
2
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.
3
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
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) | |
|---|---|
| Division of General, Restorative and Neurological Devices |
| 510(k) Number | K072152 |
|---|---|
| --------------- | --------- |
| Page | of |
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Juniper Medical, Inc. Juniper CLN1 Dermal Cooling Device
CONFIDENTIAL