(104 days)
The Juniper 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 Cooling Device a thermoelectric cooling device that applies controlled cooling to a treatment site.
The provided text describes a 510(k) summary for the Juniper Cooling Device. However, it does not include detailed acceptance criteria or a study proving the device meets specific performance metrics in the way typically expected for a scientific or clinical study.
Instead, the submission establishes substantial equivalence to predicate devices based on:
- Intended Use: The indications for use are the same as predicate devices.
- Technological Comparison: The device is described as a thermoelectric cooling device, similar to the predicates.
- Bench Testing: "Bench testing demonstrate that the Juniper Cooling Device is functionally equivalent to the predicate devices."
Therefore, most of the requested information regarding detailed acceptance criteria and a study demonstrating the device meets those criteria is not present in the provided text. The document primarily focuses on demonstrating substantial equivalence to already marketed devices.
Here's a breakdown of the available information based on your request:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Functional Equivalence to Predicate Devices | "Bench testing demonstrate that the Juniper Cooling Device is functionally equivalent to the predicate devices." |
| Indications for Use Match Predicate Devices | "The indications for use for the Juniper Cooling Device are the same as predicate devices cited in this application." |
Note: No specific numerical or quantitative acceptance criteria (e.g., cooling temperature range, cooling rate, pain reduction percentage) are provided in this summary. The "performance data" section is very general.
2. Sample size used for the test set and the data provenance
Not applicable/Not provided. The submission refers to "bench testing" but does not detail the sample size, specifics of the "test set" (e.g., number of devices tested, number of simulated skin models), or data provenance (country of origin, retrospective/prospective). This is typical for a 510(k) submission focused on substantial equivalence where detailed clinical trial data might not be required if technological equivalence and intended use are sufficient.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided. There is no mention of human experts establishing ground truth for any test data in this submission. The evaluation is based on technical comparison and bench testing for functional equivalence.
4. Adjudication method for the test set
Not applicable/Not provided. No adjudication method is described, as there isn't a human expert-based ground truth establishment process detailed.
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
Not applicable/Not provided. This device is a cooling device, not an AI-assisted diagnostic or imaging tool. Therefore, an MRMC study related to human reader performance or AI assistance is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable/Not provided. The device is a physical cooling device, not an algorithm. Therefore, a standalone algorithm performance study is not relevant. The "performance data" refers to the device's functional equivalence.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable/Not provided. The evaluation appears to be based on the device's functional characteristics observed during "bench testing" compared to predicate devices, rather than a "ground truth" derived from clinical outcomes, pathology, or expert consensus on patient data.
8. The sample size for the training set
Not applicable/Not provided. This device is not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established
Not applicable/Not provided. As it's not an AI/ML algorithm, there is no training set or associated ground truth.
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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 300Pleasanton, CA 94566 | MAY 3 1 2006 |
|---|---|---|
| TRADE NAME: | Juniper Cooling Device | |
| COMMON NAME: | Skin Refrigerant | |
| CLASSIFICATIONNAME: | Laser instrument, surgical, powered | |
| DEVICECLASSIFICATION: | Class II, 21 CFR §878.4810 | |
| PRODUCT CODE | GEX | |
| PREDICATEDEVICE: | The Juniper Cooling Device is substantially equivalent to theParadgim-Trex LLC DermaChiller 4 (K014253), to the ZimmerElektromedizin GmbH Cryo 5 (K040727), to the CuteraOptional Pulse Light Hand Picce (K050047), and to theOpusmed F1 Diode Laser System (K030235). |
SUBSTANTIALLY EQUIVALENT TO:
The Juniper Cooling Device is substantially equivalent to the Paradgim-Trex LLC DermaChiller 4 (K014253), to the Zimmer Elektromedizin GmbH Cryo 5 (K040727), to the Cutera Optional Pulse Light Hand Piece (K050047), and to the Opusmed F1 Diode Laser System (K030235).
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Juniper Cooling Device a thermoelectric cooling device that applies controlled cooling to a treatment site.
INDICATION FOR USE:
The Juniper 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.
Juniper Medical, Inc.
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Response to Formal Request for Additional Information
TECHNICAL CHARACTERISTICS:
The Juniper Cooling Device is a thermoelectric cooling device.
PERFORMANCE DATA:
Testing confirms that the Juniper Cooling Device can be used in an equivalent manner to the predicate devices. 【送料無料】【送料無料】【送料無料】【送料無料】【送料無料】【送料無料】【送料無料】【送料無料】【
BASIS FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE:
The indications for use for the Juniper Cooling Device are the same as predicate devices cited in this application. A technological comparison and bench testing demonstrate that the Juniper Cooling Device is functionally equivalent to the predicate devices.
Juniper Medical, Inc.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features the department's name in a circular arrangement around the perimeter. In the center is a stylized image of an eagle, which is a common symbol used in government logos. The eagle is depicted with its wings spread, conveying a sense of strength and protection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 3 1 2006
Juniper Medical, Inc. % Ms. Rosemary Harry Acting VP of Clinical and Regulatory Affairs 7139 Koll Center Parkway, Suite 300 Pleasanton, California 94566
Re: K060407
Trade/Device Name: Juniper Cooling Device 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 Dated: May 12, 2006 Received: May 15, 2006
Dear Ms. Harry:
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
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Page 2 - Ms. Rosemary Harry
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. This letter will allow you to begin marketing your device as described in your Section 510/kk 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/dsma/dsmamain.html
Sincerely yours,
Mark N. Melkerson
Mark N. Melkersd Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SECTION 4.
INDICATIONS FOR USE STATEMENT
Koboye7
- INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K060407
Device Name: Juniper Cooling Device
Indications for Use:
The Juniper 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.
Prescription Use x (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)
.m.ll
(Division Sign-O Division of General, Restorative, and Neurological Devices
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510(k) Number K060407
§ 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.