(117 days)
Skin cooling in conjunction with drinatological laser treatments to reduce pain and thermal damage to skin tissue.
The C300 Chiller System is a thermoelectric cooler (TECs) which utilizes the Peltier effect. The chiller employs solid-state heat pumps that cool thermoelectrically and contain no moving parts. The C300 Chiller System is contained within a single housing. The chiller console is electrically connected to a standard 110 VAC wall outlet. The unit delivers low temperature air at an adjustable rate through a treatment tube. The user interacts with the C300 Chiller System by turning the power switch to the on position and selecting the desired temperature via the display on the digital controller
The provided document is a 510(k) summary for the Reliant Technologies C300 Chiller System. It details the device, its intended use, and a comparison to predicate devices to establish substantial equivalence. However, it does not contain a detailed study with acceptance criteria and reported device performance in the format typically used for medical AI device submissions.
This document describes a physical medical device (a chiller system) rather than an AI/ML-driven diagnostic or prognostic device. Therefore, many of the requested categories for AI/ML device studies (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set size, and ground truth for training) are not applicable to the information presented in this 510(k) summary.
The closest information related to "acceptance criteria" and "device performance" in the context of this document is the claim of "Clinical Performance Data" and "Technological Characteristics" for establishing substantial equivalence.
Here's an attempt to answer the request based only on the provided text, acknowledging that much of the requested information for AI/ML devices is not present:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicit from Substantial Equivalence) | Reported Device Performance |
|---|---|---|
| Indications for Use | Identical or similar to predicate devices. | "Identical or similar indication statements." |
| Safety Data | Sufficient to determine performance as intended with no new safety/effectiveness issues. | "Sufficient safety data has been gathered to determine that the Reliant Technologies C300 Chiller System performs as clinically intended and that no new issues of safety and effectiveness are introduced." |
| Technological Characteristics | Equivalent to predicate devices (e.g., cooling capacity). | "Key technological characteristics of the Reliant Technologies C300 Chiller System, such as cooling capacity, are equivalent to the Paradigm-Trex, LLC, DermaChiller 4... and the MedArt Corporation, MedArt 520 Cooling System..." |
2. Sample size used for the test set and the data provenance
Not applicable. This is a physical device, and the evaluation for substantial equivalence does not involve a "test set" in the context of AI/ML performance evaluation studies. The document mentions "Sufficient safety data has been gathered," but does not specify the sample size or provenance of that data beyond it being part of the clinical performance data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This document does not describe an AI/ML device requiring ground truth establishment by experts for a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable.
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. This is not an AI/ML diagnostic or prognostic device designed to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical chiller system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the AI/ML sense. The "ground truth" for this device's performance would be engineering specifications (e.g., actual cooling capacity vs. designed cooling capacity) and clinical safety outcomes. The document broadly refers to "sufficient safety data" and "performs as clinically intended," but doesn't detail how this "ground truth" was established or measured.
8. The sample size for the training set
Not applicable. This is a physical device, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
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- 9 2007
OCT
K071621
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
REGULATORY AUTHORITY
Safe Medical Devices Act of 1990, 21 CFR 807.92
COMPANY NAME/CONTACT
Dan Marinsik Reliant Technologies, Inc. 464 Ellis St. Mountain View, CA 94043 650 605-2237 650 605-2037 fax dmarinsik@reliant-tech.com
NAME OF DEVICE
Trade Name: Common Name: Regulation Number Product code: Device Panel: Device Classification:
Reliant Technologies C300 Chiller System Skin Refrigerant 878.4810 GEX General Surgery/Restorative Devices Class II
LEGALLY MARKETED PREDICATE DEVICES
Name: Paradigm-Trex, LLC, DermaChiller 4 510(k) #: K014253
Name: MedArt Corporation, MedArt 520 Cooling System 510(K) #: K000503
DEVICE DESCRIPTION
The C300 Chiller System is a thermoelectric cooler (TECs) which utilizes the Peltier effect. The chiller employs solid-state heat pumps that cool thermoelectrically and contain no moving parts. The C300 Chiller System is contained within a single housing. The chiller console is electrically connected to a standard 110 VAC wall outlet. The unit delivers low temperature air at an adjustable rate through a treatment tube
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The user interacts with the C300 Chiller System by turning the power switch to the on position and selecting the desired temperature via the display on the digital controller
INDICATION FOR USE STATEMENT
The Reliant Technologies C300 Chiller System is intended for use in:
Skin cooling in conjunction with drinatological laser treatments to reduce pain and thermal damage to skin tissue.
SUBSTANTIAL EQUIVALENCE COMPARISON
Indications for Use
Substantial equivalence for the Reliant Technologies C300 Chiller System and Accessories is supported by the predicate devices listed in this submission, which have identical or similar indication statements.
Clinical Performance Data
Sufficient safety data has been gathered to determine that the Reliant Technologies C300 Chiller System performs as clinically intended and that no new issues of safety and effectiveness are introduced.
Technological Characteristics
Key technological characteristics of the Reliant Technologies C300 Chiller System, such as cooling capacity, are equivalent to the Paradigm-Trex, LLC, DermaChiller 4 as described in submission K014253 and the MedArt Corporation, MedArt 520 Cooling System as described in submission K000503.
CONCLUSION
Based on the design, materials, function, intended use and clinical evaluation, the Reliant Technologies C300 Chiller System is substantially equivalent to the devices currently marketed under the Federal Food, Drug and Cosmetic Act. No changes are being made in the laser wavelength or operating principle. Safety and effectiveness are reasonably assured, justifying 510(k) clearance.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines forming its body and head. The symbol is enclosed within a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" in a sans-serif font. The text is arranged around the upper half of the circle, with the symbol positioned in the center.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 9 2007
Reliant Technologies, Inc. % Mr. Dan Marinsik Senior Director, Clinical Regulatory, & Quality 464 Ellis Street Mountain View, California 94043
Re: K071621
Trade/Device Name: Reliant Chiller System 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: August 31, 2007 Received: September 05, 2007
Dear Mr. Marinsik:
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
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Page 2 – Mr. Dan Marinsik
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 M. Mikkelsen
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 3 – Mr. Dan Marinsik
cc: HFZ-401 DMC HFZ-404 510(k) Staff HFZ-410 DGRND/GSDB D.O. f/t:SPB:kxl:10-3-07
OC Numbers:
| Division of Enforcement A | 240-276-0115 |
|---|---|
| Dental, ENT and Ophthalmic Devices Branch | 240-276-0115 |
| OB/GYN, Gastro. & Urology Devices Branch | 240-276-0115 |
| General Hospital Devices Branch | 240-276-0115 |
| General Surgery Devices Branch | 240-276-0115 |
| Division of Enforcement B | 240-276-0120 |
| Cardiovascular & Neurological Devices Branch | 240-276-0120 |
| Orthopedic, Physical Medicine & Anesthesiology Devices Br | 240-276-0120 |
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Reliant Technologies, Inc.
Premarket Notification: Reliant Chiller System and Accessories,
INDICATIONS FOR USE STATEMENT B.
510(k) Number: K071621
Device Name: Reliant Chiller System
Indications for Use:
The Reliant Chiller System is intended for use in:
Skin cooling in conjunction with dermatological laser treatments to reduce pain and thermal damage to skin tissue.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
or Over-The
(Per 21 CFR 801.109)
Over-The-Counter Use
Alinh N. Milhem
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Confidential
5
§ 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.