(87 days)
The intended use of the Candela Dynamic Cooling Device is:
- (1) cooling of the skin prior to laser treatment
- (2) reduction of pain during laser treatment
- (3) allows for use of higher laser fluences for laser treatments, such as for hair removal and vascular lesions
- (4) reduces potential side effects of laser treatments, such as for hair removal and vascular lesions
Candela's Dynamic Cooling Device consists of 1) a source of skin refrigerant fluid (HFC 134a), 2) an electronically controlled solenoid delivery valve, and 3) electronic timing circuitry. The Dynamic Cooling Device is connected in line with a laser's triggerswitch system so that activation of the triggerswitch controls the delivery of a pulsed spray of HFC 134a just prior to the delivery of a laser pulse. The pulsed spray of skin refrigerant cools the skin as it evaporates. Thermal injury to non-vascular structures is minimized and pain associated with the laser treatment is reduced.
This document is a 510(k) summary for the Candela Dynamic Cooling Device, which is a skin refrigerant used during laser treatments. It focuses on establishing substantial equivalence to previously cleared devices rather than presenting a de novo study with acceptance criteria and performance data.
Therefore, the requested information about acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment cannot be fully provided from the given text. The document describes the device and its intended use, then asserts its substantial equivalence to predicate devices based on operating principles, materials, design, construction, methods of assembly, and other intended uses.
Based on the provided text, here is what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document does not define specific acceptance criteria or report performance metrics (e.g., cooling efficacy, pain reduction scores, side effect rates) from a study in the format typically seen for a new device claiming specific performance. Instead, it claims substantial equivalence to predicate devices, implying that their established performance is sufficient.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. No new study data (test set, sample size, or provenance) is mentioned. The submission relies on the existing clearances and data of the predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Cannot be provided. As no new test set or ground truth establishment process is described, this information is not available.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. No test set or adjudication process is detailed in this 510(k) summary.
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
- Cannot be provided. This device is a cooling device for laser treatment, not an AI-assisted diagnostic tool involving human readers. Therefore, an MRMC study is not applicable to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Cannot be provided. This device is a mechanical cooling device, not an algorithm. Standalone performance as typically described for algorithms is not relevant.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Cannot be provided. No specific ground truth establishment for a new performance claim is mentioned. The basis for safety and effectiveness is substantial equivalence to legally marketed predicate devices.
8. The sample size for the training set
- Cannot be provided. This is not a machine learning or algorithm-based device, so the concept of a "training set" is not applicable.
9. How the ground truth for the training set was established
- Cannot be provided. Not applicable (see point 8).
Summary of available information related to "proof" of meeting criteria:
The document asserts the device meets its intended use and is safe and effective by demonstrating substantial equivalence to two predicate devices:
- Candela Dynamic Cooling Device (K951033): Cleared for "cooling of the skin prior to and reduction of pain during laser treatment."
- Epidermal Chiller tip accessory to Coherent, Inc.'s Versapulse Aesthetic Surgical Laser (K972347): Cleared for "protecting the dermis from thermal injury, which reduces possible side effects such as scabbing, scarring, and hyperpigmentation" and allowing "for the utilization of higher laser fluences for laser treatment."
The current device then claims:
- Substantial equivalence to K951033 for "use of higher laser fluences and reduction of potential side effects of laser treatments."
- Substantial equivalence to K972347 for "indications for use."
The "proof" is the assertion that the operating principles, materials, design, construction, methods of assembly, and other intended uses are the same as those for the predicate device K951033. The FDA's letter confirms their review and determination of substantial equivalence, allowing the device to proceed to the market.
In the context of a 510(k) submission like this, the "acceptance criteria" are implicitly met by demonstrating that the device is as safe and effective as a legally marketed predicate device, and the "study" is the comparison and argument for substantial equivalence, rather than a new clinical trial with defined performance metrics against specific criteria.
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Koois P9
AUG 1 8 2000
510(k) Summary
General Information:
This 510(k) is to provide notification of substantial equivalence for the Candela Dynamic Cooling Device, which is substantially equivalent to previously marketed devices intended for cooling of the skin and roduction of pain during laser treatment (K951033) and for protecting the dermis from themal injury, which reduces possible side effects such as scabbing, scarring, and hyperpigmentation (K972347) and allows for the utilization of higher laser fluences for laser treatment,
| Submitted by: | Candela Corporation |
|---|---|
| 530 Boston Post Road | |
| Wayland, MA 01778-1886 | |
| Contact Person: | Joan M. Clifford |
| Date prepared: | May 19, 2000 |
| Classification: | Class II (21 CFR § 878.4810 Laser Surgical Instrument for use inGeneral and Plastic Surgery and in Dermatology) |
| Trade Name: | Candela Dynamic Cooling Device |
| Common Name: | Skin Refrigerant |
| Predicate Devices: | Candela Dynamic Cooling Device cleared under 510(k) K951033 andthe Epidermal Chiller tip accessory to Coherent, Inc.'s VersanulseAesthetic Surgical Laser cleared under 510(k) K972347 |
Description:
Candela's Dynamic Cooling Device consists of 1) a source of skin refrigerant fluid (HFC 1348), 2) an electronically controlled soleasid delivery valve, and 3) electronic timing circuity. The Dynamic Cooling Device is connected in line with a laser's triggerswitch system so that activation of the triggerswitch controls the delivery of a pulsed spray of HFC 134a just prior to the delivery of a laser pulse. The pulsed spray of skin refrigerant cools the skin as it evaporates. Thermal injury to non-vascular structures is minimized and pain associated with the laser treatment is reduced.
The intended use of the Candela Dynamic Cooling Device is to minimize injury to the skin structures during laser therapy of vascular lesions and hair removal, to reduce pain associated with laser treatment, to allow for use of higher laser fivences and to reduce potential side offects of laser treatments, such as hair removal and vascular lesions.
Summary of Substantial Equivalence:
The Candela Dynamic Cooling Device for the use of higher laser fluences and reduction of potential side effects of laser treatments is substantially equivalent to the Candela Dynamic Cooling Device which has been previously cleared for cooling of the skin prior to and reduction of pain during laser treatment. (K951033). Operating principles materials, design, construction, methods of assembly and other intended uses are the same as those for the predicate device. With respect to indications for use, Candela's Dynamic Cooling device is also substantially equivalent to Coherent Inc.'s Epidermal Chiller tip accessory (K972347).
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a bird-like figure with three wing-like lines above it. The bird-like figure appears to be in flight.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 8 2000
Ms. Joan M. Clifford Clinical Research Manager Candela Corporation 530 Boston Post Road Wayland, Massachusetts 01778
Re:
Trade Name: Candela Dynamic Cooling Device Regulatory Class: II Product Code: GEX Dated: May 19, 2000 Received: May 23, 2000
Dear Ms. Clifford:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 iff (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Joan M. Clifford
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
e R. lochner.
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Candela Dynamic Cooling Device Device Name:
Indications for Use:
The intended use of the Candela Dynamic Cooling Device is:
- (1) cooling of the skin prior to laser treatment
- (2) reduction of pain during laser treatment
- (3) allows for use of higher laser flucaccs for laser treatments, such as for hair removal and vascular lesions
- (4) reduces potential side effects of laser treatments, such as for hair removal and vascular lesions
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
.
OR
Over-The Counter Use _
(Optional format 1-2-96)
Dumas R. Jochner.
(Division Sign-Off) (Division of General Restorative Devices 510(k) Number Koole Koole & T
§ 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.