(27 days)
The CoolTouch VariZoom Variable Spot Size Reusable Fiber Optic Handpiece is indicated as an accessory for use with the CoolTouch "Varia" Nd:YAG Laser System, which has been cleared for the following indications: Hair removal (destruction of hair follicles) in all skin types and for soft tissue hemostasis of vascular lesions. For pigmented lesions appropriate for 1 or more treatments that would potentially benefit from aggressive to reduce lesion size, for patients that have not responded to other laser treatments.
The fiber optic handpiece used with the CoolTouch Varia laser system has had a fixed spot size. The user selects a 4mm, 6mm, or 8mm spot size, depending on the application. The VariZoom handpiece combines the various spot size handpieces into one, allowing the user to dial the desired spot size instead of changing handpieces. The VariZoom handpiece has the same coolant capability and incorporates a sensor to alert the user that the coolant is depleted.
The provided text describes a 510(k) premarket notification for a medical device, the CoolTouch "VariZoom" Variable Spot Size Reusable Fiber Optic Handpiece. This type of submission relies heavily on demonstrating substantial equivalence to a predicate device rather than extensive de novo clinical studies with acceptance criteria.
Therefore, the information regarding acceptance criteria, study details, and performance metrics as typically found in a clinical trial report with specific quantitative outcomes is not present in this document. The submission focuses on comparing the new device's specifications and intended use to a previously cleared predicate device.
Here's an analysis based on the information provided, highlighting the absence of typical clinical study data:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria or reported device performance in the manner of a clinical study with quantitative outcomes. The "performance" is implicitly demonstrated through the comparison of specifications to the predicate device.
| Specification | CoolTouch "Varia" Fixed Spot Size Fiber Optic Handpiece (Predicate) | CoolTouch "VariZoom" Variable Spot Size Fiber Optic Handpiece (New Device Performance) | Acceptance Criteria (Implicit) |
|---|---|---|---|
| Wavelength | 1064 nm | Same (1064 nm) | Maintain predicate's wavelength |
| Dimensions | 20cm x 5cm x 10cm (LxDxH) | Same (20cm x 5cm x 10cm) | Maintain predicate's dimensions |
| Weight | 2 lbs. | Same (2 lbs.) | Maintain predicate's weight |
| Cooling | Dynamic cooling using a solenoid valve and self-contained coolant | Same | Maintain predicate's cooling method |
| Compatibility | CoolTouch Varia Nd:YAG Laser System | Same | Maintain compatibility with predicate laser system |
| Laser Spot Size | 4, 6, 8mm (fixed) | Variable, 3mm to 10mm (variable) | Provide variable spot size within a reasonable and safe range, and encompass predicate's sizes |
| Indications | Numerous (same as predicate laser system) | Same (as predicate laser system) | Maintain predicate's indications for use |
2. Sample size used for the test set and the data provenance
No test set data from actual device usage is presented. The submission relies on comparison to a predicate device's established performance and specifications. Therefore, information about sample size, country of origin, or retrospective/prospective nature of a test set is not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. There was no test set requiring expert ground truthing as this was primarily a technical and functional equivalence submission.
4. Adjudication method for the test set
Not applicable. No test set requiring adjudication was performed.
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 device is a fiber optic handpiece for a laser system, not an AI-powered diagnostic or interpretive tool. Therefore, MRMC studies and AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a hardware device, not an algorithm.
7. The type of ground truth used
The "ground truth" equivalent in this submission is the established safety and effectiveness profile of the predicate device, the CoolTouch "Varia" Nd:YAG Laser System and its fixed spot size handpieces, as cleared by previous 510(k) submissions. The new device is deemed substantially equivalent based on its similar design, materials, and intended use as an accessory, with the primary difference being a variable spot size mechanism.
8. The sample size for the training set
Not applicable. This is not a machine learning device or algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. No training set was used.
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012982 1/2
Premarket Notification 510(k) Summary OCT - 2 2001 CoolTouch "VariZoom" Variable Spot Size Reusable Fiber Optic Handpiece
This 510(K) Summary of safety and effectiveness for the CoolTouch "VariZoom" variable spot size a reusable fiber optic handpiece is submitted in accordance with the requirements of 21 CFR 807.92.
| Applicant: | CoolTouch Corporation |
|---|---|
| Address: | 9085 Foothills BoulevardRoseville, CA 95747 |
| Contact Person: | Donald V. Johnson |
| Telephone: | (916) 677-1900 |
| Fax: | (916) 677-1901 |
| Preparation Date: | September 4, 2001 |
| Device Trade Name: | CoolTouch "VariZoom" |
| Common Name: | Laser Fiber Optic Delivery System Handpiece |
| Classification Name: | Accessory to Laser Surgical Instruments79-GEX |
| Legally Marketed PredicateDevice: | The predicate device is the CoolTouch Corporation ModelCoolTouch "Varia" Nd:YAG Laser System, 510(k) # K983984,July 7, 1999. The beam delivery system was described in the510(k); the cooling handpiece was also described in detail as anaccessory in the Operator Manual. |
| Description of theCoolTouch CorporationVariZoom handpiece: | The fiber optic handpiece used with the CoolTouch Varia lasersystem has had a fixed spot size. The user selects a 4mm,6mm, or 8mm spot size, depending on the application. TheVariZoom handpiece combines the various spot size handpiecesinto one, allowing the user to dial the desired spot size instead ofchanging handpieces. The VariZoom handpiece has the samecoolant capability and incorporates a sensor to alert the user thatthe coolant is depleted. |
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The following table describes the CoolTouch "Varia" fixed spot size handpieces and compares them to the CoolTouch "VariZoom" variable spot size handpiece.
| Specification | CoolTouch "Varia"Fixed Spot SizeFiber Optic Handpiece | CoolTouch "VariZoom"Variable Spot SizeFiber Optic Handpiece |
|---|---|---|
| Wavelength | 1064 nm | Same |
| Dimensions | 20cm x 5cm x 10cm (LxDxH) | Same |
| Weight | 2 lbs. | Same |
| Cooling | Dynamic cooling using a solenoidvalve and self-contained coolant | Same |
| Compatibility | CoolTouch Varia Nd:YAG LaserSystem | Same |
| Laser Spot Size | 4, 6, 8mm | Variable, 3mm to 10mm |
| Indications | Numerous | Same |
| 510k Number | K983984K003781K010316 | Pending |
Technical Specification Comparison
Intended use of the CootTouch Corporation VariZoom handpiece:
The intended use of the VariZoom handpiece is the same intended use as previously cleared for the CoolTouch "Varia" Nd:YAG Laser System per 510(k) #K010316.
Nonclinical Performance Data:
None.
Clinical Performance Data:
Conclusion:
None.
The CoolTouch VariZoom handpiece described in this submission is substantially equivalent to the predicate CoolTouch 4, 6, and 8mm spot size handpieces.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three wing-like shapes. The eagle is positioned to the right of a circular text element. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 2 2001
Mr. Donald V. Johnson Vice President of Operations New Star Lasers, Inc. 9085 Foothills Boulevard Roseville, California 95747
Re: K012982 Trade/Device Name: CoolTouch VariZoom Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and dermatology Regulatory Class: II Product Code: GEX Dated: September 5, 2001 Received: September 5, 2001
Dear Mr. Johnson:
We have reviewed your Section 510(k) premarket notification of intent to market the device wo nave roviewed your we determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 too based on 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.
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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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Susa Walker, MD
fa
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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Device Name
CoolTouch VariZoom Variable Spot Size Reusable Fiber Optic Handpiece
The CoolTouch VariZoom Variable Spot Size Reusable Fiber Indications for Optic Handpiece is indicated as an accessory for use with the Use CoolTouch "Varia" Nd:YAG Laser System, which has been cleared for the following indications:
Hair removal (destruction of hair follicles) in all skin types and for soft tissue Hall removal (destraction of hand hemostasis of vascular lesions. For pigmented lesions approations: 1 or or organients that would potentially benefit from aggressive to reduce resion size, for patients that have not responded to other laser treatments.
(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
510(k) Number -
Over-the-Counter Use
12
KO12982
(Division Sign-Off) (Division Signi-Olf)
Division of General, Restorative
Division of General, Devices Division of Gical Devices
Confidential
§ 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.