(351 days)
For CoolTouch VariaBreeze™ with CoolBreeze® Handpiece: Podiatry: Ablation, vaporization, incision, excision, and coagulation of soft tissue including matrixectomy, periungal and subungal warts, plantar warts, radical nail excision, and neuromas. For CoolTouch VariaBreeze™ with Toenail Handpiece: Indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.).
The CoolTouch VariaBreeze Laser System is an Nd: YAG laser using a flashlamp-pumped solid state laser rod to produce laser emission at 1064 nm. The laser consists of a cabinet that houses the following: Control panel with microcontroller and emergency stop button, standby button, ready button, and key switch; Connector port for fiber optic delivery system; Remote interlock connector; 630 to 680 nm diode aiming beam; Power supply; Cooling system; Connector port for footswitch and power cord. Delivery devices for the VariaBreeze include: CoolBreeze Handpiece for CoolBreeze Mode—Contains non-replaceable fiber optic within a flexible cable connected to the laser. A standoff at the tip allows for non-contact use, and a control dial is used to set the spot size from 2mm to 10mm. The handpiece also has cryogen for topical cooling. The handpiece is cleanable and reusable. Toenail Handpiece for Toenail Mode—The fiber optic cable attaches to the laser. The handpiece features a standoff at the tip to provide the correct placement for laser delivery to the treatment site and is reusable and cleanable.
This submission pertains to the CoolTouch VariaBreeze Nd:YAG Surgical Laser system.
The provided document does not contain information about specific "acceptance criteria" or a "study that proves the device meets the acceptance criteria" in the traditional sense of a clinical trial with performance metrics. This is a 510(k) Premarket Notification summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than independently proving safety and effectiveness through new clinical data.
Specifically, the document states:
- "Nonclinical Performance Data: None"
- "Clinical Performance Data: None"
Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document, nor can I answer questions about sample sizes, ground truth establishment, or multi-reader multi-case studies, as these types of studies were not conducted or reported in this 510(k) submission.
The "study" referenced in this 510(k) is a comparison to predicate devices to demonstrate technological equivalence. The conclusion drawn is: "The CoolTouch VariaBreeze Nd:YAG Laser System is substantially equivalent to the predicate devices for the indications requested."
Here's what can be extracted based on the provided text, addressing the relevant points:
-
A table of acceptance criteria and the reported device performance:
As stated above, no specific acceptance criteria or de novo device performance data from a dedicated study are present in this 510(k) summary. The "performance" assessment is primarily a comparison of technological characteristics to predicate devices.Characteristic (Predicate vs. New Device) CoolTouch Varia Laser System (K092964) CoolTouch Varia Breeze Laser System (K103338) Patholase PinPointe FootLaser (K093547) CoolTouch Varia Breeze Laser System (K103338) Laser Medium Nd:YAG Nd:YAG Nd:YAG Nd:YAG Wavelength 1064 nm 1064 nm 1064 nm 1064 nm Aiming Beam 532 nm 532 nm 630-680 nm 532 nm Output Power (max) 36W max 30W 6W 30W Energy per Pulse Variable to 3.9 Joules 20-200 mJ, 500-1000 mJ 20-200 mJ 20-200 mJ, 500-1000 mJ Pulse Duration 600 µsec 100-700 µsec 100-700 µsec 100-700 µsec Exposure Single pulse or repeat for continuous burst Continuous Continuous Continuous Repetition Rate 6-200 Hz 5-100 Hz 5-100 Hz 5-100 Hz Spot Size 2 - 10 mm 2 - 10 mm 1 mm (published) 1 mm (for Toenail Handpiece) and 2-10mm (for CoolBreeze Handpiece) Dimensions 31"H x 18"W x 21"D 31"H x 18"W x 21"D 14"H x 7"W x 16"D 31"H x 18"W x 21"D Weight 160 lbs (73kg) console 160 lbs (73 kg) console 36 lbs (16kg) console 160 lbs (73 kg) console Power Requirements 115VAC, 230VAC, 50/60Hz 115VAC, 230VAC, 50/60Hz 90-130VAC, 200-240 VAC, 50/60 Hz 115VAC, 230VAC, 50/60Hz -
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
No test set clinical data was provided or referenced. The submission explicitly states "Nonclinical Performance Data: None" and "Clinical Performance Data: None." -
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):
Not applicable, as no test set requiring expert ground truth was utilized or reported. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as no test set requiring adjudication was utilized or reported. -
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 laser system, not an AI-assisted diagnostic tool. No MRMC study was conducted or reported. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable, as this device is a laser system and does not involve algorithms or AI for standalone performance evaluation in this context. -
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
Not applicable, as no clinical studies requiring ground truth were conducted or reported. -
The sample size for the training set:
Not applicable, as no training set for an algorithm was used or reported. -
How the ground truth for the training set was established:
Not applicable, as no training set was used or reported.
In summary, the CoolTouch VariaBreeze Nd:YAG Surgical Laser system received 510(k) clearance based on its substantial equivalence to previously cleared predicate devices through a comparison of their technological characteristics, rather than through new clinical performance studies.
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pg 1 of 3
NOV - 1 2011
Premarket Notification 510(k) Summary (As Required by 21 CFR 807.93)
This 510(k) Summary of safety and effectiveness for the New Star Model CoolTouch VariaBreeze Nd:YAG Surgical Laser system is submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(k) summary.
| Submitter: | New Star Lasers, Inc. d.b.a. CoolTouch Inc. |
|---|---|
| Address: | 9085 Foothills BoulevardRoseville, CA 95747 |
| Contact Person: | Natalie VollrathQuality and Regulatory Manager |
| Telephone/Fax/Email: | (916) 677-1912 - Phone(916) 677-1901 - Faxnvollrath@newstarlasers.com - Email |
| Date prepared: | September 30, 2011 |
| Device Trade Name: | CoolTouch VariaBreeze™ Nd:YAG Surgical Laser |
| Common Name: | Nd: YAG Surgical Laser |
| Classification Name: | Instrument, surgical, powered, laser79-GEX21 CFR §878.4810 |
| Legally Marketed Predicate Devices: | CoolTouch Varia Nd: YAG laser system (K092964)PinPointe USA, Inc. PinPointe FootLaser Nd:YAG laser system (K093457) |
| Device Description: | The CoolTouch VariaBreeze Laser System is an Nd: YAG laser using a flashlamp-pumped solid state laser rod to produce laser emission at 1064 nm. The laser consists of a cabinet that houses the following: Control panel with microcontroller and emergency stop button, standby button, ready button, and key switchConnector port for fiber optic delivery systemRemote interlock connector630 to 680 nm diode aiming beamPower supplyCooling systemConnector port for footswitch and power cord |
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pg 2 of 3
Delivery devices for the VariaBreeze include:
| CoolBreeze Handpiece for CoolBreeze Mode—Contains non-replaceable fiber optic within a flexible cable connected to the laser. A standoff at the tip allows for non-contact use, and a control dial is used to set the spot size from 2mm to 10mm. The handpiece also has cryogen for topical cooling. The handpiece is cleanable and reusable.Toenail Handpiece for Toenail Mode—The fiber optic cable attaches to the laser. The handpiece features a standoff at the tip to provide the correct placement for laser delivery to the treatment site and is reusable and cleanable. | |
|---|---|
| Intended Use: | The CoolTouch VariaBreeze with CoolBreeze® Handpiece is intended for:Podiatry: Ablation, vaporization, incision, excision, and coagulation of soft tissue including matrixectomy, periungal and subungal warts, plantar warts, radical nail excision, and neuromas.The CoolTouch VariaBreeze with Toenail Handpiece is intended for:For use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.). |
| Comparison: | The Cooltouch VariaBreeze has the same principle of operation, the same wavelength and essentially the same pulse energy rate as the predicate devices. |
| Nonclinical Perfomance Data | None |
| Clinical Performance Data: | None |
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K1.03338 pg 3 of 3
Technological Characteristics:
| Characteristic | CoolTouchVariaLaser SystemK092964 | CoolTouchVaria BreezeLaser SystemK103338 |
|---|---|---|
| Laser Medium | Nd:YAG | Nd:YAG |
| Wavelength | 1064 nm | 1064 nm |
| Aiming Beam | 532 nm | 532 nm |
| Output Power(max) | 36W max | 30W |
| Energy per Pulse | Variable to 3.9 Joules | 20-200 mJ, 500-1000 mJ |
| Pulse Duration | 600 μsec | 100-700 μsec |
| Exposure | Single pulse or repeat forcontinuous burst | Continuous |
| Repetition Rate | 6-200 Hz | 5-100 Hz |
| Spot Size | 2 - 10 mm | 2 - 10 mm |
| Dimensions | 31"H x 18"W x 21"D | 31"H x 18"W x 21"D |
| Weight | 160 lbs (73kg) console | 160 lbs (73 kg) console |
| PowerRequirements | 115VAC, 230VAC50/60Hz | 115VAC, 230VAC50/60Hz |
| Characteristic | PatholasePinPointeFootLaserLaser SystemsK093547 | CoolTouchVaria BreezeLaser SystemK103338 |
| Laser Medium | Nd:YAG | Nd:YAG |
| Wavelength | 1064 nm | 1064 nm |
| Aiming Beam | 630-680 nm | 532 nm |
| Output Power(max) | 6W | 30W |
| Energy per Pulse | 20-200mJ | 20-200 mJ, 500-1000 mJ |
| Pulse Duration | 100-700µsec | 100-700 µscc |
| Exposure | Continuous | Continuous |
| Repetition Rate | 5-100 Hz | 5-100 Hz |
| Spot Size | 1 mm (published) | 1 mm |
| Dimensions | 14"H x 7"W x 16"D | 31"H x 18"W x 21"D |
| Weight | 36 lbs (16kg) console | 160 lbs (73 kg) console |
| PowerRequirements | 90-130VAC,200-240 VAC50/60 Hz | 115VAC, 230VAC50/60Hz |
Conclusion:
The CoolTouch VariaBreeze Nd:YAG Laser System is substantially equivalent to the predicate devices for the indications requested.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 13, 2013
New Star Lasers, Inc. % Ms. Natalie Vollrath Quality and Regulatory Manager 9085 Foothills Boulevard Roseville, California 95747
Re: K103338
Trade/Device Name: CoolTouch VariaBreeze Nd:YAG Laser System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: PDZ, GEX Dated: October 25, 2011 Received: October 25, 2011
Dear Mr. Vollrath:
This letter corrects our substantially equivalent letter of November 01, 2011.
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
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Page 2 - Ms. Natalie Vollrath
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; medical device reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours, FOR
Peter D. Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K1033.8
pg l of l
Indications For Use Statement
510(k) Number:
Device Name:
CoolTouch VariaBreeze Nd:YAG Laser System
Indications for Use:
For CoolTouch VariaBreeze™ with CoolBreeze® Handpiece:
Podiatry: Ablation, vaporization, incision, excision, and coagulation of soft tissue including matrixectomy, periungal and subungal warts, plantar warts, radical nail excision, and neuromas.
For CoolTouch VariaBreeze™ with Toenail Handpiece:
Indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.).
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
- 510(k) Number. K103358
11
§ 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.