(88 days)
The Schwartz Electro-Optics, Inc. CrystaLase 1064/532 will be indicated for removal of tattoos of various types and colors, epidermal and pigmented lesions. These indications have been cleared for marketing by the Food and Drug Administration for the cited predicated lasers. Schwartz Electro-Optics, Inc. seeks no new indications for the CrystaLase 1064/532.
From a technology perspective, theory of operation of all the aforementioned devices are While the laser mediums are identical, all the systems are similar both all the same. and electronically. Schwartz Electro-Optics, Inc. believes that the mechanically technological characteristics of the CrystaLase 1064/532 are similar to the predicate lasers. The Continuum Biomedical Medlite and the DermaLase have the ability to deliver laser energy at wavelengths of 1064 nm (Nd:YAG) and frequency doubled Nd:YAG at 532 nm (Green).
The provided text describes a 510(k) submission for the "CrystaLase 1064/532" laser system. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing the detailed results of a specific clinical study with acceptance criteria often seen for novel AI/software devices. Therefore, much of the requested information regarding acceptance criteria, sample sizes, ground truth establishment, and MRMC studies is not available in the provided text.
Here is an attempt to address the questions based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in the format typically used for performance studies (e.g., sensitivity, specificity thresholds). Instead, the acceptance criterion for regulatory clearance is "substantial equivalence" to a predicate device.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Substantial Equivalence to predicate devices (Continuum Biomedical Medlite and DermaLase) in: - Indications for Use - Technology/Theory of Operation - Safety and Effectiveness | The manufacturer "believes that the mechanically and electronically technological characteristics of the CrystaLase 1064/532 are similar to the predicate lasers." "Schwartz Electro-Optics, Inc. believes that the slight differences in the performance characteristics of these devices raises no concerns." The FDA concluded that 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." |
2. Sample Size Used for the Test Set and Data Provenance
This information is not available in the provided text. The document describes a regulatory submission based on technological similarity to predicate devices rather than a performance study with a test set of data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not available in the provided text, as a test set and ground truth in the typical sense of a diagnostic performance study are not described.
4. Adjudication Method for the Test Set
This information is not available in the provided text.
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
An MRMC study is not mentioned and is not applicable to this type of device (a laser system) and this type of regulatory submission (substantial equivalence to a predicate device based on technology and indications, not AI-assisted human performance).
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not available and is not applicable. The device is a physical laser system, not an algorithm.
7. The Type of Ground Truth Used
This information is not available. The submission relies on establishing equivalence to already cleared devices, not on proving de novo clinical accuracy against a specific ground truth.
8. The Sample Size for the Training Set
This information is not available. The document describes a laser system undergoing regulatory review, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set was Established
This information is not available. This is not applicable to the device described.
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K973603
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS SCHWARTZ ELECTRO-OPTICS, Inc. CRYSTALASE 1064/532
From a technology perspective, theory of operation of all the aforementioned devices are While the laser mediums are identical, all the systems are similar both all the same. and electronically. Schwartz Electro-Optics, Inc. believes that the mechanically technological characteristics of the CrystaLase 1064/532 are similar to the predicate lasers. The Continuum Biomedical Medlite and the DermaLase have the ability to deliver laser energy at wavelengths of 1064 nm (Nd:YAG) and frequency doubled Nd:YAG at 532 nm (Green).
In regards to safety or effectiveness of the Schwartz Electro-Optics, Inc. CrystaLase 1064/532, Schwartz Electro-Optics, Inc. believes that the slight differences in the performance characteristics of these devices raises no concerns.
- This information was prepared for the sole purpose of compliance with the Advisory: Safe Medical Devices Act of 1990. It does not imply that the procedures described herein can be performed with the equipment described without substantial risk of personal injury or death to patients due to operator error or in procedures requiring a high degree of skill.
Prescription Use
(Per 21 CFR 801.109)
IX.
(Division Sign-Off)
Division of General Restorative Device
510(k) Number
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 19 1997
Mr. Timothy J. Shea Director Schwartz Electro-Optics. Incorporated 3404 N. Orange Blossom Trail Orlando, Florida 32804
Re: K973603 Trade Name: CrystaLase 1064/532 Laser System Regulatory Class: II Product Code: GEX Dated: September 2, 1997 Received: September 22, 1997
Dear Mr. Shea:
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 III (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 requirements , 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
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Page 2 - Mr. Shea
devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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.
fciellaf
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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g7 X603
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SCHWARTZ ELECTRO-OPTICS, INC.
September 30, 1997
DEC 1 9 1997
Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, MD 20850
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Indications for Use Schwartz Electro-Optics, Inc. CrystaLase 1064/532
The Schwartz Electro-Optics, Inc. CrystaLase 1064/532 will be indicated for removal of tattoos of various types and colors, epidermal and pigmented lesions. These indications have been cleared for marketing by the Food and Drug Administration for the cited predicated lasers. Schwartz Electro-Optics, Inc. seeks no new indications for the CrystaLase 1064/532.
§ 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.