(3 days)
The SurgiLight, Inc. EX-308 Excimer laser, handpieces and laser related accessories is indicated for use for the treatment of psoriasis and for the treatment of vitiligo.
The SurgiLight EX-308 Excimer Laser is a medical device that is capable of emitting a treatment laser beam at a wavelength of 308nm under the quidance of a visible aiming beam. This laser may be used in a pulsed mode at various repetition rates.
This 510(k) submission (K020973) for the SurgiLight, Inc. EX-308 Excimer Laser does not contain the type of detailed information typically found in studies for AI/ML-driven devices. The submission focuses on demonstrating substantial equivalence to a predicate device, primarily through a comparison of technological characteristics and intended use, rather than presenting a performance study against specific acceptance criteria.
Therefore, many of the requested fields cannot be filled based on the provided text, as this device is a laser for medical treatment, not a diagnostic or AI-powered device that relies on performance metrics like sensitivity, specificity, or reader studies.
Here's a breakdown based on the provided text, highlighting what is (and isn't) present:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable. This submission doesn't define acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) that would be relevant to an AI/ML device study. The "performance" described is about the laser's physical characteristics and its ability to emit light at a specific wavelength, which are compared to a predicate device for substantial equivalence.
2. Sample size used for the test set and the data provenance
Not applicable. No test set or data provenance related to a performance study for an AI/ML device is mentioned. This submission is for a physical medical device (excimer laser).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No ground truth establishment for a test set is discussed, as this is not an AI/ML performance study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No adjudication method for a test set is mentioned.
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 a diagnostic AI/ML device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. Ground truth for an AI/ML performance study is not discussed.
8. The sample size for the training set
Not applicable. No training set is mentioned as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. No training set ground truth establishment is discussed.
Summary of Device and Approval from the Provided Text:
The SurgiLight, Inc. EX-308 Excimer Laser is a medical device designed to emit a treatment laser beam at a wavelength of 308nm for the treatment of psoriasis and vitiligo.
The 510(k) submission (K020973) sought to establish substantial equivalence to existing predicate devices (e.g., PhotoMedix K003705). The core argument for approval was that:
- The candidate and predicate laser devices are of similar technology.
- They have the same intended use (treatment of psoriasis and vitiligo).
- Based on an analysis of overall performance characteristics (implicitly, the physical characteristics and laser output, not clinical outcome studies in this document), no significant differences exist.
The FDA's approval letter confirms the determination of substantial equivalence, allowing the device to be marketed. The submission did not seek new indications for use; it relied on the existing clearances for the predicate devices.
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510(k) Summary of Safety and Effectiveness The SurgiLight, Inc. EX-308
In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.
The safety and effectiveness of the Surgil.ight, Inc. EX-308 is based upon a determination of the substantial equivalence as well as the safety and effectiveness of its predicate devices which include the following: PhotoMedix
- SurgiLight, Inc. 1. Company: 12001 Science Drive Orlando, Florida 32826 J. T Lin, Ph.D.
- SurgiLight, Inc. EX-308 Excimer Laser II. Model:
- Predicate III. The PhotoMedix K003705 Devices:
- The SurgiLight EX-308 Excimer Laser is a medical device that is capable Description: IV. of emitting a treatment laser beam at a wavelength of 308nm under the quidance of a visible aiming beam. This laser may be used in a pulsed mode at various repetition rates.
V. Indications
The SurgiLight, Inc. EX-308 Excimer laser, handpieces and laser related For Use: accessories is currently cleared for the treatment of psoriasis and will be indicated for use for the treatment of vitiligo. These indications have been cleared for marketing by the Food and Drug Administration for the cited predicated devices. SurgiLight, Inc. seeks no new indications for the EX-308 Excimer Laser. No new indications were sought in this premarket notification, clinical data was presented.
- From a design and clinical perspective, the predicate and candidate laser devices, Summary: are of similar technology and have the same intended use. Based upon an analysis of the overall performance characteristics for the devices, SurgiLight, Inc. believes that no significant differences exist. Therefore, the SurgiLight, Inc. EX-308 should not raise any concerns regarding its overall safety and/or effectiveness.
- This information was prepared for the sole purpose of Advisory: compliance with the 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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 9 2002
J. T. Lin, Ph.D. Director of Business and New Technology Development SurgiLight, Inc. 12001 Science Drive, Ste. 140 Orlando. FL 32826
Re: K020973
Trade/Device Name: SurgiLight, Inc. EX-308 Excimer Laser Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: March 27, 2001 Received: March 26, 2002
Dear Dr. Lin:
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 re rate rise wior 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 11 your de 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 - J. T. Lin, Ph.D.
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,
for Miriam C. Provost
Salie M. Witte, Ph.D., M.D.
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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Indications for Use
Page (){
510(k) Number (If known): KO20923
Device Name: SurgiLight, Inc. EX-308 Excimer Laser
Indications for Use:
The SurgiLight, Inc. EX-308 Excimer laser, handpieces and laser related accessories is indicated for use for the treatment of psoriasis and for the treatment of vitiligo.
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K020973
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
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Over-The-Counter Use
(Optional Format 1-2-96)
§ 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.