(183 days)
The NLite System is indicated for use in the specialties of Dermatology and Plastic Surgery, and in particular for the treatment of Inflammatory Acne Vulgaris`.
The NLite System is indicated for use in Dermatological and Plastic Surgery applications and this device is intended for use in the treatment of Inflammatory Acne Vulgaris.
The NLite System is a flashlamp pumped, pulsed dye laser consisting of the following:
- Main laser console incorporating the laser resonator and external optics, high . voltage delivery system, internal cooler, fluid circulation system, control unit and user interface;
- Flexible fibre optic delivery device and optical handpiece; ●
- Footswitch for pulsing control. ●
The provided text for the K024189 submission about the ICN Photonics NLite System does not contain the detailed information necessary to fully address all aspects of the request regarding acceptance criteria and the study proving the device meets them. The submission primarily focuses on establishing substantial equivalence to a predicate device and confirming safety and efficacy for its stated indications for use (treatment of Inflammatory Acne Vulgaris).
Here's a breakdown of what can and cannot be extracted from the provided documents:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria (e.g., a specific percentage reduction in lesions, or a particular success rate) or present a table of device performance against such criteria. It generally states that "Clinical data has been provided to demonstrate that the NLite system is safe and effective for the described indications for use" and "The clinical data provided has demonstrated that the specific indications for use is met and the safety and efficacy of the system has been proved."
2. Sample sized used for the test set and the data provenance
This information is not provided in the submission. There is no mention of the number of subjects in any clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the submission.
4. Adjudication method for the test set
This information is not provided in the submission.
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
The NLite System is a laser-based medical device for treating acne, not an AI-assisted diagnostic or imaging device. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study with AI assistance is not applicable and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the NLite System is a therapeutic device, not an algorithm, and intrinsically involves human-in-the-loop operation (a practitioner using the laser).
7. The type of ground truth used
While not explicitly stated as "ground truth," the studies for demonstrating safety and efficacy for a therapeutic device like this would typically rely on clinical outcomes data. This would involve pre- and post-treatment assessment of acne severity (e.g., lesion counts, grading scales), patient satisfaction, and adverse event reporting.
8. The sample size for the training set
This information is not provided. For a therapeutic device, there isn't a "training set" in the machine learning sense. The clinical studies (which would serve as the basis for evidence) are referred to globally without specific numbers.
9. How the ground truth for the training set was established
As with point 8, the concept of a "training set" with established ground truth in the machine learning context does not directly apply to this type of device. The evidence for efficacy would be established through a clinical trial where clinical endpoints (e.g., reduction in acne lesions) are measured and assessed by clinicians.
Summary of available information as per the request:
| Feature | Reported Information / Status |
|---|---|
| Acceptance Criteria | Not explicitly stated in quantitative terms. The general criterion for approval appears to be "safe and effective for the described indications for use" and that "the specific indications for use is met." |
| Reported Device Performance | "Clinical data has been provided to demonstrate that the NLite system is safe and effective." Specific performance metrics (e.g., percentage improvement in acne, side effect rates) are not detailed in this summary document. |
| Test Set Sample Size | Not provided. |
| Test Set Data Provenance | Not provided (e.g., country of origin, retrospective/prospective). |
| Number of Experts for GT | Not provided. |
| Qualifications of Experts for GT | Not provided. |
| Adjudication Method | Not applicable/Not provided. |
| MRMC Comparative Effectiveness Study | Not applicable (device is a laser for treatment, not an AI diagnostic aid). |
| Effect Size of Human Improvement with AI | Not applicable. |
| Standalone Performance Study (Algorithm only) | Not applicable (device is a physical laser system, not an algorithm). |
| Type of Ground Truth Used | Clinical outcomes data (e.g., assessment of acne severity, lesion counts, patient response, adverse event rates from clinical studies). |
| Training Set Sample Size | Not applicable in the ML sense; clinical study sample size not provided. |
| How Training Set GT was established | Not applicable in the ML sense. Efficacy evidence would be established through clinical assessment of treatment outcomes by qualified healthcare professionals during a clinical study. |
In conclusion, this 510(k) submission summary for the NLite System focuses on demonstrating substantial equivalence to a predicate device and confirming general safety and effectiveness through clinical data, rather than providing the detailed technical and statistical information typically found for AI/ML-based diagnostic devices. The details requested are not present in this regulatory document.
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JUN 2 0 2003
510(k) Summary Statement ICN Photonics NLite System
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1. General Information
- Submitter: ICN Photonics Ltd Units 1&2 Heol Rhosyn Dafen Parc Llanelli, Carmarthenshire Wales, UK, SA14 8QG
Dr Mike Kiernan - Director of Clinical Research Contact Person:
Summary Preparation Date: December 17th 2002
2. Names
Device Name: NLite System
Primary Classification Name: Laser Powered Surgical Instrument
3. Predicate Devices
- ICN Photonics Ltd NLite System, cleared August 2000, 510(k) approval . number K000811, expanded Indications for Use 510(k) approval number K013461, January 2002.
4. Product Description
The NLite System is a flashlamp pumped, pulsed dye laser consisting of the following:
- Main laser console incorporating the laser resonator and external optics, high . voltage delivery system, internal cooler, fluid circulation system, control unit and user interface;
- Flexible fibre optic delivery device and optical handpiece; ●
- Footswitch for pulsing control. ●
5. Indications for Use
The NLite system is indicated for use in the specialties of Dermatology and Plastic Surgery, and in particular for the treatment of Inflammatory Acne Vulgaris`.
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6. Rationale for Substantial Equivalence
The laser system described in this submission is cleared for marketing under 510(k) approval K000811, August 2000. No modifications to the laser system have been undertaken.
7. Safety and Efficacy Information
Clinical data has been provided to demonstrate that the NLite system is safe and effective for the described indications for use.
8. Conclusion
The NLite system has been found to be substantially equivalent to the predicate devices, specifically in technological design and operation and similar in nature to the desired physiological interactions. The design and manufacture of the device is in accordance with the relative international standards and the potential risk to operator and patient have been minimized.
The clinical data provided has demonstrated that the specific indications for use is met and the safety and efficacy of the system has been proved.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus or a series of interconnected human profiles.
Public Health Service
JUN 2 0 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Mike Kiernan Director of Clinical Research ICN Photonics Ltd Units 1 & 2 Heol Rhosyn Dafen Parc Llanelli, Carmarthenshire Wales, UK, SA 14 8QG
Re: K024189
Trade/Device Name: NLite System Regulation Number: 21 CFR 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 20, 2003 Received: March 24, 2003
Dear Mr. Kiernan:
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.
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 (OS) 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 - Dr. Mike Kiernan
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), 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) you may obtain. 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,
Miriam C. Provost
for 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 Statement as Requested by FDA
KO24189 Not Known 510(k) Number (if known):
Device Name: NLite System
Indications for Use:
The NLite System is indicated for use in Dermatological and Plastic Surgery applications and this device is intended for use in the treatment of Inflammatory Acne Vulgaris.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K024189
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
§ 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.