(90 days)
The ProLite Pulsed Light System is indicated the treatment of benign pigmented lesions and the removal of tattoos.
The ProLite Pulsed Light System delivers pulsed light at a wavelength of 550 nanometers. The device consists of three interconnected sections: The cabinet which houses the power supply, the cooling system and the microcontroller, the umbilical to the handpiece, and the handpiece, which houses the waveguide.
The provided text is a 510(k) summary for the ProLite Pulsed Light System, and it primarily focuses on establishing substantial equivalence to a predicate device rather than presenting detailed data from a specific study designed to meet pre-defined acceptance criteria for the new device.
Therefore, much of the requested information regarding acceptance criteria, specific study design, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not available in the provided document.
Here's what can be extracted based on the input:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or provide detailed performance data from a specific study. Instead, it makes a general statement of substantial equivalence to an existing predicate device.
2. Sample size used for the test set and the data provenance
The document does not provide information on a specific test set sample size or data provenance. Since it establishes substantial equivalence, it likely refers to the performance of the predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not provide information on experts used to establish ground truth.
4. Adjudication method for the test set
The document does not provide information on any adjudication method.
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 document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. This device is a pulsed light system, not an AI-driven diagnostic tool, so such a study would likely not be applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document does not describe a standalone algorithm performance study. This device is a medical instrument used by practitioners.
7. The type of ground truth used
The document does not explicitly state the type of ground truth used as it doesn't describe a specific performance study. Given the intended use (treatment of benign pigmented lesions and tattoo removal), ground truth in relevant studies for such devices typically involves clinical assessment of treatment efficacy and safety, potentially supported by photographic evidence or patient reported outcomes.
8. The sample size for the training set
The document does not provide information on a training set sample size.
9. How the ground truth for the training set was established
The document does not provide information on how ground truth for a training set was established.
Summary of what is available from the document regarding "acceptance" and "proof":
The document's central claim is:
- Conclusion: "The ProLite Pulsed Light System is substantially equivalent to other existing pulsed light systems in commercial distribution for treatment of benign pigmented lesions and the removal of tattoos in Dermatology and Plastic Surgery."
The "proof" for this "acceptance" of substantial equivalence is based on:
- Predicate Device Comparison: The ProLite Pulsed Light System is compared to the Photoderm PL System (K60772).
- Device Description: Both devices deliver pulsed light. The ProLite system delivers pulsed light at a wavelength of 550 nanometers. The document implies that the operating principles and intended use are similar enough to the predicate device to establish equivalence, rather than presenting de novo performance data.
- Intended Use: "The ProLite Pulsed Light System is indicated the treatment of benign pigmented lesions and the removal of tattoos." This matches the general scope of use for similar pulsed light systems according to the 510(k) process for substantial equivalence.
In essence, the "acceptance criteria" here implicitly refer to the FDA's criteria for substantial equivalence, and the "study that proves the device meets the acceptance criteria" is the 510(k) submission process itself, where the manufacturer demonstrates that the new device is as safe and effective as a legally marketed predicate device. The document provided is the FDA's response confirming this substantial equivalence, not a detailed clinical study report comparing performance against specific metrics.
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Attachment I 510(K) Summary ProLite Pulsed Light System
JAN 8 2002
This 510(K) Summary of safety and effectiveness for the ProLite VL Pulsed Light 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.
Lona Knapes gata 5 421 32 Vastra Frolunda,
Morgan Gustafsson
46.31.709.30.70 - Phone
ProLite Pulsed Light System
Intense Pulsed Light System
79-GEX, 21 CFR 878-48
Photoderm PL System
houses the waveguide
K number K60772
Instrument, Surgical, Powered, laser
46,31.709.30.79 - Fax morgan@medicalbiocare.com
October 5, 2001
Sweden
Applicant:
Medical Bio Care Sweden AB.
Address:
Contact Person:
Telephone / Fax / Email
Preparation Date:
Device Trade Name:
Common Name:
Classification Name:
Legally Marketed Predicate Device:
Description of the ProLite V Pulsed Light System
Intended use of the ProLite V Pulsed Light System
Performance Data:
Conclusion:
None The ProLite Pulsed Light System is substantially equivalent to other existing pulsed light systems in commercial distribution for treatment of benign pigmented lesions and
the removal of tattoos in Dermatology and Plastic Surgery.
The ProLite Pulsed Light System delivers pulsed light at a
wavelength of 550 nanometers. The device consists of three
The ProLite Pulsed Light System is indicated the treatment
of benign pigmented lesions and the removal of tattoos.
interconnected sections: The cabinet which houses the power supply, the cooling system and the microcontroller, the umbilical to the handpiece, and the handpiece, which
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/12 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three wing-like shapes, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the outer edge of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 8 2002
Medical BioCare Sweden AB c/o Ms. Connie White Hoy 908 Stetson Street Woodland, California 95776
Re: K013365
Trade/Device Name: ProLite Pulsed Light System 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: October 1, 2001 Received: October 10, 2001
Dear Ms. Hoy:
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 (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 - Ms. Connie White Hoy
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,
Stupt Rhodes
Colie M. Witten, 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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Koj3365//A'
INDICATION FOR USE STATEMENT
510(k) Number: _______________________________________________________________________________________________________________________________________________________________
Device Name: ProLite Pulsed Light System______________________________________________________________________________________________________________________________________
Indications for Use:
The ProLite Pulsed Light System is intended for the treatment of benign pigmented lesions and the removal of tattoos.
(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 Gener, Restorative and Neurological Devices | |
|---|---|---|
| 510(k) Number | K013365 | |
| 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.