(88 days)
The Plasmalite Pulsed Light System is indicated for use to remove unwanted hair in all skin types according to the Fitzpatrick Scale.
The Plasmalite Pulsed Light System delivers pulsed light at a wavelength beginning at a wavelength of 600 nm. The device consists of three interconnected sections: The cabinet which houses the internal cooling system, power supply and microcontroller, the umbilical to the handpiece, and the handpiece, which houses the waveguide
The provided text describes the Plasmalite Pulsed Light System and its substantial equivalence to a predicate device, the ProLite Pulsed Light System. However, it explicitly states that no clinical studies were specifically conducted for the Plasmalite device. Instead, it relies on the clinical studies performed for its predicate, the ProLite.
Therefore, many of the requested details about acceptance criteria, study design, and ground truth for the Plasmalite device cannot be provided directly from this document. The information below reflects what is available or inferred from the provided text, primarily referencing the predicate device's studies when mentioned.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria for the Plasmalite Pulsed Light System. It asserts substantial equivalence to the ProLite Pulsed Light System, which was previously cleared. The "performance data" section only states that the Plasmalite is technically the exact device as the ProLite.
| Acceptance Criteria | Reported Device Performance (based on predicate ProLite) |
|---|---|
| Not explicitly stated | Intended for use to remove unwanted hair in all skin types according to the Fitzpatrick Scale (as per predicate's studies for which results were submitted in K013366). |
2. Sample size used for the test set and the data provenance
The document states: "No Clinical studies were specifically conducted using the Plasmalite. The Plasmalite is technically the exact device as the predicate device, the ProLite. Results from the clinical studies for the ProLite were submitted in 510(K) number 013366."
Therefore, the sample size and data provenance information refers to the studies conducted for the predicate device, ProLite, and this specific document does not provide those details.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not available in the provided document, as no specific clinical studies for the Plasmalite device are detailed, and the details of the predicate's studies (K013366) are not included here.
4. Adjudication method for the test set
This information is not available in the provided document, as no specific clinical studies for the Plasmalite device are detailed, and the details of the predicate's studies (K013366) are not included here.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
This information is not available in the provided document. The device is a pulsed light system for hair removal, not an imaging or diagnostic device that would typically involve a multi-reader study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a medical device for hair removal, not an AI algorithm.
7. The type of ground truth used
For the predicate device (ProLite), the ground truth for hair removal studies would typically involve objective measurements of hair count reduction or clinical assessment of hair regrowth over a period. However, the specific type of ground truth used for the ProLite studies is not described in this 510(k) summary.
8. The sample size for the training set
This question is not applicable as the device is a medical device, not an AI algorithm requiring a training set in the conventional sense.
9. How the ground truth for the training set was established
This question is not applicable as the device is a medical device, not an AI algorithm.
{0}------------------------------------------------
Attachment I 510(K) Summary Plasmalite Pulsed Light System
Image /page/0/Picture/2 description: The image shows a handwritten string of characters. The string is "KO22378". The characters are written in black ink on a white background. There is a line drawn underneath the string.
This 510(K) Summary of safety and effectiveness for the Plasmalite 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.
| Applicant: | Medical Bio Care AB. |
|---|---|
| Address: | Lona Knapes gata 5421 32 Vastra Frolunda,Sweden |
| Contact Person: | Morgan Gustavsson |
| Telephone / Fax / Email | 46.31.709.30.70 - Phone46.31.709.30.79 - Faxmorgan@medicalbiocare.com |
| Preparation Date: | July 15, 2002 |
| Device Trade Name: | Plasmalite Pulsed Light System |
| Common Name: | Pulsed Light for Photoepilation |
| Classification Name: | Instrument, Surgical, Powered, laser79-GEX, 21 CFR 878-48 |
| Legally Marketed Predicate Device: | ProLite Pulsed Light System, Manufactured by MedicalBioCare was previously cleared under 510(K) numberK013366. |
| Description of the Plasmalite Pulsed LightSystem | The Plasmalite Pulsed Light System delivers pulsed light ata wavelength beginning at a wavelength of 600 nm. Thedevice consists of three interconnected sections: The cabinetwhich houses the internal cooling system, power supply andmicrocontroller, the umbilical to the handpiece, and thehandpiece, which houses the waveguide |
| Intended use of the Plasmalite PulsedLight System | The Plasmalite Pulsed Light System is indicated for use toremove unwanted hair in all skin types according to theFitzpatrick Scale. |
| Performance Data: | No Clincal studies were specifically conducted using thePlasmalite. The Plasmalite is technically the exact device asthe predicate device, the ProLite. Results from the clinicalstudies for the ProLite were submitted in 510(K) number013366. |
| Conclusion: | The Plasmalite Pulsed Light System is substantiallyequivalent to other existing pulsed light systems incommercial distribution for removal of hair in Dermatologyand Plastic Surgery. |
{1}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle's head is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
OCT 1 8 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medical Bio Care Sweden AB c/o Connie White Hoy 908 Stetson Street Woodland, California 95776
Re: K022378
Trade/Device Name: Plasmalite Pulsed Light System Regulation Number: 878.4810 Regulation Name: Instrument, surgical, powered, laser Regulatory Class: Class II Product Code: GEX Dated: July 15, 2002 Received: July 22, 2002
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.
{2}------------------------------------------------
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" (21 CFR 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 vours.
Muriam 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
{3}------------------------------------------------
INDICATION FOR USE STATEMENT
Rending 510(k) Number:
Device Name: Plasmalite Pulsed Light System
Indications for Use:
The Plasmalite Pulsed Light System is intended to remove unwanted hair for all skin types according to the Fitzpatrick Scale.
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (per 21 CFR 801.109)
OR
Over-the-Counter Use
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K622378
§ 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.