(90 days)
For skin resurfacing in the treatment of wrinkles
CB Erbium / 2.94 TM Er:YAG Laser consists of three interconnected sections: the power supply, the water cooling system and the optical bench. At 5 pulses per second an a pulse energy of 2 Joules, the average power from the laser is 10 watts.
The provided FDA 510(k) summary and associated documents describe the CB Erbium / 2.94 TM Er:YAG Laser for skin resurfacing in the treatment of wrinkles.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission acts more as a claim of equivalency rather than defining explicit quantitative acceptance criteria or performance metrics in a table. Instead, the "Comparison" and "Clinical Performance Data" sections describe the device's performance relative to a predicate device.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Effectiveness for wrinkle reduction:Comparable reduction of wrinkles to the predicate CO2 laser. | A clinical trial was conducted using a side-by-side comparison of the CB Erbium / 2.94 TM Er:YAG and a CO2 laser. The reduction of wrinkles was comparable for both lasers. |
| Safety profile:Fewer side effects and faster recovery time compared to the predicate CO2 laser. | In the same clinical trial, there were notably few side effects and faster recovery time with the CB Erbium / 2.94 TM Er:YAG Laser compared to the CO2 laser. |
| Overall Safety and Effectiveness:The device is safe and effective for its intended use. | The conclusion states: "The CB Erbium / 2.94 TM Er:YAG Laser is another safe and effective way to remove or reduce facial wrinkles." This is a general statement based on the comparative clinical trial. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document only mentions "A clinical trial was conducted." No specific number of patients or lesions is provided.
- Data Provenance: Not specified. The country of origin is not mentioned. The study is described as a "clinical trial," which implies prospective data collection, but this is not explicitly stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided in the submission. The method for assessing "reduction of wrinkles," "side effects," and "recovery time" is not detailed, nor are the qualifications of any involved assessors/experts mentioned.
4. Adjudication Method for the Test Set
- This information is not provided. Given the lack of detail on experts, an adjudication method is also not 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
- No. This is a medical device (laser), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance for human readers is not applicable and was not performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. The device is a direct treatment laser, not an algorithm. Its performance is directly observed in patients, not through a computational algorithm generating outputs that might be compared to a standalone algorithm.
7. The Type of Ground Truth Used
- The ground truth for effectiveness ("reduction of wrinkles") would likely have been based on clinical assessment by physicians or
qualified medical personnel, potentially using standardized scales (though not specified). - For safety data ("side effects" and "recovery time"), the ground truth would have been based on patient reporting and clinical observation
by healthcare providers. - It is not pathology, or outcomes data in the sense of long-term survival for oncology, but rather direct clinical observation of the treatment's immediate effects and complications.
8. The Sample Size for the Training Set
- This concept is not applicable as the device is a physical laser, not an AI model requiring a training set. The clinical trial serves as the performance verification.
9. How the Ground Truth for the Training Set Was Established
- This concept is not applicable as the device is a physical laser, not an AI model.
{0}------------------------------------------------
June 11, 1997
K970934
510(k) Summary
| Submitter: | Continuum Biomedical, Inc.6533 Sierra LaneDublin, CA 94568 |
|---|---|
| Contact: | Robert S. Anderson, Ph.D.President |
| Date Summary Prepared: | March 13, 1997 |
| Device Trade Name: | CB Erbium / 2.94 TM Er:YAG Laser |
| Common Name: | Medical laser system |
| Classification Name: | Instrument, surgical, powered, laser79-GEX21 CFR 878.48 |
| Equivalent Device: | Schwartz Electro-Optics TriLase 2940Coherent UltraPulse CO2 Laser |
| Device Description: | CB Erbium / 2.94 TM Er:YAG Laser consists of three interconnectedsections: the power supply, the water cooling system and the opticalbench. At 5 pulses per second an a pulse energy of 2 Joules, theaverage power from the laser is 10 watts. |
| Intended Use: | For skin resurfacing in the treatment of wrinkles |
| Comparison: | CB Erbium / 2.94 TM Er:YAG Laser provides comparable results asthe CO2 laser for the treatment of wrinkles, with fewer side effectsand faster recovery time. |
| Nonclinical Performance Data: | none |
| Clinical Performance Data: | A clinical trial was conducted using a side by side comparison of theCB Erbium / 2.94 TM Er:YAG and a CO2 laser. The reduction ofwrinkles was comparable for both lasers with notably few side effectsand faster recovery time with the CB Erbium / 2.94 TM Er:YAG Laser. |
| Conclusion: | The CB Erbium / 2.94 TM Er:YAG Laser is another safe and effectiveway to remove or reduce facial wrinkles. |
| Additional Information: | None requested at this time. |
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 1 1997
Ms. Laurie A. Ridener Regulatory Affairs Officer Continuum Biomedical, Inc. 6533 Sierra Lane Dublin, California 94568
ધ્રકૃ Re:
K970934 Trade Name: CB Erbium 2.94TM Er: YAG Laser Regulatory Class: II Product Code: GEX Dated: March 13, 1997 Received: March 13, 1997
Dear Ms.Ridener:
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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
{2}------------------------------------------------
Page 2 - Ms. Laurie A. Ridener
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,
[signature]
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
{3}------------------------------------------------
华
Page 1 of 1
970934
| 510(k) Number (if known): | pending |
|---|---|
| Device Name: | CB Erbium / 2.94 TM Er:YAG Laser |
| Indications for Use: | For skin resurfacing in the treatment of wrinkles |
(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 General Restorative Devices
510(k) Number K970934
Prescription Use X OR Over-the-Counter Use
(Per 21 CFR 801.109)
(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.