SCANNING DEVICE ACCESSORY FOR USE WITH THE CB DIODE/532 ND:YAG LASER by CONTINUUM BIOMEDICAL, INC.

Scanning Device Accessory for use with the CB Diode/532 TM Nd:YAG Laser for general dermatology (soft tissue ablation) and the treatment of vascular and pigmented lesions.

Device Description

The Scanning Device Accessory is a microprocessor controlled device that generates precisely defined repeatable patterns in an automated sequence to increase treatment speed and facilitate uniform ablation of tissue.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called "Scanning Device Accessory for the CB Diode/532TM Nd:YAG Laser." It explicitly states that no nonclinical or clinical performance data was provided. Therefore, no acceptance criteria or studies proving the device meets those criteria are mentioned.

Here's an analysis based on the information provided:

A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not specified.
- Reported Device Performance: Not reported.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable as no clinical or nonclinical performance data was provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable as no clinical or nonclinical performance data was provided.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as no clinical or nonclinical performance data was provided.
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 device is a scanning accessory for a laser, not an AI-assisted diagnostic tool. No MRMC study was mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is hardware, not an algorithm. No standalone performance data was provided.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable as no clinical or nonclinical performance data was provided.
The sample size for the training set
- Not applicable as no clinical or nonclinical performance data was provided. This device is hardware and not related to machine learning algorithms requiring training sets.
How the ground truth for the training set was established
- Not applicable as no clinical or nonclinical performance data was provided.

Conclusion from the provided text:

The 510(k) summary explicitly states:

"Nonclinical Performance Data: none"
"Clinical Performance Data: none"

The basis for clearance was a comparison to an equivalent predicate device, the SoftScanTM Scanning Device, Sahar Technologies, Inc. (K964684). The submission primarily focused on demonstrating substantial equivalence to this already cleared device. The "Conclusion" section states: "The Scanning Device Accessory for the CB Diode/532TM Nd: YAG Laser enhances the clinical application procedure while maintaining the performance characteristics," implying that its performance is presumed to be similar to its predicate.

Summary

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510(k) Summary

Submitter:	Continuum BiomedicalA Medical Division of Continuum Electro-Optics, Inc.6533 Sierra LaneDublin, CA 94568
Contact:	Robert S. Anderson, Ph.D.President
Date Summary Prepared:	May 20, 1997
Device Trade Name:	Scanning Device Accessory for the CB Diode/532TM Nd:YAG Laser
Common Name:	Medical laser system
Classification Name:	Instrument, surgical, powered, laser79-GEX21 CFR 878.48
Equivalent Device:	SoftScanTM Scanning Device, Sahar Technologies, Inc. (K964684)
Device Description:	The Scanning Device Accessory is a microprocessor controlled devicethat generates precisely defined repeatable patterns in an automatedsequence to increase treatment speed and facilitate uniform ablation oftissue.
Intended Use:	For general dermatology (soft tissue ablation) and the treatment ofvascular and pigmented lesions
Comparison:	The Scanning Device Accessory for the CB Diode/532TM Nd:YAGLaser is manufactured for Continuum Biomedical by SaharTechnologies, Inc. (K964684, SE 02/14/97).
Nonclinical Performance Data:	none
Clinical Performance Data:	none
Conclusion:	The Scanning Device Accessory for the CB Diode/532TM Nd: YAGLaser enhances the clinical application procedure while maintaining theperformance characteristics.
Additional Information:	None requested at this time.

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Image /page/1/Picture/2 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 lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Laurie A. Ridener Continuum Biomedical, Inc. 6533 Sierra Lane ... ... Dublin, California 94568

AUG 2 1 1997

K971903 Re:

Trade Name: Scanning Device Accessory for use with the CB Diode/532™ Nd:YAG Laser Regulatory Class: II Product Code: GEX

Dated: May 22, 1997 Received: May 23, 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 current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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.

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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,

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

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510(k) Number (if known):	pending
Device Name:	CB Diode/532 TM Nd:YAG Laser
Indications for Use:	Scanning Device Accessory for use with the CB Diode/532 TM Nd:YAG Laser for general dermatology (soft tissue ablation) and the treatment of vascular and pigmented lesions.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
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Division of General Restorative Devices

510(k) Number	K971903
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Prescription Use	OR	Over-the-Counter Use
(Per 21 CFR 801.109)		(Optional Format 1-2-96)

Regulation Number and Section

§ 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.