The Profile 1320 Laser System is indicated for use in general surgery and dermatology for the incision, excision, ablation, vaporization, coagulation, with hemostasis of soft tissue.

Device Description

Profile 1320 Laser System is an Nd:YAG laser producing emission at a wavelength of 1320 nm. It consists of a laser console, internal computer, control panel and display, an optical delivery system comprised of an articulated arm and a handpiece or scanner with cooling capability, and a footswitch.

AI/ML Overview

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that the device meets specific acceptance criteria. This document is a 510(k) premarket notification summary for a laser system, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting performance study results against defined acceptance criteria.

The 510(k) summary provided describes:

Device Trade Name: Profile 1320 Laser System
Common Name: Nd:YAG Laser System
Intended Use: "The Profile 1320 Laser System is indicated for use in general surgery and dermatology for the incision, excision, ablation, vaporization, coagulation, with hemostasis of soft tissue."
Predicate Device: CoolTouch Nd:YAG Laser System (K002347)
Rationale for Substantial Equivalence: It states the device "shares the same indications for use, similar design features (including wavelength, laser medium, power supply, cooling and control system), functional features (including power output, repetition rate, energy, spot size and fluence), and is therefore substantially equivalent to the above legally marketed predicate device."

This type of submission focuses on comparing the new device to an existing one to show it's "substantially equivalent," meaning it's as safe and effective as the predicate device, and doesn't typically include detailed clinical studies with specific acceptance criteria and performance metrics in the way a PMA (Premarket Approval) or de novo submission might.

Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria, study details, sample sizes, expert involvement, or ground truth, as this information is not present in the provided 510(k) summary.

Summary

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S C I T O N

K 022381

OCT 1 8 2002

Attachment IV

www.varant.com/station/comments/

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510(k) Summary

Submitter:	Sciton, Inc.
Address:	845 Commercial Street, Palo Alto, CA 94303
Phone:	(650) 493-9155
Fax :	(650) 493-9146
Contact Person:	Jay M. Patel, Director of Regulatory Affairs
Date Prepared:	July 15, 2002
Device Trade Name:	Profile 1320 Laser System
Common Name:	Nd:YAG Laser System
Classification Name:	Laser Surgical Instrument, 21 CFR 878.4810.
Legally MarketedPredicate Device:	CoolTouch Nd:YAG Laser System (K002347)
Description ofProfile 1320 Laser System:	Profile 1320 Laser System is an Nd:YAG laser producingemission at a wavelength of 1320 nm. It consists of a laserconsole, internal computer, control panel and display, anoptical delivery system comprised of an articulated armand a handpiece or scanner with cooling capability, and afootswitch.
Intended Use:	The Profile 1320 Laser System is indicated for use ingeneral surgery and dermatology for the incision, excision,ablation, vaporization, coagulation, with hemostasis of softtissue.
Rationale for SubstantialEquivalence:	The Profile 1320 Laser System shares the sameindications for use, similar design features (includingwavelength, laser medium, power supply, cooling andcontrol system), functional features (including poweroutput, repetition rate, energy, spot size and fluence), andis therefore substantially equivalent to the above legallymarketed predicate device.

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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 circular seal with the words "HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines representing the wings and a stylized head.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Sciton, Inc. Jay M. Patel Director, Regulatory Affairs 845 Commercial Street Palo Alto, California 94303

Re: K022381

Trade/Device Name: Profile 1320 Laser System Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: July 15, 2002

Received: July 22, 2002

Dear Mr. Patel:

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. Iisting 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 – Mr. Jay M. Patel

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 vour 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 yours,

Murian C. Parret

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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Attachment III

Statement of Indications for Use

510(k) Number (if known):

Device Name:

Indications for Use:

The Profile 1320 Laser System is indicated for use in general surgery and dermatology for the incision, excision, ablation, vaporization, coagulation and hemostasis of soft tissue.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _ (Per 21CFR801)

Over-The-Counter Use _

uriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number: K022381

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.