The Lumenis Family of Disposable Contact Tip Delivery Devices for CO2 Lasers is indicated for use in surgical applications requiring ablation, vaporization, excision, incision, and coagulation of soft tissue using laser-generated thermal energy in medical including aesthetic (dermatology and plastic surgery), podiatry, specialties, otolaryngology (ENT), gynecology (including laparoscopy), neurosurgery, orthopedics (soft tissue), arthroscopy (knee), general and thoracic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery, for the indications for use that the compatible laser system to which attached has been cleared.

Device Description

Lumenis Family of Disposable Contact Tip Delivery Devices for CO2 Lasers is comprised of the following main components:

Laser waveguide
Specially-shaped tip
Coupler connector

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Lumenis Family of Disposable Contact Tip Delivery Devices for CO2 Lasers. This document concludes that the device is substantially equivalent to existing predicate devices.

However, the provided text does not contain specific details regarding acceptance criteria and a study that definitively proves the device meets those criteria in the way typically required for AI/ML-based diagnostic devices. The submission focuses on substantial equivalence to predicate devices, which is a different regulatory pathway.

Here's an analysis of the information that is and isn't available in the document, structured according to your request:

1. A table of acceptance criteria and the reported device performance

The document states: "Performance data were provided to demonstrate that the Lumenis Family of Disposable Contact Tip Delivery Devices for CO2 Lasers operates in accordance with product specifications."

However, neither the specific acceptance criteria (e.g., minimum laser power output, tip temperature range, durability metrics) nor the quantitative reported device performance are explicitly detailed within the provided text. The submission focuses on substantial equivalence to predicate devices rather than proving a novel performance metric against a set of new acceptance criteria.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The submission does not detail specific clinical or performance studies with test sets in the context of typical AI/ML device evaluations. The performance data mentioned would likely refer to internal engineering tests or bench testing to ensure the device functions as intended, rather than a clinical trial or large-scale data analysis.

3. 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)

This information is not applicable and not provided. As this is a physical medical device (disposable contact tip for CO2 lasers), not an AI/ML diagnostic system, the concept of "experts establishing ground truth for a test set" in the context of diagnostic interpretation doesn't apply. The device's function is mechanical and thermal, not interpretative.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided for the same reasons as point 3.

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

This information is not applicable and not provided. This is a physical surgical accessory, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not applicable and not provided. This is a physical device, and the concept of "standalone algorithm performance" does not apply.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

As this is a physical device, the "ground truth" would likely relate to objective physical and functional parameters, such as:

Mechanical integrity: Does the tip remain intact during use?
Thermal performance: Does it deliver the expected thermal energy at the tip?
Material compatibility: Are the materials safe and biocompatible?
Sterility: Is the device sterile as provided?

The document states "Performance data were provided to demonstrate that the Lumenis Family of Disposable Contact Tip Delivery Devices for CO2 Lasers operates in accordance with product specifications." This implies that the ground truth for performance was defined by these product specifications, which would cover the physical and functional aspects listed above. Specific details of these specifications are not provided in the document.

8. The sample size for the training set

This information is not applicable and not provided. As a physical device, there is no "training set" in the context of machine learning. The device's design and manufacturing processes are validated, not "trained."

9. How the ground truth for the training set was established

This information is not applicable and not provided for the reasons stated in point 8.

Summary

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030033 1/2 JUL 21 2003

510(k) Summary Statement for the Lumenis Family of Disposable Contact Tip Delivery Devices for CO2 Lasers

I. General Information

Submitter:	Lumenis, Inc.2400 Condensa StreetSanta Clara, CA 95051
Contact Person:	Martha Murari, Ph.D.Senior Regulatory Affairs AssociateAnne WordenRegulatory Consultant
Summary Preparation Date:	June 26, 2003

II. Names

Lumenis Family of Disposable Contact Tip Delivery Device Names: Devices for CO2 Lasers

Primary Classification Name:

Laser Powered Surgical Instruments (and Accessories)

III. Predicate Devices

Lumenis Oral/ENT Fiber Delivery Devices (used with the UltraPulse Series CO2 . Surgical Lasers, K022060 and K974789);
ESC Sharplan Series 2900 Synthetic Contact Tips (K894211); .
. Surgical Laser Technologies (SLT) Contact and Diffuser Tips with Wavelength Conversion Surface Treatment (K010041, K980156, K882212, K872254, and K872253);
Somnus Medical Technologies Somnoplasty System (K973618); ●
ArthroCare Corporation Bipolar Electrosurgical ENTec Plasma Wands (K021364). .

Product Description IV.

Lumenis Family of Disposable Contact Tip Delivery Devices for CO2 Lasers is comprised of the following main components:

Laser waveguide ●
Specially-shaped tip ●
Coupler connector

V. Indications for Use

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030033 4/2

VI. Rationale for Substantial Equivalence

The Lumenis Family of Disposable Contact Tip Delivery Devices for CO2 Lasers shares the same or similar indications for use in surgical applications, overall dimensions, tip shapes, tip/tissue temperature, materials, sterilization process, and system compatibility, and therefore is substantially equivalent to the Oral/ENT Fiber Delivery Devices manufactured by Lumenis (K022060), the predicate Series 2900 Synthetic Contact Tips manufactured by ESC Sharplan (K894211), the SLT Contact and Diffuser Tips with Wavelength Conversion surface treatment manufactured by Surgical Laser Technologies (K010041, K980156, K882212, K872254, and K872253), the Somnoplasty System manufactured by Somnus Medical Technologies (K973618), and the Bipolar Electrosurgical ENTec Plasma Wands manufactured by ArthroCare Corporation (K021364). In addition, validation data demonstrated adequate device performance.

VII. Safety and Effectiveness Information

Performance data were provided to demonstrate that the Lumenis Family of Disposable Contact Tip Delivery Devices for CO2 Lasers operates in accordance with product specifications.

VIII. Conclusion

The Lumenis Family of Disposable Contact Tip Delivery Devices for CO2 Lasers was found to be substantially equivalent to the predicate Lumenis Oral/ENT Fiber Delivery Devices (K022060), the predicate ESC Sharplan Series 2900 Synthetic Contact Tips (K894211), the SLT Contact and Diffuser Tips with Wavelength Conversion surface treatment (K010041, K980156, K882212, K872254, and K872253), the Somnus Medical Technologies Somnoplasty System (K973618), and the ArthroCare ENTec Plasma Wands (K021364). The Lumenis Family of Disposable Contact Tip Delivery Devices for CO2 Lasers shares similar indications for use in surgical applications, design features, and similar functional features, and thus, is substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract design of an eagle with three lines extending from its head, representing health, human services, and well-being. The seal is in black and white.

JUL 2 1 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Martha Murari, Ph.D. Senior Regulatory Affairs Associate Lumenis, Inc. 2400 Condensa Street SWanta Clara, California 95051

Re: K030033

Trade/Device Name: Lumenis Family of Disposable Contact Tip Delivery Devices for CO2 Lasers Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: June 26, 2003 Received: June 27, 2003

Dear Dr. Murari:

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 - Martha Murari, Ph.D.

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), 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) you may obtain. 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,

"Miriam 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

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Indications For Use Statement as Requested by FDA

510(k) Number (if Known): K030033

Device Name: Lumenis Family of Disposable Contact Tip Delivery Devices for CO2 Lasers

Indications For Use:

The Lumenis Family of Disposable Contact Tip Delivery Devices for CO2 Lasers is indicated for use in surgical applications requiring ablation, vaporization, incision, and coagulation of soft tissue using laser-generated thermal energy in medical specialties, including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynecology (including laparoscopy), neurosurgery, orthopedics (soft tissue), arthroscopy (knee), general and thoracic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery, for the indications for use that the compatible laser system to which attached has been cleared.

Muriam C. Provost

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

510(k) Number K030033

(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

(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.