LIGHTFORCE LF 20/30 980NM SURGICAL DIODE LASER SYSTEM by MEDICAL ENERGY, INC.

The LIGHTFORCE 20/30 980mm Diode Surgical Laser is intended to provide the physician with a dependable laser system providing he/she the ability to incise, excise, vaporize and coagulate soft tissue in a variety of surgical procedures in various disciplines as listed: Dermatology ENT/Head & Neck Gynecology Gastroenterology General Surgery Neurosurgery Pulmonary Urology Proctology The LIGHTFORCE 20/30 980mm Diode Surgical Laser for soft tissue applications is accompanied by a variety of disposable fiber optic delivery systems for use in the different specialties. Each are compatible to all popular endoscopes on the market. A variety of Disposable Fiber Optic Delivery Systems are available for performing open and endoscopic surgical procedures with the LIGHTFORCE 20/30 980mm Diode Surgical Laser System for achieving incision, excision, vaporization and coagulation on soft tissue applications. These disposable fiber optic delivery systems are available in various sizes (200, 400, 600, and 1000 micron) for performing contact and non-contact laser surgery techniques by the operating physician to assist in achieving Incision/Excision/Vaporization/Coagulation at CONTROLLABLE depths of tissue penetration from 0.3mm up to 4mm.

AI/ML Overview

This is a 510(k) premarket notification for a medical device called the LIGHTFORCE 20/30 980nm Diode Laser. This type of submission is for demonstrating substantial equivalence to a predicate device, not for a de novo marketing authorization or PMA, which involve more extensive clinical studies and detailed performance criteria. Therefore, the provided documentation focuses on the intended use and equivalence rather than detailed acceptance criteria and supporting studies as typically found in submissions for AI/ML-driven devices or those requiring de novo classification.

However, based on the information provided, here's what can be inferred and what is explicitly stated:

Device Description and Intended Use:

The LIGHTFORCE 20/30 980nm Diode Surgical Laser is intended for incision, excision, vaporization, and coagulation of soft tissue in various surgical procedures across multiple medical disciplines. Key features include different fiber optic delivery systems to achieve controllable tissue penetration depths from 0.3mm to 4mm.

Acceptance Criteria for Substantial Equivalence:

For a 510(k) submission, the "acceptance criteria" are primarily established by demonstrating substantial equivalence to a legally marketed predicate device. This means the new device must have the same intended use and the same technological characteristics as the predicate, or if it has different technological characteristics, it must not raise new questions of safety and effectiveness, and demonstrate that it is at least as safe and effective as the predicate.

Given the nature of this submission (a Diode Laser for surgical use), the acceptance criteria would typically revolve around:

Safety: Meeting relevant performance standards for lasers (e.g., IEC 60601-1, IEC 60601-2-22), electrical safety, biocompatibility of patient-contacting parts (if applicable), and demonstrating controlled tissue interaction.
Effectiveness/Performance: Ability to achieve the stated surgical functions (incision, excision, vaporization, coagulation) within the specified parameters (e.g., power output, wavelength, tissue penetration depth) in a predictable and consistent manner.

Study Information (or lack thereof, typical for 510(k)):

The provided document does not describe a specific clinical study with detailed acceptance criteria, sample sizes, ground truth establishment, or multi-reader multi-case studies as would be expected for novel AI/ML devices. This is because the 510(k) pathway often relies on bench testing, engineering analysis, and performance data to demonstrate equivalence, rather than extensive clinical efficacy trials against explicit performance metrics.

The FDA's review letter explicitly states, "We have reviewed your Section 510(k) premarket notification of intent to market the device ... and have determined that the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This confirms that the basis of approval was substantial equivalence, not a standalone clinical trial proving specific performance metrics against pre-defined acceptance criteria.

Based on the provided text, the specific information requested cannot be fully populated as it pertains to detailed clinical performance studies, which are not described in this 510(k) summary.

However, I can provide a structured answer based on what a 510(k) implies and what limited information is available:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred for 510(k) - Substantial Equivalence)	Reported Device Performance (Summary from Document)
Intended Use Equivalence: Same indications for use as a legally marketed predicate device.	"The LIGHTFORCE 20/30 980mm Diode Surgical Laser is intended to provide the physician with a dependable laser system providing he/she the ability to incise, excise, vaporize and coagulate soft tissue in a variety of surgical procedures in various disciplines... for soft tissue Incision, Excision, Vaporization and Coagulation." (Matches predicate's general surgical indications).
Technological Characteristics Equivalence: Same or similar technological characteristics (e.g., laser type, wavelength, power, delivery systems) as a predicate device.	"980nm Diode Surgical Laser" (matches commonly used surgical diode lasers for soft tissue). Accompanied by various disposable fiber optic delivery systems (200, 400, 600, 1000 micron), compatible with endoscopes.
Safety: Meets relevant laser and electrical safety standards; no new questions of safety arise from any different technological characteristics.	Not explicitly detailed in the provided K041419 summary. However, compliance with standards (e.g., 21 CFR 1000-1050 for radiological health) is implied by FDA clearance.
Performance/Effectiveness: Achieves stated functions (incision, excision, vaporization, coagulation) with controllable tissue effects, equivalent to predicate.	Achieves "incise, excise, vaporize and coagulate soft tissue." Provides "CONTROLLABLE depths of tissue penetration from 0.3mm up to 4mm." Specific data proving these ranges against acceptance criteria are not detailed in this summary.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable/not provided. This 510(k) summary does not describe a clinical "test set" in the context of an effectiveness study for an AI/ML device. Performance claims would typically be supported by bench testing, engineering analysis, and possibly ex-vivo or in-vivo animal studies, but details are not included in this high-level summary.
Data Provenance: Not applicable/not provided for a clinical test set.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Number of Experts: Not applicable/not provided. Ground truth establishment by experts is not described for this type of device and submission.
Qualifications of Experts: Not applicable/not provided.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable/not provided.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study Done: No. This type of study is not relevant for a laser surgical instrument, which is not an interpretive imaging device.
Effect Size of Human Readers Improve with AI vs. Without AI: Not applicable.

6. Standalone (Algorithm Only) Performance Study

Standalone Study Done: No. This device is a surgical instrument operated directly by a human, not an algorithm.

7. Type of Ground Truth Used

Type of Ground Truth: Not applicable in the conventional sense of establishing ground truth for diagnostic or AI algorithm performance. For a surgical laser, ground truth might relate to quantifiable tissue effects (e.g., depth of penetration, zone of necrosis) demonstrated in laboratory settings or animal models, but detailed methodology is not provided in this summary.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This device is a hardware surgical instrument, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Ground Truth Establishment for Training Set: Not applicable.

Summary

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K04/419

AUG 2 6 2004

510 K General Summary

Dermatology ENT/Head & Neck Gynecology

Gastroenterology General Surgery Neurosurgery

Pulmonary Urology Proctology

The LIGHTFORCE 20/30 980mm Diode Surgical Laser for soft tissue applications is accompanied by a variety of disposable fiber optic delivery systems for use in the different specialties. Each are compatible to all popular endoscopes on the market. A variety of Disposable Fiber Optic Delivery Systems are available for performing open and endoscopic surgical procedures with the LIGHTFORCE 20/30 980mm Diode Surgical Laser System for achieving incision, excision, vaporization and coagulation on soft tissue applications.

These disposable fiber optic delivery systems are available in various sizes (200, 400, 600, and 1000 micron) for performing contact and non-contact laser surgery techniques by the operating physician to assist in achieving Incision/Excision/Vaporization/Coagulation at CONTROLLABLE depths of tissue penetration from 0.3mm up to 4mm.

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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 wavy lines representing 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

AUG 2 6 2004

Mr. David P. Lewing Director of Regulatory Affairs Medical Energy, Inc. 225 E. Zaragoza Street Pensacola, Florida 32502

Re: K041419

Trade/Device Name: LIGHTFORCE 20/30 980nm Diode Laser 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: May 25, 2004 Received: May 28, 2004

Dear Mr. Lewing:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bected by the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 use stated in the encreated 776 the enactment date of the Medical Device Amendments, or to conimeres prior to may 20, 1978) ... . ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ................................................................... and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and coometer for ( 10) read the device, subject to the general controls provisions of the Act. The r ou may, dierefore, mains 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 may or sations 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 or any 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 Crth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quarty byrovisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. David P. Lewing

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and my of your finding of substantial equivalence of your device to a legally promative noticated 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. 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 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,

Mark A. Mellman

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

510(K) Number: K041419

LIGHTFORCE 20/30 980nm Diode Laser Device Name:

Indications For Use:

For soft tissue Incision, Excision, Vaporization and Coagulation: 1.
- - Gastroenterology
- - General Surgery
- - Gynecology
- - ENT/Head & Neck
- Neurology
- Urology
- Pulmonary
- Plastic Surgery

Including:

- Gynecology-Endometrial Ablation (K871512)
- Urology Surgery (K871516)
- Rectal Patho. & Hemorrhoid (K871514)
- Gastro Intestinal Bleeding (K871515)
- Palliation of Gastro Malignancies (K871513)
- Pulmonary Obstructions (K871511A)

Prescription Use _____________________________________________________________________________________________________________________________________________________________	AND/OR	Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Part 21 CFR 801 Subpart D)		(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of General, Restorative, and Neurological Devices

510(k) Number K041419

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.