SURECAUT DIAMOND LASER KNIFE by CLINICON CORP.

The Diamond LaserKnife™ is indicated for incision and/or excision, with or without cauterization/coagulation, of soft tissue in open dental, dermatology, general and plastic surgery, neurosurgery, ophthalmology, oral surgery, oto-rhino-laryngology, podiatry, and urological procedures. Refer to the laser system Directions for Use manual for specific indications for Use.

Device Description

The Diamond LaserKnife ™ is an accessory hand piece for CO2 laser systems, that consists of a diamond cutting blade and handle coupled to a flexible fiber guide cable that conducts CO2 laser energy to the blade tip. The laser energy is emitted from the facets at the blade tip to the tissue when the laser is energized.

AI/ML Overview

The provided document is a 510(k) summary for the Diamond LaserKnife™, a laser scalpel, and does not contain a study that proves the device meets specific acceptance criteria in the manner of a clinical trial or performance study with detailed statistical outcomes.

Instead, the submission relies on demonstrating substantial equivalence to a predicate device (Sapphire Laser Scalpel, K863086). The "Conclusions Drawn from Tests and Analysis" section indicates that the device's performance was evaluated through non-clinical tests.

Therefore, the following information is extracted from the provided text, and where specific details are not available, it is explicitly stated.

Acceptance Criteria and Device Performance (Based on Substantial Equivalence to Predicate)

Acceptance Criteria Category	Acceptance Criteria	Reported Device Performance
Intended Use	The device must be indicated for incision and/or excision, with or without cauterization/coagulation, of soft tissue in open dental, dermatology, general and plastic surgery, neurosurgery, ophthalmology, oral surgery, oto-rhino-laryngology, podiatry, and urological procedures.	The Diamond LaserKnife™ is indicated for incision and/or excision, with or without cauterization/coagulation, of soft tissue in open dental, dermatology, general and plastic surgery, neurosurgery, ophthalmology, oral surgery, oto-rhino-laryngology, podiatry, and urological procedures. Specific procedures are further detailed in Attachment 2 (e.g., incisional/excisional biopsies, removal of warts, hemorrhoidectomy, incision/excision of tumors/lesions/cysts, vascular lesions, etc.).
Technological Characteristics (Cutting Mechanism)	The device should cut tissue during surgical procedures and conduct laser energy to the tissue for cauterization and coagulation, similar to the predicate.	A crystal with sharpened edges is used as a scalpel to cut tissue during surgical procedures and also conducts laser energy to the tissue to cauterize and coagulate.
Laser Energy Emission and Tissue Reaction (Fluence)	The predicted energy levels at the point of application must meet criteria derived from the performance of similar devices, based upon fluence (energy per unit area) and reaction of tissue to discrete values of fluence. This implies the device must deliver laser energy effectively for incision/excision and cauterization/coagulation, comparable to existing cleared devices.	The predicted energy levels at the point of application meet criteria derived from performance of similar devices, based upon fluence (energy per unit area) and reaction of tissue to the discrete values of fluence. The "Non-Clinical Tests" description indicates that "laser energy fields emitted from the tip when the laser is energized compared to similar devices cleared for marketing in the past" were evaluated.

Study Details (Based on available information)

Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. This was a non-clinical evaluation comparing laser energy fields, not a study involving patient data or typical "test sets" for diagnostic or clinical performance.
- Data Provenance: Not applicable. The "study" involved analysis of laser energy fields from the device itself and comparison to characteristics of similar, previously cleared devices. It was not a retrospective or prospective study from a specific country of origin in terms of patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth, in a clinical or diagnostic sense, was not established since this was a non-clinical device characteristic comparison. The "ground truth" here would be the established performance characteristics (fluence, tissue reaction) of existing, cleared laser scalpels.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- None. This type of adjudication is not relevant for the non-clinical tests described.
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 laser scalpel, a surgical instrument; MRMC studies apply to diagnostic imaging, especially with AI assistance to human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a manual surgical instrument, not an AI algorithm. Its performance is inherent in its physical and energy delivery characteristics, used by a human surgeon.
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- The "ground truth" for this substantial equivalence determination was the established and accepted performance characteristics of legally marketed predicate laser scalpels, specifically regarding laser energy emission (fluence) and its anticipated effects on tissue.
The sample size for the training set:
- Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this device.

Summary

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MED OPTICS

Dlamond LaserKnife™

Premarket Notification 1510(k)] -- K983463 1c983463

DFC 1 1 1998

FDA Premarket Notification [510(k)] Summary

Preparation Date: 24 November 1998

Contact: Gerald S. Palecki, Director, Quality and Regulatory

Device Name: Proprietary: Diamond LaserKnife™

Common: Laser Scalpel

Predicate Device: Sapphire Laser Scalpel, reference K863086

Device Description:

Intended Use:

Technological Characteristics Compared to Predicate Device:

A crystal with sharpened edges is used as a scalpel to cut tissue during surgical procedures and also conducts laser energy to the tissue to cauterize and coagulate.

Non-Clinical Tests:

The Diamond LaserKnife 1 " performance characteristics have been evaluated through analysis of laser energy fields emitted from the tip when the laser is energized compared to similar devices cleared for marketing in the past.

Conclusions Drawn from Tests and Analysis:

The predicted energy levels at the point of application meet criteria derived from performance of similar devices, based upon fluence (energy per unit area) and reaction of tissue to the discrete values of fluence.

510_CvDLK5

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 1 1998

Mr. Gerald S. Palecki Director, Quality and Regulatory Clinicon Corporation 2752 Loker Avenue West Carlsbad, California 92008

Re: K983463 Trade Name: Diamond LaserKnife™ Regulatory Class: II Product Code: GEX Dated: September 30, 1998 Received: October 1, 1998

Dear Mr. Palecki:

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 requirement, as set forth in the Quality System Regulation (OS) 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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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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Page 1 of 2

510(k) Number: K983463

Device Name: ____Diamond Laserknife™

Indications for Use:

The Diamond LaserKnife™ is indicated for incision and/or excision, with or without cauterization/coagulation, of soft tissue in open dental, dermatology, general and plastic surgery, neurosurgery, ophthalmology, oral surgery, oto-mino-laryngology, podiatry, and urological procedures.

See Attachment 2 for a listing of medical specialties and typical contact laser procedures.

510_DLK_Ind2

(Per 21 CFR 801.109)

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

Concurence of CDRH, Office of Device Evaulation (ODE)

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Division of General Restorative Devices
510(k) Number	C983463

Prescription Use (Optional Format 3-10-98)

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CLINICON CORPORATION

Premarket Notification 1510(k)] -- K983463 Diamond LaserKnife ™

Attachment 2

Listing of medical specialties and typical contact laser procedures.

1. Dentistry/Oral Surgery
  Incisional/excisional biopsies, removal of benign and cancerous lesions, frenectomy, gingivectomy, gingivoplasty, operculectomy, coagulation of graft donor sites, removal of vascular lesions, minor flap surgery, leukoplakia, and lymphangioma.

2. Dermatology

Removal of warts, neruofibromas, hemangioma, epidermal nevi, eruptive vellus hair cysts, telangiectasia, basal cell carcinoma, and granuloma.

1. General and Plastic Surgery
  Removal of skin tumors, hemorrhoidectory, lipomas, partial splenectomy, and rectal strictures. Blepharoplasty, breast reduction/reconstruction, and hair grafts.
1. Neurosurgery: Incision/excision of tumors, lesions, and cysts,
1. Ophthalmology Incision/excision of periorbital lesions.
1. Oto-rhino-laryngology

Excision of pulmonary lesions, vocal cord dysplasia and carcinoma. bronchoectorny, cordectomy, polyps, larynx leukoplakia, papillomas, lymphangioma, and myringotomy.

1. Podiatry
  Excision of Morton's neruoma, porokeratotic lesions, and plantar warts.
1. Urology
  Benign neoplasia and carcinoma of external genitalia, urethral condyloma, phimosis, and renal resection.

Prescription Use
(Per 21 CFR 801.109)

Pcolleto
(Division Sign-Off)
I.S. Central Restorative Devices 16003463

ivision Sign-Off)
ivision of General Restorative Devices 10(k) Number .

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.