The Optical Integrity General Shaped Fiber is intended to be used for vaporization, cutting, ablation and coagulation of soft tissue in conjunction with or without endoscopic equipment including laparoscopes, hysteroscopes, arthroscopes, cystoscopes, cystoscopes, gastroscopes, and colonoscopes, or for contact or non-contact surgery with or without handpieces for use in coagulation, incision/excision, ablation and vaporization of soft tissue.

The Optical Integrity GS Fiber is indicated for use in medicine and surgery in the following specialties: Urology, Plastic Surgery, Radiology, Dermatology, Pulmonology, Gastroenterology, Gynecology, ENT, General and Vascular Surgery, Lithotripsy, Arthroscopy, Podiatry, Orthopedics and Neurosurgery.

Device Description

The Optical Integrity General Shaped (GS) Fiber is a fiber optic laser delivery system consisting of a 3 meter long silica fiber, clad in fluorinated doped silica, buffered with a fluorinated acrylate and a shaped tip. As an integral part of a laser system, the GS fiber may be used for a wide variety of surgical procedures.

AI/ML Overview

The provided text for K022338 describes a medical device, the Optical Integrity General Shaped (GS) Fiber, and its intended use. However, it does not contain detailed information regarding acceptance criteria, specific study designs, sample sizes, expert qualifications, or ground truth establishment.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a comprehensive clinical study report with detailed performance metrics against predefined acceptance criteria.

Based only on the provided text, I can infer the following about how the device meets its claims:

Acceptance Criteria and Reported Device Performance: This information is not
explicitly stated in the provided document. The document states "Bench testing was performed to demonstrate that the device will perform as intended," but it does not specify what those "intentions" (i.e., acceptance criteria) were, nor does it list specific performance results like accuracy, sensitivity, specificity, etc., that would typically be found in a performance table. The focus of the 510(k) is on the technological characteristics and comparison to predicate devices, not on quantitative performance metrics against specific criteria.
Sample Size and Data Provenance for Test Set: This information is not provided in the document. The text mentions "Bench testing," which implies laboratory-based tests, but no details on the number of samples used or if any human-derived data was involved. Given it's "bench testing," it's likely physical or engineering tests on the fiber itself, not a clinical test set with patient data.
Number of Experts and Qualifications: This information is not provided. Bench testing typically involves engineers or technicians, not medical experts in the way clinical studies do for ground truth establishment.
Adjudication Method: This information is not applicable or provided. Adjudication methods like 2+1 or 3+1 are used in clinical trials involving human readers/interpreters to establish ground truth from discrepancies. Bench testing does not involve this type of adjudication.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: An MRMC comparative effectiveness study was not mentioned in the document. This type of study would be relevant for evaluating the impact of AI on human reader performance, which is not the focus of this 510(k) for a laser delivery fiber.
Standalone Performance Study (Algorithm Only): A standalone performance study was not mentioned. This device is a physical fiber optic laser delivery system, not an algorithm.
Type of Ground Truth Used: For "bench testing," the "ground truth" would be engineering specifications, physical measurements, and performance benchmarks relevant to the fiber's function (e.g., optical power transmission, durability, beam profile, heat dissipation). The document does not specify the exact type of ground truth used for these bench tests.
Sample Size for Training Set: This information is not applicable or provided. The device is a physical product, not an AI/ML algorithm that requires a training set.
How Ground Truth for Training Set was Established: This information is not applicable or provided for the reasons mentioned above.

Summary based on available information:

Criterion	Acceptance Criteria	Reported Device Performance
Acceptance Criteria & Performance Table	Not explicitly stated in the document. The general intent is that the device "will perform as intended" based on bench testing.	"Bench testing was performed to demonstrate that the device will perform as intended." No specific quantitative results are provided.
Sample Size (Test Set) & Data Provenance	Not specified. Bench testing implies laboratory/engineering samples, not clinical data.	Not specified.
Number & Qualifications of Experts (Ground Truth)	Not applicable in the context of device bench testing.	Not applicable.
Adjudication Method (Test Set)	Not applicable.	Not applicable.
MRMC Comparative Effectiveness Study	No MRMC study was mentioned.	Not mentioned.
Standalone Performance Study (Algorithm Only)	Not applicable; this is a physical device, not an algorithm.	Not applicable.
Type of Ground Truth Used	Engineering specifications, physical properties, and performance benchmarks for fiber optic laser delivery systems (inferred).	Not explicitly stated.
Sample Size (Training Set)	Not applicable; this is a physical device, not an AI/ML algorithm.	Not applicable.
Ground Truth Establishment (Training Set)	Not applicable.	Not applicable.

The 510(k) summary (K022338) for the Optical Integrity General Shaped Fiber primarily focuses on establishing substantial equivalence to existing predicate devices through technological characteristic comparison and general bench testing, rather than presenting detailed clinical performance data against specific acceptance criteria.

Summary

{0}------------------------------------------------

K022338

ATTACHMENT 6 - 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Optical Integrity General Shaped Fiber

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Optical Integrity, Inc. 8317 Front Beach Road, Suite 21 Panama City Beach, FL 32407 Contact: Joe D. Brown

Phone: 850-233-5512 Facsimile: 850-233-3658 Email: jbrown@opticalintegrity.com

Name of Device and Name/Address of Sponsor

Trade Name: Optical Integrity General Shaped Fiber Classification Name: Laser Surgical Instrument Accessories

Predicate Devices

Wave Form Manufacturing Prolase General Shaped Fiber (K020673) InnovaOuartz General Shaped Fiber (K954904), single use InnovaQuartz General Shaped Fiber (K994010), reuse Dornier Medilas H Fibers (K001243) Lumenis Slimline Fibers (K990947)

Device Description

Indications for Use

Technological Characteristics and Performance Data

Design changes made to the Optical Integrity GS Fiber are the addition of an internal proprietary quartz sleeve reflector which protects the laser focusing lens from back splatter of vaporized metal from the connector ferrule and the addition of an optical secondary memory cladding to help guide a steerable endoscope with the optical fiber.

Bench testing was performed to demonstrate that the device will perform as intended.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling an abstract symbol. The symbol consists of three stylized human profiles facing right, with three curved lines above them, resembling a bird in flight. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

Public Health Service

OCT 1 6 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Optical Integrity, Inc. Joe D. Brown President 8317 Front Beach Road, Suite 21 Panama City Beach, Florida 32407-4893

Re: K022338

Trade/Device Name: Optical Integrity General Shaped Fiber Regulation Number: 878.4810 Regulation Name: Laser Surgical Instrument Accessories Regulatory Class: Class II Product Code: GEX Dated: July 15, 2002 Received: July 18, 2002

Dear Mr. Brown:

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.

{2}------------------------------------------------

Page 2 -- Mr. Joe D. Brown

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 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 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,

Stypt Rlurdu
Célia 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

{3}------------------------------------------------

PREMARKET NOTIFICATION

INDICATIONS FOR USE STATEMENT

510(k) Number:

K022-338

Device Name: Optical Integrity General Shaped Fibers

Indications for Use:

The Optical Integrity General Shaped Fiber is intended to be used in vaporization, cutting, ablation and coagulation of soft tissue in conjunction with or without endoscopic equipment including laparoscopes, hysteroscopes, arthroscopes, cystoscopes, cystoscopes, ureteroscopes, gastroscopes and colonoscopes, or for contact or non-contact surgery with or without handpiece for use in coagulation, incision/excision, ablation and vaporization of soft tissue.

The Optical Integrity General Shaped Fiber is indicated for use in medicine and surgery in the following medical specialties:

Urology .
Plastic Surgery .
Radiology .
Dermatology .
. Pulmonology
Gastroenterology .
Gynecology .
ENT .
Lithotripsy ●
General and Vascular Surgery ●
Arthroscopy ●
. Podiatry
Orthopedics .
Neurosurgery

Concurrence of CDRH, Office of Evaluation (ODE)

or Over-the-Counter Use Prescription Use

Stupt Rlurdu

ion of General, Restorative and Neurological Devices

510(k) Number_KOZZ338

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.