The Wave Form Manufacturing Prolase 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, ureteroscopes, bronchoscopes, cystoscopes, gastroscopes, arthroscopes, colonoscopes, or for open surgery in contact or non-contact surgery with or without handpieces for use in coagulation, incision/excision, ablation and vaporization of soft tissue.

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

Device Description

The Wave Form Manufacturing Prolase General Shaped (PGS) 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 PGS fiber may be used for a wide variety of surgical procedures.

AI/ML Overview

The provided text does not contain detailed information about acceptance criteria and a study proving the device meets these criteria in the typical format one would expect for a medical device. Instead, it describes a 510(k) submission for a laser surgical instrument accessory, the Wave Form Manufacturing Prolase General Shaped Fiber.

The primary goal of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to prove performance against specific acceptance criteria through a comprehensive clinical study. The document states: "Bench testing was performed to demonstrate that the device will perform as intended." This implies that the device's performance was evaluated against its design intent, likely comparing it to the predicate devices, rather than against explicit, quantified, and publicly reported acceptance criteria.

Without a more detailed report of the bench testing, I cannot create the requested tables and information. However, I can infer some aspects based on common 510(k) practices and the provided limited text.

Here's an attempt to address your request based on the available information, with significant limitations due to the nature of the provided text:

Inferred Acceptance Criteria and Performance (Based on "Bench Testing" and "Substantial Equivalence")

Since the provided document is a 510(k) summary, formal "acceptance criteria" and a detailed "study" demonstrating performance against those criteria, as you might find for a PMA (Premarket Approval) or later-stage clinical trials, are not explicitly presented. The core of a 510(k) is demonstrating substantial equivalence to predicate devices. The "bench testing" mentioned was likely conducted to show that the device performed similarly to its predicate devices in relevant functional and safety aspects.

1. Table of Acceptance Criteria and Reported Device Performance

Given the lack of explicit criteria and performance data in the provided text, this table is based on inferences about what would typically be tested for a laser fiber and what "performed as intended" (bench testing) and "substantial equivalence" might imply.

Acceptance Criteria Category (Inferred)	Specific Acceptance Criteria (Inferred)	Reported Device Performance (Inferred from "Bench Testing was performed to demonstrate that the device will perform as intended" and 510(k) clearance)
Laser Delivery Efficiency	Efficient transmission of laser energy from laser source to the distal tip.	Demonstrated to be comparable to predicate devices. (Pass)
Mechanical Integrity/Durability	Ability to withstand bending, tension, and handling without breakage or damage affecting performance.	Demonstrated to be acceptable for intended surgical use. (Pass)
Biocompatibility	Materials are non-toxic and do not cause adverse reactions in the body.	Materials are standard for such devices or have established biocompatibility. (Implied Pass based on clearance)
Sterility (where applicable)	Device maintains sterility until use.	Packaging and sterilization methods deemed adequate. (Implied Pass based on clearance)
Thermal Performance at Tip	Controlled and predictable energy delivery at the working end.	Demonstrated to be comparable to predicate devices for vaporization, cutting, ablation, and coagulation. (Pass)
Tip Integrity/Shaping Maintenance	The shaped tip maintains its form during use for consistent energy delivery.	Demonstrated to be effective. (Pass)
Compatibility with Laser Systems	Ability to connect and function safely with appropriate laser systems.	Demonstrated compatibility with relevant laser platforms. (Pass)
Reflectance/Backscatter Protection	Effectiveness of the internal proprietary quartz sleeve reflector in protecting the laser focusing lens.	Demonstrated to protect the focusing lens from back splatter. (Pass)
Secondary Cladding Functionality	Ability of the optical secondary memory cladding to guide a steerable endoscope.	Demonstrated to aid in guiding a steerable endoscope. (Pass)

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

Sample Size: Not specified. "Bench testing" typically involves a controlled number of units, perhaps a small batch from production or engineering prototypes, rather than a large statistical sample like in clinical trials.
Data Provenance: Not specified, but "bench testing" implies data was generated in a lab setting by the manufacturer (Wave Form Manufacturing, Inc.). This would be prospective data generated specifically for the 510(k) submission. There is no mention of country of origin of data beyond the manufacturer's location in Oregon, USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not Applicable. For "bench testing" of device performance attributes (like laser delivery, mechanical integrity, etc.), ground truth isn't typically established by clinical experts in the same way it would be for diagnostic accuracy studies involving medical images or patient outcomes. The "ground truth" would be the engineering specifications and performance expectations derived from the predicate devices and general knowledge of fiber optics and laser physics.
If any expert review was involved, it would likely be internal engineering or quality control personnel.

4. Adjudication Method for the Test Set

None Specified/Not Applicable. Adjudication methods (like 2+1, 3+1) are common in clinical studies where subjective interpretation (e.g., image reading) requires consensus. For bench testing of physical device properties, results are typically objective measurements against engineering specifications, not subject to variable interpretation that would require expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. An MRMC study is relevant for diagnostic devices that involve human interpretation (e.g., reading medical images). The Wave Form Manufacturing Prolase General Shaped Fiber is a surgical instrument accessory; its effectiveness is evaluated through its functional performance, not human interpretative accuracy. Therefore, this type of study would not be applicable or expected for this device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Not Applicable. This question relates to AI/ML algorithms. The Wave Form Manufacturing Prolase General Shaped Fiber is a physical medical device (laser fiber), not an AI algorithm. Therefore, "standalone" performance in this context is not relevant. The device operates inherently without human-in-the-loop for its basic functional aspects, but it is a tool used by a human surgeon.

7. The Type of Ground Truth Used

For bench testing, the "ground truth" would be engineering specifications, established performance parameters of the predicate devices, and industry standards for laser surgical fibers. For example, a certain laser power output at the tip would be expected, or the fiber would be expected to withstand a certain bend radius without breaking.

8. The Sample Size for the Training Set

Not Applicable. This question is also relevant for AI/ML algorithms. For a physical medical device like a laser fiber, there is no "training set" in the computational sense. The device is designed and manufactured based on engineering principles and predicate device characteristics, not "trained" on data.

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

Not Applicable. As there is no training set, this question is not applicable.

Summary Limitations:

The provided text only briefly mentions "Bench testing was performed to demonstrate that the device will perform as intended" as part of the "Technological Characteristics and Performance Data" and confirms the device's clearance via 510(k) due to "substantial equivalence" to predicate devices. Without access to the actual bench test report or the detailed 510(k) submission, specific acceptance criteria and detailed quantitative performance data cannot be extracted. The strength of the 510(k) process is demonstrating equivalence to existing safe and effective devices, which often relies on non-clinical (bench or animal) testing rather than extensive human clinical trials for many Class II devices.

Summary

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MAY 3 0 2002

CD20673 ATTACHMENT 6 - 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Wave Form Manufacturing Prolase General Shaped Fiber

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

Wave Form Manufacturing, Inc. 8095 SW Nimbus Ave, Bldg. 12 Beaverton, Oregon 97008 Contact: Charles R. Watkins

Phone: 800-332-8749 Facsimile: 503-643-6314 Email: chuckw@waveformsys.com Date Prepared: February 28, 2002

Name of Device and Name/Address of Sponsor

Trade Name: Wave Form Manufacturing Prolase General Shaped Fiber Classification Name: Laser Surgical Instrument Accessories

Predicate Devices

InnovaQuartz 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

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Technological Characteristics and Performance Data

Design changes made to the Wave Form Manufacturing PGS 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.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Wave Form Manufacturing, Inc. c/o Mr. Joe Brown Optical Integrity 8317 Front Beach Road Panama City Beach, FL 32407

MAY 3 0 2002

Re: K020673

R02007-5
Trade/Device Name: Wave Form Manufacturing Prolase General Shaped Fibers Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: February 28, 2002 Received: March 1, 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 for associated in the 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). and Cosmotion (110) that the device, subject to the general controls provisions of the Act. The I ou may , and controls 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 If your de roo is exach 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. Joe 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" (21CFR 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,

Miriam C. Provost

Por 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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PREMARKET NOTIFICATION

INDICATIONS FOR USE STATEMENT

510(k) Number: 020673

Device Name: Wave Form Manufacturing Prolase General Shaped Fibers

Indications for Use:

The Wave Form Manufacturing Prolase 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, bronchoscopes, 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 Wave Form Manufacturing Prolase General Shaped Fiber is indicated for use in medicine and surgery in the following medical specialties:

Urology
Plastic Surgery ●
Radiology .
Dermatology .
Pulmonolgy .
Gastroenterology ●
Gynecology ●
General and Vascular Surgery .
Lithotripsy
Arthroscopy ●
Podiatry .

Association

Orthopedics
Neurosurgery
Plastic Surgery
ENT
Concurrence of CDRH, Office of Evaluation (ODE)

Prescription Use

Over-the-Counter Use

usiam C. Provost

n of General, Restorative and Neurological Devices

510(k) Number K620673

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.