Indicated for incision/excision, ablation, and coagulation (homeostasis) when attached to cleared laser systems such as KTP, Nd:YAG, Argon, Diode, Ho:YAG and ER:YAG wavelengths for the indications for which the lasers have been cleared.

Device Description

The OptiLite™ Holmium Laser Fibers are intended to be used with legally cleared laser systems to deliver laser energy. The fiber delivery system is typically used in conjunction with a rigid or flexible endoscope to access the surgical site. The laser fibers work on the principle of total internal reflection. Laser energy is focused into a glass silica fiber at the proximal end and traverses the length of the fiber by means of total reflection. The fiber is able to contain the laser beam and funnels the laser energy from the proximal end to the distal end.

AI/ML Overview

The provided text describes the 510(k) submission for the OptiLite™ Holmium Laser Fibers. However, it does not contain the detailed information necessary to answer all parts of your request, particularly regarding specific acceptance criteria for device performance, the study design for such performance, sample sizes for test/training sets, expert qualifications, adjudication methods, or MRMC studies.

The document indicates that the device's substantial equivalence is based on its similarity to existing predicate devices regarding "indications for use and technology," and that "Biocompatibility, sterility and performance testing were performed in accordance to Food and Drug Administration quidance's and recognized international standards." However, the details of these performance tests and their specific acceptance criteria are not included in the provided text.

Therefore, I can only provide information based on what is explicitly stated or can be inferred from the text. Many sections of your request will be answered with "Not provided in the text."

Acceptance Criteria and Study Details for OptiLite™ Holmium Laser Fibers

Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Functionality:
- Deliver laser energy from proximal to distal end for incision/excision, ablation, and coagulation.	"The fiber is able to contain the laser beam and funnels the laser energy from the proximal end to the distal end." No specific quantitative metrics for energy delivery or efficacy are provided. Performance testing was done, but specific results or acceptance thresholds are not detailed.
Biocompatibility:	"Biocompatibility...testing were performed in accordance to Food and Drug Administration guidance's and recognized international standards." No specific acceptance criteria or results reported.
Sterility:	"Sterility...testing were performed in accordance to Food and Drug Administration guidance's and recognized international standards." No specific acceptance criteria or results reported.
Compatibility: (with specific laser systems)	"Indicated for incision/excision, ablation, and coagulation (homeostasis) when attached to cleared laser systems such as KTP, Nd:YAG, Argon, Diode, Ho:YAG and ER:YAG wavelengths for the indications for which the lasers have been cleared." No specific performance metrics or acceptance criteria for this compatibility are detailed.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided in the text. The document only states that "Performance testing were performed," but no details on the sample size (e.g., number of fibers tested, number of procedures simulated), type of data, or provenance are given.
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)
- Not applicable / Not provided in the text. This type of information is typically relevant for AI/imaging devices involving interpretive tasks. For a laser fiber, the "ground truth" would be established through engineering and biological performance standards, not expert adjudication of images. The text does not mention any expert involvement in establishing ground truth for performance testing.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided in the text. Adjudication methods are typically used for establishing ground truth in diagnostic studies involving human interpretation. This is not relevant for the described performance testing of a laser fiber.
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
- Not applicable / Not provided in the text. An MRMC study is relevant for AI-assisted diagnostic or interpretive tasks. The OptiLite™ Holmium Laser Fiber is a medical device for delivering laser energy, not an AI or imaging device, so such a study would not be applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Not provided in the text. This question is also relevant for AI/algorithm-based diagnostic devices. The OptiLite™ Holmium Laser Fiber is a physical medical device. Its "standalone performance" refers to its ability to function as designed (deliver laser energy, biocompatibility, sterility) which was stated as having been tested.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Based on engineering and biological performance standards. The text indicates "Biocompatibility, sterility and performance testing were performed in accordance to Food and Drug Administration quidance's and recognized international standards." This implies that the "ground truth" for evaluating the device's performance would be established by predefined engineering specifications (e.g., laser energy transmission efficiency, damage thresholds) and biological safety standards (e.g., cytotoxicity, irritation). No mention of expert consensus, pathology, or outcomes data for establishing the performance 'ground truth' is made.
The sample size for the training set
- Not applicable / Not provided in the text. Training sets are used in machine learning and AI. This device is a physical, non-AI medical device; therefore, no training set in the AI sense would be used. The text does not mention any data sets used for "training" the device.
How the ground truth for the training set was established
- Not applicable / Not provided in the text. As explained above, this device does not involve a training set in the context of AI.

Summary

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OptiLite™ Holmium Laser Fiber STED 510(k) submission Cook Urological, Incorporated November 26, 2007

510(k) SUMMARY

JAN 23 2008

Submitted by:	Cindy FooteRegulatory Affairs SpecialistCook Urological, Incorporated1100 West Morgan StreetSpencer, IN 47460November 20, 2007
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Device:Trade Name:	OptiLite™ Holmium Laser Fibers
Proposed Classification Name:	Laser Instrument, Surgical, Powered21 CFR Part 878.4810Class II, GEX

K073496#### Predicate Devices:

The OptiLite™ Holmium Laser Fibers are similar with respect to indications for use and technology to existing predicate devices in commercial distribution. Specifically, the Optilite™ Holmium Laser Fibers are similar to the AccuFlex™ Holmium Laser Fibers (K994010) manufactured by InnovaQuartz, Incorporated, distributed by Boston Scientific Corporation. The OptiLite™ Holmium Laser Fibers are identical to the OptiLITE™ IX Laser Surgery Accessories (K992866) manufactured by Convergent Laser Technologies and distributed by Cook Urological. Incorporated.

Device Description:

Substantial Equivalence:

The Cook® Cervical Ripening Balloon is comparable with respect to intended use to the published predicate device description and meets the requirements for 510(k) substantial equivalence.

Test Data:

Biocompatibility, sterility and performance testing were performed in accordance to Food and Drug Administration quidance's and recognized international standards. Testing data and information is included in this submission.

Company Confidential Cook Urological

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing right, with three curved lines above them.

JAN 23 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Cook Urological, Inc. % Ms. Cindy Foote Regulatory Affairs Specialist 1100 W. Morgan Street Spencer, Indiana 47460

Re: K073496 Trade/Device Name: OptiLite™ Holmium Laser Fibers 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: November 26, 2007 Received: December 12, 2007

Dear Ms. Foote:

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

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Page 2 - Ms. Cindy Foote

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.

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark M. Mulhern

Mark N. Melkerson 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 (if known):	073496
Device Name:	OptiLiteTM Holmium Laser Fibers
Indications for Use:	Indicated for incision/excision, ablation, and coagulation(homeostasis) when attached to cleared laser systems suchas KTP, Nd:YAG, Argon, Diode, Ho:YAG and ER:YAGwavelengths for the indications for which the lasers havebeen cleared.

Prescription Use?_____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use_ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Millman

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

510(k) Number K073496

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.