The Accutech Family of PowerFlex laser delivery devices (bare fibers, sidefire fibers, ENT fibers, and Endoprobes) are indicated for incision/ excision, ablation, and coagulation (hemostasis) when attached to cleared laser systems such as KTP, Nd:YAG, Argon, Diode and Ho:YAG wavelengths (488 - 2100 nm) for the indications for which the lasers have been cleared, including: general and cosmetic surgery, intraoral soft-tissue, otolaryngology, arthroscopy, gastroenterology, general surgery, dermatology & plastic surgery, neurosurgery, gynecology, urology, ophthalmology and pulmonary surgery.

Device Description

The Accutech Family of PowerFlex Laser Delivery Devices is comprised of the following main components (by fiber optic configuration type): Bare Fibers - No Sheaths - Glass fiber optic with jacket - SMA connector Bare Fibers - With Sheaths - Glass fiber optic with jacket - Sheath - SMA connector SideFire Fibers - Glass fiber optic with jacket with distal (patient contact) fiber tip encased in glass capillary tube - SMA connector - Adjustable handle (tightens on fiber to allow user to direct laser energy to desired target site) Endoprobes/ ENT Fibers - A glass fiber optic protected by a medical grade stainless steel needle/ cannula (patient contact) and handle at the distal end and by a plastic jacket from the proximal to distal end - SMA connector Additional Accessory(ies) - Optional Radiofrequency identification (RF ID) connector for use with INTERmedic Diode Laser Family of lasers (as specified to Accutech Medical by INTERmedic for use with their laser systems)

AI/ML Overview

The provided text is a 510(k) summary for the Accutech Family of PowerFlex Laser Delivery Devices. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed performance studies against specific acceptance criteria. Therefore, most of the requested information (acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training data, and ground truth establishment) is not present in the provided document.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Not specified in this document. The submission focuses on demonstrating substantial equivalence to predicate devices, implying functional similarity rather than quantifiable performance metrics against pre-defined criteria.	The document states the device shares "the same or similar indications for use, device operation, overall technical and functional capabilities" as the predicate devices. However, specific performance metrics are not provided.

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified.
Data Provenance: Not specified. This document is a 510(k) summary, which typically summarizes the results of various tests (e.g., biocompatibility, sterilization, performance testing) but does not usually include details like geographical origin of test data or whether it was retrospective or prospective, especially for a device like a laser delivery fiber.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable/Not specified. The device is a laser delivery fiber. "Ground truth" in the context of expert consensus is typically associated with diagnostic devices, where human experts interpret medical images or data. For a surgical accessory like this, performance is usually assessed through engineering tests, ex-vivo or in-vivo animal studies, and potentially human clinical use (though often not required to establish substantial equivalence for accessory devices).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable/Not specified. See point 3.

5. 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. This device is a laser delivery system, not an AI-assisted diagnostic or therapeutic system involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a physical medical instrument, not a software algorithm. Its "performance" is inherently tied to its physical interaction with a laser system and a user.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not applicable/Not specified. Performance for this type of device is usually validated through engineering bench testing (e.g., power transmission, durability, sterility) and potentially preclinical (animal) or limited clinical studies demonstrating safe and effective use when paired with cleared laser systems. The document states that the device is for "incision/ excision, ablation, and coagulation (hemostasis)" but does not detail how the ground truth for these actions would be established for the delivery fiber itself, beyond functional verification.

8. The sample size for the training set:

Not applicable. As a physical accessory, there is no "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established:

Not applicable. See point 8.

In summary, the provided 510(k) summary for the Accutech Family of PowerFlex Laser Delivery Devices focuses on demonstrating substantial equivalence based on similar indications for use, device operation, and technical/functional capabilities to predicate devices. It does not contain the detailed performance testing, acceptance criteria, sample sizes, expert evaluations, or ground truth methodologies typically associated with studies for diagnostic AI devices, as it is a different class of medical device.

Summary

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Section 5 - 510(k) Summary or 510(k) Statement

I. General Information

Submitter:

Accutech Medical Technologies, Inc. 125 Fleming Drive Cambridge, Ontario NIT 2B8 Canada

Contact Person:

Gregory Berzak Regulatory Affairs Officer Tel: 519-620-3900, ext. 1901

Summary Preparation Date: February 4. 2009

II. Names

Device Names: Accutech Family of PowerFlex Laser Delivery Devices

Primary Classification Names: Accessory for, Laser Powered Surgical Instruments

III. Predicate Devices

. Accutech EndoLite Probe (K061025)
Cook Urological OptiLite™ Holmium Laser Fibers (K073496); .
FiberTech (FT) Fiber Optic Delivery Systems (K050738); .
Technology Delivery Systems MaxiFlex Fiberoptic Energy Delivery System . (K013300)

IV. Product Description

The Accutech Family of PowerFlex Laser Delivery Devices is comprised of the following main components (by fiber optic configuration type):

Bare Fibers - No Sheaths

Glass fiber optic with jacket .
. SMA connector

Bare Fibers - With Sheaths

Glass fiber optic with jacket .
Sheath .
SMA connector .

SideFire Fibers

Glass fiber optic with jacket with distal (patient contact) fiber tip encased in . glass capillary tube
SMA connector .
Adjustable handle (tightens on fiber to allow user to direct laser energy to � desired target site)

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Endoprobes/ ENT Fibers

A glass fiber optic protected by a medical grade stainless steel needle/ cannula ● (patient contact) and handle at the distal end and by a plastic jacket from the proximal to distal end
SMA connector .

Additional Accessory(ies)

Optional Radiofrequency identification (RF ID) connector for use with ● INTERmedic Diode Laser Family of lasers (as specified to Accutech Medical by INTERmedic for use with their laser systems)

V. Indications for Use

VI. Rationale for Substantial Equivalence

The Accutech Family of PowerFlex Laser Delivery Devices shares the same or similar indications for use, device operation, overall technical and functional capabilities, and therefore is substantially equivalent to the predicate devices.

VII. Safety and Effectiveness Information

The review of the indications for use and technical characteristics provided demonstrates that the Accutech Family of PowerFlex Laser Delivery Devices is substantially equivalent to the predicate devices.

VIII. Conclusion

The Accutech Family of PowerFlex Laser Delivery Devices was found to be substantially equivalent to the predicate devices.

The Accutech Family of PowerFlex Laser Delivery Devices shares the same or similar indications for use, similar design features, and functional features with, and thus is substantially equivalent to, the predicate devices.

0016

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, rendered in a simple, bold design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 4 2009

Accutech Medical Technologies, Inc. % A L Voss Associates Ms. Anne Worden 3637 Bernal Avenue Pleasanton, California 94566

Re: K090281

Trade/Device Name: Accutech Family of PowerFlex Laser Delivery Devices 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: February 4, 2009 Received: February 5. 2009

Dear Ms. Worden:

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. Anne Worden

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 postmaties surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Prestmaner, 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.

f ti mid. for

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 Statement

K090 2281 510(k) Number (if known):

Device Name: Accutech Family of PowerFlex Laser Delivery Devices

Indications for Use:

The Accutech Family of PowerFlex laser delivery devices (bare fibers, sidefire fibers, ENT fibers, and Endoprobes) are indicated for incision, ablation, and coagulation (hemostasis) when attached to cleared laser systems such as KTP, Nd:YAG, Argon, Diode and Ho:YAG wavelengths (488 - 2100 nm) for the indications for which the lasers have been cleared, including: general and cosmetic surgery, intraoral soft-tissue, otolaryngology, arthroscopy, gastroenterology, general surgery, dermatology & plastic surgery, neurosurgery, gynecology, urology, ophthalmology and pulmonary surgery.

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)

Neil R. Oyler Forman

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

510(k) Number K090228

0014

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.