The MaxiFlex - Fiberoptic Energy Delivery System is designed to deliver lase energy to perform: general surgical, dermatological, intraoral soft tissue, orthopaedic, maxillo-facial, and cosmetic surgery. The MaxiFlex fiber is intended for energy delivery for ablating, incising, excising, vaporization and coagulation of soft tissues within the medical/surgical specialties noted above using a contact fiber optic based laser system.

The device is suitable for use for all applications for which the laser output unit is 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 delivery fiber cables, consist of multi-mode, single core optical fibers available in 200, 400, and 1000um diameters. The standard SMA 905 fiber connector terminates one end of the delivery fiber, which is attached to the SMA union at the rear panel of the laser box. The fiber is stripped of its protective jacket in accordance with the laser manufacturers instructions and is cleaved to provide laser radiation output.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the MaxiFlex Fiberoptic Energy Delivery System:

This document is a 510(k) premarket notification for a medical device seeking substantial equivalence to already legally marketed devices. It's important to understand that 510(k) submissions generally do not involve new clinical studies or elaborate performance testing to establish novel acceptance criteria. Instead, they demonstrate that a new device is as safe and effective as a predicate device through comparison of features, materials, and intended use.

Therefore, the concept of "acceptance criteria" in this context is primarily about demonstrating that the MaxiFlex Fiberoptic Energy Delivery System's features, functional specifications, and intended uses are substantially equivalent to those of the identified predicate devices without raising new questions of safety or effectiveness. The "study" proving this is essentially the comparative analysis presented in the document itself.

Here's the breakdown based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Demonstrated Equivalence to Predicate Devices)	Reported Device Performance (MaxiFlex Fiberoptic Energy Delivery System)
Type of laser compatibility: Compatible with various surgical laser types (e.g., Diode, crystal fiber-optic based lasers, any surgical laser equipment fitted with an SMA 905 connector, Nd:YAG, HO:YAG or Argon).	Diode & crystal fiber-optic based lasers. Implicitly compatible with SMA 905 connector lasers due to connector type.
Wavelength range: Ability to deliver energy across relevant surgical laser wavelengths (e.g., 532-1400 nm, 532-1054 nm).	532-2100 nm. (Broader range than predicate devices, which implies equivalence or improvement within relevant spectrum).
Maximum output power: Capable of handling relevant maximum laser output powers (e.g., 100 Watts, 60 Watts).	100 Watts. (Matches or exceeds predicate device capabilities).
Operation mode: Supports common laser operation modes (Continuous wave and pulsed).	Continuous wave and pulsed. (Matches predicate device capabilities).
Delivery system (fiber core sizes): Offers fiber core sizes suitable for surgical applications (e.g., 200, 400, 600, 800, 1000 um core quartz fiber).	Multi-mode 200, 400, 600 and 1000 um core quartz fiber. (Offers comparable range to predicate devices, including all listed sizes from the predicates).
Sterility: User sterilized via steam at specific parameters (270°/10min. exposure).	User sterilized - Steam - 270°/10min. exposure. (Matches predicate device method).
Connector Type: Standardized connector for laser systems (SMA 905 connector).	SMA 905 connector. (Matches predicate device connector type).
Intended Use and Indications for Use: Broad application in various medical/surgical specialties for tissue ablation, incision, excision, vaporization, and coagulation.	Designed to deliver laser energy to perform: general surgical, dermatological, intraoral soft tissue, orthopaedic, maxillo-facial, and cosmetic surgery. Intended for energy delivery for ablating, incising, excising, vaporization and coagulation of soft tissues within the medical/surgical specialties noted above using a contact fiber optic based laser system. Suitable for use for all applications for which the laser output unit is cleared, including: general and cosmetic surgery, intraoral soft-tissue, otolaryngology, arthroscopy, gastroenterology, general surgery, dermatology & plastic surgery, neurosurgery, gynecology, urology, ophthalmology and pulmonary surgery. (Demonstrates substantially equivalent and, in some cases, broader indications than predicate devices).

Study Proving Acceptance Criteria:

The "study" presented here is a premarket notification (510(k)) submission's comparative analysis for substantial equivalence. It does not involve a traditional clinical efficacy study with quantitative patient outcomes.

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

Test Set Sample Size: Not applicable in the context of a 510(k) substantial equivalence submission for this type of device. There isn't a "test set" of patient data in the sense of a clinical trial. The "test" is the comparison of the new device's specifications and intended use against those of legally marketed predicate devices.
Data Provenance: The data provenance comes from the publicly available specifications and intended uses of three predicate devices: StrateFire, InnovaQuartz, and one labeled "SE?". These are legally marketed devices in the United States. The data about the MaxiFlex device is provided by the manufacturer (Technology Delivery Systems, Inc.). This is a retrospective comparison against existing device information.

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

Number of Experts: Not explicitly stated or applicable in the traditional sense. The "ground truth" for a 510(k) comparison is regulatory clearance of the predicate devices and the technical specifications provided by their manufacturers (and the applicant for the new device). FDA reviewers (medical officers, engineers, etc.) with relevant expertise are the ones who assess the substantial equivalence.
Qualifications of Experts: FDA scientific and regulatory staff are the "experts" who determine if the device is substantially equivalent to predicates based on the provided technical and descriptive information. Their qualifications would include relevant scientific and medical backgrounds (e.g., engineering, medical physics, clinical specialties).

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. There is no qualitative assessment of a test set by multiple experts requiring adjudication. The comparison is based on objective technical specifications and intended uses as detailed in the submission. The FDA makes the final determination of substantial equivalence.

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

MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is typically performed to assess human reader performance (e.g., radiologists interpreting images) with and without AI assistance, which is not relevant for a surgical fiberoptic energy delivery system in a 510(k) submission.

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

Standalone Performance Study: No, a standalone performance study (algorithm only) was not done. This device is a physical instrument (fiberoptic cable) for delivering laser energy, not an algorithm or AI system.

7. The Type of Ground Truth Used

Type of Ground Truth: The ground truth used here is the established regulatory clearance and publicly available specifications/intended uses of the predicate devices. The manufacturer of the MaxiFlex device asserts that its device is equivalent to these legally marketed devices in terms of its characteristics and intended applications. The FDA then verifies this assertion based on the submitted documentation.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. As this is not an AI/machine learning device, there is no "training set" in that context. If interpreted as internal testing data for the MaxiFlex fiber itself, this document does not specify any sample sizes for design verification or validation testing. A 510(k) relies on comparison to predicates and adherence to recognized standards, rather than new extensive clinical trials for devices of this nature.

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

Ground Truth for Training Set: Not applicable, as there is no "training set" for an AI/ML algorithm involved. For the predicate devices, their "ground truth" (i.e., their safety and effectiveness) was established through their own regulatory clearance processes, which might have involved different types of testing or comparisons depending on their original classification and pathway to market.

Summary

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APR 1 6 2002

Technology Delivery Systems, Inc. MaxiFlex Fiber September 25, 2001

	Summary of Safety and Effectiveness Information
		TECHNOLOGY DELIVERY SYSTEMS, INC.
		SEPTEMBER 6, 2001
Regulatory Authority:	Safe Medical Devices Act of 1990, 21 CFR 807.92
Device Name:
Trade Name:	MaxiFlex Fiberoptic Energy Delivery System
Common Name(s):	Surgical Laser System
Classification Name(s):	Laser, Surgical
Establishment Name & Registration Number:

Name: Technology Delivery Systems, Inc. Number: applied/pending

3. Classification(s):

& 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. Class II.

Device Class:	Class II for all requested indications
Classification Panel:	General and Plastic Surgery & Others
Product Code(s):	GEX

4. Section 514 Compliance

TECHNOLOGY DELIVERY SYSTEMS. INC. intends to comply fully with the general controls authorized under Sections 501, 502, 510, 516, 518, 519, and 520 of the Food, Drug, and Cosmetic Act.

5. Performance Standards

United States Food and Drug Administration mandated performance standards for this device exist and are provided under Sections 21 CFR 1010 & 1020. In addition, various voluntary performance standards are Voluntary standards utilized include Standard Operating Procedures, vendor & process utilized. certification and qualification procedures, Quality Systems Regulations, ISO materials standards and cGMP & ISO 9000 series quality regulations.

TECHNOLOGY DELIVERY SYSTEMS, INC. also meets appropriate general controls authorized under Sections 501, 502, 510, 516, 518, 519, and 520 of the Food, Drug, and Cosmetic Act.

6. Special Controls:

All Class II devices are subject to Special Controls.

7. Labeling:

The laser system discussed in this premarket notification will be manufactured by Technology Delivery Systems, Inc. and labeled as such. Technology Delivery Systems, Inc. will market the system exclusively to healthcare facilities, physicians and dentists. In addition to the usual package and identification

MaxFlx.doc

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K013300 2/3

Technology Delivery Systems, Inc. MaxiFlex Fiber September 25, 2001

labeling, the following additional Warnings, Cautions statements are displayed as appropriate on or within the device packaging. They are repeated here for ease of review.

Federal (United States) Law restricts this device to sale by or on the order of a physician or Warning: dentist only.

Summary Basis of Equivalence: 8.

The surgical laser fiber optic bundle described in this document is substantially equivalent to the referenced legally marketed laser system fiber optic bundles in that the sizes, operational parameters, indications for The following use, warnings, cautions, precautions and care and handling are essentially the same. comparison chart presents the features of all these fiber optic bundles.

ರು. Predicate Device (legally marketed comparison devices)

Technology Delivery Systems, Inc. believes that the following surgical laser fiber optic systems noted in the table are substantially equivalent to the MaxiFlex - Fiberoptic Energy Delivery System.

FEATURE	MaxiFlex Fiberoptic EnergyDelivery System	StrateFire	InnovaQuartz	SE?
Type of laser	Diode & crystal fiber-opticbased lasers	Any surgical laser equipmentfitted with an SMA 905connector	Nd:YAG, HO:YAG or Argon	YES
Wavelength	532-2100 nm	532-1400 nm	532-1054	YES
Max output power	100 Watts	100 Watts	60 Watts	YES
Operation mode	Continuous wave and pulsed	Continuous wave and pulsed	Continuous wave and pulsed	YES
Delivery system	Multi-mode 200, 400, 600 and1000 um core quartz fiber	Multi-mode 400, 600, 800 and1000 um core quartz fiber	Multi-mode 200, 400, 600 umcore quartz fiber,	YES
Sterility:	User sterilized - Steam - 270°/10min. exposure	User sterilized - Steam - 270°/10min. exposure	User sterilized - Steam - 270°/10min. exposure
Connector Type:	SMA 905 connector	SMA 905 connector	SMA 905 connector	YES
Intended Use andIndications for Use	The MaxiFlex - FiberopticEnergy Delivery System isdesigned to deliver laser energyto perform: general surgical,dermatological, intraoral softtissue, orthopaedic, maxillo-facial, and cosmetic surgery.The MaxiFlex fiber is intendedfor energy delivery for ablating,incising, excising, vaporizationand coagulation of soft tissueswithin the medical/surgicalspecialties noted above using acontact fiber optic based lasersystem.The device is suitable for usefor all applications for whichthe laser output unit is cleared,including: general and cosmeticsurgery, intraoral soft-tissue,otolaryngology, arthroscopy,gastroenterology, generalsurgery, dermatology & plasticsurgery, neurosurgery,gynecology, urology,ophthalmology and pulmonarysurgery.	Ablation and hemostasis intreatment of gynecological andurological conditions, as well asmultiple applications ingastroenterology and generalsurgery.	Vaporization, coagulation,hemostasis, and incision of soft-tissue. For use with Nd: YAG,HO:YAG or Argon lasersystems cleared for medical useaccepting an SMA 905connector.	YES

MaxFlx.doc

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10. Device Description:

11. Applicant Name & Address:

Technology Delivery Systems, Inc. 1354 Del Plaza, Suite 8 Baton Rouge, LA 70815 225.927.7885 - 225.926.2401

12. Company Contact:

Mr. Gary Ventrella Technology Delivery Systems, Inc. 1354 Del Plaza, Suite 8 Baton Rouge, LA 70815 225.927.7885 - 225.926.2401

13. Submission Correspondent:

Mr. David W. Schlerf Buckman Company, Inc. 200 Gregory Lane, Suite C -100 Pleasant Hill, CA 94523-3389 925.356.2640 - 925.356.2654 - fax

14. Manufacturing Facility:

The devices are physically manufactured in the USA by Technology Delivery Systems, Inc. for distribution in the U.S.A.

15. Sterilization, Packaging & Storage Information:

The device is not supplied sterile. All packages should be intact upon receipt. Packaging should be inspected on arrival for evidence of shipping damage. Damaged packaging may indicate the presence of unsafe product and it should not be used until carefully inspected. If the package or product is damaged, the product should not be used and should be returned. Product must be handled, stored and opened in such a way that it is protected from inadvertent damage or contamination. When used, the product must be placed into use following the recommended cleaning and sterilization procedure including accepted surgical sterile technique.

MaxFlx.doc

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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines representing the serpent entwined around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus. The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 6 2002

Technology Systems, Inc. c/o Mr. David W. Schlerf Buckman Company, Inc. 200 Gregory Lane, Suite C-100 Pleasant Hill, CA 94523-3389

Re: K013300

Trade/Device Name: MaxiFlex - Fiberoptic Energy Delivery System 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: March 5, 2002 Received: March 6, 2002

Dear Mr. Schlerf:

We have reviewed your Section 510(k) premarket notification of intent to market the device wo nave a nowe 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 use sunce in the encreours) is the enactment date of the Medical Device Amendments, or to oonimer to Prix) 2011-11-11 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 Oosmeter Flor (110) and the device, subject to the general controls provisions of the Act. The I ou may y attests 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 or any i 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. David W. Schlerf

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

for 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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Page _ of 1

510(k) Number: K DI3300

MaxiFlex - Fiberoptic Energy Delivery System Device Name(s):

Intended Use(s) of the Device:

The MaxiFlex - Fiberoptic Energy Delivery System is designed to deliver lase energy to perform: general surgical, dermatological, intraoral soft tissue, orthopaedic, maxillo-facial, and The MaxiFlex fiber is intended for energy delivery for ablating, incising, cosmetic surgery. excising, vaporization and coagulation of soft tissues within the medical/surgical specialties noted above using a contact fiber optic based laser system.

The device is suitable for use for all applications for which the laser output unit is cleared, including: general and cosmetic surgery, intraoral soft-tissue, otolaryngology, arthroscopy, including, general surgery, dermatology & plastic surgery, neurosurgery, gynecology, urology, ophthalmology and pulmonary surgery.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

MaxFlx.doc

Muriam C. Patvost

(Optional format 1-2-96)

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

510(k) Number

Over-The-Counter Use

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.