MAXIFLEX FIBER OPTIC ENERGY DELIVERY SYSTEM

K013300 · Technology Delivery Systems, Inc. · GEX · Apr 16, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K013300
• Device Name: MAXIFLEX FIBER OPTIC ENERGY DELIVERY SYSTEM
• Applicant: Technology Delivery Systems, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Apr 16, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MaxiFlex - Fiberoptic Energy Delivery System is designed to deliver laser 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, general surgery, dermatology & plastic surgery, neurosurgery, gynecology, urology, ophthalmology and pulmonary surgery.

Device Story

MaxiFlex Fiberoptic Energy Delivery System consists of multi-mode, single-core quartz optical fibers (200, 400, 600, 1000um diameters) with SMA 905 connectors. Device attaches to existing surgical laser systems (diode/crystal-based) to deliver laser energy (532-2100 nm) to target tissue. Operated by physicians or dentists in healthcare facilities; device is non-sterile and requires user-performed steam sterilization (270°F/10min). Fiber is stripped and cleaved to emit laser radiation for contact-based soft tissue ablation, incision, excision, vaporization, and coagulation. Output is controlled by the host laser unit; clinical benefit derived from precise tissue interaction during surgical procedures.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence is based on physical and performance characteristics compared to legally marketed predicate devices.

Technological Characteristics

Multi-mode, single-core quartz optical fibers; diameters 200, 400, 600, 1000um. SMA 905 connector interface. Compatible with diode and crystal-based laser systems (532-2100 nm). Supports continuous wave and pulsed operation modes. Max power 100 Watts. Non-sterile; user-sterilizable via steam (270°F/10min).

Indications for Use

Indicated for patients requiring soft tissue ablation, incision, excision, vaporization, or coagulation across various surgical specialties including general, plastic, dermatological, intraoral, orthopaedic, maxillo-facial, otolaryngology, arthroscopy, neurosurgery, gynecology, urology, ophthalmology, and pulmonary surgery. Contraindications are not explicitly stated, but use is restricted to prescription by a physician or dentist.

Regulatory Classification

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.

Predicate Devices

• StrateFire
• InnovaQuartz

Submission Summary (Full Text)

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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

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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 Energy<br>Delivery System | StrateFire | InnovaQuartz | SE? |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|
| Type of laser | Diode & crystal fiber-optic<br>based lasers | Any surgical laser equipment<br>fitted with an SMA 905<br>connector | 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 and<br>1000 um core quartz fiber | Multi-mode 400, 600, 800 and<br>1000 um core quartz fiber | Multi-mode 200, 400, 600 um<br>core quartz fiber, | YES |
| Sterility: | User sterilized - Steam - 270°<br>/10min. exposure | User sterilized - Steam - 270°<br>/10min. exposure | User sterilized - Steam - 270°<br>/10min. exposure | |
| Connector Type: | SMA 905 connector | SMA 905 connector | SMA 905 connector | YES |
| Intended Use and<br>Indications for Use | The MaxiFlex - Fiberoptic<br>Energy Delivery System is<br>designed to deliver laser energy<br>to perform: general surgical,<br>dermatological, intraoral soft<br>tissue, orthopaedic, maxillo-<br>facial, and cosmetic surgery.<br>The MaxiFlex fiber is intended<br>for energy delivery for ablating,<br>incising, excising, vaporization<br>and coagulation of soft tissues<br>within the medical/surgical<br>specialties noted above using a<br>contact fiber optic based laser<br>system.<br>The device is suitable for use<br>for all applications for which<br>the laser output unit is cleared,<br>including: general and cosmetic<br>surgery, intraoral soft-tissue,<br>otolaryngology, arthroscopy,<br>gastroenterology, general<br>surgery, dermatology & plastic<br>surgery, neurosurgery,<br>gynecology, urology,<br>ophthalmology and pulmonary<br>surgery. | Ablation and hemostasis in<br>treatment of gynecological and<br>urological conditions, as well as<br>multiple applications in<br>gastroenterology and general<br>surgery. | Vaporization, coagulation,<br>hemostasis, and incision of soft-<br>tissue. For use with Nd: YAG,<br>HO:YAG or Argon laser<br>systems cleared for medical use<br>accepting an SMA 905<br>connector. | YES |

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#### 10. 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.

#### 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.

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

OR

Muriam C. Patvost

(Optional format 1-2-96)

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

510(k) Number

10

Over-The-Counter Use