FLEXGUARD

K070924 · Allmed Systems, Inc. · GEX · Jun 21, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K070924
• Device Name: FLEXGUARD
• Applicant: Allmed Systems, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jun 21, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2

Intended Use

The FlexGuard Family of sheath's are intended for use in surgical procedures using flexible scopes and other approved flexible or rigid fiber optic delivery devices, to protect the working channel from damage when a laser fiber is introduced and also to provide irrigation to the surgical site when used for incision, ablation, vaporization and coagulation of soft tissue with any approved laser with a wavelength from 532nm to 2100nm in medical specialties including: Urology, Gasteroenterology, Thoracic, Head and Neck, Pulmonary, Gynecology, ENT and General Surgery

Device Story

FlexGuard is a flexible sheath system designed to protect the working channel of flexible scopes or surgical devices from mechanical damage during laser fiber introduction. The device assembly consists of a flexible sheath and a fiber clamp/Yee piece. The sheath tip protrudes approximately 3mm beyond the laser fiber; the entire assembly is inserted into the scope's working channel. It accommodates laser fibers ranging from 200 to 600 microns in diameter. Beyond protection, the device facilitates irrigation to the surgical site. It is intended for use by physicians in clinical or surgical settings during procedures involving laser wavelengths from 532nm to 2100nm. The device acts as a physical barrier and conduit, ensuring the integrity of the endoscope while enabling therapeutic laser delivery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Flexible sheath assembly with fiber clamp/Yee piece. Designed for laser fibers 200-600 micron diameter. Compatible with laser wavelengths 532nm-2100nm. Mechanical protection and irrigation conduit. No electronic or software components.

Indications for Use

Indicated for patients undergoing surgical procedures requiring laser incision, ablation, vaporization, or coagulation of soft tissue in urology, gastroenterology, thoracic, head and neck, pulmonary, gynecology, ENT, and general surgery, using flexible or rigid fiber optic delivery devices.

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

• Cook - Laser Ureteral Catheter

Submission Summary (Full Text)

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K070924

# Attachment V

JUN 2 1 2007

## 510(k) Summary

#### 1.General Information

Submitter:

AllMed Systems Inc. 9232 Klemetson Drive Pleasanton CA 94588

Phone: [phone]

Fax [phone]

Contact Person Peter Allen

Date Prepared 4th April 2007

#### 2. Names

| Device Name | FlexGuard Family |
|---------------------|------------------|
| Classification Name | Laser Accessory |

## 3. Predicate Device

Cook - Laser Ureteral Catheter

## 4. Product Description

The FlexGuard is a family of flexible sheaths that are used to protect the working channel of a flexible scope or surgical device from mechanical damage when the laser fiber is introduced into the working channel. The tip of the FlexGuard is allowed to protrude approx 3mm beyond the laser fiber, this assembly is then inserted into the working channel of the scope. The FlexGuard Family is designed to work with a range of laser fibers from 200 micron to 600 micron diameter.

It consists of:

{1}------------------------------------------------

Flexible Sheath Fiber clamp/Yee piece

Reference Attachment II for photographs detailing and describing the Reference Attachments of the FlexGuard. Reference Appendix VIII for a list of fibers that can be used in conjunction with the FlexGuard

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AllMed Systems, Inc. % Mr. Peter Allen President 9232 Klemetson Drive Pleasanton, California 94588

JUN 2 1 2007

Re: K070924

Trade/Device Name: FlexGuard 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, FED

Dated: May 4, 2007 Received: May 7, 2007

Dear Mr. Allen:

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 -- Mr. Peter Allen

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (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) This letter will anow you to ogin maining of substantial equivalence of your device to a legally premarket notheation: "The PDA miams of casification 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 If you desire specific acrivaliance at [phone]. Also, please note the regulation entitled, Coniact the Office of Compilance in (21CFR Part 807.97). You may obtain Whisolanding of Nierence to promotion on your the Act from the Division of Small other general information on Jour response Assistance at its toll-free number [phone] or Manufacturers, International and Octress http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Malkerson

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: K070924

FlexGuard Device Name:

Indications For Use:

The FlexGuard Family of sheath's are intended for use in surgical procedures using flexible scopes and other approved flexible or rigid fiber optic delivery devices, to protect the working channel from damage when a laser fiber is introduced and also to provide irrigation to the surgical site when used for incision, ablation, vaporization and coagulation of soft tissue with any approved laser with a wavelength from 532nm to 2100nm in medical specialties including: Urology, Gasteroenterology, Thoracic, Head and Neck, Pulmonary, Gynecology, ENT and General Surgery

(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
62.4

Number 167095

**510(k) Number-**

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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