GENADYNE A4-XLR8 WOUND VACUUM SYSTEM

K090638 · Genadyne Biotechnologies, Inc. · OMP · Apr 29, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K090638
• Device Name: GENADYNE A4-XLR8 WOUND VACUUM SYSTEM
• Applicant: Genadyne Biotechnologies, Inc.
• Product Code: OMP · General, Plastic Surgery
• Decision Date: Apr 29, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4780
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Genadyne A4-XLR8 Wound Vacuum System is indicated for use in patients who would benefit from negative pressure wound therapy particularly as the device may promote wound healing by the removal of excess exudates, infectious material and tissue debris.

Device Story

Portable suction device providing negative pressure wound therapy (NPWT). Device applies controlled vacuum to wound site via accessory wound sealing kits; removes excess exudates, infectious material, and tissue debris to promote healing. Operated by healthcare professionals or patients in clinical or home settings. Output consists of continuous or intermittent negative pressure; allows monitoring of wound environment. Benefits include accelerated wound healing through debris removal and exudate management.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by performance testing and device comparison to the predicate.

Technological Characteristics

Portable suction pump; Class II device (21 CFR 878.4780). System includes pump unit and accessory wound sealing kits. Operates via negative pressure generation. Technical specifications and materials are identical to the predicate device (K082676).

Indications for Use

Indicated for patients requiring negative pressure wound therapy to promote healing via removal of excess exudates, infectious material, and tissue debris.

Regulatory Classification

Identification

A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.

Predicate Devices

• Genadyne A4 Wound Vacuum System (K082676)

Submission Summary (Full Text)

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K090636 page 1/2

#### Special 510k Summary

#### General Information

- 1. Applicant:
Genadyne Biotechnologies Inc. 65 Watermill Lane, Great Neck, NY 11021 (t) 516.487.8787 (f) 516.487.7878 www.genadyne.com

APR 2 9 2009

- 2. Contact Person: Mr. Chien-Ming GOH (Andrew) Vice President Genadyne Biotechnologies Inc. 65 Watermill Lane, Great Neck, NY 11021 Tel: [phone] Fax: [phone] [e-mail]
## 3. Trade/Proprietary Name Including Model Number of Device:

Genadyne A4-XLR8 Wound Vacuum System

# 4. Common Name or Classification Name (21 CFR Part 807.87) of Device:

Powered Suction Pump (21 CFR 878.4780, Product Code

OMP)

### 5. Class in which Device has been placed:

- Class II
### 6. Reason for Premarket Notification:

Introduction of a new device that is a modification of a legally marketed device.

# 7. Identification of Legally Marketed Device Which We Claim Substantial Equivalence (Predicate Device):

Genadyne A4 Wound Vacuum System (K082676)

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K090638 page 2/2

## 8. Compliance with Requirements of the Federal FD&C Act:

The General and Restorative Device Panel (DGRD) has classified this device as Class II, 21 CFR 878.4780

OMP Product Code:

## 9. Kit Certification and Information:

This device kit is exactly the same as its predicate device (K082676)

#### 10. Description of the Device

The product is a portable suction device that may promote wound healing when used with accessory wound sealing kits.

## 11. Intended use of the Device

Genadyne A4-XLR8 Wound Vacuum System is indicated for use in patients who would benefit from negative pressure wound therapy particularly as the device may promote wound healing by the removal of excess exudates, infectious material and tissue debris.

### 12. Substantial Equivalence

In establishing substantial equivalence to the predicate device. Genadyne Biotechnologies evaluated the indications for use, material, technology, product specifications, and energy requirements of the system. Performance testing has been completed to demonstrate the safe and effective use of the Genadyne A4-XLR8 Wound Vacuum System for the intended use.

### 13. Summary of Safety and Effectiveness

Performance testing and device comparison demonstrates that the subject device is substantially equivalent to the predicate device, and is safe and effective for the intended use.

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Public Health Service

Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, facing left. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# APR 9 9 2009

Genadyne Biotechnologies, Inc. % Mr. Chien-Ming Goh Vice President 65 Watermill Lane Great Neck, New York 11021

Re: K090638

Trade/Device Name: Genadyne A4-XLR8 Wound Vacuum System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: II Product Code: OMP Dated: April 20, 2009 Received: April 23, 2009

Dear Mr. Goh:

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.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

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

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Page 2 - Mr. Chien-Ming Goh

[phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at [phone]. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

For Nelo V

O.K.

Mark N. Melkerson 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):

K090638

Device Name: Genadyne A4-XLR8 Wound Vacuum System

Indications For Use:

The Genadyne A4-XLR8 Wound Vacuum System is indicated for use in patients who would benefit from negative pressure wound therapy particularly as the device may promote wound healing by the removal of excess exudates, infectious material and tissue debris.

Prescription Use (Per 21 CFR 801 Subpart D)

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)

Daniel Krane fee MXM

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

**510(k) Number** K990638