XLR8 White Foam Dressing Kit and XLR8 White Foam Small Dressing Kit and

K142646 · Genadyne Biotechnologies, Inc. · OMP · Apr 30, 2015 · General, Plastic Surgery

Device Facts

• Record ID: K142646
• Device Name: XLR8 White Foam Dressing Kit and XLR8 White Foam Small Dressing Kit and
• Applicant: Genadyne Biotechnologies, Inc.
• Product Code: OMP · General, Plastic Surgery
• Decision Date: Apr 30, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4780
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Genadyne XLR8 White Foam Dressing Kit is intended to be used in conjunction with the Genadyne A4-XLR8 Wound Vacuum System (K090638) to deliver negative pressure wound therapy to the wound. Genadyne A4-XLR8 Wound Vacuum System is indicated for patients who would benefit from a suction device particularly as the device may promote wound healing by the removal of excess exudates, infectious material and tissue debris. XLR8 White Foam Dressing is appropriate for use on the following wounds: Pressure ulcers Diabetic/Neuropathic Ulcers Venous insufficiency Ulcers Traumatic wounds Post-operative and dehisced surgical wounds Skin flap and grafts

Device Story

Genadyne XLR8 White Foam Dressing Kit comprises a polyvinyl alcohol (PVA) foam, silicone port, and transparent polyurethane adhesive film. Used in conjunction with the Genadyne A4-XLR8 Wound Vacuum System; the kit facilitates negative pressure wound therapy (NPWT). The foam is placed into the wound bed, sealed with the transparent film, and connected via the silicone port to the vacuum pump. The system applies negative pressure to the wound site to remove excess exudates, infectious material, and tissue debris, thereby promoting wound healing. The device is intended for prescription use in clinical or home settings under the guidance of a healthcare provider. The healthcare provider monitors the wound and the system's performance to adjust therapy as needed. The kit is provided sterile.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993-5 (cytotoxicity) and ISO 10993-10 (sensitization and intracutaneous injection). Performance bench testing confirmed component compatibility and adherence to acceptability criteria. Stability testing (2-year accelerated aging and real-time) confirmed bioburden, packaging, seal integrity, and performance.

Technological Characteristics

Materials: Polyvinyl Alcohol (foam), Silicone (port), Polyurethane (film). Sensing/Actuation: Passive dressing component for NPWT. Connectivity: None (standalone dressing). Sterilization: Gamma radiation (foam), Ethylene Oxide (port/film). Form factor: Various foam sizes (e.g., 20x15x1 cm to 7.5x10x1 cm).

Indications for Use

Indicated for patients requiring negative pressure wound therapy for pressure ulcers, diabetic/neuropathic ulcers, venous insufficiency ulcers, traumatic wounds, post-operative/dehisced surgical wounds, and skin flaps/grafts.

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

• A4-XLR8 Foam Dressing (K092992)

Reference Devices

• Genadyne A4-XLR8 Wound Vacuum System (K090638)
• Genadyne A4 Wound Vacuum System (K082676)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three faces in profile, stacked on top of each other. The faces are oriented to the right and are connected to form a single, flowing shape. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 30, 2015

Genadyne Biotechnologies Incorporated Mr. Chien-Ming (Andrew) Goh Vice President 16 Midland Avenue Hicksville, New York 11801

Re: K142646

Trade/Device Name: Genadyne XLR8 White Foam Dressing Kit Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: March 27, 2015 Received: March 30, 2015

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 note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical

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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 Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

for

Sincerely yours,

# David Krause -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K142646

Device Name Genadyne XLR8 White Foam Dressing Kit

#### Indications for Use (Describe)

Genadyne XLR8 White Foam Dressing Kit is intended to be used in conjunction with the Genadyne A4-XLR8 Wound Vacuum System (K090638) to deliver negative pressure wound. Genadyne A4-XLR8 Wound Vacuum System is indicated for patients who would benefit from a suction device particularly as the device may promote wound healing by the removal of excess exudates, infectious material and tissue debris.

XLR8 White Foam Dressing is appropriate for use on the following wounds:

- Pressure ulcers
- Diabetic/Neuropathic Ulcers
- · Venous insufficiency Ulcers
- · Traumatic wounds
- · Post-operative and dehisced surgical wounds
- · Skin flap and grafts

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

| <table border="0"><tr><td><div align="left"> <input name="" type="checkbox" value=""/> <span>For use in connection with a FEE-Only Retirement Plan</span> </div></td></tr></table> | <div align="left"> <input name="" type="checkbox" value=""/> <span>For use in connection with a FEE-Only Retirement Plan</span> </div> | <table border="0"><tr><td><div align="left"> <input name="" type="checkbox" value=""/> <span>For use in connection with a FEE-Based Retirement Plan</span> </div></td></tr></table> | <div align="left"> <input name="" type="checkbox" value=""/> <span>For use in connection with a FEE-Based Retirement Plan</span> </div> |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| <div align="left"> <input name="" type="checkbox" value=""/> <span>For use in connection with a FEE-Only Retirement Plan</span> </div> | | | |
| <div align="left"> <input name="" type="checkbox" value=""/> <span>For use in connection with a FEE-Based Retirement Plan</span> </div> | | | |

|× | Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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### Traditional 510k Summary

| General Information | Date: 4/29/2015 | |
|---------------------|---------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. | Applicant | Genadyne Biotechnologies, Inc.<br>16 Midland Ave,<br>Hicksville, NY 11801<br>(t) 516.487.8787<br>(f) 516.977-8974 |
| 2. | Contact Person | Mr. Chien-Ming GOH (Andrew)<br>Vice President<br>Genadyne Biotechnologies Inc.<br>16 Midland Ave,<br>Hicksville, NY 11801<br>(t) 516.217.0101<br>(f) 516.977.8974 |
| 3. | Trade Name | Genadyne XLR8 White Foam Dressing Kit<br>(Ref:PVA-FOAM1) |
| 4. | Common Name | Foam Dressing |
| 5. | Classification Name | Negative Pressure Wound Therapy Powered<br>Suction Pump and Accessories |
| 6. | Regulation Number | 21 CFR 878.4780 |
| 7. | Product Code | OMP |
| 8. | Class in which Device has<br>been placed | Class II |
| 9. | Panel | General & Plastic Surgery |
| 10. | Reason for Premarket<br>Notification | New Device |
| 11. | Identification of Legally<br>Marketed Device Which We<br>Can Claim Substantial<br>Equivalence (Predicate<br>Device) | A4-XLR8 Foam Dressing K092992 |
| 12. | Brief Description of Device | The Genadyne XLR8 White Foam Kit consists of a<br>XLR8 Port, XLR8 Transparent Film and a XLR8<br>White Foam. Each component are packaged,<br>sealed and sterilized individually and then bagged |

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#### Indications for use 13. [21 CFR 807.92(a)(5)]

Genadyne XLR8 White Foam Dressing Kit is intended to be used in conjunction with the Genadyne A4-XLR8 Wound Vacuum System (K090638) to deliver negative pressure wound therapy to the wound. Genadyne A4-XLR8 Wound Vacuum System is indicated for patients who would benefit from a suction device particularly as the device may promote wound healing by the removal of excess exudates, infectious material and tissue debris.

XLR8 White Foam Dressing is appropriate for use on the following wounds:

- Pressure ulcers ●
- Diabetic/Neuropathic Ulcers .
- Venous insufficiency Ulcers ●
- Traumatic wounds ●
- Post-operative and dehisced surgical ● wounds
- . Skin flap and grafts

The Genadyne XLR8 White Foam Dressing Kit is a Rx only device.

### 14. Technological Characteristics

| No. | | Foam | Port Tubing | Film |
|-----|--------------------|-----------------------------------------------------------------------|-------------|--------------|
| 1. | Materials<br>Used: | Polyvinyl Alcohol<br>Dressing | Silicone | Polyurethane |
| 2. | Size: | 20 cm x 15 cm x 1 cm<br>15 cm x 10 cm x 1 cm<br>7.5 cm x 10 cm x 1 cm | 31 inches | 26 x 30 cm |

### Table of Comparison to Predicate Devices:

| Parameters | Predicate | New |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Parameters | Genadyne<br>A4-XLR8 Foam Dressing | Genadyne<br>XLR8 White Foam Dressing Kit |
| 510(k) Number | K092992 | TBD |
| Indications for Use | Genadyne A4-XLR8 Foam Dressing is<br>intended to be used in conjunction with<br>the Genadyne A4 Wound Vacuum<br>System (K082676) to deliver negative<br>pressure wound therapy to the wound. | Genadyne XLR8 White Foam Dressing<br>Kit is intended to be used in conjunction<br>with the Genadyne A4-XLR8 Wound<br>Vacuum System (K090638) to deliver<br>negative pressure wound therapy to the |

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| | Genadyne A4 Wound Vacuum System is<br>indicated for patients who would benefit<br>from a suction device, particularly as the<br>device may promote wound healing by<br>the removal of excess exudates,<br>infectious material and tissue debris.<br>A4-XLR8 Foam Dressing is appropriate<br>for use on the following<br>wounds:Pressure ulcers Diabetic/Neuropathic Ulcers Venous insufficiency ulcers Traumatic wounds Post-operative and dehisced surgical wounds Skin flap and graft | wound. Genadyne A4-XLR8 Wound<br>Vacuum System is indicated for patients<br>who would benefit from a suction device<br>particularly as the device may promote<br>wound healing by the removal of excess<br>exudates, infectious material and tissue<br>debris.<br>XLR8 White Foam Dressing is<br>appropriate for use on the following<br>wounds: Pressure ulcers Diabetic/Neuropathic Ulcers Venous insufficiency ulcers Traumatic wounds Post-operative and dehisced surgical wounds Skin flap and grafts |
|------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Foam Dressing<br>Material | Flexible Polyether and Polyester<br>Polyurethane Foam | Polyvinyl Alcohol Dressing |
| Hydrophobic | Yes | Yes |
| Sizes: | 7.5 cm X 10 cm x 3.3cm<br>12.5 cm x 18 cm x 3.3 cm<br>15 cm x 26 cm x 3.3 cm | 20 cm x 15 cm x 1 cm<br>15 cm x 10 cm x 1 cm<br>7.5 cm x 10 cm x 1 cm |
| For use with Negative<br>Pressure Wound<br>Therapy Systems | Yes | Yes |
| Sterile | Yes | Yes |
| Sterilization Method | EO | Gamma Radiation for White Foam, EO<br>for Silicone Port and Transparent Film |
| Kit Content | Silicone Tubing<br>Transparent Adhesive Film | Silicone Port<br>Transparent Adhesive Film |

## 15. Summary of Non clinical Tests

| Device | Tests | Rationale |
|------------------------|----------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| XLR8 White Foam<br>Kit | ISO 10993-5<br>L929 Neutral Red<br>Uptake<br>Cytotoxicity Test | Based on the criteria of the protocol and the ISO<br>10993-5 Guidelines, the test article meets the<br>requirements of the tests and s not considered to<br>have a cytotoxic effect. |
| | ISO 10993-10<br>Kligman<br>Maximization Test | Based on the defined scoring system of Kligman,<br>this is a Grade 1 reaction and the test article is<br>classified as having weak allergenic potential. A<br>Grade 1 sensitization rate is not considered<br>significant and the test article meets the<br>requirements of the ISO 10993-10 guidelines. |
| | ISO 10993-10<br>Intracutaneous<br>Injection Test | The test article sites did not show a significantly<br>greater biological reaction than the sites injected<br>with the control article. Based on the criteria of the<br>protocol, the test article meets the requirements<br>of the ISO 10993-10 guidelines. |
| | Bench Tests for<br>Performance | Results from the bench test shows that the<br>dressing kit components are all compatible and |

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| Evaluation | performs up to the acceptability criteria. |
|----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Stability Test | Stability tests was performed on our foams and<br>components with 2 year accelerated aging and<br>continuous real time. Devices has passed and met<br>all expectations of the stability tests in terms of<br>bioburden, packaging, seal integrity and<br>performance. |

- Conclusion & 16. Determination of Substantial Equivalence
Based on the information presented above, it is concluded that the XLR8 White Foam Dressing Kit is substantially equivalent to the predicate devices and is safe and effective to be used together with a negative pressure wound therapy device.