Who is the manufacturer of GENADYNE SPIRO FOAM DRESSING KIT?

Genadyne Biotechnologies, Inc. filed the 510(k) submission for GENADYNE SPIRO FOAM DRESSING KIT (K141961).

What is the FDA product code for GENADYNE SPIRO FOAM DRESSING KIT?

OMP. It is classified under 21 CFR 878.4780 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for GENADYNE SPIRO FOAM DRESSING KIT?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like GENADYNE SPIRO FOAM DRESSING KIT?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

GENADYNE SPIRO FOAM DRESSING KIT

Q: What are the predicate devices for GENADYNE SPIRO FOAM DRESSING KIT?

A4-XLR8 Foam Dressing (K092992).

K141961 · Genadyne Biotechnologies, Inc. · OMP · Mar 26, 2015 · General, Plastic Surgery

Device Facts

Record ID	K141961
Device Name	GENADYNE SPIRO FOAM DRESSING KIT
Applicant	Genadyne Biotechnologies, Inc.
Product Code	OMP · General, Plastic Surgery
Decision Date	Mar 26, 2015
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4780
Device Class	Class 2
Attributes	Therapeutic

Intended Use

Genadyne Spiro 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 materials and tissue debris.

Device Story

Spiro Foam Dressing Kit is a single-use wound dressing; used with Genadyne A4-XLR8 Wound Vacuum System to deliver negative pressure wound therapy. Input: wound exudates, infectious materials, tissue debris. Transformation: foam dressing facilitates suction-based removal of wound fluids; promotes healing. Output: negative pressure environment at wound site. Used in clinical settings by healthcare providers. Benefits: promotes wound healing via exudate removal. Kit includes flexible polyether/polyester polyurethane foam, silicone tubing, and transparent adhesive film; housed in Tyvek/Mylar peel pouch.

Clinical Evidence

Bench testing only. Biocompatibility testing per ISO 10993 (cytotoxicity, sensitization, irritation, pyrogenicity, systemic toxicity) showed no significant biological reaction. Sterilization validation per ISO 11135 confirmed 10^-6 SAL. Stability testing (accelerated aging, peel, bubble, ship, microbial challenge) confirmed 2-year shelf life. Extractable/leachable analysis of foam colorants showed no significant chemical compounds above reporting limits.

Technological Characteristics

Materials: Flexible polyether and polyester polyurethane foam, silicone tubing, polyurethane film. Sensing/Actuation: Passive dressing for negative pressure delivery. Dimensions: 104 cm length x 1.9 cm width x 1.6 cm height. Sterilization: Ethylene oxide (ISO 11135). Connectivity: None (standalone dressing).

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)

Related Devices

K092992 — A4-XLR8 FOAM DRESSING · Genadyne Biotechnologies, Inc. · Jun 29, 2010
K082211 — RENASYS-F NEGATIVE PRESSURE WOUND THERAPY FOAM DRESSING KITS · Smith & Nephew, Inc. · Nov 14, 2008
K133333 — UNI NPWT FOAM DRESSING KIT, UNI NPWT FOAM DRESSING KIT, UNI NPWT FOAM DRESSING KIT · Blue Ocean Medical Product, LLC · Dec 31, 2014
K221888 — Genadyne Hybrid Foam Dressings · Genadyne Biotechnologies, Inc. · Jun 12, 2023
K161935 — Avance Foam Dressing Kit - XL · Molnlycke Health Care Us, LLC · Nov 4, 2016

Submission Summary (Full Text)

{0}------------------------------------------------ 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 human profiles facing right, with flowing lines representing hair or clothing. The profiles are stacked on top of each other, creating a sense of depth. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 26, 2015 Genadyne Biotechnologies Incorporated Mr. Chien-Ming Goh Vice President 16 Midland Avenue Hicksville, New York 11801 Re: K141961 Trade/Device Name: Spiro Foam Dressing Kit Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: February 23, 2015 Received: February 25, 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set {1}------------------------------------------------ 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours. # Jennifer R. Stevenson -S For 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K141961 Device Name Spiro Foam Dressing Kit ### Indications for Use (Describe) Genadyne Spiro Foam Dressing Kit is intended to be used in conjunction with the Genadyne A4-XLR8 Wound Vacuum System (K09063) 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 materials and tissue debris. Spiral 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><tr><td></td><td>Transactional, Identified in a PPE Vehicle Category Filing</td></tr><tr><td></td><td>One-Time, Non-Transactional, PPE Vehicle Category Filing</td></tr></table> | | Transactional, Identified in a PPE Vehicle Category Filing | | One-Time, Non-Transactional, PPE Vehicle Category Filing | |-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|-------------------------------------------------------------------------|---------------|-----------------------------------------------------------------------| | | Transactional, Identified in a PPE Vehicle Category Filing | | | | | | | One-Time, Non-Transactional, PPE Vehicle Category Filing | | | | | |× | Prescription Use (Part 21 CFR 801 Subpart D) | | Over-The-Counter Use (21 CFR 801 Subpart C) # CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ 2014 # Traditional 510k Summary | General Information | | Date: July 10, 2014 | | |---------------------|---------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | 1. | Applicant | Genadyne Biotechnologies, Inc. 16 Midland Ave, Hicksville, NY 11801 (t) 516.487.8787 (f) 516.977-8974 | | | 2. | Contact Person | Mr. Chien-Ming GOH (Andrew) Vice President Genadyne Biotechnologies Inc. 16 Midland Ave, Hicksville, NY 11801 (t) 516.217.0101 (f) 516.977.8974 | | | 3. | Trade Name | Genadyne Spiro Foam Dressing Kit (Ref: XF-SPMK1) | | | 4. | Common Name | Foam Dressing | | | 5. | Classification Name | Powered Suction Pump | | | 6. | Regulation Number | 21 CFR 878.4780 | | | 7. | Product Code | OMP | | | 8. | Class in which Device has been placed | Class II | | | 9. | Panel | General & Plastic Surgery | | | 10. | Reason for Premarket Notification | New Device | | | 11. | Identification of Legally Marketed Device Which We Can Claim Substantial Equivalence (Predicate Device) | A4-XLR8 Foam Dressing K092992 | | | 12. | Brief Description of Device | Gendayne Spiro Foam Dressing Kit is a single-use dressing is housed in a Tyvek/Mylar Peel Pouch. | | {4}------------------------------------------------ #### 13. Indications for use [21 CFR 807.92(a)(5)] Genadyne Spiro 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 materials and tissue debris. Spiro 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 . | No. | | Foam | Port Tubing | Film | |-----|--------------------|---------------------------------------------------------------------------------------|-------------|--------------| | 1. | Materials Used: | Flexible Polyether and Polyester Polyurethane Foam | Silicone | Polyurethane | | 2. | Size: | 104 +/- 1.5 cm uncoiled length x 1.9 +/- .3 cm width x 1.6 +/-0.15 cm height | 31 inches | 26 x 30 cm | # 14. Technological Characteristics # Table of Comparison to Predicate Devices: | | Predicate | New | |---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Parameters | Genadyne A4-XLR8 Foam Dressing | Genadyne Spiro Foam Dressing Kit | | 510(k) Number | K092992 | | | Indications for Use | Genadyne A4-XLR8 Foam Dressing Kits are intended to be used in conjunction with the Genadyne Wound Vacuum System to deliver negative pressure to the wound. Genadyne Wound Vacuum System is indicated for patients who would benefit from a suction device particularly as the device may promote wound healing by the | Genadyne Spiro 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 | {5}------------------------------------------------ | | removal of excess exudates, infectious materials and tissue debris. | promote wound healing by the removal of excess exudates, infectious materials and tissue debris. | |------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | A4-XLR8 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 | A4-XLR8 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 | | Foam Dressing Material | Flexible Polyether and Polyester Polyurethane Foam | Flexible Polyether and Polyester Polyurethane Foam | | Hydrophobic | Yes | Yes | | Sizes: | 7.5 cm X 10 cm x 3.3cm 12.5 cm x 18 cm x 3.3 cm 15 cm x 26 cm x 3.3 cm | 104 +/- 1.5 cm uncoiled length x 1.9 +/- .3 cm width x 1.6 +/-0.15 cm height | | For use with Negative Pressure Wound Therapy Systems | Yes | Yes | | Sterile | Yes | Yes | | Kit Content | Silicone Tubing Transparent Adhesive Film | Silicone Tubing Transparent Adhesive Film | #### Non Clinical Tests 15. | XLR8 Spiro Dressing Kit | Biocompatibility tests were performed on the dressing kit in accordance to ISO 10993. Report can be found in 013_Attachment_D in the RTA submission. | In Report 13-02487-G1, the green foam dressing kit meets the requirements of the test as per ISO 10993-5, and is not considered to have a cytotoxic effect. In Report 13-02487-G2, the green foam dressing kit meets the requirements of the ISO 10993-10 guidelines. It did not show a significantly greater biological reaction than the sites injected with the control article. In Report 13-02487-G3, the green foam dressing kit displayed a Grade 1 sensitization rate and based on the scoring system of Kligman as per ISO 10993-10 guidelines, it is not considered significant and is classified as having a weak allergenic potential. In Report 13-02487-G4, the green foam dressing kit is considered non-pyrogenic and meets the requirements of the Pyrogen Test, as per ISO 10993-11 guidelines. In Report 13-02487-G5, the green foam kit did not induce a significantly greater biological reaction than the control extracts, when tested in Swiss Albino mice, therefore it is considered negative based on standards set by ISO 10993-11. | |-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| {6}------------------------------------------------ | Sterilization validation was performed in accordance to ISO 11135. Report can be found in 016_Attachment I in the original submission. | The sterilization activity confirms a $10^{-6}$ sterility assurance level (SAL), by utilizing the half-cycle overkill approach which demonstrated total inactivation of a $10^{-6}$ BI at half exposure time, on a four (4) pallet load of wound vacuum dressing sets. | |----------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Stability test was performed and the report can be found in 015_Attachment H in the original submission. | In the stability test, we performed:- 1. Accelerated aging test 2. Peel test 3. Bubble test 4. Ship test 5. Package aerosol spore challenge test All test results shows that the packages met the requirements of the protocol for 2 year equivalent aging. No significant degradation of seal was observed, bubble test showed no leaks at any test points, microbial challenge shows good resistance and no significant degradation, and bubble test after ship test showed no leaks. | | Colorant test was performed on the blue and yellow colorant that makes the green foam. The report can be found in 015_Attachment F. | In Report 14-04232-N1, a test to determine the extractable amount of chemical compounds from sponsor test material was performed. In the test against metals, no elements above reporting limit were detected in any of the colorants except for sodium in Reactint Blue X3LV. However, sodium was also observed in the control solution (purified water) this presence of sodium cannot be unequivocally attributed to blue colorant. In the test against volatile organic compound (VOC), no VOC were observed in any of the colors nor samples. In the SVOC analysis of the purified water extract, no SVOC attributable to the test article were observed. No SVOC were observed in colorant solutions. In the target NVOC analysis of purified water extracts, no target-NVOC attributable to the test article were observed. No NVOC were observed in the colorant solutions. In the Non-Target NVOC in purified water extracts, no additional peaks were observed in the LC chromatogram of samples compared to the LC chromatogram of control. | - Conclusion & Based on the information presented above, it is 16. Determination of concluded that the Spiro Foam Dressing Kit is Substantial Equivalence substantially equivalent to the predicate device.