NPWT WOUND DRESSING KIT- MEDIUM, NPWT WOUND DRESSING KIT- LARGE

{0}------------------------------------------------ # 510(k) Summary # 807.92(c) # SPONSOR Company Name: Company Address: | Telephone: | 317-849-2675 | |-----------------|----------------| | Fax: | 866-271-2580 | | Contact Person: | Jon D. Speer | | Date Prepared: | April 29, 2014 | Cork Medical Products 6406 Castleway Court Indianapolis, IN 46250 # DEVICE NAME Trade Name: Common / Usual Name: Classification Name: | Regulation Number: | | |--------------------|--| | Product Code: | | | Device Class: | | | Panel: | | # PREDICATE DEVICE Table 1 - Predicate Devices | Company | Brand Name | 510(k) Number | |-----------------------------------|-------------------------------------|---------------| | Genadyne<br>Biotechnologies, Inc. | A4 Wound Dressing Vacuum System Kit | K082676 | | Genadyne<br>Biotechnologies, Inc. | A4-XLR8 Foam Dressing | K092992 | # DEVICE DESCRIPTION Cork Medical Products NPWT Wound Dressing Kit is comprised of components necessary to dress a wound for negative pressure wound therapy. The kit includes reticulated, 30 pores per inch (PPI), polyether, polyurethane foam; transparent polyurethane film drape with adhesive backing; and port pad assembly comprised of silicone port pad, drainage tubing, luer connector, pinch clamp, and transparent polyurethane film drape with adhesive backing. P. 16 807.92(a)(2) 807.92(a)(1) Cork NPWT Wound Dressing Kit Negative Pressure Wound Therapy Powered Suction Pump and Accessories 21 CFR 878.4780 OMP Class II General & Plastic Surgery Cork Medical Products NPWT Wound Dressing Kit ## 807.92(a)(3) 807.92(a)(4) {1}------------------------------------------------ The kits are available in two (2) sizes: medium and large based on the size of the foam. The medium foam is: 0.75″ x 5″ x 8″. The large foam is 0.75″ x 6″ x 10″. Each kit is single-use and housed in a Tyvek peel pouch, which is sterilized using ethylene oxide. #### DEVICE INTENDED USE #### 807.92(a)(5) Cork Medical Products NPWT Wound Dressing Kit is intended to be used in conjunction with the Genadyne XLR8 Pump to deliver negative pressure wound therapy to the wound. When used in conjunction with a NPWT pump system, Cork Medical Products NPWT Wound Dressing Kit 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. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. #### PREDICATE PRODUCT COMPARISON TABLE #### 807.92(a)(6) | Component | Cork Medical Products NPWT Wound<br>Dressing Kit K132004 | Genadyne Biotechnologies, Inc. A4 Wound<br>Dressing Vacuum System Kit & A4-XLR8<br>Foam Dressing K082676 & K092992<br>(predicate) | |----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Wound Foam -<br>Material | Reticulated polyether based polyurethane<br>foam (A30M) | Reticulated polyether based polyurethane<br>foam (A30M) | | Wound Foam -<br>Sizes | Medium: 0.75" x 5" x 8"<br>Larger: 0.75" x 6" x 10" | Small: 2.5-cm x 6-cm x 6-cm (~1" x 2.36" x<br>2.36")<br>Medium: 2-cm x 10-cm x 15-cm (~0.79" x<br>3.94" x 5.91")<br>Large: 2.5-cm x 15-cm x 25-cm (~1 x 5.91"<br>x 9.84") | | Wound Foam -<br>Biocompatibility | Yes - data provided by UFP Technologies<br>(foam manufacturer) | Yes | | Wound Foam -<br>510(k) | To be determined | K092992 | | Wound Drape -<br>Material | Transparent polyurethane film with<br>adhesive backing | Transparent film dressing | | Wound Drape -<br>Biocompability | Yes - data provided by George Medical for<br>DermaMed medical grade acrylic | None specified | | Wound Drape -<br>510(k) | K951842 & K990955 (via George Medical,<br>LLC) | K082676 | | Port Pad Assembly | Silicone port pad<br>Drainage tubing<br>Luer connector<br>Pinch clamp<br>Port Pad Skirt (Transparent polyurethane<br>film with adhesive backing) | Silicone port pad<br>Drainage tubing<br>Luer connector<br>Pinch clamp<br>Transparent film with adhesive backing | | Port Pad - 510(k) | K132004 (this submission) | K082676 | | Sterilization<br>Method | Ethylene Oxide | Individual kit components individually<br>sterilized by Ethylene Oxide or Gamma<br>Irradiation | Table 2 - Predicate Comparisons {2}------------------------------------------------ | Regulation Number<br>/ Product Code | 21 CFR 878.4780 / OMP | 21 CFR 878.4780 / OMP | |-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | Cork Medical Products NPWT Wound<br>Dressing Kit is intended to be used in<br>conjunction with the Genadyne XLR8 Pump<br>to deliver negative pressure wound therapy<br>to the wound.<br><br>When used in conjunction with a NPWT<br>pump system, Cork Medical Products NPWT<br>Wound Dressing Kit 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. | K082676: The Genadyne A4 Wound<br>Vacuum System is indicated for use in<br>patients who would benefit from negative<br>pressure wound therapy particularly as<br>the device may promote wound healing<br>by the removal of excess exudates,<br>infectious material and tissue debris.<br>(NOTE: K082676 includes accessory kit<br>comprised of gauze, transparent film<br>dressing, and silicone flat drain.)<br><br>K092992: Genadyne A4-XLR8 Foam<br>Dressing is intended to be used in<br>conjunction with the Genadyne A4<br>Wound Vacuum System (K082676) to<br>deliver negative pressure wound therapy<br>to the wound. Genadyne A4 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 tissues<br>debris. | ### NONCLINICAL TESTS ### 807.92(b)(1) To ensure the Cork Medical Products NPWT Wound Dressing Kit is substantially equivalent to the Genadyne A4 Wound Dressing Vacuum System Kit and A4-XLR8 Foam Dressing, Cork Medical analyzed the performance of the Cork Wound Kit against the predicate device. The specific head to head performance testing conducted to demonstrate substantial equivalence is: - Continuous Mode Low Negative Pressure (-40-mmHg) Test ◆ - Continuous Mode Typical Negative Pressure (-125-mmHg) Test . - Continuous Mode High Negative Pressure (-200-mmHg) Test . - Intermittent Mode Test - . Leakage Alarm Test - Blockage Alarm Test . - Canister Full Alarm Test . Performance tests used simulated wound exudate. Pressure measurements were taken using a wound test bed fixture. ### SUMMARY OF BIOCOMPATIBILITY COMPLIANCE TESTS #### 807.92(b)(1) A Biocompatibility Risk Assessment was completed by Nelson Laboratories evaluating the biocompatibility of the entire Cork Medical Products Wound Dressing Kit. {3}------------------------------------------------ Additional biocompatibility testing was performed on the wound foam and wound drape components, the patient contacting components, for surface device, breached or compromised surface, with a prolonged (24 hours - 30 day) contact per ISO 10993 testing standards. The specific biocompatibility testing performed on the wound foam and wound drape was: - . Cytotoxicity Test - . Intracuteneous Reactivity Test - . Sensitization Test All biocompatibility test results were negative and passed the pre-defined test acceptance criteria. Additional biocompatibility information has been provided for each of the individual components included in the Cork Medical Products Wound Dressing Kit, as follows: - . Wound Foam - Summary of ISO 10993 biocompatibility tests performed on material by UFP o Technologies listed on A-30M specification. - Crest Foam A-30M MAF 1837- FDA Registration Certificate. o - Wound Drape & Port Pad Drape . - Summary of ISO 10993 biocompatibility tests performed on DermaMed medical grade o acrylic adhesive provided. - NOTE: The port pad drape is not in contact with the patient. Biocompatibility not o required. - . Silicone Port Pad - This material is not in contact with the patient. Biocompatibility not required. o - Wacker Silicones Elastosil® R 420/60 S. o - . Port Pad tubing - This material is not in contact with the patient. Biocompatibility not required. o - Dow Corning Silastic® RX-50 medical grade tubing. o - Luer connector This material is not in contact with the patient. Biocompatibility not required. . - Pinch Clamp This material is not in contact with the patient. Biocompatibility not required. . #### CLINICAL TESTS No clinical testing provided. #### SUBSTANTIAL EQUIVALENCE The results of the nonclinical tests performed demonstrate the performance of the Cork Medical Products Wound Dressing Kit is substantially equivalent to the performance of the predicate device, Genadyne A4 Wound Dressing Vacuum System Kit and A4-XLR8 Foam Dressing. The results of the nonclinical tests and summary of biocompatibility compliance tests demonstrate the Cork Medical Products Wound Dressing Kit is safe. # 807.92(b)(3) 807.92(b)(2) {4}------------------------------------------------ To further establish substantial equivalence to the predicate device, Genadyne A4 Wound Dressing Vacuum System Kit and A4-XLR8 Foam Dressing, Cork Medical Products evaluated the indications for use, materials, technology, and product specifications for the product. As a result of this analysis along with performance testing, Cork Medical has demonstrated substantial equivalence of the Cork Medical Products NPWT Wound Dressing Kit for its indications for use. . {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers. ### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 2, 2014 Cork Medical Products LLC % Mr. Jon Speer Creo Quality, LLC P.O. Box 1784 Martinsville, Indianapolis 46151 Re: K132004 Trade/Device Name: Cork Medical Products NPWT Wound Dressing Kit Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: March 7. 2014 Received: March 19, 2014 Dear Mr. Speer: 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 docs 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 complics with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any reathal the Act is requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical CFR & Far 807), adeimg (21 CFR 803); good manufacturing practice requirements as set {6}------------------------------------------------ Page 2 - Mr. Jon Speer 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/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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, Binita S. Ashars 2014.05.02 16:41:54 -04'00' Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration #### Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date. January 31, 2017 Soo PRA Statemant below. #### 510(k) Number (if known) K 132004 Device Name Cork Medical Products NI WT Wound Dressing Ku #### Indications for Use (Describe) Cork Mcdical Products NYWT Wound Dressing Kit is intended to be used in conjunction with the Genadyne XLR8 Pump to deliver negative pressure wound therapy to the wound. When used in conjunction with a NPWT puny system. Cork Medical Products NPWT Wound Dressing Kit 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. Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) please do not write below this line – continue on a separate page if needed. #### FOR FDA USE ONLY Concurrence of Conter for Devices and Radiological Health (CDRH) (Signature) # Peter L. Hudson -S 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 lime for this collection of information is estimated to average 79 hours per response, industry the processed of a processed of a processed of a processed of a pro The Uurden time in this Collection of information to vees, gather and maintain the data needed and completer as any other aspect ume to review the collection of information. Send comments regarding this burden astimate 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@ida.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of of conduct of upos it displays a currently valid OMB number " FORM FDA 3881 (1/14) Page i of 1 PAC Publishing Group, 510(k) 1445-70 E