Occlusion Detection Dressing Kit

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 September 22, 2017 Cardinal Health Beth Foster Regulatory Affairs Manager 1500 S Waukegan Rd Waukegan, Illinois 60085 Re: K171499 Trade/Device Name: Occlusion Detection Dressing Kit Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: OMP Dated: August 29, 2017 Received: August 30, 2017 Dear Beth Foster: 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 {1}------------------------------------------------ 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 (DICE) 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" (21 CFR 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 (DICE) 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, # David Krause -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) K171499 #### Device Name Cardinal Health NPWT Occlusion Detection Dressing Kit and Canister Indications for Use (Describe) The Cardinal Health NPWT device is an integrated wound management system, indicated for the application of continual or intermittent negative pressure wound therapy. The system may promote wound healing by the removal of fluids, including wound exudates, irrigation fluids and infectious materials. The system is intended for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. The system is intended for use in acute, extended and home care settings. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|----------------------------------------------------------| | <div></div> | <div></div> Prescription Use (Part 21 CFR 801 Subpart D) | | <div></div> | <div></div> Over-The-Counter Use (21 CFR 801 Subpart C) | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Cardinal Health NPWT Dressing Kit and Canister Modification Traditional 510(k) ## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS ## Cardinal Health NPWT Occlusion Detection Dressing Set and Canister (A summary of safety and effectiveness information in accordance with the requirements of 21 | 510(k) Number: | K171499 | |-------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Applicant: | Cardinal Health<br>1500 S Waukegan Road<br>Waukegan, IL 60085 | | Establishment<br>Registration Number: | 3006367520 | | Regulatory Affairs<br>Contact: | Beth Foster | | Telephone: | 954-585-5145 | | Fax: | N/A | | E-mail: | beth.foster@cardinalhealth.com | | Date Summary Prepared: | May 22, 2017 | | Trade Name: | Cardinal Health NPWT Occlusion Detection Dressing Kit and Canister | | Common Name: | Negative Pressure Wound Therapy Dressing Kit and Canister | | Classification Name: | Powered Suction Pump (21 CFR 878.4780) | | Classification Panel: | General & Plastic Surgery | | Regulatory Class: | Class II | | Product Code(s): | OMP | | Legally marketed device(s) to which equivalence is claimed: | K150124 Cardinal Health NPWT PRO HC | | Reason for 510(k) Submission: | Modification of the tubing and fluid canister to allow detection of blockage or an occlusion that may occur in the dressing or within the tubing, which in turn triggers an alarm on the pump. | | Device Description: | The Cardinal Health NPWT system consists of a powered suction pump device that provides continuous or intermittent negative pressure (SVED – K142916, PRO/PRO to GO/PRO at HOME – K143016, PRO HC – K150124) with a built-in placement holder for the fluid collection canister, various sizes and shapes of polyurethane foam dressing, canister tubing with clamps and connectors, polyurethane drape with adhesive, and fluid collection | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Cardinal Health. The logo consists of a stylized red bird-like design above the company name. The text "CardinalHealth" is written in a sans-serif font, with the first letter capitalized and the rest in lowercase. Cardinal Health NPWT Dressing Kit and Canister Modification Traditional 510(k) canisters. The pump devices are AC-powered, portable suction devices with battery backup that provide localized negative pressure to remove fluids and infectious materials from the wound. The devices must be used with the Cardinal Health NPWT dressing kits, which are available in various foam sizes. Each Cardinal Health NPWT dressing kit contains an occlusion detection tubing set. various sizes of polyurethane foam, and a polyurethane drape with adhesive. The purpose of this submission is to modify 1) the tubing in the dressing kits and 2) the disposable fluid collection canister to allow detection of blockage or an occlusion that may occur in the dressing or within the tubing, which in turn triggers an alarm on the pump. The modification consists of a dual lumen tubing set with a twist and lock port that attaches to a disposable fluid collection canister. The canister is modified with three ports in the cap of the canister. One port accepts the twist and lock end of the tubing set for collection of exudate from the wound, and two ports connects to sensors within the pump device. The modifications to the tubing set and the fluid collection canister cap do not require any software or hardware changes to the NPWT pump devices. There are no changes to the Indications for Use for any of the NPWT devices. The Cardinal Health NPWT device is an integrated wound Indications for Use: management system, indicated for the application of continual or intermittent negative pressure wound therapy. The system may promote wound healing by the removal of fluids, including wound exudates, irrigation fluids, body fluids and infectious materials. The system is intended for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. The system is intended for use in acute, extended and home care settings. | Characteristics | | | |---------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Feature | Cardinal Health NPWT Dressing Kit<br>with Occlusion Detection | Cardinal NPWT PRO HC Dressing<br>Kit without Occlusion Detection<br>K150124 | | Indications for Use | Same as predicate | The Cardinal Health NPWT SVED<br>PRO Family and PRO HC are<br>integrated wound management<br>systems, indicated for the<br>application of continual or<br>intermittent negative pressure<br>wound therapy to the wound as the<br>device may promote wound healing<br>by the removal of fluids, including | | | | wound exudates, irrigation fluids,<br>body fluids and infectious materials.<br>The system is intended for patients<br>with chronic, acute, traumatic,<br>subacute and dehisced wounds,<br>partial-thickness burns, ulcers (such<br>as diabetic pressure), flaps and<br>grafts. The system is intended for<br>use in acute, extended and home<br>care settings. | | Product Code | OMP | OMP | | Patient Population | Same as predicate | Adult single patient | | Environment of Use | Same as predicate | Hospitals, Clinics, Long Term Care<br>and Home Care settings | | Used in conjunction with Cardinal<br>Health NPWT pump devices | Same as predicate | Yes | | Alarms | • Low Pressure/Leak<br>• Canister Full/Blockage<br>• Low Battery | • Low Pressure/Leak<br>• Canister Full<br>• Low Battery | | Drape | Same as predicate | Polyurethane film with gentle<br>acrylic adhesive | | Foam Dressings | Same as predicate | • Black foam (Polyurethane),<br>Hydrophobic, Open pore structure<br>(400-600 microns) with multiple<br>foam sizes:<br>Sm: 10x8x3 cm<br>Med: 20x12.5x3cm<br>Lg: 25x15x3cm<br>XLg: 58.5x33x3cm<br>• White foam hydrophilic, high<br>density, smaller pore size, flexible<br>wet or dry<br>• Black foam (Polyurethane),<br>Hydrophobic, Open pore structure<br>(600-900 microns)<br>Strips -25x3.8 x1.3 cm | | Tubing | • Polyurethane tubing with ABS<br>plastic port<br>• Dual lumen tubing with<br>SpeedConnect<br>• Twist and lock port for<br>attachment to canister | • Polyvinyl chloride tubing with<br>French connect port<br>• Single lumen tubing with<br>SpeedConnect<br>• French connect port to attach for<br>attachment to canister | | Canister | • Twist and lock port for<br>attachment to tubing<br>• Porous hydrophobic filter to<br>prevent fluid ingress<br>• 300cc and 500cc canister volume | • Grommet port for attachment to<br>tubing<br>• Porous hydrophobic filter to<br>prevent fluid ingress<br>• 300cc and 500cc canister volume | | Biocompatibility | Non-cytotoxic<br>Non-sensitizing<br>Non-irritating | Non-cytotoxic<br>Non-sensitizing<br>Non-irritating | | Sterilization | Same as predicate | EtO Sterilization | ### Comparison of Technological otomiation {5}------------------------------------------------ Image /page/5/Picture/0 description: The image contains the Cardinal Health logo. The logo consists of a stylized red graphic above the text "CardinalHealth". The graphic is composed of several curved lines that converge at a point, resembling a stylized bird in flight or a medical symbol. The text is in a sans-serif font, with "Cardinal" in a slightly larger and bolder font than "Health". Cardinal Health NPWT Dressing Kit and Canister Modification Traditional 510(k) ## Performance Data The following performance data were provided in support of the substantial equivalence determination. There were no Clinical or {6}------------------------------------------------ | CardinalHealth | Cardinal Health NPWT Dressing Kit and Canister Modification<br>Traditional 510(k) | |----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Animal Performance Studies required for substantial equivalence<br>determination. | | | Bench Testing<br>The following testing has been conducted to verify that the<br>modifications of the Dressing Kit and Canister, allowing the<br>detection of a blockage or occlusion, will perform as intended with<br>the Cardinal Health NPWT devices: | | | Proper functioning of device features and alarms<br>●<br>Pressure stability testing<br>●<br>Exudate removal testing<br>●<br>Usability testing<br>● | | Conclusions | The performance data demonstrate that the modifications to the<br>NPWT Dressing Kit and Canister function as intended with no<br>change in safety or effectiveness of the system and are considered | substantially equivalent to the predicate device.