PICO Single Use Negative Pressure Wound Therapy System

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 April 18, 2017 Smith & Nephew Medical Limited Samantha Neilson Regulatory Affairs Manager, Advanced Wound Management 101 Hessle Road Hull, HU3 2BN GB Re: K163387 Trade/Device Name: Pico Single Use Negative Pressure Wound Therapy System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: OMP Dated: March 17, 2017 Received: March 20, 2017 Dear Samantha Neilson: 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 devicerelated 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. {1}------------------------------------------------ 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" (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 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 Binita S. Ashar, M.D., M.B.A., F.A.C.S. for 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) K163387 Device Name PICO Single Use Negative Pressure Wound Therapy System Indications for Use (Describe) PICO is indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via removal of low to moderate levels of exudate and infectious materials. Appropriate wound types include: - Chronic - Acute - Traumatic - Subacute and dehisced wounds - Partial-thickness burns - Ulcers (such as diabetic or pressure) - Flaps and grafts - Closed Surgical incisions PICO Single Use Negative Pressure Wound Therapy System is suitable for use both in a hospital and homecare setting. X 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}------------------------------------------------ ## SECTION 7: 510(K) SUMMARY # PICO Single Use Negative Pressure Wound Therapy System | General Information | | |------------------------------------|-----------------------------------------------------------------------------| | Submitter Name/Address: | Smith & Nephew Medical Limited 101 Hessle Road, Hull HU3 2BN United Kingdom | | Establishment Registration Number: | 8043484 | | Contact Person: | Samantha Neilson, Regulatory Affairs Manager | | Phone Number | +44 1482 673790 | | Date Prepared: | November 30, 2016 | | Device Description | | | Trade Name: | PICO Single Use Negative Pressure Wound Therapy System | | Common or Usual Name: | Negative Pressure Wound Therapy | | Classification Name: | Powered suction pump (21 CFR 878.4780) | | Regulatory Class: | Class II | | Product Code: | OMP | | Predicate Device Information | | | <b>510(k) Number:</b> | K112127 | |-----------------------|-------------| | <b>Device:</b> | PICO Single | Use Negative Pressure Wound Therapy System {4}------------------------------------------------ Clearance Date: May 16, 2012 | 510(k) Number: | K151436 | |-----------------|-----------------------------------------------------------| | Device: | PICO Single Use Negative Pressure<br>Wound Therapy System | | Clearance Date: | Jan 28, 2016 | #### Device Description PICO Single Use Negative Pressure Wound Therapy System is a small, lightweight, portable suction device consisting of an electric motor driven, twindiaphragm, vacuum pump connected to a super-absorbent, gentle adhesive dressing. The pump, dressing and secondary fixations strips are supplied sterile and single use. The dressing is applied to the wound and secondary fixation strips are placed over the outside edges to help hold the dressing in place. When the suction pump is turned on, air is pulled out of the dressing creating negative pressure and drawing excess fluid from the wound into the dressing. The pump is battery operated and is supplied with two AA lithium batteries which provide up to 168 hours (7 days) of battery life depending upon leak rate. The batteries can be replaced if required. The pump is programmed to stop working after 168 hours (7 days) of use and will not re-start after this time, even with new batteries. Negative pressure will not be applied at this point. PICO Single Use Negative Pressure Wound Therapy System is suitable for use in both a hospital and homecare setting. A carry bag is not provided with the system however will be available to order separately. #### Indications for Use PICO is indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via removal of low to moderate levels of exudate and infectious materials. Appropriate wound types include: {5}------------------------------------------------ - Chronic - Acute - Traumatic - Subacute and dehisced wounds - Partial-thickness burns, Ulcers (such as diabetic or pressure) - Flaps and grafts - · Closed surgical incisions PICO Single Use Negative Pressure Wound Therapy System is suitable for use in both a hospital and homecare setting. ## Comparison between New and Predicate Devices The Indications for Use statement of the PICO Single Use Negative Pressure Wound Therapy System is identical to the predicate devices. The technological principal for delivering the negative pressure wound therapy for both the subject and predicate devices are identical. The proposed modifications to the cleared device include: - (a) a change in the design of the tube connecting the pump to the dressing, - (b) introduction of two new dressings with new shape configuration but identical material of construction, - (c) the introduction (addition to existing range) of PICO NPWT systems with single dressing, - (d) the introduction of a new packaging configuration. ## Non-Clinical Tests (Bench) The following bench tests have successfully been completed: - · Wound Model Testing of PICO kits 10x20cm, 25x25cm, small multisite 15x20cm, large multisite 20x25cm dressings at moderate flow rate The results of the tests showed that all of the dressings managed fluid at a flow rate modelling a moderately exuding wound (1.1 g/cm²/24 hours) for a simulated wound of 25% of the dressing absorbent pad area. The results also showed that {6}------------------------------------------------ the dressings maintained negative pressure within the test requirements of -60 mmHq to -100 mmHg for a minimum of 95% of the test time at the simulated wound base throughout the test. Based on the results of the tests it can be concluded that the proposed modifications did not affect the performance of the PICO System. - Wound Model Testing of PICO kits 10x20cm, 25x25cm, small multisite . 15x20cm, large multisite 20x25cm dressings at low flow rate The results of the tests showed that all of the dressings managed fluid at a flow rate modelling a low exuding wound (0.6 g/cm²/24 hours) for a simulated wound of 25% of the dressing area. The results also showed that the dressings maintained negative pressure within the test requirements of -60 mmHg to -100 mmHg for a minimum of 95% of the test time at the simulated wound base throughout the test. Based on the results of the tests it can be concluded that the proposed modifications did not affect the performance of the PICO System. - Wound Model Testing of PICO kits 25x25cm dressings at moderate flow rate (vertical orientation) The results of the tests showed that all of the dressings managed fluid at a flow rate modelling a moderately exuding wound (1.1 g/cm²/24 hours) for a simulated wound of 25% of the dressing area. The results also showed that the dressings maintained negative pressure within the test requirements of -60 mmHg to -100 mmHg for a minimum of 95% of the test time at the simulated wound base throughout the test. Based on the results of the tests it can be concluded that the proposed modifications did not affect the performance of the PICO System. - Wound Model Testing of PICO kits 25x25cm dressings at low flow rate . (vertical orientation) The results of the tests showed that all of the dressings managed fluid at a flow rate modelling a low exuding wound (0.6 g/cm²/24 hours) for a simulated wound of 25% of the dressing area. The results also showed that the dressings {7}------------------------------------------------ maintained negative pressure within the test requirements of -60 mmHg to -100 mmHq for a minimum of 95% of the test time at the simulated wound base throughout the test. Based on the results of the tests it can be concluded that the proposed modifications did not affect the performance of the PICO System. ### Biocompatibility and Sterilization Testing The biocompatibility of PICO Single Use Negative Pressure Wound Therapy System has been demonstrated through assessment according to ISO 10993-1 Biological Evaluation of Medical Devices. Appropriate tests have been conducted using PICO with Soft Port Dressing or representative samples that had been packaged and sterilised. These tests included cytotoxicity, sensitization, irritation, a sub-acute dermal toxicity study (wound healing), sub-acute toxicity and genotoxicity which assessed the PICO with Soft Port Dressing or representative materials. In addition, further endpoints have been assessed with reference to FDA quidance 'Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The secondary fixation strips, PVC tubing, connector, pump body and button are the same as previously cleared under 510(k) K151436 and 510(k) K112127. The test reports submitted in these 510(k)s are still valid and have not been included in this 510(k) notice. The results of the studies listed above confirm that the PICO Single Use Negative Pressure Wound Therapy System is safe for its intended use. In addition, ethylene oxide residual testing has been performed in accordance with ISO 10993-7 which confirms that PICO with Soft Port Dressing and fixation strips comply with the allowable residual limits for ethylene oxide (EO) and ethylene chlorohydrin (ECH). ### Electrical Safety and Electromagnetic Compatibility (EMC) There are no changes made to the pump cleared under 510(k) K151436 Jan 28, 2016. All the electrical safety compliance certificates previously submitted are still valid. {8}------------------------------------------------ ## Conclusions In establishing substantial equivalence to the predicate devices, Smith & Nephew Medical Ltd evaluated the indications for use, materials, technology, product specifications and energy requirements of the device. Performance testing, service life testing and electrical safety testing has been completed to demonstrate that the modified PICO Single Use Negative Pressure Wound Therapy System is substantially equivalent to the predicate for the intended use.