PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PICO Fluid Management Pack

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font. October 30, 2020 Smith & Nephew Medical Limited Steeve Lamvohee Regulatory Affairs Director 101 Hessle Road Hull, Yorkshire HU3 2BN United Kingdom Re: K202157 Trade/Device Name: PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PICO Fluid Management Pack Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: OMP Dated: July 31, 2020 Received: August 3, 2020 Dear Steeve Lamvohee: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. {1}------------------------------------------------ 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Kimberly M. Ferlin, Ph.D. Assistant Director (Acting) DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ 510(k) Number (if known) K202157 Device Name PICO 7 Single Use Negative Pressure Wound Therapy System #### Indications for Use (Describe) PICO 7 Single Use Negative Pressure Wound Therapy System 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 7 Single Use Negative Pressure Wound Therapy Systems are suitable for use both in a hospital and homecare setting. | Type of Use (Select one or both, as applicable) | | |---------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------| | <div> <span> </span> <span>Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> | <div> <span> </span> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> | ## 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 {3}------------------------------------------------ 510(k) Number (if known) K202157 Device Name PICO 7Y Single Use Negative Pressure Wound Therapy System #### Indications for Use (Describe) PICO 7Y Single Use Negative Pressure Wound Therapy System 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 7Y Single Use Negative Pressure Wound Therapy Systems are suitable for use both in a homecare setting. | Type of Use (Select one or both, as applicable) | |-----------------------------------------------------------------------------------------------| | <span style="text-decoration: overline;"></span> 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 {4}------------------------------------------------ 510(k) Number (if known) K202157 #### Device Name PICO 14 Single Use Negative Pressure Wound Therapy System #### Indications for Use (Describe) PICO 14 Single Use Negative Pressure Wound Therapy System 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 14 Single Use Negative Pressure Wound Therapy Systems are suitable for use both in a homecare setting. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------| | <div> <span> <b> </b> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | ## 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 {5}------------------------------------------------ 510(k) Number (if known) #### K202157 Device Name PICO Fluid Management Pack #### Indications for Use (Describe) PICO single use negative pressure systems are indicated for patients who would benefit from a suction device (negative pressure wound therapy) as they 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 systems are suitable for use both in a hospital and homecare setting. | Type of Use (Select one or both, as applicable) | | |---------------------------------------------------------------------------------------------------------------------------|--| | <span> <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | | | <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> | | ## 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 {6}------------------------------------------------ PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, and the PICO Fluid Management Pack. | I. Submitter | | |------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Owner<br>Name/Address: | Smith &Nephew Medical Limited<br>101 Hessle Road<br>Hull<br>HU3 2BN<br>United Kingdom | | Establishment<br>Registration<br>Number: | 8043484 | | Contact Person: | Dr Steeve Lamvohee, Regulatory Affairs Director | | Phone Number: | +44 7583 048727 | | Date Prepared: | 08 Sep 2020 | | II. Device | | | Trade Names: | PICO 7 Single Use Negative Pressure Wound Therapy System<br>PICO 7Y Single Use Negative Pressure Wound Therapy System<br>PICO 14 Single Use Negative Pressure Wound Therapy System<br>PICO Fluid Management Pack | | Common or Usual<br>Name: | Negative Pressure Wound Therapy powered suction pump | | Classification Name: | Powered suction pump (21 CFR 878.4780) | | Regulatory Class: | Class II | | Product Code: | OMP | | 510(k) Number: | K202157 | | III. Predicate Device | | | 510(k) Number: | K180698 | | Device name: | PICO 7 Single Use Negative Pressure Wound Therapy System | | Clearance Date: | 21 August 2018 | | Recall Information: | The predicate has not been the subject of any recall | {7}------------------------------------------------ Use Negative Pressure Wound Therapy Systems Traditional 510(k) Premarket Notification K202157 # IV. Device Description All of the PICO devices (PICO 7 (K180698), PICO 7Y (K182323), and PICO 14 (K191760) are canister-free single-use Negative Pressure Wound Therapy (NPWT) Systems and use an absorbent dressing connected to a small NPWT pump by a tubing and port. The dressing manages wound exudate by a combination of absorption and evaporation. The pump provides for a -80mmHg nominal pressure under the dressing, applying Negative Pressure Wound Therapy (NPWT) to the wound. PICO Fluid Management Pack are packs of 5 individually packaged PICO Dressings designed for use with PICO devices. # V. Indications for Use PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System. PICO 14 Single Use Negative Pressure Wound Therapy System. and the PICO Fluid Management Pack are 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 7, PICO 7 Y and PICO 14 Single Use Negative Pressure Wound Therapy Systems are suitable for use in both a hospital and homecare setting. # VI. Comparison of Technological Characteristics with the Predicate Device The technological principle for delivering the negative wound therapy for the subject devices and predicate device are identical. The differences between the subject devices and the predicate device are: - · Updated text for Magnet Warning - · Removal of Pump warning label {8}------------------------------------------------ # Smith Nephew Traditional 510(k) Premarket Notification K202157 | Items | Subject Devices:<br>PICO 7 Single Use Negative<br>Pressure Wound Therapy<br>System, PICO 7Y Single Use<br>Negative Pressure Wound<br>Therapy System, PICO 14 Single<br>Use Negative Pressure Wound<br>Therapy System, PICO Fluid<br>Management Pack | Predicate Device:<br>PICO 7 Single Use<br>Negative Pressure<br>Wound Therapy System | Comparison | |-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications For<br>Use | PICO 7 Single Use Negative<br>Pressure Wound Therapy<br>System, PICO 7Y Single Use<br>Negative Pressure Wound<br>Therapy System, PICO 14 Single<br>Use Negative Pressure Wound<br>Therapy System, and PICO Fluid<br>Management Pack are<br>indicated for patients who would<br>benefit from a suction device<br>(NPWT) as it may promote<br>wound healing via removal of<br>low to moderate levels of<br>exudate and infectious materials.<br>Appropriate wound types<br>include:<br>Chronic<br>Acute<br>Traumatic<br>Subacute and dehisced wounds<br>Partial-thickness burns<br>Ulcers (such as diabetic or<br>pressure)<br>Flaps and grafts<br>Closed surgical incisions<br>PICO 7, PICO 7Y, PICO 14<br>Single Use Negative Pressure<br>Wound Therapy Systems and<br>PICO Fluid Management Pack is<br>suitable for use both in a hospital<br>and homecare setting. | PICO 7 Single Use<br>Negative Pressure<br>Wound Therapy System<br>is indicated for patients<br>who would benefit from<br>a suction device<br>(NPWT) as it may<br>promote wound healing<br>via removal of low to<br>moderate levels of<br>exudate and infectious<br>materials. Appropriate<br>wound types include:<br>Chronic<br>Acute<br>Traumatic<br>Subacute and dehisced<br>wounds<br>Partial-thickness burns<br>• Ulcers (such as diabetic<br>or pressure)<br>Flaps and grafts<br>Closed surgical incisions<br>PICO 7 Single Use<br>Negative Pressure<br>Wound Therapy System<br>is suitable for use both in<br>a hospital and homecare<br>setting. | Same | | Environment of<br>use | Hospital, home | Hospital, home | Same | | Items | Subject Devices:<br>PICO 7 Single Use Negative<br>Pressure Wound Therapy<br>System, PICO 7Y Single Use<br>Negative Pressure Wound<br>Therapy System, PICO 14 Single<br>Use Negative Pressure Wound<br>Therapy System, PICO Fluid<br>Management Pack | Predicate Device:<br>PICO 7 Single Use<br>Negative Pressure<br>Wound Therapy System | Comparison | | Patient<br>Population | Patients who would benefit from<br>a suction device (negative<br>pressure wound therapy) | Patients who would<br>benefit from a suction<br>device (negative<br>pressure wound therapy) | Same | | Materials | PU Plastic pump casing | PU Plastic pump casing | Same | | Single-use or<br>Reusable | Single use | Single use | Same | | Method of<br>Sterilization | Pump, dressing and fixation<br>strips sterilized by ethylene oxide | Pump, dressing and<br>fixation strips sterilized<br>by ethylene oxide | Same | | Biocompatibility | Dressing complies with ISO<br>10993 | Dressing complies with<br>ISO 10993 | Same | | Type of Pump | Custom designed "voice-coil"<br>pump controlled by<br>microprocessor | Custom designed<br>"voice-coil" pump<br>controlled by<br>microprocessor | Same | | Electrical Safety<br>Testing | Complies with IEC 60601-1, IEC<br>60601-1-2, IEC 60601-1-11 | Complies with IEC<br>60601-1, IEC 60601-1-<br>2, IEC 60601-1-11 | Same | | Instructions for<br>Use | Addition of the word medical<br>• If you have an electronic<br>medical device and are helping<br>take care of somebody else using<br>the PICO 7 system.<br>As requested by the FDA,<br>addition of "MR Unsafe. You<br>must remove the PICO 7 pump<br>from the dressing before entering<br>the MRI suite. Do not bring<br>PICO 7 into the MRI scan room.<br>The device presents a projectile<br>hazard." | • If you have an<br>electronic device and are<br>helping take care of<br>somebody else using the<br>PICO 7 system<br>N/A | Magnet warning<br>box in HCP and<br>Patient IFU<br>changed<br>Addition of<br>warning to HCP<br>and Patient IFU | | | Texts amended in "Important<br>Information Section" and<br>"Glossary of Symbols" | The PICO [#] pumps<br>contain a MAGNET.<br>Keep the PICO [#] | Important<br>Information and<br>Glossary of | | Items | Subject Devices:<br>PICO 7 Single Use Negative<br>Pressure Wound Therapy<br>System, PICO 7Y Single Use<br>Negative Pressure Wound<br>Therapy System, PICO 14 Single<br>Use Negative Pressure Wound<br>Therapy System, PICO Fluid<br>Management Pack | Predicate Device:<br>PICO 7 Single Use<br>Negative Pressure<br>Wound Therapy System | Comparison | | | The PICO [#] pumps contain a<br>MAGNET. Keep the PICO [#]<br>pumps at least 4 inches (10 cm)<br>away from other medical devices<br>at all times. As with all electrical<br>medical equipment, failure to<br>maintain appropriate distance<br>may disrupt the operation of<br>nearby medical devices. | pumps at least 4 inches<br>(10 cm) away from other<br>medical devices at all<br>times. Failure to do so<br>can cause the other<br>medical device to fail<br>which can result in<br>serious harm including<br>death. | Symbols in HCP<br>and Patient IFU<br>changed.<br>Texts removed<br>"Failure to do so<br>can cause the<br>other medical<br>device to fail<br>which can result<br>in serious harm<br>including death."<br>Texts added "As<br>with all electrical<br>medical<br>equipment,<br>failure to<br>maintain<br>appropriate<br>distance may<br>disrupt the<br>operation of<br>nearby medical<br>devices." | | Warning Label<br>on front of Pump | No warning label on the front of<br>the pump. | <br> | Warning Label<br>Removed | | | | Image: PICO 7 pump | | {9}------------------------------------------------ # Smith Nephew Traditional 510(k) Premarket Notification K202157 {10}------------------------------------------------ Traditional 510(k) Premarket Notification K202157 # VII. Performance Data Performance data provided in previously cleared 510(k)s for PICO 7, PICO 7Y and PICO 14 Single Use Negative Pressure Wound Therapy Systems (including PICO Fluid Management Pack) continue to support substantial equivalence. Additional data is provided to support the proposed change including testing of magnetic field, an analysis of postmarket surveillance, and a risk {11}------------------------------------------------ Traditional 510(k) Premarket Notification K202157 analysis. In the cleared 510(k)s for PICO 7, PICO 7Y and PICO 14 Single Use Negative Pressure Wound Therapy Systems (including PICO Fluid Management Pack), the device met requirements for: Biocompatibility: - FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, "Biological ● Evaluation of Medical Devices Part 1: Evaluation and Testing,"" May 1, 1995, - International Standard ISO 10993-1 "Biological Evaluation of Medical Devices Part 1: ● Evaluation and Testing Within a Risk Management Process," as recognized by FDA. Testing included the following: - Cytotoxicity - Sensitization - . Irritation - Systemic toxicity - Pyrogen Testing # Electrical Safety and Electromagnetic Compatibility: - IEC 60601-1 ● - IEC 60601-1-11 - IEC 60601-1-6 ● - IEC 60601-1-2 # Wound model testing: - Wound exudate ● - Wound size - NPWT Wound flow rate ● - Testing duration - Pressure sampling rates ● ## Magnetic Field Testing: Bench testing demonstrated that the average magnetic field strength of PICO Family pump is weaker than multiple everyday devices (e.g. laptops, phones, tablets, and headphones). These products are abundant in today's society and do not pose an unacceptable risk to patients with implantable medical devices (IMDs). The PICO pump does not significantly change the magnetic environment an IMD user may encounter. ## Post Market and Risk Analysis: A systematic literature review was conducted of IMDs and magnetic interference and this demonstrated that although the risk of magnetic interference with implantable medical devices exists, the risk is not as high as had been originally assessed. Magnetic fields are present in the everyday environment which are comparable with those presented by the PICO devices, however, there are no risks that have been reported in the clinical literature that relate to actual death or serious harm. A comprehensive review of over 60,000 records from the MAUDE database as well as the Smith +Nephew PICO devices complaint data confirmed the literature review outcome. # VIII. Conclusion Data to confirm substantial equivalence to the predicate were provided in the FDA cleared 510(k) for PICO Family of Single Use Negative Pressure Wound Therapy Systems. The proposed labeling changes are supported by updated IFUs, evaluation of risk and updated risk analysis, and magnetic strength testing. The subject devices are substantially equivalent to the predicate device.