Anscare SIMO Negative Pressure Wound Therapy (NPWT) System

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. May 4, 2020 BenQ Materials Corporation Isabel Tsai Regulatory Affairs Department 29 Jianguo E. Rd., Guishan Taoyuan, TW 33341 Re: K193185 Trade/Device Name: Anscare SIMO Negative Pressure Wound Therapy (NPWT) System Regulation Number: 21 CFR 878.4683 Regulation Name: Non-Powered Suction Apparatus Device Intended For Negative Pressure Wound Therapy Regulatory Class: Class II Product Code: OKO Dated: January 15, 2020 Received: January 22, 2020 Dear Isabel Tsai: 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. 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You must comply with all the Act's {1}------------------------------------------------ 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 (OS) 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 mediation-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. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K193185 #### Device Name Anscare SIMO Negative Pressure Wound Therapy (NPWT) System (SIMO System) #### Indications for Use (Describe) SIMO 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 excess exudate and infectious materials. SIMO System is suitable for use in both hospital and homecare setting and is indicated for the following wound types: - · Chronic wounds - · Acute wounds - · Traumatic wounds - · Subacute and dehisced wounds - · Partial-thickness burns - · Ulcers (such as diabetic or pressure) - · Flaps and grafts - · Closed surgical incisions Type of Use (Select one or both, as applicable) 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}------------------------------------------------ Anscare SIMO Negative Pressure Wound Therapy (NPWT) System ## 510(k) Summary # General Information: | Type of Submission: | Traditional | |----------------------|--------------------------------------------------------------------| | Submitter: | BenQ Materials Corporation | | Address: | No. 29, Jianguo E. Rd., Gueishan, Taoyuan,<br>33341, Taiwan, R.O.C | | Phone: | +886-3-374-8800 | | Fax: | +886-3-374-8888 | | Contact: | Isabel Tsai<br>(Isabel.Tsai@BenQMaterials.com) | | Registration number: | 3010256218 | | Date prepared: | May 4, 2020 | # Identification of the Device: | Device Name: | Anscare SIMO Negative Pressure Wound<br>Therapy (NPWT) System | |-----------------------------------------|-----------------------------------------------------------------------------------------| | Classification Name: | Non-Powered suction apparatus device<br>intended for negative pressure wound<br>therapy | | Device Classification: | Class II | | Regulation Number: | 21 CFR 878.4683 | | Panel: | General & Plastic Surgery | | Product Code: | OKO | | Identification of the Predicate Device: | | | Predicate Device Name: | SNaP® Wound Care System | |------------------------|-----------------------------------------------------------------------------------------| | Manufacturer: | Spiracur Inc. | | Classification Name: | Non-Powered suction apparatus device<br>intended for negative pressure wound<br>therapy | | Device Classification: | Class II | {4}------------------------------------------------ | BenQ Materials Corporation<br>510(k) Notification | Anscare SIMO Negative<br>Pressure Wound Therapy<br>(NPWT) System | |---------------------------------------------------|------------------------------------------------------------------| | Regulation Number: | 21 CFR 878.4683 | | Panel: | General & Plastic Surgery | | Product Code: | OKO | | 510(k) Number: | K151710 | | Reference Device | PICO Single Use Negative Pressure Wound | | Name: | Therapy System | | Manufacturer: | Smith & Nephew Medical Inc. | | Classification Name: | Powered suction pump | | Device Classification: | Class II | | Regulation Number: | 21 CFR 878.4780 | | Panel: | General & Plastic Surgery | | Product Code: | OMP | | 510(k) Number: | K151436 | | Clearance Date: | January 28, 2016 | ## Device Descrintion #### 1.1 Device Identification: Anscare SIMO Negative Pressure Wound Therapy (NPWT) System including non-sterilized SIMO Pump and sterilized SIMO Dressing. Patient is able to carry the SIMO Pump easily in the pocket or a belt holder (additional accessory). Anscare SIMO Negative Pressure Wound Therapy (NPWT) System is also called "SIMO System" in the following description. SIMO System has 3 types of model variants including "2 SIMO Dressings and 1 SIMO Pump", "2 SIMO Dressings and 1 SIMO Pump with 1 holder" and "3 SIMO Dressings". Each type has 4 models, and each modelcontains 4 different sizes of SIMO dressing separately. {5}------------------------------------------------ Anscare SIMO Negative Pressure Wound Therapy (NPWT) System ### 1.2 Device Characteristics: SIMO System is for single person use only. SIMO Pump could use for 30 days. The SIMO Dressing is sterilized by Ethylene Oxide and single-use. ### 1.3 Environment of Use: SIMO System is suitable for use both in a hospital and homecare setting. ### 1.4 Brief Written Description of the Device: SIMO System including non-sterilized negative pump and sterilize dressing. The negative pressure wound therapy is provided by a pump (-125±15mmHg) up to 30 days by manual and may promote wound healing via the removal of exudate. The negative pressure is provided by the SIMO Pump, and the exudates of wound bed is managed by the dressing. SIMO Dressing is applied to the wound. It should be changed in line with standard wound management guidelines, typically every 3-4 days up to 7 days. More frequent dressing changes may be required depending on the level of exudates, condition of the dressing, wound type/size, orientation of dressing, environmental considerations and/or other patient the considerations. #### Indication for use SIMO 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 excess exudate and infectious materials. SIMO System is suitable for use in both hospital and homecare setting and is indicated for the following wound types: - Chronic wounds - Acute wounds - Traumatic wounds ● - Subacute and dehisced wounds {6}------------------------------------------------ Anscare SIMO Negative Pressure Wound Therapy (NPWT) System - Partial-thickness burns - Ulcers (such as diabetic or pressure) - Flaps and grafts - Closed surgical incisions Comparison of Technological characteristics with the predicate device SIMO System is substantially equivalent in intended use to the predicate devices: SNaP® Wound Care System (K151710). The device is indicated for negative pressure wound therapy (NPWT) that is intended for wound management via application of continual negative pressure to the wound for removal of fluids, including wound exudate and infectious materials. SIMO System and the predicate device (SNaP® Wound Care System) are both non-powered, negative pressure wound therapy device used for the same indicated use. Both systems utilize manually pump to generate the negative pressure gradient. The SIMO System is canister-free. Exudate is retained in the absorbent dressing and allows fluid to evaporate. The technology is similar to the reference device: PICO Single Use Negative Pressure Wound Therapy System (K151436) which has similar absorbable NPWT dressing component, mechanism and performance compared with the subject device. {7}------------------------------------------------ # Device Comparison Table Anscare SIMO Negative Pressure Wound Therapy | Brand and product<br>Items | Anscare SIMO System | SNaP® Wound Care<br>System | PICO Single Use<br>Negative Pressure Wound<br>Therapy System | BenQ Materials Corporation<br>510(k) Notification | | Anscare SIMO Negative<br>Pressure Wound Therapy<br>(NPWT) System | | | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|--------------------------|------------------------------------------------------------------|--------------------------------------|---------------------------| | FDA regulation status | K193185 | K151710 | K151436 | Technology | External use only | Yes | Yes | Yes | | Regulatory Class | Class II | Class II | Class II | | Therap. Delivery<br>Mode | Continuous | Continuous | Continuous | | Product code | OKO | OKO | OMP | | Structure | Pump + tube +<br>dressing | Pump + tube +<br>canister + dressing | Pump + tube +<br>dressing | | Manufacturer | BenQ Materials Corp. | Spiracur Incorporated | Smith & Nephew<br>medical Ltd. | | Power supply | Manual | Manual | Powered | | Indications for Use | SIMO System is<br>indicated for patients<br>who would benefit<br>from a suction device<br>(negative pressure<br>wound therapy) as it<br>may promote wound<br>healing via removal<br>of excess exudate and<br>infectious materials.<br>SIMO System is<br>suitable for use in<br>both hospital and<br>homecare setting and<br>is indicated for the<br>following wound<br>types:<br>• Chronic<br>wounds<br>• Acute wounds<br>• Traumatic<br>wounds<br>• Subacute and<br>dehisced wounds<br>• Partial-thickness<br>burns<br>• Ulcers (such as<br>diabetic or pressure)<br>• Flaps and grafts<br>• Closed surgical<br>incisions | SNaP System with<br>SNaP Cartridge<br>(60cc):<br>The SNaP® Wound<br>Care System is<br>indicated for patients<br>who would benefit<br>from wound<br>management via the<br>application of<br>negative pressure,<br>particularly as the<br>device may promote<br>wound healing<br>through the removal<br>of excess exudate,<br>infectious material<br>and tissue debris. The<br>SNaP® Wound Care<br>System is indicated<br>for removal of small<br>amounts of exudate<br>from chronic, acute,<br>traumatic, subacute<br>and dehisced wounds,<br>partial-thickness<br>burns, ulcers (such as<br>diabetic, venous or<br>pressure), surgically<br>closed incisions, flaps<br>and grafts.<br>SNaP System with<br>SNaP Plus Cartridge<br>(150cc):<br>The SNaP® Wound<br>Care System is | PICO is indicated for<br>patients who would<br>benefit from a suction<br>device (negative<br>pressure wound<br>therapy) as it may<br>promote wound healing<br>via removal of low to<br>moderate levels of<br>exudate and infectious<br>materials.<br>Appropriate wound<br>types include:<br>• Chronic<br>• Acute<br>• Traumatic<br>• Subacute and dehisced<br>wounds<br>• Partial-thickness burns<br>• Ulcers (such as<br>diabetic or pressure)<br>• Flaps and grafts<br>• Closed surgical<br>incisions<br>• PICO Single Use<br>Negative Pressure<br>Wound Therapy<br>System is suitable for<br>use in both hospital<br>and homecare setting. | | Max pump<br>pressure | 125 mmHg | 125 mmHg | 100 mmHg | | Biocompatibility | Pass | Pass | Pass | | | | | | | indicated for patients<br>who would benefit<br>from wound<br>management via the<br>application of<br>negative pressure,<br>particularly as the<br>device may promote<br>wound healing<br>through the removal<br>of excess exudate,<br>infectious material<br>and tissue debris. The<br>SNaP® Wound Care<br>System is indicated<br>for removal of<br>exudate from chronic,<br>acute, traumatic,<br>subacute and dehisced<br>wounds, partial-<br>thickness burns,<br>ulcers (such as<br>diabetic, venous or<br>pressure), surgically<br>closed incisions, flaps<br>and grafts. | | | | | | | | | {8}------------------------------------------------ # K193185 {9}------------------------------------------------ # K193185 Anscare SIMO Negative | BenQ Materials Corporation<br>510(k) Notification | | | Pressure Wound Therapy<br>(NPWT) System | | |---------------------------------------------------|---------------|----------------|-----------------------------------------|----------------| | Technology | Sterilization | Ethylene Oxide | Gamma | Ethylene Oxide | | | Shelf-life | 3 Years | 2 Years | 3 Years | {10}------------------------------------------------ Anscare SIMO Negative Pressure Wound Therapy (NPWT) System #### Performance Testing - Bench In order to ensure Anscare SIMO Negative Pressure Wound Therapy (NPWT) System effective, we designed performance test item to description of the evaluation and the test conclusion are as below: - Tubing Tensile Strength Test To conduct this test for testing the user's pull on it, the testing is for tubing tensile strength test. Based on the test results, we can see that our SIMO System is within the safe range of tube tensile strength and will not fail the treatment due to careless pulling of the user and will not cause any user safety and functional problems. - Adhesive test To conduct this test for testing the product viscosity does not meet the specifications after sterilization, resulting in the user functional and safety concerns. Based on the test results, we can see that our dressing viscosity meet the specifications after sterilization, so it will not lead to user safety and functional problems. - Function Test after Drop Testing To conduct this test for testing the product would not cause component failure due to the user's careless dropping, resulting in the user's safety and functional risks. According to the test results, we can see that if the user uses the device without pay attention and caused falling, it will not lead to malfunction, caused by user safety and security concerns. - Life Time for 30 Days Test To conduct this test for testing the product does not cause fatigue or malfunction of the pump due to the increase in the frequency of uses, resulting in safety and functional risks to the user. According to the test results, we can see that our device has been pressed 150 times, the stable pressure output of the device does not cause malfunction due to falling, it is still normal use, does not lead to the user's safety and functionality problems. {11}------------------------------------------------ Anscare SIMO Negative Pressure Wound Therapy (NPWT) System - Simulation Test To conduct this test for the make sure the product could be welloperated under different circumstances of exudate, low(0.3 ml/cm2/24h) and moderate (1.1 ml/cm-/24h), and the ability in providing stable pressure and managing exudate. We can conclude that Anscare SIMO System can provide effective and stable negative managing exudate, such as permeability. pressure for evapotranspiration rate, and the liquid reflux rate (the ability to keep exudate in the dressing), and the performance tests are all pass. Last but not least, the Smart pattern of Anscare SIMO System is designed not only to notify patients about the condition of negative pressure wound therapy, but to avoid patients failing to judge the changing timing of the dressing, making it more effective and efficient in wound healing. - HFE/UE Report Anscare SIMO NPWT system has been found to be safety and effective for the intended users (healthcare professional, a caregiver or patient) uses and use environments. 15 HCPs and 15 lay users were recruits for the validation testing with the different tasks and use scenario. The conclusion was supported by the HFE/UE processes which complied with "Applying Human Factors and Usability Engineering to Medical Devices Guidance for Industry and Food and Drug Administration Staff (2016)" and analysis of the results. {12}------------------------------------------------ Anscare SIMO Negative Pressure Wound Therapy (NPWT) System #### Biocompatibility and Sterilization Testing SIMO dressing is the patient direct contacting component of the SIMO System. Further, in the choice of our materials, SIMO Dressing was similar to the predicate device, it was only different from two additional layers. To prove there is no additional safety concern, the biocompatibility evaluation for the SIMO Dressing was conducted in accordance with ISO-10993-1, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing'. Appropriate tests had been conducted using final product that has been packaged and sterilized. The testing included the following tests: - In Vitro Cytotoxicity Test - Skin Sensitization Test - Intracutanous Skin irritation Study - Acute Intravenous Systemic Toxicity Study - Acute Intraperitoneal Systemic Toxicity Study - Pyrogen Test - Subacute/subchronic toxicity study - Implantation study - Phthalate leachables study From the results and analysis above, it shows that the SIMO system passed the evaluated biocompatibility tests. Additional, SIMO Dressing is the part of SIMO System which will come in to direct contact with the wounds and normal skin of patients. Concerning the risk of the microbial infection, we conduct the EO sterilization to the SIMO Dressing. To make sure the sterile conditions and sterilization process, we conducted the sterilization valuation in accordance with ISO 11135, Sterilization of health-care products - Ethylene oxide -Requirement for the development, validation and routine control of a sterilization process for medical devices'. The residual testing had been performed in accordance with ISO 10993-7 which confirm the SIMO Dressing comply with the allowable residual limits for ethylene oxide (EO) {13}------------------------------------------------ and its reaction products. #### Conclusion Anscare SIMO Negative Pressure Wound Therapy (NPWT) System has similar indications for use and technological characteristics to the predicate device. The non-clinical data, biocompatibility test, sterilization test demonstrates the substantial equivalence of the SIMO System to the SNaP® Wound Care System (K151710). Anscare SIMO Negative Pressure Wound Therapy (NPWT) System