FORYOU NPWT DEVICE

{0}------------------------------------------------ K113236 p1/5 # 510(k) Summary FEB 1 2 2013 #### 1. Submitter Information Sponsor Name: Foryou Medical Electronics Co., Ltd. Address: No. 1, North Shang Xia Road, Dong Jiang Hi-tech Dist., Huizhou City, Guangdong, 516000, China Contact Person: Jian Jiqi (President) Phone: +86-752-5300546 Fax: +86-752-5300666 E-mail: info@ForyouNPWT.com Web: www.ForyouNPWT.com ### Application Correspondent Information: Company Name: Regulatory & Quality Solutions Address: 3919 William Penn Highway, Suite 200 Contact Person: Scott Wright (Principal Regulatory & Quality Advisor) Tel: 724.327.0230 x217 Fax: 724-734-5783 Email: swright@raqasolutions.com #### 2. Subject Device Information | Type of 510(k) submission: | Traditional | |----------------------------|------------------------------------------------------| | Common Name: | Negative Pressure Wound Therapy Device | | Trade Name: | Foryou NPWT NP32 Device | | Classification Name: | Negative Pressure Wound Therapy Powered Suction Pump | | Review Panel: | General & Plastic Surgery | | Product Code: | OMP | | Regulation Number: | 21 CFR 878.4780 | | Regulation Class: | 2 | #### 3. Predicate Device Information Sponsor: Smith & Nephew, Inc. KCI USA. Inc. {1}------------------------------------------------ K113236 p 2/5 | Device Name: | RENASYS* EZ Plus ActiV.A.C. Therapy Unit<br>Negative Pressure Wound<br>Therapy | |--------------------|--------------------------------------------------------------------------------| | 510(k) Number: | K082426 K063692 | | Product Code: | OMP OMP | | Regulation Number: | 21 CFR 878.4780 21 CFR 878.4780 | | Regulation Class: | 2 2 | #### Device Description 4. Foryou NPWT NP32 Device is an AC-powered, portable suction pump with a back-up battery. The pump is used in combination with wound dressing kits, a bacteria filter, suction tubing, drainage tubing, and a disposable canister. Foryou NPWT NP32 Device is designed for hospital use only with specified wound dressing kits to deliver a recommended therapeutic range of -55mmHg of continuous or intermittent negative pressure wound therapy to the wound, which may promote wound healing through the removal of excess exudates, infectious material, and tissue debris by: - preparing the wound bed for closure � - ◆ reducing edema - promoting granulation tissue formation and perfusion � - removing exudate and infectious material � The wound dressing kits, bacteria filter, suction tubing, drainage tubing, and disposable carister are not included in the Forvou NPWT device package. #### 5. Intended Use Foryou NPWT NP32 Device is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing through the removal of excess exudates, infectious material, and tissue debris. #### Non-Clinical Testing 6. Non-clinical testing was performed to assess the safety and effectiveness of the Foryou NPWT NP32 Device. The non-clinical tests included bench testing using a mock wound model, electrical safety testing, EMC compatibility testing, biocompatibility testing, software unit testing and software integration testing. The electrical safety and EMC compatibility tests were conducted in accordance with IEC 60601-1 and IEC 60601-1-2, respectively. All tests that were created for the Foryou NPWT NP32 had passing results with acceptance criteria successfully met, which demonstrates the safety & effectiveness of the device. The following FDA Guidance Documents were used as part of this submission package. {2}------------------------------------------------ K113236 p3/5 - Class II Special Controls Guidance Document: Non-powered Suction Apparatus Device . intended for Negative Pressure Wound Therapy (NPWT); November 10, 2010 - FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical . Devices; May 2005 #### Comparison to Predicate Device 7. The Foryou NPWT NP32 Device has the same intended use and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between the Foryou NPWT NP32 Device and its predicate devices raise no new issues of safety or effectiveness. | Elements of<br>Comparison | Subject Device | Predicate Devices | | Verdict | |--------------------------------|----------------------------------------------------------|-----------------------------------------------|-----------------------------------------------------------|--------------| | Product Name | Foryou NPWT NP32<br>Device | RENASYS EZ | ActiV.A.C. Therapy<br>Unit | - - | | K Number | Applying | K082426 | K063692 | -- | | Product Code | OMP | OMP | OMP | SE | | Regulation Number | 21 CFR 878.4780 | 21 CFR 878.4780 | 21 CFR 878.4780 | SE | | ELECTRICAL REQUIREMENT | | | | | | Device Rating | Power Input: 100-<br>240Vac, 47-63Hz,<br>1.62-0.72A | Power Input: 100-<br>240Vac, 50/60Hz,<br>90VA | Power Input:100-<br>240Vac, 47-63<br>Hz, .72A<br>@ 115Vac | Note 1 | | PERFORMANCE SPECIFICATION | | | | | | Maximum Vacuum | 155 mmHg | 200mmHg | 200mmHg | SE<br>Note 2 | | Battery Life | About 20 hours (-<br>155mmHg<br>continuous<br>operation) | About 40 hours | 14 hours | SE<br>Note 2 | | Earth Protection | Class II | Class II | Class II | SE | | Patient Protection | Type B | Type BF | Type B | Note 2 | | Ingress Protection | IPX1 | IPX2 | IPX0 | Note 3 | | Operating Mode | Continuous or<br>Intermittent Mode | Continuous or<br>Intermittent<br>Mode | Continuous or<br>Intermittent<br>Mode | SE | | DIMENSIONS/WEIGHT | | | | | | Dimensions | 270mm x 228mm x<br>205mm | 361mm x 240mm x<br>170mm | 193 x 152 x 64 mm | Note 2 | | Weight | 2.4kg | 3.3kg | 1.08Kg | Note 2 | | OPERATING & STORAGE CONDITIONS | | | | | {3}------------------------------------------------ K113236 p 4/5 | Elements of<br>Comparison | Subject Device | Predicate Devices | Verdict | | |-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|--------| | Storage<br>Environment | Temperature: -10-<br>50°C<br>Humidity: 5-85%<br>RH<br>Atmospheric<br>Pressure: 700-<br>1060hPa | Temperature: -10-<br>55°C<br>Humidity: 30-70%<br>RH<br>Atmospheric<br>Pressure: 700-<br>1060hPa | Temperature: -20-<br>60°C<br>Humidity: 0-95%<br>RH<br>Atmospheric<br>Pressure: 700-<br>1060hPa | Note 2 | | Working<br>Environment | Temperature: 0-<br>40°C<br>Humidity: 30-75%<br>RH<br>Atmospheric<br>Pressure: 700-<br>1060hPa | Temperature: 5-<br>35°C<br>Humidity: 30-70%<br>RH<br>Atmospheric<br>Pressure: 700-<br>1060hPa | Temperature: 5-<br>40°C<br>Humidity: 0-95%<br>RH<br>Atmospheric<br>Pressure: 700-<br>1060hPa | Note 2 | | Evaluation | | | | | | Electrical,<br>Mechanical and<br>Thermal Evaluation | IEC 60601-<br>1:1988+A1:1991+A2:<br>1995<br>IEC 60601-1-2:2007 | IEC 60601-<br>1:1988+A1:1991+A2:<br>1995<br>IEC 60601-1-2:2007 | IEC 60601-<br>1:1988+A1:1991+A<br>2:1995<br>IEC 60601-1-<br>2:2007 | SE | | Biocompatibility<br>Evaluation | The recommended<br>accessories are FDA<br>cleared, which are<br>evaluated by the<br>biocompatibility<br>standard ISO 10993<br>-5, -10. | The biocompatibility<br>of the accessories is<br>evaluated as per the<br>requirements of the<br>ISO 10993 -5, -10<br>standards. | The biocompatibility<br>of the accessories<br>is evaluated as per<br>the requirements of<br>the ISO 10993 -5, -<br>10 standards. | SE | | Recommended Accessories | | | | | | Wound Dressing Kit | Smith & Nephew<br>NPWT Foam<br>Dressing Kits | Smith & Nephew<br>NPWT Foam<br>Dressing Kits | | SE | | Canister Kit | Bemis Health Care,<br>800cc Suction<br>Canister | Smith & Nephew<br>800cc Suction<br>Canister | | | | Bacteria Filter | Porous Media,<br>DDF47 Bacteria<br>Filter | In-Line Bacteria<br>Overflow Filter | | Note 4 | ### Note 1 Both the subject device and the predicate devices are in compliance with IEC 60601- 1:1988+A1:1991+A2:1995. The differences in their ratings do not affect the safety and effectiveness. ### Note 2 Although there are some differences in performance specifications, dimensions/weight, and operating & storage conditions between the subject device and the predicate devices, these differences do not affect {4}------------------------------------------------ K113236 p5/5 the safety and effectiveness. Both the subject device and the predicate devices are in compliance with IEC 60601-1:1988+A1:1991+A2:1995 and "Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document: Non-powered Suction Apparatus Device Intended for Negative Pressure Wound Therapy (NPWT)". ### Note 3 The ingress testing was evaluated through risk management and determined to be acceptable at IPX1. ### Note 4 Foryou NPWT NP32 Device is defined as a NPWT pump only and the device package does not include the recommended accessories in the User Manual. The recommended accessories are similar to the predicate devices and were evaluated during performance testing. ### 8. Conclusion The Foryou NPWT NP32 Device is as safe and effective as its predicate devices. The Foryou NPWT Device has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between the Foryou NPWT NP32 Device and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the Foryou NPWT NP32 Device is as safe and effective as its predicate devices. Thus, the Foryou NP32 NPWT Device is substantially equivalent. ## 9. Summary Prepared Date 9 January 2013 {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 stylized eagle or bird symbol, with three curved lines representing the wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. #### 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 February 12, 2013 Foryou Medical Electronics Company, Limited % Regulatory and Quality Solutions, LLC Mr. Scott Wright Principal Regulatory and Quality Advisor 3919 William Penn Highway, Suite 200 Murrysville, Pennsylvania 15668 Re: K113236 Trade/Device Name: Foryou NPWT NP32 Device Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: January 18, 2013 Received: January 17, 2013 Dear Mr. Wright: 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 {6}------------------------------------------------ Page 2 - Mr. Scott Wright device-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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. #### FOR Peter D. Rumm -S Mark N. Melkerson · Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ K113236 ### Indications for Use Statement 510(k) Number (if known): K113236 Device Name: Foryou NPWT NP32 Device #### Indications for Use: Foryou NPWT NP32 Device is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing through the removal of excess exudates, infectious material, and tissue debris. Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) # Jiyoung Daing (Division Sign-Off) Division of Surgical Devices 510(k) Number __K113236