FORYOU NPWT DEVICE

K113236 · Foryou Medical Electronics Co, Ltd. · OMP · Feb 12, 2013 · General, Plastic Surgery

Device Facts

• Record ID: K113236
• Device Name: FORYOU NPWT DEVICE
• Applicant: Foryou Medical Electronics Co, Ltd.
• Product Code: OMP · General, Plastic Surgery
• Decision Date: Feb 12, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4780
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Foryou NPWT NP32 is an AC-powered, portable suction pump with backup battery; intended for hospital use. Device connects to external wound dressing kits, bacteria filter, suction/drainage tubing, and disposable canister. Pump delivers continuous or intermittent negative pressure (up to -155mmHg) to wound site. Operation removes exudates, infectious material, and tissue debris; prepares wound bed for closure; reduces edema; promotes granulation tissue formation and perfusion. Healthcare providers operate device to manage wound therapy. Output is negative pressure suction; clinical decision-making relies on provider assessment of wound healing progress. Benefits include potential acceleration of wound healing.

Clinical Evidence

Bench testing only. Testing included mock wound model performance, electrical safety (IEC 60601-1), EMC compatibility (IEC 60601-1-2), and biocompatibility (ISO 10993-5, -10). All tests met acceptance criteria.

Technological Characteristics

AC-powered portable suction pump; Class II electrical safety; Type B patient protection; IPX1 ingress protection. Operating modes: continuous or intermittent. Max vacuum: 155 mmHg. Biocompatibility per ISO 10993-5, -10. Standards: IEC 60601-1, IEC 60601-1-2.

Indications for Use

Indicated for patients requiring suction therapy to promote wound healing via removal of excess exudates, infectious material, and tissue debris.

Regulatory Classification

Identification

A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.

Predicate Devices

• RENASYS EZ (K082426)
• ActiV.A.C. Therapy Unit (K063692)

Submission Summary (Full Text)

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# 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: [phone]

Fax: [phone]

E-mail: [e-mail]

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: [phone] x217 Fax: [phone]

Email: [e-mail]

#### 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.

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| 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.

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- 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 | | | | |

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| 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

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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

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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

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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 [phone] or [phone] 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

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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