(468 days)
Not Found
No
The summary describes a standard negative pressure wound therapy device with a pump and associated components. There is no mention of AI, ML, or any features that would suggest the use of such technologies for data analysis, decision-making, or adaptive therapy. The testing described is standard for medical devices and does not indicate AI/ML model training or validation.
Yes
The device is described as promoting wound healing through various mechanisms, including preparing the wound bed, reducing edema, and promoting granulation tissue formation. These actions are therapeutic in nature. It is also referred to as delivering "negative pressure wound therapy."
No
The device description clearly states it is a "suction pump" used to promote wound healing by removing exudates and infectious material, and preparing the wound bed, rather than to diagnose a condition.
No
The device description explicitly states it is an AC-powered, portable suction pump with a back-up battery, which are hardware components.
Based on the provided information, the Foryou NPWT NP32 Device is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to promote wound healing through the removal of excess exudates, infectious material, and tissue debris using negative pressure. This is a therapeutic intervention applied directly to the patient's wound.
- Device Description: The device is a suction pump used in combination with wound dressing kits and other components to apply negative pressure to a wound. This is a physical therapy device.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (like blood, urine, or tissue) to diagnose a condition, monitor a disease, or screen for health issues. IVD devices are specifically designed for these purposes.
- Anatomical Site: The device is applied to a wound, which is a physical location on the body, not a biological sample.
In summary, the Foryou NPWT NP32 Device is a therapeutic medical device used for wound management, not a diagnostic device used for testing biological samples.
N/A
Intended Use / 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.
Product codes
OMP
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital use only
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4780 Powered suction pump.
(a)
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.(b)
Classification. Class II.
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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: +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.
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| Device Name: | RENASYS* EZ Plus ActiV.A.C. Therapy Unit
Negative Pressure Wound
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
| Comparison | Subject Device | Predicate Devices | Verdict | |
|---|---|---|---|---|
| Product Name | Foryou NPWT NP32 | |||
| Device | RENASYS EZ | ActiV.A.C. Therapy | ||
| 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- | |||
| 240Vac, 47-63Hz, | ||||
| 1.62-0.72A | Power Input: 100- | |||
| 240Vac, 50/60Hz, | ||||
| 90VA | Power Input:100- | |||
| 240Vac, 47-63 | ||||
| Hz, .72A | ||||
| @ 115Vac | Note 1 | |||
| PERFORMANCE SPECIFICATION | ||||
| Maximum Vacuum | 155 mmHg | 200mmHg | 200mmHg | SE |
| Note 2 | ||||
| Battery Life | About 20 hours (- | |||
| 155mmHg | ||||
| continuous | ||||
| operation) | About 40 hours | 14 hours | SE | |
| 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 | |||
| Intermittent Mode | Continuous or | |||
| Intermittent | ||||
| Mode | Continuous or | |||
| Intermittent | ||||
| Mode | SE | |||
| DIMENSIONS/WEIGHT | ||||
| Dimensions | 270mm x 228mm x | |||
| 205mm | 361mm x 240mm x | |||
| 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
| Comparison | Subject Device | Predicate Devices | Verdict | |
|---|---|---|---|---|
| Storage | ||||
| Environment | Temperature: -10- | |||
| 50°C | ||||
| Humidity: 5-85% | ||||
| RH | ||||
| Atmospheric | ||||
| Pressure: 700- | ||||
| 1060hPa | Temperature: -10- | |||
| 55°C | ||||
| Humidity: 30-70% | ||||
| RH | ||||
| Atmospheric | ||||
| Pressure: 700- | ||||
| 1060hPa | Temperature: -20- | |||
| 60°C | ||||
| Humidity: 0-95% | ||||
| RH | ||||
| Atmospheric | ||||
| Pressure: 700- | ||||
| 1060hPa | Note 2 | |||
| Working | ||||
| Environment | Temperature: 0- | |||
| 40°C | ||||
| Humidity: 30-75% | ||||
| RH | ||||
| Atmospheric | ||||
| Pressure: 700- | ||||
| 1060hPa | Temperature: 5- | |||
| 35°C | ||||
| Humidity: 30-70% | ||||
| RH | ||||
| Atmospheric | ||||
| Pressure: 700- | ||||
| 1060hPa | Temperature: 5- | |||
| 40°C | ||||
| Humidity: 0-95% | ||||
| RH | ||||
| Atmospheric | ||||
| Pressure: 700- | ||||
| 1060hPa | Note 2 | |||
| Evaluation | ||||
| Electrical, | ||||
| Mechanical and | ||||
| Thermal Evaluation | IEC 60601- | |||
| 1:1988+A1:1991+A2: | ||||
| 1995 | ||||
| IEC 60601-1-2:2007 | IEC 60601- | |||
| 1:1988+A1:1991+A2: | ||||
| 1995 | ||||
| IEC 60601-1-2:2007 | IEC 60601- | |||
| 1:1988+A1:1991+A | ||||
| 2:1995 | ||||
| IEC 60601-1- | ||||
| 2:2007 | SE | |||
| Biocompatibility | ||||
| Evaluation | The recommended | |||
| accessories are FDA | ||||
| cleared, which are | ||||
| evaluated by the | ||||
| biocompatibility | ||||
| standard ISO 10993 | ||||
| -5, -10. | The biocompatibility | |||
| of the accessories is | ||||
| evaluated as per the | ||||
| requirements of the | ||||
| ISO 10993 -5, -10 | ||||
| standards. | The biocompatibility | |||
| of the accessories | ||||
| is evaluated as per | ||||
| the requirements of | ||||
| the ISO 10993 -5, - | ||||
| 10 standards. | SE | |||
| Recommended Accessories | ||||
| Wound Dressing Kit | Smith & Nephew | |||
| NPWT Foam | ||||
| Dressing Kits | Smith & Nephew | |||
| NPWT Foam | ||||
| Dressing Kits | SE | |||
| Canister Kit | Bemis Health Care, | |||
| 800cc Suction | ||||
| Canister | Smith & Nephew | |||
| 800cc Suction | ||||
| Canister | ||||
| Bacteria Filter | Porous Media, | |||
| DDF47 Bacteria | ||||
| Filter | In-Line Bacteria | |||
| 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
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
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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
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