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 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Foryou NPWT NP32 Device, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The 510(k) summary for the Foryou NPWT NP32 Device primarily focuses on demonstrating substantial equivalence to predicate devices through comparisons of technological characteristics and performance specifications. The "acceptance criteria" are implied by the device's ability to meet industry standards and demonstrate comparable performance to predicate devices without raising new safety or effectiveness concerns.

Table of Acceptance Criteria and Reported Device Performance:

Since this is a submission based on substantial equivalence, the "acceptance criteria" are often the performance characteristics of the predicate devices or compliance with recognized standards. The "reported device performance" refers to the Foryou NPWT NP32 Device's own specifications.

Characteristic / Acceptance Criteria (Implied by Predicate Performance/Standards)	Foryou NPWT NP32 Device Performance (Reported)	Verdict
Electrical Requirements
Power Input: 100-240Vac, 50/60Hz, ~90VA (Predicate Range)	Power Input: 100-240Vac, 47-63Hz, 1.62-0.72A	Note 1: In compliance with IEC 60601-1, differences don't affect safety/effectiveness.
Performance Specification
Maximum Vacuum: 200mmHg (Predicate)	155 mmHg	SE (Substantially Equivalent) - Note 2: Differences don't affect safety/effectiveness.
Battery Life: 14-40 hours (Predicate Range)	About 20 hours (-155mmHg continuous operation)	SE - Note 2: Differences don't affect safety/effectiveness.
Earth Protection: Class II (Predicate)	Class II	SE
Patient Protection: Type B or BF	Type B	Note 2: Differences don't affect safety/effectiveness.
Ingress Protection: IPX0-IPX2 (Predicate Range)	IPX1	Note 3: Evaluated through risk management and acceptable at IPX1.
Operating Mode: Continuous or Intermittent Mode	Continuous or Intermittent Mode	SE
Dimensions/Weight
Dimensions: (Predicate Range)	270mm x 228mm x 205mm	Note 2: Differences don't affect safety/effectiveness.
Weight: (Predicate Range)	2.4kg	Note 2: Differences don't affect safety/effectiveness.
Operating & Storage Conditions
Storage Environment: (Predicate Range)	Temperature: -10-50°C, Humidity: 5-85% RH, Atmospheric Pressure: 700-1060hPa	Note 2: Differences don't affect safety/effectiveness.
Working Environment: (Predicate Range)	Temperature: 0-40°C, Humidity: 30-75% RH, Atmospheric Pressure: 700-1060hPa	Note 2: Differences don't affect safety/effectiveness.
Evaluations
Electrical, Mechanical and Thermal Evaluation: IEC 60601-1, IEC 60601-1-2	Compliance with IEC 60601-1, IEC 60601-1-2	SE
Biocompatibility Evaluation: ISO 10993 -5, -10	Biocompatibility of accessories evaluated	SE
Recommended Accessories: Smith & Nephew NPWT Foam Dressing Kits	Smith & Nephew NPWT Foam Dressing Kits	SE

Study Details:

Sample size used for the test set and the data provenance:
- The provided document does not specify a "test set" in the context of clinical or performance data involving human subjects. The non-clinical testing involved "bench testing using a mock wound model." The sample size for this mock wound model is not provided.
- Data Provenance: The document does not provide information on country of origin or whether any data was retrospective or prospective, as it does not report on clinical studies with human participants. It focuses on bench testing and compliance with recognized standards.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable as there is no mention of a human-reviewed "test set" for ground truth establishment. The evaluation relies on engineering tests and compliance with standards.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not applicable as there is no mention of a human-reviewed "test set" requiring adjudication.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This device is a negative pressure wound therapy pump, not an AI-assisted diagnostic tool for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, a form of standalone performance was assessed through non-clinical bench testing. The device's performance (e.g., maximum vacuum, battery life) was evaluated independently against specifications and predicate device characteristics, without human interaction in its core function assessment, beyond operating the test equipment.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical testing, the "ground truth" was established by engineering specifications, recognized industry standards (e.g., IEC 60601-1, IEC 60601-1-2, ISO 10993-5, -10), and the performance characteristics of legally marketed predicate devices. The device's performance was compared to these established benchmarks.
The sample size for the training set:
- Not applicable. This document describes a medical device (a pump), not a machine learning or AI algorithm that would typically require a training set.
How the ground truth for the training set was established:
- Not applicable. As above, there is no mention of a training set for an algorithm.

Summary

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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 UnitNegative Pressure WoundTherapy
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.

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

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 ofComparison	Subject Device	Predicate Devices		Verdict
Product Name	Foryou NPWT NP32Device	RENASYS EZ	ActiV.A.C. TherapyUnit	- -
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, 47-63Hz, .72A@ 115Vac	Note 1
PERFORMANCE SPECIFICATION
Maximum Vacuum	155 mmHg	200mmHg	200mmHg	SENote 2
Battery Life	About 20 hours (-155mmHgcontinuousoperation)	About 40 hours	14 hours	SENote 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 orIntermittent Mode	Continuous orIntermittentMode	Continuous orIntermittentMode	SE
DIMENSIONS/WEIGHT
Dimensions	270mm x 228mm x205mm	361mm x 240mm x170mm	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 ofComparison	Subject Device	Predicate Devices	Verdict
StorageEnvironment	Temperature: -10-50°CHumidity: 5-85%RHAtmosphericPressure: 700-1060hPa	Temperature: -10-55°CHumidity: 30-70%RHAtmosphericPressure: 700-1060hPa	Temperature: -20-60°CHumidity: 0-95%RHAtmosphericPressure: 700-1060hPa	Note 2
WorkingEnvironment	Temperature: 0-40°CHumidity: 30-75%RHAtmosphericPressure: 700-1060hPa	Temperature: 5-35°CHumidity: 30-70%RHAtmosphericPressure: 700-1060hPa	Temperature: 5-40°CHumidity: 0-95%RHAtmosphericPressure: 700-1060hPa	Note 2
Evaluation
Electrical,Mechanical andThermal Evaluation	IEC 60601-1:1988+A1:1991+A2:1995IEC 60601-1-2:2007	IEC 60601-1:1988+A1:1991+A2:1995IEC 60601-1-2:2007	IEC 60601-1:1988+A1:1991+A2:1995IEC 60601-1-2:2007	SE
BiocompatibilityEvaluation	The recommendedaccessories are FDAcleared, which areevaluated by thebiocompatibilitystandard ISO 10993-5, -10.	The biocompatibilityof the accessories isevaluated as per therequirements of theISO 10993 -5, -10standards.	The biocompatibilityof the accessoriesis evaluated as perthe requirements ofthe ISO 10993 -5, -10 standards.	SE
Recommended Accessories
Wound Dressing Kit	Smith & NephewNPWT FoamDressing Kits	Smith & NephewNPWT FoamDressing Kits		SE
Canister Kit	Bemis Health Care,800cc SuctionCanister	Smith & Nephew800cc SuctionCanister
Bacteria Filter	Porous Media,DDF47 BacteriaFilter	In-Line BacteriaOverflow 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 (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

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K113236

Indications for Use Statement

510(k) Number (if known): K113236

Device Name: Foryou NPWT NP32 Device

Indications for Use:

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

Regulation Number and Section

§ 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.