The RENASYS GO is indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via removal of fluids, including irrigation and body fluids, wound exudates and infectious materials.

Appropriate wound types include:

· Chronic
· Acute
· Traumatic
· Sub-acute and dehisced wounds
· Ulcers (such as pressure or diabetic)
· Partial-thickness burns
· Flaps and grafts

Device Description

The RENASYS GO NPWT device is a modification to predicate device K088375. It is a lightweight suction pump device intended for wound management via application of continuous or intermittent negative pressure wound therapy to the wound for removal of fluids, including wound exudates, irrigation fluids, and infectious materials. The RENASYS GO NPWT device is designed to deliver negative pressure wound therapy to a closed environment over a wound in order to drain exudates from the wound site to help promote wound healing.

The closed environment over the wound is created by applying a sterile foam or gauze wound dressing to the wound site and connecting the sealed wound to the suction pump via a tube that connects to the disposable canister. The suction pump delivers negative pressure wound therapy and removes the exudates from the wound site to the disposable canister.

The device provides negative pressure wound therapy to the wound at a range of pressure settings between 40-200mmHg. The device can operate either by a mains power supply or internal battery.

RENASYS GO uses an integral waste canister that is supplied non-sterile, single-use with a volume capacity of 300ml or 750ml. The waste canister is attached to the pump device by two clips on either side of the canister. The canister is permanently sealed to minimize the potential of users coming into contact with exudates. Safety features include a 1.0 micron filter in the top of the canister to resist fluid penetration into the device, as well as a 0.2 micron bacterial filter to prevent the passage of airborne bacteria. Each sealed canister contains a solidifier which acts as a gelling agent to the exudate.

A tube is permanently attached to the bottom of the waste canister through an inlet port. A connector attached to the distal end of the canister tube attaches to the corresponding tubing included in each Smith & Nephew NPWT dressing kit.

The RENASYS GO device is compatible with RENASYS Foam and Gauze dressing kits with Soft Port which were cleared under 510(k) K142979.

AI/ML Overview

The provided text describes modifications to an existing negative pressure wound therapy (NPWT) device, the RENASYS GO, and the testing conducted to demonstrate its substantial equivalence to a predicate device (K083375). As this is a 510(k) submission, the focus is on substantial equivalence rather than establishing novel acceptance criteria for a new device. Therefore, the "acceptance criteria" here largely refer to demonstrating that the modified device performs comparably to the predicate and meets relevant safety and performance standards.

Here's an analysis based on your request, understanding that "acceptance criteria" are implied by the scope of a 510(k) modification rather than explicitly listed as performance targets in the same way a new device might have:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied by 510(k) and testing)	Reported Device Performance
Pumping capacity equivalent to predicate device.	Verification completed: Pumping capacity is equivalent to the predicate device.
Delivers negative pressure wound therapy (continuous/intermittent) identical to predicate.	Verification completed: Device delivers negative pressure wound therapy in a continuous and intermittent operating mode identical to the predicate device.
Complete Blockage/Canister Overcapacity alarm functionality.	Verification completed: Alarm functionality tested using wound fluid simulating real exudate chemistry and protein.
System performance in foreseeable fault conditions.	Verification completed: System performance evaluated in foreseeable fault conditions.
System performance with high air leaks at the dressing site.	Verification completed: System performance evaluated with high air leaks at the dressing site.
System performance in worst-case scenarios with ranges of exudate viscosity and protein.	Verification completed: System performance evaluated in worst-case scenarios with ranges of exudate viscosity and protein content.
Blockage/Canister Over-capacity & Leak Alarm assertion in vertical orientation.	Verification completed: Alarm assertion verified in vertical orientation.
Blockage/Canister Over-capacity & Leak Alarm assertion in horizontal face up orientation.	Verification completed: Alarm assertion verified in horizontal face up orientation.
Blockage/Canister Over-capacity & Leak Alarm assertion in horizontal face down orientation.	Verification completed: Alarm assertion verified in horizontal face down orientation.
Performance at increased heights above the wound.	Verification completed: Performance evaluated at increased heights above the wound.
O-Ring durability.	Verification completed: O-Ring durability verified.
Compliance with IEC 60601 3rd Edition (Electrical safety, usability, alarm systems, home care).	Verification completed: Electrical safety testing in accordance with IEC 60601 3rd Edition standards successfully completed. Software verification and usability studies demonstrated acceptable device performance and compliance.
Software validation for alarm functionality improvements.	Verification completed: Software validation and comprehensive verification testing completed, demonstrating acceptable device performance. Software documentation assembled per FDA guidance for Moderate Level of Concern.
Performance of 750ml canister.	Verification completed: Comprehensive verification completed which demonstrated acceptable device performance for the 750ml canister.
Robustness of canister and alternate materials of construction.	Verification completed: Comprehensive verification completed which demonstrated acceptable device performance for the modified canister design and materials.
Usability/clarity of canister markings for change indicator.	Verification completed: Usability studies completed to verify labeling changes (markings on canister for change indicator).
Compliance with relevant medical device standards (ISO 14971, ISO 15223, IEC 62366, ANSI/AAMI, etc.).	Declared Compliance: Device complies with listed standards: ISO 14971, ISO 15223-1, ISO 15223-2, IEC 60601-1 (3rd Ed.), IEC 60601-1-6 (3rd Ed.), IEC 60601-1-8 (2nd Ed.), IEC 60601-1-11 (1st Ed.), IEC 62366, ANSI/AAMI ES60601-1, RTCA/DO-160G, ANSI/AAMI HE75, IEC CISPR-25, EN 50121-3-2.

2. Sample Size Used for the Test Set and Data Provenance

The document describes bench testing ("Non-Clinical Tests (Bench)") and verification testing. It does not specify sample sizes (e.g., number of devices tested for each condition). The testing appears to be conducted by the manufacturer, Smith & Nephew, Inc., and therefore the "data provenance" would be internal company testing. There is no mention of external data sources or clinical data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

N/A. This document pertains to bench and verification testing for a device modification, demonstrating substantial equivalence. The "ground truth" for these tests relates to engineering specifications and performance against known standards or the predicate device, not expert interpretation of medical images or patient outcomes.

4. Adjudication Method for the Test Set

N/A. As the testing mentioned is bench and verification testing against engineering specifications and standards, there is no mention or need for a medical expert adjudication method like 2+1 or 3+1.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No. The document explicitly states that "Non-Clinical Tests (Bench)" were performed. It does not describe any human reader studies or MRMC comparative effectiveness studies.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

N/A. This device is a negative pressure wound therapy pump, not an AI/algorithm-based diagnostic or therapeutic device. The "performance" described is the functioning of the pump and its alarm systems, which is inherently standalone in its operation (i.e., the pump operates without continuous human "in-the-loop" interaction for its core function, though it is used by a human).

7. The Type of Ground Truth Used

The "ground truth" for the tests described is primarily:

Engineering specifications and design requirements: For aspects like pumping capacity, negative pressure range, O-ring durability, and performance in various conditions.
Predicate device performance: To demonstrate equivalence in core functionalities.
Regulatory and consensus standards: Such as IEC 60601 series for electrical safety, usability, and alarm systems, and ISO standards for risk management.
Simulated wound fluid chemistry: For testing alarm functionality.

8. The Sample Size for the Training Set

N/A. This document describes a medical device (a pump) and its modifications, not a machine learning or AI algorithm that requires a training set. The "software modifications" mentioned relate to alarm functionality and compliance with standards, implying traditional software engineering and testing, not AI model training.

9. How the Ground Truth for the Training Set Was Established

N/A. See point 8.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three lines forming its body and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 29, 2016

Smith & Nephew, Inc. Ms. Laura Reynolds Director of Regulatory Affairs 970 Lake Carillon Drive Suite 110 St. Petersburg, Florida 33716

Re: K152163

Trade/Device Name: Renasys Go Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: September 26, 2016 Received: September 26, 2016

Dear Ms. Reynolds:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

{1}------------------------------------------------

the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

David Krause -S

for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

510(k) Number (if known)

K152163

Device Name

RENASYS GO Negative Pressure Wound Therapy Device

Indications for Use (Describe)

Appropriate wound types include:

· Chronic
· Acute
· Traumatic
· Sub-acute and dehisced wounds
· Ulcers (such as pressure or diabetic)
· Partial-thickness burns
· Flaps and grafts

Type of Use (Select one or both, as applicable)

Z 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.qov

"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}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the Smith & Nephew logo. The logo consists of a stylized flower-like graphic on the left, followed by the text "We are smith&nephew". The words "We are" are in gray, while "smith&nephew" is in orange.

Wound Management 727 392-1261

F 727 392-6914 or 727 392-0797 Smith & Nephew, Inc. 970 Lake Carillon Drive Customer Care Center: 1 800 876-1261 Suite 300 www.smith-nephew.com St. Petersburg, FL 33716

510(k) Summary

General Information Submitters Name/Address: Smith & Nephew, Inc. 970 Lake Carillon Drive Suite 300 St. Petersburg, FL 33716 Establishment Registration Number: 3006760724 Contact Person: Laura Reynolds Director Regulatory Affairs Phone Number: (727) 686-8736 Date Prepared: September 29, 2016 Device Description RENASYS™ GO Negative Pressure Wound Trade Name: Therapy Device Generic/Common Name: Powered Suction Pump Classification Name: Powered Suction Pump; 21 CFR 878.4780 Product Code: OMP

Predicate Device Information

Subject Device	Predicate Device	510k#	ClearanceDate
RENASYS GO NegativePressure Wound TherapyDevice	RENASYS GO NegativePressure Wound TherapyDevice	K083375	02/25/2009

{4}------------------------------------------------

Device Description

RENASYS GO Negative Pressure Wound Therapy Device

The device provides negative pressure wound therapy to the wound at a range of pressure settings between 40-200mmHg. The device can operate either by a mains power supply or internal battery.

RENASYS GO Canisters

The RENASYS GO device is compatible with RENASYS Foam and Gauze dressing kits with Soft Port which were cleared under 510(k) K142979.

Indications for Use

RENASYS GO Negative Pressure Wound Therapy Device

RENASYS GO is indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via removal of fluids, including irrigation and body fluids, wound exudates and infectious materials.

Appropriate wound types include:

. Chronic
Acute .

{5}------------------------------------------------

Traumatic ●
Sub-acute and dehisced wounds ●
Ulcers (such as pressure or diabetic) .
. Partial-thickness burns
Flaps and grafts .

The indications for use of the subject device are identical to the predicate, except "Examples of" has been removed from appropriate wound types.

Comparison of Technological Characteristics

The RENASYS GO Negative Pressure Wound Therapy (NPWT) device and canisters that are the subject of this submission are substantially equivalent to the previously cleared versions of the RENASYS GO Negative Pressure Wound Therapy (NPWT) device and canisters. There has been no change to the indications for use, operating principle, mechanism of action or fundamental scientific technology of the predicate device. Generally, software and hardware modifications were made to improve alarm functionality and to meet IEC 60601 3rd Edition requirements. A 750ml canister has been added as an additional option for highly exuding wounds. Thus the subject and predicate devices have substantially equivalent technological characteristics.

Summary Comparison between New and Predicate Devices

	Subject Device:	Predicate Device:510(k)# K083375
	510(k)#K152163
Trade Name:	RENASYS GO NPWT	RENASYS GO NPWT
Indications for Use:	The RENASYS GO isindicated for patients whowould benefit from asuction device (negativepressure wound therapy)as it may promote woundhealing via removal offluids, including irrigationand body fluids, woundexudates and infectiousmaterials.Appropriate wound typesinclude:• Chronic• Acute• Traumatic• Sub-acute anddehisced wounds• Ulcers (such aspressure or	The RENASYS GO isindicated for patients whowould benefit from asuction device (negativepressure wound therapy)as it may promote woundhealing via removal offluids, including irrigationand body fluids, woundexudates and infectiousmaterials.Examples of appropriatewound types include:• Chronic• Acute• Traumatic• Sub-acute anddehisced wounds• Ulcers (such aspressure or

RENASYS GO NPWT

{6}------------------------------------------------

	Subject Device:510(k)#K152163	Predicate Device:510(k)# K083375
Trade Name:	RENASYS GO NPWTdiabetic)• Partial-thicknessburns• Flaps and grafts	RENASYS GO NPWTdiabetic)• Partial-thicknessburns• Flaps and grafts
Principle of Operation	Same as predicate	Therapy unit deliverssoftware controllednegative pressure woundtherapy to the wound site.
Operating Time(Battery)	Same as predicate	20 hours Therapy
Negative PressureRange	Same as predicate	40-200mmHg
Components	• Therapy unit• 300mL canister• 750mL canister	• Therapy unit• 300mL canister

Table of Modifications

Modification	Reason For Change	Verification TestingPerformed
Hardware and Softwaremodifications	To improve alarm functionality	Software validation andcomprehensiveverification testing wascompleted whichdemonstratedacceptable deviceperformance
Software and labelingrevisions	IEC 60601 3rd EditionCompliance	Software verification andusability studies werecompleted whichdemonstratedacceptable deviceperformance. Electricalsafety testing inaccordance with IEC60601 3rd Editionstandards has beensuccessfully completed.
Addition of RENASYSGO 750ml canister	Additional option for highlyexuding wounds	Comprehensiveverification wascompleted whichdemonstratedacceptable deviceperformance
Design change to	To improve robustness of	Comprehensive

{7}------------------------------------------------

Modification	Reason For Change	Verification TestingPerformed
canister andqualification of alternatematerials ofconstruction	device and aidmanufacturability	verification wascompleted whichdemonstratedacceptable deviceperformance
Markings on canisteradded to includechange indicator	To aid/alert user toappropriate change interval	Usability studies werecompleted to verifylabeling changes

Non-Clinical Tests (Bench)

RENASYS GO Negative Pressure Wound Therapy Device

Testing has been conducted to verify the modifications to the RENASYS GO NPWT device meet design specifications and demonstrate substantial equivalence to the predicate device.

The list below summarizes the bench testing undertaken and successfully completed for the RENASYS GO NPWT device:

. Pumping capacity is equivalent to the predicate device.
Verification that the device delivers negative pressure wound therapy in a continuous and intermittent operating mode identical to the predicate device.
. Verification of Complete Blockage/Canister Overcapacity alarm functionality using wound fluid designed to simulate chemistry and protein content of real exudate.
Verification of system performance in foreseeable fault conditions.
Verification of system performance when running with high air leaks at the dressing site.
Verification of system performance in worst case scenarios with ranges of exudate viscosity and protein content.
Verification of Blockaqe/Canister Over-capacity & Leak Alarm assertion when . used in a vertical orientation.
Verification of Blockage/Canister Over-capacity & Leak Alarm assertion when ● used in a horizontal face up orientation.
Verification of Blockage/Canister Over-capacity & Leak Alarm assertion when ● used in a horizontal face down orientation.
. Verification of Renasys GO performance at increased heights above the wound.
. Verification of O-Ring durability.

The software documentation in this submission has been assembled according to the recommendations in the FDA document. Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, dated May 11, 2005. The software Level of Concern has been evaluated and determined to be Moderate, and appropriate documentation included, as recommended by the cited FDA guidance.

{8}------------------------------------------------

Device complies with the following standards:

. ISO 14971:2012 Medical Devices - Application of Risk Management to Medical Devices
. ISO 15223-1:2012 Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied Part 1: General requirements. (General)
ISO 15223-2:2010 Medical devices Symbols to be used with medical device ● labels, labelling, and information to be supplied-Part 2: Symbol development, selection and validation. (General)
. IEC 60601-1:2005 (3rd Edition). Medical Electrical Equipment - Part 1: General Requirements for Safety
. IEC 60601-1-6:2010 (3rd Edition) Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
IEC 60601-1-8:2006 (2nd Edition) Medical electrical equipment Part 1-8: ● General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical
IEC 60601-1-11:2010 (1st Edition) Medical Electrical Equipment Part 1-11: ● General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
IEC 62366:2007 (1st Edition) Medical devices Application of usability . engineering to medical devices
ANSI/AAMI ES60601-1:2005 Version (R2012) Medical Electrical Equipment -Part 1: General Requirements for Basic Safety and Essential Performance
RTCA/DO-160G, Environmental Conditions and Test Procedures for Airborne Equipment, Sections 18, 19, 20.4, 20.5, 21.4, 21.5.
ANSI/AAMI HE75:2009 Human Factor Engineering-Design of Medical Devices
IEC CISPR-25 2008, 3rd Ed. Vehicles, Boats and Internal Combustion Engines-● Radio Disturbance Characteristics.
EN 50121-3-2 Part 3-2:2015 Railway Applications Electromagnetic Compatibility

Conclusions

In establishing substantial equivalence to the currently marketed predicate device, Smith & Nephew, Inc. evaluated the indications for use, materials, technology, product specifications and energy requirements of the device. Performance testing and electrical safety testing has been successfully completed to demonstrate that the RENASYS GO NPWT device and canisters are substantially equivalent to the predicate devices for the intended use.

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.