RENASYS TOUCH 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

The RENASYS TOUCH is intended for use in acute care settings and other professional healthcare environments where product use is conducted by or under the supervision of a qualified healthcare professional.

Device Description

The RENASYS TOUCH NPWT device 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 TOUCH 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 RENASYS 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 25-200mmHg. The device can operate either by a mains power supply or internal battery.

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

The RENASYS TOUCH device is also compatible with RENASYS AB Abdominal Dressing Kit with Soft Port cleared under 510(k) K143133.

RENASYS TOUCH is suitable for use in acute care settings and other professional healthcare environments where product use is conducted by or under the supervision of a qualified healthcare professional.

AI/ML Overview

The provided document is a 510(k) summary for the RENASYS TOUCH Negative Pressure Wound Therapy (NPWT) device. It details the device's comparison to a predicate device and the non-clinical tests performed to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in a quantitative, pass/fail manner. Instead, it describes performance testing aimed at demonstrating "substantial equivalence" to the predicate device (RENASYS EZ MAX NPWT). The "reported device performance" is largely qualitative, affirming that the device "meets design specifications" and functions "as intended" under various conditions.

Acceptance Criteria (Implied - Demonstrated Substantial Equivalence via)	Reported Device Performance
System performance with full range of RENASYS Foam and Gauze NPWT Dressing Kits with Soft Port and RENASYS AB Abdominal Kit with Soft Port.	Verified
System performance when operating with two Soft Ports via a Y-connector with both foam and gauze wound fillers.	Verified
Alarms functionality using wound fluid designed to simulate chemistry and protein content of real exudate.	Verified
System performance with "Intermittent NPWT" mode selected across a range of wound model sizes and pressure settings.	Verified
System performance in various combinations of challenge conditions.	Evaluated and verified
Battery life of the RENASYS TOUCH at the minimum and maximum available therapy settings.	Evaluated
Software Documentation according to FDA guidance (May 11, 2005) for Moderate Level of Concern.	Assembled and deemed appropriate, recommending appropriate documentation included.
Compliance with various ISO, IEC, AAMI/ANSI standards (e.g., ISO13485, ISO 14971, IEC 60601 series, IEC 62366, IEC 62304, AAMI/ANSI HE75, ISO 10993 series).	Device complies with listed standards.
Electrical safety testing	Successfully completed

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

The document describes "bench testing" which implies in-vitro or simulated environments.

Sample Size: Not explicitly stated for any of the tests. The descriptions "full range of RENASYS Foam and Gauze NPWT Dressing Kits," "range of wound model sizes and pressure settings," and "various combinations of challenge conditions" suggest multiple test scenarios were run, but specific numbers are not provided.
Data Provenance: The tests are "Non-Clinical Tests (Bench)," indicating they were conducted in a laboratory setting. There is no information about country of origin, retrospective or prospective data.

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

This type of information is not applicable to the provided document. The tests performed are bench tests (engineering verification) against design specifications and recognized standards, not clinical studies requiring human expert adjudication for ground truth. The "ground truth" here is the expected performance based on engineering principles and regulatory standards.

4. Adjudication Method for the Test Set

This is not applicable as the tests are non-clinical bench tests. The concept of adjudication (e.g., 2+1, 3+1) is typically relevant for clinical studies where human interpretation of data is being evaluated against a consensus of experts.

5. 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

There is no mention of an MRMC comparative effectiveness study, nor any AI component in this device. This document describes a traditional medical device (negative pressure wound therapy pump) and its regulatory submission based on substantial equivalence to a predicate, not an AI-powered diagnostic or therapeutic device.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. The RENASYS TOUCH NPWT device is a hardware product with embedded software for control (as noted, it's software-controlled compared to the predicate's analog control). It is not an "algorithm only" device, but a system that requires human interaction and supervision. The software documentation focused on meeting FDA guidance for software in medical devices, not on standalone algorithm performance for diagnosis or treatment.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the non-clinical bench tests, the "ground truth" is implied to be:

Design Specifications: The device's performance was verified against its established design requirements.
Engineering Principles: The tests confirm the physical and mechanical operation aligns with expected engineering outcomes.
Regulatory Standards: Compliance with various ISO, IEC, and AAMI/ANSI standards acts as a form of "ground truth" for safety and performance in a regulated environment.
Predicate Device Performance: The primary goal is to demonstrate "substantial equivalence" to the predicate device, meaning its performance falls within acceptable parameters similar to the legally marketed predicate.

8. The Sample Size for the Training Set

There is no mention of a training set. This is a traditional medical device, not a machine learning or AI device that typically involves training data.

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

As there is no mention of a training set, this question is not applicable.

Summary

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

August 4, 2016

Smith & Nephew Medical, Ltd. c/o Ms. Laura Reynolds Smith & Nephew, Inc. 970 Lake Carillon Dr., Suite 110 St. Petersburg, FL 33716

Re: K153209

Trade/Device Name: RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters, RENASYS TOUCH Carry Bag, Carry Strap, RENASYS Y -Connector, RENASYS TOUCH IV Pole/Bed Clamp, RENASYS TOUCH Class 2 Power Supply Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: July 1, 2016 Received: July 5, 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

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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 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 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/Resourcesfor You/Industry/default.htm. 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 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

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

Enclosure

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Indications for Use

510(k) Number (if known) K153209

Device Name

RENASYS TOUCH 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)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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Wound Management Smith & Nephew Medical Ltd. 101 Hessle Road Hull HU3 2BN England

T 44 (0) 1482 225 181 F 44 (0) 1482 328 326 www.smith-nephew.com

Image /page/3/Picture/2 description: The image shows the Smith & Nephew logo. The logo consists of a stylized orange flower-like symbol, followed by the text "We are smith&nephew". The text "We are" is in gray, while "smith&nephew" is in orange, matching the color of the flower symbol.

510(k) Summary

General Information Submitters Name/Address: Smith & Nephew Medical 101 Hessle Road Hull, HU3 2BN England Establishment Reqistration Number: 8043484 Contact Person: Laura Reynolds Director Regulatory Affairs Phone Number: (727) 686-8736 July 18, 2016 Date Prepared: Device Description Trade Name: RENASYS™ TOUCH Negative Pressure Wound 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 TOUCHNegative Pressure WoundTherapy Device	RENASYS EZ MAX NegativePressure Wound TherapyDevice ( Primary Predicate )	K142979	04/29/2015
RENASYS Y-Connector	Invia Liberty Negative PressureWound Therapy System	K142626	06/12/2015

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Device Description

RENASYS TOUCH Negative Pressure Wound Therapy Device

The device provides negative pressure wound therapy to the wound at a range of pressure settings between 25-200mmHg. The device can operate either by a mains power supply or internal battery.

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

The RENASYS TOUCH device is also compatible with RENASYS AB Abdominal Dressing Kit with Soft Port cleared under 510(k) K143133.

RENASYS TOUCH Canisters

RENASYS TOUCH uses an integral waste canister that is supplied non-sterile, singleuse with a volume capacity of 300ml or 800ml. 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 hydrophobic filter to prevent liquid penetration into the pump, supplemented with an additional filter in the top of the canister as a redundant feature. Each sealed canister contains a solidifier which acts as a gelling agent to the exudate. A 300ml canister without solidifier is also offered.

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 to the corresponding tubing included in each Smith & Nephew NPWT dressing kit.

RENASYS Y-Connector

The RENASYS Y-Connector is an accessory device used to connect two wound dressings to one pump. The Y-Connector is compatible with Smith & Nephew RENASYS Foam and Gauze wound dressing kits with Soft Port.

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The Y-Connector is constructed of PVC tubing with identical interface connectors as the Soft Port and canister components to which it connects. Performance testing has been completed to demonstrate the device and system functions as intended when used with the Y-Connector.

Indications for Use

Appropriate wound types include:

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

Comparison of Technological Characteristics

The RENASYS TOUCH Negative Pressure Wound Therapy (NPWT) device and canisters that are the subject of this submission are substantially equivalent to the predicate RENASYS EZ MAX Negative Pressure Wound Therapy (NPWT) device and associated canisters. Both devices have the same indications for use, contraindications and fundamental scientific technology. Both devices interface with identical RENASYS Foam and Gauze Dressing Kits and both use disposable canisters for exudate collection. Both devices contain similar alarms.

Primary differences between the devices are the RENASYS TOUCH device is software controlled whereas the RENASYS EZ MAX device is analog controlled. The RENASYS TOUCH device also has a large full-color touchscreen for enhanced user interface during operation.

Performance testing has demonstrated that although the two devices have some technological differences, the performance of the subject device is substantially equivalent to the predicate, and raises no new questions of safety or efficacy.

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Summary Comparison between New and Predicate Devices

RENASYS TOUCH NPWT Device and Canisters

	Subject Device:	Predicate Device: 510(k)#K142979
Trade Name:	RENASYS TOUCH NPWT	RENASYS EZ MAX NPWT
Indications for Use:	Identical	Identical
Principle of Operation	Therapy unit delivers softwarecontrolled negative pressurewound therapy to the woundsite (continuous andintermittent).	Therapy unit delivers analoguecontrolled negative pressure woundtherapy to the wound site(continuous and intermittent).
Operating Time(Battery)	Up to 16 hours therapy	Up to 40 hours therapy
Negative PressureRange	25-200mmHg	40-200mmHg
Associated Canisters	300mL canister with solidifier800mL canister with solidifier300mL canister without solidifier	250mL Canister with solidifier800mL Canister with solidifier
User Interface	Full color touchscreen and 3control buttons	Adjustable pressure selector controlknob on front casing; analogvacuum gauge displays pressuresetting
Environment of use	Acute care and otherprofessional healthcareenvironments where productuse is conducted by or underthe supervision of a qualifiedhealthcare provider	Acute care and other professionalhealthcare environments whereproduct use is conducted by orunder the supervision of a qualifiedhealthcare provider

RENASYS Y-Connector

	Subject Device	Predicate Device 510(k) #142626
	RENASYS Y-Connector	Invia Liberty NPWT System Y-Connector
Indications for Use	Substantially Equivalent	Substantially Equivalent
Materials	Substantially Equivalent	Substantially Equivalent
Single Use orReusable	Single Use	Single Use
Method of Sterilization	Non-Sterile	Sterile - Method unknown
Biocompatibility	Substantially Equivalent	Substantially Equivalent

Non-Clinical Tests (Bench)

Performance testing has been conducted to verify the RENASYS TOUCH NPWT device meets design specifications and demonstrate substantial equivalence to the predicate devices.

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

. Verification of system performance with full range of RENASYS Foam and Gauze NPWT Dressing Kits with Soft Port and RENASYS AB Abdominal Kit with Soft Port.
Verification of system performance when operating with two Soft Ports via a Y-● connector with both foam and gauze wound fillers.
Verification of alarms functionality using wound fluid designed to simulate . chemistry and protein content of real exudate.
Verification of system performance with "Intermittent NPWT" mode selected ● across a range of wound model sizes and pressure settings.
. Verification of system performance in various combinations of challenge conditions.
Evaluation of battery life of the RENASYS TOUCH at the minimum and maximum ● available therapy settings.

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.

Device complies with the following standards:

ISO13485:2003, Medical Devices Quality Management Systems ●
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)
. BS EN 1041:2008 +A1:2013 Information Supplied by the Manufacturer with Medical Devices
. IEC 60601-1-2:2014 4" Edition Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests, Interpretation Sheet
. IEC 60601-1:2005 (3º Edition) + Am.1:2012 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance
IEC 60601-1-6:2010 3ª Edition Medical electrical equipment Part 1-6: General ● requirements for basic safety and essential performance - Collateral standard: Usability
IEC 60601-1-8:2006 (2™ Edition) + Am.1:2012 for use in conjunction with IEC ● 60601-1:2005 (3″ Edition) + Am.1:2012 Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral

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Standard: General requirements, tests and quidance for alarm systems in medical electrical equipment and medical electrical

. IEC 62366:2007 186 Edition Medical devices - Application of usability engineering to medical devices
· IEC 62304:2006 1st Edition, Medical device software Software life cycle processes
AAMI/ ANSI HE75:2009 Human Factor Engineering-Design of Medical Devices ●
. ISO 10993-1 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing
ISO 10993-5 Biological evaluation of medical devices -- Part 5: Tests for In Vitro . cytotoxicity
ISO 10993-10 Biological evaluation of medical devices Part 10: Tests for . irritation and skin sensitization
ISO 10993-3 Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
ISO 10993-7 Biological evaluation of medical devices Part 7: Ethylene oxide . sterilization residuals [Including: Technical Corrigendum 1 (2009)]

Conclusion

In establishing substantial equivalence to the predicate devices, Smith & Nephew evaluated the indications for use, principal of operation, technology, product specifications, energy requirements and materials of the device and accessories. Performance testing, electrical safety testing and software verification has been successfully completed to demonstrate that the RENASYS TOUCH NPWT device and accessories 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.