(273 days)
No
The device description and performance studies focus on the mechanical function of a suction pump for negative pressure wound therapy and do not mention any AI or ML capabilities.
Yes
The device is indicated for patients who would benefit from a suction device as it may promote wound healing via removal of fluids.
No
Explanation: The device is described as a suction pump that removes fluids and promotes wound healing, which falls under therapeutic use, not diagnostic. Its function is to treat a condition rather than to identify or analyze one.
No
The device description explicitly states it is a "lightweight suction pump device" and describes its physical components and function in delivering negative pressure wound therapy, indicating it is a hardware device with potentially embedded software.
Based on the provided text, the RENASYS TOUCH device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- RENASYS TOUCH Function: The RENASYS TOUCH is a suction pump device used for Negative Pressure Wound Therapy (NPWT). Its primary function is to apply negative pressure to a wound to remove fluids and promote healing. It does not perform any diagnostic tests on bodily fluids or tissues.
- Intended Use: The intended use clearly states it's a "suction device (Negative Pressure Wound Therapy)" to promote wound healing via fluid removal.
- Device Description: The description reinforces its function as a suction pump for wound management and exudate removal.
- Lack of Diagnostic Testing: There is no mention of the device analyzing or testing any biological samples for diagnostic purposes. The "Verification of alarms functionality using wound fluid designed to simulate chemistry and protein content of real exudate" is a performance test of the device's alarm system, not a diagnostic test of the exudate itself.
Therefore, the RENASYS TOUCH is a therapeutic device used for wound management, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
OMP
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Wound site
Indicated Patient Age Range
Not Found
Intended User / Care Setting
acute care settings and other professional healthcare environments where product use is conducted by or under the supervision of a qualified healthcare professional.
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)
Performance testing has been conducted to verify the RENASYS TOUCH NPWT device meets design specifications and demonstrate substantial equivalence to the predicate devices.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health and Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three faces in profile, stacked on top of each other.
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
1
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
2
Indications for Use
510(k) Number (if known) K153209
Device Name
RENASYS TOUCH Negative Pressure Wound Therapy Device
Indications for Use (Describe)
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.
| 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) |
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.gov
"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
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# | Clearance
Date |
|------------------------------------------------------------|------------------------------------------------------------------------------------------|---------|-------------------|
| RENASYS TOUCH
Negative Pressure Wound
Therapy Device | RENASYS EZ MAX Negative
Pressure Wound Therapy
Device ( Primary Predicate ) | K142979 | 04/29/2015 |
| RENASYS Y-Connector | Invia Liberty Negative Pressure
Wound Therapy System | K142626 | 06/12/2015 |
4
Device Description
RENASYS TOUCH Negative Pressure Wound Therapy Device
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.
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.
5
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
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.
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.
6
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 software
controlled negative pressure
wound therapy to the wound
site (continuous and
intermittent). | Therapy unit delivers analogue
controlled negative pressure wound
therapy to the wound site
(continuous and intermittent). |
| Operating Time
(Battery) | Up to 16 hours therapy | Up to 40 hours therapy |
| Negative Pressure
Range | 25-200mmHg | 40-200mmHg |
| Associated Canisters | 300mL canister with solidifier
800mL canister with solidifier
300mL canister without solidifier | 250mL Canister with solidifier
800mL Canister with solidifier |
| User Interface | Full color touchscreen and 3
control buttons | Adjustable pressure selector control
knob on front casing; analog
vacuum gauge displays pressure
setting |
| Environment of use | Acute care and other
professional healthcare
environments where product
use is conducted by or under
the supervision of a qualified
healthcare provider | Acute care and other professional
healthcare environments where
product use is conducted by or
under the supervision of a qualified
healthcare 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 or | ||
| Reusable | 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.
7
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
8
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.