(59 days)
No
The summary describes a standard negative pressure wound therapy device that applies suction and manages fluids. There is no mention of AI or ML in the intended use, device description, or performance studies. The testing focuses on basic device functionality and equivalence to a predicate device.
Yes.
The device is indicated to "promote wound healing" and treats various "wound types," which are therapeutic actions.
No
The device is described as a suction device (negative pressure wound therapy) intended for wound management primarily through the removal of fluids. Its function is therapeutic (promoting healing and removing materials), not for identifying or investigating the nature of a disease or condition.
No
The device description explicitly states it is a "lightweight, suction device" and mentions components like a "pump," "tube," "disposable canister," and operation via "mains power supply or internal battery," indicating it is a hardware device with integrated software, not a software-only device.
Based on the provided information, the RENASYS EZ PLUS NPWT 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 EZ PLUS Function: The RENASYS EZ PLUS is a negative pressure wound therapy device. Its function is to apply suction to a wound to remove fluids and promote healing. It operates externally to the body and does not analyze biological samples for diagnostic purposes.
- Intended Use: The intended use clearly states it's a "suction device (negative pressure wound therapy)" for "removal of fluids." This is a therapeutic function, not a diagnostic one.
- Device Description: The description reinforces its function as a "suction device intended for wound management via application of continuous or intermittent negative pressure wound therapy."
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
Therefore, the RENASYS EZ PLUS NPWT device falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The RENASYS EZ PLUS NPWT 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
RENASYS EZ PLUS professional healthcare facility model (REF 66800697) 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
OMP
Device Description
The RENASYS EZ PLUS Negative Pressure Wound Therapy (NPWT) device is a lightweight, suction 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 pump is connected to the wound dressing via a tube connected to a disposable canister. The device provides negative pressure wound therapy to the wound at a range of pressure settings and removes exudates from the wound site to the disposable canister. The device can operate either by a mains power supply or internal battery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional healthcare facility model (REF 66800697) 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.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Tests (Bench)
Testing has been conducted to verify the modifications to the RENASYS EZ PLUS NPWT 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 EZ PLUS NPWT device:
- Pumping capacity is equivalent to the predicate device.
- Device provides negative pressure at individual pressure settings, identical 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 Canister Full 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of three human profiles facing right, with flowing lines representing hair or clothing. The profiles are arranged in a staggered formation, creating a sense of depth. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Smith and Nephew Incorporated Ms. Laura Reynolds Director Regulatory Affairs 970 Lake Carillon Drive, Suite 110 Saint Petersburg, Florida 33716
Re: K151326
Trade/Device Name: RENASYS™ EZ PLUS Negative Pressure Wound Therapy Device Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: June 23, 2015 Received: June 24, 2015
July 16, 2015
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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/ResourcesforYou/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.
For
Sincerelv vours.
Joshua C. Nipper -S
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
RENASYS™ EZ PLUS Negative Pressure Wound Therapy Device
Indications for Use (Describe)
The RENASYS EZ PLUS NPWT 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
RENASYS EZ PLUS professional healthcare facility model (REF 66800697) 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)
|X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
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."
FORM FDA 3881 (8/14)
Page 1 of 1
3
Wound Management 727 392-1261
Smith & Nephew. Inc. F 727 392-6914 or 727 392-0797 970 Lake Carillon Drive Customer Care Center: 1 800 876-1261 Suite 110 www.smith-nephew.com St. Petersburg, FL 33716
510(k) Summary
| General Information | |
|---|---|
| Submitters Name/Address: | Smith & Nephew, Inc. |
| 970 Lake Carillon Drive | |
| Suite 110 | |
| St. Petersburg, FL 33716 | |
| Establishment Registration Number: | 3006760724 |
| Contact Person: | Laura Reynolds |
| Director Regulatory Affairs | |
| Phone Number: | (727) 329-7702 |
| Date Prepared: | July 16, 2015 |
| Device Description | |
| Trade Name: | RENASYS™ EZ PLUS 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 EZ PLUS Negative
Pressure Wound Therapy Device | RENASYS EZ MAX Negative
Pressure Wound Therapy Device | K142979 | 04/29/2015 |
Device Description
RENASYS EZ PLUS Negative Pressure Wound Therapy Device
The RENASYS EZ PLUS Negative Pressure Wound Therapy (NPWT) device is a lightweight, suction 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 pump is connected to the wound dressing via a tube connected to a disposable canister. The device provides negative pressure wound therapy to the wound at a range of pressure settings and removes exudates from the wound site to the disposable canister. The device can operate either by a mains power supply or internal battery.
4
The technological characteristics of the subject device have not changed from the predicate device.
RENASYS Canisters
The 800ml and 250ml canisters are non-sterile, single use devices with a lid that is ultrasonically welded on. The canister kits contain a combination of solidifier gel pack, bacterial overflow guard that attaches to the pump and canister tubing that attaches to the Soft Port assembly.
The 800ml canister without solidifier is a non-sterile, single use device with a lid that is ultrasonically welded on. The canister kit contains a bacterial overflow quard that attaches to the pump and canister tubing that attaches to the Soft Port assembly.
Indications for Use
RENASYS EZ PLUS Negative Pressure Wound Therapy Device
The RENASYS EZ PLUS NPWT 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
RENASYS EZ PLUS professional healthcare facility model (REF 66800697) 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.
The indications for Use statement are the same for both devices except the product name and code.
Summary Comparison between Subject and Predicate Devices
| | Subject Device:
RENASYS EZ PLUS NPWT | Predicate Device:
RENASYS™ EZ MAX NPWT
(K142979) |
|----------------------------------------------|-----------------------------------------|--------------------------------------------------------|
| Indications for Use: | Identical | Identical |
| Components | Substantially equivalent | Substantially equivalent |
| Principle of Operation | Identical | Identical |
| Operating Time (Battery) | Identical | Identical |
| Negative Pressure
Range | Identical | Identical |
| High Flow/Leak Rate
Alarm Threshold Limit | Same | Same |
| Sterilization | N/A | N/A |
5
| | Subject Device:
RENASYS EZ PLUS NPWT | Predicate Device:
RENASYS™ EZ MAX NPWT
(K142979) |
|--------------------------|--------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Biocompability | No patient contact materials | No patient contact materials |
| Software | N/A | N/A |
| Locking Feature | Identical | Identical |
| On/Off Switch Protection | Front case protrusions
(shrouds) built in the front
case on either side of the
ON/OFF switch. | Switch protection added to
the front of the case on all
sides of the ON/OFF switch |
| Alarm indications | Flashing LED, except the
battery failure Solid yellow
LED
Audible indication | Solid LED illumination, except
the battery charging indicator
Audible indication modified to
comply with 60601-1-8 2nd
edition |
| IV Pole mount | Affixes to IV poles up to 1 ¼"
pole diameter. | Redesign to combine IV
Pole/Bed Rail Mount. IV Pole
Mount will affix to poles up to
2" diameter. |
| Bed rail mount | Back of device has folding
stainless steel bed hooks to fit
up to 2 ¼" in diameter. | Redesign to combine IV
Pole/Bed Rail Mount. Bed
Rail Mount will accommodate
bed rails up to 3" in diameter. |
RENASYS EZ PLUS NPWT Canisters Only
| | Subject Device:
RENASYS EZ PLUS NPWT | Predicate Device:
RENASYS EZ MAX
NPWT(K142979) |
|------------------------------------------------------------------------------|-----------------------------------------|------------------------------------------------------|
| Canisters | Identical | Identical |
| Bacterial Overflow
Guard housing material | Identical | Identical |
| 250ml S-Canister resin | Identical | Identical |
| 800ml S-Canister and
(including lid) and
250ml S-Canister lid
resin | Identical | Identical |
| 800ml S-Canister;
amount of solidifier | Identical | Identical |
Non-Clinical Tests (Bench)
RENASYS EZ PLUS Negative Pressure Wound Therapy Device
Testing has been conducted to verify the modifications to the RENASYS EZ PLUS NPWT 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 EZ PLUS NPWT device:
6
- . Pumping capacity is equivalent to the predicate device.
- . Device provides negative pressure at individual pressure settings, identical 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 Canister Full 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.
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 980:2008 Graphical Symbols for use in the labeling of Medical Devices
- BS EN 1041:2008 +A1:2013 Information Supplied by the Manufacturer with Medical Devices
- IEC 60601-1-2:2007(2"0 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: :1988 + A1:1991 + A2:1995 Medical Electrical Equipment - Part 1: General Requirements for Safety
- . UL 60601-1 Medical Electrical Equipment Part 1 General Requirements for Basic Safety and Essential Performance 1st ed.
Conclusions
In establishing substantial equivalence to the predicate devices, Smith & Nephew, Inc. evaluated the indications for use, materials, technology, product specifications and energy requirements of the device. Performance testing has been successfully completed to demonstrate that the RENASYS EZ PLUS NPWT device and canisters are substantially equivalent to the predicate devices for the intended use.