(265 days)
Not Found
No
The device description and performance studies focus on the mechanical and functional aspects of negative pressure wound therapy, with no mention of AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes.
The device is used for wound management and promotes wound healing via the removal of fluids, which clearly states its therapeutic purpose.
No
The device is described as a "suction device" or "Negative Pressure Wound Therapy (NPWT) 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." Its function is to remove fluids and promote healing, not to diagnose a condition.
No
The device description clearly outlines hardware components such as a pump, canister, tubing, and power supply, indicating it is not a software-only device.
Based on the provided text, the RENASYS EZ MAX and the associated kits are not In Vitro Diagnostic (IVD) devices.
Here's why:
- Intended Use: The intended use is for wound healing via the application of negative pressure to remove fluids. This is a therapeutic intervention applied directly to the patient's wound, not a test performed on a sample taken from the patient to diagnose a condition or monitor a biological process.
- Device Description: The device is described as a "suction device" and a "Negative Pressure Wound Therapy (NPWT) device." Its function is to apply negative pressure and collect exudate. This is a physical therapy, not a diagnostic test.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples (blood, urine, tissue, etc.) to provide diagnostic information. There is no mention of reagents, assays, or any form of in vitro analysis.
Therefore, the RENASYS EZ MAX and its associated kits are therapeutic devices, specifically for Negative Pressure Wound Therapy, and do not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
RENASYS™ EZ MAX Negative Pressure Wound Therapy Device:
RENASYS EZ MAX 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 MAX professional healthcare facility model (REF 66801309) 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.
RENASYS™ AB Abdominal Dressing Kit with Soft Port Device:
RENASYS AB Abdominal Kit with Soft Port is indicated for temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries are necessary.
It is intended to be used in open abdominal wounds with exposed viscera, including but not limited to abdominal compartment syndrome.
The use of RENASYS Abdominal Kit with Soft Port is intended for use in acute hospital care settings (trauma, general and plastic surgery wards) and should ideally be applied in the operating theatre.
Product codes (comma separated list FDA assigned to the subject device)
OMP, FTL
Device Description
RENASYS EZ MAX Negative Pressure Wound Therapy Device
The RENASYS EZ MAX Negative Pressure Wound Therapy (NPWT) device is a lightweight, suction device intended for wound management via application of continuous or intermittent neqative 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. The technological characteristics of the new device have not changed.
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.
RENASYS AB Abdominal Dressing Kit with Soft Port
RENASYS AB Abdominal Dressing Kit with Soft Port consists of the following components:
- Two large hydrophobic, reticulated polyurethane foam dressings that incorporate several ● cuts to facilitate custom sizing, if needed.
- One organ protection layer made of non-adherent clear polyurethane film perforated with slits. The slits in the organ protection layer facilitate fluid removal under negative pressure wound therapy.
- . Six 12" x 8" polyurethane transparent film drapes with acrylic adhesive backing. The drapes are placed over the foam and surrounding intact skin to create an airtight seal for the application of negative pressure wound therapy.
- . One Soft Port suction assembly with tubing that attaches to the exudate collection canister. The Soft Port assembly is placed over a hole cut in the drape to facilitate application of negative pressure wound therapy to the wound.
The abdominal kit is designed specifically for use with the RENASYS EZ MAX negative pressure wound therapy devices and canisters.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Wound types: Chronic, Acute, Traumatic, Sub-acute and Dehisced wounds, Ulcers (such as pressure or diabetic), Partial-thickness burns, Flaps and grafts.
Abdominal wall openings, open abdominal wounds with exposed viscera (abdominal compartment syndrome).
Indicated Patient Age Range
Not Found
Intended User / Care Setting
RENASYS EZ MAX Negative Pressure Wound Therapy Device:
professional healthcare facility model (REF 66801309) 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.
RENASYS AB Abdominal Dressing Kit with Soft Port:
intended for use in acute hospital care settings (trauma, general and plastic surgery wards) and should ideally be applied in the operating theatre.
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)
RENASYS EZ MAX Negative Pressure Wound Therapy Device
Testing has been conducted to verify the modifications to the RENASYS EZ MAX 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 MAX NPWT device:
- Pumping capacity is equivalent to the predicate device. ●
- . Device provides negative pressure wound therapy 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.
RENASYS AB Abdominal Dressing Kit with Soft Port
Testing has been conducted to verify the modifications to the RENASYS AB Abdominal Dressing Kit with Soft Port meet design specifications and demonstrate substantial equivalence to the predicate device.
- . Verification that the Soft Port serves as a conduit between RENASYS EZ MAX NPWT device and RENASYS AB Abdominal Dressing Kit with Soft Port by transmitting negative pressure wound therapy and collecting exudate flows.
- . Verification that the Soft Port functions throughout the recommended maximum elapsed time of 48 hours between dressing changes.
Performance testing, and electrical safety testing has been successfully completed to demonstrate that the RENASYS EZ MAX NPWT device and canisters, and the RENASYS AB Abdominal Dressing Kit with Soft Port are substantially equivalent to the predicate devices for the intended uses.
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.
K142979, K132446, K102001, K112784
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.
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 seal of the U.S. Department of Health and Human Services. The seal features an abstract design of an eagle with three human profiles incorporated into its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 22, 2016
Smith and Nephew Incorporated Ms. Laura Reynolds Director of Regulatory Affairs 970 Lake Carillon Drive, Suite 110 Saint Petersburg, Florida 33716
Re: K143133
Trade/Device Name: RENASYS™ EZ MAX Negative Pressure Wound Therapy Device, RENASYS™ AB Abdominal Dressing Kit with Soft Port Device Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP, FTL Dated: June 8, 2015 Received: June 9, 2015
Dear Ms. Reynolds:
This letter corrects our substantially equivalent letter of July 23, 2015.
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
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
Indications for Use
510(k) Number (if known) K143133
Device Name
RENASYS™ EZ MAX Negative Pressure Wound Therapy Device
Indications for Use (Describe)
RENASYS EZ MAX 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 MAX professional healthcare facility model (REF 66801309) 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)
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."
3
Indications for Use
510(k) Number (if known) K143133
Device Name
RENASYSTM AB Abdominal Dressing Kit with Soft Port Device
Indications for Use (Describe)
RENASYS AB Abdominal Kit with Soft Port is indicated for temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries are necessary.
It is intended to be used in open abdominal wounds with exposed viscera, including but not limited to abdominal compartment syndrome.
The use of RENASYS Abdominal Kit with Soft Port is intended for use in acute hospital care settings (trauma, general and plastic surgery wards) and should ideally be applied in the operating theatre.
| 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)
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."
4
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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 www.smith-nephew.com Suite 110 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 1, 2015 |
| Device Description | |
| Trade Name: | RENASYST™ EZ MAX Negative Pressure Wound |
| Therapy (NPWT) Device | |
| Generic/Common Name: | Powered Suction Pump |
| Classification Name: | Powered Suction Pump; 21 CFR 878.4780 |
| Product Code: OMP | |
| Trade Name: | RENASYS™ AB Abdominal Dressing Kit with Soft |
| Port™ Device | |
| Generic/Common Name: | Mesh, Surgical Polymeric |
| Classification Name: | Mesh, Surgical Polymeric; 21 CFR 878.3300 |
| Product Code: FTL |
Predicate Device Information
| Predicate Device | 510k# | Clearance
Date |
|--------------------------------------------------------|---------|-------------------|
| RENASYS EZ MAX Negative Pressure Wound Therapy Device | K132446 | 10/23/2013 |
| RENASYS EZ PLUS Negative Pressure Wound Therapy Device | K102001 | 08/06/2010 |
| RENASYS AB Abdominal Dressing Kit with Soft Port | K112784 | 11/22/2011 |
5
| Predicate Device | 510k# | Clearance
Date |
|--------------------------------------------------------------------------------------------------------------------------------|---------|-------------------|
| RENASYS EZ MAX Negative Pressure Wound Therapy Device and
RENASYS Foam and Gauze NPWT Wound Dressing Kits with Soft
Port | K142979 | 04/29/2015 |
Device Description
RENASYS EZ MAX Negative Pressure Wound Therapy Device
The RENASYS EZ MAX Negative Pressure Wound Therapy (NPWT) device is a lightweight, suction device intended for wound management via application of continuous or intermittent neqative 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. The technological characteristics of the new device have not changed.
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.
RENASYS AB Abdominal Dressing Kit with Soft Port
RENASYS AB Abdominal Dressing Kit with Soft Port consists of the following components:
- Two large hydrophobic, reticulated polyurethane foam dressings that incorporate several ● cuts to facilitate custom sizing, if needed.
- One organ protection layer made of non-adherent clear polyurethane film perforated with slits. The slits in the organ protection layer facilitate fluid removal under negative pressure wound therapy.
- . Six 12" x 8" polyurethane transparent film drapes with acrylic adhesive backing. The drapes are placed over the foam and surrounding intact skin to create an airtight seal for the application of negative pressure wound therapy.
- . One Soft Port suction assembly with tubing that attaches to the exudate collection canister. The Soft Port assembly is placed over a hole cut in the drape to facilitate application of negative pressure wound therapy to the wound.
The abdominal kit is designed specifically for use with the RENASYS EZ MAX negative pressure wound therapy devices and canisters.
Indications for Use
RENASYS EZ MAX Negative Pressure Wound Therapy Device
6
The RENASYS EZ MAX 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 MAX professional healthcare facility model (REF 66801309) 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.
RENASYS AB Abdominal Dressing Kit with Soft Port
The RENASYS AB Abdominal Dressing Kit with Soft Port is indicated for temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries are necessary. It is intended to be used in open abdominal wounds with exposed viscera, including but not limited to abdominal compartment syndrome.
The RENASYS AB Abdominal Dressing Kit with Soft Port is intended for use in acute hospital settings (trauma, general and plastic surgery wards) and should ideally be applied in the operating theatre.
Summary Comparison between New and Predicate Devices
RENASYS EZ MAX NPWT
| New Device: 510(k) K143133 | Predicate Device: 510(k)# K142979 | Predicate Device: 510(k)# K132446 | |
|---|---|---|---|
| Trade Name: | RENASYS EZ MAX NPWT | RENASYS EZ MAX Negative Pressure Wound Therapy Device and RENASYS Foam and Gauze NPWT Wound Dressing Kits with Soft Port | RENASYS EZ MAX NPWT |
| Indications for Use: | Substantially equivalent | Substantially equivalent | Substantially equivalent |
| Components | Substantially equivalent | Substantially equivalent | Substantially equivalent |
| Principle of Operation | Identical | Identical | Identical |
| Operating Time (Battery) | Identical | Identical | Identical |
7
| New Device: | Predicate Device: | Predicate Device: | |
|---|---|---|---|
| 510(k) K143133 | 510(k)# K142979 | 510(k)# K132446 | |
| Trade Name: | RENASYS EZ MAX | ||
| NPWT | RENASYS EZ MAX | ||
| Negative Pressure | |||
| Wound Therapy | |||
| Device and RENASYS | |||
| Foam and Gauze | |||
| NPWT Wound | |||
| Dressing Kits with | |||
| Soft Port | RENASYS EZ MAX | ||
| NPWT | |||
| Negative Pressure | |||
| Range | Identical | Identical | Identical |
| High Flow/Leak Rate | |||
| Alarm Threshold | |||
| Limit | Identical | Identical | Identical |
| Sterilization | N/A | N/A | N/A |
| Biocompability | No patient contact | ||
| materials | No patient contact | ||
| materials | No patient contact | ||
| materials | |||
| Alarms and | |||
| Indicators | Identical | Identical | Identical |
| Software | N/A | N/A | N/A |
RENASYS EZ MAX NPWT Canisters Only
| | New Device:
510(k) K143133 | Predicate Device:
510(k)# K142979 | Predicate Device:
510(k)# K102001 |
|--------------------------------|----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|
| Trade Name: | RENASYS EZ MAX
NPWT | RENASYS EZ MAX
Negative Pressure
Wound Therapy Device
and RENASYS Foam
and Gauze NPWT
Wound Dressing Kits
with Soft Port | RENASYS EZ PLUS
NPWT |
| Indications for
Use: | Substantially equivalent | Substantially equivalent | Substantially equivalent |
| Bacterial Overflow
Guard | Material change to softer
plastic outer casing of
filter | Material change to softer
plastic outer casing of
filter | Plastic outer casing of
filter |
| Material | Substantially equivalent | Substantially equivalent | Substantially equivalent |
| Canister without
solidifier | New | New | N/A |
| Canisters with
Solidifier | Substantially equivalent | Substantially equivalent | Substantially equivalent |
8
RENASYS AB Abdominal Dressing Kit with Soft Port
| New Device: | Predicate Device: | |
|---|---|---|
| Trade Name: | 510(k) K143133 | |
| RENASYS AB Abdominal | ||
| Dressing Kit with Soft Port | 510(k)# K112784 | |
| RENASYS AB | ||
| Abdominal Dressing Kit | ||
| with Soft Port | ||
| Indications for Use: | Indicated for temporary bridging | |
| of abdominal wall openings | ||
| where primary closure is not | ||
| possible and/or repeat | ||
| abdominal entries are | ||
| necessary. It is intended to be | ||
| used in open abdominal wounds | ||
| with exposed viscera, including | ||
| but not limited to abdominal | ||
| compartment syndrome. |
This dressing kit is intended for
use in acute hospital settings
(trauma, general and plastic
surgery wards) and should
ideally be applied in the
operating theatre. | Identical |
| Materials: | Substantially equivalent | Substantially equivalent |
| Soft Port Assembly: | Increased aperture size
Two slits in paper release liner | Smaller aperture size
One slit in paper release
liner |
| Single-use or
Reusable: | Single-use | Single-use |
| Method of
Sterilization: | Identical | Identical |
| Biocompatibility: | All components comply with ISO
10993 | All components comply
with ISO 10993 |
| Packaging: | Substantially equivalent | Substantially equivalent |
| Kit Shelf-life | 12 months | 12 months |
Table of Modifications
| Modification | Reason For Change | Verification Testing
Performed |
|------------------------------------------------------------------------------------------------------|--------------------|------------------------------------------------------------------------------------------------------------------------------|
| Modification to the
release paper liner of the
Soft Port assembly to add
an additional slit | Improved usability | Comprehensive verification
was completed which
demonstrated acceptable
device performance and
improved usability |
9
| Modification | Reason For Change | Verification Testing
Performed |
|--------------------------------------------------------------------------------------------------------------------------|---------------------------|------------------------------------------------------------------------------------------------------------------------------|
| Modification to increase
the Soft Port aperture size | Improved usability | Comprehensive verification
was completed which
demonstrated acceptable
device performance |
| Modification of the hole
size and geometry in the
mid and bottom poly
sheet layers of the Soft
Port Assembly | Improve manufacturability | Comprehensive verification
was completed which
demonstrated acceptable
device performance and
improved usability |
Non-Clinical Tests (Bench)
RENASYS EZ MAX Negative Pressure Wound Therapy Device
Testing has been conducted to verify the modifications to the RENASYS EZ MAX 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 MAX NPWT device:
- Pumping capacity is equivalent to the predicate device. ●
- . Device provides negative pressure wound therapy 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.
RENASYS AB Abdominal Dressing Kit with Soft Port
Testing has been conducted to verify the modifications to the RENASYS AB Abdominal Dressing Kit with Soft Port meet design specifications and demonstrate substantial equivalence to the predicate device.
- . Verification that the Soft Port serves as a conduit between RENASYS EZ MAX NPWT device and RENASYS AB Abdominal Dressing Kit with Soft Port by transmitting negative pressure wound therapy and collecting exudate flows.
- . Verification that the Soft Port functions throughout the recommended maximum elapsed time of 48 hours between dressing changes.
There have been no other changes to patient contacting materials from the predicate devices.
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 .
10
- 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(3rd 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 (3rd edition). Medical Electrical Equipment - Part 1: General Requirements for Safety
- ANSI/AAMI ES60601-1:2005 Version (R2012) Medical Electrical Equipment Part 1: ● General Requirements for Basic Safety and Essential Performance
- 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 60601-1-6:2010 (3rd Edition) Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- IEC 62366:2007 (1st edition) Medical devices Application of usability engineering to . medical devices. (General)
- . ISO 11135: 2014 Medical Devices - Validation and routine control of ethylene oxide sterilization
- . ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
- . ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
- ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing with a risk management process
- . AAMI/ANSI HE75:2009 Human Factor Engineering-Design of Medical Devices
Conclusions
In establishing substantial equivalence to the currently marketed predicate devices, 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 EZ MAX NPWT device and canisters, and the RENASYS AB Abdominal Dressing Kit with Soft Port are substantially equivalent to the predicate devices for the intended uses.