(57 days)
No
The summary describes a negative pressure wound therapy dressing kit and its components, with no mention of AI or ML technology. The testing focuses on mechanical and biological performance.
Yes.
The device is used for temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries are necessary, and in conjunction with negative pressure wound therapy pumps, indicating a therapeutic function in wound management.
No
The device is indicated for temporary bridging of abdominal wall openings and intended to be used in open abdominal wounds. It is a wound care device, not a diagnostic one.
No
The device description clearly outlines physical components like foam dressings, an organ protection layer, film drapes, and a Soft Port suction port assembly with tubing. The performance studies also focus on the physical properties and function of these hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for temporary bridging of abdominal wall openings and managing open abdominal wounds with exposed viscera using negative pressure wound therapy. This is a therapeutic and surgical application, not a diagnostic one.
- Device Description: The device consists of dressings, an organ protection layer, film drapes, and a suction port assembly. These are all components used for wound management and therapy, not for analyzing samples from the human body to provide diagnostic information.
- Lack of Diagnostic Function: There is no mention of the device being used to test or analyze biological samples (like blood, urine, tissue, etc.) to diagnose a condition, monitor a disease, or screen for health issues.
- Performance Studies: The performance studies focus on the mechanical and functional aspects of the device (exudate removal, connection security, biocompatibility), not on diagnostic accuracy or performance metrics like sensitivity, specificity, etc.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnostic purposes. This device's function is entirely focused on the physical management and healing of wounds.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FTL
Device Description
The RENASYS™ AB Abdominal Dressing Kit with Soft Port consists of two large hydrophobic reticulated polyurethane foam dressings that incorporate several cuts to facilitate custom sizing if needed. Also included in the kit are a polyurethane organ protection layer, six transparent film drapes and a Soft Port suction port assembly with tubing that attaches to the exudate canister. The kit is designed specifically for abdominal wounds and is supplied sterile, single use.
The modification to this kit is the inclusion of a Soft Port suction port, to replace the existing suction port.
The RENASYS AB Abdominal Dressing Kit is used in conjunction with Smith & Nephew RENASYS EZ and RENSASYS EZ PLUS negative pressure wound therapy pumps and canister kits, which have been cleared under 510(k) numbers K082426 and K091470.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Abdominal wall openings, open abdominal wounds with exposed viscera
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Acute hospital settings (trauma, general and plastic surgery wards), 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)
Design verification testing has been conducted to verify the Soft Port suction device meets the required specifications and functions equivalent to the existing suction port component in the kit. Testing verified that the Soft Port meets the design specifications and demonstrated substantial equivalence to the predicate device.
Summary of testing conducted:
- Laboratory testing was completed to confirm the Soft Port and the existing suction port demonstrate comparable performance patterns when tested with clottable blood.
- Testing to verify that the Soft Port performs to specification when it is placed under excessive ・ weight, becomes blocked by compression, folding, or is subjected to particulate challenge.
- -Testing to verify the Soft Port assembly will effectively remove exudate from the abdomen at the predetermined flow rate for a minimum of 48 hours.
- Testing to verify that the new "quick-click" connector establishes a secure connection to the exudate canister tubing.
The following biocompatibility testing for all kit components has been successfully completed per applicable parts of ISO 10993:
Kit Component: Foam
Tests Completed: Cytotoxicity, Irritation, Sensitization
Kit Component: Organ Protection Layer
Tests Completed: Cytotoxicity, Irritation, Sensitization, Implantation, Sub-acute Toxicity, Genotoxicity
Kit Component: Transparent Film Drape
Tests Completed: Cytotoxicity, Irritation, Sensitization
Kit Component: Soft Port Suction Assembly
Tests Completed: Genotoxicity, Cytotoxicity, Irritation, Sensitization, Sub-acute Toxicity
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
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.
0
NOV 2 2 2011
10f3
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 D. Reynolds |
| Director, Regulatory Affairs | |
| Phone Number: | (727) 329-7702 |
| Date Prepared: | November 1, 2011 |
| Trade Name: | RENASYS™™ AB Abdominal Dressing Kit with Soft |
| Port | |
| Generic/Common Name: | NPWT Abdominal Wound Dressing Kit |
| Classification Name: | Mesh, Surgical, Polymeric, 21 CFR 878.3300 |
| Product Classification/Code: | Class II, FTL |
| Predicate Device Information |
| 510(k) # | Device | Manufacturer | Clearance Date |
|---|---|---|---|
| K100787 | RENASYS™ F/AB | ||
| Abdominal Dressing Kit | Smith & Nephew, Inc. | 9/17/2010 | |
| K110647 | RENASYS Foam and | ||
| Gauze NPWT Wound | |||
| Dressing Kits with Soft | |||
| Port | Smith & Nephew, Inc. | 6/22/2011 |
Device Description
The RENASYS™ AB Abdominal Dressing Kit with Soft Port consists of two large hydrophobic reticulated polyurethane foam dressings that incorporate several cuts to facilitate custom sizing if needed. Also included in the kit are a polyurethane organ protection layer, six transparent film drapes and a Soft Port suction port assembly with tubing that attaches to the exudate canister. The kit is designed specifically for abdominal wounds and is supplied sterile, single use.
The modification to this kit is the inclusion of a Soft Port suction port, to replace the existing suction port.
The RENASYS AB Abdominal Dressing Kit is used in conjunction with Smith & Nephew RENASYS EZ and RENSASYS EZ PLUS negative pressure wound therapy pumps and canister kits, which have been cleared under 510(k) numbers K082426 and K091470.
1
2 of 2
Indications for Use
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.
Non-Clinical Tests (Bench)
Design verification testing has been conducted to verify the Soft Port suction device meets the required specifications and functions equivalent to the existing suction port component in the kit. Testing verified that the Soft Port meets the design specifications and demonstrated substantial equivalence to the predicate device.
Summary of testing conducted:
- Laboratory testing was completed to confirm the Soft Port and the existing suction port demonstrate comparable performance patterns when tested with clottable blood.
- Testing to verify that the Soft Port performs to specification when it is placed under excessive ・ weight, becomes blocked by compression, folding, or is subjected to particulate challenge.
- -Testing to verify the Soft Port assembly will effectively remove exudate from the abdomen at the predetermined flow rate for a minimum of 48 hours.
- Testing to verify that the new "quick-click" connector establishes a secure connection to the exudate canister tubing.
The following biocompatibility testing for all kit components has been successfully completed per applicable parts of ISO 10993:
| Kit Component | Tests Completed |
|---|---|
| Foam | Cytotoxicity |
| Irritation | |
| Sensitization | |
| Organ Protection Layer | Cytotoxicity |
| Irritation | |
| Sensitization | |
| Implantation | |
| Sub-acute Toxicity | |
| Genotoxicity | |
| Transparent Film Drape | Cytotoxicity |
| Irritation | |
| Sensitization | |
| Soft Port Suction Assembly | Genotoxicity |
| Cytotoxicity | |
| Irritation | |
| Sensitization | |
| Sub-acute Toxicity |
2
4112784
3.83
Conclusion
In establishing substantial equivalence to the currently marketed devices, Smith & Nephew, Inc evaluated the indications for use, materials, technology and product specifications of the device. Performance testing has been successfully completed to demonstrate that the RENASYS AB Abdominal Dressing Kit with Soft Port is substantially equivalent to the marketed device and is appropriate for the intended use.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle in flight. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
NOV 2 2 2011
Smith & Nephew, Inc. % Ms. Laura D. Reynolds Director, Regulatory Affairs 970 Lake Carillon Drive, Suite 110 St. Petersburg, Florida 33716
Re: K112784
Trade/Device Name: RENASYS™ AB Abdominal Kit with Soft Port Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTL Dated: November 01, 2011 Received: November 02, 2011
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
4
Page 2 -- Ms. Laura D. Reynolds
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K1|2784
Device Name: RENASYS™ AB Abdominal Kit with Soft Port
Indications for Use:
The 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 RENASYS AB Abdominal 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.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Kurech MXIM
al. Orthopedic,
510(k) Number K112784