(382 days)
Not Found
No
The summary describes a negative pressure wound therapy dressing kit and its components. There is no mention of AI or ML technology in the device description, intended use, or performance studies. The performance studies focus on physical properties and fluid transport, not algorithmic performance.
Yes.
The device is a negative pressure wound therapy device, which is indicated for temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries may be required in patients with open abdominal wounds with exposed viscera and organs, and including but not limited to patients with abdominal compartment syndrome. Through its defined indications, negative pressure wound therapy is a therapeutic intervention.
No
Explanation: The device is a negative pressure wound therapy device, which is used for treatment (transporting exudates) rather than diagnosis.
No
The device description clearly outlines physical components like foam, film, and a transfer pad, and the performance studies focus on physical properties like drapability, tear strength, tensile strength, and fluid transport. It is a hardware-based negative pressure wound therapy dressing kit.
Based on the provided information, this 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.
- Device Function: The Avance® Foam Abdominal Dressing Kit is a negative pressure wound therapy device. Its function is to apply negative pressure to an open abdominal wound to remove exudates and promote healing. It is a physical device applied externally to the body.
- Intended Use: The intended use clearly describes a physical intervention on an open wound, not a diagnostic test performed on a sample.
The device's purpose is therapeutic (wound management), not diagnostic (analyzing samples for medical information).
N/A
Intended Use / Indications for Use
The Avance® Foam Abdominal Dressing Kit is indicated for temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries may be required. Its intended use is with patients who have open abdominal wounds with exposed viscera and organs, and including but not limited to patients with abdominal compartment syndrome. It is intended for use in acute hospital settings (trauma, general and plastic surgery wards) and should ideally be applied in the operating theatre. The dressing kit is intended for use together with the Avance NPWT pump and its accessories.
Product codes
OXJ, OMP
Device Description
The Avance® Foam Abdominal Dressing Kit is a negative pressure wound therapy device intended to provide negative pressure to the wound bed and thereby transport exudates from the wound. The Avance® Foam Abdominal Dressing Kit is a combination of different components developed and arranged to meet the needs of the clinical for specific size and types of wounds.
The Avance® Foam Abdominal Dressing Kit is together with the Avance® Pump and it's accessories is a complete negative pressure system for managing open abdomens. 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.
The Avance® Foam Abdominal Dressing Kit consists of the following components:
Avance® Organ·Contact Layer (OCL) is based on an oval polyurethane film with fenestrations and is placed in the open abdomen to protect and contain intestines.
Avance® Abdominal Foam is placed over the OCL with the intention to distribute the pressure across the wound surface and allow passage of fluids and exudates through to the negative pressure system.
Avance® Film with Safetac® Technology 20x40 cm in size, is a flexible, transparent film dressing consisting of a thin polyurethane film coated with a soft silicone adhesive. The soft silicone layer adheres gently to dry peri-wound skin, but not to a moist wound surface. The soft silicone layer is covered with a polvethylene release film. It is applied over the wound filler and surrounding skin with the intension to fixate the wound filler and create an airtight seal.
A vance® Transfer Pad is intended to transport exudates from the abdominal cavity to the canister. A hole is cut in the sealant before attaching the Transfer Pad.
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 and organs, abdominal cavity, open abdomens
Indicated Patient Age Range
Not Found
Intended User / Care Setting
acute hospital 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)
The kit was tested in conjunction with the pump and the performance results were as follows:
- . The vacuum level values measured in the wound model are within the chosen levels and shows a constant and uniform behavior.
- . The fluid was efficiently transported from the wound model without blockage or problems.
The Avance® Foam Abdominal Dressing Kit was subjected to the following tests to assure reliable design and performance under the specified testing parameters.
These tests were comprised of:
Drapability - Testing showed that all test articles were successfully subjected to the testing criteria for drapability. The predetermined acceptance criteria were met.
Tear Strength- Testing showed that all test articles were successfully subjected to the testing criteria for tear strength. The predetermined acceptance criteria were met.
Tensile Strength- Testing showed that all test articles were successfully subjected to the testing criteria for tensile strength. The predetermined acceptance criteria were met.
Fluid Transport- Testing showed that all test articles were successfully subjected to the testing criteria for fluid transport. The predetermined acceptance criteria were met.
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
§ 878.3300 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
APR 1 4 2014 K130852
、
510(k) SUMMARY
This 510(k) summary of safety and efficacy information is being submitted in accordance with the requirements of 21 CFR 807.92(c).
| Date Prepared: | March 20, 2013 |
|---|---|
| Submitter: | Mölnlycke Health Care US, LLC |
| 5550 Peachtree Parkway, Suite 500 | |
| Norcross, GA 30092 | |
| Angela L. Bunn, RAC | |
| Director, Regulatory Affairs of the Americas | |
| Tel: 678-250-7930 | |
| Fax: 678-250-7981 | |
| e-mail: angela.bunn@molnlycke.com | |
| Trade/Proprietary Name: | Avance® Foam Abdominal Dressing Kits |
| Common Name: | NPWT Dressing Kits |
| Classification Name: | Powered Suction Pump and Surgical Mesh |
| Predicate Device Name(s): | Avance® Foam Dressing Kits (K122132) |
| RENASYS™ AB Abdominal Dressing Kit | |
| (K112784) |
Description of Device:
The Avance® Foam Abdominal Dressing Kit is a negative pressure wound therapy device intended to provide negative pressure to the wound bed and thereby transport exudates from the wound. The Avance® Foam Abdominal Dressing Kit is a combination of different components developed and arranged to meet the needs of the clinical for specific size and types of wounds.
The Avance® Foam Abdominal Dressing Kit is together with the Avance® Pump and it's accessories is a complete negative pressure system for managing open abdomens. 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.
The Avance® Foam Abdominal Dressing Kit consists of the following components:
Avance® Organ·Contact Layer (OCL) is based on an oval polyurethane film with fenestrations and is placed in the open abdomen to protect and contain intestines.
1
Avance® Abdominal Foam is placed over the OCL with the intention to distribute the pressure across the wound surface and allow passage of fluids and exudates through to the negative pressure system.
Avance® Film with Safetac® Technology 20x40 cm in size, is a flexible, transparent film dressing consisting of a thin polyurethane film coated with a soft silicone adhesive. The soft silicone layer adheres gently to dry peri-wound skin, but not to a moist wound surface. The soft silicone layer is covered with a polvethylene release film. It is applied over the wound filler and surrounding skin with the intension to fixate the wound filler and create an airtight seal.
A vance® Transfer Pad is intended to transport exudates from the abdominal cavity to the canister. A hole is cut in the sealant before attaching the Transfer Pad.
Intended Use/Indication for Use:
The Avance® Foam Abdominal Dressing Kit is indicated for temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries may be required. Its intended use is with patients who have open abdominal wounds with exposed viscera and organs, and including but not limited to patients with abdominal compartment syndrome. It is intended for use in acute hospital settings (trauma, general and plastic surgery wards) and should ideally be applied in the operating theatre. The dressing kit is intended for use together with the Avance NPWT pump and its accessories.
Performance Data:
The kit was tested in conjunction with the pump and the performance results were as follows:
- . The vacuum level values measured in the wound model are within the chosen levels and shows a constant and uniform behavior.
- . The fluid was efficiently transported from the wound model without blockage or problems.
The Avance® Foam Abdominal Dressing Kit was subjected to the following tests to assure reliable design and performance under the specified testing parameters.
These tests were comprised of:
Drapability - Testing showed that all test articles were successfully subjected to the testing criteria for drapability. The predetermined acceptance criteria were met. Tear Strength- Testing showed that all test articles were successfully subjected to the testing criteria for tear strength. The predetermined acceptance criteria were met.
Tensile Strength- Testing showed that all test articles were successfully subjected to the testing criteria for tensile strength. The predetermined acceptance criteria were met.
2
Fluid Transport- Testing showed that all test articles were successfully subjected to the testing criteria for fluid transport. The predetermined acceptance criteria were met.
Biocompatibility:
. /
This table includes the testing criteria required as well as the test outcomes for the components within the Avance® Foam Abdominal Dressing Kit.
| Avance® Foam Abdominal Dressing Kit Components
| Biological Assessment Requirements for Testing based on ISO 10993 | ||
|---|---|---|
| Component | Toxicological | |
| Evaluation under ISO | ||
| 10993 for Product | ||
| Categorization | Testing Outcome | |
| Organ Contact Layer | Cytotoxicity Sensitization Irritation/Intracutaneous | |
| Reactivity Acute Systemic Toxicity Subchronic Toxicity Genotoxicity Implantation | Met Met Met Met Met Met Met | |
| Foam | Cytotoxicity Sensitization Irritation/Intracutaneous | |
| Reactivity | Pass Pass Met | |
| Transparent Film | Cytotoxicity Sensitization Irritation/Intracutaneous | |
| Reactivity | Pass Pass Met | |
| Transfer Pad | Cytotoxicity Sensitization Irritation/Intracutaneous | |
| Reactivity | Pass Pass Met |
Clinical Testing:
No clinical data was required.
Product Comparison to Predicate(s)
All of the kit components with the exception of the Organ Contact Layer have been cleared for use as a NPWT dressing kit under K122132. The components used in this abdominal dressing kit (with the exception of the Organ Contact Layer) are identical to those in material and function of the components cleared under K122132. The only difference in any one of those components is the size and shape of the foam.
3
The Avance® Foam Abdominal Dressing Kit has the same indication for use as the RENASYS™ AB Abdominal Dressing Kit (KI12784) and the same types of kit components.
Conclusion:
Based on the information presented in this submission, it can be concluded that the Avance® Foam Abdominal Dressing Kit is substantially equivalent to the current Avance® Foam Dressing Kits (K122132) and the RENASY'S™ AB Abdominal Dressing Kit (K112784) predicate(s) with respect to intended use, materials, design, and technological characteristics.
4
Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure with outstretched arms.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-Gbills Silver Spring, MD 20993-0002
April 14, 2014
Molylcke Health Care US, LLC Ms. Angela L. Bunn. RAC Director, Regulatory Affairs of the Americas 5550 Peachtree Parkway, Suite 500 Norcross, Georgia 30092
Re: K130852
Trade/Device Name: Avance® Form Abdominal Dressing Kit Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: OXJ, OMP Dated: February 24, 2014 Received: February 25, 2014
Dear Ms. Bunn:
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
5
Page 2 - Ms. Angela L. Bunn, RAC
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 Small Manufacturers, International and Consumer Assistance at its tollfree 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.
Sincerely yours,
David Krause -S
for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
INDICATIONS FOR USE
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K130852
Device Name: Avance® Foam Abdominal Dressing Kit
Indications For Use:
The Avance® Foam Abdominal Dressing Kit is indicated for temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries may be required. Its intended use is with patients who have open abdominal wounds with exposed viscera and organs, and including but not limited to patients with abdominal compartment syndrome. It is intended for use in acute hospital settings (trauma, general and plastic surgery wards) and should ideally be applied in the operating theatre. The dressing kit is intended for use together with the Avance NPWT. pump and its accessories.
Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jiyoung Dang -S
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