(17 days)
Not Found
No
The 510(k) summary describes a biological mesh material and its intended use for surgical repair. There is no mention of software, algorithms, image processing, or any terms related to AI or ML.
Yes.
The device is intended for the surgical repair of damaged or ruptured soft tissue membranes and reconstruction, indicating a therapeutic purpose.
No
The device is described as a soft tissue patch and mesh for surgical repair and reinforcement, with no indication of diagnostic capability.
No
The device description clearly states it is a "fibrous mesh of acellular porcine dermal collagen and its constituent elastin fibers," indicating a physical, implantable material, not software.
Based on the provided information, the Bard® PelviSoft™ Acellular Collagen BioMesh is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for surgical repair of soft tissue where weakness exists, specifically for urethral procedures, vaginal prolapse, and pelvic floor reconstruction. This is a therapeutic and structural use within the body, not for diagnosing a condition by examining samples outside the body.
- Device Description: The description details a sterile, moist mesh made of acellular porcine dermal collagen. This is a material intended for implantation or surgical use, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVD devices are used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening. The Bard® PelviSoft™ is a surgical implant/patch.
N/A
Intended Use / Indications for Use
Bard® PelviSoft™ Acellular Collagen BioMesh is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. It is specifically indicated for urethral procedures, vaginal prolapse and reconstruction of the pelvic floor.
Product codes
FTM
Device Description
Bard® PelviSoft™ Acellular Collagen BioMesh is a sterile, off-white, moist. tough but flexible fibrous mesh of acellular porcine dermal collagen and its constituent elastin fibers. Presented moist in sterile saline, Bard® PelviSoft™ Acellular Collagen BioMesh is double vacuum-packed and heat sealed in peel-open aluminum foil (inner) and peel-open polyester/polvethylene (outer) pouches which are impermeable to oxygen and moisture.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urethral, vaginal, pelvic floor
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Bard® PelviSoft™ Acellular Collagen BioMesh is substantially equivalent to the predicate devices with regard to biocompatibility (Permacol®), materials (Permacol®) and product characterization (Permacol® and SurgiSIS™). The modified design does not raise any new safety or effectiveness issues.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Permacol®, SurgiSIS™
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
K031332/p1
MAY 1 5 2003
510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
A. SUBMITTER INFORMATION:
| Submitter's Name: | C. R. Bard, Inc., Urological Division |
|---|---|
| Address: | 8195 Industrial Blvd. |
| Covington, GA 30014 | |
| Contact Person: | Terrina Wilder |
| Contact Person's Telephone Number: | 770-784-6160 |
| Contact Person's Fax: | 770-784-6419 |
| Date of Preparation: | April 21, 2003 |
B. DEVICE NAME:
| Trade Name: | Bard® PelviSoft™ Acellular Collagen BioMesh |
|---|---|
| Common / Usual Name: | Surgical Mesh |
| Classification Name: | Polymeric Surgical Mesh (21 CFR 878.3300) |
C. PREDICATE DEVICE NAME:
Trade Name: Permacol® Acellular Collagen Matrix SurgiSIS™
D. DEVICE DESCRIPTION:
Bard® PelviSoft™ Acellular Collagen BioMesh is a sterile, off-white, moist. tough but flexible fibrous mesh of acellular porcine dermal collagen and its constituent elastin fibers. Presented moist in sterile saline, Bard® PelviSoft™ Acellular Collagen BioMesh is double vacuum-packed and heat sealed in peel-open aluminum foil (inner) and peel-open polyester/polvethylene (outer) pouches which are impermeable to oxygen and moisture.
E. Intended Use:
Bard® PelviSoft™ Acellular Collagen BioMesh is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. It is specifically indicated for urethral procedures, vaginal prolapse and reconstruction of the pelvic floor.
F. TECHNOLOGICAL CHARACTERISTICS SUMMARY:
The processing and materials of Bard® PelviSoft™ Acellular Collagen BioMesh and Permacol®, the predicate device, are the same.
1
031332/pz
G. Performance Data Summary:
Bard® PelviSoft™ Acellular Collagen BioMesh is substantially equivalent to the predicate devices with regard to biocompatibility (Permacol®), materials (Permacol®) and product characterization (Permacol® and SurgiSIS™). The modified design does not raise any new safety or effectiveness issues.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
MAY 1 5 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Terrina Wilder Senior Regulatory Affairs Specialist C.R. Bard, Inc. Urological Division 8195 Industrial Boulevard Covington, Georgia 30014
Re: K031332
Trade/Device Name: Bard® PelviSoft™ Acellular Collagen BioMesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM Dated: April 25, 2003 Received: April 29, 2003
Dear Ms. Wilder:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
3
Page 2 - Ms. Terrina Wilder
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:
Indications for Use:
Bard® PelviSoft™ Acellular Collagen BioMesh is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. It is specifically indicated for urethral procedures, vaginal prolapse, and reconstruction of the pelvic floor.
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K 03/332
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)
| Prescription Use
| (Per 21 CFR 801.109) | ✓ |
|---|---|
| ------------------------------------------ | --- |
OR
| Over-The-Counter Use | |
|---|---|
| ---------------------- | -- |
(Optional Format 1/2/96)