(25 days)
Not Found
No
The document describes a physical surgical mesh made of collagen and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device description indicates it is a surgical mesh for reinforcing and repairing soft tissue, which is a structural or supportive function rather than a therapeutic one (i.e., treating or curing a disease).
No
Explanation: The device is indicated for reinforcement and repair of soft tissue, which is a therapeutic function, not a diagnostic one. It does not mention any diagnostic capabilities such as detecting or identifying a disease or condition.
No
The device description clearly states it is a "single layer porous, cross-linked collagen patch," which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that BioBlanket™ Surgical Mesh is for the reinforcement and repair of soft tissue during surgical procedures. This is a therapeutic and structural function within the body, not a diagnostic test performed on samples outside the body.
- Device Description: The device is a surgical mesh comprised of collagen, designed to be implanted. This is consistent with a surgical implant, not a diagnostic reagent or instrument.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. BioBlanket™ Surgical Mesh does not fit this description.
N/A
Intended Use / Indications for Use
BioBlanket™ Surgical Mesh is indicated for use in general surgical procedures for the reinforcement and repair of soft tissue where weakness exists including, but not limited to defects of the thoracic wall, muscle flap reinforcement, rectal and vaginal prolapse, reconstruction of the pelvic floor, hernias, suture line reinforcement and reconstructive procedures. The device is also intended for reinforcement of the soft tissues which are repaired by suture or suture anchors, limited to the supraspinatus, during rotator cuff repair surgery. The device is intended for one time use.
Product codes (comma separated list FDA assigned to the subject device)
FTM, OXB, OXE, OXH, OWY, PAI, PAJ
Device Description
BioBlanket™ Surgical Mesh is comprised of a single layer porous, cross-linked collagen patch that is supplied sterile and for one-time use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic wall, muscle, rectal, vaginal, pelvic floor, supraspinatus
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)
BioBlanket™ Surgical Mesh has been subjected to biocompatibility, integrity, in-vitro and in-vivo performance tests. The device passed the requirements of all tests.
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.
Not Found
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
Kensey Nash Corporation 510(k) Application: BioBlanket™ Surgical Mesh
Image /page/0/Picture/1 description: The image shows the text "K061030" in large, bold font. Below this, the text "510(k) Summary" is visible, also in bold font. The text appears to be part of a document or label, possibly related to a medical device or regulatory submission.
MAY - 9 2006
Submitted by:
Kensey Nash Corporation 735 Pennsylvania Drive Exton, PA 19341
Contact Person:
Deborah A. Racioppi, RA Compliance Manager Ph: 610-594-4389 Fax: 610-524-0265 March 22, 2006
Date Prepared: 510(k) #: Device: Trade Name: Common/Usual Name: Proposed Classification:
BioBlanket™ Surgical Mesh Surgical Mesh, Tissue Repair Biomaterial Surgical Mesh 21 CFR Part 878.3300 (79 FTM) Class II
Device Description:
BioBlanket™ Surgical Mesh is comprised of a single layer porous, cross-linked collagen patch that is supplied sterile and for one-time use.
Intended Use:
BioBlanket™ Surgical Mesh is indicated for use in general surgical procedures for the reinforcement and repair of soft tissue where weakness exists including, but not limited to defects of the thoracic wall, muscle flap reinforcement, rectal and vaginal prolapse, reconstruction of the pelvic floor, hernias, suture line reinforcement and reconstructive procedures. The device is also intended for reinforcement of the soft tissues which are repaired by suture or suture anchors, limited to the supraspinatus, during rotator cuff repair surgery. The device is intended for one time use.
Substantial Equivalence:
In terms of Section 510(k) substantial equivalence, BioBlanket™ Surgical Mesh is similar to the predicate collagen-based surgical mesh devices listed below previously cleared for commercial distribution. The BioBlanket™ Surgical Mesh is substantially equivalent in terms of intended use, technological characteristics, performance and material.
| Manufacturer | Device | 510(k) | ProCode |
|---|---|---|---|
| Kensey Nash Corp. | BioBlanket™ Surgical Mesh | K043259 | FTM |
| Kensey Nash Corp. | BioBlanket™ Surgical Mesh | K041923 | FTM |
Performance Data:
BioBlanket™ Surgical Mesh has been subjected to biocompatibility, integrity, in-vitro and in-vivo performance tests. The device passed the requirements of all tests.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 16, 2014
Kensey Nash Corporation % Ms. Deborah A. Racioppi RA Compliance Manager 735 Pennsylvania Drive Exton, Pennsylvania 19341
Re: K061030
Trade/Device Name: BioBlanket" Surgical Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTM, OXB, OXE, OXH, OWY, PAI, PAJ Dated: April 12, 2006 Received: April 14, 2006
Dear Ms. Racioppi:
This letter corrects our substantially equivalent letter of May 9, 2006.
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. Iisting 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
2
Page 2 - Ms. Deborah A. Racioppi
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/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. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Kensey Nash Corporation 510(k) Application: BioBlanket™ Surgical Mesh
Indications For Use Statement
510(k) Number (if known): K 06/03 >
Devicc Name: BioBlanket™ Surgical Mesh
Indications for Use:
BioBlanket™ Surgical Mesh is indicated for use in general surgical procedures for the reinforcement and repair of soft tissue where weakness exists including, but not limited to defects of the thoracic wall, muscle flap reinforcement, rectal and vaginal prolapse, reconstruction of the pelvic floor, hernias, suture line reinforcement and reconstructive procedures. The device is also intended for reinforcement of the soft tissues which are repaired by suture or suture anchors, limited to the supraspinatus, during rotator cuff repair surgery. The device is intended for one time use.
Prescription Use X (Per 21 CFR 801 Subpart D) OR
Over-the-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
el.qMDE.
Division of General, Restorative, and Neurological Devices
510(k) Number_ko61030
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