BIOBLANKET SURGICAL MESH

K061030 · Kensey Nash Corporation · FTM · May 9, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K061030
• Device Name: BIOBLANKET SURGICAL MESH
• Applicant: Kensey Nash Corporation
• Product Code: FTM · General, Plastic Surgery
• Decision Date: May 9, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

BioBlanket™ Surgical Mesh is a single-layer, porous, cross-linked collagen patch. Used by surgeons in clinical settings for soft tissue reinforcement and repair. Device provides mechanical support to weakened tissues or suture lines; facilitates tissue repair in general surgical procedures and rotator cuff surgeries (specifically supraspinatus). Supplied sterile for one-time use. No complex electronics or software involved.

Clinical Evidence

Bench testing only. Device subjected to biocompatibility, integrity, in-vitro, and in-vivo performance testing. All tests met requirements.

Technological Characteristics

Single-layer, porous, cross-linked collagen patch. Sterile, single-use. No electronic components or software.

Indications for Use

Indicated for patients requiring soft tissue reinforcement or repair in general surgery, including thoracic wall defects, muscle flaps, rectal/vaginal prolapse, pelvic floor reconstruction, hernias, and suture line reinforcement. Also indicated for supraspinatus soft tissue reinforcement during rotator cuff repair. For one-time use.

Regulatory Classification

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.

Predicate Devices

• BioBlanket™ Surgical Mesh (K043259)
• BioBlanket™ Surgical Mesh (K041923)

Submission Summary (Full Text)

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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: [phone] 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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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

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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 [phone] or [phone] 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 [phone] or [phone] 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

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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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