REBOUND HRDV

K083467 · Minnesota Medical Development, Inc. · FTL · Apr 23, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K083467
• Device Name: REBOUND HRDV
• Applicant: Minnesota Medical Development, Inc.
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Apr 23, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

REBOUND HRD V is intended to assist in the repair and/or reinforcement of hernia or other soft tissue defects where weakness exists and where the support of a nonabsorbable material is preferred.

Device Story

REBOUND HRD V is a self-expanding surgical mesh for hernia repair. Device features a super-elastic, multi-stranded nitinol frame and PTFE mesh fabric. Designed for placement over hernia defects with at least 4 cm of circumferential overlap. Frame allows folding into a supplied loading cannula for laparoscopic insertion through access ports; also suitable for open incisional approaches. Device conforms to patient anatomy to provide stability. Supplied sterile for single use. Available in three sizes to accommodate varying hernia types and surgeon preference. Used by surgeons in clinical settings to reinforce soft tissue weaknesses.

Clinical Evidence

Bench testing only.

Technological Characteristics

Surgical mesh; nitinol frame (super-elastic, multi-stranded); PTFE mesh fabric; self-expanding; three sizes; sterile; single-use; laparoscopic or open surgical delivery.

Indications for Use

Indicated for repair and/or reinforcement of hernia or soft tissue defects requiring nonabsorbable support.

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

• REBOUND HRD (K063671, K080393)

Submission Summary (Full Text)

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K083467
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## Section 5 – 510(k) Summary

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| Applicant: | Minnesota Medical Development, Inc.<br>14305 21st Avenue North, Suite 100<br>Plymouth, MN 55447 | APR 23 2009 |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact Person: | Julie Bulver<br>Principal Consultant, Alquest, Inc.<br>Telephone: [phone]<br>Fax: [phone]<br>Email: [e-mail] | |
| Date Prepared: | November 21, 2008 | |
| Trade Name: | REBOUND HRD®V | |
| Product Classification<br>and Code: | 21 CFR §878.3300, Surgical Mesh<br>Class: II<br>Product Code: FTL | |
| Predicate Device: | REBOUND HRDTM | |
| Device Description: | The REBOUND HRD V (Hernia Repair Device) is a self-expanding<br>nitinol framed surgical mesh designed for placement directly over the<br>hernia defect so that there is at least 4 cm of circumferential overlap of<br>the hernia defect by the device. The REBOUND HRD V conforms to<br>the anatomy while providing stability. The super-elastic multi-stranded<br>nitinol frame allows the device to be folded into a loading cannula<br>(supplied in the product package) and inserted laparoscopically through<br>an appropriately sized access port. It may also be placed via an open<br>incisional approach. The REBOUND HRD V is supplied sterile and is<br>designed as a single use device. It is manufactured in three sizes to<br>accommodate different hernia types, anatomies and surgeon preference. | |
| Intended Use: | REBOUND HRD V is intended to assist in the repair and/or<br>reinforcement of hernia or other soft tissue defects where weakness<br>exists and where the support of a nonabsorbable material is preferred. | |
| Summary of<br>Technological<br>Characteristics: | REBOUND HRD V introduces additional shapes and sizes with similar<br>device characteristics as the predicate device. The device is<br>manufactured of the same frame materials as the predicate device. The<br>mesh fabric material is made of PTFE. Device modifications were<br>made in accordance with design control requirements. Design<br>verification and validation activities were performed as identified<br>during risk analysis. | |
| Conclusion: | REBOUND HRD V is substantially equivalent to the REBOUND<br>HRDTM (K063671, K080393) in regards to the indications for use, the<br>basic operating principle, materials, sterilization, packaging and shelf-life. | |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Minnesota Medical Development, Inc. % Mr. Steve Nuss Chief Marketing Officer 14305 21st Avenue, North Suite 100 Plymouth, Minnesota 55447

Re: K083467

Trade/Device Name: REBOUND HRD® V Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: March 20, 2009 Received: March 24, 2009

Dear Mr. Nuss:

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.

APR 2 3 2009

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 forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Steve Nuss

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at [phone]. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sincerely yours,

Mark N. Milken

Mark N. Melkerson Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Section 4 - Indications For Use Statement

510(k) Number (if known): K 083467

Device Name:

Indications for Use:

REBOUND HRD® V is intended to assist in the repair and/or reinforcement of hernia or other soft tissue defects where weakness exists and where the support of a nonabsorbable material is preferred.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/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)

Daniel Krane

for mxy

(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

510(k) Number K083467