MODIFICATION TO REBOUND HRD

• K Number: K080393
• Device Name: MODIFICATION TO REBOUND HRD
• Manufacturer: MINNESOTA MEDICAL DEVELOPMENT, INC.
• Date Cleared: 2008-03-13 ( 29 days)
• Product Code: FTL
• Regulation Number: 878.3300
• Type: Special
• Panel: General & Plastic Surgery
• Reference & Predicate Devices: K063671
• Predicate For: K083467

Intended Use

REBOUND HRD™ 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 Description

The REBOUND HRD™ (Hernia Repair Device) is a self-expanding nitinol framed surgical mesh designed for placement between the fascia and fully closed peritoneum so that it covers the direct and indirect space with at least a 15mm margin beyond the edges of the hernia defect. The REBOUND HRD™ conforms to the anatomy while providing stability; eliminating the need for anchoring. The superelastic multi-stranded nitinol frame allows the device to be folded into a loading cannula (supplied in the product package) and inserted laparoscopically through a 10-12mm access port. It may also be placed via an open incision approach using the same dissection and positioning methods described for the laparoscopic technique. The REBOUND HRD™ is supplied sterile and is designed as a single use device. It is manufactured in several shapes to accommodate different hernia types, anatomies and surgeon preference.

AI/ML Overview

The provided document is a 510(k) summary for the REBOUND HRD™ (Hernia Repair Device), which is a surgical mesh. This type of document is filed and reviewed by the FDA to determine if a new medical device is "substantially equivalent" to an existing legally marketed device (predicate device).

Critically, a 510(k) summary (like the one provided) does not typically contain detailed information about specific acceptance criteria or an analytical study proving that the device meets those criteria, as you would find for a device making novel claims or undergoing a Pre-Market Approval (PMA) process. The focus of a 510(k) is to demonstrate substantial equivalence to a predicate device based on similar technological characteristics, materials, and intended use.

Therefore, many of the specific questions regarding acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment cannot be answered from the provided text. The document states: "Design verification and validation activities were performed as identified during risk analysis. REBOUND HRD™ is substantially equivalent to the REBOUND HRD™ (K063671) in regards to the indications for use, the basic operating principle, materials, sterilization, packaging and shelf-life." This general statement implies that such activities were done, but it does not describe them.

Based on the information available in the provided text, here's what can be inferred or directly stated:

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Acceptance Criteria and Device Performance:

Since this is a 510(k) submission, the primary "acceptance criterion" from the FDA's perspective is substantial equivalence to a predicate device. This means the new device is as safe and effective as a legally marketed device. Specific performance metrics are generally not detailed in the summary itself, but rather referenced as being similar to the predicate.

Acceptance Criterion (Implied for 510(k))	Reported Device Performance (from summary)
Intended Use Equivalence	"REBOUND HRD™ is substantially equivalent to the REBOUND HRD™ (K063671) in regards to the indications for use..."
Basic Operating Principle Equivalence	"...the basic operating principle..."
Material Equivalence	"...materials..." (The device is manufactured of the same materials as the predicate device.)
Sterilization Equivalence	"...sterilization..."
Packaging Equivalence	"...packaging..."
Shelf-life Equivalence	"...shelf-life."
Performance in Repair/Reinforcement (implied from predicate)	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."
Ability to be folded and inserted laparoscopically	The superelastic multi-stranded nitinol frame allows the device to be folded into a loading cannula and inserted laparoscopically through a 10-12mm access port.
Ability to be placed via open incision	May also be placed via an open incision approach.
Conformity to anatomy and stability	REBOUND HRD™ conforms to the anatomy while providing stability; eliminating the need for anchoring.

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Study Information (Based on limitations of a 510(k) summary):

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not provided in the document. A 510(k) summary typically doesn't include details of specific clinical or analytical studies unless they were conducted to a demonstrate a specific performance characteristic not covered by the predicate. The document merely states "Design verification and validation activities were performed as identified during risk analysis."

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not provided in the document. This level of detail is characteristic of clinical efficacy or diagnostic studies, which are generally not the primary focus of a 510(k) summary for a "substantially equivalent" surgical mesh.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not provided in the document. See point 2.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No. This is not applicable to the REBOUND HRD™ device. This device is a surgical mesh, not an AI-powered diagnostic or assistive tool. An MRMC study is used for evaluating human reader performance with medical images.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • No. This is not applicable to the REBOUND HRD™ device. As noted above, this is a surgical mesh.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • Not provided in the document. The basis for "ground truth" (if any specific outcome data was collected beyond comparison to the predicate) would likely be clinical outcomes, surgical success rates, or anatomical integrity assessments, but these are not detailed.

7. The sample size for the training set:

   • Not applicable / Not provided. Surgical meshes are not "trained" in the way AI algorithms are. If the question refers to design verification/validation testing, those sample sizes are not disclosed here.

8. How the ground truth for the training set was established:

   • Not applicable / Not provided. See point 7.

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In summary, the provided document is a regulatory filing focused on establishing substantial equivalence for a surgical mesh, not a detailed scientific study report with specific performance metrics and study designs that would answer most of your questions. The "study" proving the device meets acceptance criteria is primarily an analysis demonstrating its similarities to the predicate device (REBOUND HRD™ K063671) in terms of materials, operating principles, and intended use, along with successful completion of internal design verification and validation activities, the specifics of which are not disclosed in this summary.

Summary

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080393

Minnesota Medical Development, Inc. Applicant: 14305 2156 Avenue North, Suite 100 Plymouth, MN 55447 Contact Person: Julie Bulver Senior Consultant, Alquest, Inc. Telephone: [phone] Fax: [phone] Email: [e-mail] February 11, 2008 Date Prepared: REBOUND HRD™ Trade Name: Product Classification 21 CFR §878.3300, Surgical Mesh and Code: Class: II Product Code: FTL REBOUND HRD™ Predicate Device: Device Description: The REBOUND HRD™ (Hernia Repair Device) is a self-expanding nitinol framed surgical mesh designed for placement between the fascia and fully closed peritoneum so that it covers the direct and indirect space with at least a 15mm margin beyond the edges of the hernia defect. The REBOUND HRD™ conforms to the anatomy while providing stability; eliminating the need for anchoring. The superelastic multi-stranded nitinol frame allows the device to be folded into a loading cannula (supplied in the product package) and inserted laparoscopically through a 10-12mm access port. It may also be placed via an open incision approach using the same dissection and positioning methods described for the laparoscopic technique. The REBOUND HRD™ is supplied sterile and is designed as a single use device. It is manufactured in several shapes to accommodate different hernia types, anatomies and surgeon preference. REBOUND HRD™ is intended to assist in the repair and/or Intended Use: reinforcement of hernia or other soft tissue defects where weakness exists and where the support of a nonabsorbable material is preferred. The device is manufactured of the same materials as the predicate Summary of Technological device and introduces additional shapes and sizes with similar device characteristics as the predicate device. Device modifications were Characteristics: made in accordance with design control requirements. Design verification and validation activities were performed as identified during risk analysis. REBOUND HRD™ is substantially equivalent to the REBOUND Conclusion: HRD™ (K063671) in regards to the indications for use, the basic operating principle, materials, sterilization, packaging and shelf-life.

Section 5 - 510(k) Summary

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Image /page/1/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains an emblem of an eagle with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the emblem.

MAR 1 3 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Alquest. Inc. % Ms. Julie Bulver Senior Consultant 4050 Olson Memorial Highway Suite 350 Minneapolis, Minnesota 55422

Re: K080393

Trade/Device Name: REBOUND HRD™ Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: February 11, 2008 Received: February 13, 2008

Dear Ms. Bulver:

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

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Page 2 - Ms. Julie Bulver

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.

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 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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,

Mark N Millman

Mark N. Melkerson Director 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

Device Name:

Indications for Use:

REBOUND HRD™ 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)

(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number K080393

Regulation Number and Section

§ 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.