(150 days)
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.
The REBOUND HRD V (Hernia Repair Device) is a self-expanding nitinol framed surgical mesh designed for placement directly over the hernia defect so that there is at least 4 cm of circumferential overlap of the hernia defect by the device. The REBOUND HRD V conforms to the anatomy while providing stability. The super-elastic multi-stranded nitinol frame allows the device to be folded into a loading cannula (supplied in the product package) and inserted laparoscopically through an appropriately sized access port. It may also be placed via an open incisional approach. The REBOUND HRD V is supplied sterile and is designed as a single use device. It is manufactured in three sizes to accommodate different hernia types, anatomies and surgeon preference.
The provided text is a 510(k) summary for the REBOUND HRD® V surgical mesh. This document does not contain the detailed technical study information typically found in a device's design verification and validation reports. Therefore, I cannot fully answer your request.
Here's what I can extract and what is missing based on the provided text:
Acceptance Criteria and Reported Device Performance (Missing)
The document states: "Design verification and validation activities were performed as identified during risk analysis." However, it does not explicitly list the acceptance criteria for these activities or the reported device performance metrics against those criteria. It only concludes that the device is substantially equivalent to the predicate.
Missing Information/Cannot Answer based on provided text:
- A table of acceptance criteria and the reported device performance: This information is not present. The document summarizes the device's characteristics and its equivalence to a predicate, but doesn't detail performance metrics.
- Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not mentioned in the provided text.
- 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 mentioned. This type of information would be relevant for devices that rely on expert review for ground truth, which this surgical mesh does not appear to.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable as this is not a diagnostic device relying on expert adjudication of results.
- 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: Not applicable. This is a medical device (surgical mesh), not an AI-powered diagnostic tool.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device (surgical mesh), not an AI algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned. For a surgical mesh, ground truth for performance would typically involve biomechanical testing, animal studies, or clinical outcomes (which are implied but not detailed).
- The sample size for the training set: Not applicable as this is not an AI/machine learning device.
- How the ground truth for the training set was established: Not applicable as this is not an AI/machine learning device.
What the document does indicate:
- Device Type: Surgical mesh (REBOUND HRD® V)
- Intended Use: 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.
- Predicate Device: REBOUND HRDTM (K063671, K080393)
- Conclusion for Equivalence: The REBOUND HRD V is substantially equivalent to the predicate in regards to indications for use, basic operating principle, materials, sterilization, packaging, and shelf-life.
- Study Type Implied: Design verification and validation activities were performed according to design control requirements and risk analysis. These would typically include bench testing for mechanical properties, biocompatibility, sterility, and possibly animal studies, but the specifics are not provided.
- Data Provenance (Implicit): The studies would have been conducted by Minnesota Medical Development, Inc. or contractors. The country of origin of data is not specified, but the applicant is based in the USA. The studies would be considered prospective for the device development, but the clinical implications are evaluated against existing predicate devices.
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K083467
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Section 5 – 510(k) Summary
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| Applicant: | Minnesota Medical Development, Inc.14305 21st Avenue North, Suite 100Plymouth, MN 55447 | APR 23 2009 |
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| Contact Person: | Julie BulverPrincipal Consultant, Alquest, Inc.Telephone: 763.588.9839Fax: 763.287.3836Email: julieb@alquest.com | |
| Date Prepared: | November 21, 2008 | |
| Trade Name: | REBOUND HRD®V | |
| Product Classificationand Code: | 21 CFR §878.3300, Surgical MeshClass: IIProduct Code: FTL | |
| Predicate Device: | REBOUND HRDTM | |
| Device Description: | The REBOUND HRD V (Hernia Repair Device) is a self-expandingnitinol framed surgical mesh designed for placement directly over thehernia defect so that there is at least 4 cm of circumferential overlap ofthe hernia defect by the device. The REBOUND HRD V conforms tothe anatomy while providing stability. The super-elastic multi-strandednitinol frame allows the device to be folded into a loading cannula(supplied in the product package) and inserted laparoscopically throughan appropriately sized access port. It may also be placed via an openincisional approach. The REBOUND HRD V is supplied sterile and isdesigned as a single use device. It is manufactured in three sizes toaccommodate different hernia types, anatomies and surgeon preference. | |
| Intended Use: | REBOUND HRD V is intended to assist in the repair and/orreinforcement of hernia or other soft tissue defects where weaknessexists and where the support of a nonabsorbable material is preferred. | |
| Summary ofTechnologicalCharacteristics: | REBOUND HRD V introduces additional shapes and sizes with similardevice characteristics as the predicate device. The device ismanufactured of the same frame materials as the predicate device. Themesh fabric material is made of PTFE. Device modifications weremade in accordance with design control requirements. Designverification and validation activities were performed as identifiedduring risk analysis. | |
| Conclusion: | REBOUND HRD V is substantially equivalent to the REBOUNDHRDTM (K063671, K080393) in regards to the indications for use, thebasic 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 (240) 276-0115. 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 (240) 276-3464. 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 (800) 638-2041 or (240) 276-3150 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
§ 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.