(248 days)
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.
The Rebound HRD™ (Hernia Repair Device) is a self-expanding Nitinol framed/surgical mesh designed for the repair of both inguinal and ventral hernias. The Rebound HRD™ is 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 HRDTM conforms to the anatomy while providing stability; eliminating the need for anchoring. The super-elastic, multi-strand, Nitinol frame allows the device to be folded into the supplied 10mm 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.
The provided text does not contain acceptance criteria for a device performance study, nor does it describe a study that directly proves the device meets specific performance acceptance criteria.
Instead, this document is a 510(k) summary for a medical device (REBOUND HRD™ hernia mesh device) seeking substantial equivalence to predicate devices. The summary outlines the device's description, indications for use, and a summary of testing conducted to support its safety and substantial equivalence, but not a study designed to meet specific performance "acceptance criteria" in the way a clinical trial or performance study report would.
Here's a breakdown of the requested information based on what is available and what is not available in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Not Specified in Document) | Reported Device Performance (Summary of Testing) |
|---|---|
| (No specific quantitative or qualitative acceptance criteria were provided for device performance in the document.) | - Biocompatibility: Confirmed that processing and additional materials do not alter the excellent biocompatibility of the basic mesh. |
| - Weld Testing: Performed. (No specific results or acceptance criteria given). | |
| - Burst Strength Testing (on assembly): Performed. (No specific results or acceptance criteria given). | |
| - Deployment: Device successfully deployed through a cannula. (No specific success rate or criteria given). | |
| - Fatigue Testing: Performed. (No specific results or acceptance criteria given). | |
| - MRI Compatibility: Confirmed MRI compatibility. (No specific details of compatibility criteria or results given). | |
| - Animal Testing (In-vivo): Demonstrated the device will stay in place, will stay together when implanted, can be detected via X-ray, and has tissue response typical for this type of implant. (No specific quantitative acceptance criteria or detailed results given). | |
| - Instructions for Use: Evaluated. (No specific evaluation method or criteria given). |
2. Sample Size Used for the Test Set and Data Provenance
The document describes several types of testing (biocompatibility, mechanical, in-vivo animal testing, MRI compatibility) but does not specify sample sizes for any of these tests. It also does not mention a "test set" in the context of human clinical data or imaging data. The testing described appears to be primarily bench testing and animal studies, not human clinical trials. Therefore, data provenance (country of origin, retrospective/prospective) is not applicable in the context of human data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not Applicable. The document does not describe a study involving expert assessment of a "test set" to establish ground truth for a diagnostic or AI device. The testing mentioned (biocompatibility, mechanical, animal) involves laboratory measurements and observations by technical and scientific personnel, not expert interpretation of clinical cases.
4. Adjudication Method for the Test Set
Not Applicable. As there is no described test set requiring expert interpretation and ground truth establishment, no adjudication method is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document does not describe an MRMC comparative effectiveness study. This type of study is typically performed for diagnostic imaging devices to evaluate the impact of an AI algorithm on human reader performance. The Rebound HRD™ is a hernia mesh device, not an imaging or diagnostic AI device.
6. Standalone (Algorithm Only) Performance Study
No. The Rebound HRD™ is a physical medical device (hernia mesh), not an algorithm or AI system. Therefore, a standalone algorithm performance study is not applicable.
7. Type of Ground Truth Used
The concept of "ground truth" as typically applied in AI/diagnostic studies (e.g., pathology, outcomes data) is not directly applicable to the testing described for this physical device. The "truth" for the various engineering and biological tests performed would be established by:
- Biocompatibility: Standardized assays and histological examination, comparing against established norms for biocompatible materials.
- Mechanical Testing: Measured physical properties (weld strength, burst strength, fatigue life) against design specifications or engineering standards.
- Animal Testing: Direct observation during implantation, gross pathology, and histology of explanted tissue. This provides "actual" biological response.
- MRI Compatibility: Measurements of susceptibility artifacts, heating, and other parameters in an MRI environment according to standards.
8. Sample Size for the Training Set
Not Applicable. The Rebound HRD™ is a physical medical device; it does not involve an AI algorithm or a "training set" in the computational sense.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As there is no training set mentioned, this question is not relevant to the provided text.
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510(k) Summary
Submitted on behalf of:
| Company Name: | Minnesota Medical Development, Inc. (MMDI) | AUG 16 200 |
|---|---|---|
| Address: | 14305 21st Avenue North, Suite 100Plymouth, MN 55447 | |
| Telephone: | 763-354-7100 | |
| Fax: | 763-354-7001 | |
| by: | Elaine Duncan, M.S.M.E., RACPresident, Paladin Medical, Inc.PO Box 560Stillwater, MN 55082 | |
| Telephone: | 715-549-6035 | |
| Fax: | 715-549-5380 | |
| CONTACT PERSON: | Elaine Duncan | |
| DATE PREPARED: | December 8, 2006 | |
| TRADE NAME: | REBOUND HRDTM hernia mesh device | |
| COMMON NAME: | hernia mesh | |
| CLASSIFICATION NAME: | surgical mesh | |
| PRO CODE: | FTL |
SUBSTANTIALLY EQUIVALENT TO:
VITAMESHTM MacroPorous PP Surgical Mesh K060520 and K963141 Kugel Hernia Patch
DESCRIPTION of the DEVICE: The Rebound HRD™ (Hernia Repair Device) is a self-expanding Nitinol framed/surgical mesh designed for the repair of both inguinal and ventral hernias. The Rebound HRD™ is 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 HRDTM conforms to the anatomy while providing stability; eliminating the need for anchoring. The super-elastic, multi-strand, Nitinol frame allows the device to be folded into the supplied 10mm 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.
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.
SUMMARY of TESTING: The polymer mesh is the same mesh as submitted in a predicate submission. Therefore the testing concentrated on questions of potential new risks from adding the wire frame. Confirming biocompatibility testing demonstrated that processing and additional materials do not alter the excellent biocompatibility of the basic mesh. Testing included weld testing, burst strength testing on the assembly, deployment of the device through a cannula and fatigue testing. In addition, MRI compatibility testing was conducted to assure MRI compatibility. Animal testing demonstrated the device will stay in place, will stay together when implanted, can be detected via X-ray, and has tissue response typical for this type of implant. Instructions for use were evaluated as well.
| REBOUND HRD™ Hernia Repair Device by MMDI | |
|---|---|
| 510(k) Submission | Section 5, page 2 of 2 |
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Public Health Service
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 16 2007
Minnesota Medical Development, Inc. % Paladin Medical, Inc. Ms. Elaine Duncan, M.S., RAC President P.O. Box 560 Stillwater, Minnesota 55082-0560
Re: K063671
Trade/Device Name: REBOUND HRD™ (Hernia Mesh Device) Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: August 1, 2007 Received: August 2, 2007
Dear Ms. Duncan:
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. Elaine Duncan, M.S., RAC
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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,
Mark A. 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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Indications for Use
510(k) Number (if known):
REBOUND HRD™ (Hernia Mesh Device) 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 (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N. Melkman
(Division Sign-Off) Division of Gener I. Restorative. and Neurological Devices
510(k) Number K063671
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§ 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.