(248 days)
Not Found
No
The description focuses on the material properties and mechanical function of the device (Nitinol frame, mesh, self-expanding, deployment). There is no mention of any software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended to assist in the repair and/or reinforcement of hernia or other soft tissue defects, which are therapeutic interventions.
No
The device description indicates it is a surgical mesh designed to repair hernias, not to diagnose them.
No
The device description clearly describes a physical implantable device made of Nitinol and surgical mesh, supplied with a loading cannula. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The Rebound HRD™ is a physical implant designed to repair and reinforce soft tissue defects like hernias. It is a surgical mesh with a frame that is placed within the body.
- Lack of Diagnostic Activity: The device does not perform any tests on biological samples to provide diagnostic information. Its function is purely mechanical and structural.
Therefore, the Rebound HRD™ falls under the category of a surgical implant or medical device, not an in vitro diagnostic.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FTL
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
510(k) Summary
Submitted on behalf of:
| Company Name: | Minnesota Medical Development, Inc. (MMDI) | AUG 16 200 |
|---|---|---|
| Address: | 14305 21st Avenue North, Suite 100 | |
| Plymouth, MN 55447 | ||
| Telephone: | 763-354-7100 | |
| Fax: | 763-354-7001 | |
| by: | Elaine Duncan, M.S.M.E., RAC | |
| President, Paladin Medical, Inc. | ||
| PO Box 560 | ||
| Stillwater, 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
2
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
3
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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