(150 days)
Not Found
No
The description focuses on the physical properties and mechanical function of a surgical mesh device. There is no mention of AI, ML, image processing, or data analysis capabilities.
No
The device is a surgical mesh designed to assist in the repair and/or reinforcement of hernias or soft tissue defects, which is a structural repair rather than a therapeutic treatment.
No
The device is described as a surgical mesh intended for repair and reinforcement of soft tissue defects, which is a therapeutic function, not a diagnostic one. It assists in the physical repair of tissue, rather than identifying or characterizing a medical condition.
No
The device description clearly states it is a "self-expanding nitinol framed surgical mesh," indicating it is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "assist in the repair and/or reinforcement of hernia or other soft tissue defects." This describes a surgical device used directly on the patient's body for structural support.
- Device Description: The description details a "self-expanding nitinol framed surgical mesh" designed for placement over a hernia defect. This is a physical implant used during surgery.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside the body to provide information about a patient's health status, diagnose conditions, or monitor treatment. The provided information does not mention any such use or interaction with biological specimens for diagnostic purposes.
Therefore, the REBOUND HRD® V is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
FTL
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hernia or other soft tissue defects
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K083467
1/1
Section 5 – 510(k) Summary
. . . . . . . .
. ·
· ·····
· ······
. ... .
| Applicant: | Minnesota Medical Development, Inc.
14305 21st Avenue North, Suite 100
Plymouth, MN 55447 | APR 23 2009 |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact Person: | Julie Bulver
Principal Consultant, Alquest, Inc.
Telephone: 763.588.9839
Fax: 763.287.3836
Email: julieb@alquest.com | |
| Date Prepared: | November 21, 2008 | |
| Trade Name: | REBOUND HRD®V | |
| Product Classification
and Code: | 21 CFR §878.3300, Surgical Mesh
Class: II
Product Code: FTL | |
| Predicate Device: | REBOUND HRDTM | |
| Device Description: | 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. | |
| 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. | |
| Summary of
Technological
Characteristics: | REBOUND HRD V introduces additional shapes and sizes with similar
device characteristics as the predicate device. The device is
manufactured of the same frame materials as the predicate device. The
mesh fabric material is made of PTFE. Device modifications were
made in accordance with design control requirements. Design
verification and validation activities were performed as identified
during risk analysis. | |
| Conclusion: | REBOUND HRD V is substantially equivalent to the REBOUND
HRDTM (K063671, K080393) in regards to the indications for use, the
basic operating principle, materials, sterilization, packaging and shelf-life. | |
1
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.
2
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
3
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