(90 days)
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No
The summary describes a surgical mesh and its physical properties and testing, with no mention of AI or ML.
Yes
The device, 3D Anatomical™ Mesh, is used for inguinal hernia repair and ventral abdominal wall hernia repair, which are medical treatments for specific conditions.
No
The device is a mesh intended for surgical repair of hernias, which is a therapeutic purpose, not a diagnostic one. Its description and performance studies focus on material properties relevant to implantation, not disease detection or monitoring.
No
The device description and performance studies clearly indicate that the device is a physical mesh implant made of polypropylene, not a software-only device.
No, 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: The description clearly states that 3D Anatomical™ Mesh is a mesh intended for surgical implantation to repair hernias. It is a physical implant, not a test performed on a sample.
- Intended Use: The intended uses are surgical procedures (hernia repair), not diagnostic testing.
- Performance Studies: The performance studies described are related to the physical properties of the mesh (weave density, tensile strength, burst strength) and its chemical composition, not diagnostic accuracy metrics like sensitivity or specificity.
Therefore, based on the provided information, 3D Anatomical™ Mesh is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The singular intended use of 3D Anatomical™ Mesh is hernia repair.
Product codes (comma separated list FDA assigned to the subject device)
FTL
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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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.
0
FAX NO. :
JUN 17 1999
Jun. 07 1999 10:56AM P2
K990730
ATTACHMENT D: SUMMARY OF SAFETY AND EFFECTIVENESS 3D Anatomical™ Mesh
1. Standards and Intended Use:
At present, and to the best of our knowledge, there are no standards for polypropylene surgical mesh. The 3D Anatomical™ Mesh will conform to all future international standards for polypropylene mesh prostheses. The singular intended use of 3D Anatomical™ Mesh is hernia repair.
2. Manufacturing Procedures:
3D Anatomical™ Mesh is manufactured in a class 10,000 clean room environment in accordance with ISO 9001 and EN 46001 regulations. Full traceability will be maintained on all production lots.
3. Prior In-Vitro Tests and Clinical Experience:
3D Anatomical™ Mesh is CE marked (no. 0413)
In-vitro testing of the 3D Anatomical™ Mesh was conducted by Institut Textile de France, Ecully, France and produced the following results:
| a) weave density: | 0.91g/cm³ |
|---|---|
| b) tensile strength: | 3D Anatomical™ Mesh must exceed 40 daN |
| (greater than 50% elongation prior to rupture) | |
| c) burst strength: | 3D Anatomical™ Mesh must exceed 500 kPa |
| Clinical experience of 3D Anatomical™ Mesh began internationally | |
| in 1994 and now includes thousands of mesh implants. |
In-vitro chemical testing was performed by Laboratoire de Rheologie des Matieres Plastiques, St. Etienne, France and concluded:
- a) through comparative infrared spectrometry, a lot batch of 3D Anatomical polypropylene was positively compared to a reference polypropylene that was specified to be a monofilament, 100% polypropylene homopolymer.
- b) Through comparative thermal analysis, both the lot batch of 3D Anatomical polypropylene and the reference polypropylene sample exhibited fusion temperatures between 160°C and 175°C and both exhibited crystallization above 60%.
1
- Contact Information: Inquiries should be directed to: Santerra Medical Technology, Inc. 5451 Hilltop Avenue Lake Elmo, MN 55042-9539 Tel: (651) 704-9160 Fax: (651) 704-9191
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with three lines representing its wings and two curved lines representing its body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 17 1999
Mr. David P. Lang Chief Executive Officer Santerra Medical Technology, Inc. 5451 Hilltop Avenue Lake Elmo, Minnesota 55042
Re: K990930 Trade Name: 3D Anatomical™ Mesh Regulatory Class: II Product Code: FTL Dated: March 16, 1999 Received: March 19, 1999
Dear Mr. Lang:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Mr. David P. Lang
This letter will allow you to begin marketing your device as described in your 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 vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Celia M. Witten, Ph.D Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/2 description: The image shows a document with the date "Apr. 29 1996 01:01PM" printed on it. The document also has the identifier "P2" printed on it. There is a large, handwritten number "K990930" on the document.
510(k) Number (if known):
3D AnatomicaI™ Mesh Device Name:
Indications For Use:
The indications for use of 3D Anatomical™ Mesh are:
- l) inguinal hernia repair
-
- ventral abdominal wall hernia repair
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-O)
Division of General Restorative Devices
510(k) Number C990430
Prescription Use
(21 CFR 801.109)
OR
Over-The-Counter Use
・
(Optional Format 1-2-96)