(90 days)
The indications for use of 3D Anatomical™ Mesh are:
- l) inguinal hernia repair
-
- ventral abdominal wall hernia repair
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.
The provided document, K990730: 3D Anatomical™ Mesh, describes in-vitro testing and clinical experience for a surgical mesh, but it does not contain information about acceptance criteria related to device performance in a study setting, nor does it detail a study proving the device meets such criteria.
The document does list some in-vitro test results that can be interpreted as de-facto acceptance criteria for manufacturing and material properties, but these are not presented as "acceptance criteria" for a clinical or performance study proving efficacy or safety in a patient population.
Here's an analysis based on the information available in the provided text, while highlighting the absence of information for most of your requested points:
Acceptance Criteria and Device Performance
The document presents in-vitro test results for the 3D Anatomical™ Mesh. These can be considered the required performance specifications that the manufactured mesh must meet.
| Acceptance Criteria (In-vitro) | Reported Device Performance (In-vitro) | Notes |
|---|---|---|
| Weave density: N/A | 0.91g/cm³ | This is a reported characteristic, not given as a specific minimum/maximum criteria. |
| Tensile strength: > 40 daN (> 50% elongation prior to rupture) | "must exceed 40 daN (greater than 50% elongation prior to rupture)" | The device reportedly meets this criterion. |
| Burst strength: > 500 kPa | "must exceed 500 kPa" | The device reportedly meets this criterion. |
| Comparative infrared spectrometry: Positive comparison to reference polypropylene (monofilament, 100% homopolymer) | Positive comparison | Confirmed chemical composition. |
| Comparative thermal analysis: Fusion temperatures between 160°C and 175°C, crystallization above 60% | Fusion temperatures between 160°C and 175°C, crystallization above 60% | Confirmed thermal properties. |
Missing Information for Device Acceptance Criteria and Performance Studies:
The following points cannot be addressed from the provided text as the document focuses on pre-market notification for a 510(k) submission, which typically relies on substantial equivalence and in-vitro data rather than extensive clinical efficacy studies with predefined acceptance criteria.
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- No information about a "test set" for performance evaluation in humans. The in-vitro tests were conducted by Institut Textile de France and Laboratoire de Rheologie des Matieres Plastiques (both in France).
- 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 applicable as no clinical performance "test set" with ground truth is described.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable.
- 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 diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable for a clinical performance study. For the in-vitro tests, the ground truth is established by standardized laboratory testing methods and comparison to reference materials.
- The sample size for the training set
- Not applicable. This is a medical device, not a machine learning algorithm that requires a "training set."
- How the ground truth for the training set was established
- Not applicable.
Clinical Experience Mentioned:
While not a formal "study" proving acceptance criteria, the document states:
- "Clinical experience of 3D Anatomical™ Mesh began internationally in 1994 and now includes thousands of mesh implants."
This indicates post-market surveillance data or anecdotal reports (prior to the 1999 filing) rather than a controlled study specifically designed to meet pre-defined acceptance criteria for efficacy or safety. The 510(k) approval process often relies on existing clinical use and substantial equivalence to a predicate device rather than new, large-scale clinical trials for every device.
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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 internationallyin 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%.
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- 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
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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.
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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)
§ 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.