(36 days)
The ACell UBM Surgical Mesh is intended for implantation to reinforce soft tissues. The device is intended for one-time use.
The ACell UBM Surgical Mesh is composed of porcine collagen and is supplied sterile in single sheet sizes ranging from 16 cm squared to 360 cm squared.
Here's an analysis of the provided text regarding the ACell UBM Surgical Mesh, focusing on acceptance criteria and supporting studies:
This document is a 510(k) Premarket Notification summary for the ACell UBM Surgical Mesh. It largely focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria or results from a rigorous clinical study.
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, specific quantitative acceptance criteria are not explicitly stated. The document broadly claims that the device "passed the requirements of all tests and was shown to be safe and effective." Without specific metrics (e.g., tensile strength, biocompatibility indices, degradation rates), a table of acceptance criteria and reported performance cannot be generated.
The "Discussion of tests and test results" section states:
- Acceptance Criteria (Implicit/General): To "assess the biocompatibility and the performance of the material."
- Reported Device Performance: "It passed the requirements of all tests and was shown to be safe and effective as a surgical mesh for soft tissue reinforcement."
This statement is a high-level summary without any detailed, quantifiable results.
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide details on the sample size used for any specific tests or the provenance of the data (e.g., country of origin, retrospective/prospective). It only mentions "a number of tests" were performed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This information is not provided. The document doesn't describe the use of experts to establish a "ground truth" for test sets. The tests mentioned appear to be material and biological assessments, not expert-adjudicated clinical outcomes.
4. Adjudication Method for the Test Set
No adjudication method is described, as the tests mentioned are not clinical trials requiring human expert review with adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study is not mentioned or implied in this 510(k) summary. This type of study is more common for diagnostic imaging devices involving interpretation by multiple readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable. The ACell UBM Surgical Mesh is a physical medical device (surgical mesh), not an algorithm or AI system. Therefore, the concept of "standalone performance" in the context of AI does not apply.
7. The Type of Ground Truth Used
The concept of "ground truth" as typically used in AI/diagnostic studies (e.g., pathology, clinical outcomes) is not explicitly detailed for this submission. The "tests" mentioned are likely in-vitro, in-vivo (animal), and potentially some form of biocompatibility assessments, where "ground truth" would be the results of standard laboratory analyses rather than clinical outcomes or expert consensus on patient data.
8. The Sample Size for the Training Set
This question is not applicable. The ACell UBM Surgical Mesh is a physical medical device, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set was Established
This question is not applicable for the same reason as above.
Summary of Device-Specific Information from the Text:
- Device Trade Name: ACell UBM Surgical Mesh
- Device Common Name: Surgical mesh
- Classification Name: Mesh, Surgical (FTM, 21 CFR 878.3300)
- Predicate Devices: K021637 (ACell, Inc., ACell UBM Lyophilized Wound Dressing), K980431 (Cook Biotech, Inc., SurgiSIS®)
- Device Description: Composed of porcine collagen, supplied sterile in single sheet sizes ranging from 16 cm² to 360 cm².
- Intended Use/Indications for Use: Implantation to reinforce soft tissue, intended for one-time use.
- Conclusion: Substantially equivalent to predicate devices with respect to material composition, device characteristics, and intended use.
- Tests Performed: "A number of tests to assess the biocompatibility and the performance of the material." Details of these tests and their specific results are not included in this summary.
Key takeaway: This document is a 510(k) Premarket Notification summary, which aims to demonstrate substantial equivalence to legally marketed predicate devices. It typically provides an overview of testing rather than the granular detail of a full clinical study report, especially concerning specific acceptance criteria and detailed quantitative results. The criteria outlined in the input prompt are more relevant to AI/diagnostic device submissions than for a physical surgical mesh device like this one.
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APR 1 4 2004
Submitter: ACell, Inc.
ACell UBM Surgical Mesh Abbreviated 510(k) Premarket Notification
KO4062
Section 9.0 510(k) SUMMARY—ACell UBM Surgical Mesh
| Submitter Name: | ACell, Incorporated |
|---|---|
| Submitter Address: | 10555 Guilford RoadSuite 113Jessup, Maryland 20790 |
| Contact Person: | James R. DeFrancescoChief Executive Officer |
| Phone Number:Fax Number: | 410-715-1700410-715-4511 |
| Date Prepared: | March 9, 2004 |
| Device Trade Name: | ACell UBM Surgical Mesh |
| Device CommonName: | Surgical mesh |
| Classification Name: | Mesh, Surgical (FTM, 21 CFR 878.3300) |
| Predicate Devices: | K021637, ACell, Inc., ACell UBM Lyophilized Wound DressingK980431, Cook Biotech, Inc., SurgiS/S® |
| Device Description: | The ACell UBM Surgical Mesh is composed of porcine collagen and issupplied sterile in single sheet sizes ranging from $16 cm^2$ to $360 cm^2$ . |
| Intended Use: | The ACell UBM Surgical Mesh is intended for implantation to reinforcesoft tissue. The device is intended for one-time use. |
| Discussion of testsand test results: | The ACell UBM Surgical Mesh was subjected to a number of tests toassess the biocompatibility and the performance of the material. Itpassed the requirements of all tests and was shown to be safe andeffective as a surgical mesh for soft tissue reinforcement. |
| Conclusion: | This device, with respect to material composition, device characteristicsand intended use, is substantially equivalent to the predicate devices. |
:
...
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 4 2004
ACell, Inc. c/o Ms. Patsy J. Trisler, J.D., RAC 5610 Wisconsin Avenue, #304 Chevy Chase, Maryland 20815
Re: K040621
Trade/Device Name: ACell UBM Surgical Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: FTM Dated: March 9, 2004 Received: March 9, 2004
Dear Ms. Trisler:
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 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.
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Page 2 - Ms. Patsy J. Trisler, J.D., RAC
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 (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Sincerely yours,
Mark Milliken
Celia M. Witten, Ph.D., M.D. 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): $04062(
ACell UBM Surgical Mesh Device Name:
Indications for Use:
The ACell UBM Surgical Mesh is intended for implantation to reinforce soft tissues. The device is intended for one-time use.
Prescription Use × Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
(Posted November 13, 2003) 510(k) Number K040621 Page 1 of 1
§ 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.