(83 days)
ULTRAPRO Plug is a partially absorbable device used to fill and reinforce inguinal hernia defects. ULTRAPRO Plug is indicated for open repair of groin hernia defects.
The ULTRAPRO Plug device is composed of two sterile components: a thermoformed, three-dimensional plug and a flat, preshaped onlay patch. The ULTRAPRO Plug device is indicated for the open repair of groin hernia defects.
The provided text describes the ULTRAPRO Plug, a surgical mesh device for hernia repair. While it outlines the device's description, intended use, and comparison to predicate devices, it does not contain information related to acceptance criteria, specific performance metrics, or a study design involving a test set, expert adjudication, or AI assistance. The document focuses on establishing substantial equivalence to previously approved devices based on material composition and general performance, rather than providing detailed performance data from a clinical or standalone study.
Therefore, most of the requested information cannot be extracted from the provided text.
Here's what can be inferred:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as quantifiable metrics for device performance. The "acceptance criteria" here refer to meeting regulatory requirements for substantial equivalence.
- Reported Device Performance:
- Biological Reactivity: "acceptable for its intended use."
- Functional Performance: "meets or exceeds all functional requirements."
- Basis of Claim: Substantial equivalence to predicate devices (ULTRAPRO Mesh and BARD Mesh PerFix Plug) based on similar technological characteristics and materials.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This information is not provided. The document refers to "bench and animal testing" but does not specify sample sizes or data provenance for these tests, nor does it detail a "test set" in the context of device performance evaluation against specific criteria.
3. 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)
- This information is not provided. The document relies on existing regulatory approvals of predicate devices and general biocompatibility/functional testing. There is no mention of a "ground truth" derived from expert consensus for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not provided. No adjudication method is mentioned as there is no described test set requiring one.
5. 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
- This information is not provided. The device is a physical surgical implant, not an AI-assisted diagnostic tool. Therefore, an MRMC study with human readers and AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This information is not provided. As mentioned above, this is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" implicitly used for the device's safety and effectiveness relies on comparison to legally marketed predicate devices and their established safety and efficacy profiles. For the specific performance data mentioned:
- Biological reactivity: Likely based on standardized in vitro and in vivo toxicology tests (ISO 10993-1).
- Functional performance: Likely based on bench tests and animal studies designed to assess mechanical properties and tissue integration, with "ground truth" being predefined engineering specifications or biological responses.
8. The sample size for the training set
- This information is not applicable/provided. There is no "training set" in the context of this traditional medical device approval process. This concept is typically relevant for machine learning or AI models.
9. How the ground truth for the training set was established
- This information is not applicable/provided.
In summary, the provided document is a 510(k) summary for a traditional medical device demonstrating substantial equivalence, not a performance study report for an AI/ML diagnostic or assistive tool. Thus, many of the requested details regarding acceptance criteria for an algorithm and study design involving a test set, experts, and AI are not present.
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Summary of Safety and Effectiveness
Information supporting claims of substantial equivalence, as defined under the Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness is summarized below.
Submitted by:
Bryan A. Lisa Sr. Regulatory Affairs Associate ETHICON, Inc., A Johnson & Johnson Company Route 22 West, PO Box 151 Somerville, NJ 08876
APR 1 7 2007
Name/Classification of Device:
Class II in 21 CFR § 878.3300, Surgical Mesh (FTL)
Trade Name:
ULTRAPRO* Plug
Predicate Devices:
ULTRAPRO* Mesh (ETHICON, Inc.) - K033337 BARD Mesh PerFix Plug (Davol, Inc.) - K922916
Statement of Intended Use:
ULTRAPRO Plug is a partially absorbable device used to fill and reinforce inguinal hernia defects. ULTRAPRO Plug is indicated for open repair of groin hernia defects.
Device Description:
The ULTRAPRO Plug device is composed of two sterile components: a thermoformed, three-dimensional plug and a flat, preshaped onlay patch. The ULTRAPRO Plug device is indicated for the open repair of groin hernia defects.
Summary of Technological Characteristics of New Device to Predicate Devices:
The modified device has similar technological characteristics as the predicate devices. Like currently marketed devices, it is a sterile, mesh implant intended for the repair of hernia defects. The proposed device is made of nonabsorbable and absorbable polymers, which are identical to those found in ULTRAPRO Mesh, currently marketed by ETHICON, Inc.
Performance Data:
Biological reactivity of the materials has been assessed using methods specified in ISO 10993-1, and the material was found to be acceptable for its intended use. Results of functional performance testing (bench and animal testing) indicate that the proposed device meets or exceeds all functional requirements.
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BAL-2007-001
22
Conclusions:
Based on the similarities to the predicate devices identified in this submission, we conclude that the modified device is substantially equivalent to the predicate devices under the Federal Food, Drug, and Cosmetic Act.
.
:
- Trademark of ETHICON, Inc.
510(K) SUMMARY
.. .
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ethicon, Inc. % Mr. Bryan A. Lisa Sr. Regulatory Affairs Associate Route 22 West, P.O. Box 151 Somerville, New Jersey 08876
APR 1 7 2007
Re: K070224
Trade/Device Name: ULTRAPRO* Plug Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: April 6, 2007 Received: April 9, 2007
Dear Mr. Lisa:
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 - Mr. Bryan A. Lisa
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,
For Pete O Rum
Mark N. Melkerson
Director
m
D&P Dir
4/1/09
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): K870224
Device Name: ULTRAPRO* Plug
Indications for Use:
ULTRAPRO Plug is indicated for open repair of groin hernia defect
hernia defects.
(Division Sign-Off) (Division of General, Restorative, and Neurological Devices
*Trademark.
510(k) Number
(21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
§ 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.