(27 days)
The VivoSorb Sheet is indicated for the use as a temporary wound support, to reinforce soft tissues where weakness exists, or for the repair of hernia or other fascial defects that require the addition of a reinforcing material to obtain the desired surgical result. The resorbable protective film minimizes tissue attachment to the device in case of direct contact with the viscera.
The VivoSorb Sheet is designed to be a flexible and transparent resorbable Device poly (DL-lactide-co-s-caprolactone) sheet to provide support to soft tissue Description where weakness exists. The VivoSorb Sheet is provided sterile in Tyvek pouch packages in a variety of sizes.
This document is a 510(k) summary for the VivoSorb Sheet, a medical device. It does not describe an AI/ML powered device, therefore the standard acceptance criteria for such a device are not applicable.
Here's an analysis of the provided information, focusing on the device's performance claims and the study used to support them, based on the document's content:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly define "acceptance criteria" in a quantitative manner as would be expected for an AI system, nor does it present specific numerical performance targets. Instead, it relies on demonstrating substantial equivalence to predicate devices through various tests.
| Acceptance Criterion (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Safety | - Biocompatibility testing provided reasonable scientific evidence. |
| - Animal tests provided reasonable scientific evidence. | |
| - Evaluation based on literature comparison. | |
| - Compared favorably to predicate devices (Surgi Wrap K031955, IMMIX K032673) in terms of safety. | |
| Effectiveness (Functionality) | - Design verification tests and analyses performed, including: |
| - In vitro suture retention testing | |
| - In vitro degradation testing | |
| - Aging testing | |
| - Mechanical testing | |
| - Design, fundamental technology, and intended use are substantially equivalent to predicate devices. | |
| - Mechanical and physical property testing provided reasonable scientific evidence. | |
| Intended Use | Meets indications for use as a temporary wound support, to reinforce soft tissues where weakness exists, or for the repair of hernia or other fascial defects. |
| Resorbable protective film minimizes tissue attachment. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the sample sizes used for the "design verification tests" or "animal tests." It only lists the types of tests performed (e.g., in vitro suture retention, degradation, aging, mechanical, biocompatibility, animal tests).
- Data Provenance: The document does not provide details on the country of origin of the data or whether the studies were retrospective or prospective. It only mentions "design verification tests and analyses" and "animal tests."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable to this document as it describes a physical medical device and its performance, not an AI/ML system that requires ground truth established by experts. The "ground truth" here would be the physical properties and biological responses observed in the tests.
4. Adjudication Method for the Test Set
This information is not applicable for the same reason as point 3. No expert adjudication method is described or required for the device's physical and biological testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
This information is not applicable. The device is a physical surgical mesh, not an AI system intended to assist human readers. Therefore, an MRMC study is not relevant.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This information is not applicable. The device is a physical surgical mesh, not an algorithm.
7. The Type of Ground Truth Used
For this physical device, the "ground truth" was established through:
- Objective Measurement/Pathology: This would include direct measurements from the "in vitro suture retention testing," "in vitro degradation testing," "aging testing," and "mechanical testing." For "biocompatibility testing" and "animal tests," "pathology" (histological analysis, observation of biological responses) would be used to assess safety and interaction with biological tissues.
- Literature and Predicate Device Comparison: The determination of "substantial equivalence" also relies on the established performance and safety profiles of the predicate devices and existing scientific literature.
8. The Sample Size for the Training Set
This information is not applicable. This is a physical device, not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. As it's not an AI/ML model, there is no "training set" and associated ground truth in that context. The "ground truth" for the device's development would be based on engineering principles, material science, and biological understanding, informed by pre-clinical testing mentioned in point 7.
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NOV - 8 2004
510(k) Summary of Safety and Effectiveness
| Submitter: | Polyganics BVL.J. Zielstraweg 19713 GX, GroningenThe Netherlandswww.polyganics.com |
|---|---|
| ContactPerson: | Jan NieuwenhuisManaging DirectorTel : +31 50 588 6588Fax : +31 50 588 6599Mobile : +31 653 211 303E-mail : jan.nieuwenhuis@polyganics.com |
| DatePrepared: | Oct 7, 2004 |
| GeneralProvisions: | Trade Name: VivoSorb SheetCommon Name: Absorbable Polymeric Surgical MeshClassification Name: Surgical Mesh, Polymeric, 21 CFR 878.3300Device Classification: Class II |
| PredicateDevices: | Surgi Wrap MAST MacroPore, Inc K031955 IMMIXTM Obi OsteoBiologics K032673 |
| PerformanceStandards | For the VivoSorb Sheet performance, the FDA, under section 514 of theFood, Drug and Cosmetic Act, has not established standards. |
| Indicationsfor Use | The VivoSorb Sheet is indicated for the use as a temporary wound support,to reinforce soft tissues where weakness exists, or for the repair of hernia orother fascial defects that require the addition of a reinforcing material toobtain the desired surgical result. The resorbable protective film minimizestissue attachment to the device in case of direct contact with the viscera. |
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The VivoSorb Sheet is designed to be a flexible and transparent resorbable Device poly (DL-lactide-co-s-caprolactone) sheet to provide support to soft tissue Description where weakness exists.
The VivoSorb Sheet is provided sterile in Tyvek pouch packages in a variety of sizes.
safety and effectiveness of the VivoSorb Sheet have been Performance The demonstrated via data collected from design verification tests and analyses. Data: The design verification testing consisted of the following:
- In vitro suture retention testing -
- In vitro degradation testing ।
- Aging testing -
- Mechanical testing -
of The design, fundamental technology and intended use (safety and efficacy) Summary featured with the VivoSorb Sheet are substantially equivalent to those Substantial featured with the competitor devices Surgi Wrap (ref. 510(k) 031995; Equivalence MarcoPore, Inc) and the Immix™ (ref. 510(k) 032673, Obi OsteoBiologics, Inc).
Biocompatibility, mechanical and physical property testing and in vitro degradation testing provide reasonable scientific evidence that VivoSorb Sheet is substantially equivalent to the predicate devices. Evaluation of the Polyganics VivoSorb Sheet based on biocompatibility testing, animal tests, results from literature and the comparison of the VivoSorb Sheet with its predicate devices, shows that the VisoSorb Sheet is safe for implantation.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus, featuring three horizontal lines that curve upwards and to the right, with a wavy line beneath them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 8 2004
Ms. Jan Nieuwenhuis Managing Director Polyganics BV L.J. Zielstraweg 1 9713 GX Groningen The Netherlands
Re: K042811
Trade/Device Name: VivoSorb® Sheet Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: FTL Dated: October 8, 2004 Received: October 14, 2004
Dear Ms. Nieuwenhuis:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications felerenced above and nave determined the article predicate devices marketed in interstate for use stated in the encreate) to regists the Medical Device Amendments, or to connine.co prior to May 20, 1978, are example with the provisions of the Federal Food, Drug, devices that nave been recuire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, dicierore, market the act include requirements for annual registration, listing of general controls provisions of use ice, 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 If your device is classified (600 a00 royals. Existing major regulations affecting your device can may be subject to back additions, 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 r lease be advised that i Dr o lesames as our device complies with other requirements of the Act that I DA has made a acterimalations administered by other Federal agencies. You must or any I cacal statutes and regarations and limited to: registration and listing (21
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Page 2 - Ms. Jan Nieuwenhuis
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as setforth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the sections in the quality by books of the provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and w you to ought timaing of substantial equivalence of your device to a legally prematics notification: "The Pro 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 If you desire specific 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 other general mionnation of Journer 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 yours,
Miriam C. Provost
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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VivoSorb® Sheet K042811
bioresorbable soft tissue fixation
POLYGANICS
Indications for Use Form
K042811 510(k) Number:
Device Name: VivoSorb® Sheet
Indications for Use:
The VivoSorb Sheet is indicated for the use as a temporary wound support, to reinforce soft tissues where weakness exists, or for the repair of hernia or other fascial defects that require the addition of a reinforcing material to obtain the desired surgical result. The resorbable protective film minimizes tissue attachment to the device in case of direct contact with the viscera.
x Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Division of General, Restorative, and Neurological Devices
510(k) Number K042811
25-Oct-04
§ 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.