(27 days)
No
The document describes a resorbable sheet for tissue support and repair, with performance studies focused on mechanical and degradation properties. There is no mention of AI, ML, image processing, or data sets typically associated with AI/ML applications.
Yes
The device is described as a "temporary wound support" and "reinforcing material" for soft tissues, hernias, and fascial defects, which directly addresses medical conditions for therapeutic purposes.
No
Explanation: The device is indicated as a temporary wound support and reinforcing material for soft tissues, hernias, and fascial defects, which are therapeutic functions, not diagnostic.
No
The device description clearly states it is a physical sheet made of poly (DL-lactide-co-s-caprolactone) and is provided in sterile packages. It is a resorbable implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "temporary wound support, to reinforce soft tissues where weakness exists, or for the repair of hernia or other fascial defects." This describes a device used in vivo (within the body) for structural support and repair.
- Device Description: The description of a "flexible and transparent resorbable poly (DL-lactide-co-s-caprolactone) sheet" further supports its use as an implantable or surgically placed material.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used outside the body to analyze samples and provide diagnostic information. This device is used inside the body for surgical repair and support.
N/A
Intended Use / 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.
Product codes
FTL
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues, hernia or other fascial defects, viscera
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The safety and effectiveness of the VivoSorb Sheet have been demonstrated via data collected from design verification tests and analyses. The design verification testing consisted of the following:
- In vitro suture retention testing
- In vitro degradation testing
- Aging testing
- Mechanical testing
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
NOV - 8 2004
510(k) Summary of Safety and Effectiveness
| Submitter: | Polyganics BV
L.J. Zielstraweg 1
9713 GX, Groningen
The Netherlands
www.polyganics.com |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact
Person: | Jan Nieuwenhuis
Managing Director
Tel : +31 50 588 6588
Fax : +31 50 588 6599
Mobile : +31 653 211 303
E-mail : jan.nieuwenhuis@polyganics.com |
| Date
Prepared: | Oct 7, 2004 |
| General
Provisions: | Trade Name: VivoSorb Sheet
Common Name: Absorbable Polymeric Surgical Mesh
Classification Name: Surgical Mesh, Polymeric, 21 CFR 878.3300
Device Classification: Class II |
| Predicate
Devices: | Surgi Wrap MAST MacroPore, Inc K031955 IMMIXTM Obi OsteoBiologics K032673 |
| Performance
Standards | For the VivoSorb Sheet performance, the FDA, under section 514 of the
Food, Drug and Cosmetic Act, has not established standards. |
| 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. |
1
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.
2
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
3
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
4
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