(34 days)
Not Found
Not Found
No
The description focuses on the material composition, physical properties, and intended surgical use of a resorbable film. There is no mention of any computational or analytical functions that would suggest the use of AI or ML.
Yes
The device is described as reinforcing or bridging material for surgical repair of tissues and defects, which aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
The device is described as a reinforcing or bridging material for surgical repair, not for diagnostic purposes. It is used to provide temporary wound support and reinforce soft tissue.
No
The device description clearly states it is a physical implantable material made of polymers, provided in sheets of various sizes and thicknesses, and intended for surgical use. This is a hardware device, 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 describes a device used in vivo (within the body) for surgical repair and reinforcement of soft tissue and fascial defects. IVDs are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a physical implantable material (sheets of polymer) designed to be surgically placed. This is consistent with a surgical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or functions of an IVD.
Therefore, the IMMIX™ PlastiFilm is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The IMMIX™ PlastiFilm is to be used wherever temporary wound support is required, to reinforce soft tissue where weakness exists, or for the repair of hernia or other fascial defects that require the addition of a reinforcing, or bridging material to obtain the desired surgical result. This includes, but is not limited to the following procedures: vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor and sacral colposuspension.
Product codes (comma separated list FDA assigned to the subject device)
79FTL
Device Description
The IMMIX™ PlastiFilm is manufactured using poly(D,L-lactide-coglycolide) polymer and triethyl 2-acetylcitrate or tributyl 2-acetylcitrate. The device will be provided in sheets of 10 mm x 10 mm to 120 mm x 120mm. Other shapes and sizes will be provided as needed for particular surgical procedures. Additionally, the device can be cut with scissors to obtain desired shapes and sizes.
The thickness of the IMMIX™ PlastiFilm will range from 50 to 300 microns, according to the region to be treated, and will be provided with and without macroporous holes. The holes will range from 100 microns to 1000 microns in diameter. The holes may be aligned, offset, or random patterns. The borders of the sheets may be aligned with the holes to attach suture material.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, hernia, fascial defects, vaginal, colon, rectal, pelvic floor
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility assessment performed by an independent certified laboratory demonstrated the biocompatibility of the materials used for this device. Degradation testing performed in a physiological buffered saline solution at 37 ℃ showed that the device is fully resorbable over a period of months. OsteoBiologics performed suture pullout testing on a family of PlastiFilm products, which are identical in material composition. The results demonstrated that the films could withstand substantial loads and deformations before its physical integrity is compromised, therefore supporting the suitability of the IMMIX™ PlastiFilm for use in a clinical situation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Ko32673
OCT = 2 2003
510(k) SUMMARY
| Submitter | Contact |
|---|---|
| Image: OBI Logo | |
| OsteoBiologics, Inc. | |
| 12500 Network, Suite 112 | |
| San Antonio, Texas 78249, USA | Gabriele G. Niederauer, Ph.D. |
| Director of Research and Development | |
| Phone: 210-690-2131 (ext. 228) | |
| Fax: 210-690-2559 | |
| E-mail: gabi@obi.com |
| Date of Summary: | August 28, 2003 |
|---|---|
| Common Name: | Polymeric Surgical Mesh |
| Proprietary Name: | IMMIX™ PlastiFilm |
| Device Classification: | Polymeric surgical mesh (Product Code 79FTL) is a Class I |
| prosthetic device, per 21 CFR §878.3300 |
510(k) Number:
Description of Device: The IMMIX™ PlastiFilm is manufactured using poly(D,L-lactide-coglycolide) polymer and triethyl 2-acetylcitrate or tributyl 2-acetylcitrate. The device will be provided in sheets of 10 mm x 10 mm to 120 mm x 120mm. Other shapes and sizes will be provided as needed for particular surgical procedures. Additionally, the device can be cut with scissors to obtain desired shapes and sizes.
The thickness of the IMMIX™ PlastiFilm will range from 50 to 300 microns, according to the region to be treated, and will be provided with and without macroporous holes. The holes will range from 100 microns to 1000 microns in diameter. The holes may be aligned, offset, or random patterns. The borders of the sheets may be aligned with the holes to attach suture material.
Intended Use: The IMMIX™ PlastiFilm is to be used wherever temporary wound support is required, to reinforce soft tissue where weakness exists, or for the repair of hernia or other fascial defects that require the addition of a reinforcing, or bridging material to obtain the desired surgical result. This includes, but is not limited to the following procedures: vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor and sacral colposuspension.
Testing: Biocompatibility assessment performed by an independent certified laboratory demonstrated the biocompatibility of the materials used for this device. Degradation testing performed in a physiological buffered saline solution at 37 ℃ showed that the device is fully resorbable over a period of months. OsteoBiologics performed suture pullout testing on a family of PlastiFilm products, which are identical in material composition. The results demonstrated that the films could withstand substantial loads and deformations before its physical integrity is compromised, therefore supporting the suitability of the IMMIX™ PlastiFilm for use in a clinical situation.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 2 2003
Gabriele G. Niederauer, Ph.D. Director of Research and Development OsteoBiologics, Inc. 12500 Network, Suite 112 San Antonio, Texas 78249-3308
Re: K032673
Trade/Device Name: IMMIX™ PlastiFilm Regulation Number: 21 CFR 878.3300 Regulation Name: Polymeric surgical mesh Regulatory Class: II Product Code: FTL Dated: August 28, 2003 Received: September 2, 2003
Dear Dr. Niederauer:
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 10 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.
2
Page 2 - Gabriele G. Niederauer, Ph.D.
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 yours,
Miriam C. Provost
ﻌ
to 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
3
2.4 Indications For Use (Form)
| INDICATIONS FOR USE | |
|---|---|
| 510(k) Number (if known): | K032673 |
| Device Name: | IMMIX™ PlastiFilm |
| Indications For Use: | The IMMIX™ PlastiFilm is to be used wherever temporary wound support is required, to reinforce soft tissue where weakness exists, or for the repair of hernia or other fascial defects that require the addition of a reinforcing, or bridging material to obtain the desired surgical result. This includes, but is not limited to the following procedures: vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor and sacral colposuspension. |
(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 Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number: K032673
| Prescription Use | X | OR | Over-The-Counter Use | __________ |
|---|---|---|---|---|
| (Per 21 CFR 801.109) |
1.00.0
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