(135 days)
Not Found
Not Found
No
The summary describes a surgical mesh made of standard materials and intended for mechanical reinforcement. There is no mention of any computational or analytical capabilities, let alone AI/ML.
Yes.
The device is a surgical mesh intended for use as a prosthesis in general surgery for various repairs, which is a therapeutic purpose.
No
The device is a surgical mesh intended for repair and reinforcement of abdominal wall, hernia, and prolapse, which are therapeutic rather than diagnostic purposes.
No
The device description explicitly states it is constructed of polypropylene or polyester mesh, which are physical materials, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. These tests are performed outside of the body (in vitro).
- Device Description and Intended Use: The description clearly states that Glucamesh™/Glucatex™ Surgical Mesh is a surgical mesh intended for implantation into the body to reinforce tissues during surgery. This is an in vivo (within the living body) application, not an in vitro test.
The information provided about the device's composition, intended use in surgery, and implantation by a surgeon all point to it being a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
This mesh is intended for the use as a prosthesis in general surgery for surgical treatment of abdominal wall reinforcement, hernia repairs, eventrations, rectal and genitourinary prolapse.
This mesh is used for the repair of abdominal wall reinforcements, hernia repairs, eventrations, rectal or genitourinary prolapses.
Glucamesh™/Glucatex™ Surgical Mesh is intended for the use as a prosthesis in general surgery for surgical treatment of abdominal wall reinforcement, hernia repairs, eventrations, rectal and genitourinary prolapse. The meshes are biocompatible and not biodegradable. The device is intended to be implanted by a qualified surgeon.
Product codes (comma separated list FDA assigned to the subject device)
FTL
Device Description
Glucatex mesh is constructed of polypropylene or polyester which is identical in composition to that used in Prolene Soft Mesh, Mersitence or Biomesh. The mesh affords excellent strength, durability and surgical adaptability, with sufficient porosity for necessary tissue ingrowth.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal wall, hernia, rectal, genitourinary
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified surgeon
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)
Sufficient bench testing was conducted in accordance with the FDA guidance document "Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh."
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
OCT 1 7 2002
Summary of Safety and Effectiveness (As required by 21 CFR 807.92)
Device Name: GlucaMesh and or Glucatex (Polypropylone/Polyester) Mesh.
Predicate Device Name: Prolene Soft (Polypropylene), Mersilene (Polyester ) and Biomesh (polypropylene) mesh.
Device Description Glucatex mesh is constructed of polypropylene or polyester which is identical in composition to that used in Prolene Soft Mesh, Mersitence or Biomesh. The mesh affords excellent strength, durability and surgical adaptability, with sufficient porosity for necessary tissue ingrowth.
Intended Use This mesh is intended for the use as a prosthesis in general surgery for surgical treatment of abdominal wall reinforcement, hernia repairs, eventrations, rectal and genitourinary prolapse.
Indications Statement This mesh is used for the repair of abdominal wall reinforcements, hernia repairs, eventrations, rectal or genitourinary prolapses.
Technological Characteristics For technical characteristics, the values established for GlucaMesh and Glucatex are similar to those established by Prolene, Mersilenc and Biomesh which were constructed of polypropylenc and polyester.
Performance Data Sufficient bench testing was conducted in accordance with the FDA guidance document "Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh."
Conclusions Based on the 510(k) summaries and 510(k) statements (21 ClFR 807) and the information provided herein, we conclude that the new device is substantially equivalent to the Predicate Device(s) under the Federal Food, Drug and Cosmetic Act.
| Contact | Philip B. Lawin, Ph.D.
President
Brennen Medical
1290 Hammond Road
St. Paul, MN 55110
Contact Telephone Number 651-429-7413 |
|---------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Date | October 8, 2002 |
Phillip B. Lawin, Ph. D.
President
Date: 10/9/02
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles overlapping each other, creating a sense of depth and unity. The profiles are arranged in a way that suggests movement or progress.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 7 2002
Brennen Medical, Inc. Phillip B. Lawin, Ph.D. President 1290 Hammond Road St. Paul, Minnesota 55110
Re: K021835
Trade/Device Name: Brennen Medical Surgical Mesh. GlucaMesh/Glucatex Regulation Number: 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTL Dated: August 8, 2002 Received: August 12, 2002
Dear Dr. Lawin:
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.
2
Page 2 – Dr. Phillip B. Lawin
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
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
K 021835
Page 1 of 1
510(k) Number (If Known):
Device Name: Brennen Medical GlucaMesh Surgical Mesh
INDICATIONS FOR USE:
Glucamesh™/Glucatex™ Surgical Mesh is intended for the use as a prosthesis in general surgery for surgical treatment of abdominal wall reinforcement, hernia repairs, eventrations, rectal and genitourinary prolapse. The meshes are biocompatible and not biodegradable. The device is intended to be implanted by a qualified surgeon.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109) ✓
OR
Over-The Counter-Use (Optional Format 1-2-96)
Atpt Rurle
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________