(122 days)
Not Found
No
The description focuses on the physical components and materials of a surgical mesh and its delivery system, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is a surgical mesh used to support soft tissue and repair hernias, which is a structural or mechanical function, not a therapeutic one that treats disease or provides biological/physiological therapy.
No
Explanation: The device is a surgical mesh system used to support soft tissue and repair hernias. Its description focuses on its material composition, implantation method, and intended use as a reinforcing or bridging material, rather than on diagnostic capabilities like detecting, monitoring, or identifying disease.
No
The device description explicitly states it is comprised of a Mesh Implant and two suture assemblies, which are physical components made of materials like polyethylene terephthalate (PET) and platinum/iridium markers. It also mentions disposable delivery instruments. This clearly indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "support soft tissue where weakness exists, or for the repair of hernias requiring the addition of a reinforcing, or bridging material." This describes a surgical implant used directly on the patient's body for structural support and repair.
- Device Description: The device is a "Surgical Mesh System" comprised of an "Implant" and "suture assembles." It is "inserted through the aperture of the tissue defect and affixed to surrounding soft tissue." This is a description of a medical device used in a surgical procedure.
- Lack of IVD Characteristics: IVD devices are used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. The provided description does not mention any such use or interaction with biological specimens for diagnostic purposes.
Therefore, the Inclose™ Surgical Mesh System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The mesh may be used to support soft tissue where weakness exists, or for the repair of hernias requiring the addition of a reinforcing, or bridging material, such as the repair of groin hernias.
Product codes (comma separated list FDA assigned to the subject device)
FTL
Device Description
The Inclose ™ Surgical Mesh System is comprised of a Mesh Implant and two suture assembles (Anchor Bands). The implanted components are provided sterile and preloaded on their respective disposable delivery instruments. The Mesh Implant is an expandable braided patch that is inserted through the aperture of the tissue defect and affixed to surrounding soft tissue with the Anchor Bands. Materials utilized in the construct of the implanted components consist of polyethylene terephthalate (PET). In addition, two platinum/iridium markers are placed on monofilament fibers and positioned toward the proximal end of the mesh. These two markers are located 180° from each other and are intended to facilitate identification of the Inclose™ Mesh Implant following surgery. Standard operating room sutures may also be utilized for fixation of the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue, groin hernias
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 and bench testing have been completed and support the safety and effectiveness of the Inclose™ Surgical Mesh System.
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.
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
K050969 1/2
SECTION 2
AUG 1 8 2005
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
| Submitter: | Anulex Technologies, Inc.
5600 Rowland Road, Suite 280
Minnetonka, MN 55343 |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Tim Miller
Vice President, Regulatory and Clinical Affairs
Anulex Technologies, Inc.
5600 Rowland Road, Suite 280
Minnetonka, MN 55343
Direct: 952-224-4003
Fax: 952-224-4040
E-mail: tmiller@anulex.com |
| Date Prepared: | April 15, 2005 |
| Trade Name: | Inclose ™ Surgical Mesh System |
| Classification Name:
and Number: | Surgical mesh, polymeric; 21CFR 878.3300 |
| Product Code: | FTL |
| Predicate Device(s): | The Inclose ™ Surgical Mesh System is substantially
equivalent to: |
| | Bard® Mesh PerFix® Plug
(K922916 - Decision Date: 8/24/1992) |
| | Ethicon Mersilene Polyester Fiber Mesh
(K851086 -- Decision Date: 5/21/1985) |
| Device Description: | The Inclose ™ Surgical Mesh System is comprised of a
Mesh Implant and two suture assembles (Anchor Bands).
The implanted components are provided sterile and
preloaded on their respective disposable delivery
instruments. The Mesh Implant is an expandable braided
patch that is inserted through the aperture of the tissue
defect and affixed to surrounding soft tissue with the
Anchor Bands. Materials utilized in the construct of the |
1
| | implanted components consist of polyethylene
terephthalate (PET). In addition, two platinum/iridium
markers are placed on monofilament fibers and positioned
toward the proximal end of the mesh. These two markers
are located 180° from each other and are intended to
facilitate identification of the Inclose™ Mesh Implant
following surgery. |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Standard operating room sutures may also be utilized for
fixation of the device. |
| Intended Use: | The mesh may be used to support soft tissue where
weakness exists, or for the repair of hernias requiring the
addition of a reinforcing, or bridging material, such as the
repair of groin hernias. |
| Functional and
Safety Testing: | Biocompatibility and bench testing have been completed
and support the safety and effectiveness of the Inclose™
Surgical Mesh System. |
| Conclusion: | The Inclose™ Surgical Mesh System is substantially
equivalent in intended use, scientific technology, materials
and design to predicate devices in interstate commerce. |
.
2
ੀ ਦਿ 。 12
2
AUG 1 8 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Tim Miller VP, Regulatory and Clinical Affairs Anulex Technologies, Inc. 5600 Rowland Road, Suite 280 Minnetonka, Minnesota 55343
Re: K050969
Trade/Device Name: Inclose™ Surgical Mesh System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: July 28, 2005 Received: July 29, 2005
Dear Mr. Miller:
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.
Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three heads, representing the department's commitment to health, human services, and well-being. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" written around it. The logo is simple and recognizable, conveying the department's mission and purpose.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) rms lotter will and in yourse FDA finding of substantial equivalence of your device to a legally promation hotification. "Theesults 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 other general 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
lane buch MD
for
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: Inclose™ Surgical Mesh System
Indications For Use:
The mesh may be used to support soft tissue where weakness exists, or for the repair of hernias requiring the addition of a reinforcing, or bridging material, such as the repair of groin hernias.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sauberc Bneeldfon Mulkerson
Division of General, Restorative, and Neurological Devices
Page 1 of 1
510(k) Number K050961