(122 days)
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.
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.
The provided text describes a 510(k) summary for the Anulex Technologies Inclose™ Surgical Mesh System. This document focuses on demonstrating substantial equivalence to predicate devices, rather than establishing performance against specific acceptance criteria through a clinical study.
Therefore, many of the requested sections regarding acceptance criteria, device performance, study design, and ground truth establishment cannot be found in the provided text. The K050969 document for the Inclose™ Surgical Mesh System is a 510(k) premarket notification. These notifications primarily demonstrate substantial equivalence to legally marketed predicate devices, not novel performance claims through clinical trials with established acceptance criteria.
Here's what can be extracted based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly defined for novel performance claims. | The device is deemed "substantially equivalent in intended use, scientific technology, materials and design to predicate devices in interstate commerce." |
| Functional and Safety Testing Results: "Biocompatibility and bench testing have been completed and support the safety and effectiveness of the Inclose™ Surgical Mesh System." (Specific results or metrics are not detailed). |
2. Sample size used for the test set and the data provenance
- Sample size: Not applicable or not provided. This is a 510(k) submission, not a new clinical study with a test set. The submission relies on demonstrating equivalence to existing predicate devices.
- Data provenance: Not applicable. The "study" referenced is primarily bench and biocompatibility testing, not human-subject testing with a test set for performance evaluation in the usual sense for AI/medical device performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No ground truth establishment for a test set is described or implied in this 510(k) summary.
4. Adjudication method for the test set
- Not applicable. No adjudication method for a test set is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is a surgical mesh, not an AI-assisted diagnostic or therapeutic device that would involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a physical surgical implant, not an algorithm.
7. The type of ground truth used
- Not applicable. No ground truth as defined for evaluating a diagnostic or AI device is mentioned. The "ground truth" for this device's safety and effectiveness implicitly relies on the established safety and effectiveness of its predicate devices, supported by bench and biocompatibility testing.
8. The sample size for the training set
- Not applicable. This device is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. This device is not an AI algorithm requiring a training set.
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K050969 1/2
SECTION 2
AUG 1 8 2005
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
| Submitter: | Anulex Technologies, Inc.5600 Rowland Road, Suite 280Minnetonka, MN 55343 |
|---|---|
| Contact Person: | Tim MillerVice President, Regulatory and Clinical AffairsAnulex Technologies, Inc.5600 Rowland Road, Suite 280Minnetonka, MN 55343Direct: 952-224-4003Fax: 952-224-4040E-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 substantiallyequivalent 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 aMesh Implant and two suture assembles (Anchor Bands).The implanted components are provided sterile andpreloaded on their respective disposable deliveryinstruments. The Mesh Implant is an expandable braidedpatch that is inserted through the aperture of the tissuedefect and affixed to surrounding soft tissue with theAnchor Bands. Materials utilized in the construct of the |
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| implanted components consist of polyethyleneterephthalate (PET). In addition, two platinum/iridiummarkers are placed on monofilament fibers and positionedtoward the proximal end of the mesh. These two markersare located 180° from each other and are intended tofacilitate identification of the Inclose™ Mesh Implantfollowing surgery. | |
|---|---|
| Standard operating room sutures may also be utilized forfixation of the device. | |
| Intended Use: | The mesh may be used to support soft tissue whereweakness exists, or for the repair of hernias requiring theaddition of a reinforcing, or bridging material, such as therepair of groin hernias. |
| Functional andSafety Testing: | Biocompatibility and bench testing have been completedand support the safety and effectiveness of the Inclose™Surgical Mesh System. |
| Conclusion: | The Inclose™ Surgical Mesh System is substantiallyequivalent in intended use, scientific technology, materialsand design to predicate devices in interstate commerce. |
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2
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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.
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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
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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
§ 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.