(106 days)
Not Found
No
The summary describes a physical surgical mesh and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No.
Sportmesh™ is intended for reinforcement of soft tissue, not for direct therapeutic treatment of a condition or disease. It provides mechanical support and a scaffold for tissue incorporation.
No
Sportmesh is a surgical mesh primarily used for reinforcement of soft tissue, not for identifying, monitoring, or predicting medical conditions.
No
The device description clearly states that Sportmesh™ is a knitted fabric made from ARTELON fibers, supplied in sheet form. This indicates a physical, implantable medical device, not a software-only device.
Based on the provided information, Sportmesh™ is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Sportmesh™'s Intended Use: Sportmesh™ is intended for surgical implantation to reinforce soft tissue. It is a physical device used in the body, not a tool for analyzing samples from the body.
- Device Description: The description details a knitted fabric made from fibers, designed for surgical use. This aligns with a surgical implant, not an IVD.
- Lack of IVD Characteristics: The document does not mention any analysis of biological samples, chemical reactions, or diagnostic information being generated by the device.
Therefore, Sportmesh™ falls under the category of a surgical implant or mesh, not an IVD.
N/A
Intended Use / Indications for Use
Sportmesh™ is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists. Sportmesh™ is also intended for reinforcement of soft tissues that are repaired by suture or suture anchors, limited to the supraspinatus, during rotator cuff repair surgery.
Sportmesh™ is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff. Sutures used to repair the full sutures or bone anchors used to ottach the i sutures or bone anchors used to attach the tissue to the bone, provide mechanical strength for the tendon repair. Sportmesh™ reinforces soft tissue and provides a degradable scaffold that is incorporated in the patient's own tissue a
Product codes (comma separated list FDA assigned to the subject device)
FTM, FTL
Device Description
Sportmesh™is a knitted fabric made from ARTELON fibers. This construction permits the mesh to be cut into any desired shape or size without unraveling. The device is supplied in sheet form in sterile double layer peelable packaging.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, supraspinatus (limited to), rotator cuff
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)
A collection of tests has been conducted and successfully completed including biocompatibility safety studies (ISO 10993 standards), and mechanical testing in accordance Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh; Guidance for Industry and/or for FDA Reviewers/Staff and/or Compliance. The results demonstrate that Sportmesh™ provides appropriate mechanical properties for its use in soft tissue repair.
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.
K042809, K031969, K001738, 033337, K0428, K031969, K021969, K021056
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.
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JAN J 9 2006
Summary of Safety and Effectiveness
In accordance with 21 CFR 807.92, the following information constitutes Artimplant AB's summary for the Sportmesh™.
SUBMITTER'S NAME: | Artimplant AB |
---|---|
ADRESS: | Hulda Mellgrens gata 5, SE-421 32 Västra Frölunda, Sweden |
CONTACT PERSON: | Ajrulla Zuta |
TELEPHONE NUMBER: | +46 31 7465600 |
FAX NUMBER: | +46 31 7465660 |
DATE OF SUBMISSION: | October 4, 2005 |
l. Identification of device
Proprietary Name: Sportmesh™ Common Name: Surgical Mesh, RC Patch, Rotator cuff patch Classification Status: Class II per regulations 878 3300 Product Code: FTM
2. Equivalent devices
Sportmesh™ is substantially equivalent to: Organogenesis, Inc's FortaFlex™ Surgical Mesh (K042809) DePuy, Inc's Restore® Orthobiologic Soft Tissue Implant (K031969, K001738) Ethicon, Inc's ULTRAPRO™Mesh (033337) Davol's Marlex Mesh (pre-Amendments)
3. Description of the Device
Sportmesh™is a knitted fabric made from ARTELON fibers. This construction permits the mesh to be cut into any desired shape or size without unraveling. The device is supplied in sheet form in sterile double layer peelable packaging.
4. Intended use
Sportmesh™ is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists. Sportmesh™ is also intended for reinforcement of soft tissues that are repaired by suture or suture anchors, limited to the supraspinatus, during rotator cuff repair surgery.
Sportnesh™ is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff. Sutures used to repair the tear, and sutures or bone anchors used to attach the tissue to the bone, provide mechanical strength for the tendon repair. Sportmesh™ reinforces soft tissue and provides a degradable scaffold that is incorporated in the patient's own tissue.
ನ. Comparison to predicate device.
Sportmesh™ is equivalent to the Organogenesis, Cuffpatch™ Surgical Mesh (K042809). DePuy, Inc's Restore® Orthobiologics Soft Tissus Implant (K03)969), Ethicon (K0428)
UI TDADBOTHM - 1, (80000), 1), 1800000), Ethicon (K031969), Ethicon, Inc's ULTRAPRO™Mesh (033337), Tissue Science's Permacol (K021969), Eldiconi, Inc S
Mesh (pre-Amendments) 337), Tissue Science's Permacol (K021056) and Davol's Marlex Mesh (pre-Amendments) with respect to intended use and technological characteristics.
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6. Discussion of performance testing.
A collection of tests has been conducted and successfully completed including biocompatibility safety studies (ISO 10993 standards), and mechanical testing in accordance Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh; Guidance for Industry and/or for FDA Reviewers/Staff and/or Compliance. The results demonstrate that Sportmesh™ provides appropriate mechanical properties for its use in soft tissue repair.
7. Conclusion
Based on comparison to the predicate devices, the Sportmesh™ is substantially equivalent to legally-marketed devices and presents no new concerns about safety and effectiveness.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an abstract design of an eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN ] 9 2006
Artimplant AB c/o Ms. Terry Sheridan Powell Regulatory Consultant M Squared Associates 719 A Street, NE Washington, District of Columbia 20002
Re: K052830
Trade/Device Name: Artimplant AB Sportmesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: December 9, 2005 Received: December 12, 2005
Dear Ms. Powell:
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
3
Page 2 - Ms. Powell
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.
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 (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 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/industry/support/index.html.
Sincerely vours
Sincerely yours,
Barbara Buehr
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): K 0528 30
Artimplant A Device Name:
Indications for Use:
Sportmesh™ is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists. Sportmesh™ is also intended for reinforcement of soft tissues that are repaired by suture or suture anchors, limited to the supraspinatus, during rotator cuff repair surgery.
Sportmesh™ is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff. Sutures used to repair the full
sutures or bone anchors used to ottach the i sutures or bone anchors used to attach the tissue to the bone, provide mechanical strength for the tendon repair. Sportmesh™ reinforces soft tissue and provides a degradable scaffold that is incorporated in the patient's own tissue a
Prescription Use X (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
K052830 (barbarabuchbinder Page 1 of 1
(Division Sign-Off) for WM
Division of General, Re-rorative, and Neurological Devices
510(k) Number_ 1505 2430