(71 days)
Not Found
No
The device description and performance studies focus on the material properties and mechanical performance of a surgical mesh, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended for soft tissue reinforcement during surgical procedures, which is a therapeutic purpose.
No
The device is a tissue reinforcement intended for surgical procedures to strengthen soft tissue, not to diagnose medical conditions.
No
The device description clearly states it is a "knitted fabric made from Artelon® fibers" and is supplied in "sheet form," indicating it is a physical, hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "reinforcement of soft tissue where weakness exists" and for "reinforcement of soft tissues that are repaired by suture or suture anchors, during tendon repair surgery". This describes a surgical implant used in vivo (within the body) to support and reinforce tissue.
- Device Description: The description details a "knitted fabric made from Artelon® fibers" supplied sterile in sheet form. This is consistent with a surgical mesh or implant.
- Lack of IVD Characteristics: An IVD device is 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 information contains none of these characteristics. There is no mention of analyzing biological samples or providing diagnostic information.
Therefore, SportMesh™ Artelon® Tissue Reinforcement is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
SportMeshTM/ Artelon® Tissue Reinforcement is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists.
SportMeshTM/ Artelon® Tissue Reinforcement is also intended for reinforcement of soft tissues that are repaired by suture or suture anchors, during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, or quadriceps tendons.
SportMeshTM Artelon® Tissue Reinforcement is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. 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. SportMeshTM/ Artelon® Tissue Reinforcement reinforces soft tissue and provides a degradable scaffold that is incorporated into the patient's own tissue.
Product codes
FTL
Device Description
SportMeshTM / Artelon® Tissue Reinforcement is a knitted fabric made from Artelon® fibers. The construction permits the mesh to be cut into any desired shape or size without unraveling. The device is supplied sterile in sheet form in double laver peelable packaging.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
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 with 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 SportMeshTM Artelon® Tissue Reinforcement provides appropriate mechanical properties for its use in soft tissue repair.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K042809, K071065, K053562, K052830
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
-1.12
SECTION 5. 510(K) SUMMARY
In accordance with 21 CFR 878.3300, the following information constitutes Artimplant AB's summary for the SportMeshTM /Artelon® Tissue Reinforcement.
A. SUBMITTER INFORMATION
SUBMITTER'S NAME: Artimplant AB Hulda Mellgrens gata 5. SE-421 32 Västra Frölunda. Sweden ADRESS: CONTACT PERSON: Ajrulla Zuta TELEPHONE NUMBER: +46 31 7465600 FAX NUMBER: +46 31 7465660 DATE OF SUBMISSION: 07/06/2007 ESTABLISHMENT REGISTRATION NUMBER: 3004878714
B. DEVICE IDENTIFICATION
DEVICE TRADE NAME: DEVICE COMMON NAME: CLASSIFICATION NAME: CLASSIFICATION REGULATION: REGULATORY CLASS: PRODUCT CODE: ADVISORY PANEL:
SportMeshTM, Artelon® Tissue Reinforcement Surgical Mesh Surgical Mesh, Polymeric 21 CFR 878.3300 Class II FTL General and Plastic Surgery
C. PREDICATE DEVICES
SportMesh™M Artelon® Tissue Reinforcement is substantially equivalent to:
- · K042809; CuffPatchTM, Organogenesis Inc
- · K071065; OrthADAPTM Bioimplant, Pegasus Biologics
- · K053562; Zimmer® Collagen Repair Patch, Tissue Science Laboratories
- · K052830; SportMeshTM, Artimplant AB
D. DEVICE DESCRIPTION:
SportMesh™ / Artelon® Tissue Reinforcement is a knitted fabric made from Artelon® fibers. The construction permits the mesh to be cut into any desired shape or size without unraveling. The device is supplied sterile in sheet form in double laver peelable packaging.
E. INTENDED USE:
SportMesh™/ Artelon® Tissue Reinforcement is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists.
SportMesh™/ Artelon® Tissue Reinforcement is also intended for reinforcement of soft tissues that are repaired by suture anchors, during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, or quadriceps tendons,
SportMesh™ Artelon® Tissue Reinforcement is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff, patellar, Achilles,
Artimplant
ર્ભ SportMesh™/ Artelon® Tissue Reinforcement 510(k)
1
biceps, or quadriceps tendons. 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™/ Artelon® Tissue Reinforcement reinforces soft tissue and provides a degradable scaffold that is incorporated into the patient's own tissue.
F. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
SportMesh™/ Artelon® Tissue Reinforcement is identical to the predicate Artimplant's SportMesh™ (K052830) with respect to its material composition. Each of the indications for use of the SportMesh™ Artelon® Tissue Reinforcement device are shared by one or more of the predicate devices. Performance data demonstrate that SportMesh™/ Artelon® Tissue Reinforcement is technologically equivalent to one or more of the predicate devices, and that the SportMesh™ Artelon® Tissue Reinforcement demonstrates performance characteristics that are equivalent to the predicate devices. Therefore, SportMesh™ Artelon® Tissue Reinforcement is substantially equivalent to the predicate devices for the specified indications.
G. PERFORMANCE DATA
A collection of tests has been conducted and successfully completed including biocompatibility safety studies (ISO 10993 standards), and mechanical testing in accordance with 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™Artelon® Tissue Reinforcement provides appropriate mechanical properties for its use in soft tissue repair.
H. CONCLUSION
Based on comparison to the predicate devices, SportMesh™ Artelon® Tissue Reinforcement is substantially equivalent to legally marketed devices and presents no new concerns of safety and effectiveness.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three heads, representing the department's focus on health, human services, and the well-being of the population. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 8 2007
Artimplant AB % M Squared Associates, Inc. Terry Sheridan Powell 719 A Street, Northeast Washington, District of Columbia 20002
Re: K071887
Trade/Device Name: SportMesh" /Artelon® Tissue Reinforcement Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: July 6, 2007 Received: July 9, 2007
Dear Ms. Clark:
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.
3
Page 2 - Terry Sheridan Powell
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Mark A. Millhiser
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
SECTION 4. INDICATIONS FOR USE STATEMENT
Indications for Use
510(k) Number (if known): K 5 7 887 to be assigned
Device Name: SportMesh™/ ArteIon® Tissue Reinforcement
Indications for Use:
SportMesh™ Artelon® Tissue Reinforcement is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists.
SportMesh™/ Artelon® Tissue Reinforcement is also intended for reinforcement of soft tissues that are repaired by suture or suture anchors, during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, or quadriceps tendons.
SportMesh™ Artelon® Tissue Reinforcement is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. 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™/ Artelon® Tissue Reinforcement reinforces soft tissue and provides a degradable scaffold that is incorporated into the patient's own tissue.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D) Subpart C)
(21 CFR 807
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Over-The-Counter Use _
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark H. Millenson
510(k) Number
Page 1 of __ 1_
Artimplant
SportMesh™/ Artelon® Tissue Reinforcement 510(k) 5