(88 days)
No
The device description and intended use focus on mechanical soft tissue fixation using a loop and button/sleeve system. There is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
Yes
The device is described as being used for soft tissue to bone fixation for various repairs and reconstructions across multiple anatomical sites (e.g., Bankart lesion repair, ACL/PCL repair/reconstruction). These are therapeutic functions aimed at treating medical conditions.
No
Explanation: The document describes a device used for soft tissue to bone fixation for various repairs and reconstructions. Its purpose is to physically attach tissue, not to diagnose medical conditions through imaging, analysis of physiological signals, or other diagnostic methods.
No
The device description clearly states it is comprised of physical components like a ZipLoop™, Button, Sleeve structure, and passing suture, all made of materials like UHMWPE or polyester. This indicates a hardware-based medical device, not software-only.
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 "soft tissue to bone fixation" in various anatomical locations. This describes a surgical implant used in vivo (within the body) to repair or reconstruct tissues.
- Device Description: The description details the physical components of the device (ZipLoop, Button, Sleeve, passing suture) and how they function mechanically to fix soft tissue to bone. This is consistent with a surgical 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, this device is a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The Sleeve and Button Soft Tissue Devices utilizing ZipLoop™ Technology are intended for soft tissue to bone fixation for the following indications:
Shoulder
Bankart lesion repair, SLAP lesion repair, Acromio-clavicular repair, Capsular shift/capsulolabral reconstruction, Deltoid repair, Rotator cuff tear repair, Biceps tenodesis
Foot and Ankle
Medial/lateral repair and reconstruction, Mid- and forefoot repair, Hallux valgus reconstruction, Metatarsal ligament/tendon repair or reconstruction, Achilles tendon repair
Elbow
Ulnar or radial collateral ligament reconstruction, Lateral epicondylitis repair, Biceps tendon reattachment
Knee
Extra-capsular repair: MCL, LCL, and posterior oblique ligament Iliotibial band tenodesis, Patellar tendon repair, VMO advancement, Joint capsule closure
Hand and Wrist
Collateral ligament repair, Scapholunate ligament reconstruction, Tendon transfers in phalanx, Volar plate reconstruction
Hip
Acetabular labral repair
In addition to the aforementioned indications, the Button Soft Tissue Devices (all sizes) and size specific Sleeve Soft Tissue Devices (as shown in Table 1) are indicated for the following:
Knee
ACL/PCL repair/reconstruction ACL/PCL patellar bone-tendon-bone grafts Double-Tunnel ACL reconstruction
Product codes
MBI, JDR
Device Description
The Sleeve and Button Soft Tissue Devices are comprised of a ZipLoop™ , a Button or a coreless Sleeve structure, and a passing suture. A ZipLoop™ is constructed from ultra high molecular weight polyethylene (UHMWPE) or polyester. It is passed through the Sleeve or Button, thus creating a soft tissue fixation device that bunches or locks against the bone when deployed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Foot and Ankle, Elbow, Knee, Hand and Wrist, Hip
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)
Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use. Clinical Testing: None provided as a basis for substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
K07'704
Image /page/0/Picture/1 description: The image shows the logo for Biomet Inc. The logo is in black and white and features the company name in a stylized font. The letters are bold and blocky, with the "T" extending to the top and bottom of the other letters. The word "INC" is written vertically to the right of the "T".
510(k) Summary
28 2 2000
Preparation Date: June 20, 2007
Applicant/Sponsor: Biomet Sports Medicine (Formerly known as Arthrotek, Inc.)
Contact Person: Elizabeth Wray
Proprietary Name: Sleeve and Button Soft Tissue Devices
Common Name: Soft tissue fixation device
Classification Name:
- MAI (888.3030): Fastener, fixation, biodegradable, soft tissue .
- MBI (888.3040): Fastener, fixation, nondegradable, soft tissue #
Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
| Device | Multitak SS Suture
System™ | BioRaptor™ | Cruciate Ligament
Button (PolySuture
Button) |
|---------------|-------------------------------|----------------|----------------------------------------------------|
| Manufacturer | Bonutti Research | Smith & Nephew | Biomet Sports Medicine* |
| 510(k) Number | K973015 | K053344 | K813581 |
Device Description: The Sleeve and Button Soft Tissue Devices are comprised of a ZipLoop™ , a Button or a coreless Sleeve structure, and a passing suture. A ZipLoop™ is constructed from ultra high molecular weight polyethylene (UHMWPE) or polyester. It is passed through the Sleeve or Button, thus creating a soft tissue fixation device that bunches or locks against the bone when deployed.
Indications for Use/Intended Use:
The Sleeve and Button Soft Tissue Devices utilizing ZipLoop™ Technology are intended for soft tissue to bone fixation for the following indications:
Shoulder
Bankart lesion repair, SLAP lesion repair, Acromio-clavicular repair, Capsular shift/capsulolabral reconstruction, Deltoid repair, Rotator cuff tear repair, Biceps tenodesis
Foot and Ankle
Medial/lateral repair and reconstruction, Mid- and forefoot repair, Hallux valgus reconstruction, Metatarsal ligament/tendon repair or reconstruction, Achilles tendon repair
Elbow
Ulnar or radial collateral ligament reconstruction, Lateral epicondylitis repair, Biceps tendon reattachment
Image /page/0/Picture/23 description: The image is a low-resolution picture that is mostly white. There are some black spots scattered throughout the image. The black spots are concentrated in the upper left and upper right corners of the image. The black spots are more sparse in the center of the image.
5-1
1
Knee
Extra-capsular repair: MCL, LCL, and posterior oblique ligament Iliotibial band tenodesis, Patellar tendon repair, VMO advancement, Joint capsule closure
Hand and Wrist
Collateral ligament repair, Scapholunate ligament reconstruction, Tendon transfers in phalanx, Volar plate reconstruction
Hip
Acetabular labral repair
In addition to the aforementioned indications, the Button Soft Tissue Devices (all sizes) and size specific Sleeve Soft Tissue Devices (as shown in Table 1) are indicated for the following:
Knee
ACL/PCL repair/reconstruction ACL/PCL patellar bone-tendon-bone grafts Double-Tunnel ACL reconstruction
Table 1
| Sleeve Size | |||
|---|---|---|---|
| UHMWPE/ | |||
| Polypropylene | Polyester | UHMWPE/ | |
| Polypropylene | Polyester | ||
| #2-0 or > | -- | #2 or > | -- |
| #2-0 or > | -- | -- | #0 or > |
| -- | #2 or > | -- | #5 or > |
Example: The following sleeve device combination may be used for ACL/PCL indications: #2-0 UHMWPE/Polypropylene Loop + #2 UHMWPE/Polypropylene Sleeve
Note: The loop and sleeve sizes denote the diameter of the original UHMWPE/Polypropylene or polyester braided fiber.
Summary of Technologies: The technological characteristics (materials, design, sizing, and indications) of the Sleeve and Button Soft Tissue Devices are similar or identical to the predicate device or other previously cleared devices.
Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use.
Clinical Testing: None provided as a basis for substantial equivalence.
All trademarks are property of Biomet, Inc. except Multitak SS Suture System™ of BloRaptor™ of Smith & Nephew.
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 depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Biomet Manufacturing Corp. % Ms. Elizabeth Wray Regulatory Affairs Specialist P.O. Box 587 Warsaw, Indiana 46581-0587
SEP 1 7 2007
Re: K071704
Trade/Device Name: Biomet Sleeve and Button Soft Tissue Devices Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI, JDR Dated: June 20, 2007 Received: June 21, 2007
Dear Ms. Wray:
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 -
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) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours,
Sincerely yours,
Barbara Buettner
Mark N. Melkerson 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 ●フレフ●4
Sleeve and Button Soft Tissue Devices ________________________________________________________________________________________________________________________________________ Device Name: ________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The Sleeve and Button Soft Tissue Devices utilizing ZipLoop™ Technology are intended for soft tissue to bone fixation for the following indications:
Shoulder
Bankart lesion repair, SLAP lesion repair, Acromio-clavicular repair, Capsular shift/capsulolabral reconstruction, Deltoid repair, Rotator cuff tear repair, Biceps tenodesis
Foot and Ankle
Medial/lateral repair and reconstruction, Mid- and forefoot repair, Hallux valgus reconstruction, Metatarsal ligament/tendon repair or reconstruction, Achilles tendon repair
Elbow
Ulnar or radial collateral ligament reconstruction, Lateral epicondylitis repair, Biceps tendon reattachment
Knee
Extra-capsular repair: MCL, LCL, and posterior oblique ligament Iliotibial band tenodesis, Patellar tendon repair, VMO advancement, Joint capsule closure
Hand and Wrist
Collateral ligament repair, Scapholunate ligament reconstruction, Tendon transfers in phalanx, Volar plate reconstruction
Hip
Acetabular labral repair
Prescription Use YES (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use NO (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)
Durkare buen
Restorative. and Neurological Devices
510(k) Number K071704 4-1
Page 1 of 2
5
In addition to the aforementioned indications, the Button Soft Tissue Devices (all sizes) and size specific Sleeve Soft Tissue Devices (as shown in Table 1) are indicated for the following:
Knee
ACL/PCL repair/reconstruction ACL/PCL patellar bone-tendon-bone grafts Double-Tunnel ACL reconstruction
Table 1
| Loop Size | Sleeve Size | ||
|---|---|---|---|
| UHMWPE/ | |||
| Polypropylene | Polyester | UHMWPE/ | |
| Polypropylene | Polyester | ||
| #2-0 or > | -- | #2 or > | -- |
| #2-0 or > | -- | -- | #0 or > |
| -- | #2 or > | -- | #5 or > |
The following sleeve device combination may be used for ACL/PCL indications: Example: #2-0 UHMWPE/Polypropylene Loop + #2 UHMWPE/Polypropylene Sleeve
The loop and sleeve sizes denote the diameter of the original Note: UHMWPE/Polypropylene or polyester braided fiber.
| Prescription Use | YES |
|---|---|
| (Part 21 CFR 801 Subpart D) |
AND/OR
| Over-The-Counter Use | NO |
|---|---|
| (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)