(169 days)
No
The device description and intended use are purely mechanical, and there are no mentions of AI, ML, image processing, or data training/testing.
No
Explanation: The device is a suture anchor used to reattach soft tissue to bone, which is a structural repair rather than a therapeutic treatment for a disease or condition. While it aids in healing and stabilization, its primary function is mechanical support.
No
Explanation: The device is a suture anchor used to reattach soft tissue to bone and stabilize it during healing, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a "threaded, bioabsorbable suture anchor" made of poly-L/D-lactide copolymer, which is a physical, implantable medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "reattach soft tissue to bone in orthopaedic surgical procedures." This is a surgical implant used directly in the body for mechanical support and tissue repair.
- Device Description: The description details a physical implant (suture anchor) made of a bioabsorbable material, preloaded with sutures and a driver. This is a surgical device, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the body (like blood, urine, tissue), detecting biomarkers, or providing information for diagnosis.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used in vivo (inside the body) for surgical repair.
N/A
Intended Use / Indications for Use
The Duet™ Suture Anchor is intended for use in the reattachment of soft tissue to bone by arthroscopy or direct visualization. This indication is substantial equivalent with Bionx Implants Inc. SmartAnchor (K972783), Bankart Tack (K973849), Contour Labral Nail (K992567, K003970), BioCuff™ (K001378) and BioCuff™ C (K013057), Arthrex Inc. Bio-Absorbable Corkscrew (K990361) Bio-Absorbable Corkscrew Suture Anchor (K990987), Bio-Absorbable CorkScrew Suture Anchor (K003227) and TissueTak (K990340), Innovasive Devices, Inc. BioROC EZ (K973381), RC Multi-Suture Anchor (K992458) and Sutureless Anchor (K984490), Instrument Makar, Inc,Biologically Quiet Biosphere (K963396) and Biologically Ouiet Mini-Screw Suture Anchor (K960555), Linvatec Corporation Bio-Anchor (K964805, K963369, K983186) and BioRC Anchor (K990110), Mitek Surgical Products Panalok (K950272), Panalok RC (K970896) and Absorbable Toggle Anchor (K964013), Acufex Inc. Suretac 6.0, 8,0 (K911837) and DePuy Inc. De Puy Dupont Phantom Suture Anchor (K964921).
The Bionx Duet™ Suture Anchor is a bioabsorbale screw-in suture anchor that is preloaded on a disposable inserter device with two non-absorbable, braided, polyester #2 sutures. The Duet™ Suture Anchor is manufactured from Self-Reinforced (96/4D) PLA Copolymer that retains 90% strength through 20 weeks and completely resorbs over a period of several years in vivo. The unique Self-Reinforced Copolymer provides high initial mechanical strength required for insertion and through the healing phase (20 weeks) with complete absorption occurring over several years. The unique absorption profile of the Copolymer allows the anchor to gradually loose strength as the collagen fibers of the repair form and gain strength. The Copolymer is inert, non-collagenous and non-pyrogenic through the absorption process. The Duet™ Suture Anchor is indicated for use in arthroscopic or open surgical procedures to reattach soft tissue to the bone.
The Duet™ Suture Anchor is contraindicated in the following conditions:
- Surgical procedures other than those listed. 1.
- Conditions that may compromise Anchor fixation (osteopenic, comminuted 2. bone, pathologic conditions in the soft tissues to be attached, etc.)
- Conditions that may retard healing (poor blood supply, past or potential 3. infection, etc).
- Active infection. 4.
- Conditions that may limit the patients ability or willingness to restrict റ് activities or follow directions during the healing period.
- Foreign body sensitivity to materials. 6.
-
- Patients with suspected or known allergy to the implant or suture materials.
Product codes (comma separated list FDA assigned to the subject device)
MAI, HWC
Device Description
Duet™ Suture Anchor is threaded, bioabsorbable suture anchor, provided as preloaded with two non-absorbable, braided, polyester #2 sutures, one of them is green and another one is white. Diameter of the anchor is 6.0mm and length 16.5mm. It is assembled with sutures with needles into single use, sterile, disposable driver and packaged into blister with a punch. The Duet™ Suture Anchor is made of poly-L/D-lactide copolymer. The poly-L/D-lactide material equals the raw material used in previously cleared Bionx Implants Inc. SmartNail™ (K993074), Meniscus Arrow™ (K993453), SmartScrew ACL™ (K993073), SmartScrew (K012001), The Wedge™ (K000616), Contour Labral Nail (K003970), BioCuff (K001378) and BioCuff C (K013057).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Not Found
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.
K972783, K973849, K992567, K003970, K001378, K013057, K990361, K990987, K003227, K990340, K973381, K992458, K984490, K963396, K960555, K964805, K963369, K983186, K990110, K950272, K970896, K964013, K911837, K964921
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.
K993074, K993453, K993073, K012001, K000616, K003970, K001378, K013057
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
§ 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
K020056 page 193
JUN 2 6 2002
510(k) Summary Bionx Implants Inc. Duet Suture Anchor™
Submitter's Name, Address, Telephone Number, and Contact Person
Bionx Implants, Inc. 1777 Sentry Parkway West Gwynedd Hall, Suite 400 Blue Bell, PA 19422
Gerard S. Carlozzi Contacts: President and Chief Executive Officer Phone: (215) 643-5000 (215) 653-0984 Facsimile:
Bionx Implants Ltd. Tuija Annala Director, Quality and Regulatory Affairs P.O.Box 3 FIN-33721 Tampere Finland Phone: 358-3-316 5679 Facsimile: 358-3-316 5629
Date prepared: December 18, 2001
Name of the device:
| A. | Trade or Proprietary Name: | Duet™ Suture Anchor |
|---|---|---|
| B. | Common Name: | Bioabsorbable suture anchor |
| C. | Classification Name: | Biodegradable soft tissue fixation |
| fastener (87MAI) | ||
| D. | Device Product Code: | MAI |
| E. | Regulatory Classification: | Class II |
Predicate Device:
The Duet™ Suture Anchor is intended for use in the reattachment of soft tissue to bone by arthroscopy or direct visualization. This indication is substantial equivalent with Bionx Implants Inc. SmartAnchor (K972783), Bankart Tack (K973849),
1
Contour Labral Nail (K992567, K003970), BioCuff™ (K001378) and BioCuff™ C (K013057), Arthrex Inc. Bio-Absorbable Corkscrew (K990361) Bio-Absorbable Corkscrew Suture Anchor (K990987), Bio-Absorbable CorkScrew Suture Anchor (K003227) and TissueTak (K990340), Innovasive Devices, Inc. BioROC EZ (K973381), RC Multi-Suture Anchor (K992458) and Sutureless Anchor (K984490), Instrument Makar, Inc,Biologically Quiet Biosphere (K963396) and Biologically Ouiet Mini-Screw Suture Anchor (K960555), Linvatec Corporation Bio-Anchor (K964805, K963369, K983186) and BioRC Anchor (K990110), Mitek Surgical Products Panalok (K950272), Panalok RC (K970896) and Absorbable Toggle Anchor (K964013), Acufex Inc. Suretac 6.0, 8,0 (K911837) and DePuy Inc. De Puy Dupont Phantom Suture Anchor (K964921).
Intended Use:
The Bionx Duet™ Suture Anchor is a bioabsorbale screw-in suture anchor that is preloaded on a disposable inserter device with two non-absorbable, braided, polyester #2 sutures. The Duet™ Suture Anchor is manufactured from Self-Reinforced (96/4D) PLA Copolymer that retains 90% strength through 20 weeks and completely resorbs over a period of several years in vivo. The unique Self-Reinforced Copolymer provides high initial mechanical strength required for insertion and through the healing phase (20 weeks) with complete absorption occurring over several years. The unique absorption profile of the Copolymer allows the anchor to gradually loose strength as the collagen fibers of the repair form and gain strength. The Copolymer is inert, non-collagenous and non-pyrogenic through the absorption process. The Duet™ Suture Anchor is indicated for use in arthroscopic or open surgical procedures to reattach soft tissue to the bone.
The Duet™ Suture Anchor is contraindicated in the following conditions:
- Surgical procedures other than those listed. 1.
- Conditions that may compromise Anchor fixation (osteopenic, comminuted 2. bone, pathologic conditions in the soft tissues to be attached, etc.)
- Conditions that may retard healing (poor blood supply, past or potential 3. infection, etc).
- Active infection. 4.
- Conditions that may limit the patients ability or willingness to restrict റ് activities or follow directions during the healing period.
- Foreign body sensitivity to materials. 6.
-
- Patients with suspected or known allergy to the implant or suture materials.
Device Description:
Duet™ Suture Anchor is threaded, bioabsorbable suture anchor, provided as preloaded with two non-absorbable, braided, polyester #2 sutures, one of them is green and another one is white. Diameter of the anchor is 6.0mm and length 16.5mm. It is assembled with sutures with needles into single use, sterile, disposable driver and packaged into blister with a punch. The Duet™ Suture Anchor is made of poly-L/D-
2
page 3 of 3
lactide copolymer. The poly-L/D-lactide material equals the raw material used in previously cleared Bionx Implants Inc. SmartNail™ (K993074), Meniscus Arrow™ (K993453), SmartScrew ACL™ (K993073), SmartScrew (K012001), The Wedge™ (K000616), Contour Labral Nail (K003970), BioCuff (K001378) and BioCuff C (K013057).
Substantial Equivalence:
All of these devices have the same intended use and principles of operation and very similar technological characteristics. Furthermore, the minor technological differences between the Bionx Implants Inc. Duet™ Suture Anchor and the predicate devices do not raise any new issues of safety or effectiveness.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three human profiles incorporated into its design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 6 2002
Ms. Tuija Annala Director Quality and Regulatory Affairs Bionx Implants Ltd. P.O. Box 3. FIN-33721 Tampere, Finland
Re: K020056
Trade/Device Name: Duet™ Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: April 5, 2002 Received: April 8, 2002
Dear Ms. Annala:
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
4
Page 2 - Ms. Tuija Annala
(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.
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
Mark N-Mullene
for Celia M. Witten, Ph.D., M.D.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE
510(K) Number (if known):
Device Name:
Duet™ Suture Anchor
Indications for Use:
The Bionx Duet™ Suture Anchor is intended for use to reattach soft tissue to bone in orthopaedic surgical procedures. The device may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules, to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.
The Bionx Duet™ Suture Anchor is contraindicated in 1) Surgical procedures other than those listed, 2) Conditions that may compromise Anchor fixation (osteopenic, comminuted bone, pathologic conditions in the soft tissues to be attached, etc., 3)Conditions that may retard healing (poor blood supply, past or potential infection, etc), 4) Active infection, 5) Conditions that may limit the patients ability or willingness to restrict activities or follow directions during the healing period, 6)Foreign body sensitivity to materials, 7) Patients with suspected or known allergy with implant or suture materials.
(Please do not write below this line - continue on another page is needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
No OR Over-The-Counter Use
Mark A. Millman
vision Sign-Division of Genat 91. Restorative and Neurological Devices
510(k) Number.