(22 days)
No
The 510(k) summary describes a bioabsorbable suture anchor and its preloaded suture material. There is no mention of AI or ML technology in the intended use, device description, or any other section. The purpose of the submission is an amendment for a new preloaded suture material.
Yes.
The device is described as "suture anchors" intended "to reattach soft tissue to bone in orthopaedic surgical procedures," specifically by "stabiliz[ing] the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period," which directly addresses a health condition.
No
The device description clearly states that these are "suture anchors intended for use to reattach soft tissue to bone in orthopaedic surgical procedures," functioning as an implant for stabilization during healing, not for diagnosing conditions.
No
The device description clearly states it is a bioabsorbable suture anchor preloaded on a disposable inserter device, which are physical components, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "reattach soft tissue to bone in orthopaedic surgical procedures." This is a surgical implant used directly on the patient's body.
- Device Description: The description details a "bioabsorbable suture anchor" and "non-absorbable sutures" used for surgical fixation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) during surgery.
N/A
Intended Use / Indications for Use
Duet™ and Impact™ Suture Anchors are 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 Duet™ and Impact™ Suture Anchors are 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.
Product codes (comma separated list FDA assigned to the subject device)
MAI, JDR
Device Description
Duet™ Suture Anchor and Impact™ Suture Anchors are bioabsorbale suture anchors that are preloaded on a disposable inserter device with two non-absorbable sutures. Originally they were preloaded with non-absorbable, braided, polyester #2 sutures, one of them is green and another one is white.
Purpose of this special 510(k) premarket notification is amendment of new preloaded suture material into Duet™ and Impact™ suture anchor product lines. The new suture, Herculine is non-absorbable, braided, ultra-high molecular weight polyethylene #2 suture. In coloured version 2 filaments are replaced by blue polypropylene monofilaments Herculine suture meets USP requirements for knot tensile strength and needle attachment strength.
The amendment of optional suture material has no effect on intended use, principles of operation, production methods, raw material or sterilization of Duet™ Suture Anchor (K020056) and Impact™ Suture Anchor (K030388).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone
Indicated Patient Age Range
Not Found
Intended User / Care Setting
orthopaedic surgical procedures
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.
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
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
K042966 orgeffl
NOV 1 9 2004
510(k) Summary Linvatec Biomaterials Modification of Duet™ and Impact™ Suture Anchor (K020056, K030388)
Submitter´s Name, Address, Telephone Number, and Contact Person
Linvatec Biomaterials Ltd. Tuija Annala Director, Quality and Regulatory Affairs P.O.Box 3 FIN-33721 Tampere Finland, Europe 358-3-316 5600 Phone: Facsimile: 358-3-316 5629
Date prepared: August 11th, 2004
Name of the device:
| A. | Trade or Proprietary Name: | Duet™ Suture Anchor and Impact™
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 Devices:
The predicate devices are the previously cleared Linvatec Biomaterials (the previous Bionx Implants) Duet™ Suture Anchor (K020056) and Impact™ Suture Anchor (K030388).
Duet™ Suture Anchor and Impact™ Suture Anchors are bioabsorbale suture anchors that are preloaded on a disposable inserter device with two non-absorbable sutures. Originally they were preloaded with non-absorbable, braided, polyester #2 sutures, one of them is green and another one is white
1
1
Purpose of this special 510(k) premarket notification is amendment of new preloaded suture material into Duet™ and Impact™ suture anchor product lines. The new suture, Herculine is non-absorbable, braided, ultra-high molecular weight polyethylene #2 suture. In coloured version 2 filaments are replaced by blue polypropylene monofilaments Herculine suture meets USP requirements for knot tensile strength and needle attachment strength.
The amendment of optional suture material has no effect on intended use, principles of operation, production methods, raw material or sterilization of Duet™ Suture Anchor (K020056) and Impact™ Suture Anchor (K030388).
Substantial Equivalence:
The new models have the following similarities to the cleared models of Duet™ Suture Anchor (K020056) and Impact™ Suture Anchor (K030388):
- has the same indicated use -
- uses the same operating principle ﺘﮯ
- incorporates the same basic designs of implants -
- ﺘﺮ is manufactured by machining
- is packaged and sterilized using the same materials and processes -
- has the same shelf life -
In summary, the amendment of new suture material described in this notification is, in our opinion, substantially equivalent to the predicate device.
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 9 2004
Ms. Tuija Annala Director, Quality and Regulatory Affairs Linvatec Biomaterials Ltd. P.O. Box 3 Hermiankatu 6-8 L FIN 33721 Tampere, Finland
Re: K042966
Trade/Device Name: Duet™ and Impact™ Suture Anchor Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: MAI, JDR Dated: August 11, 2004 Received: October 28, 2004
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 (21
3
Page 2 - Ms. Tuija Annala
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), 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) you may obtain. 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 vours.
L. Mark A. Milken
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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P. ! yl
INDICATIONS FOR USE
510(K) Number (if known): __
Device Name:
Duet™ and Impact™ Suture Anchor
Indications for Use:
Duet™ and Impact™ Suture Anchors are 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 Duet™ and Impact™ Suture Anchors are 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 Yes OR Over-The-Counter Use No
(Per 21 CFR 801.109)
Mark A Millerman
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number*K042966*