(84 days)
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No
The device description and performance studies focus on the mechanical properties and surgical application of a physical implant (suture anchor) and do not mention any computational or data-driven components.
Yes
The device is described as an implantable anchor used for "soft tissue to bone suture fixation" for various repairs and reconstructions of anatomical structures, which are therapeutic interventions.
No
Explanation: The provided text describes a medical device, the RSTA device, as an implantable anchor used for soft tissue to bone suture fixation in various parts of the body. Its intended use is for surgical repair and reconstruction, not for diagnosis. The "Intended Use / Indications for Use" section lists surgical procedures, which are treatments, not diagnostic processes.
No
The device description clearly outlines a physical implantable device made of poly (L-lactic) acid, including its dimensions, materials, and associated hardware (suture, needles, driver). This is not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. They are used outside of the body.
- Device Description: The description clearly states that this device is an "anchor" intended for "soft tissue to bone suture fixation." It is a physical implant used within the body during surgery.
- Intended Use: The intended uses listed are all surgical procedures involving the repair and reconstruction of soft tissues and ligaments within the body.
- Lack of Diagnostic Information: The text does not mention any analysis of biological samples or the provision of diagnostic information about a patient's condition.
Therefore, this device falls under the category of a surgical implant or medical device used for treatment, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The devices are intended for soft tissue to bone suture fixation for the following indications:
Shoulder
- Bankart lesion repairs -
- SLAP lesion repairs -
- Acromio-clavicular separations repairs -
- Rotator cuff tear repairs ー
- Capsular shift or capsulolabral reconstructions -
- Biceps tenodesis -
- Deltoid repairs -
Foot and Ankle
- Medial or lateral instability repairs/reconstructions ー
- Achilles tendon repairs/reconstructions -
- Midfoot reconstructions -
- Hallux valgus reconstructions -
Elbow. Wrist, and Hand
- Scapholunate ligament reconstructions -
- Ulnar or radial collateral ligament reconstructions -
- Tennis elbow repair .
- Biceps tendon reattachment -
Knee
-
Extra-capsular repairs
- medial collateral ligament --
- -lateral collateral ligament
- -posterior oblique ligament
-
Iliotibial band tenodesis
-
-Patellar tendon repairs
Product codes
Not Found
Device Description
The RSTA device is manufactured using poly (L-lactic) acid in a proprietary process. The anchor is a fully threaded device 12 mm in length and 5.0 mm in diameter. The anchor contains an eyelet to which a USP Size No. 2 braided polyester nonabsorbable suture and two suture needles are attached. A hex drive at the proximal end of the anchor attaches to a disposable torque limiting driver used for insertion of the anchor. The anchor requires predrilling and tapping procedures prior to implantation. Following implantation of the anchor, the free ends of the suture are used to reattach the soft tissue to the bony site.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Shoulder, Foot and Ankle, Elbow, Wrist, Hand, Knee
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The RSTA device was tested for pullout strength in dry white pine wood and in varying types of porcine bone. The RSTA device demonstrated strength far above that of the No. 2 suture used clinically with the device, thereby ensuring that the suture will fail prior to any portion of the anchor. Pullout testing in white pine wood and porcine bone also demonstrated superior pullout strength when compared to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Resorbable Soft Tissue Attachment Device manufactured by Zimmer, QuickAnchor™ manufactured by Mitek, Bio-Anchor™ Absorbable Suture Anchor manufactured by Linvatec, Statak® Soft Tissue Attachment Device manufactured by Zimmer
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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
Image /page/0/Picture/1 description: The image shows the logo for Zimmer. The logo consists of a large, bold letter 'Z' inside of a circle. Below the circle, the word 'zimmer' is written in lowercase letters. The logo is black and white.
AUG - 1 1996
P.O. Box 708 Warsaw, IN 46581-0708 219 267-6131
Summary of Safety and Effectiveness
Resorbable Soft Tissue Attachment Device, 5.0 mm Diameter
Submitted by .
Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581-0708
-
Prepared by .
Lynnette Whitaker Manager Regulatory Affairs -
. Date
May 8, 1996 -
. Trade Name
Resorbable Soft Tissue Attachment Device -
Common Name .
Resorbable Soft Tissue Anchor -
. Classification Name
None Assigned
Predicate Devices .
- Resorbable Soft Tissue Attachment Device manufactured by Zimmer -
- QuickAnchor™ manufactured by Mitek -
Image /page/0/Picture/22 description: The image contains a number. The number is 50. The number is written in a bold, sans-serif font. The number is black and is set against a white background.
1
- Bio-Anchor™ Absorbable Suture Anchor manufactured by Linvatec
- Statak® Soft Tissue Attachment Device manufactured by Zimmer .
Device Description
The RSTA device is manufactured using poly (L-lactic) acid in a proprietary process. The anchor is a fully threaded device 12 mm in length and 5.0 mm in diameter. The anchor contains an eyelet to which a USP Size No. 2 braided polyester nonabsorbable suture and two suture needles are attached. A hex drive at the proximal end of the anchor attaches to a disposable torque limiting driver used for insertion of the anchor. The anchor requires predrilling and tapping procedures prior to implantation. Following implantation of the anchor, the free ends of the suture are used to reattach the soft tissue to the bony site.
Intended Use
The devices are intended for soft tissue to bone suture fixation for the following indications:
Shoulder
- Bankart lesion repairs -
- SLAP lesion repairs -
- Acromio-clavicular separations repairs -
- Rotator cuff tear repairs ー
- Capsular shift or capsulolabral reconstructions -
- Biceps tenodesis -
- Deltoid repairs -
Foot and Ankle
- Medial or lateral instability repairs/reconstructions ー
- Achilles tendon repairs/reconstructions -
- Midfoot reconstructions -
- Hallux valgus reconstructions -
Elbow. Wrist, and Hand
- Scapholunate ligament reconstructions -
- Ulnar or radial collateral ligament reconstructions -
- Tennis elbow repair .
- Biceps tendon reattachment -
2
Knee
-
Extra-capsular repairs
- medial collateral ligament --
- -lateral collateral ligament
- -posterior oblique ligament
-
Iliotibial band tenodesis
-
-Patellar tendon repairs
Performance Data
The RSTA device was tested for pullout strength in dry white pine wood and in varying types of porcine bone. The RSTA device demonstrated strength far above that of the No. 2 suture used clinically with the device, thereby ensuring that the suture will fail prior to any portion of the anchor. Pullout testing in white pine wood and porcine bone also demonstrated superior pullout strength when compared to the predicate devices.
RA05601K.510