(268 days)
Not Found
No
The device description and intended use are purely mechanical and do not mention any computational or analytical capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is a PLLA suture anchoring device used for bladder neck suspension, which is a structural support device rather than one that delivers therapy or has a direct therapeutic effect.
No
Explanation: The device is an implantable suture anchoring device used for bladder neck suspension to treat female urinary incontinence. It is a therapeutic device, not a diagnostic one, as it does not gather or interpret data to identify a condition.
No
The device description clearly describes a physical, implantable medical device made of PLLA, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Linvatec Bio-Anchor is a surgical implant used to physically support the bladder neck. It is a mechanical device used in vivo (within the body) during a surgical procedure.
- Intended Use: The intended use is for "bladder neck suspension for female urinary incontinence due to urethral hypermobility," which is a surgical intervention, not a diagnostic test.
- Device Description: The description details a physical anchor made of PLLA and suture, designed for implantation.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
The Bio-Anchor is a surgical device, specifically an implantable anchor, used to treat a medical condition through a physical intervention.
N/A
Intended Use / Indications for Use
The Linvatec Bio-Anchor is indicated for bladder neck suspension for female urinary incontinence due to urethral hypermobility.
Product codes (comma separated list FDA assigned to the subject device)
MAI
Device Description
The Bio-Anchor is a PLLA suture anchoring device. The device is cylindrical in shape with three circular ribs perpendicular to the long axis. The first and second ribs are the same size, with the proximal, third rib wider to allow for a centrally located eyelet running perpendicular to the long axis of the device. Freely passing suture is then threaded onto the Bio-Anchor by the surgeon. The lack of permanent attachment of the suture to the Bio-Anchor allows the use of sliding knots. Once the Bio-Anchor is implanted, the ends of the suture are passed through the soft tissue and tied for reattachment. Synthetic non-absorbable, polyester USP #0, #1, or #2 suture is recommended for use with this device.
The material used for this device is:
Anchor - Poly (L-lactic) acid (PLLA)
The Bio-Anchor Absorbable Suture Anchor is available in sizes ranging from 2.5mm to 5.2mm diameter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bladder neck
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.
K953954, K892126, K944051, K926384, K950275, K932925
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
K963360 1884
MAY 2 2 1997
March 10, 1997
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, Linvatec Corporation is hereby submitting the 510(k) Summary of Safety and Effectiveness for the Bio-Anchor, 510(k) Number K963369.
A. Submitter
Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908
B. Company Contact
Carol A. Weideman, Ph.D. Manager, Regulatory and Clinical Affairs
C. Device Name
Trade Name: Bio-Anchor Common Name: Suture Anchor Soft tissue to bone fixation device Classification Name:
Predicate/Legally Marketed Devices D.
Linvatec Revo/Mini Revo Mitek GII Anchor and Absorbable Anchor Zimmer Statak Device Zimmer Resorbable Soft Tissue Attachment Device Vesica Medical, Inc.
1
Summary of Safety and Effectiveness Bio-Anchor" Absorbable Suture Anchor 510(k) # K963369 Page 2
E. Device Description
The Bio-Anchor is a PLLA suture anchoring device. The device is cylindrical in shape with three circular ribs perpendicular to the long axis. The first and second ribs are the same size, with the proximal, third rib wider to allow for a centrally located eyelet running perpendicular to the long axis of the device. Freely passing suture is then threaded onto the Bio-Anchor by the surgeon. The lack of permanent attachment of the suture to the Bio-Anchor allows the use of sliding knots. Once the Bio-Anchor is implanted, the ends of the suture are passed through the soft tissue and tied for reattachment. Synthetic non-absorbable, polyester USP #0, #1, or #2 suture is recommended for use with this device.
The material used for this device is:
Anchor - Poly (L-lactic) acid (PLLA)
ii Intended Use
The Linvatec Bio-Anchor is indicated for bladder neck suspension for female urinary incontinence due to urethral hypermobility.
- The Bio-Anchor Absorbable Suture Anchor is available in sizes ranging from 2.5mm to 5.2mm diameter.
G. Substantial Equivalence
The Bio-Anchor™ Absorbable Suture Anchor is substantially equivalent in function and intended use to the Mitek Surgical Products GII Anchor, Zimmer's Statak and Resorbable Soft Tissue Attachment Device, Vesica Medical's Bone Anchor System. The material is the same (PLLA) as Zimmer's Resorbable device.
The similarities/dissimilarities to the predicates are shown in the attached table.
2
Summary of Safety and Effectiveness Bio-Anchor" Absorbable Suture Anchor 510(k) # K963369 Page 3
Revo
Mitek
fixation
Soft tissue to bone
Suspension
ffixation - Bladder Neck
1
or Brocker
Linvatec:
tedlouts
Linvatec:
Anchors
redicate
Mitek:
510(k) Number
Mitek GII Anchor
1510(k) Number K892126
Preloaded Soft Tissue
Bio-Anchor
SUBSTANTIAL EQUIVALENCE INFORMATION:
Single-Use Sizes 000 ర్యాల Company Name Reusable Single-use 2.5mm - 5.2mm diameter Bio-Anchor Bladder neck suspension Poly (L-lactic) acid for female urinary ETO Sterilized Shipped sterile incontinence due to urethral hypermobility. Soft tissue to bone Single-use Suture Anchor with Preloaded Suture Revo/Mini Titanium Alloy
6AI-4V-ELI
CHART OF SIMILARITIES AND DISSIMILARITIES
Suture: Non-absorbable
Braided Polyester
.
Titanium Alloy
Gamma
Sterilization
Single-use
Method
Unknown
Shipped sterile
Sterilization
Shipped sterile
q:\510k97\1963369.fda
3 ું જ -
Anchors: 2.5mm - 5.2mm
2.4mm X 14mm
Suture: USP Sizes #0 to #2
3
| Company Name | Device Name | Intended Use | Material | Single-Use Reusable | Sizes |
|---|---|---|---|---|---|
| Products | |||||
| Mitek: | |||||
| Mitek Absorbable | |||||
| Anchor | |||||
| 510(k) Number | |||||
| K944051 | Mitek | Soft tissue to bone | |||
| fixation - Bladder Neck | |||||
| Suspension | Poly (L-lactic) acid and | ||||
| Nitinol | Single-use | ||||
| Sterilization | |||||
| Method | |||||
| Unknown | |||||
| Shipped sterile | Not provided | ||||
| Predicate | |||||
| Zimmer: | |||||
| Statak Device | |||||
| 510(k) Number | |||||
| K926384 | Statak | Soft tissue to bone | |||
| fixation - Bladder Neck | |||||
| Suspension | Titanium | ||||
| TI-6Al-4V Alloy |
2 Braided Suture | Single-use
Gamma
Sterilization
Shipped sterile | 2.5mm - 5.2mm diameter |
| Predicate
Zimmer Resorbable Soft
Tissue Attachment
Device
510(k) Number
K950275 | Resorbable
Soft Tissue
Attachment
Device | Soft tissue to bone
fixation | Poly (L-Lactic) Acid
2 Braided Suture | Single-use
Gamma
Sterilization
Shipped sterile | 5.0mm - 5.2mm diameter |
| Predicate
Vesica Medical, Inc.:
Bone Anchor System
510(k) Number
K932925 | Bone Anchor
System | Soft tissue to bone
attachment for urological
application - bladder neck
suspension | Titanium alloy
#1, #2 Suture Size | Single-use
EtO Sterilization
Shipped sterile | 3.75mm diameter |
q:\510k97\x963369.fda
ﻤﺴﺴﺴﺴﺴﺴ
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and head. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUM SERVICES USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 2 1997
Carol A. Weideman, Ph.D. Manaqer Regulatory_and Clinical Affairs Linvatec Corporation 11311 Concept Boulevard Largo, Florida 34643
Re : K963369 BioAnchor™ Absorbable Suture Anchor Trade Name: Requlatory Class: II Product Code: MAI Dated: March 10, 1997 Received: March 11, 1997
Dear Dr. Weideman:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
5
Page 2 - Carol A. Weideman, Ph.D.
This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celta M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
11311 Concept Boulevard Largo. Florida 33773-4908 813 392-6464
May 16, 1997
510(k) Number (if known): K963369
Device Name: BIO-ANCHOR™ ABSORBABLE SUTURE ANCHOR
Indications for Use:
Bladder Neck Suspension
The Linvatec Bio-Anchor is indicated for bladder neck suspension for female urinary incontinence due to urethral hypermobility.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
cosell
(Division Sign-Off) Division of General Restorative D 510(k) Number .
OR Prescription Use_ (Per 21 CFR 801.109)
Over-the-Counter Use
(Optional Format 1-2-96)
A Bristol-Myers Squibb Company
ﺍﻟﻤﺴﺎﻋﺪ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘ