(268 days)
Bladder Neck Suspension
The Linvatec Bio-Anchor is indicated for bladder neck suspension for female urinary incontinence due to urethral hypermobility.
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.
The provided text is a 510(k) Summary of Safety and Effectiveness for a medical device (Bio-Anchor Absorbable Suture Anchor) submitted to the FDA in 1997. This type of document is a premarket notification for demonstrating substantial equivalence to a legally marketed predicate device, not a study designed to prove the device meets specific acceptance criteria based on performance data.
Therefore, the document does not contain the acceptance criteria, reported device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC study results, standalone algorithm performance, or details on how ground truth was established for training and test sets as typically found in a clinical study report.
Here's why this information is missing and an explanation based on the document type:
This 510(k) submission focuses on demonstrating substantial equivalence to existing, legally marketed devices. It does this by:
- Describing the device: Its material (PLLA), shape, and mechanism of action.
- Stating its intended use: Bladder neck suspension for female urinary incontinence due to urethral hypermobility.
- Identifying predicate devices: Linvatec Revo/Mini Revo, Mitek GII Anchor and Absorbable Anchor, Zimmer Statak Device, Zimmer Resorbable Soft Tissue Attachment Device, and Vesica Medical, Inc. Bone Anchor System.
- Comparing the new device to predicates: A table highlights similarities and dissimilarities in materials, intended use, sterilization, and sizes. The key similarity emphasized is the material (PLLA) with the Zimmer Resorbable device and the intended use with several predicates.
The FDA's review and approval (as indicated by the letter in Section 4 and 5) signify that they found the device substantially equivalent to predicates and thus determined it to be safe and effective for its stated intended use, based on the information provided and comparisons to established devices. It does not imply that a new clinical study with specific acceptance criteria was performed or reported in this document.
If such a study were conducted, its results would typically be included as part of the submission, detailing methods, endpoints, statistical analyses, and performance metrics. However, for a 510(k) requiring substantial equivalence, extensive comparative performance data against specific acceptance criteria is often not required if equivalence can be demonstrated through other means (e.g., material, design, and intended use similarity to predicate devices).
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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.
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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.
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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
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| Company Name | Device Name | Intended Use | Material | Single-Use Reusable | Sizes |
|---|---|---|---|---|---|
| ProductsMitek:Mitek AbsorbableAnchor510(k) NumberK944051 | Mitek | Soft tissue to bonefixation - Bladder NeckSuspension | Poly (L-lactic) acid andNitinol | Single-useSterilizationMethodUnknownShipped sterile | Not provided |
| PredicateZimmer:Statak Device510(k) NumberK926384 | Statak | Soft tissue to bonefixation - Bladder NeckSuspension | TitaniumTI-6Al-4V Alloy# 2 Braided Suture | Single-useGammaSterilizationShipped sterile | 2.5mm - 5.2mm diameter |
| PredicateZimmer Resorbable SoftTissue AttachmentDevice510(k) NumberK950275 | ResorbableSoft TissueAttachmentDevice | Soft tissue to bonefixation | Poly (L-Lactic) Acid# 2 Braided Suture | Single-useGammaSterilizationShipped sterile | 5.0mm - 5.2mm diameter |
| PredicateVesica Medical, Inc.:Bone Anchor System510(k) NumberK932925 | Bone AnchorSystem | Soft tissue to boneattachment for urologicalapplication - bladder necksuspension | Titanium alloy#1, #2 Suture Size | Single-useEtO SterilizationShipped sterile | 3.75mm diameter |
q:\510k97\x963369.fda
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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.
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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
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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
§ 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.