(262 days)
Bladder Neck Suspension
The Linvatec Preloaded Soft Tissue Anchor is indicated for bladder neck suspension for femine urinary incontinence due to urethral hypermobility.
The Preloaded Soft Tissue Anchor has an attached non-absorbable braided polyester suture through the eyelet. The suture is attached to a threading wire by a shrink tubing sleeve. Once the anchor is securely seated in the driver, the suture is cut on the device side of the shrink tubing and implantation can proceed.
The material used for this device is:
Anchor: Titanium Alloy
Suture: Non-absorbable braided polyester
Sleeve: Shrink tubing
Threading Wire: 316 Stainless Steel
The provided document does not contain a study that proves the device meets specific acceptance criteria in the manner requested. Instead, it is a 510(k) summary for a medical device (Linvatec Preloaded Soft Tissue Anchor) seeking clearance based on substantial equivalence to predicate devices.
Therefore, many of the requested sections regarding a specific study's methodology, results against acceptance criteria, sample sizes, expert involvement, and ground truth establishment cannot be extracted from this document.
However, I can provide information based on the overall purpose of a 510(k) submission, which is to demonstrate substantial equivalence to legally marketed predicate devices, implying that the new device is as safe and effective.
Here's what can be inferred or directly stated from the document:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not specify formal "acceptance criteria" in terms of performance metrics (e.g., tensile strength, pull-out force) with specific numerical targets and the device's performance against them. Instead, the "acceptance criteria" for a 510(k) submission are implicitly met if the device demonstrates substantial equivalence to predicate devices.
The document indicates:
- Acceptance Criteria (Implied for 510(k)): Substantial equivalence in intended use, material, and function to legally marketed predicate devices.
- Reported Device Performance: The document states, "Testing supports the equivalency to the predicate devices." (Page 2) and "The Preloaded Soft Tissue Anchor is substantially equivalent in function and intended use to the Mitek GII Anchor and the Zimmer Statak device." (Page 2).
| Criterion (Implied) | Performance Demonstrated (Abridged from document) |
|---|---|
| Intended Use Equivalence | "Soft tissue to bone fixation" and "Bladder neck suspension for female urinary incontinence due to urethral hypermobility." (Matches predicates) |
| Material Equivalence | Anchor: Titanium Alloy 6Al-4V-ELI; Suture: Non-absorbable Braided Polyester (Similar/Equivalent to predicates which use Titanium Alloy and Braided Suture) |
| Function Equivalence | Functions as a "soft tissue to bone fixation device." (Implied by substantial equivalence claim; supported by "Testing supports the equivalency.") |
| Safety and Effectiveness (Implied by equivalence) | Demonstrated through comparison to legally marketed predicate devices, with dissimilarities not raising new questions of safety or effectiveness. |
2. Sample size used for the test set and the data provenance
The document does not describe a clinical "test set" with a specific sample size. The evaluation for substantial equivalence would typically involve engineering testing (e.g., mechanical strength tests) comparing the new device to predicate devices, rather than a clinical trial with human subjects for efficacy for 510(k). No information about data provenance (country of origin, retrospective/prospective) is provided, as it's not a clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. No clinical "test set" requiring ground truth established by experts is mentioned or described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable. No clinical "test set" or adjudication method is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable. The device is a soft tissue anchor, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study, human readers, or AI assistance is relevant here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. The device is a mechanical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Ground truth in the clinical sense (e.g., for diagnostic accuracy) is not described. The basis for safety and effectiveness is substantial equivalence to predicates, which relies on a comparison of design, materials, intended use, and potentially performance data (e.g., mechanical testing) that demonstrates comparable characteristics without raising new safety or effectiveness concerns.
8. The sample size for the training set
This information is not applicable. The device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable. The device is not an AI/ML algorithm.
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Image /page/0/Picture/0 description: The image shows the logo for Linvatec, along with the number K963932 written above it in cursive. The Linvatec logo consists of a stylized geometric shape to the left of the company name. The geometric shape is made up of three black squares, each with a white chevron inside. The company name "Linvatec" is written in bold, black letters to the right of the geometric shape.
JUN 20 1997
11311 Concept Boulevard Largo, Florida 33773 813 399-5334 Fax 813 399-5264
Carol A. Weideman, Ph.D.
Manager, Regulatory and Chineal Alfans
March 21, 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 Preloaded Soft Tissue Anchor, 510(k) Number # K963932.
A. Submitter
Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908
Company Contact B.
Carol A. Weideman, Ph.D. Manager, Regulatory and Clinical Affairs
C. Device Name
Revo®/Mini-Revo® Trade Name: Bone Screw Common Name: Soft tissue to bone fixation device Classification Name:
D. Predicate/Legally Marketed Devices
Mitek Gil Anchor Zimmer Statak Device
Image /page/0/Picture/17 description: The image shows a geometric design to the left of the text "A Bris". The geometric design is a hexagon made up of smaller triangles. Each of the smaller triangles has an arrow pointing towards the center of the hexagon.
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Summary of Safety and Effectiveness Preloaded Soft Tissue Anchor 510(k) # K963932 Page 2 of 3
E. Device Description
The Preloaded Soft Tissue Anchor has an attached non-absorbable braided polyester suture through the eyelet. The suture is attached to a threading wire by a shrink tubing sleeve. Once the anchor is securely seated in the driver, the suture is cut on the device side of the shrink tubing and implantation can proceed.
The material used for this device is:
Anchor: Titanium Alloy Suture: Non-absorbable braided polyester Sleeve: Shrink tubing Threading Wire: 316 Stainless Steel
F. Intended Use
The Preloaded Soft Tissue Anchor is a device used to attach soft tissue to bone fixation except anterior or posterior cruciate ligament repair or reconstruction. This device is indicated for bladder neck suspension for female urinary incontinence due to urethral hypermobility.
The Preloaded Soft Tissue Anchor is available in sizes ranging from 2.5mm to 5.2mm diameter.
G. Substantial Equivalence
The Preloaded Soft Tissue Anchor is substantially equivalent in function and intended use to the Mitek GII Anchor and the Zimmer Statak device. The anchors are all made of metal/metal alloy materials. Testing supports the equivalency to the predicate devices. The similarities/dissimilarities to the predicates are shown in the attached table.
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Summary of Safety and Effectiveness Preloaded Soft Tissue Anchor 510(k) # K963932 Page 3 of 3
SUBSTANTIAL EQUIVALENCE INFORMATION:
(
..............................................................................................................................................................................
The similarities/dissimilarities to the predicate device/material are shown in the following table.
CHART OF SIMILARITIES AND DISSIMILARITIES
| Company Name | Device Name | Intended Use | Material | Single-UseReusable | Sizes |
|---|---|---|---|---|---|
| New ProductLinvatec:Preloaded Soft TissueAnchors | Revo/Mini- Revo | Soft tissue to bonefixationBladder neck suspensionfor female urinaryincontinence due tourethral hypermobility. | Titanium Alloy6Al-4V-ELISuture: Non-absorbableBraided Polyester | Single-useGammaSterilizationShipped sterile | Suture Anchor with Preloaded SutureAnchors: 2.5mm - 5.2mmSuture: USP Sizes #0 to #2 |
| PredicateMitek:Mitek GII Anchor510(k) NumberK892126 | Mitek | Soft tissue to bonefixation - Bladder NeckSuspension | Titanium Alloy | Single-useSterilizationMethodUnknownShipped sterile | 2.4mm X 14mm |
| PredicateZimmer:Statak Device510(k) NumberK926384 | Statak/MiniStatak | Soft tissue to bonefixation - Bladder NeckSuspension | TitaniumTI-6Al-4V AlloySuture: Non-absorbableBraided Suture | Single-useGammaSterilizationShipped sterile | 2.5mm - 5.2mm diameterSuture USP Sizes #0 to #2 |
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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized human figure with outstretched arms, symbolizing care and protection. The figure is positioned within a circle, with the text "DEPARTMENT OF HEALTH & HUM SERVICES - USA" encircling the top and left portions of the circle. The overall design is simple and conveys a sense of government service and public health.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 20 1997
Carol A. Weideman, Ph.D. Manager, Requlatory and Clinical Affairs Linvatec Corporation …………… 11311 Concept Boulevard Largo, Florida 33773
K963932 Re: Trade Name: Revo® and Mini-Revo® Preloaded Soft Tissue Anchor Requlatory Class: II Product Code: MBI Dated: March 21, 1997 Received: March 24, 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, Drug, 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, good manufacturing practice, labeling, and prohibitions aqainst 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical
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Page 2 - Carol A. Weideman, Ph.D.
General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory 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 requlations.
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,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
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Image /page/5/Picture/0 description: The image shows the word "Linvatec" in bold, black font, with a geometric logo to the left. The logo consists of three nested, angled shapes that resemble chevrons or arrowheads, also in black. The overall impression is a clean and professional brand representation.
11311 Concept Boulevard Targo, H - 34643-813-392-6464
March 21, 1997
: 上一篇:
of the Freedom of information Act
utemation is exempt from , se pues cueer Exemplions 3 ano d
510(k) Number (if known): K963932_ --------
Device Name: PRELOADED SOFT TISSUE ANCHOR
Indications for Use:
Bladder Neck Suspension
The Linvatec Preloaded Soft Tissue Anchor is indicated for bladder neck suspension for femine 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)
Prescription Use_X (Per 21 CFR 801.109) Over-the-Counter Use_
Mihail Rauk
ivision of General Restorative Devices
OR
(Optional Format 1-2-96)
q:\510k.97[K963932](https://510k.innolitics.com/device/K963932).fda
Image /page/5/Picture/17 description: The image shows the logo for Bristol-Myers Squibb Company. The logo consists of a geometric design on the left and the text "A Bristol-Myers Squibb Company" on the right. The geometric design is a complex pattern of lines and shapes, while the text is in a simple, sans-serif font. The logo is likely used to represent the company's brand identity.
§ 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.