(88 days)
To provide interference fixation of soft tissue graft and bone-tendon-bone patellar graft during cruciate ligament repair through arthroscopy or arthrotomy.
The titanium cannulated interference screw is tapered and has a smooth threaded design, which provides interference fixation of soft tissue grafts and bone-tendon-bone patellar grafts during cruciate ligament repair through arthroscopy or arthrotomy. The screw comes in lengths between 20 and 50 mm and diameters between 7mm and 12mm, resulting in a screw adapted to the morphology of the graft and patient.
The provided text is a 510(k) summary for a medical device called the "Titanium cannulated interference screw." This document primarily focuses on demonstrating substantial equivalence to a predicate device and outlines the intended use and design, rather than detailing a study with acceptance criteria and performance metrics typically found in AI/software device submissions.
Therefore, many of the requested categories for a study proving device performance (acceptance criteria, sample sizes, expert involvement, ground truth, MRMC study, standalone performance) cannot be answered directly from this 510(k) summary. These types of studies are not typically required for a mechanical device like an interference screw seeking substantial equivalence.
Here's what can be extracted based on the provided text, and where information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable. The 510(k) summary for this mechanical device does not present specific acceptance criteria or quantitative performance metrics in the way a software or AI device submission would. The acceptance is based on demonstrating substantial equivalence to a legally marketed predicate device.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. There is no mention of a "test set" in the context of evaluating performance against specific criteria, as this is a mechanical interference screw, not a diagnostic or AI device. The comparison is primarily dimensional and functional equivalence to a predicate.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. There is no mention of experts establishing a "ground truth" for a test set.
4. Adjudication Method for the Test Set
Not applicable. No test set or adjudication method is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
Not applicable. An MRMC study is relevant to diagnostic interpretation by human readers, often with AI assistance. This device is a surgical implant, not an imaging or diagnostic tool.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This is a mechanical device, not an algorithm.
7. The Type of Ground Truth Used
Not applicable. "Ground truth" as understood in AI/diagnostic studies is not relevant here. The "truth" in this context is the established safety and efficacy of the predicate device for its intended use.
8. The Sample Size for the Training Set
Not applicable. No "training set" exists for a mechanical device like this in the context of a 510(k) submission focused on substantial equivalence.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
Summary of Device and its Equivalence (from the 510(k) summary):
- Device Name: Titanium cannulated interference screw
- Intended Use: To provide interference fixation of soft tissue grafts and bone-tendon-bone patellar grafts during cruciate ligament repair through arthroscopy or arthrotomy.
- Predicate Device: K010595: Alaron Technologies, LLC.
- Basis for Substantial Equivalence: The submission states, "The titanium cannulated interference screw and the predicate device have the same overall design. In addition, the small differences in design do not affect the use, safety and effectiveness, between the device and the predicate device."
- Design Details: Tapered, smooth threaded design, comes in lengths between 20-50mm and diameters between 7-12mm.
This 510(k) relies on demonstrating that the new device is sufficiently similar to a previously cleared device that no new questions of safety or effectiveness are raised, rather than providing new performance data from a clinical or analytical study with defined acceptance criteria.
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510(k) SUMMARY FOR THE TITANIUM CANNULATED INTERFERENCE SCREW
JUN 2 5 2002
510k #: K02/030
Company: Future Medical Systems. Inc. Address: 504 McCormick Drive. Glen Burnie, MD 21061 Phone: 410 761 9411 ext. 11 410 760 9422 Fax:
Mr Patrick Janin Contact:
Date of submission: 3/28/2002
Name of device:
Titanium cannulated interference screw
Common or usual name:
Titanium interference screw
Classification:
Smooth or threaded bone fixation fastener: 888.3040
Predicate device:
K010595: Alaron Technologies, LLC.
Device intended use, description and substantial equivalence:
The titanium cannulated interference screw is tapered and has a smooth threaded design. which provides interference fixation of soft tissue grafts and bone-tendon-bone patellar grafts during cruciate ligament repair through arthroscopy or arthrotomy.
The screw comes in lengths between 20 and 50 mm and diameters between 7mm and 12mm. resulting in a screw adapted to the morphology of the graft and patient.
The titanium cannulated interference screw and the predicate device have the same overall design. In addition, the small differences in design do not affect the use, safety and effectiveness, between the device and the predicate device.
Based on these similarities and equivalences we believe our titanium cannulated interference screw and the Alaron interference screw K010595 are substantially equivalent for the interference fixation of soft tissue and Bone Tendon Bone graft in cruciate ligament reconstruction through arthroscopy or arthrotomy.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 5 2002
Mr. Patrick Janin Manager Future Medical Systems, Inc. 504 McCormick Drive Glen Burnie, MD 21061
Re: K021030
Trade/Device Name: Titanium cannulated interference screw Regulation Number: 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: March 28, 2002 Received: March 29, 2002
Dear Mr. Janin:
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 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.
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Page 2 - Mr. Patrick Janin
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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 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" (21CFR Part 807.97). 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,
Sincerely yours,
for Mark A. Melkerson
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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510 K Number: K021030
Page 1 of 1
Device name: Titanium cannulated interference screw
INDICATIONS FOR USE:
To provide interference fixation of soft tissue graft and bone-tendon-bone patellar graft during cruciate ligament repair through arthroscopy or arthrotomy.
for Mark N. Mulkerson
(Division Sign-Off) Division of General, Restorative and Netwological Devices
510(k) Number K021030
(Please do not write below this Line-Continue on another page if needed.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter-Use (Optional Format 1)
§ 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.