(44 days)
The MegaFix-T™ Titanium Interference Screw is intended for tibial and femoral fixation (primary anchorage) of tendon grafts in anterior and posterior cruciate ligament reconstruction.
The MegaFix-T™ is composed of titanium, which is commonly used in medical devices for a wide range of application and has a long history of biocompatibility for human use.
The provided documents are a 510(k) summary and FDA clearance letter for a medical device called the "Karl Storz MegaFix-T™ Titanium Interference Screw." This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing the detailed performance studies typically associated with AI/software devices.
Therefore, the information requested in your prompt (acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance) is not part of this 510(k) submission.
This document describes a traditional medical device (an interference screw for ACL reconstruction), not an AI/software device. As such, the specific metrics and study designs relevant to AI/software device validation (e.g., AUC, sensitivity, specificity, MRMC studies, ground truth establishment by experts for imaging data) are not applicable and are not found within this 510(k) submission.
The submission focuses on:
- Device Identification: Karl Storz MegaFix-T™ Titanium Interference Screw
- Intended Use: Tibial and femoral fixation of tendon grafts in anterior and posterior cruciate ligament reconstruction.
- Device Description: Composed of titanium, used in medical devices for biocompatibility.
- Substantial Equivalence: Demonstrated to predicate devices due to similar basic features and intended use. Minor differences raise no new issues of safety and effectiveness.
There are no details on acceptance criteria and a study that proves the device meets the acceptance criteria in the context of an AI/software device. The safety and effectiveness for this device are based on its material (titanium) and its substantial equivalence to previously cleared devices.
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Image /page/0/Picture/0 description: The image shows a logo for "STORZ". The logo is in white against a black background. The letter "O" in the logo is replaced by a black circle with a smaller white circle inside. Below the main logo, there is smaller text that reads "Karl Storz Endoscopy".
Karl Storz Endoscopy-America, Inc. 600 Corporate Pointe 5th Floor Culver City, California 90230-7600 Phone 310 338 8100
Toll Free 800 421 0837 Fax 310 410 5527
K030368
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document is accurate and complete to the best of KSEA's knowledge.
| Applicant: | Karl Storz Endoscopy - America, Inc.600 Corporate Pointe DriveCulver City, CA 90230(310) 338-8100 | MAR 20 2003 |
|---|---|---|
| Contact: | Mario T. MarceloRegulatory Affairs Associate | |
| Device Identification: | Common Name:Cannulated Titanium Interference Screw | |
| Trade Name: (optional)Karl Storz MegaFix TTM Titanium Interference Screw |
Indication: The MegaFix-T™ Titanium Interference Screw is intended for tibial and femoral fixation (primary anchorage) of tendon grafts in anterior and posterior cruciate ligament reconstruction.
Device Description: The MegaFix-T™ is composed of titanium, which is commonly used in medical devices for a wide range of application and has a long history of biocompatibility for human use.
Substantial Equivalence: The MegaFix-T™ is substantially equivalent to the predicate devices since the basic features and intended use are similar. The minor differences between the MegaFix-TTM and the predicate devices raise no new issues of safety and effectiveness, as these minor differences have no effect on the performance, function or intended use of the device.
Signed:
Mario T. Marcelo Regulatory Affairs Associate
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 0 2003
Mr. Mario T. Marcelo Regulatory Affairs Associate Karl Storz Endoscopy America, Inc 600 Corporate Pointe 5th Floor Culver City, CA 90230-7600
Re: K030368
Trade/Device Name: Karl Storz MegaFix-T™ Titanium Interference Screw Regulation Number: 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: January 31, 2003 Received: February 4, 2003
Dear Mr. Marcelo:
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. Mario T. Marcelo
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 you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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 yours,
Sincerely, yours,
Mark N. Mulhern
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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K030368
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510(k) Number (if known): Not yet assigned
Device Name: Karl Storz MegaFix-T™ Titanium Interference Screw
Indications for Use: The MegaFix-T™ Titanium Interference Screw is intended for tibial and femoral fixation (primary anchorage) of tendon grafts in anterior and posterior cruciate ligament reconstruction.
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Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use: OR Over-The Counter Use: (Per 21 CFR 801.109) (Optional Format 1-2-96) 003 10(k) Number
N/A