(90 days)
Not Found
Not Found
No
The summary describes a mechanical fixation device made of titanium and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is described as a button fixation device for surgical correction and implant replacement, indicating it is an orthopedic implant rather than a device for treating or curing a disease or condition.
No
The device description states it is a "button fixation device" intended for "tibial fixation for surgical correction of cruciate ligament ruptures," indicating it is a therapeutic or surgical device, not one used for diagnosis.
No
The device description explicitly states the device is a "button fixation device" composed of "titanium," indicating it is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Endotack is for "tibial fixation for surgical correction of cruciate ligament ruptures as well as for cruciate ligament implant replacement." This describes a surgical implant used in vivo (within the body) to provide mechanical support.
- Device Description: The description confirms it's a "button fixation device" made of titanium, which is a material used for implants.
- Lack of IVD Characteristics: IVD devices are used in vitro (outside the body) to examine specimens (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such use or interaction with biological specimens for diagnostic purposes.
Therefore, the Endotack is a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The Endotack is intended for use to provide tibial fixation for surgical correction of cruciate ligament ruptures.
The Endotack is intended for use to provide tibial fixation for surgical correction of cruciate ligament ruptures as well as for cruciate ligament implant replacement.
Product codes
MBI
Device Description
The Endotack is a button fixation device. The body contact portions of the Endotack are composed of titanium, which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility for human use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tibial
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows a logo with the word "SO" in large, stylized letters above the word "Corporation" in smaller letters. The "O" in "SO" is represented by a solid black circle. The image has a grainy, high-contrast appearance, which may be due to the image quality or the original design of the logo.
A NID SER DE FOR THE BASE BA BE BA BE BE BE
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 KSSM's knowledge.
| Applicant: | Karl Storz Sports Medicine
81 West Street
Attleboro, MA 02703 | K022853
Page 1 of |
|------------------------|-------------------------------------------------------------------------------|----------------------|
| Contact: | James A. Lee, Ph.D.
Senior Regulatory Affairs Specialist
(310) 410 2769 | NOV 2 5 2002 |
| Device Identification: | Common Name:
Suture anchor | |
| | Trade Name: (optional)
Endotack | |
Indication: The Endotack is intended for use to provide tibial fixation for surgical correction of cruciate ligament ruptures.
The Endotack is a button fixation device. The body contact Device Description: portions of the Endotack are composed of titanium, which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility for human use.
Substantial Equivalence: The Endotack is substantially equivalent to the predicate device since the basic features and intended uses are the similar. The minor difference between the Endotack and the predicate device raises no new issues of safety and effectiveness, as this difference has no effect on the performance, function or intended use of these devices.
Signed:
:
James A. Lee, Ph.D. Senior Regulatory Affairs Specialist
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image contains the words "Public Health Service" in a simple, sans-serif font. The text is arranged on a single line, with each word clearly separated. The overall impression is clean and straightforward, suggesting an official or institutional context.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
James A. Lee, Ph.D. Senior Regulatory Affairs Specialist Karl Storz Endoscopy-America, Inc. 600 Corporate Pointe, 5th Floor Culver City, California 90230-7600
Re: K022853
Trade/Device Name: Endotack Regulation Number: 21 CFR 888.3040 Regulation Name: Fastener, fixation, nondegradable, soft tissue Regulatory Class: Class II Product Code: MBI Dated: August 22, 2002 Received: August 27, 2002
Dear Dr. Lee:
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. Isting 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.
Image /page/1/Picture/11 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
2
Page 2 -- Dr. James A. Lee -
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. 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 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 yours.
sincerely yours,
Ro Mark N Melhurn
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
3
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510(k) Number (if known): K022853
Device Name: Endotack
Indications for Use: The Endotack is intended for use to provide tibial fixation for surgical correction of cruciate ligament ruptures as well as for cruciate ligament implant replacement.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
(Division Sign-Off)
Division of General. Restorative and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________
| Prescription Use: | |
|---|---|
| (Per 21 CFR 801.109) | |
| OR Over-The-Counter Use: |
(Optional Format 1-2-96)