(60 days)
This instrument is a manually operated arthroscopic surgical device intended for suture fixation in the repair of tendons and ligaments.
The Karl Storz Flipptack is a manually operated arthroscopic surgical device intended for suture fixation in the repair of tendons and ligaments. The body contact portions of the KSEA Flipptack 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.
The provided text describes a 510(k) submission for a medical device called the KSEA Flipptack, a manually operated arthroscopic surgical device intended for suture fixation in the repair of tendons and ligaments.
Crucially, the provided document is a 510(k) summary and approval letter, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed performance study with acceptance criteria in the manner you've outlined for diagnostic or AI-based devices.
Therefore, most of the information you've requested regarding acceptance criteria, study details, sample sizes, expert ground truth, and comparative effectiveness studies is not present in this type of regulatory submission for this particular device.
Here's an explanation based on the provided text, addressing what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance
- Not Applicable / Not Provided. This document does not establish specific performance acceptance criteria (e.g., sensitivity, specificity, accuracy) for the KSEA Flipptack in the way one would for a diagnostic or AI device. The core of a 510(k) submission for this type of device is demonstrating substantial equivalence to a legally marketed predicate device based on similar intended use, technology, materials, and safety/effectiveness profiles.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Provided. This document does not describe any specific clinical test set, sample size, or data provenance from a performance study for the KSEA Flipptack itself. Substantial equivalence for this type of surgical instrument is typically established through a comparison of device characteristics (materials, design, intended use) and, if applicable, bench testing rather than a clinical performance study with human subjects validating specific metrics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable / Not Provided. There is no mention of a test set requiring expert adjudication or ground truth establishment in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided. As there's no test set described, there's no adjudication method mentioned.
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
- Not Applicable. This device is a surgical instrument (suture anchor), not an AI-assisted diagnostic or image analysis tool. Therefore, an MRMC study or AI assistance is irrelevant to its regulatory submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a physical surgical instrument, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable / Not Provided. Ground truth (in the clinical performance sense) is not established or discussed for this type of device in this document.
8. The sample size for the training set
- Not Applicable. As this is not an AI/ML device, there is no training set.
9. How the ground truth for the training set was established
- Not Applicable. As this is not an AI/ML device, there is no training set or ground truth establishment relevant to an AI model.
Summary of Device in the provided text:
- Device Name: KSEA Flipptack
- Intended Use: Manually operated arthroscopic surgical device intended for suture fixation in the repair of tendons and ligaments.
- Device Description: Composed of titanium, used for suture fixation.
- Regulatory Goal: Substantial Equivalence to a predicate device.
- Conclusion of Document: FDA determined the device is substantially equivalent to devices marketed prior to May 28, 1976. This allows the device to be marketed.
This 510(k) summary primarily demonstrates that the KSEA Flipptack is similar enough to existing, legally marketed devices that it raises no new questions of safety or effectiveness, therefore it does not require brand new, extensive performance studies typically associated with novel or AI-driven technologies.
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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) 558-1500 |
|---|---|
| Contact: | Kevin KennanSenior Regulatory Affairs Specialist |
| Device Identification: | Common Name:Suture anchor |
Trade Name: (optional) Karl Storz Flipptack
Indication: The KSEA Flipptack is a manually operated arthroscopic surgical device intended for suture fixation in the repair of tendons and ligaments.
Device Description: The Karl Storz Flipptack is a manually operated arthroscopic surgical device intended for suture fixation in the repair of tendons and ligaments. The body contact portions of the KSEA Flipptack 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 Karl Storz Flipptack is substantially equivalent to the predicate device since the basic features and intended uses are the same. The minor difference between the Karl Storz Flipptack 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:
Kevin Kennan
Senior Regulatory Affairs Specialist
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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
SEP 2 2 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Kevin Kennan Senior Requlatory Affairs Specialist Karl Storz Endoscopy America Incorporated 600 Corporate Pointe Drive Culver City, California 90230-8100
Re : K982571 Trade Name: KSEA Flipptack Requlatory Class: II Product Codes: MBI, HRX, GED Dated: July 22, 1998 Received: July 24,1998
Dear Mr. Kennan:
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 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 (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 current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical 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
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Page 2 - Mr. Kevin Kennan
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 at (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
Enclosure
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510(k) Number (if known):
510(k) Number (if known):
Device Name: KSEA Flipptack
Indications for Use: This instrument is a manually operated arthroscopic surgical device intended for suture fixation in the repair of tendons and ligaments.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K982571 |
| Prescription Use: | X |
|---|---|
| (Per 21 CFR 801.109) |
OR Over-The-Counter Use:
(Optional Format 1-2-96)000000
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§ 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.