(60 days)
Not Found
Not Found
No
The summary describes a manually operated surgical device with no mention of AI or ML capabilities.
No
The device is described as a surgical instrument for suture fixation, not a device that provides therapy for a disease or condition.
No
Explanation: The device is described as a "surgical device intended for suture fixation in the repair of tendons and ligaments," indicating a therapeutic rather than diagnostic purpose.
No
The device description explicitly states it is a "manually operated arthroscopic surgical device" with "body contact portions composed of titanium," indicating it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "suture fixation in the repair of tendons and ligaments." This describes a surgical procedure performed on the body, not a test performed on samples taken from the body.
- Device Description: The description details a "manually operated arthroscopic surgical device" made of titanium. This is consistent with a surgical instrument used during a procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely mechanical and surgical.
N/A
Intended Use / Indications for Use
The KSEA Flipptack is a manually operated arthroscopic surgical device intended for suture fixation in the repair of tendons and ligaments.
Product codes
MBI, HRX, GED
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
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 Drive
Culver City, CA 90230
(310) 558-1500 |
|------------------------|---------------------------------------------------------------------------------------------------------------|
| Contact: | Kevin Kennan
Senior 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
00004 d
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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
3
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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