(239 days)
No
The summary describes a purely mechanical, absorbable fixation device with no mention of software, algorithms, or data processing for decision-making or analysis.
No
Explanation: A therapeutic device is used to treat a disease or condition. This device is a fixation device used to secure grafts in ACL and PCL reconstruction, which is a supportive mechanical function rather than a direct therapeutic treatment.
No
The device is described as a "cortical fixation device" used for securing grafts in ligament reconstruction, indicating it is a surgical implant rather than a device used for diagnosis.
No
The device description clearly states it is a physical implant made from absorbable material, not software.
Based on the provided information, the BioButton™ is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the BioButton™ is a "cortical fixation device used for secondary fixation in conjunction with an interference screw to secure soft tissue or bone-tendon-bone grafts in ACL and PCL reconstruction." This describes a surgical implant used to physically secure tissue within the body.
- Device Description: The description details a "sterile, single-use fixation device made from an absorbable homopolymer" that is implanted into the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The BioButton™ does not perform any such analysis of biological samples. It is a physical implant.
The mentions of MRI and CAT scan are for visualizing the implanted device after surgery, not for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
The BioButton™ is a cortical fixation device used for secondary fixation in conjunction with an interference screw to secure soft tissue or bone-tendon-bone grafts in ACL and PCL reconstruction.
Product codes
HWC
Device Description
The BioButton™ is a sterile, single-use fixation device made from an absorbable homopolymer derived from Poly (L-lactic) Acid that will gradually be metabolized The implant is attached to a soft tissue or bone-tendon-bone by the body. allograft during anterior and posterior cruciate ligament autograph or The implant is radiotranslucent with regard to intraoperative reconstruction. fluoroscopy, but it can be visualized with MRI and CAT scan.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
intraoperative fluoroscopy, MRI, CAT scan
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)
Testing has been done to prove safety and effectiveness of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K973758, 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
SEP 1 7 1999
September 2, 1999
SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, Linvatec Corporation is hereby submitting the 510(k) Summary of Safety and Effectiveness for the BioButton™ - Recessed Ligament Button, 510(k) Number K990194.
A. Submitter
Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908
14990194
Company Contact B.
Laura Seneff Manager, Regulatory Affairs
C. Device Name
| Trade Name: | BioButton™ |
|---|---|
| Common Name : | Recessed Ligament Button |
| Classification Names : | Smooth or threaded |
| metallic bone fixation | |
| fastener 888.3040 | |
| Proposed Class/Device : | Class II-87 HWC |
Predicate/Legally Marketed Devices D.
Product Code
BioScrew® Absorbable Interference Screw Linvatec Corporation
Hewson Ligament Guide and Button Richards Manufacturing Company, Inc.
1
Summary of Safety and Effectiveness BioButton™ - Recessed Ligament Button 510(k) # K990194 September 2, 1999 Page 2 of 3
E. Device Description
The BioButton™ is a sterile, single-use fixation device made from an absorbable homopolymer derived from Poly (L-lactic) Acid that will gradually be metabolized The implant is attached to a soft tissue or bone-tendon-bone by the body. allograft during anterior and posterior cruciate ligament autograph or The implant is radiotranslucent with regard to intraoperative reconstruction. fluoroscopy, but it can be visualized with MRI and CAT scan.
F. Intended Use
The BioButton is a cortical fixation device used for secondary fixation in conjunction with an interference screw to secure soft tissue or bone-tendon-bone grafts in ACL and PCL reconstruction.
G. Substantial Equivalence
The BioButton™ is substantially equivalent in function and intended use to the Hewson Ligament Button, Richards Manufacturing Co., Inc.
The BioButton is substantially equivalent in materials used to the BioScrew® Absorbable Interference Screw (Linvatec Corporation) - 510(K)# K973758.
Testing has been done to prove safety and effectiveness of the device.
The similarities/dissimilarities to the predicate are shown in the attached table.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a bird or an abstract human figure with three horizontal lines above it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 7 1999
Ms. Laura D. Seneff Manager, Regulatory Affairs Linvatec Corporation 11311 Concept Blvd Largo, Florida 33773
Re: K990194
Trade Name: BioButton™ Recessed Ligament Button Regulatory Class: II Product Code: HWC Dated: June 22, 1999 Received: June 23, 1999
Dear Ms. Seneff:
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 Regulations, 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 Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, 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 Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2- Ms. Laura D. Seneff
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 tollfree 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.
Cella M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
September 2, 1999
Page 1 of 1
510(k) Number: K990194
Device Name: BioButton™ - Recessed Ligament Button
Indications for Use:
The BioButton™ is a cortical fixation device used for secondary fixation in conjunction with an interference screw to secure soft tissue or bone-tendon-bone grafts in ACL and PCL reconstruction.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use OR
(Per 21 CFR 801.109)
Over-the-Counter Use
(Division Sign-Off)
(Division Shon-Off 510(k) Numb
(Optional Format 1-296)