(70 days)
No
The device description and performance studies focus on the mechanical properties of a plate and screw system for wrist fusion, with no mention of AI or ML.
No
The device is a surgical implant designed for rigid fixation of the wrist joint to treat various conditions, which aligns with the definition of a therapeutic device.
No
The device is an orthopedic implant system designed for wrist fusion. Its indications for use describe conditions it is used to treat, not conditions it diagnoses.
No
The device description explicitly states that the system includes an implant (plate and screws) and associated instrumentation, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The INTEGRA Total Wrist Fusion System is a surgical implant (plate and screws) used to fuse the wrist joint. It is a physical device implanted in the body, not a test performed on a sample outside the body.
- Intended Use: The intended use describes the conditions for which the device is used in patients, all of which involve surgical intervention and physical repair of the wrist joint.
Therefore, based on the provided information, the INTEGRA Total Wrist Fusion System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The INTEGRA Total Wrist Fusion System is indicated for use in patients with:
- Posttraumatic arthritis of the joints of the wrist .
- Rheumatoid wrist deformities requiring restoration ●
- Complex carpal instability .
- Post-septic arthritis of the wrist .
- Severe unremitting wrist pain related to motion .
- Brachial plexus nerve palsies .
- Tumor resection .
- Spastic deformation .
- Pain and/or loss of function due to osteoarthritis
- Revision of failed partial wrist fusions
Product codes (comma separated list FDA assigned to the subject device)
LXT, HRS
Device Description
The INTEGRA Total Wrist Fusion System offers rigid fixation capabilities for the wrist joint of patients utilizing a plate and screw system. The system includes the implant, consisting of the plate and screws, as well as associated instrumentation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
wrist joint
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)
Tests have been performed to verify the mechanical suitability of the device. Results demonstrate that the mechanical properties of the INTEGRA Total Wrist Fusion System are substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached 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 contains the number 093163 at the top left. Below the number is the logo for Integra LifeSciences Corporation. The logo consists of a series of horizontal lines above the text "INTEGRA LIFESCIENCES CORPORATION".
311 Enterprise Drive • Plainsboro, NJ 08536 • (609) 275-0500 • Fax: (609) 275-9445 • www.Integra-LS.com
510(K) SUMMARY
DEC 1 5 2009
INTEGRATM Total Wrist Fusion System
Submitter's name and address:
Integra LifeSciences Corporation 4900 Charlemar Drive Cincinnati, OH 45227, USA Tel: (513) 533-7932 Fax: (513) 271-0957
Contact person and telephone number
Stephen Beier Regulatory, Quality, Clinical Affairs Associate Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536, USA Tel: (609) 936-5436 Fax: (609) 275-9445 Email: stephen.beier@Integra-LS.com
Date Summary was prepared:
Monday, October 5, 2009
Name of the device:
| Proprietary Name: | INTEGRA Total Wrist Fusion System |
|---|---|
| Common Name: | Appliance, fixation, nail/blade/plate combination, multiple |
| component, metal composite; | |
| Plate, fixation, bone | |
| Classification Name: | Single/multiple component metallic bone fixation appliances and |
| accessories (21CFR 888.3030) | |
| Device Product Code: | LXT: |
| HRS | |
| Classification Panel: | Orthopedic |
1
Image /page/1/Picture/0 description: The image shows the number K093163 at the top left. Below that is the logo for Integra LifeSciences Corporation. The logo has a series of curved lines above the word INTEGRA, which is in bold, block letters. Below that is the phrase LIFESCIENCES CORPORATION, also in bold, block letters.
311 Enterprise Drive · Plainsboro, NJ 08536 · (609) 275-0500 · Fax: (609) 275-9445 · www.Integra-LS.com
Substantial Equivalence:
The INTEGRA™ Total Wrist Fusion System is substantially equivalent to the commercially available devices, Synthes® Wrist Fusion Set, K000558, Synthes® Locking Compression Plate (LCP) Wrist Fusion Set, K042355, and KMI Wrist Fusion System, K991873, which have all been recommended for classification as Class II by the Orthopedic Panel of the Food and Drug Administration. In addition, the Ø3.5mm Surfix® screws utilized in this design were previously cleared through 510(k) K063820 on February 8, 2007.
Device Description:
The INTEGRA Total Wrist Fusion System offers rigid fixation capabilities for the wrist joint of patients utilizing a plate and screw system. The system includes the implant, consisting of the plate and screws, as well as associated instrumentation.
Indications for Use:
The INTEGRA Total Wrist Fusion System is indicated for use in patients with:
- . Posttraumatic arthritis of the joints of the wrist
- Rheumatoid wrist deformities requiring restoration .
- Complex carpal instability ●
- Post-septic arthritis of the wrist .
- Severe unremitting wrist pain related to motion ●
- . Brachial plexus nerve palsies
- . Tumor resection
- . Spastic deformation
- Pain and/or loss of function due to osteoarthritis .
- Revision of failed partial wrist fusions .
Testing and Test Results:
Tests have been performed to verify the mechanical suitability of the device. Results demonstrate that the mechanical properties of the INTEGRA Total Wrist Fusion System are substantially equivalent to the predicate devices.
Conclusion
The INTEGRA Total Wrist Fusion System is substantially equivalent to the predicate devices.
The new product does not change the intended use or fundamental scientific technology of the device, nor does it raise any new issues of safety or effectiveness.
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 stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The text is in all caps and is written in a sans-serif font. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Integra LifeSciences Corporation % Mr. Stephen Beier Regulatory, Quality, Clinical Affairs Associate 311 Enterprise Drive Plainsboro, New Jersey 08536
DEC 1 5 2009
Re: K093163
Trade/Device Name: INTEGRA Total Wrist Fusion System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, LXT Dated: October 5, 2009 Received: October 6, 2009
Dear Mr. Beier:
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 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
3
Page 2 - Mr. Stephen Beier
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Sonata 3
Image /page/3/Picture/7 description: The image shows a handwritten letter 'f' in cursive. The letter has a loop at the top and extends downwards with a curved tail. The stroke width varies, suggesting it was written with a pen or brush.
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): N/A
Device Name: INTEGRATM Total Wrist Fusion System
Indications For Use:
The INTEGRA Total Wrist Fusion System is indicated for use in patients with:
- Posttraumatic arthritis of the joints of the wrist .
- Rheumatoid wrist deformities requiring restoration ●
- Complex carpal instability .
- Post-septic arthritis of the wrist .
- Severe unremitting wrist pain related to motion .
- Brachial plexus nerve palsies .
- Tumor resection .
- Spastic deformation .
- Pain and/or loss of function due to osteoarthritis
- Revision of failed partial wrist fusions
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(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 Surgical, Orthopedic,
and Restorative Devices
510(k) Number K093163
APPENDIX B - Page 1 of 1