(346 days)
No
The device description and performance studies focus solely on the mechanical properties and design of bone screws for fixation. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes.
The device is described as "implants (screws) intended for fixation of fractures, non-unions, arthrodeses and osteotomies of the small bones in the hand and foot," which falls under the definition of a therapeutic device as it treats a medical condition.
No
Explanation: The device is described as an internal fixation system consisting of bone screws intended for the fixation of fractures, osteotomies, or fusions. Its purpose is to physically fixate bones, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states that the system consists of "bone screws of various designs and sizes," which are physical hardware components.
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 screws are for the "fixation of fractures, and osteotomies of the small bones in the hand and foot." This describes a surgical implant used directly on the patient's body to treat a physical condition.
- Device Description: The description details bone screws made of titanium alloy, designed to fixate bones. This aligns with a surgical implant, not a device used to test samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (like blood, urine, tissue), detecting markers, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The proposed indications for use for the Integra® CAPTURE™ Screw System are as follows: "The CAPTURE™ Screw System implants (screws) are intended for fixation of fractures, and osteotomies of the small bones in the hand and foot. The implants are intended for single use only.
The proposed indications for use for the Integra® Ti6® Internal Fixation System are as follows: "The Ti6@ Internal Fixation System implants (screws) are intended for fixation of fractures, non-unions, arthrodeses and osteotomies of the small bones in the hand and foot. The implants are intended for single use only.
Product codes
HWC
Device Description
The Integra® CAPTURETM Screw System and Integra® Ti6® Internal Fixation System consists of bone screws of various designs and sizes intended to fixate bones in cases of fractures, osteotomies, or fusions. The screws are self- drilling and self-tapping, and are manufactured from Ti-6Al-4V titanium alloy. This submission presents new cannulated (Digital Fusion) and non-cannulated (QuickSnap) screw designs that are line extensions to the current Integra® CAPTURE™ Screw System and Integra® Ti6® Internal Fixation System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small bones in the hand and foot
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
Non-Clinical Performance Data: The following non-clinical performance analysis was conducted per ASTM F543 in order to establish substantial equivalence.
- Torsional Strength
- Driving Torque
- Axial Pullout Strength
The Digital Fusion and OuickSnap performed substantially equivalent or better when compared to the predicate device.
Clinical Performance Data: Clinical performance data was not necessary to demonstrate substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 14, 2017
Ascension Orthopedics Blesson Abraham Senior Regulatory Affairs Specialist 8700 Cameron Road Austin, Texas 78754
Re: K162153
Trade/Device Name: Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: June 14, 2017 Received: June 15, 2017
Dear Blesson Abraham:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Vincent J. Devlin -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K162153
Device Name
Integra® CAPTURETM Screw System & Integra® Ti6® Internal Fixation System
Indications for Use (Describe)
The proposed indications for use for the Integra® CAPTURE™ Screw System are as follows:
"The CAPTURE™ Screw System implants (screws) are intended for fixation of fractures, and osteotomies of the small bones in the hand and foot. The implants are intended for single use only.
The proposed indications for use for the Integra® Ti6® Internal Fixation System are as follows: "The Ti6@ Internal Fixation System implants (screws) are intended for fixation of fractures, non-unions, arthrodeses and osteotomies of the small bones in the hand and foot. The implants are intended for single use only.
| Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------- |
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Page 1 of 2
510(k) Summary
| Sponsor: | Ascension Orthopedics
8700 Cameron Road
Austin, TX 78754-3832, USA |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Blesson Abraham
Senior Regulatory Affairs Specialist
512-852-3942
512-368-1423 |
| Date: | August 1, 2016 |
| Establishment Registration Number: | 1651501 |
| Trade Name: | Integra® CAPTURE™ Screw System &
Integra® Ti6® Internal Fixation System |
| Common Name: | Bone Screw |
| Product Code: | HWC – Screw, Fixation, Bone |
| Classification: | 21 CFR §888.3040 – Smooth or threaded metallic bone
fixation fastener |
| Classification Panel: | Orthopedic |
| Predicate Devices: | Smith & Nephew, Inc. VLP Foot Plating, Screw System and
Accessories, K090675, cleared on June 4, 2009. |
| | Wright Medical Technology, Inc. WRIGHTTM Compression
Screw, K082320, cleared on November 5, 2008. |
| | Koby Surgical. Koby Surgical Internal Fixation System,
K060026, cleared on January 26, 2006. |
| Device Description: | The Integra® CAPTURETM Screw System and Integra® Ti6®
Internal Fixation System consists of bone screws of various
designs and sizes intended to fixate bones in cases of
fractures, osteotomies, or fusions. The screws are self- drilling
and self-tapping, and are manufactured from Ti-6Al-4V
titanium alloy. This submission presents new cannulated
(Digital Fusion) and non-cannulated (QuickSnap) screw
designs that are line extensions to the current Integra®
CAPTURE™ Screw System and Integra® Ti6® Internal Fixation
System. |
| Intended Use: | The proposed indications for use for the Integra®
CAPTURE™ Screw System are as follows:
"The CAPTURE™ Screw System implants (screws) are
intended for fixation of fractures, non-unions, arthrodeses, and
osteotomies of the small bones in the hand and foot. The
implants are intended for single use only. |
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Image /page/4/Picture/3 description: The image shows the logo for INTEGRA. The word "INTEGRA" is in large, gray, sans-serif font. Below the word "INTEGRA" is the phrase "LIMIT UNCERTAINTY" in a smaller, green, sans-serif font. To the right of the word "INTEGRA" is a green graphic consisting of several squares of different sizes.
The proposed indications for use for the Integra® Ti6® Internal Fixation System are as follows:
"The Ti6" Internal Fixation System implants (screws) are intended for fixation of fractures, non-unions, arthrodeses and osteotomies of the small bones in the hand and foot. The implants are intended for single use only.
The additional Integra® CAPTURE™ Screw System and Basis of Substantial Equivalence: Integra® Ti6® Internal Fixation System QuickSnap and Digital Fusion screws have the same intended use and fundamental scientific technology as the predicate devices. Sizing differences between the subject and predicate devices have been assessed and do not present new issues of safety or efficacy. Anodization surface treatment of the subject devices does not present new issues to safety or efficacy. Therefore, the proposed Integra® CAPTURE™ Screw System and Integra® Ti6® Internal Fixation System QuickSnap and Digital Fusion screws, anodization, are substantially equivalent to the predicate devices.
Non-Clinical Performance Data: The following non-clinical performance analysis was conducted per ASTM F543 in order to establish substantial equivalence.
-
- Torsional Strength
-
- Driving Torque
- Axial Pullout Strength 3.
The Digital Fusion and OuickSnap performed substantially equivalent or better when compared to the predicate device.