(56 days)
No
The document describes a physical implant for bone fixation and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is an implant for fixation of osteotomies and reconstruction, which is a structural support rather than a device with a direct therapeutic effect like drug delivery or stimulation.
No
The device is an implant used for the fixation and reconstruction of bones during surgical procedures to correct deformities, not for diagnosing conditions.
No
The device description clearly states it is a "one-piece threaded device intended to be implanted into the medullary bone," indicating it is a physical implant, not software.
Based on the provided information, the DigiFuse® implant is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the "fixation of osteotomies and reconstruction of the lesser phalanges during procedures to correct deformities of the toes and fingers." This describes a surgical implant used directly on the patient's body for structural support and correction.
- Device Description: The description details a "one-piece threaded device intended to be implanted into the medullary bone." This further confirms it's a physical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a physiological state, health, or disease.
IVDs are used to perform tests on samples taken from the body, while the DigiFuse® implant is a therapeutic device implanted within the body.
N/A
Intended Use / Indications for Use
The DigiFuse® implant is indicated for the fixation of osteotomies and reconstruction of the lesser phalanges during procedures to correct deformities of the toes and fingers. Indications include:
- Hammer toe deformity
- Claw toe deformity
- Mallet toe deformity
- Other deformities of the feet and hands
The DigiFuse® implants are intended for single use only.
Product codes
HWC
Device Description
The Integra® DigiFuse® Implant is a one-piece threaded device intended to be implanted into the medullary bone of the lesser toes. The implant is offered in several variations consisting of the combination of 2.0mm and 2.5mm, 0° and 10° blades, as well as standard and short blade options.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lesser phalanges, toes and fingers, medullary bone of the lesser toes, feet and hands
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)
Non-clinical evaluation and dimensional analysis was done to confirm substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Metasurg DigiFuse Implant – K111536, OsteoMed Extend 2.0/2.4 Cannulated Screw System – K062863, NewDeal K-Wire – K022599
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
Image /page/0/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 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.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 29, 2015
Ascension Orthopedics % Ms. Jayana Kenana Regulatory Associate Integra LifeSciences 311 Enterprise Drive Plainsboro, New Jersey 08536
Re: K152527
Trade/Device Name: Integra® Digifuse® Cannulated Intramedullary Fusion System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: August 19, 2015 Received: September 3, 2015
Dear Ms. Kenana:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
Page 2 - Ms. Jayana Kenana
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 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" (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 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 yours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES. Food and Drug Administration
Indications for Use
510(k) Number (if known) K152527
Device Name
Integra® DigiFuse® Cannulated Intramedullary Fusion System
Indications for Use (Describe)
The DigiFuse® implant is indicated for the fixation
of osteotomies and reconstruction of the lesser
phalanges during procedures to correct deformities of the toes and fingers.
Indications include:
· Hammer toe deformity
- · Claw toe deformity
- · Mallet toe deformity
- · Other deformities of the feet and hands
The DigiFuse® 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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6. 510(k) Summary
| Submitter Information – 807.92(a)(1) | |
|---|---|
| Sponsor Name | Integra LifeSciences Corporation |
| Address | 311 Enterprise Drive |
| Plainsboro, NJ 08536 | |
| Name of Contact Person | Jayana Kenana |
| Phone Number | 609-936-2657 |
| Fax Number | 609-275-9445 |
| Establishment Registration Number | 1651501 |
| Date Prepared | October 21, 2015 |
| Name of Device – 807.92(a)(2) | |
| Trade of Proprietary Name | Integra® DigiFuse® |
| Common or Usual Name | Cannulated Intramedullary Fusion System |
| Classification Name | Smooth & threaded metallic bone fixation fasteners |
| Classification Panel | Orthopedics |
| Regulation | Class II, 21 CFR 888.3040 |
| Product Code | HWC |
| Material | Titanium Alloy (Ti 6A1-4V ELI) |
| Legally marketed device(s) to which equivalence is claimed – 807.92(a)(3) | |
| Metasurg DigiFuse Implant – K111536 | |
| OsteoMed Extend 2.0/2.4 Cannulated Screw System – K062863 | |
| NewDeal K-Wire – K022599 | |
| Device Description – 807.92(a)(4) | |
| The Integra® DigiFuse® Implant is a one-piece threaded device intended to be implanted into |
the medullary bone of the lesser toes. The implant is offered in several variations consisting of the combination of 2.0mm and 2.5mm, 0° and 10° blades, as well as standard and short blade options.
4
Integra LifeSciences Corporation
Traditional 510(k) Integra DigiFuse Cannulated Intramedullary Fusion System
Intended Use
The DigiFuse® implant is indicated for the fixation of osteotomies and reconstruction of the lesser phalanges during procedures to correct deformities of the toes and fingers. Indications include:
- · Hammer toe deformity
- · Claw toe deformity
- Mallet toe deformity
- Other deformities of the feet and hands
The DigiFuse® implants are intended for single use only.
Conclusion:
The Integra® DigiFuse® Implant is composed as the same material as the predicate device from MetaSurg (K111536) and the only difference is the proposed device will be adding two new lengths. The two new lengths are also included in the length range of the predicate device passed by Osteomed (K062863). There are no design, material, or indication differences between the proposed device and predicate devices. Non-clinical evaluation and dimensional analysis was done to confirm substantial equivalence.