(29 days)
Not Found
No
The device description focuses on the mechanical properties of Nitinol staples and a heating system for activation. There is no mention of AI or ML in the intended use, device description, or the specific sections for AI/ML information.
Yes
The device is used for fixation of bone fragments, osteotomies, joint arthrodesis, and soft tissue to bone, which are all therapeutic interventions aimed at repairing or stabilizing tissues within the body.
No
The device is described as a system for fixation of bone fragments, osteotomies, joint arthrodesis, and soft tissue to bone, which are therapeutic and reconstructive uses, not diagnostic ones.
No
The device description clearly outlines multiple hardware components including staples, a Warm System with electrodes and heating wire, a current source, drill bits, a drill guide, an impactor, forceps, and a locator pin. This is not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The InteliFUSE, Inc. Warm System with StimuLinks is a surgical device used for the fixation of bone fragments, osteotomies, joint arthrodesis, and soft tissue to bone. It is implanted directly into the body to provide structural support and stability.
- Lack of Specimen Analysis: The device does not involve the collection, preparation, or analysis of any specimens from the human body. Its function is purely mechanical and thermal within the body.
Therefore, based on the provided information, the InteliFUSE, Inc. Warm System with StimuLinks is a surgical implant/device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
For bone to bone and soft tissue to bone fixation.
The InteliFUSE, Inc. Warm System with StimuLinks are used as a system for the following indications:
- hand and foot bone fragment and osteotomy fixation and joint arthrodesis
- fixation of proximal tibial metaphysis osteotomy
- fixation of soft tissue to bone such as anterior cruciate reconstruction.
Product codes
JDR
Device Description
The system consists of two and four prong staples for use in various fixation techniques. The Nitinol staples have prongs which are parallel during insertion. Application of heat from the Warm System to the staple causes the prongs to deflect inward. This inward deflection results in staple compression and retention. The heat is applied through two electrodes in an autoclavable heating wire. The electrodes are applied to the back of the implanted staple to activate heating. An accessory pack is provided with the Warm System and includes the resterilizable current source, drill bits of different sizes for creating proper hole diameters, a drill guide for depth gauging, an impactor for tapping the staples in place, forceps, and a locator pin. The accessory pack components are all commercially available finished devices. The 2 prong StimuLink staples are available in wire thicknesses from 1.2 x 1.2 mm to 2mm x 3 mm, and in lengths and heights from 5 to 30 mm, including uneven prong heights. Four prong plates for multiaxial loads are available in ranges from 15 x 6 x 6 mm to 15 x 6 x 10 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand and foot bone, proximal tibial metaphysis
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K051408
May, 2005
$\rho^{i}/_{2}$
InteliFUSE, Inc. Traditional 510(k) Warm System with StimuLinks
JUN 2 9 2005
TAB 4
PREMARKET NOTIFICATION [510(K)] SUMMARY
- March, 2005
| Trade Name: | InteliFUSE, Inc. Warm System with StimuLinks |
|---|---|
| Common Name: | Bone Staple |
| Classification Name: | Staple, Bone Fixation (per 21 CFR section 888.3030) |
| Manufacturer's Name: | InteliFUSE, Inc. |
| 5520 Willow Street | |
| New Orleans, LA 70115 | |
| 504-864-8111 | |
| Corresponding Official: | Sharon Rockwell |
| Regulatory Affairs Consultant | |
| 5582 Chalon Road | |
| Yorba Linda, CA 92886 | |
| Phone: (714) 695-9269 | |
| Fax: (714) 779-0406 | |
| Predicate Device(s): | Memograph Staple, Warm System, K993714, approved |
| February 25, 2000 (for hand and foot bone fragment, | |
| osteotomy and fixation of soft tissue to bone) | |
| Device Description: | The system consists of two and four prong staples for use in |
| various fixation techniques. The Nitinol staples have prongs | |
| which are parallel during insertion. Application of heat from | |
| the Warm System to the staple causes the prongs to deflect | |
| inward. This inward deflection results in staple compression | |
| and retention. The heat is applied through two electrodes in | |
| an autoclavable heating wire. The electrodes are applied to | |
| the back of the implanted staple to activate heating. | |
| Intended Use: | For bone to bone and soft tissue to bone fixation. |
| Technological | |
| Characteristics: | The Warm System uses the Joule effect of electrical current |
| in a conductor to increase the temperature of the Nitinol | |
| staple. Internal circuitry controls the heating effect such that | |
| a limiting temperature of 55°C is achieved in a maximum of | |
| 5 seconds. |
CONFIDENTIAL This document and the information contained herein may not be reproduced, used or disclosed without written permission from IntelliFUSE, Inc.
1
KOT.408 p²/2
May, 2005
InteliFUSE, Inc. Traditional 510(k) Warm System with StimuLinks
An accessory pack is provided with the Warm System and includes the resterilizable current source, drill bits of different sizes for creating proper hole diameters, a drill guide for depth gauging, an impactor for tapping the staples in place, forceps, and a locator pin. The accessory pack components are all commercially available finished devices.
The 2 prong StimuLink staples are available in wire thicknesses from 1.2 x 1.2 mm to 2mm x 3 mm, and in lengths and heights from 5 to 30 mm, including uneven prong heights. Four prong plates for multiaxial loads are available in ranges from 15 x 6 x 6 mm to 15 x 6 x 10 mm.
CONFIDENTIAL This document and the information contained herein may not be reproduced, used or disclosed without written permission from InteliFUSE, Inc.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 9 2005
Ms. Sharon Rockwell Regulatory Consultant InteliFUSE Incorporated 5520 Willow Street New Orleans, Louisiana 70115
Re: K051408 Trade/Device Name: InteliFUSE, Inc. Warm System with StimuLinks Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: JDR Dated: May 27, 2005 Received: May 31, 2005
Dear Ms. Rockwell:
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 such 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); 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.
3
Page 2 - Ms. Sharon Rockwell
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0120 . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours,
Stup Rhodes
am C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
TAB 3
INDICATIONS FOR USE
Kos1408 510(k) Number:
Device Name: InteliFUSE, Inc. Warm System with StimuLinks
Indications for Use:
The InteliFUSE, Inc. Warm System with StimuLinks are used as a system for the following indications:
-
hand and foot bone fragment and osteotomy fixation and joint arthrodesis
-
fixation of proximal tibial metaphysis osteotomy
-
fixation of soft tissue to bone such as anterior cruciate reconstruction.
X Prescription Use (per 21 CFR 801 Subpart D)
Or
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Of
Division of General, Restorative, and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________
3-1
CONFIDENTIAL This document and the information contained herein may not be reproduced, used or disclosed without written permission from InteliFUSE, Inc.