(90 days)
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Not Found
No
The summary describes a mechanical device (shape memory alloy staples) and a heating system. There is no mention of AI, ML, image processing, or data analysis that would indicate the use of such technologies.
No.
The device is used for fixation of bone fragments and soft tissue, which are structural and mechanical functions, not therapeutic.
No
The device is described as a system for fixation (e.g., of bone fragments, soft tissue to bone) using shape memory alloy staples, which is a therapeutic rather than a diagnostic function.
No
The device description clearly outlines hardware components including shape memory alloy staples, a Warmsystem Console, portable InteliFUSER warming devices, and various instruments for surgical procedures.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a system for surgical fixation of bone and soft tissue. This is a therapeutic and structural application, not a diagnostic one.
- Device Description: The device is described as shape memory alloy staples and associated warming devices and instruments for insertion. This aligns with surgical implants and tools, not diagnostic reagents or analyzers.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosis.
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's function is entirely focused on physically fixing anatomical structures.
N/A
Intended Use / Indications for Use
The InteliFUSE, Inc. Warmsystem with StimuLinks is used as a system for the following indications:
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hand and foot bone fragment and osteotomy fixation and joint arthrodesis.
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fixation of proximal tibial metaphysis osteotomy.
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fixation of soft tissue to bone such as anterior cruciate reconstruction.
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fixation of maxillofacial and mandibulofacial fractures and osteotomies.
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fixation of unloaded craniofacial bone fractures and craniostomies. The StimuLinks are contraindicated for craniofacial patients with a skull thickness less than the selected prong length.
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adjunctive fixation of small bone fragments. These fragments may be located in long bones such as the femur, fibula and tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in flat bones such as the pelvis, scapula and sternum.
Product codes
JDR
Device Description
The InteliFUSE, Inc. StimuLinks are shape memory alloy staples available in various sizes and guages appropriate for the fixation of bone to bone or soft tissue to bone. The staples have prongs which are parallel during insertion. Application of heat from the Warmsystem Console, or from the portable InteliFUSER warming devices results in compression and retention of the staples. Accessories to the System include instruments for locating drill holes, gauging hole depth, and inserting and tamping the staples in place.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand, foot, proximal tibial metaphysis, soft tissue, maxillofacial, mandibulofacial, craniofacial bone, femur, fibula, tibia, humerus, ulna, radius, clavicle, ribs, pelvis, scapula, sternum
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Bench testing demonstrated that both the Warmsystem console and hand held units properly heat the StimuLinks until the staple is transformed and the prongs deflect. The Warmsystem console testing included electrical and mechanical safety when used for its intended purpose. The portable units are provided sterile using a validated ethylene oxide sterilization cvcle, and a sterility assurance level (SAL) of 100 has been demonstrated. StimuLinks are radiation sterilized at a minimum dose validated to attain a sterility assurance level (SAL) of 10t. StimuLinks meet the ISO 10993 standards for biocompatibility.
Key Metrics
Not Found
Predicate Device(s)
Memograph Staple System with OSStaples Warmsytem with StimuLinks
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
Image /page/0/Picture/2 description: The image contains the word "INTELI" in a textured, pixelated font on the left side. To the right of "INTELI" is the word "FUSE" in a bold, sans-serif font where the letters are connected. Below the word "FUSE" is the phrase "Education. Making. Careers. Elevated."
510(K) SUMMARY (21 CFR 807.92)
INTELIFUSE, INC. WARMSYSTEM WITH STIMULINKS
- 510(k) Owner: InteliFUSE, Inc. Canal Place, Suite 2300 365 Canal Street New Orleans, LA 70130 Tel: 818-952-2677 Fax: 818-952-9922
- Contact Person: Sharon Rockwell Tel: 714-695-9269 E-mail: srockwell(@writeme.com
- Date Prepared: December, 2005
- Trade Name: Warmsystem with StimuLinks
- Common Name: Bonc fixation staples
- Classification Name: Bone fixation staples per 21 CFR 888.3030, JDR
- Predicate Devices: Memograph Staple System with OSStaples Warmsytem with StimuLinks
- Device Description: The InteliFUSE, Inc. StimuLinks are shape memory alloy staples available in various sizes and guages appropriate for the fixation of bone to bone or soft tissue to bone. The staples have prongs which are parallel during insertion. Application of heat from the Warmsystem Console, or from the portable InteliFUSER warming devices results in compression and retention of the staples. Accessories to the System include instruments for locating drill holes, gauging hole depth, and inserting and tamping the staples in place.
- Intended Use: The InteliFUSE, Inc, Warmsystem with StimuLinks is used as a system for the following indications:
l ) hand and foot bone fragment and osteotomy fixation and joint arthrodesis.
1
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fixation of proximal tibial metaphysis osteotomy.
-
fixation of soft tissue to bone such as anterior cruciate reconstruction.
-
fixation of maxillofacial and mandibulofacial fractures and osteotomies.
fixation of unloaded craniofacial bone fractures and ર) for The StimuLinks arc contraindicated craniostomies. craniofacial patients with a skull thickness less than the selected prong length.
- adjunctive fixation of small bone fragments. These fragments may be located in long bones such as the femur, fibula and tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in flat bones such as the pelvis, scapula and sternum
The indications are identical to those of the predicate device, the BioMedical Enterprises, Inc. Memograph System with OSStaples.
Technological
The Warmsystem Console applies an electrical current through two Characteristics: electrodes to the back of a Nitinol StimuLink to warm it above the transition temperature (45°C) causing the prongs to deflect inward. The console uses AC wall current stepped down via an electrical transformer. Heating is almost immediate. The Warmsystem is provided as a bench console or as one of two sterile hand held units, the InteliFUSER I (single battery) or the InteliFUSER II (dual battery). Both the console and portable devices apply heat using the same Joule effect. The user applies heat until the staple is transformed and the prongs deflect. This results in the compression across a fracture or fusion site during surgery.
Non-Clinical
Performance Data: Bench testing demonstrated that both the Warmsystem console and hand held units properly heat the StimuLinks until the staple is transformed and the prongs deflect. The Warmsystem console testing included electrical and mechanical safety when used for its intended purpose. The portable units are provided sterile using a validated ethylene oxide sterilization cvcle, and a sterility assurance level (SAL) of 100 has been demonstrated. StimuLinks are radiation sterilized at a minimum dose validated to attain a
2
sterility assurance level (SAL) of 10t. StimuLinks meet the ISO 10993 standards for biocompatibility.
- The Warmsystem with Clinical testing was not required. Clinical Data: StimuLinks is CE marked and the device is available in the US for hand and foot bone fragment and osteotomy fixation and joint arthrodesis, fixation of proximal tibial metaphysis osteotomy, and fixation of soft tissue to bone such as anterior cruciate reconstruction.
- The non-clinical test results demonstrate that both the Warmsystem Conclusions: console and the hand held heating units supply the required degree of heat to transform the StimuLink staples.
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services. The seal features an eagle-like symbol with three stylized lines forming its body and wings. The seal is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in a circular arrangement.
Public Health Service
3 2006 APR
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
InteliFUSE, Inc. c/o Ms. Sharon Rockwell President Rockwell & Associates 5582 Chalon Road Yorba Linda, California 92886
K060014 Re:
Trade/Device Name: Warmsystem with StimuLinks Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Codes: JDR Dated: March 15, 2006 Received: March 16, 2006
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
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Page 2 - Ms. Sharon Rockwell
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. 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 yours,
Herbert Semler
Mark N. Melkerson, M.S. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K060014
Device Name: InteliFUSE, Inc. Warmsystem with StimuLinks
The InteliFUSE, Inc. Warmsystem with Stimul.inks is 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.
-
fixation of maxillofacial and mandibulofacial fractures and osteotomies.
-
fixation of unloaded craniofacial bone fractures and craniostomies. The StimuLinks are contraindicated for craniofacial patients with a skull thickness less than the selected prong length.
-
adjunctive fixation of small bone fragments. These fragments may be located in long bones such as the femur, fibula and tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in flat bones such as the pelvis, scapula and sternum.
Prescription Use X x (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 (ODF.)
Page of ______________________________________________________________________________________________________________________________________________________________________
Hulut Leman wo
Division of General, Restorati and Neurological Devices
510(k) Number K060014