(223 days)
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No
The provided text does not mention AI, ML, or any related concepts like image processing, deep neural networks, or training/test sets, which are typically associated with AI/ML medical devices. The description focuses on the mechanical function of an external fixation system.
Yes
The device is used for correction and stabilization of extremity bones for conditions like fractures, contractures, limb lengthening, and deformities, which are therapeutic applications.
No
Explanation: The device is described as a "Spider Frame Computer Assisted External Fixation system used as a temporary or permanent method of correction and stabilization of the extremity bones," and its indications are for conditions like joint contractures, fractures, deformities, and limb lengthening. These are all therapeutic or corrective actions, not diagnostic ones. There is no mention of the device identifying or characterizing a disease or condition.
No
The device is described as a "Spider Frame Computer Assisted External Fixation system," which inherently implies a physical hardware component (the external fixation frame) in addition to any potential software assistance. The description focuses on the mechanical function of the system for bone correction and stabilization.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device is a "Computer Assisted External Fixation system used as a temporary or permanent method of correction and stabilization of the extremity bones." It is used on the body to fix bones and correct deformities.
- Intended Use: The indications for use all relate to treating conditions of the bones and joints directly on the patient's body, not analyzing samples taken from the body.
Therefore, based on the provided information, this device is a surgical device or orthopedic device, not an IVD.
N/A
Intended Use / Indications for Use
Spider Frame Computer Assisted External Fixation system used as a temporary or permanent method of correction and stabilization of the extremity bones.
Indications are:
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- Post-Traumatic joint contracture which has resulted in loss of range of motion
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- Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction
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- Open and closed fracture fixation
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- Pseudoarthrosis of long bones
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- Limb lengthening by epiphyseal or metaphyseal distraction
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- Correction of bony or soft tissue deformities
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- Correction of segmental bony or soft tissue defects
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- Joint arthrodesis
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- Infected fractures or nonunions,
Product codes (comma separated list FDA assigned to the subject device)
KTT
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
extremity bones, long bones
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 27, 2017
Tasarimmed Tibbi Mamuller Sanayi Ve Ticaret A.s. Sumru Alperen Deputy General Manager Demirkapi Topcular Mahallesi Topcular Caddesi Set Ustu No. 3 Istanbul. TR 34055 TR
Re: K170482 Trade/Device Name: Spider Frame External Fixation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: KTT Dated: September 12, 2017 Received: September 14, 2017
Dear Sumru Alperen:
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
1
the quality systems (OS) 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" (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 yours, Katherine D. Kavlock -
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) K170482
Device Name
Spider Frame External Fixation System
Indications for Use (Describe)
Spider Frame Computer Assisted External Fixation system used as a temporary or permanent method of correction and stabilization of the extremity bones.
Indications are:
-
- Post-Traumatic joint contracture which has resulted in loss of range of motion
-
- Fractures and disease which generally may result in joint contractures or loss of
- range of motion and fractures requiring distraction
-
- Open and closed fracture fixation
-
- Pseudoarthrosis of long bones
-
- Limb lengthening by epiphyseal or metaphyseal distraction
-
- Correction of bony or soft tissue deformities
-
- Correction of segmental bony or soft tissue defects
-
- Joint arthrodesis
-
- Infected fractures or nonunions,
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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