(77 days)
No
The summary does not mention AI, ML, or related terms, and the described features (spine curve reconstruction, automatic angle calculation) can be achieved with traditional algorithms.
No.
The "Intended Use / Indications for Use" states that the device is "intended to measure the angle of spinal deformity as an aiding tool for the diagnosis and monitoring of spinal deformities". This indicates a diagnostic and monitoring function, not a therapeutic one. It does not treat or alleviate the condition.
Yes
The device is described as "an aiding tool for the diagnosis and monitoring of spinal deformities."
Unknown
The summary describes the device's function and features, which are software-based (reconstruction, calculation, indication). However, it mentions "points sampled by the Sensor" without describing the sensor itself or whether it is part of the Ortelius 800 device or a separate, required hardware component. Without this clarification, it's impossible to definitively state if the Ortelius 800 is software-only.
Based on the provided information, the Ortelius 800 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Ortelius 800 Function: The description clearly states the Ortelius 800 is intended to "measure the angle of spinal deformity" and "reconstruct spine curves based on the points sampled by the Sensor." This involves direct measurement of the body's structure, not analysis of biological samples.
- Lack of Biological Sample Mention: There is no mention of the device interacting with or analyzing any biological samples.
The Ortelius 800 falls under the category of a medical device used for diagnosis and monitoring, but specifically a device that interacts with the body's physical structure rather than its biological components.
N/A
Intended Use / Indications for Use
The Ortelius 800 is a prescriptive device intended to measure the angle of spinal deformity as an aiding tool for the diagnosis and monitoring of spinal deformities such as scoliosis and kyphosis.
The Ortelius 800 may be used in medical clinics/institutes.
Product codes
KQX
Device Description
The Ortelius 800 is a device designed for the measuring and monitoring spine deformities.
The Ortelius 800 enables the following features:
- · Spine curve reconstruction based on the points sampled by the Sensor.
- · Automatically calculated spine deformity angles of the primary curve.
- · Indication of the extreme vertebra from which the spine deformity angle was calculated.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spinal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical clinics/institutes
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
§ 888.1500 Goniometer.
(a)
Identification. A goniometer is an AC-powered or battery powered device intended to evaluate joint function by measuring and recording ranges of motion, acceleration, or forces exerted by a joint.(b)
Classification. (1) Class I (general controls) for a goniometer that does not use electrode lead wires and patient cables. This device is exempt from the premarket notification procedures of subpart E of part 807 of this chapter subject to § 888.9.(2) Class II (special controls) for a goniometer that uses electrode lead wires and patient cables. The special controls consist of:
(i) The performance standard under part 898 of this chapter, and
(ii) The guidance entitled “Guidance on the Performance Standard for Electrode Lead Wires and Patient Cables.” This device is exempt from the premarket notification procedures of subpart E of part 807 of this chapter subject to § 888.9.
0
510(K) SUMMARY
Ortelius 800
510(k) Number K 6(1827 pl /2
Applicant's Name:
Orthoscan Ltd. P.O.B. 281 Yokneam Eilit, 20692 Israel Tel: 972-4-9937363 Fax: 972-4-9937364
Contact Person:
Shoshana Friedman, RAC Push-med Ltd. 117 Ahuzah St. Ra'anana 43373, Israel Tel: 972-9- 7718130 Fax: 972-9-7718131
Date Prepared:
June 2001
Trade Name:
Ortelius 800
Classification Name:
Goniometer
Classification:
The FDA has classified Goniometer as class II devices (product code 87 KQX, Regulation No. 888.1500) and they are reviewed by the Orthopedic Panel.
1
Predicate Device:
- Orthopedic Systems, Inc. Scoliometer cleared under K832494 .
- Skill Technologies, 3D-SPINE, cleared under K962377 .
Performance Standards:
No performance standards have been established for such device under Section No performance Startal Food, Drug, and Cosmetic Act. However, the Ortelius 800 514 of the rederar rood, Drag, IEC 60601-1; EN 60601-1; UL 2601-1; CSA-C22.2; IEC 60601-2 1993; EN 60601-4; EN-1441.
Intended Use:
The Ortelius 800 is a prescriptive device intended to measure the angle of spinal The Orients 000 is a presentator for the diagnosis and monitoring of spinal deformities such as scoliosis and kyphosis.
The Ortelius 800 may be used in medical clinics/institutes.
Device Description:
The Ortelius 800 is a device designed for the measuring and monitoring spine deformities.
The Ortelius 800 enables the following features:
- · Spine curve reconstruction based on the points sampled by the Sensor.
- · Automatically calculated spine deformity angles of the primary curve.
- · Indication of the extreme vertebra from which the spine deformity angle was calculated.
Substantial Equivalence:
Orthoscan Ltd. believes that, based on validations and performance testing Orthosoan Eld. Och 10 is substantially equivalent to its predicate device cited above without raising new safety and/or effectiveness issues.
2
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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 8 2001
Ms. Shoshana Friedman, RAC Push-med Ltd. 117 Ahuza Street Ra'ananna 43373 Israel
Re: K011827
Trade/Device Name: Ortelius 800 Regulation Number: 888.1500 Regulatory Class: II Product Code: KQX Dated: June 6, 2001 Received: June 12, 2001
Dear Ms. Friedman:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. Page 2 - Ms. Shoshana Friedman
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Page 2 - Ms. Shoshana Friedman
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely vours,
h. Mark N. Mellemson
Celia M. Witten, Ph.D., M.D. Director
Division of General, Restorative and Neurological Devices Office of Devices Evaluation Center for Devices and Radiological Devices
Enclosure
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INDICATIONS FOR USE STATEMENT
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Ortelius 800 Device Name:
Indications for Use:
The Ortelius 800 is a prescriptive device intended to measure the angle of spinal deformity as an aiding tool for the diagnosis and monitoring of spinal deformities such as scoliosis and kyphosis.
The Ortelius 800 may be used in medical clinics/institutes.
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
510(k) Number ________________________________________________________________________________________________________________________________________________________________
Prescription Use (Per 21 CFR 801.109) OR
Over the Counter Use
Mark N Millburn
Division Sign-Off) Division of General, Restorative and Neurological Devices
KO1182
510(k) Number_
7-6