ORTELIUS 800

K011827 · Orthoscan , Ltd. · KQX · Aug 28, 2001 · Orthopedic

Device Facts

• Record ID: K011827
• Device Name: ORTELIUS 800
• Applicant: Orthoscan , Ltd.
• Product Code: KQX · Orthopedic
• Decision Date: Aug 28, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1500
• Device Class: Class 1

Intended 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.

Device Story

Ortelius 800 is a goniometer for measuring and monitoring spinal deformities. Device uses a sensor to sample points along the spine; reconstructs spinal curve; automatically calculates deformity angles of primary curve; identifies extreme vertebrae used for calculation. Used in medical clinics/institutes by healthcare professionals. Output provides quantitative spinal measurements to assist clinicians in diagnosing and monitoring conditions like scoliosis and kyphosis, potentially improving patient management.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Goniometer; electronic sensor-based measurement system. Complies with IEC 60601-1, EN 60601-1, UL 2601-1, CSA-C22.2, IEC 60601-2, EN 60601-4, and EN-1441 standards. Features automated calculation of spinal deformity angles and curve reconstruction.

Indications for Use

Indicated for patients requiring measurement of spinal deformity angles to aid in the diagnosis and monitoring of scoliosis and kyphosis. For use in medical clinics/institutes by prescription.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Orthopedic Systems, Inc. Scoliometer (K832494)
• Skill Technologies, 3D-SPINE (K962377)

Submission Summary (Full Text)

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#### 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: [phone] Fax: [phone]

#### Contact Person:

Shoshana Friedman, RAC Push-med Ltd. 117 Ahuzah St. Ra'anana 43373, Israel Tel: [phone] Fax: [phone]

## 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.

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#### 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.

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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