SMARTSTEP SYSTEM/SMARSTEP CLINIC SYSTEM

K060150 · Andante Medical Devices , Ltd. · IRN · Feb 23, 2006 · Physical Medicine

Device Facts

• Record ID: K060150
• Device Name: SMARTSTEP SYSTEM/SMARSTEP CLINIC SYSTEM
• Applicant: Andante Medical Devices , Ltd.
• Product Code: IRN · Physical Medicine
• Decision Date: Feb 23, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 890.5575
• Device Class: Class 2

Indications for Use

The SmartStep™ System is intended to sense the amount of weight applied to the planter surface of the foot during rehabilitation. The System alerts the user and/or therapist with alarm when the weight exceeded the pre-selected value. Furthermore, the SmartStep™ System is intended to be used in any situation in which therapist and/or patient would benefit from objectively assessing the amount of weight that is being applied to a lower limb.

Device Story

SmartStep™ is a gait monitoring and biofeedback system; consists of a pressure-sensing flexible insole, a control unit, and PC software. Insole placed in patient shoe; manual pump inflates insole compartments. System measures weight applied to plantar surface; alerts therapist/patient via alarm when weight exceeds pre-selected threshold. Used in clinical settings under supervision of physician or physiotherapist. PC software acts as patient medical record and assessment tool. Provides objective data to assist in gait therapy and weight-bearing skill training; helps patients maintain specific weight-bearing ranges.

Clinical Evidence

Bench testing only. Electrical, electromagnetic, and software verification and validation testing performed to ensure safety and efficacy of modified components.

Technological Characteristics

System includes flexible pressure-sensing insole, manual inflation pump, control unit, and PC software. Complies with IEC 60601-1, IEC 60601-1-2, AAMI/ISO 14971-1, and FCC CFR parts 15 (Subparts B & C). Features wireless control unit, battery-powered operation, and PC-based software interface.

Indications for Use

Indicated for patients undergoing weight-bearing restrictions and gait therapy training requiring objective assessment of weight applied to the lower limb during rehabilitation.

Regulatory Classification

Identification

A powered external limb overload warning device is a device intended for medical purposes to warn a patient of an overload or an underload in the amount of pressure placed on a leg.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.

Predicate Devices

• Andante SmartStep™ System (K023161)

Submission Summary (Full Text)

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Kobo150

# FEB 2 3 2006

## 510(K) SUMMARY

Andante Medical Devices LTD.

## SmartStep™ System

## 7.1.1 Applicant's Name:

Andante Medical Devices Ltd. Omer Industrial Park Bldg. 8b. P.O. Box 3023 Omer 84965, ISRAEL Tel: [phone] Fax: [phone] [e-mail]

## 7.1.2 Contact Person:

Dorit Winitz, Ph. D Biomedical Strategy (2004) Ltd. Moshe Aviv Tower, 34th Floor, 7 Jabotinsky Street Ramat Gan 52520, Israel Tel: [phone] Fax: [phone] [e-mail]

## 7.1.3 Date Prepared:

January, 2006

## 7.1.4 Trade Name:

SmartStep™ System/ SmartStep™ Clinic System

#### 7.1.5 Classification Name:

Device, Warning, Overload, External

#### 7.1.6 Classification:

Class II; Product Code IRN; Regulation No. 890.5575

## 7.1.7 Predicate Devices

Andante SmartStep™ System (K023161)

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2/5 KAb6150

## 7.1.8 Device Description:

The SmartStep™ System is a monitoring & biofeedback system for gait the Umar 8000 - " Dy 500" The device is a tool, which is intended to assist the clinicians to accurately assess patients who are undergoing weight bearing restrictions and gait therapy training.

The SmartStep™ is used to measure the amount of weight being applied to an affected limb, to teach and promote specific weight bearing skills and to test patient's ability to maintain a weight bearing range.

The SmartStep™ system is to be used under the supervision of physician or licensed health care provider such as physiotherapist.

The SmartStep™ System is comprised of the following three main subelements:

- Flexible Insole that is placed in the patient's shoe, acting as a . pressure-sensing element.
- Control Unit, connected to PC Software. ■
- PC Software that acts as a patient medical record and patient l assessment tool.

A Manual Pump is used to inflate the Insole compartments.

## 7.1.9 Intended Use:

The SmartStep™ System is intended to sense the amount of weight applied to the planter surface of the foot during rehabilitation. The System alerts the user and/or therapist with alarm when the weight exceeded the pre-selected value. Furthermore, the SmartStep™ System is intended to be used in any situation in which therapist and/or patient would benefit from objectively assessing the amount of weight that is being applied to a lower limb.

## 7.1.10 Performance Standards:

No performance standards have been established for such device under Section 514 of the Federal Food, Drug, and Cosmetic Act. However, the SmartStep™ System complies with the voluntary standards such as IEC 60601-1, IEC 60601-1-2, AAMI/ISO 14971-1, and with the FCC requirements of CFR, parts 15, Subparts B & C.

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## 7.1.11 Performance Data & Substantial Equivalence

The SmartStep™ System is substantially equivalent in all aspects, e.g., technological characteristics, mode of operation, performance characteristics, intended use, etc., to the commercially available SmartStep™ System. The principle changes between the devices include:

#### 1. Control Unit

- 1.1 The design of the Control Unit was changed to improve its ergonomic design and to enable a wireless operated unit.
- Inflation connectors were added to the Control Unit to enable on-1.2 line monitoring of the inflation status.
- The operation modes were re-organized and the vibration feedback 1.3 was eliminated.
- 1.4 Fault-condition indications and battery automatic shut-off capability were added.
- 1.5 Part of the electronic components of the Control Unit, such as microcontroller, battery and charger, were changed to improve device performance and reliability.

#### 2. Manual Pump

The insole inflation pump was improved to include a Manual Pump rather than a syringe.

- Software and User Interface క.
- 3.1 The PC User Interface was improved to include more intuitive, simple and clear GUI and to support multilingual User Interface.
- 3.2 Several functions and options were added to the PC Software.
- 3.3 The Software (PC and Control Unit) as a whole has been upgraded.

Electrical and electromagnetic testing and verification and validation testing of the Software were performed to ensure that the modified SmartStep™ System does not raise any new questions of safety and efficacy. Based on these tests results, Andante Medical devices Ltd. believes that the modified SmartStep™ System is substantially equivalent to the cleared SmartStep™ System, without raising new safety and/or effectiveness issues.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. Inside the circle is a stylized image of three human figures.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 3 2006

Andante Medical Devices Ltd. C/O Dorit Winitz, Ph.D Biomedical Strategy (2004) Ltd. Moshe Aviv Tower, 34th floor 7 Jabotinsky Street Ramat, Gan 52520, Israel

Re: K060150

Trade/Device Name: SmartStepTM System/ SmartStep™ Clinic System Regulation Number: 21 CFR 890.5575 Regulation Name: Powered External Limb Overload Warning Device Regulatory Class: II Product Code: IRN Dated: January 15, 2006 Received: January 28, 2006

Dear Dr. Winitz:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becareer in the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 use stated in the encreativent of the enactment date of the Medical Device Amendments, or to conninered print to may 20, 1978, accordance with the provisions of the Federal Food. Drug, de rices that have been rocksonied in quire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, merely mains 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 may or sabyer to basil as a same as a 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 I toast of actived that I Dr instan that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I vatuation and including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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## Page 2 - Dr. Dorit Winitz

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Doctors over device as described in your Section 5 10(k)
This letter will allow you to begin marketing your device as described in your I ms letter will anow you to begin manketing your arrial equivalence of your device to a legally premarket nothleation. The PDA miding of backandary of 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 If you desire specific advice for your act [phone]. Also, please note the regulation entitled, a Colliact the Office of Compullios as (21 ) notification" (21CFR Part 807.97). You may obtain Misolanuing by reference to premanter for the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number [phone] or Manufacturers, International and Ochess http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Herbert Lewinsohn

Mark N. Melkerson Acting 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): ____________________________________________________________________________________________________________________________________________________

SmartStep™ System/ SmartStep™ Clinic System Device Name:

Indications for Use:

The SmartStep™ System/ SmartStep™ Clinic System is intended to sense the amount of weight applied to the planter surface of the foot during rehabilitation. The System alerts the user and/or therapist with alarm when the weight exceeded the pre-selected value. Furthermore, the SmartStep™ System/ SmartStep™ Clinic System is intended to be used in any situation in which therapist and/or patient would benefit from objectively assessing the amount of weight that is being applied to a lower limb.

Prescription Use V (Part 21 C.F.R. 801 Subpart D) AND/OR

Over-The-Counter Use (Part 21 C.F.R. 807 Subpart C)

KO60150

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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| | (Division Sign-Off) |
| | Division of General, Restorative, |
| 7-10 | and Neurological Devices |
| | 510(k) Number_ |