(78 days)
Not Found
No
The description focuses on sensing weight and providing biofeedback based on pre-selected values, without mentioning any learning or adaptive algorithms.
Yes
The device is intended to assist in gait training and reeducation during rehabilitation by providing biofeedback on weight bearing, which directly supports the therapeutic process.
No
The device is described as a biofeedback system and a tool to assist clinicians in assessing patients during gait training. It measures weight applied to a limb and alerts the user if a pre-selected value is exceeded. While it provides objective assessment of weight bearing, its primary function is to monitor and provide feedback for rehabilitation, rather than to diagnose a condition or disease.
No
The device description explicitly states that the system is comprised of three sub-elements, including a "Flexible Foot force insole" and a "Central Processing Unit (CPU)," which are hardware components.
Based on the provided information, the SmartStep System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- SmartStep Function: The SmartStep System directly measures the weight applied to the plantar surface of the foot in vivo (within the living body). It does not analyze samples taken from the body.
- Intended Use: The intended use is for sensing weight during rehabilitation, providing biofeedback, and assessing weight-bearing status. This is a functional measurement related to physical therapy and rehabilitation, not a diagnostic test based on analyzing biological samples.
Therefore, the SmartStep System falls under the category of a medical device used for physical measurement and biofeedback, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SmartStep System is intended to sense the amount of weight applied to the plantar surface of the foot during rehabilitation. The device 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.
Product codes
IRN
Device Description
The SmartStep System is a biofeedback system for gait training and reeducation. The device is a tool to assist clinicians 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 rang. A patient's weight bearing status is important to know because it is an indicator of overall progress, and with certain conditions, under-weight bearing or over-weight bearing can lead to complication in the rehabilitation process.
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 three sub elements:
Flexible Foot force insole that is placed on the inside of a shoe worn by the patient over a sock.
Central Processing Unit (CPU)- the unit is connected to computer software.
Computer software that acts as a patient medical record and patient assessment tool.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
plantar surface of the foot, lower limb
Indicated Patient Age Range
Not Found
Intended User / Care Setting
user and/or therapist; under the supervision of physician or licensed health care provider such as physiotherapist.
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)
Based on validations and performance testing results, Andante Medical Devices Ltd. believes that the SmartStep System is substantially equivalent to its predicate device cited above without raising new safety and/or effectiveness issues.
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
§ 890.5575 Powered external limb overload warning device.
(a)
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.(b)
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.
0
510(K) SUMMARY
SmartStep System
510(k) Number K_ ○ 2 3 L G 1
Applicant's Name:
DEC 1 0 2002
Andante Medical Devices Ltd. 15 Yehoshua Hatsoref Street Beer-Sheva 84106, Israel Tel.: 972-8-6239043 Fax: 972-8-6231246
Contact Person:
Orly Maor Push-med Ltd. 117 Ahuzah St. Ra'anana 43373, Israel Tel: 972-9-7718130 Fax: 972-9-7718131
Date Prepared:
September 2002
Trade Name:
SmartStep System
Classification Name:
DEVICE, WARNING, OVERLOAD, EXTERNAL LIMB, POWERED
Classification:
The FDA has classified Enteroscopes as class II devices (product code IRN, Regulation No. 890.5575) and they are reviewed by the Physical Medicine Panel.
1
page 2 of 3
Predicate Device:
- Ped Alert Plenet manufactured by Planet Products Corp USA (former ● Orbitec Technologies Corp.) cleared under K950656.
- ForceGuard manufactured by Impact Monitors, Inc. USA cleared under ● K955034.
- AccuTread™ System manufactured by Chattanooga Group Inc. cleared ● under K991313.
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 60601-2, IEC 60601-1-4, EN-1441.
Intended Use:
The SmartStep System is intended to sense the amount of weight applied to the plantar surface of the foot during rehabilitation. The device 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 Description:
The SmartStep System is a biofeedback system for gait training and reeducation. The device is a tool to assist clinicians 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 rang. A patient's weight bearing status is important to know because it is an indicator of overall progress, and with certain conditions, under-weight bearing or over-weight bearing can lead to complication in the rehabilitation process.
The SmartStep system is to be used under the supervision of physician or licensed health care provider such as physiotherapist.
2
K023161
page 3 of 3
The SmartStep system is comprised of three sub elements:
Flexible Foot force insole that is placed on the inside of a shoe worn by the patient over a sock.
Central Processing Unit (CPU)- the unit is connected to computer software.
Computer software that acts as a patient medical record and patient assessment tool.
Substantial Equivalence:
Based on validations and performance testing results, Andante Medical Devices Ltd. believes that the SmartStep System is substantially equivalent to its predicate device cited above without raising new safety and/or effectiveness issues.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
nd Drug Administration 00 Corporate Boulevard Rockville MD 20850
DEC 1 0 2002
Mr. Orly Maor Push-Med Ltd. for Andante Medical Devices Ltd. 117. Ahuza Street Ra'ananna 43373, ISRAEL
Re: K023161
Trade/Device Name: Andante SmartStep System Regulation Number: 21 CFR 890.5575 Regulation Name: Powered External Limb Overload Warning Device Regulatory Class: II Product Code: IRN Dated: September 18, 2002 Received: September 23, 2002
Dear Mr. Maor:
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.
Image /page/3/Picture/12 description: The image shows a partial view of a logo or emblem. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the edge of the image. A stylized graphic element, consisting of a series of curved lines, is also visible.
4
Page 2 - Mr. Orly Maor
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); 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 (301) 594- _ . 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours.
Mark N. Millman
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE STATEMEN
510(k) Number (if known):
Device Name:
SmartStep System
Indications for Use:
The SmartStep System is intended to sense the amount of weight applied to the plantar surface of the foot during rehabilitation. The device 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.
(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
for Mark n Melleen
(Division Sign-Off)
eral, Restorative
510(k) Number k0231