← Product Code [IRN](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRN) · K023161 # SMARTSTEP SYSTEM (K023161) _Andante Medical Device, Ltd. · IRN · Dec 10, 2002 · Physical Medicine · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRN/K023161 ## Device Facts - **Applicant:** Andante Medical Device, Ltd. - **Product Code:** [IRN](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRN.md) - **Decision Date:** Dec 10, 2002 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 890.5575 - **Device Class:** Class 2 - **Review Panel:** Physical Medicine - **Attributes:** Therapeutic ## 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. ## Device Story SmartStep is a biofeedback system for gait training/reeducation. Input: weight applied to plantar surface of foot via flexible insole placed inside shoe. Processing: Central Processing Unit (CPU) monitors weight against pre-selected threshold; integrated with computer software for patient assessment and medical record keeping. Output: audible alarm to user/therapist when weight exceeds threshold. Used in clinical settings under supervision of physician or physiotherapist. Benefits: assists clinicians in assessing weight-bearing status; promotes specific weight-bearing skills; monitors patient progress; prevents complications from improper weight-bearing during rehabilitation. ## Clinical Evidence Bench testing only. Compliance with voluntary standards IEC 60601-1, IEC 60601-2, IEC 60601-1-4, and EN-1441. ## Technological Characteristics System components: flexible foot force insole, Central Processing Unit (CPU), and computer software. Operates as a powered external limb overload warning device. Complies with IEC 60601-1, IEC 60601-2, IEC 60601-1-4, and EN-1441 standards. ## Regulatory 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 - Ped Alert Plenet ([K950656](/device/K950656.md)) - ForceGuard ([K955034](/device/K955034.md)) - AccuTread™ System ([K991313](/device/K991313.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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 --- **Source:** [https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRN/K023161](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRN/K023161) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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