(106 days)
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Not Found
No
The description focuses on a mechanical device with adjustable components and mentions the optional use of basic, legally marketed gait analysis software, which is not supplied with the device and is used by the practitioner to inform calibration, not as an integrated AI/ML component. There is no mention of AI, ML, or related concepts in the summary.
Yes
The device is intended to temporarily reduce knee pain and improve lower extremity function, which are therapeutic effects for patients with knee osteoarthritis.
No
The device is described as a treatment system used to adjust weight/force distribution on a lower limb to reduce pain and improve function in patients with knee osteoarthritis. While legally marketed gait analysis software may be used by practitioners to inform calibration or collect measurements, the AposTherapy System itself is not described as providing a diagnosis or diagnostic information.
No
The device description clearly outlines physical components like shoe-like uppers, convex units (Pertupods), a screw fixation mechanism, soft spacers, weight discs, hard spacers, and wedge spacers. While software may be used by practitioners, it is not part of the supplied device.
No, this device is not an IVD (In Vitro Diagnostic).
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 detect diseases, conditions, or infections.
- AposTherapy System Function: The AposTherapy System is a biomechanical device worn externally on the feet. Its purpose is to adjust weight distribution and provide physical therapy to the lower limbs. It does not analyze biological samples.
- Intended Use: The intended use clearly states it's for adjusting weight/force distribution and helping to reduce pain and improve function in patients with knee osteoarthritis. This is a therapeutic and rehabilitative function, not a diagnostic one.
- Device Description: The description details shoe-like uppers, convex units, and adjustment mechanisms. There is no mention of components for sample collection or analysis.
- Lack of Biological Sample Analysis: The entire description focuses on the physical interaction of the device with the patient's lower limbs and gait, not on the analysis of any biological material.
Therefore, based on the provided information, the AposTherapy System falls under the category of a physical medicine device, not an In Vitro Diagnostic. The predicate device listed (21 C.F.R. 890.3475) is for a "Lower extremity exercise system," which further supports its classification as a physical therapy/rehabilitation device.
N/A
Intended Use / Indications for Use
The AposTherapy System is intended to be used by trained professionals for adjusting the distribution of weight/force(s) that is being applied to a lower limb. The AposTherapy System is intended for patients with knee osteoarthritis, to help temporarily reduce knee pain and improve lower extremity function during activities of daily living.
Product codes
QDT
Device Description
The AposTherapy System consists of a pair of shoe-like uppers with two convex units (Pertupods) on the sole of each shoe, a screw fixation mechanism for securely attaching the Pertupod to the track and, if required, soft spacers, weight discs, hard spacers, and wedge spacers. Legally marketed gait analysis software may be used by practitioners to help inform their calibration of the biomechanical device, but the software is not supplied with the device.
The device is worn over socks, so it has no direct contact with the patient. Based on a preliminary evaluation of pain, function, and quality of life, a personalized therapy program is created to meet the patient's treatment needs using the personally calibrated device. Practitioners may use basic, legally marketed gait analysis software (not provided with the device) to collect measurements from various movements (e.g., velocity, step length, single limb support) as part of the treatment program. The patient's progress is assessed periodically; the device is then further adjusted and the therapy program updated as needed to achieve the pre-defined goals. The device is intended to be worn only during the time scheduled by the practitioner (e.g., 30 minutes a day).
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
lower limb, lower extremities
Indicated Patient Age Range
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Intended User / Care Setting
trained professionals, practitioner
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing: The AposTherapy System underwent non-clinical testing conducted to ensure that the device can perform as intended. In all instances, the AposTherapy System functioned as intended and each test's success criteria were met.
Clinical testing: A prospective, randomized, sham-controlled clinical trial that enrolled 220 knee OA patients was completed. The data from this study is the primary evidence to support device clearance. The results of the study demonstrate that the AposTherapy System temporarily improves lower extremity function during activities of daily living and reduces knee pain due to OA in the intended treatment population. Specifically, WOMAC global scores at week 24 were 1.37±1.15 and 2.47±1.80 in the AposTherapy and sham arms, respectively (1.10 mean difference, Cohen's d of 0.73). In addition, 83% of the AposTherapy arm (95% Cl: 74% - 89%) and 42% of the sham arm (95% Cl: 33% - 52%) achieved 50% change in WOMAC 24 (adjusted odds ratio: 6.67 (95% Cl: 3.54-12.58) and adjusted Mantel-Haenszel risk difference of 0.42 (95% Cl: 0.28 – 0.52)).
Additional clinical evidence from the published literature and other independent studies investigating the device's performance for knee pain and function outcomes have been completed and are supplemental evidence in support of device clearance. These supplemental sources also show that the AposTherapy System has been thoroughly investigated and has achieved consistent improvement on knee pain and function outcomes.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
WOMAC global scores at week 24 were 1.37±1.15 and 2.47±1.80 in the AposTherapy and sham arms, respectively (1.10 mean difference, Cohen's d of 0.73). 83% of the AposTherapy arm (95% Cl: 74% - 89%) and 42% of the sham arm (95% Cl: 33% - 52%) achieved 50% change in WOMAC 24 (adjusted odds ratio: 6.67 (95% Cl: 3.54-12.58) and adjusted Mantel-Haenszel risk difference of 0.42 (95% Cl: 0.28 – 0.52)).
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 890.3475 Limb orthosis.
(a)
Identification. A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement. Examples of limb orthoses include the following: A whole limb and joint brace, a hand splint, an elastic stocking, a knee cage, and a corrective shoe.(b)
Classification. Class I (general 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. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, regarding general requirements concerning records and § 820.198, regarding complaint files.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
November 16, 2018
APOS Medical Assets Ltd. % Janice Hogan Partner Hogan Lovells U.S. LLP 1735 Market Street, Floor 23 Philadelphia, Pennsylvania 19103
Re: K182090
Trade/Device Name: AposTherapy System Regulation Number: 21 CFR 890.3475 Regulation Name: Limb Orthosis Regulatory Class: Class I Product Code: ODT Dated: October 25, 2018 Received: October 25, 2018
Dear Janice Hogan:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
1
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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Vivek J. Pinto -S
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K182090
Device Name AposTherapy System
Indications for Use (Describe)
The AposTherapy System is intended to be used by trained professionals for adjusting the distribution of weight/force(s) that is being applied to a lower limb. The AposTherapy System is intended for patients with knee osteoarthritis, to help temporarily reduce knee pain and improve lower extremity function during activities of daily living.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY - K182090 APOS Medical Assets Ltd.'s AposTherapy System
Submitter
APOS Medical Assets Ltd. 7 Hapelech Street Tel-Aviv, Israel 6816727
Phone: 917-993-2911
Contact Person: Cliff Bleustein, MD, MBA, Chief Medical Officer
Date: November 16, 2018
Name of Device: AposTherapy System
Common or Usual Name: Orthosis, Shoe with adjustable sole units
Classification Name: 21 C.F.R. 890.3475, Limb orthosis
Regulatory Class: Class I
Product Code: QDT, Shoe with adjustable sole units
Predicate Device: Substantially equivalent to 21 C.F.R. 890.3475
Device Description
The AposTherapy System consists of a pair of shoe-like uppers with two convex units (Pertupods) on the sole of each shoe, a screw fixation mechanism for securely attaching the Pertupod to the track and, if required, soft spacers, weight discs, hard spacers, and wedge spacers. Legally marketed gait analysis software may be used by practitioners to help inform their calibration of the biomechanical device, but the software is not supplied with the device.
The device is worn over socks, so it has no direct contact with the patient. Based on a preliminary evaluation of pain, function, and quality of life, a personalized therapy program is created to meet the patient's treatment needs using the personally calibrated device. Practitioners may use basic, legally marketed gait analysis software (not provided with the device) to collect measurements from various movements (e.g., velocity, step length, single limb support) as part of the treatment program. The patient's progress is assessed periodically; the device is then further adjusted and the therapy program updated as needed to achieve the pre-defined goals. The device is intended to be worn only during the time scheduled by the practitioner (e.g., 30 minutes a day).
4
Intended Use / Indications for Use
The AposTherapy System is intended to be used by trained professionals for adjusting the distribution of weight/force(s) that is being applied to a lower limb. The AposTherapy System is intended for patients with knee osteoarthritis, to help temporarily reduce knee pain and improve lower extremity function during activities of daily living.
Summary of Technological Characteristics
The intended use of the device is consistent with the classification regulation for a limb orthosis, which defines a class I, 510(k)-exempt device. The adjunctive indication for knee pain due to osteoarthritis does not represent a separate intended therapeutic effect or raise different questions of safety or effectiveness as compared to legally marketed devices of this type, because pain reduction is an outcome of the intended use to re-align limbs and improve their function.
The fundamental technological characteristics of the AposTherapy System are consistent with the classification regulation for a limb orthosis. As defined in 21 C.F.R. § 890.3475, the subject device is worn on the lower extremities, and is used to align body structures for functional improvement. Corrective shoes are specifically listed in the regulation as examples of this type of device.
Moreover, the AposTherapy System's underlying technological principle/mechanism of action is shared with other legally marketed devices. Specifically, Apos Therapy achieves the intended clinical purpose through two mechanisms: 1) adjusting the foot's points of contact with the ground to affect the distribution of weight/force(s) applied to the lower limb, and 2) instability during gait exercise. As noted above, the subject device is in the form of an orthosis shoe, consistent with devices cleared under 21 C.F.R. § 890.3475. The AposTherapy System, like other corrective shoes, is calibrated to the individual patient's needs and adjusted as the patient progresses, and with clinician's assessment of load bearing, gait, and related indicators of function and/or pain at baseline and throughout the course of treatment.
Performance Data
The AposTherapy System underwent non-clinical testing conducted to ensure that the device can perform as intended. In all instances, the AposTherapy System functioned as intended and each test's success criteria were met.
In addition, clinical testing was performed to demonstrate the device's safety and effectiveness for the proposed indications. A prospective, randomized, sham-controlled clinical trial that enrolled 220 knee OA patients was completed. The data from this study is the primary evidence to support device clearance. The results of the study demonstrate that the AposTherapy System temporarily improves lower extremity function during activities of daily living and reduces knee pain due to OA in the intended treatment population. Specifically, WOMAC global scores at week 24 were 1.37±1.15 and 2.47±1.80 in the AposTherapy and sham arms, respectively (1.10 mean difference, Cohen's d of 0.73). In addition, 83% of the AposTherapy arm (95% Cl: 74% - 89%) and 42% of the sham arm (95% Cl: 33% - 52%) achieved 50% change in WOMAC 24 (adjusted odds
5
ratio: 6.67 (95% Cl: 3.54-12.58) and adjusted Mantel-Haenszel risk difference of 0.42 (95% Cl: 0.28 – 0.52)).
Additional clinical evidence from the published literature and other independent studies investigating the device's performance for knee pain and function outcomes have been completed and are supplemental evidence in support of device clearance. These supplemental sources also show that the AposTherapy System has been thoroughly investigated and has achieved consistent improvement on knee pain and function outcomes. Consequently, the totality of the data strongly supports clearance of the device for use in patients with knee OA to temporarily improve knee pain and lower extremity function during activities of daily living.
Conclusions
The AposTherapy System fits within the definition set forth in the classification regulation for a limb orthosis device. Moreover, the AposTherapy System has the same intended use and similar indications for use, technological characteristics, and principles of operation as other legally marketed limb orthoses. Finally, bench and clinical data demonstrate that the AposTherapy System is as safe and effective as other leqally marketed lower limb orthoses. Thus, the AposTherapy System is substantially equivalent.