(92 days)
Not Found
Unknown
The description mentions "computer-controlled orthosis" and that the device "integrates seamlessly with movements initiated by the user themselves, and provides assistance based on the detected activity." While this implies some level of intelligent control and adaptation, the summary does not explicitly use terms like AI, ML, or describe the underlying algorithms in a way that confirms the use of these technologies. It could be using other forms of control systems.
Yes
The "Intended Use / Indications for Use" states the device is "intended to help assist ambulatory function in rehabilitation settings," which is a therapeutic purpose.
No
Explanation: The device description clearly states its purpose is to "assist ambulatory function" and describes it as an "ambulatory assistive device." It does not mention any function related to diagnosing medical conditions.
No
The device description clearly states it is a "robotic exoskeleton" and a "computer-controlled orthosis" that is "fitted to the lower body" and "powered at the knee," indicating it is a physical hardware device with integrated software, not a software-only device.
Based on the provided information, the Keeogo device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to assist ambulatory function in rehabilitation settings for individuals with stroke who have gait deficiencies. This is a therapeutic and assistive function, not a diagnostic one.
- Device Description: The device is described as an ambulatory assistive device that provides complementary force to the knee joint to aid in movement. It does not analyze biological samples or provide diagnostic information about a patient's condition.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on the analysis of biological samples.
The Keeogo is clearly an assistive medical device designed to aid in physical rehabilitation and mobility, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The Keeogo is robotic exoskeleton that fits orthotically on the user's waist, thigh, and shin, outside of clothing. The device is intended to help assist ambulatory function in rehabilitation settings under the supervision of a trained healthcare professional for the following population:
Individuals with stroke who have gait deficient hip (MMT Hip >= 3) and knee strength (MMT Knee >= 2) and who are capable of standing and initiating gait movement without assistance.
The trained healthcare professional must successfully complete a training program prior to fitting and tuning the device. The device is not intended for sports.
Product codes
PHL
Device Description
KeeogoTM Dermoskeleton System is an ambulatory assistive device that is fitted to the lower body, and is powered at the knee. This computer-controlled orthosis provides complementary force to the knee joint to assist with: (1) knee flexion and extension in the swing phase of gait, and (2) eccentric knee control and extension in the weight bearing phase.
KeeogoTM Dermoskeleton System does not move through a pre-determined pattern of movement, but rather integrates seamlessly with movements initiated by the user themselves, and provides assistance based on the detected activity.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
User's waist, thigh, and shin. Assists at the knee joint.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained healthcare professional / rehabilitation settings
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)
Non-Clinical Performance Data:
Several performance tests were conducted with the Keeogo™ Dermoskeleton System to demonstrate safety, effectiveness, and usability:
- Durability
- Vibration IEC 60601-1-11
- Electrical Safety IEC 60601-1
- Electromagnetic Compatibility (EMC) IEC 60601-1-2
- Usability IEC 62366
- Battery Safety IEC 62133:2012
- Sensor accuracy
- Biocompatibility testing in accordance with ISO 10993-1:2009, ISO 10993-5 & ISO 10993-10
Clinical Performance:
- Trial Registration: URL: http://www.clinicaltrials.gov, Identifier: NCT03986320
- Trial Design: Interventional, comparative, single-arm trial
- Trial Sites:
- The Shirley Ryan AbilityLab (Chicago, Illinois, USA)
- Human Performance and Engineering Research (HPER) (West Orange, New Jersey, USA)
- James J Peters VA Medical Center - Center for the Medical Consequences of Spinal Cord Injury (Bronx, New York, USA)
- Assistive Technology Clinic (ATC) (Toronto, Ontario, Canada)
- Condition: Stroke
- Test Groups: Keeogo – Intervention
- Intervention:
- Week 1: 3 baseline sessions
- Week 2: 3 device familiarization sessions
- Week 3: 3 Keeogo testing sessions
- Total Subjects:
- Safety Population (Visit 1): N=55. Age: 58 +/- 11. Gender: 26 female, 29 male. Hemiparesis: 25 left-side, 30 right-side. Stroke Legacy: 70 +/- 81 months. MMT: Hip: MMT >= 3+ (flexors & extensors), Knee: MMT >= 2 (flexors & extensors).
- Effectiveness Population: N=48. Age: 58 +/- 11. Gender: 23 female, 25 male. Hemiparesis: 23 left-side, 25 right-side. Stroke Legacy: 74 +/- 84 months. MMT: Hip: MMT >= 3+ (flexors & extensors), Knee: MMT >= 2 (flexors & extensors).
- Clinical Outcome Assessments:
- Baseline (each of three baseline test visits)
- Intervention (each of three device test visits)
- Post (after 9 visits)
- Results:
- Gait Quality Assessment, Wisconsin Gait Scale:
- Units: scalar
- Scale Range: [13.35, 42] = [healthy gait, max gait disability]
- Mean (SD):
- Baseline: 20.36 (3.22)
- Gait with Device: 17.76 (2.54)
- Change from Baseline (Paired test):
- Minimum Clinically Important Difference: 2.25
- Improvement: 2.60 (1.71)
- 95% Confidence interval for Improvement: 2.60 +/- 0.55
- Significance: P-Value = p
- Gait Quality Assessment, Wisconsin Gait Scale:
§ 890.3480 Powered lower extremity exoskeleton.
(a)
Identification. A powered lower extremity exoskeleton is a prescription device that is composed of an external, powered, motorized orthosis that is placed over a person's paralyzed or weakened limbs for medical purposes.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Elements of the device materials that may contact the patient must be demonstrated to be biocompatible.
(2) Appropriate analysis/testing must validate electromagnetic compatibility/interference (EMC/EMI), electrical safety, thermal safety, mechanical safety, battery performance and safety, and wireless performance, if applicable.
(3) Appropriate software verification, validation, and hazard analysis must be performed.
(4) Design characteristics must ensure geometry and materials composition are consistent with intended use.
(5) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Performance testing must include:
(i) Mechanical bench testing (including durability testing) to demonstrate that the device will withstand forces, conditions, and environments encountered during use;
(ii) Simulated use testing (
i.e., cyclic loading testing) to demonstrate performance of device commands and safeguard under worst case conditions and after durability testing;(iii) Verification and validation of manual override controls are necessary, if present;
(iv) The accuracy of device features and safeguards; and
(v) Device functionality in terms of flame retardant materials, liquid/particle ingress prevention, sensor and actuator performance, and motor performance.
(6) Clinical testing must demonstrate a reasonable assurance of safe and effective use and capture any adverse events observed during clinical use when used under the proposed conditions of use, which must include considerations for:
(i) Level of supervision necessary, and
(ii) Environment of use (
e.g., indoors and/or outdoors) including obstacles and terrain representative of the intended use environment.(7) A training program must be included with sufficient educational elements so that upon completion of training program, the clinician, user, and companion can:
(i) Identify the safe environments for device use,
(ii) Use all safety features of device, and
(iii) Operate the device in simulated or actual use environments representative of indicated environments and use.
(8) Labeling for the Physician and User must include the following:
(i) Appropriate instructions, warning, cautions, limitations, and information related to the necessary safeguards of the device, including warning against activities and environments that may put the user at greater risk.
(ii) Specific instructions and the clinical training needed for the safe use of the device, which includes:
(A) Instructions on assembling the device in all available configurations;
(B) Instructions on fitting the patient;
(C) Instructions and explanations of all available programs and how to program the device;
(D) Instructions and explanation of all controls, input, and outputs;
(E) Instructions on all available modes or states of the device;
(F) Instructions on all safety features of the device; and
(G) Instructions for properly maintaining the device.
(iii) Information on the patient population for which the device has been demonstrated to have a reasonable assurance of safety and effectiveness.
(iv) Pertinent non-clinical testing information (
e.g., EMC, battery longevity).(v) A detailed summary of the clinical testing including:
(A) Adverse events encountered under use conditions,
(B) Summary of study outcomes and endpoints, and
(C) Information pertinent to use of the device including the conditions under which the device was studied (
e.g., level of supervision or assistance, and environment of use (e.g., indoors and/or outdoors) including obstacles and terrain).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
September 09, 2020
B-Temia Inc. % Kristin Davenport Of Counsel Covington & Burling LLP 850 10th St NW Washington, DC 20001
Re: K201539
Trade/Device Name: Keeogo Dermoskeleton System Regulation Number: 21 CFR 890.3480 Regulation Name: Powered Lower Extremity Exoskeleton Regulatory Class: Class II Product Code: PHL Dated: May 31, 2020 Received: June 9, 2020
Dear Kristin Davenport:
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Heather Dean, PhD Acting Assistant Director, Acute Injury Devices DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201539
Device Name Keeogo Dermoskeleton System
Indications for Use (Describe)
The Keeogo is robotic exoskeleton that fits orthotically on the user's waist, thigh, and shin, outside of clothing. The device is intended to help assist ambulatory function in rehabilitation settings under the supervision of a trained healthcare professional for the following population:
Individuals with stroke who have gait deficient hip (MMT Hip ≥ 3) and knee strength (MMT Knee ≥ 2) and who are capable of standing and initiating gait movement without assistance.
The trained healthcare professional must successfully complete a training program prior to fitting and tuning the device. The device is not intended for sports.
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
| General
| Information: | Sponsor's Name: | B-Temia, Inc. |
|---|---|---|
| Address: | 4780, rue St-Félix - unité 105 | |
| St-Augustin-de-Desmaures (QC) G3A 2J9 | ||
| Canada | ||
| Contact Person: | Alexandre Jokic | |
| VP Regulatory, Clinical Affairs and Quality | ||
| Assurance, B-Temia Inc. | ||
| Address: | 4780, rue St-Félix - unité 105 | |
| St-Augustin-de-Desmaures (QC) G3A 2J9 | ||
| Canada | ||
| Telephone: | 418-653-1010 ext. 248 | |
| Fax Number: | 418 653-0155 | |
| Date Prepared: | May 31, 2020 | |
| Subject Device: | Trade Name: | Keeogo™ Dermoskeleton System |
| Common Name: | Powered Exoskeleton | |
| Product Code: | PHL | |
| FDA Regulation: | 21 CFR 890.3480 Powered lower extremity | |
| exoskeletons | ||
| Device Classification: | Class II | |
| Predicate Device: | Trade Name: | Honda Walking Assist Device |
| Common Name: | Powered Exoskeleton | |
| Product Code: | PHL | |
| FDA Regulation: | 21 CFR 890.3480 Powered lower extremity | |
| exoskeletons | ||
| Device Classification: | Class II | |
| Premarket Notification: | K181294 | |
| Indications for | ||
| Use: | The Keeogo™ Dermoskeleton System is robotic exoskeleton that fits | |
| orthotically on the user's waist, thigh, and shin, outside of clothing. The | ||
| device is intended to help assist ambulatory function in rehabilitation | ||
| settings under the supervision of a trained healthcare professional for the | ||
| following population: |
Individuals with stroke who have gait deficits and sufficient hip
(MMT Hip $≥$ 3) and knee strength (MMT Knee $≥$ 2) and who are capable
of standing and initiating gait movement without assistance. | |
| Description of
device: | KeeogoTM Dermoskeleton System is an ambulatory assistive device that is
fitted to the lower body, and is powered at the knee. This computer-
controlled orthosis provides complementary force to the knee joint to
assist with: (1) knee flexion and extension in the swing phase of gait, and
(2) eccentric knee control and extension in the weight bearing phase. | |
| | KeeogoTM Dermoskeleton System does not move through a pre-
determined pattern of movement, but rather integrates seamlessly with
movements initiated by the user themselves, and provides assistance based
on the detected activity. | |
The trained healthcare professional must successfully complete a training program prior to fitting and tuning the device. The device is not intended for sports.
4
Several performance tests were conducted with the Keeogo™ Non-Clinical Performance Data Dermoskeleton System to demonstrate safety, effectiveness, and usability: Add here
- Durability
- Vibration IEC 60601-1-11
- Electrical Safety IEC . 60601-1
- . Electromagnetic Compatibility (EMC) IEC 60601-1-2
- . Usability IEC 62366
- . Battery Safety IEC 62133:2012
- . Sensor accuracy
- . Biocompatibility testing in accordance with ISO 10993-1:2009, ISO 10993-5 & ISO 10993-10)
| Clinical
Performance | Trial
Registration | URL: http://www.clinicaltrials.gov
Identifier: NCT03986320 | | |
|-------------------------|-----------------------|-----------------------------------------------------------------------------------------------------------------------------|------------------------------|-----------------------------|
| | Trial Design | Interventional, comparative, single-arm trial | | |
| | Trial Sites | • The Shirley Ryan AbilityLab (Chicago, Illinois, USA) | | |
| | | • Human Performance and Engineering Research
(HPER) (West Orange, New Jersey, USA) | | |
| | | • James J Peters VA Medical Center - Center for the
Medical Consequences of Spinal Cord Injury (Bronx,
New York, USA) | | |
| | | • Assistive Technology Clinic (ATC) (Toronto, Ontario,
Canada) | | |
| | | | | |
| | Condition | Stroke | | |
| | Test Groups | Keeogo – Intervention | | |
| | Intervention | • Week 1: 3 baseline sessions
• Week 2: 3 device familiarization sessions
• Week 3: 3 Keeogo testing sessions | | |
| | Total Subjects | Population | Safety Population
Visit 1 | Effectiveness
Population |
| | | N | 55 | 48 |
| | | Age | $58 \pm 11$ | $58 \pm 11$ |
5
| | Gender | 26 female, 29
male | 23 female, 25
male |
|------------------------------------|----------------------------------------------------------|-------------------------------------------------------------------|--------------------------------------------|
| | Hemiparesis | 25 left-side, 30
right-side | 23 left-side, 25
right-side |
| | Stroke
Legacy | $70 \pm 81$ months | $74 \pm 84$ months |
| | | Hip: MMT ≥ 3+
(flexors &
extensors), | Hip: MMT ≥ 3+
(flexors &
extensors), |
| | MMT | Knee: MMT ≥ 2
(flexors &
extensors) | Knee: MMT ≥ 2
(flexors &
extensors) |
| Clinical
Outcome
Assessments | | ● Baseline (each of three baseline test visits) | |
| | | ● Intervention (each of three device test visits) | |
| | | ● Post (after 9 visits) | |
| Results | | Gait Quality Assessment, Wisconsin Gait Scale | |
| | | Units: scalar | |
| | | Scale Range: [13.35, 42] = [healthy gait, max gait
disability] | |
| | | Mean (SD) | |
| | | Baseline: 20.36 (3.22) | |
| | | Gait with Device: 17.76 (2.54) | |
| | Change from Baseline (Paired test) | | |
| | Minimum Clinically Important Difference: 2.25 | | |
| | Improvement: 2.60 (1.71) | | |
| | 95% Confidence interval for Improvement: $2.60 \pm$ 0.55 | | |
| | Significance: P-Value = p