(177 days)
Not Found
No
The summary describes a robotic exoskeleton with sensors and adjustable settings controlled by a healthcare professional. There is no mention of AI, ML, or any learning algorithms used for gait analysis, assistance adaptation, or other functions. The control appears to be based on pre-set parameters adjusted by the user.
Yes
The device is described as "intended to help assist ambulatory function in rehabilitations" for individuals with stroke who have gait deficits, directly addressing a health condition.
No
The device is an exoskeleton intended to assist ambulatory function in rehabilitation and is not designed to diagnose medical conditions or diseases.
No
The device description clearly states it is a "robotic exoskeleton" with physical components like motors, sensors, and a battery, which are hardware. While it uses software for control, it is not a software-only device.
Based on the provided information, the GEMS-H device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- GEMS-H Function: The GEMS-H is a robotic exoskeleton that is worn externally on the body to assist with physical movement (ambulatory function). It does not analyze biological samples.
- Intended Use: The intended use clearly states it's for assisting ambulatory function in rehabilitation, not for diagnostic testing.
The GEMS-H is a medical device, specifically a rehabilitation device or assistive device, but it does not fall under the category of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The GEMS-H is a robotic exoskeleton that fits orthotically on the wearer's waist and thighs, outside of clothing. The device is intended to help assist ambulatory function in rehabilitations under the supervision of a trained healthcare professional for the following population:
· Individuals with stroke who have gait deficits and exhibit gait speeds of at least 0.4 m/s and are able to walk at least 10 meters with assistance from a maximum of one person.
The trained healthcare professional must successfully complete a training program prior to use of the device. The device is not intended for sports.
Product codes (comma separated list FDA assigned to the subject device)
PHL
Device Description
The GEMS-H is a lightweight, robotic exoskeleton designed to help assist ambulatory function of stroke patients who meet the assessment criteria, in rehabilitations under the supervision of a trained healthcare professional. The GEMS-H device provides assistance to the patient during hip flexion and extension.
The device is worn over clothing around the wearer's waist and fastened with Velcro straps to assists hip flexion and extension. The device weighs 4.7 lbs (2.1 kg) and has two motors that run on a single rechargeable battery. The device is equipped with joint angle and electrical current sensors to monitor hip joint angle and torque output, respectively.
The assist torque is transmitted to the wearer's thighs via thigh support frames. A trained healthcare professional, who operates the device, can change assist settings through software that runs on the tablet PC.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Waist, thighs, hip joint
Indicated Patient Age Range
18-85 years
Intended User / Care Setting
Trained healthcare professional, in rehabilitation institutions / Outpatient clinic (Indoors)
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)
Study Type: Prospective, single arm, interventional, longitudinal, open-label, single center
Sample Size: 53 subjects enrolled, 41 completed the entire protocol.
AUC: Not Found
MRMC: Not Found
Standalone Performance: Not Found
Key Results:
Primary Endpoints - Safety: Over the course of the study, 738 training sessions were completed by the 41 subjects (18 training sessions per study subject). Thirty-four AEs were reported for an overall AE rate of 4.6 %. Six AEs were determined to be possibly device-related for a potential device-related AE rate of 0.8 %. No AEs were determined to be probably or definitely related to the device.
Primary Endpoints - Effectiveness: The group mean change from baseline to post-training (after 18 sessions) for self-selected gait speed (10 Meter Walk Test) measured without the device was +0.12 m/s (p
§ 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
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April 21, 2022
Samsung Electronics Co., Ltd. % Kyoungju Kim Consultant MDLab Inc. Room 804, 161-17 Magokjungang-ro, Gangseo-gu, Seoul South Korea, 07788
Re: K213452
Trade/Device Name: GEMS-H Regulation Number: 21 CFR 890.3480 Regulation Name: Powered lower extremity exoskeleton Regulatory Class: Class II Product Code: PHL Dated: March 23, 2022 Received: March 24, 2022
Dear Kyoungju Kim:
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 Assistant Director, Acute Injury Devices Team 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
Device Name GEMS-H
Indications for Use (Describe)
The GEMS-H is a robotic exoskeleton that fits orthotically on the wearer's waist and thighs, outside of clothing. The device is intended to help assist ambulatory function in rehabilitations under the supervision of a trained healthcare professional for the following population:
· Individuals with stroke who have gait deficits and exhibit gait speeds of at least 0.4 m/s and are able to walk at least 10 meters with assistance from a maximum of one person.
The trained healthcare professional must successfully complete a training program prior to use of the device. The device is not intended for sports.
| 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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3
Samsung Electronics Co., Ltd.
510(k) Summary
Submitter
Samsung Electronics Co., Ltd. Minhyung Lee, Ph.D. 129, Samsung-Ro, Yeongtong-Gu, Suwon-Si, Gyeonggido, 16677 South Korea Email: mhyung.lee@samsung.com Phone: +82-2-6147-3805 Fax: +82-2-6147-7980
Official Correspondent
MDLab Inc. Kyoungju Kim, Consultant. Room 804, 161-17, Magokjungang-ro, Gangseo-gu, Seoul South Korea. 07788 Email: kj.kim@mdlab.co.kr Phone: +82-10-2264-5341 Fax: 82-2-3664-0830
Device Information
- Trade Name: GEMS-H ●
- Common Name: Powered exoskeleton
- Classification Name: Powered lower extremity exoskeleton
- Product Code: PHL
- Panel: Neurology
- Regulation Number: 21 C.F.R. § 890.3480
- Device Class: Class II ●
- Date prepared: 04/11/2022 ●
Predicate Device
K181294, Honda Walking Assist Device (by Honda Motor Company, Ltd.)
Device Description
The GEMS-H is a lightweight, robotic exoskeleton designed to help assist ambulatory function of stroke patients who meet the assessment criteria, in rehabilitations under the supervision of a trained healthcare professional. The GEMS-H device provides assistance to the patient during hip flexion and extension.
The device is worn over clothing around the wearer's waist and fastened with Velcro straps to assists hip flexion and extension. The device weighs 4.7 lbs (2.1 kg) and has two motors that run on a single rechargeable battery. The device is equipped with joint angle and electrical current sensors to monitor hip joint angle and torque output, respectively.
The assist torque is transmitted to the wearer's thighs via thigh support frames. A trained healthcare professional, who operates the device, can change assist settings through software that runs on the tablet PC.
4
Indications for use
The GEMS-H is a robotic exoskeleton that fits orthotically on the wearer's waist, and thighs outside of clothing. The device is intended to help assist ambulatory function in rehabilitation institutions under the supervision of a trained healthcare professional for the following population:
- Individuals with stroke who have gait deficits and exhibit gait speeds of at least 0.4 m/s and are able to walk at least 10 meters with assistance from a maximum of one person.
The trained healthcare professional must successfully complete a training program prior to use of the device. The device is not intended for sports.
Substantial Equivalence Comparison
The subject and predicate device (K181294) have the same intended use, and nearly identical indications for use, and are similar in design, technology, functions, and principle of operation.
Both devices are intended to help assist ambulatory function in individuals with stroke who have gait deficits and exhibit gait speeds of at least 0.4 m/s and are able to walk at least 10 meters with assistance from a maximum of one person. Both are worn around the wearer's waist and thighs and assist with hip joint flexion and extension. They also have two motors that run on a single pack of rechargeable batteries. They are equipped with angle and current sensors to monitor hip joint angle and torque output respectively. Both devices provide an assistive torque that is transmitted to the wearer's thighs via thigh frames. Both devices can change assist settings through software that runs on a touchscreen tablet device.
The differences in technological characteristics between the subject and predicate are as follows:
- . Range of Motion: The GEMS-H has a smaller range of motion than predicate device. Since the GEMS-H's range of motion falls within the predicate's range, this difference does not raise different safety or effectiveness questions.
- Device Weight: The GEMS-H weighs less than the predicate due to its design. The difference in weight does not raise different questions of safety or effectiveness.
- Battery Specification: The GEMS-H can be operated from a minimum of 1 hour to a maximum of . 2 hours, while the predicate device only allows 1 hour of continuous operation. This difference does not raise different questions of safety or effectiveness.
- . Actuator specifications: The maximum torque of the GEMS-H is larger than that of the predicate. However, even though the motors of the GEMS-H are capable of producing a maximum of 12 Nm± 15%, the maximum torque will not be reached in all cases and for all patients. The trained physical therapist can monitor the torque in real time and change the setting on the tablet PC to control the generated maximum torque. In addition, any potential risk associated with the higher maximum torque is mitigated through the exclusion criteria that exclude patients with severe osteoporosis (as determined by a physician) from study participation. Likewise, the proposed labeling contains a contraindication for patients with heterotopic ossification or severe osteoporosis. As a result, this difference in maximum torque does not raise different questions of safety or effectiveness.
5
Samsung Electronics Co., Ltd.
The following table summarizes the similarities and differences between the subject and predicate devices.
| Subject Device | Primary Predicate Device | Differences/Similarity | |
|---|---|---|---|
| FDA 510(k) No. | K213452 | K181294 | |
| Company | Samsung Electronics Co., Ltd. | Honda Motor Company | |
| Trade/Device | |||
| Name | GEMS-H | Honda Walking Assist Device | |
| Regulation No. | 21 CFR 890.3480 | 21 CFR 890.3480 | Identical |
| Regulation Name | Powered exoskeleton | Powered exoskeleton | Identical |
| Regulatory Class | Class 2 | Class 2 | Identical |
| Product Code | PHL | PHL | Identical |
| Indication for use | The GEMS-H is a robotic exoskeleton that fits | ||
| orthotically on the wearer's waist and thighs, | |||
| outside of clothing. The device is intended to | |||
| help assist ambulatory function in | |||
| rehabilitation institutions under the | |||
| supervision of a trained healthcare | |||
| professional for the following population: | |||
| · Individuals with stroke who have gait deficits | |||
| and exhibit gait speeds of at least 0.4 m/s and | |||
| are able to walk at least 10 meters with | |||
| assistance from a maximum of one person. | |||
| The trained healthcare professional must | |||
| successfully complete a training program prior | |||
| to use of the device. The device is not intended | |||
| for sports. | The Honda Walking Assist Device is a robotic | ||
| exoskeleton that fits orthotically on the user's | |||
| waist and thigh, outside of clothing. The device | |||
| is intended to help assist ambulatory function | |||
| in rehabilitation institutes under the | |||
| supervision of a trained healthcare professional | |||
| for the following population: | |||
| • Individuals with stroke who have gait | |||
| deficits and exhibit gait speeds of at least 0.4 | |||
| m/s and are able to walk at least 10 meters | |||
| with assistance from a maximum of one | |||
| person. | |||
| The trained healthcare professional must | |||
| successfully complete a training program prior | |||
| to use of the device. The devices are not | |||
| intended for sports. | Identical | ||
| Body coverage | Worn around the waist & thighs | Worn around the waist & thighs | Identical |
| Mobility aid | Optional (e.g., walker, cane, harness) | Optional (e.g., walker, cane) | Similar |
| Device limit on | |||
| patient's gait speed | None | None | Identical |
| Type of Surface for | |||
| training | Smooth, cement, carpet | Smooth, cement, carpet | Identical |
| Subject Device | Primary Predicate Device | Differences/Similarity | |
| Height of Patient | 61 in to 75 in (1.55 m to 1.91 m) | 55 in to ~79 in (1.4 m to 2.0 m) | Similar |
| Weight of Patient | 99 lbs (45 kg) up to 220 lbs (100 kg) and BMI17) |
- Ability to walk at least 10 m with maximum 1 person assist
- Physician approval for patient participation
- Able to safely fit into device specification and tolerate minimum assistance |
| Study Product(s),
Dose, Route,
Regimen | | GEMS-H |
| Duration of
administration | | After baseline testing was completed, subjects began 18 training sessions with the
GEMS-H in the outpatient clinic with a licensed physical therapist. The training
sessions were customized for each individual subject. Each session included 30
minutes of gait task specific training. And an additional 15 minutes is used to focus
on patient-specific goals related to functional mobility and balance. If appropriate,
the 15 minutes could also be used for additional gait training. Training sessions |
| | | were conducted indoors only. Training sessions occurred 2-3 times a week for 6–
8 weeks to complete the training protocol. |
| Environment of
use | | Outpatient clinic (Indoors) with smooth, cement, carpet surfaces, stairs, slopes less
than 5 degrees, and treadmills. |
| Statistical
methods | | 10MWT, 6MWT, Balance and functional mobility |
| | | Primary endpoint |
| | Safety: | |
| | Over the course of the study, 738 training sessions were completed by the 41
–
subjects (18 training sessions per study subject). Thirty-four AEs were
reported for an overall AE rate of 4.6 %. | |
| | Six AEs were determined to be possibly device-related for a potential device–
–
related AE rate of 0.8 %. No AEs were determined to be probably or definitely
related to the device. | |
| | Effectiveness: | |
| | The group mean change from baseline to post-training (after 18 sessions) for
–
self-selected gait speed (10 Meter Walk Test) measured without the device
was +0.12 m/s (p