GEMS-H

K213452 · Samsung Electronics Co., Ltd. · PHL · Apr 21, 2022 · Physical Medicine

Device Facts

• Record ID: K213452
• Device Name: GEMS-H
• Applicant: Samsung Electronics Co., Ltd.
• Product Code: PHL · Physical Medicine
• Decision Date: Apr 21, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3480
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

GEMS-H is a lightweight (4.7 lbs) robotic exoskeleton worn around waist and thighs; assists hip flexion and extension during gait. Input data includes hip joint angle and torque output via integrated sensors. Device uses two motors powered by a rechargeable battery; assist settings are adjusted by a trained physical therapist via a tablet PC application. Used in rehabilitation institutions; therapist monitors torque in real-time. Output provides assistive torque to thighs via support frames; helps improve ambulatory function and gait speed in stroke patients. Failsafe feature disables motor torque, rendering device passive if needed.

Clinical Evidence

Prospective, single-arm, open-label study (N=41) in stroke patients. Primary endpoint: safety (AEs) and effectiveness (improvement ≥ 0.14 m/s in 10MWT gait speed). Results: 0.8% device-related AE rate; mean gait speed improvement +0.12 m/s (p<0.0001) without device, +0.16 m/s (p<0.0001) with device. 6MWT improved by 53.28 m (p<0.0001).

Technological Characteristics

Powered lower extremity exoskeleton; 2 motors (hip); rechargeable Li-ion battery (21.6V, 2950 mAh). Sensors: joint angle and electrical current. Materials: biocompatible (ISO 10993). Connectivity: tablet PC interface. Standards: IEC 60601-1, IEC 60601-1-2, IEC 62304, IEC 62133-2. IP20 rating.

Indications for Use

Indicated for stroke patients with gait deficits, gait speeds ≥ 0.4 m/s, and ability to walk ≥ 10 meters with max one-person assistance. Contraindicated for patients with heterotopic ossification or severe osteoporosis.

Regulatory Classification

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.

Special Controls

In combination with the general controls of the FD&C Act, the Powered Exoskeleton is subject to the following special controls:

*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).

Predicate Devices

• Honda Walking Assist Device (K181294)

Submission Summary (Full Text)

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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.

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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 ([e-mail]) or phone [phone] 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

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### 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) | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| <span> <span style="font-family: DejaVu Sans, sans-serif;"> ✔ </span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> <span style="font-family: DejaVu Sans, sans-serif;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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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: [e-mail] Phone: [phone] Fax: [phone]

### Official Correspondent

MDLab Inc. Kyoungju Kim, Consultant. Room 804, 161-17, Magokjungang-ro, Gangseo-gu, Seoul South Korea. 07788 Email: [e-mail] Phone: [phone] Fax: [phone]

### 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.

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### 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.

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### 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<br>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<br>orthotically on the wearer's waist and thighs,<br>outside of clothing. The device is intended to<br>help assist ambulatory function in<br>rehabilitation institutions under the<br>supervision of a trained healthcare<br>professional for the following population:<br>· Individuals with stroke who have gait deficits<br>and exhibit gait speeds of at least 0.4 m/s and<br>are able to walk at least 10 meters with<br>assistance from a maximum of one person.<br>The trained healthcare professional must<br>successfully complete a training program prior<br>to use of the device. The device is not intended<br>for sports. | The Honda Walking Assist Device is a robotic<br>exoskeleton that fits orthotically on the user's<br>waist and thigh, outside of clothing. The device<br>is intended to help assist ambulatory function<br>in rehabilitation institutes under the<br>supervision of a trained healthcare professional<br>for the following population:<br>• Individuals with stroke who have gait<br>deficits and exhibit gait speeds of at least 0.4<br>m/s and are able to walk at least 10 meters<br>with assistance from a maximum of one<br>person.<br>The trained healthcare professional must<br>successfully complete a training program prior<br>to use of the device. The devices are not<br>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<br>patient's gait speed | None | None | Identical |
| Type of Surface for<br>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 BMI< 35 kg/ m² | <220 lbs (100 kg) | Similar |
| Control Method | Handheld interface to allow physical therapist<br>to control and operate the device remotely | Handheld interface for physical therapist | Identical |
| Device Range of<br>Motion | Hip: 100° flexion to 40° extension | Hips: 113° flexion to 47° extension | Different. The subject device has a smaller<br>motion range than the predicate device. This<br>difference does not raise different safety or<br>effectiveness questions. |
| Device Weight | 4.7 lbs (2.1 kg) | 5.95 lbs (2.7 kg) | Similar. The GEMS-H weighs less than the<br>predicate device; the difference in weight does<br>not raise different questions of safety or<br>effectiveness. |
| Battery<br>specifications | • Rechargeable lithium ion.<br>• 21.6V, 2,950 mAh,<br>• 2 hr charge time<br>• Minimum 2 Hr. of continuous walking* (with<br>gain = 7, delay = 0.25 s)<br>• Minimum 1 Hr. of continuous walking* (with<br>gain = 8, delay = 0.25 s)<br>* at a walking speed of about 1.9 ~ 2.5 MPH<br>(0.8 ~ 1.1 m/s) | • Rechargeable lithium ion,<br>• 22.2 V, 1 A-h,<br>• 2 hr charge time<br>• 1 hr continuous operation | Similar.<br>The GEMS-H can be operated from a<br>minimum of 1 hour to a maximum of 2 hours,<br>while the predicate device only allows 1 hour<br>of continuous operation. This difference does<br>not raise different questions of safety or<br>effectiveness. |
| Actuator<br>Specifications | 2 motors (2 at hip)<br>12 Nm ± 15% max torque | 2 motors (2 at hip)<br>4 Nm max torque | Different.<br>The maximum torque of the GEMS-H is larger<br>than that of the predicate. However, even<br>though the motors of the GEMS-H are capable<br>of producing a maximum of 12 Nm± 15%, this<br>is the maximum allowable torque and is not<br>recommended for all patients under all training<br>conditions. Rather, the trained physical<br>therapist shall monitor the torque in real time<br>and change the setting on the tablet PC to |
| | Subject Device | Primary Predicate Device | Differences/Similarity |
| | | | control the generated maximum torque. In<br>addition, any potential risk associated with the<br>higher maximum torque is mitigated through<br>the exclusion criteria that exclude patients with<br>severe osteoporosis (as determined by a<br>physician) from study participation. Likewise,<br>the proposed labeling contains a<br>contraindication for patients with heterotopic<br>ossification or severe osteoporosis. As a result,<br>this difference in maximum torque does not<br>raise different questions of safety or<br>effectiveness. |
| Training Program | Yes | Yes | Identical |
| Certification<br>Program | Yes | Yes | Identical |
| Feedback | Visual & auditory feedback on both the<br>handheld controller & device | Visual & auditory feedback on both the<br>handheld controller & device | Identical |
| Fall Detection and<br>Mitigation | None | None | Identical |
| Failsafe Feature | Motor torque disables; device becomes<br>passive | Motor torque disables; device becomes passive | Identical |
| Operating<br>Temperature | 32°F to 86°F (0°C to 30°C) | 32 °F to 86 °F (0 °C to 30 °C) | Identical |
| Operating | 30% to 85% RH | 30% to 85% | Identical |
| Patient population | Individuals with stroke who have gait deficits<br>and exhibit gait speeds of at least 0.4 m/s and<br>are able to walk at least 10 meters with<br>assistance from a maximum of one person. | Individuals with stroke who have gait deficits<br>and exhibit gait speeds of at least 0.4 m/s and<br>are able to walk at least 10 meters with<br>assistance from a maximum of one person. | Identical |

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### Samsung Electronics Co., Ltd.

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### Samsung Electronics Co., Ltd.

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### Non-Clinical Testing

The subject device was tested to the following standards.

- Electrical safety testing according to ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, ● C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
- Electromagnetic compatibility (EMC) testing according to IEC 60601-1-2:2014
- Usability engineering test according to IEC 60601-1-6:2013
- Vibration testing and thermal shock testing
- Battery safety testing according to IEC 62133-2:2017 Edition 1.0
- Software Verification and validation testing according to IEC 62304:2015 ●
- . Radio frequency wireless technology according to the procedure given in FCC Rules Part 15 Subpart B and FCC Rules Part 15 Subpart C, 15.247
- ANSI IEEE C63.27-2017 American National Standard for Evaluation of Wireless Coexistence
- Particulate resistance (IP20) according to IEC 60529:2013, Edition 2.2
- . Biocompatibility Testing such as In Vitro Cytotoxicity (ANSI AAMI ISO 10993-5:2009/(R)2014), Skin Sensitization (ANSI AAMI ISO 10993-10:2010/(R)2014) and Intracutaneous Reactivity (ANSI AAMI ISO 10993-10:2010/(R)2014)
- . Performance testing such as cyclic loading testing vibration testing, thermal shock testing, driving part durability testing, Velcro testing and worst-case frame testing
- Other Bench testing such as Safety according to the Range of Motion, Max. angular velocity, Max. Torque Test, Static Torque Tracking Performance, Providing Assistive Torque Test at DOC Walking Mode for Walking and Stopping, Generation of assistive torque patterns according to the change in option during DOC mode test, Continuous use time and Noise.

### Clinical Testing

Samsung conducted a prospective, single arm, interventional, open-label, single center study with the GEMS-H in stroke patients. The study enrolled 53 subjects, of whom 41 completed the entire protocol. Each subject completed 18 indoor sessions of training with the GEMS-H in the outpatient clinic with a licensed physical therapist.

A summary of the clinical trial is provided below.

| Title | Safety and Effectiveness on Functional Mobility Following Samsung Gait<br>Enhancing and Motivating System-Hip (GEMS-H) Device Training in Sub-Acute<br>and Chronic Stroke: A Pivotal Study | |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Protocol Number | 00210372…