(88 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on TENS and PMS therapy controlled by an app, without mentioning any AI/ML capabilities.
Yes.
The device description explicitly states that ENSO 2 provides "professional-grade transcutaneous electrical nerve stimulation (TENS) therapy," and its intended use section describes its application for pain relief and muscle performance improvement, which are therapeutic functions.
No
The provided text explicitly states the device's intended use is for "symptomatic relief and management of chronic intractable pain," "temporary relief of pain," and "to improve and facilitate muscle performance." These are therapeutic, not diagnostic, functions.
No
The device description explicitly states the system consists of a main ENSO Device, a disposable Gel Pad, and a charging cable with AC adapter, in addition to the ENSO App. This indicates the presence of hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The description clearly states the device is a transcutaneous electrical nerve stimulation (TENS) and powered muscle stimulation (PMS) device. It applies electrical stimulation to the skin for pain relief and muscle performance.
- Intended Use: The intended use is for symptomatic relief of pain and improving muscle performance, not for analyzing biological samples.
- Device Description: The components (device, gel pad, charging cable, app) and how it's used (applied to skin, controlled wirelessly) are consistent with a TENS/PMS device, not an IVD.
The information provided focuses on the device's function in applying electrical stimulation externally to the body, which is the core characteristic of a TENS/PMS device, not an IVD.
N/A
Intended Use / Indications for Use
A transcutaneous electrical nerve stimulation (TENS) Mode which is indicated for the symptomatic relief and management of chronic intractable pain, and for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities., and A powered muscle stimulation (PMS) mode which is indicated to improve and facilitate muscle performance in healthy muscles. The ENSO Model 2 should be applied to normal, healthy, dry and clean skin of adult patients.
Product codes (comma separated list FDA assigned to the subject device)
NUH, NGX
Device Description
The Hinge Health ENSO® Device System consists of the main ENSO Device, a disposable Gel Pad, and a charging cable with AC adapter for recharging. The ENSO App is used to access and control the device.
ENSO 2 is a wearable medical device that provides professional-grade transcutaneous electrical nerve stimulation (TENS) therapy along with an easy-to-use interface within a compact design. The device system consists of the main ENSO 2 Device, a disposable Gel Pad, and a charging cable with AC adapter for recharging the Device. ENSO 2 is controlled wirelessly using the Hinge Health app on a compatible Mobile Device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg)
Indicated Patient Age Range
adult patients
Intended User / Care Setting
Not Found
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)
Hinge Health determined that bench and non-clinical testing were sufficient to demonstrate that the ENSO Device System is as safe and effective as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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).
Not Found
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).
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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 & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
February 23, 2024
Hinge Health, Inc. % Dawn Norman Regulatory Consultant EBG Advisors, Inc. 1227 25th Street, NW Suite 700 Washington, District of Columbia 20037
Re: K233784
Trade/Device Name: ENSO (Model 2) Regulation Number: 21 CFR 882.5890, 21 CFR 890.5850 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, NGX Dated: November 10, 2023 Received: November 27, 2023
Dear Dawn Norman:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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).
2
Sincerely,
Robert Kang -S
for Pamela Scott
Assistant Director DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K233784
Device Name ENSO (Model 2)
Indications for Use (Describe)
A transcutaneous electrical nerve stimulation (TENS) Mode which is indicated for the symptomatic relief and management of chronic intractable pain, and for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities., and
A powered muscle stimulation (PMS) mode which is indicated to improve and facilitate muscle performance in healthy muscles.
The ENSO Model 2 should be applied to normal, healthy, dry and clean skin of adult patients.
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) | X |
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4
Traditional 510(k) Summary
| Manufacturer: | Hinge Health ™ Incorporated
455 Market Street, Suite 700
San Francisco, CA 94105
USA
Phone (855) 902-2777 |
|-----------------|-----------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Dawn N. Norman, MS |
- Partner MRC Global, LLC Phone (618) 604-3064 Email: Dawn.Norman@askmrcglobal.com
February 21, 2024 Date Prepared:
DEVICE INFORMATION
| Trade/Proprietary Name: | ENSO® Device System 510(k) |
|---|---|
| Common Name: | |
| Classification Names: | Transcutaneous Nerve Stimulator |
| Transcutaneous Electrical Nerve Stimulator for Pain Relief, Powered Muscle Stimulator | |
| 21 CFR 882.5890 and 21 CFR 890.5850 | |
| Class II | |
| Device Product Codes: NUH, NGX |
PREDICATE DEVICE INFORMATION
| Predicate Device: | K160052 (CUR Model 1) |
|---|---|
| Trade/Proprietary Name: | CUR Model 1 |
| Common Name: | |
| Classification Names: | Transcutaneous Nerve Stimulator |
| Stimulator, Nerve, Transcutaneous, Over-The- | |
| Counter |
21 CFR 882.5890 and 21 CFR 890.5850 Class II Device Product Codes: NUH, NGX
ENSO® Device System 510(k)
5
Product Description:
The Hinge Health ENSO® Device System consists of the main ENSO Device, a disposable Gel Pad, and a charging cable with AC adapter for recharging. The ENSO App is used to access and control the device.
The detailed device description and Engineering drawings for the ENSO® Device System can be found in Description Section of the eSTAR form.
The ENSO Device System that is the subject of this submission is a modification to the predicate Cur 1 Device System (K160052) that was cleared on May 20, 2016.
The subject of the present Traditional 510(k) submission is a modification of CUR Model 1. The device that is the subject of this 510(k) submission is identical to the predicate device (K160052) in terms of intended use, indications for use, charger function/materials. AC adaptor, gel pad tape, overall functionality. design, type of mating connections, biocompatibility and packaging. The subject device and the predicate share the same fundamental scientific technology and intended use.
Compared to the predicate device (K160052), the subject device uses several enhancements to improve device functionality and operation (see Performance Testing Section for details). The main changes are:
- ·Contraindications, remove implanted metal devices
- ·Extend gel pad expiration date period from 12mo to 18mo and then 18mo to 24mo
- ·Improve battery shelf life
- •Minor software updates to add functionality and change system requirements.
- ·Add over-the-air (OTA) firmware update ability
There are no changes to the product's intended use, indications for use, functionality, biocompatibility, and packaging.
The ENSO Device System that is the subject of this submission meets the specifications for electrical output for TENS and EMS Modes, and IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, ISO 10993-1, ISO 10993-5 and -10.
Indications for Use (for this submission):
The Hinge Health ENSO Device System is intended to be used in the following: A transcutaneous electrical nerve stimulation (TENS) Mode which is indicated for the symptomatic relief and management of chronic intractable pain, and for temporary relief of pain associated with sore and aching muscles in the shoulder,
ENSO® Device System 510(k)
6
waist, back, neck, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. , and
A powered muscle stimulation (PMS) mode which is indicated to improve and facilitate muscle performance in healthy muscles.
The ENSO Device should be applied to normal, healthy, dry and clean skin of adult patients.
With the exception of the addition of Hinge Health's "ENSO" brand name, there are no changes to the indications for use or intended use from the previously cleared CUR Model 1 predicate (K160052). Form FDA 3881. Indications for Use. can be found in the 510(k) submission. The addition of the "ENSO" brand name to the Indications for Use statement is not considered a change because the product line has been branded "ENSO" since it was launched in the USA in 2017.
Performance Testing
No performance standards applicable to this device have been adopted under Section 514 of the Food, Drug and Cosmetic Act. Performance testing of the ENSO Device System was conducted in accordance with the various international standards listed below and in the Performance Testing - Bench Section of this 510(k) submission.
Performance testing of the subject device modification (ENSO 2) was conducted in accordance with the following standards and test methods as seen in Figure 5-1.
| Test Method | Standard(s) | |
|---|---|---|
| Safety | IEC 60601-1 | |
| IEC 60601-1-6 | ||
| IEC 60601-2-10 | ||
| IEC 60601-1-11 | ||
| IEC 60529 | ||
| IEC 62133-2 | ||
| IEC 62368 | ||
| EMC | IEC 60601-1-2 | |
| FCC §15.107 & ICES Issue 5, (Nov. 2014 Update), | ||
| Conducted Emissions | ||
| FCC §15.109 & CAN/CSA-CISPR 22-10 Table 6 and ICES- | ||
| 003 Issue 5 (Nov. 2014 Update), Radiated Emissions | ||
| FCC § 1.1310, RF Exposure Evaluation | ||
| RSS-102, Issue 5:2015+A1:2021, RF Exposure Evaluation | ||
| SoftwareIEC 62304 |
Figure 5-1 Test Method and Standards
ENSO® Device System 510(k)
7
| Test Method | Standard(s) |
|---|---|
| Usability | IEC 62366-1 |
| Biocompatibility | ISO 10993-1 |
| ISO 10993-5 | |
| ISO 10993-10 | |
| Packaging and | |
| Shelf-life | ASTM D6862 |
| ASTM D3330/ | |
| ASTM D3331 | |
| ASTM F1980 |
Basis of Substantial Equivalence
The ENSO® Device System that is the subject of this submission has the following similarities to the predicate CUR Model 1 cleared under K160052:
- similar material ●
- same intended use ●
- same indications for use ●
- similar design ●
- similar sizes and dimensions .
- same type of mating components ●
- same biocompatibility .
- . same packaging methods
8
Comparison Table - Indications for Use
Figure 5-2: Indications for Use Comparison Table
| ENSO® Device System | |||
|---|---|---|---|
| Attribute | Subject Device | ||
| (ENSO 2, K233784) | Predicate | ||
| (CUR Model 1, K160052) | Comments | ||
| Indications for | |||
| Use | A transcutaneous electrical nerve stimulation (TENS) Mode | ||
| which is indicated for the symptomatic relief and management of | |||
| chronic intractable pain, and for temporary relief of pain | |||
| associated with sore and aching muscles in the shoulder, waist, | |||
| back, neck, upper extremities (arm) and lower extremities (leg) | |||
| due to strain from exercise or normal household work activities., | |||
| and | |||
| A powered muscle stimulation (PMS) mode which is indicated to | |||
| improve and facilitate muscle performance in healthy muscles. | |||
| The ENSO® Model 2 should be applied to normal, healthy, dry | |||
| and clean skin of adult patients. | A transcutaneous electrical nerve stimulation (TENS) Mode | ||
| which is indicated for the symptomatic relief and management of | |||
| chronic intractable pain, and for temporary relief of pain | |||
| associated with sore and aching muscles in the shoulder, waist, | |||
| back, neck, upper extremities (arm) and lower extremities (leg) | |||
| due to strain from exercise or normal household work activities., | |||
| and | |||
| A powered muscle stimulation (PMS) mode which is indicated to | |||
| improve and facilitate muscle performance in healthy muscles. | |||
| The CUR Model 1 should be applied to normal, healthy, dry and | |||
| clean skin of adult patients. | Identical | ||
| except for | |||
| device name | |||
| and model | |||
| Class | II | II | Identical |
| Product Code | NUH; NGX | NUH; NGX | Identical |
| Regulation | 21 CFR 882.5890 and 21 CFR 890.5850 | 21 CFR 882.5890 and 21 CFR 890.5850 | Identical |
9
Comparison Table – Contraindications
| ENSO® Device System | |||
|---|---|---|---|
| Attribute | Subject Device | ||
| (ENSO 2, K233784) | Predicate | ||
| (CUR Model 1, K160052) | Comments | ||
| Contraindications | Contraindication: Do not use this device if you have a cardiac | ||
| pacemaker, implanted defibrillator, or other implanted | |||
| electronic device. Such use could cause electric shock, | |||
| burns, electrical interference, or death. | |||
| Warning: Do not apply stimulation over or near metallic | |||
| implants | Do not use this device if you have a cardiac pacemaker, | ||
| implanted defibrillator, or other implanted metallic or | |||
| electronic device. Such use could cause electric shock, | |||
| burns, electrical interference, or death. | Identical except "metallic" | ||
| was removed and the | |||
| warning was added |
Figure 5-3: Contraindications Comparison Table
Comparison Table – Design Features
Figure 5-4: Design Feature Comparison Table
| ENSO® Device System | ||||
|---|---|---|---|---|
| Attribute | Subject Device | |||
| (ENSO 2, K233784) | Predicate | |||
| (CUR Model 1, K160052) | Comments | |||
| Design Comparison | ENSO 2 is a wearable medical device that | |||
| provides professional-grade transcutaneous | ||||
| electrical nerve stimulation (TENS) therapy | ||||
| along with an easy-to-use interface within a | ||||
| compact design. The device system consists of | ||||
| the main ENSO 2 Device, a disposable Gel | ||||
| Pad, and a charging cable with AC adapter for | ||||
| recharging the Device. | CUR 1 is a wearable medical device that provides | |||
| professional-grade transcutaneous electrical nerve | ||||
| stimulation (TENS) therapy along with an easy-to-use | ||||
| interface within a compact design. The device system | ||||
| consists of the main Cur 1 Device, a disposable Gel Pad, | ||||
| and a charging cable with AC adapter for recharging the | ||||
| Device. | ||||
| Cur 1 is controlled wirelessly using the Cur Mobile app on a | Identical | |||
| ENSO 2 is controlled wirelessly using the Hinge | ||||
| Health app on a compatible Mobile Device. | compatible Mobile Device. | |||
| Sizes | Disposable gel pad- Large | |||
| Disposable gel pad- Standard | Disposable gel pad | Identical | ||
| ENSO® Device System | ||||
| Attribute | Subject Device | |||
| (ENSO 2, K233784) | Predicate | |||
| (CUR Model 1, K160052) | Comments | |||
| Anatomical Sites | •shoulder | |||
| •waist | ||||
| •back | ||||
| •neck | ||||
| •upper extremities (arm) | ||||
| •lower extremities (leg) | •shoulder | |||
| •waist | ||||
| •back | ||||
| •neck | ||||
| •upper extremities (arm) | ||||
| •lower extremities (leg) | Identical | |||
| Biocompatibility/ Material | Tested per ISO 10993-1 | |||
| ISO 10993-5 and -10 | Tested per ISO 10993-1 | |||
| ISO 10993-5 and -10 | Equivalent | |||
| biocompatibility results | ||||
| for gel pad and tape | ||||
| Power Source(s) | Lithium-ion Polymer chemistry, and allow | |||
| charging at 4.20V | 3.7V Lithium-Polymer battery (rechargeable) | Equivalent or better | ||
| battery life | ||||
| Method of Line Current | ||||
| Isolation | Physically isolated; device cannot connect to | |||
| electrodes and battery recharger concurrently | Physically isolated; device cannot connect to electrodes and | |||
| battery recharger concurrently | Identical | |||
| Patient Leakage Current |
- Normal Condition (μΑ) | Battery powered
(