(130 days)
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.
CUR is a high-quality wearable medical device that provides professional-grade TENS therapy along with an easy-to-use interface and compact aesthetic design. It is comprised of the main CUR device, a disposable gel pad, and a charging cable with AC adapter for recharging the device.
A use session typically begins with the user placing the Gel Pad on the skin near the location of pain, attaching the CUR Device to the Gel Pad using the magnetic attachment points on the bottom surface of the Device and on the plastic connector of the Gel Pad. The user then presses the power "start/stop" button on the Device to begin treatment. The user may use buttons on the Device labeled with standard ISO "+" and "-" symbols to control the intensity of treatment. They also may connect the Device to a compatible Mobile Device via Bluetooth and control treatment through the CUR Mobile App. After treatment is finished, the user may leave the Device attached to the Gel Pad until the next treatment session, or may remove the Device from the Gel Pad and attach the Device to the Charging Base using the magnetic attachment points on the Device and Charging Base to store and re-charge the Device.
CUR Model 1 may be used for pain relief on most parts of the body. Intended placements include:
- Shoulder ●
- Waist ●
- Back
- Neck
- Upper extremities (arm) ●
- Lower extremities (leg)
Do not place CUR Model 1 on the throat, chest, or head.
The disposable Gel Pad utilizes a high-quality polyacrylate hydrogel material that provides excellent patient comfort, biocompatibility, and adherence to a wide range of skin types. Pads typically last about 6-10 days with regular daily use and storage before needing to be replaced. And since the Device uses an internal rechargeable battery for power, no other batteries or consumables are needed offering increased convenience and positive benefit to the environment.
The Mobile App provides access to treatment controls and usage instructions for the device from a compatible mobile device. This is an added convenience for cases where the user would rather adjust the treatment from their mobile devices rather than directly from the app and also a means of providing detailed warnings and usage instructions information in a portable way that the user can access at any time.
The provided text describes the Thimble Bioelectronics CUR Model 1, a transcutaneous electrical nerve stimulator (TENS) and powered muscle stimulation (PMS) device. The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than directly presenting a standalone study for the device against specific acceptance criteria.
However, based on the non-clinical testing section and the comparison tables, we can infer the acceptance criteria are largely related to meeting established electrical performance specifications and international safety/performance standards.
Here's an analysis of the requested information:
1. A table of acceptance criteria and the reported device performance
Since specific acceptance criteria are not explicitly listed in a direct "acceptance criteria table" in the document, these are inferred from the technological characteristics comparison with predicate devices and the non-clinical testing performed against recognized standards. The "reported device performance" refers to the CUR Model 1's measured electrical specifications.
| Acceptance Criterion (Inferred) | Reported Device Performance (CUR Model 1) | Justification/Reference |
|---|---|---|
| Electrical Safety Standards Compliance | Complies with IEC 60601-1:2012, IEC 60601-2-10:2012, IEC 60601-1-11:2010 | "Verification and validation test results established that the device meets its intended use... including compliance with the following standards: Safety: IEC 60601-1... IEC 60601-2-10... IEC 60601-1-11" (Page 10) |
| EMC Standards Compliance | Complies with IEC 60601-1-2:2014, FCC Part 15 | "EMC: IEC 60601-1-2:2014... FCC part 15" (Page 10) |
| Software Standards Compliance | Complies with IEC 62304:2006 | "Software: IEC 62304:2006" (Page 10) |
| Usability Standards Compliance | Complies with IEC 62366-1:2015 | "Usability: IEC 62366-1:2015" (Page 10) |
| Biocompatibility Standards Compliance | Complies with ISO 10993-5:2009, ISO 10993-10:2010 | "Biocompatibility: ISO 10993-5:2009... ISO 10993-10:2010" (Page 10) |
| Patient Leakage Current (Normal Condition) | < 10 µA (Battery powered) | Table 2: Basic Unit Characteristics Comparison Table (Page 6). Matches predicate devices. |
| Patient Leakage Current (Single Fault Condition) | < 50 µA (Battery powered) | Table 2: Basic Unit Characteristics Comparison Table (Page 6). Matches predicate devices. |
| Average DC Current through Electrodes | < 0.1 µA | Table 2: Basic Unit Characteristics Comparison Table (Page 6). Better than one predicate, matches other. |
| Automatic Overload Trip | Yes | Table 2: Basic Unit Characteristics Comparison Table (Page 6). Matches predicate devices. |
| Automatic No-Load Trip | Yes | Table 2: Basic Unit Characteristics Comparison Table (Page 6). Matches predicate devices. |
| Automatic Shut Off | Yes | Table 2: Basic Unit Characteristics Comparison Table (Page 6). Matches predicate devices. |
| Maximum Output Voltage (TENS) | 42.6V @ 500Ω to 87.8V @ 10kΩ (depending on mode) | Table 3: Output Specification for TENS Mode Comparison Table (Page 7). Comparable to predicate devices. |
| Maximum Output Current (TENS) | 8.8 mA @ 10kΩ to 86.3 mA @ 500Ω (depending on mode) | Table 3: Output Specification for TENS Mode Comparison Table (Page 7). Comparable to predicate devices. |
| Maximum Phase Charge (TENS) | 4.14 µC @ 500Ω to 7.45 µC @ 500Ω (depending on mode) | Table 3: Output Specification for TENS Mode Comparison Table (Page 8). Comparable to predicate devices. |
| Maximum Output Voltage (PMS) | 38.4V @ 500Ω to 85.0V @ 10kΩ | Table 4: Output Specifications for EMS Mode Comparison Table (Page 9). Comparable to predicate device. |
| Maximum Output Current (PMS) | 8.1 mA @ 10kΩ to 76.7 mA @ 500Ω | Table 4: Output Specifications for EMS Mode Comparison Table (Page 9). Comparable to predicate device. |
| Maximum Phase Charge (PMS) | 16.21 µC @ 500Ω | Table 4: Output Specifications for EMS Mode Comparison Table (Page 9). Comparable to predicate device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states, "Thimble determined that bench and non-clinical testing were sufficient to demonstrate that the CUR Model 1 device is as safe and effective as the predicate devices." (Page 10)
- Sample Size: Not specified for non-clinical testing, but typically refers to a statistically significant number of test units or components tested according to engineering and quality assurance protocols for device performance, and materials tested for biocompatibility. No human subject data (test set) is mentioned for clinical performance.
- Data Provenance: The tests are described as "bench and non-clinical testing" conducted by Thimble Bioelectronics (a US company, based on the address). This indicates laboratory or bench-top testing rather than clinical data from patients. The document does not specify the country of origin of the data or if it was retrospective or prospective in a clinical sense, as it was non-clinical.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The document states that no clinical testing was performed to establish ground truth from human experts. The assessment was based on non-clinical engineering and performance testing against established standards and comparison to predicate devices, not on expert interpretations of medical results.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As no clinical test set with human data or expert review was conducted, no adjudication method was used.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a TENS/PMS stimulator, not an AI-assisted diagnostic or interpretive device. No MRMC study was performed, nor would it be relevant for this type of medical device which directly delivers electrical stimulation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device does not involve an "algorithm only" component in the sense of AI or diagnostic interpretation. Its "performance" is its ability to generate electrical signals according to specifications. The device operates either directly through physical buttons or via a mobile app interface.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's acceptable performance is defined by compliance with recognized international safety and performance standards (e.g., IEC 60601 series, ISO 10993 series, FCC Part 15) and by meeting its own design specifications as verified through electrical, mechanical, and software testing. It also uses the performance characteristics of legally marketed predicate devices (NeuroMetrix ASCEND and Philips Consumer Lifestyle PulseRelief) as a basis for demonstrating substantial equivalence. No clinical "ground truth" (e.g., pain relief scores, muscle performance measurements) from patient outcomes was used in this submission.
8. The sample size for the training set
Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable, as no training set was used.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized design of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in a single, continuous line. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 20, 2016
Thimble Bioelectronics, Inc. Shaun Rahimi CEO 2011 26th St. Ste. 202 San Francisco. CA 94107
Re: K160052
Trade/Device Name: Cur Model 1 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NUH, NGX Dated: April 15. 2016 Received: April 20, 2016
Dear Shaun Rahimi:
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. 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.
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 (reporting of medical device
{1}------------------------------------------------
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael J.Hoffmann -A
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K160052
Device Name CUR Model 1
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 CUR Model 1 should be applied to normal, healthy, dry and clean skin of adult patients.
| Type of Use (Select one or both, as applicable) | ||
|---|---|---|
| ☐ Research Use (Part 21 CFR 821 Subpart B)☑ Study That Controls (21 CFR 821 Subpart C) | ☐ Research Use (Part 21 CFR 821 Subpart B) | ☑ Study That Controls (21 CFR 821 Subpart C) |
| ☐ Research Use (Part 21 CFR 821 Subpart B) | ☑ Study That Controls (21 CFR 821 Subpart C) |
_ | Prescription Use (Part 21 CFR 801 Subpart D)
|X Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for Thimble Bioelectronics. The logo consists of a stylized flower-like symbol on the left, followed by the word "Thimble" in a bold, sans-serif font. Below "Thimble" is the word "Bioelectronics" in a smaller, lighter font. The logo is simple and modern, with a focus on the company name.
510(k) Summary for CUR Model 1
This 510(k) Summary has been created per the requirements of the Safe Medical Device Act (SMDA) of 1990, and the content is provided in conformance with 21 CFR Part 807.92
| Submitter Information: | |
|---|---|
| Sponsor Name | Thimble Bioelectronics, Inc. |
| Contact Person | Shaun Rahimi, CEO |
| Address | 2011 26th St. Ste. 202San Francisco, CA 94107 |
| Telephone | (408) 799-8783 |
| Fax | ----- |
| shaun@cur.me | |
| Submission Date | January 09, 2016 |
Submitter Information:
Device Information:
| Device Name | CUR Model 1 |
|---|---|
| Common Name | Transcutaneous Nerve Stimulator |
| Classification Name | Stimulator, Nerve, Transcutaneous, Over-The-Counter |
| Classification | Class II21 CFR 882.5890; 21 CFR 890.5850Neurology |
Predicate Devices
The CUR device is substantially equivalent to the NeuroMetrix ASCEND (K104333) and the Philips Consumer Lifestyle PulseRelief (K151035) devices.
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Image /page/4/Picture/0 description: The image contains the logo for Thimble Bioelectronics. The logo consists of a stylized leaf-like symbol on the left, followed by the word "Thimble" in a bold, sans-serif font. Below "Thimble" is the word "Bioelectronics" in a smaller, lighter font. The logo is simple and modern, with a focus on the company name.
Device Description
CUR is a high-quality wearable medical device that provides professional-grade TENS therapy along with an easy-to-use interface and compact aesthetic design. It is comprised of the main CUR device, a disposable gel pad, and a charging cable with AC adapter for recharging the device.
A use session typically begins with the user placing the Gel Pad on the skin near the location of pain, attaching the CUR Device to the Gel Pad using the magnetic attachment points on the bottom surface of the Device and on the plastic connector of the Gel Pad. The user then presses the power "start/stop" button on the Device to begin treatment. The user may use buttons on the Device labeled with standard ISO "+" and "-" symbols to control the intensity of treatment. They also may connect the Device to a compatible Mobile Device via Bluetooth and control treatment through the CUR Mobile App. After treatment is finished, the user may leave the Device attached to the Gel Pad until the next treatment session, or may remove the Device from the Gel Pad and attach the Device to the Charging Base using the magnetic attachment points on the Device and Charging Base to store and re-charge the Device.
CUR Model 1 may be used for pain relief on most parts of the body. Intended placements include:
- Shoulder ●
- Waist ●
- Back
- Neck
- Upper extremities (arm) ●
- Lower extremities (leg)
Do not place CUR Model 1 on the throat, chest, or head.
The disposable Gel Pad utilizes a high-quality polyacrylate hydrogel material that provides excellent patient comfort, biocompatibility, and adherence to a wide range of skin types. Pads typically last about 6-10 days with regular daily use and storage before needing to be replaced. And since the Device uses an internal rechargeable battery for power, no other batteries or consumables are needed offering increased convenience and positive benefit to the environment.
The Mobile App provides access to treatment controls and usage instructions for the device from a compatible mobile device. This is an added convenience for cases where the user would rather adjust the treatment from their mobile devices rather than directly from the app and also a means of providing detailed warnings and usage instructions information in a portable way that the user can access at any time.
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
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Image /page/5/Picture/0 description: The image contains the logo for Thimble Bioelectronics. The logo consists of a stylized leaf-like symbol on the left, followed by the word "Thimble" in a bold, sans-serif font. Below "Thimble" is the word "Bioelectronics" in a smaller, lighter font. The logo is simple and modern, with a focus on the company's name and field of expertise.
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.
Substantial Equivalence
The CUR Model 1 device indications for use and technological characteristics are substantially equivalent to the NeuroMetrix ASCEND device application (K104333) and Philips Consumer Lifestyle PulseRelief device application (K151035).
Comparison Table – Indications for Use
Table 1: Indications for Use Comparison Table
| Parameter | Subject Device | Predicate | Predicate |
|---|---|---|---|
| CUR Model 1 | NeuroMetrixASCEND(K104333) | Philips ConsumerLifestyle PulseRelief(K151035) | |
| Indication forUse | A transcutaneous electrical nervestimulation (TENS) Mode whichis indicated for the symptomaticrelief and management ofchronic intractable pain, and fortemporary relief of painassociated with sore and achingmuscles in the shoulder, waist,back, neck, upper extremities(arm) and lower extremities (leg)due to strain from exercise ornormal household workactivities. , andA powered muscle stimulation(PMS) mode which is indicatedto improve and facilitate muscleperformance in healthy muscles.The CUR Model 1 should beapplied to normal, healthy, dryand clean skin of adult patients. | ASCEND is intended foruse as a transcutaneouselectrical nerve stimulationdevice for the symptomaticrelief and management ofchronic intractable pain.ASCEND is intended foruse as a transcutaneouselectrical nerve stimulationdevice for temporary reliefof pain associated with soreand aching muscles in thelower extremities due tostrain from exercise ornormal household and workactivities.The device may be usedduring sleep. The device islabeled for use only withcompatible NeuroMetrixelectrodes. | The OTC TENS/EMSstimulator PulseRelief isdesigned to be used fortemporary relief of painassociated with sore andaching muscles in theshoulder, waist, back,neck, upper extremities(arm) and lowerextremities (leg) due tostrain from exercise ornormal household workactivities. It should beapplied to normal,healthy, dry and cleanskin of adult patients, andis to be used for stimulatehealthy muscles in orderto improve and facilitatemuscle performance. |
| Class | II | II | II |
| Product Code | NUH; NGX | NUH | NUH; NGX |
| Regulation | 21 CFR 882.5890(b) | 21 CFR 882.5890(b) | 21 CFR 882.5890(b) |
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Image /page/6/Picture/0 description: The image shows the logo for Thimble Bioelectronics. The logo consists of a stylized leaf-like symbol on the left, followed by the word "Thimble" in a bold, sans-serif font. Below "Thimble" is the word "Bioelectronics" in a smaller, lighter font. The logo is simple and modern, with a focus on the company's name and field of expertise.
| Number | CFR 890.5850 | 21 CFR 890.5850 |
|---|---|---|
| -------- | -------------- | ----------------- |
Comparison Tables – Technological Characteristics
Basic Unit Characteristics
Table 2: Basic Unit Characteristics Comparison Table
| Parameter | ThimbleCUR Model 1 | NeurometrixAscend | PhilipsPulserelief | |
|---|---|---|---|---|
| 510(k) Number | (to be assigned) | K140333 | K151035 | |
| Device Name and Model Number | CUR Model 1 | Ascend | PulseRelief | |
| Manufacturer | Thimble Bioelectronics | NeuroMetrix | PhilipsConsumerLifestyle | |
| Power Source(s) | 3.7V Lithium-Polymerbattery (rechargeable) | 3.7V Lithium-ionbattery(rechargeable) | 3.7V Lithium-ion | |
| Method of Line Current Isolation | Physically isolated;device cannot connectto electrodes andbattery rechargerconcurrently | Physically isolated;device cannotconnect toelectrodes andbattery rechargerconcurrently | N/A | |
| Patient Leakage Current | Battery powered | Battery powered | Battery powered | |
| - Normal Condition (μA) | (< 10 μA) | (< 10μA) | (< 10μA) | |
| Patient Leakage Current | Battery powered | Battery powered | Battery powered | |
| - Single Fault Condition (µA) | (< 50 μA) | (< 100μA) | (< 50μA) | |
| Average DC current through electrodeswhen device is on but no pulses are beingapplied (μΑ) | < 0.1μA | < 1μA | 0 μΑ | |
| Number of Output Modes | 3 TENS, 1 EMS | 1 | 15 TENS, 5 EMS | |
| Number of OutputChannels: | Synchronous orAlternating? | 1 | 1 | 1 |
| Method ofChannelIsolation | N/A | N/A | N/A | |
| Regulated Current or Regulated Voltage? | Current | Current | Current | |
| Software/Firmware/MicroprocessorControl? | Yes | Yes | Yes | |
| Automatic Overload Trip? | Yes | Yes | Yes | |
| Automatic No-Load Trip? | Yes | Yes | Yes | |
| Automatic Shut Off? | Yes | Yes | Yes | |
| User Override Control? | Yes | Yes | Yes | |
| Indicator Display: | On/Off Status? | Yes | Yes | Yes |
| Low Battery? | Yes | Yes | Yes (on app) | |
| Voltage/CurrentLevel? | Yes | No | Yes (on app) |
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Image /page/7/Picture/0 description: The image shows the logo for Thimble Bioelectronics. The logo consists of a stylized leaf-like symbol on the left, followed by the word "Thimble" in a bold, sans-serif font. Below "Thimble" is the word "Bioelectronics" in a smaller, lighter font. The logo is simple and modern, with a focus on the company's name and field of expertise.
| Parameter | ThimbleCUR Model 1 | NeurometrixAscend | PhilipsPulserelief |
|---|---|---|---|
| Compliance with Voluntary Standards? | IEC 60601-1IEC 60601-1-2IEC 60601-2-10ISO 10993-5 and -10 | IEC 60601-1IEC 60601-1-2EN 1497 60601-2-10ISO 10993-5 and -10 | IEC 60601-1, IEC60601-1-2, IEC60601-2-10, ISO10993-5 and -10 |
| Compliance with 21 CFR 898? | N/A | Yes | Yes |
| Weight (g) | 11.5 g | 82 g | 62 g |
| Dimensions (mm) (W x H x D) | 36 x 36 x 8.5 | 176 x 63 x 18 | 2 units, each 54 x 54 x14 |
| Housing Materials and Construction | Polycarbonate plastic | Plastic, Velcro®straps (Nylon) | PC/ABS plastic |
Output Specifications Table for TENS Modes
Table 3: Output Specification for TENS Mode Comparison Table
| Parameter | CUR Model 1Mode A(Default Mode) | CUR Model 1Mode B | CUR Model 1Mode C | PulseRelief(K151035) | NeuroMetrix ASCEND(K140333) | |
|---|---|---|---|---|---|---|
| Waveform (e.g., pulsed monophasic, biphasic) | Biphasic,Asymmetrical | Biphasic,Symmetrical | Biphasic,Symmetrical | Biphasic,Symmetrical | Biphasic, Symmetrical | |
| Shape (e.g., rectangular, spike) | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | |
| Maximum Output Voltage (volts)(+/-10%) | 42.6V @ 500Ω | 43.2V @ 500Ω | 42.9V @ 500Ω | 31 @500Ω | 50V @ 500Ω | |
| 85.2V @ 2kΩ | 85.4V @ 2kΩ | 86.0V @ 2kΩ | 69 @ 2 kΩ | 100V @ 2kΩ | ||
| 87.0V @ 10kΩ | 85.4V @ 10kΩ | 87.8V @ 10kΩ | 70 @10 kΩ | 100V @ 10kΩ | ||
| Maximum Output Current (mA)(+/-10%) | 85.1 mA @500Ω | 86.3 mA @500Ω | 85.6 mA @500Ω | 62 @500Ω | 100mA @ 500Ω | |
| 43.1 mA @ 2kΩ | 43.2 mA @ 2kΩ | 43.5 mA @2kΩ | 34 @ 2 kΩ | 50mA @ 2kΩ | ||
| 8.8 mA @ 10kΩ | 8.8 mA @ 10kΩ | 8.8 mA @10kΩ | 7 @10 kΩ | 10mA @ 10kΩ | ||
| Duration of primary (depolarizing) phase (usec) | 91.7 usec | 90.5 usec | 51.0 usec | 25 ~175 µs | 100 µs | |
| Pulse Duration (both phases) (usec) | 91.7 usec | 221 usec | 142 usec | 60 ~ 350 µs | 200µs, additional 30µsinter-phase delay | |
| Frequency (Hz) | 40-130 Hz | 40-130 Hz | 120-160 Hz | 1 ~ 100 Hz | Random, mean 80Hz,uniform distribution 60-100Hz | |
| Formultiphasicwaveformsonly: | Symmetricalphases? | Yes | Yes | |||
| Phase Duration(include units),(state range, ifapplicable),(both phases, ifasymmetrical) | No91.7 usec(primary phase)0 usec @ 500Ω(second phase) | Yes90.5 usec | Yes51.0 usec | 25 ~ 175 µs | 100µs (each phase) |
1 Duration of second phase is load dependent.
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Image /page/8/Picture/0 description: The image shows the logo for Thimble Bioelectronics. The logo consists of a stylized leaf-like symbol on the left, followed by the word "Thimble" in a bold, sans-serif font. Below "Thimble" is the word "Bioelectronics" in a smaller, lighter font.
| Parameter | CUR Model 1Mode A(Default Mode) | CUR Model 1Mode B | CUR Model 1Mode C | PulseRelief(K151035) | NeuroMetrix ASCEND(K140333) |
|---|---|---|---|---|---|
| Net Charge (microcoulombs (µC) per pulse) (If zero, state how this was achieved) | 7.16µC @ 500Ω(Nominally 0µC @500Ω per pair of consecutive pulses, zero net current) | Nominally 0µC @ 500Ω, zero net current | Nominally 0µC @ 500Ω, zero net current | 0µC @ 500Ω | Nominally 0µC @ 500Ω, zero net current |
| Maximum Phase Charge, (µC) | 7.16 µC @ 500Ω | 7.45 µC @ 500Ω | 4.14 µC @ 500Ω | 1.6 ~ 6.8 µC @ 500Ω | 10 µC @ 500Ω |
| Maximum Current Density, (mA/cm2, r.m.s.) | 0.35 mA/cm2 @500Ω | 0.50 mA/cm2 @500Ω | 0.42 mA/cm2 @500Ω | 0.002 ~ 0.045 @500Ω | 0.51 mA/cm2 @ 500Ω |
| Maximum Average Current (average absolute value), mA | 0.94 mA @500Ω | 1.85 mA @500Ω | 1.28 mA @500Ω | 0.06 ~1.36 @500Ω | 1.6 mA @ 500Ω |
| Maximum Average Power Density, (W/cm2), (using smallest conductive surface area) | 1.50 mW/cm2 @500Ω | 3.05 mW/cm2 @500Ω | 2.09 mW/cm2 @500Ω | 0.24 ~ 1.69 @500Ω | 3.6 mW/cm2 @ 500Ω |
| Burst Mode (i.e., pulse trains): | (a) Pulses per burstN/A | N/A | N/A | 5, 7 | N/A |
| (b) Bursts per secondN/A | N/A | N/A | 1,2,3 | N/A | |
| (c) Burst duration (seconds)N/A | N/A | N/A | 62.5 ~ 87.5 | N/A | |
| (d) Duty Cycle:Line (b) x Line (c)N/A | N/A | N/A | 6.3%~ 19% | N/A |
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Output Specifications Table for PMS Modes
Table 4: Output Specifications for EMS Mode Comparison Table
| Parameter | CUR Model 1(Preset Mode D) | PulseRelief(K151035) | |
|---|---|---|---|
| Mode or Program Name | Measured(or Nominal as noted) | from 510k | |
| Waveform (e.g., pulsed monophasic, biphasic) | Biphasic, Symmetrical | Biphasic, Symmetrical | |
| Shape (e.g., rectangular, spike) | Rectangular | Rectangular | |
| Maximum Output Voltage (volts) (+/-10%) | 38.4V @ 500Ω | 31 @500Ω | |
| 85.0V @ 2kΩ | 69 @ 2 kΩ | ||
| 85.0V @ 10kΩ | 70 @10 kΩ | ||
| Maximum Output Current (mA) (+/-10%) | 76.7 mA @ 500Ω | 62 @500Ω | |
| 43.0 mA @ 2kΩ | 34 @ 2 kΩ | ||
| 8.1 mA @ 10kΩ | 7 @10 kΩ | ||
| Duration of primary (depolarizing) phase (usec) | 221.5 usec | 75 ~175 µs | |
| Pulse Duration (both phases) (usec) | 483.8 usec | 150 ~ 350 µs | |
| Frequency (Hz) | 2-15 Hz | 40 ~ 65 Hz | |
| Formultiphasic | Symmetrical phases? | Yes | Yes |
| waveformsonly: | Phase Duration (include units), (state range, ifapplicable), (both phases, if asymmetrical) | 221.5 usec | 75 ~ 175 µs |
| Net Charge (microcoulombs (µC) per pulse) (If zero, state howthis was achieved) | Nominally 0uC @ 500Ω,zero net current | 0uC @ 500Ω | |
| Maximum Phase Charge, (μC) | 16.21uC @ 500Ω | 4.7 ~10.9 uC @ 500Ω | |
| Maximum Current Density, (mA/cm2, r.m.s.) | 0.16mA/cm2 @500Ω | 0.0019 ~ 0.037 @500Ω | |
| Maximum Average Current (average absolute value), mA | 0.22 mA @500Ω | 0.047 ~ 0.93 @ 500Ω | |
| Maximum Average Power Density, (W/cm2), (using smallestconductive surface area) | 0.315 mW/cm2 @500Ω | 0.62~1.15 mW/cm2 @500Ω | |
| Burst Mode(i.e., pulse | (a) Pulses per burst | N/A | N/A |
| trains): | (b) Bursts per second | N/A | N/A |
| (c) Burst duration (seconds) | N/A | N/A | |
| (d) Duty Cycle: Line (b) x Line (c) | N/A | N/A |
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Image /page/10/Picture/0 description: The image shows the logo for Thimble Bioelectronics. The logo consists of a stylized leaf-like symbol on the left, followed by the word "Thimble" in a bold, sans-serif font. Below "Thimble" is the word "Bioelectronics" in a smaller, lighter font. The logo is simple and modern, with a focus on the company's name and field of expertise.
Non-Clinical Testing
Non-clinical verification testing of the CUR Model 1 device included electrical, mechanical, and software tests to show the device meets its design specifications. Validation and performance testing validates that the device meets its user needs. Verification and validation test results established that the device meets its intended use, that it is as safe, as effective, and performs as well as the predicate devices, and that no new issues of safety and effectiveness were raised. The CUR device was designed, verified, and validated according to the company's Design Control process and has been subjected to extensive safety and performance testing as shown in the test results provided in this submission. Verification and Validation testing data demonstrate that the device meets all of its specifications including compliance with the following standards:
Safety:
- . IEC 60601 1: 2005 + CORR. 1:2006 + CORR. 2:2007 + AM1:2012 (or IEC 60601-1: 2012 reprint)
- IEC 60601-2-10: 2012 (Second Edition) ●
- IEC 60601-1-11: 2010 (First Edition):
EMC:
- . IEC 60601-1-2:2014
- . FCC part 15 RADIO FREQUENCY DEVICES, Subpart B-Unintentional Radiators, Subpart C-Intentional Radiators.
Software:
- IEC 62304:2006 .
Usability
-
. IEC 62366-1:2015
Biocompatibility: -
ISO 10993-5:2009 .
-
. ISO 10993-10:2010
Clinical Testing
Thimble determined that bench and non-clinical testing were sufficient to demonstrate that the CUR Model 1 device is as safe and effective as the predicate devices.
Conclusion
The intended use and basic technological characteristics of the CUR Model 1 device are substantially equivalent with those of the references predicate devices. Any technological differences do not raise new questions regarding safety and effectiveness. The verification, validation, and performance data presented in this submission demonstrate that the CUR Model 1 device is substantially equivalent to the predicate Ascend and PulseRelief devices.
§ 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).