(384 days)
To be used for temporary relief of pain associated with sore and aching muscles in the upper and lower extremities (e.g., arm and/or leg) and lower back due to strain from exercise or normal household and work activities.
The 5000Z/Firefly is a portable, single channel TENS device with two pre-programmed operational modes. It is powered by 2 standard AAA alkaline or rechargeable batteries. All operational modes produce the Prizm Medical Bi-Sourced waveform. The user selects a pre-programmed mode by using the program buttons to select one of two program options. The user is able to adjust the intensity up or down. The 5000Z/Firefly is intended for Over-the-Counter sale. The 5000Z/Firefly battery icon on the LED will flash when the batteries need replacement.
This document is a 510(k) summary for the Prizm Medical 5000Z/Firefly Transcutaneous Nerve Stimulator (TENS) system. The purpose of this document is to demonstrate "substantial equivalence" to a predicate device, not to present a study proving the device meets specific acceptance criteria in the typical sense of a clinical trial for a new therapeutic claim.
Therefore, the requested information about acceptance criteria, study design, sample sizes, ground truth establishment, expert adjudication, and MRMC studies is largely not applicable in the context of this 510(k) submission. This document focuses on demonstrating that the new device has similar technological characteristics and performance to already cleared predicate devices.
However, I can extract information related to non-clinical testing that verifies the device meets its own product specifications, which could be considered its internal "acceptance criteria."
Here's the breakdown:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list "acceptance criteria" in a quantitative, pass/fail manner for clinical efficacy. Instead, it provides a comparison of technological characteristics of the subject device (Prizm Medical 5000Z/Firefly) against several predicate devices. The "reported device performance" in this context refers to the technological specifications of the subject device.
| Product Characteristics | Acceptance Criteria (Implied: Match predicate characteristics/safe operation) | Reported Device Performance (Prizm Medical 5000Z/Firefly) |
|---|---|---|
| Power Source | Safe and effective power delivery | Two "AAA" standard alkaline batteries or rechargeable |
| Number of Output Modes | Consistent with predicate device functionality | 2 |
| Number of Output Channels | Consistent with predicate device functionality | 1 (twin peak, monophasic) |
| Regulated Current/Voltage | Yes (Safety and consistent output) | Yes |
| Software/Firmware/Microprocessor Control? | Yes (Functionality and safety) | Yes |
| Automatic Shut Off | Yes (Safety feature) | Yes |
| User Override Control | Yes (User control and safety) | Yes |
| Indicator Display: On/Off Status | Yes (User feedback) | Yes |
| Low Battery Indicator | Yes (User feedback) | Yes |
| Volt/Current Level Indicator | Yes (User feedback) | Yes |
| Timer Range (minutes) | Consistent with predicate device functionality | Nonadjustable 30 min / Nonadjustable 20 min |
| Compliance with 21 CFR 898 | N/A (no lead wires) | N/A (no lead wires) |
| Weight | Comparable to predicate devices | Approximately 1.8 oz. without battery |
| Size | Comparable to predicate devices | 3.75" x 2.0" x 1.0" |
| Housing Material | Durable and safe | ABS plastic |
| Waveform | Consistent with predicate device and intended TENS therapy | Monophasic, Twin peak |
| Maximum Output Voltage | Within safe and effective range (200V) | 200V |
| Maximum Output Current | Within safe and effective range (0.384 mA) | 0.384 mA |
| Pulse Duration | Consistent with predicate device and intended TENS therapy | 100 (usec) |
| Frequency / Hz | Consistent with predicate device and intended TENS therapy | 1 to 120Hz |
| Maximum Phase Charge | Within safe limits (3.2 µC (500 Ω load)) | 3.2 µC (500 Ω load) |
| Maximum current density (500Ω) | Within safe limits (0.0256 mA/cm²) | 0.0256 mA/cm² |
| Maximum Average Current (500Ω) | Within safe limits (0.64 mA) | 0.64 mA |
| Maximum Average Power Density (500Ω) | Within safe limits (5.12 mW/cm²) | 5.12 mW/cm² |
| Phase duration | Consistent with predicate device and intended TENS therapy | 100 microseconds (usec) |
| Output type | Consistent with predicate device and intended TENS therapy | Constant voltage |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set (for clinical efficacy): Not applicable. The document explicitly states: "The Prizm Medical 5000Z/Firefly TENS System does not require clinical testing in order to determine substantial equivalence to the predicate unmodified device because the programs and electrical output characteristics of the two devices are the same." Therefore, there was no clinical "test set" in the sense of patient data.
- Data Provenance: The "data" presented is largely engineering and technical specifications of the device and its predicates, not patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not applicable. As no clinical "test set" was used for efficacy, there was no ground truth to be established by experts in a clinical context. The "ground truth" here is the technical specifications of the device, established through engineering design and testing.
4. Adjudication Method for the Test Set
- Not applicable. No clinical test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This type of study is for evaluating human performance (e.g., radiologists diagnosing images) with and without AI assistance. This device is a TENS unit, not an AI diagnostic tool, so an MRMC study is completely irrelevant.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Not applicable. This device is a TENS unit that directly delivers electrical stimulation to a user. It is not an algorithm that performs a standalone function without human interaction in the sense of diagnosis or interpretation. The "algorithm" here refers to the device's electrical output programs, which are inherent to its function. The non-clinical testing verifies that these programs perform according to specifications.
7. Type of Ground Truth Used
- For the non-clinical testing mentioned, the "ground truth" would be the engineering design specifications and recognized electrical safety standards. The device was tested to ensure it met these predetermined, objective, and measurable criteria (e.g., output voltage, current, frequency, timing, safety features).
8. Sample Size for the Training Set
- Not applicable. As this is a TENS device and not an AI/machine learning algorithm that requires a "training set" of data, there is no training set sample size.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. No training set for an AI algorithm.
Summary of the Study that Proves the Device Meets its (Internal) Acceptance Criteria (Product Specifications):
The document describes Non-clinical Testing which includes:
- Software verification: Carried out according to FDA guidance for software in medical devices. This ensures the software embedded in the device functions as intended and safely.
- Electrical and mechanical tests: These tests were performed to demonstrate that the device meets its product specifications (the "acceptance criteria" in this context) across a range of operating and storage conditions. This would involve rigorous bench testing of the device's output (voltage, current, frequency, waveform), timer accuracy, button functionality, display indicators, battery life, and physical durability.
- Validation testing: This was conducted to show that the device meets user needs according to marketing requirements. This implies usability testing and confirmation that the device effectively delivers the intended stimulation.
The conclusion states: "The non-clinical testing demonstrates that the Prizm Medical 5000Z/Firefly TENS System performs as well as the predicate device(s). There are no new safety or effectiveness issues concerning the new device." This indicates that the results of the non-clinical tests confirmed that the device's performance aligns with its specifications and is comparable to previously cleared devices, thus deeming it substantially equivalent.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, with a bird-like element above them, possibly representing an eagle or another bird of prey.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 3, 2014
Prizm Medical, Inc. Mr. Jim Johnson CEO 1236 Doker Drive Modesto, CA 95351
Re: K133502
Trade/Device Name: Prizm Medical 5000Z/Firefly Regulation Number: 21 CFR 882.5890 Regulation Name: Stimulator, Nerve Transcutaneous, Over-The-Counter Regulatory Class: Class II Product Code: NUH Dated: August 21, 2014 Received: November 05, 2014
Dear Mr. Johnson,
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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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" (21CFR 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.
Felipe Aquel -S
Carlos L. Peña, PhD, MS for 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) K133502
Device Name
Prizm Medical 5000Z Firefly Transcutaneous Nerve Stimulator
Indications for Use (Describe)
To be used for temporary relief of pain associated with sore and aching muscles in the upper and lower extremities (e.g., arm and/or leg) and lower back due to strain from exercise or normal household and work activities.
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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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) SUMMARY
I. SUBMITTER
510(k) Owner: Prizm Medical, Inc.
Address: 1236 Doker Drive
Modesto, CA 95351
Phone number: 770-622-0933
Contact person: Jim Johnson, CEO
Date prepared: October 22, 2013
II. DEVICE
Trade name: Prizm Medical 5000Z/Firefly Common name: Electrical Stimulator OTC TENS Classification name: Stimulator, Nerve Transcutaneous, Over-The-Counter Classification Number: 21 CFR 882.5890
Product Code: NUH
Classification: II
PREDICATE DEVICE III.
Predicate device(s): Prizm Medical 5000Z System (K033122) Axelgaard Mfg. Co. Ltd. UltraStim Kit (K013532) Hollywog, LLC The Pain Pilot (K120500) Omron Healthcare, Inc. PM3030 (K110068)
INDICATIONS FOR USE IV.
The Prizm Medical 5000Z/Firefly TENS System is to be used for temporary relief of pain associated with sore and aching muscles in the upper and lower extremities (e.g., arm and/or leg), and low back due to strain from exercise or normal household and work activities.
V. DEVICE DESCRIPTION
The 5000Z/Firefly is a portable, single channel TENS device with two pre-programmed operational modes. It is powered by 2 standard AAA alkaline or rechargeable batteries. All operational modes produce the Prizm Medical Bi-Sourced waveform. The user
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selects a pre-programmed mode by using the program buttons to select one of two program options. The user is able to adjust the intensity up or down. The 5000Z/Firefly is intended for Over-the-Counter sale. The 5000Z/Firefly battery icon on the LED will flash when the batteries need replacement.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE
The Prizm Medical 5000Z/Firefly TENS System has the same indications for use as the predicate device. The functional technological characteristics are the same in that there are no changes to the output modes (waveforms) or programs for the 5000Z/Firefly compared to the 5000Z system. The differences between the 5000Z system and 5000Z/Firefly are an increase in voltage, and the user interface. The 5000Z system has a small LED display and membrane switches for controlling and displaying adjustable settings. The 5000Z/Firefly has a key mat style push button system and a larger LED screen controlling and displaying the adjustable settings.
| ProductCharacteristics | Subject Device | Predicate (K033122) | Predicate (K013532) | Predicate (K120500) | Predicate (K110068) |
|---|---|---|---|---|---|
| Prizm Medical, Inc.5000Z / Firefly | Prizm Medical, Inc.5000Z™ System | Axelgaard Mfg. Co.Ltd. UltraStim Kit | Hollywog, LLCThe Pain Pilot | Omron Healthcare, Inc.PM3030 | |
| Power Source | Two "AAA" standardalkaline batteries orrechargeable | One "AAA" alkalinebattery | One 9-volt alkalinebattery | Two "AAA" standardalkaline batteries | Two "AAA" standardalkaline batteries |
| Number of OutputModes | 2 | 2 | 5 | 4 | 3 |
| Number of OutputChannels | 1 (twin peak,monophasic) | 1 (twin peak,monophasic) | 1 (Asymmetricbiphasic) | 1 (Asynchronous-biphasic) | 1 (Asynchronous-biphasic) |
| Regulated Current /Voltage | Yes | Yes | Yes | Yes | Yes |
| Software/Firmware/MicroprocessorControl? | Yes | Yes | Yes | Yes | Yes |
| Automatic Shut Off | Yes | Yes | Yes | Yes | Yes |
| User Override Control | Yes | Yes | Yes | Yes | Yes |
| Indicator Display:On/Off Status | Yes | Yes | Yes | Yes | Yes |
| Low Battery | Yes | Yes | Yes | Yes | Yes |
| Volt/Current Level | Yes | Yes | Yes | No | Yes |
| Timer Rang (minutes) | Nonadjustable 30 min/Nonadjustable 20 min | Nonadjustable 30 min/Nonadjustable 20 min | Nonadjustable 30 min | Nonadjustable 30 min | Nonadjustable 30 min |
| Compliance with 21CFR 898 | N/A (no lead wires) | Yes | Yes | Yes | Yes |
| Weight | Approximately 1.8 oz.without battery | Approximately 2 oz.without battery | 120g with battery | 4.8 oz. w/ includedbattery | 2.1 oz. w/ included battery |
| Size | 3.75" x 2.0" x 1.0" | 1.8" x 1.9" x 0.48" | 10 cm x 6 cm x 2.1 cm | 7.5" x 3.5" x0.7" | 2.17" x 3.74" x 0.74" |
| Housing Material | ABS plastic | ABS plastic | Plastic | ABS plastic | ABS plastic |
| Waveform | Monophasic | Monophasic | Asymmetric biphasic | Asynchronous-biphasic | Asynchronous-biphasic |
| Shape | Twin peak | Twin peak | Asynchronous | Asynchronous | Rectangular |
| Maximum OutputVoltage | 200V | 100V | 40V | 55V | 35.4V |
| Maximum Output | 0.384 mA | 0.192 mA | 80 mA | 110 mA | 4.4 mA |
Substantial Equivalence Matrix
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Substantial Equivalence Matrix
| Product | Subject Device | Predicate (K033122) | Predicate (K013532) | Predicate (K120500) | Predicate (K110068) |
|---|---|---|---|---|---|
| Characteristics | Prizm Medical, Inc. | Prizm Medical, Inc. | Axelgaard Mfg. Co. | Hollywog, LLC | Omron Healthcare, Inc. |
| 5000Z / Firefly | 5000Z™ System | Ltd. UltraStim Kit | The Pain Pilot | PM3030 | |
| Pulse Duration | 100 (usec) | 100 (usec) | 260 (usec) | 120 - 240 (usec) | Unspecified |
| Frequency / Hz | 1 to 120Hz | 1 to 120Hz | 3 to 100Hz | 5 to 100Hz | 1 to 100Hz |
| Maximum Phase | 3.2 µC (500 ≤2 load) | 3.0 µC (500 ≤2 load) | 5.0 µC (500 ≤2 load) | Unspecified | 133 µC (500 ≤2 load) |
| Charge | |||||
| Maximum current | 0.0256 mA/cm2 | 0.0076 mA/cm2 | 1.81mA/area of | 0.12 mA/cm2 | 0.095 mA/cm2 |
| density (500Ω2) | electrode | ||||
| Maximum Average | 0.64 mA | 0.12 mA | Unspecified | 1.6 mA | 3.5 mA |
| Current (500Ω) | |||||
| Maximum Average | 5.12 mW/cm2 | 1.92mW/cm2 | Unspecified | 0.69mW/cm2 | 89mW/cm2 |
| Power Density (500Ω) | |||||
| Phase duration | 100 microseconds | 100 microseconds | 300 microseconds | 120-480 (usec) | Unspecified |
| (usec) | (usec) | (usec) | |||
| Output type | Constant voltage | Constant voltage | Constant current | Constant current | Constant current |
VII. PERFORMANCE DATA
Non-clinical Testing:
The software verification has been carried out according to the FDA guidance for the content of premarket submissions for software contained in medical devices.
Verification of the Prizm Medical 5000Z/Firefly TENS System includes electrical and mechanical tests to show that the device meets its product specifications over a range of operating and storage conditions.
Validation testing for the Prizm Medical 5000Z/Firefly TENS System includes testing to show the device meets user needs according to marketing requirements.
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Clinical Testing:
The Prizm Medical 5000Z/Firefly TENS System does not require clinical testing in order to determine substantial equivalence to the predicate unmodified device because the programs and electrical output characteristics of the two devices are the same.
CONCLUSION VIII.
Technological characteristics, features, specifications, materials and intended uses of the Prizm Medical 5000Z/Firefly TENS System are substantially equivalent to the predicate device(s). The electrical stimulation provided by the Prizm Medical 5000Z/Firefly TENS System is similar to the commonly employed TENS devices that have been cleared for marketing without prescription labeling. The engineering differences do not: (1) affect the intended use or (2) alter the fundamental scientific technology of the device. The non-clinical testing demonstrates that the Prizm Medical 5000Z/Firefly TENS System performs as well as the predicate device(s). There are no new safety or effectiveness issues concerning the new device.
§ 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).