(384 days)
Not Found
No
The device description and performance studies do not mention any AI or ML capabilities. The device has pre-programmed modes and user-adjustable intensity, which are typical features of traditional TENS devices.
Yes
The device is a TENS device, which is a type of therapeutic device used for pain relief, as stated in its intended use.
No
The device is described as a TENS device used for temporary pain relief, not for diagnosing conditions.
No
The device description explicitly states it is a "portable, single channel TENS device" powered by batteries and includes physical components like program buttons and an LED display. The performance studies also mention electrical and mechanical tests, indicating hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices that are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided information clearly describes a TENS (Transcutaneous Electrical Nerve Stimulation) device. Its intended use is for the temporary relief of pain associated with sore and aching muscles. This is a therapeutic device that applies electrical stimulation to the body's surface, not a device that analyzes biological samples.
The description and intended use are entirely focused on external application for pain relief, which is the function of a TENS device, not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes
NUH
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper and lower extremities (e.g., arm and/or leg) and lower back
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-the-Counter Use
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
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.
Key Metrics
Not Found
Predicate Device(s)
K033122, K013532, K120500, K110068
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/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
1
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
4
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.
| Product
| Characteristics | 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, LLC | ||||
| The Pain Pilot | Omron Healthcare, Inc. | ||||
| PM3030 | |||||
| Power Source | Two "AAA" standard | ||||
| alkaline batteries or | |||||
| rechargeable | One "AAA" alkaline | ||||
| battery | One 9-volt alkaline | ||||
| battery | Two "AAA" standard | ||||
| alkaline batteries | Two "AAA" standard | ||||
| alkaline batteries | |||||
| Number of Output | |||||
| Modes | 2 | 2 | 5 | 4 | 3 |
| Number of Output | |||||
| Channels | 1 (twin peak, | ||||
| monophasic) | 1 (twin peak, | ||||
| monophasic) | 1 (Asymmetric | ||||
| biphasic) | 1 (Asynchronous- | ||||
| biphasic) | 1 (Asynchronous- | ||||
| biphasic) | |||||
| Regulated Current / | |||||
| Voltage | Yes | Yes | Yes | Yes | Yes |
| Software/Firmware/ | |||||
| Microprocessor | |||||
| Control? | 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 21 | |||||
| CFR 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/ included | |||
| battery | 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 Output | |||||
| Voltage | 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.