(315 days)
The Pantheon Research Electrostimulator 4c.Pro, 8c.Pro, 12c.Pro, & 9c3i are for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
The Pantheon Research Pro Series electro-acupuncture stimulators are electrical stimulators that introduce calibrated and controlled electrical impulses into acupuncture needles inserted into patients for therapeutic purposes. These devices are built in 5 models: the 4c.Pro. 6c.Pro. 12c.Pro. and 9c3i models. The Pantheon electro-acupuncture stimulator series does not come equipped with acupuncture needles. The practitioners should select 510(k) cleared needles
This document is a 510(k) Pre-market Notification for the Pantheon Electrostimulator Models 4c.Pro, 6c.Pro, 8c.Pro, 12c.Pro, and 9c3i. It aims to demonstrate substantial equivalence to a predicate device.
Here's the breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" for performance metrics in a numerical or target-based format. Instead, it demonstrates performance by comparing technical characteristics to the predicate device and by complying with relevant safety and EMC standards. The implicit acceptance criteria are that the device's technical characteristics are comparable or safer than the predicate, and that it passes the specified electrical safety, EMC, and biocompatibility tests.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Indications for Use: Equivalent to legally marketed predicate. | The Pantheon Research Electrostimulator 4c.Pro, 6c.Pro, 8c.Pro, 12c.Pro, & 9c3i are for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states. This is identical to the predicate device's intended use. |
| Device Type: Equivalent to predicate. | Stimulator, Electro-Acupuncture (Identical to predicate). |
| Product Code: Equivalent to predicate. | BWK (Identical to predicate). |
| Authorized Use: Equivalent to predicate. | Prescription Use (Identical to predicate). |
| Accessory Attachment Methods: Comparable to predicate. | Leads: alligator clips on wires (Identical to predicate). |
| Voltage: Within acceptable range for electro-acupuncture. | 2.95 Vrms @ 300 ohm; 14.5 Vrms @ 2500 ohm; 24.9 Vrms @ 10000 ohm. (Predicate: 20 V @ 500 ohms, 30 V @ 10,000 ohms. The subject device has lower voltage output at comparable impedances, suggesting a safer profile.) |
| Current: Within acceptable range for electro-acupuncture, preferably lower/safer than predicate. | 5.76 mA rms @ 300 ohms; 0 to 600 microamperes. (Predicate: Low: 0-20 mA, High: 0-40 mA. The subject device has significantly lower current, notably in microamperes, which is safer.) |
| Max. Power Density: Provided and considered acceptable. | .248 W/cm² @300 ohms, 500hz. (Not available for predicate, but provided as a characteristic). |
| Max Current Density: Provided and considered acceptable. | 9.78 MA rms @300 ohms, 500 hz. (Not available for predicate, but provided as a characteristic). |
| Frequency: Comparable or within functional range of predicate. | 0.5 to 200 Hertz (for 4c.Pro, 6c.Pro, 8c.Pro, 12c.Pro). 0.5 to 500 Hertz (for 9c3i only). (Predicate: L: 1 ~ 20 Hz, M: 20 ~ 150 Hz, H: 150 ~ 500 Hz. The ranges are largely comparable, with the 9c3i model matching the highest predicate frequency). |
| Pulse Width: Comparable to predicate. | 400 microseconds. (Predicate: 250 microseconds. The subject device has a longer pulse width, still within acceptable electro-acupuncture parameters). |
| Pulse Shape (Design & Measurement): Equivalent to predicate. | Asymmetric Biphasic Square wave (Identical to predicate). |
| Power Supply: Safe and functional. | 4, 6, 8, 12c.Pro: 2 9v batteries. 9c3i: 4 9v batteries. (Predicate: One 9 V Battery. Different battery configuration, but still battery-powered). |
| Rated Power Consumption: Provided and considered acceptable. | DC 18 V @ <30 mA. (Predicate: DC 9V. Different to predicate due to different power supply, but provided). |
| Battery Life: Provided. | 18.8 hours (30mA max. @ a load of 620 ohms). (Not available for predicate, but provided). |
| Environmental Operating & Storage Conditions: Comparable to predicate. | Operating Temp: 10-40 degrees C. Storage Temp: 10-60 degrees C. (Identical to predicate). Humidity (Use): 30-85%. Humidity (Storage): 30-95%. (Identical to predicate). Barometric Pressure (Use & Storage): 700-1060 Pa. (Identical to predicate). |
| Safety Features: At least equivalent to or improved over predicate. | Device cannot turn ON unless all outputs knobs are first turned OFF. Prevents accidental shocking of patient. Multiple internal safety features to prevent electronic malfunction, such as current limiting resisters that are redundant. (Predicate: None listed. The subject device has enhanced safety features.) |
| Test Functions: Provides functional checks. | 1) Clip lead tester, 2) Output tester, 3) Auto battery tester, 4) Manual battery test. (Predicate: None listed. The subject device has enhanced test functions). |
| Electrical Safety and EMC: Compliance with international standards. | Electrical Safety: IEC 60601-1: Ed.2, Amd 1, Amd 2, Corrigendum 1. IEC 60601-2-10: First Edition; Amendment 1. EMC: EN 60601-1-2:2007 / IEC 60601-1-2:2007 (Class B for Emissions, Immunity for Non Life-Supporting Equipment). (Compliance with these standards is explicitly stated). |
| Biocompatibility: Compliance with international standards. | Testing was performed in accordance with ISO 10993-1. (Compliance with this standard is explicitly stated). |
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 describes non-clinical testing for electrical safety, EMC, and biocompatibility. These types of tests typically use a sample of the manufactured device itself and do not involve patient data or study subjects in the way a clinical trial would. Therefore, there is no mention of a "test set" in the context of patient data, nor its provenance, as this submission is for an electro-acupuncture stimulator supported by technical and safety standards rather than a disease-detection or diagnostic device.
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)
This section is not applicable as the submission relies on technical and safety standard compliance, and a comparison of technical characteristics to a predicate device, rather than a clinical study with a "test set" requiring expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable for the same reasons as #3.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an electro-acupuncture stimulator, not an AI-powered diagnostic or assistive device for "human readers."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. The device is an electro-acupuncture stimulator, and it does not contain an "algorithm" in the sense of a decision-making or diagnostic AI algorithm. Its performance is evaluated based on its electrical output characteristics and safety compliance, not a standalone algorithm's accuracy.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance relies on compliance with established international electrical safety and electromagnetic compatibility (EMC) standards, and biocompatibility standards (ISO 10993-1). Additionally, the technical specifications (voltage, current, frequency, pulse width, etc.) are compared to those of a legally marketed predicate device to demonstrate substantial equivalence. No patient-specific outcomes data, pathology, or expert consensus on clinical findings are mentioned as ground truth for this type of device submission.
8. The sample size for the training set
This section is not applicable as this device does not involve machine learning or AI that would require a "training set."
9. How the ground truth for the training set was established
This section is not applicable for the same reasons as #8.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 7, 2014
Pantheon Research c/o Yolanda Smith Smith Associates 1468 Harwell Ave. Crofton, MD 21114
Re: K133980
Trade/Device Name: Pantheon Electrostimulator Models 4c.Pro, 6c.Pro, 8c.Pro, 12c.Pro, 9c3i Regulation Number: Unclassified Regulation Name: Electro-Acupuncture Stimulator Regulatory Class: Unclassified Product Code: BWK Dated: October 10, 2014 Received: October 10, 2014
Dear Ms. Smith:
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/Resourcesfor You/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,
Michael J. Hoffmann -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) K133980
Device Name
Pantheon Electrostimulator Models 4c.Pro, 6c.Pro, 8c.Pro, 12c.Pro, 9c3i
Indications for Use (Describe)
The Pantheon Research Electrostimulator 4c.Pro, 8c.Pro, 12c.Pro, & 9c3i are for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary 807.92(c)
| SPONSOR | 807.92(a)(1) | |
|---|---|---|
| Company Name: | Pantheon Research | |
| Company Address | 626A Venice BlvdVenice, California 90291 | |
| Telephone: | 310-822-4965 | |
| Contact Person: | John Hubacher |
Summary Preparation Date: December 13, 2013
DEVICE NAME
807.92(a)(2) Trade Name: Pantheon Electrostimulator 4c.Pro, 6c.Pro, 8c.Pro, 12c.Pro, & 9c3i Common/Usual Name: Electro-Acupuncture Stimulator Classification Name: Electro-Acupuncture Stimulator Regulation Number: Unclassified Product Code: BWK Device Class: Unclassified Panel: Neurology
PREDICATE DEVICE
807.92(a)(3)
Legally Marketed Equivalent Device
| 510k Number | Product | Company |
|---|---|---|
| K081943 | Model ES-130 Electro-AcupunctureDevice o | Ito Co., Ltd. |
DEVICE DESCRIPTION
The Pantheon Research Pro Series electro-acupuncture stimulators are electrical stimulators that introduce calibrated and controlled electrical impulses into acupuncture needles inserted into patients for therapeutic purposes.
These devices are built in 5 models: the 4c.Pro. 6c.Pro. 12c.Pro. and 9c3i models.
The Pantheon electro-acupuncture stimulator series does not come equipped with acupuncture needles. The practitioners should select 510(k) cleared needles
DEVICE INTENDED USE
The intended use of the Pantheon Research Electro-Stimulators (Models 4c Pro, 6c. Pro, 8c. Pro, 12c. Pro, and 9c3i) are electro-acupuncture devices for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
807.92(a)(4)
807.92(a)(5)
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Caution: Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
| Subject Device:Pantheon Electrostimulators4c.Pro, 6c.Pro, 8c.Pro, 12c.Pro, 9c3i | Predicate Device:Ito ES 130 | |
|---|---|---|
| K Number | K081943 | |
| Manufacturer | Pantheon Research | Ito Co., Ltd |
| Trade Name | Pantheon Electrostimulators 4c.Pro,6c.Pro, 8c.Pro, 12c.Pro, and 9c3i | ES-130 |
| Device Type | Stimulator, Electro-Acupuncture | Stimulator, Electro-Acupuncture |
| Product Code | BWK | BWK |
| Authorized Use | Prescription Use | Prescription Use |
| Indications for Use | The Pantheon Research Electrostimulator4c.Pro, 6c.Pro, 8c.Pro, 12c.Pro, & 9c3i arefor use in the practice of acupuncture byqualified practitioners of acupuncture asdetermined by the states. | The intended use of the ES-130 is anElectro-Acupuncture Device for use in thepractice of acupuncture by qualifiedpractitioners of acupuncture as determinedby the states. |
| Accessory AttachmentMethods | Leads: alligator clips on wires | Leads: alligator clips on wire |
| Voltage | 2.95 Vrms @ 300 ohm; 14.5Vrms @ 2500 ohm; 24.9 Vrms @ 10000ohm. | 20 V @ 500 ohms , 30 V @ 10,000 ohms |
| Current: milliampereMicroampere: | 5.76 mA rms @ 300 ohms0 to 600 microamperes | Low: 0-20 mAHigh: 0-40 mA |
| Max. Power density | .248 W/cm² @300 ohms, 500hz. | NA |
| Max Current density | 9.78 MA rms @300 ohms, 500 hz | NA |
| Frequency | .5 to 200 Hertz. (PantheonElectrostimulators 4c.Pro, 6c.Pro, 8c.Pro,12c.Pro)..5 to 500 Hertz (PantheonElectrostimulator 9c3i only) | L: 1 ~ 20 HzM: 20 ~ 150 HzH: 150 ~ 500 Hz |
| Pulse Width | 400 micro seconds | 250 micro seconds |
| Pulse Shape (Design) | Asymmetric Biphasic Square wave | Asymmetric Biphasic Square Wave |
| Pulse Shape(Measurement) | Asymmetric Biphasic Square wave | Asymmetric Biphasic square wave |
| Power Supply | 4, 6, 8, 12c.Pro: 2 9v batteries9c3i: 4 9v batteries | One 9 V Battery |
| Rated PowerConsumption | DC 18 V @ <30 ma. | DC 9V (Cannot be connected with AC/DCConverter) |
| Battery Life | 18.8 hours (30mA max. @ a load of 620ohms) | |
| Buzzer | All yes. Used as machine diagnosticAlarm for safety alert. | No |
| LCD | No. | No |
| Operating Temp:Storage : | 10-40 degrees C10 -60 degrees C | 10 -40 degrees C10 - 60 degrees C |
| Humidity::UseStorage | 30-85%30 - 95% | 30 - 85%30 - 95% |
| Barometric Pressure: Use:Storage: | 700-1060 Pa700-1060 Pa | 700 - 1060 Pa700 - 1060 Pa |
| Safety Features | Device cannot turn ON unless all outputsknobs are first turned OFF. Preventsaccidental shocking of patient.Multiple internal safety features to preventelectronic malfunction, such as currentlimiting resisters that are redundant. | None |
| Test Functions | 1) Clip lead tester2) Output tester, to test if the output ispresent3) Auto battery tester, test batteryautomatically and provides warning lightand sound if battery is low.4) Manual battery test, allows manualchecking of battery level. | None |
COMPARISON OF TECHNICAL CHARACTERISTICS
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NONCLINICAL AND CLINICAL TEST
807.92(b)
SAFETY and EFFECTIVENESS
Electrical Safety and EMC Testing IEC 60601-1: Issued:1988/12/30 Ed:2 Medical Electrical Equipment Part 1: General Requirements for Safety; Amendment 1; 1991, Amendment 2; 1995, Corrigendum 1; 1995
IEC 60601-2-10 Medical Electrical Equipment Part : Particular Requirements for the Safety of Nerve and Muscle Stimulators- First Edition; Amendment 1: 09-2001.
EN 60601-1-2:2007 IEC 60601-1-2:2007 Class B for Emissions, Immunity for Non Life-Supporting Equipment
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Biocompatibility
Testing was performed in accordance with ISO 10993-1.
CONCLUSION
807.92(b)(3)
The Pantheon Electrostimulators, 4c.Pro, 8c.Pro, 12c.Pro and 9c3i are substantially equivalent to the predicate device in Indications for Use, operating principle and technological characteristics, with the addition of safety features, such as lower current level and safety features for safe use and equipment testing. Electrical Safety and EMC testing to IEC standards, and biocompatibility testing to 10993 has concluded that the device does not introduce significant questions of safety and efficacy and is substantially equivalent to the predicate.
N/A