(315 days)
Not Found
No
The summary describes a standard electro-acupuncture stimulator and does not mention any AI or ML capabilities, data sets for training or testing, or performance metrics typically associated with AI/ML algorithms.
Yes
The device description states it introduces electrical impulses into acupuncture needles "for therapeutic purposes."
No
The device is described as an electro-acupuncture stimulator used to introduce electrical impulses for therapeutic purposes, not for diagnosis.
No
The device description explicitly states it is an "electrical stimulator" that introduces "calibrated and controlled electrical impulses," indicating it is a hardware device. The performance studies also include electrical safety and EMC testing, which are relevant to hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "use in the practice of acupuncture by qualified practitioners of acupuncture". This involves applying electrical impulses to acupuncture needles inserted into a patient's body for therapeutic purposes. This is a direct interaction with the patient's body, not the examination of specimens derived from the human body.
- Device Description: The device is described as an "electrical stimulator that introduce calibrated and controlled electrical impulses into acupuncture needles inserted into patients". This further confirms its function as a therapeutic device applied to the patient.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, urine, tissue, etc.) or to provide information about a physiological state, health, disease, or congenital abnormality based on such examination.
IVD devices are specifically designed to perform tests on samples taken from the body to provide diagnostic information. This device is designed to treat the body directly.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
BWK
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified practitioners of acupuncture / Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
Biocompatibility Testing was performed in accordance with ISO 10993-1.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
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
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/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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary 807.92(c)
| SPONSOR | 807.92(a)(1) | |
|---|---|---|
| Company Name: | Pantheon Research | |
| Company Address | 626A Venice Blvd | |
| Venice, 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-Acupuncture | |
| Device 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)
4
Caution: Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
| | Subject Device:
Pantheon Electrostimulators
4c.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 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. | The intended use of the ES-130 is an
Electro-Acupuncture Device for use in the
practice of acupuncture by qualified
practitioners of acupuncture as determined
by the states. |
| Accessory Attachment
Methods | Leads: alligator clips on wires | Leads: alligator clips on wire |
| Voltage | 2.95 Vrms @ 300 ohm; 14.5
Vrms @ 2500 ohm; 24.9 Vrms @ 10000
ohm. | 20 V @ 500 ohms , 30 V @ 10,000 ohms |
| Current: milliampere
Microampere: | 5.76 mA rms @ 300 ohms
0 to 600 microamperes | Low: 0-20 mA
High: 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. (Pantheon
Electrostimulators 4c.Pro, 6c.Pro, 8c.Pro,
12c.Pro).
.5 to 500 Hertz (Pantheon
Electrostimulator 9c3i only) | L: 1 ~ 20 Hz
M: 20 ~ 150 Hz
H: 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 batteries
9c3i: 4 9v batteries | One 9 V Battery |
| Rated Power
Consumption | DC 18 V @