(260 days)
Not Found
No
The device description and performance studies do not mention any AI or ML components or algorithms. The device is a simple electrical stimulator with no processing capabilities beyond basic stimulation.
Yes
The device description indicates it is an electrical nerve stimulator for the stimulation of the vagus nerve via the ear, used in the practice of electro-acupuncture by qualified practitioners, which directly implies a therapeutic application. The intended use for acupuncture also positions it as a therapeutic device.
No
The device description indicates it is a "battery-powered, electrical nerve stimulator" for "stimulation of the vagus nerve via the ear," which is a therapeutic function, not a diagnostic one.
No
The device description explicitly details hardware components such as a battery, stimulator housed in plastic, electrode cable, and needles. It is not solely software.
Based on the provided information, the Stivax device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Stivax Function: The Stivax is an electro-acupuncture device that directly stimulates the vagus nerve via the ear using acupuncture needles. It is a therapeutic device, not a diagnostic one. It does not analyze any biological samples.
- Intended Use: The intended use clearly states it's for "stimulation of the vagus nerve via the ear" in the practice of acupuncture. This is a treatment modality, not a diagnostic process.
Therefore, the Stivax falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Stivax is an electro-acupuncture device 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 Stivax is a single use, battery-powered, electrical nerve stimulator which is used for the stimulation of the vagus nerve via the ear. The device connects an electrode cable to two sterile (radiation) acupuncture needles that have been applied by a healthcare practitioner. The stimulator connects to a clip holder on medical grade adhesive tape. The stimulator (with tape) adheres to the patient, behind the ear.
The STIVAX and the sterile (radiation) stimulation double needle are intended for single use.
The device consists of the stimulator and a stimulation double needle. The device cannot be recharged. The device has no connection to any external devices except the electrode.
The stimulator is housed in plastic. It is connected through a plug to the stimulation double needle (needles made of titanium, insulated wire). The power is supplied by a 3 V battery (type CR1220).
The dimensions of the device are W x H x D 34 x 7 x 20 mm, the weight is 4.41 g with battery.
The device is activated by connecting the stimulation double needle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vagus nerve via the ear
Indicated Patient Age Range
Adults
Intended User / Care Setting
Clinician; Clinics, hospital and home environments
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)
Non-Clinical Testing Summary:
We have performed bench tests and found that the Stivax System met all requirements specifications and standards requirements. Testing includes the following:
- Verification Testing to insure the device meets its specifications .
- . Testing of hazard mitigations
- . Testing for compliance to AAMI ANSI ES60601-1
- . Testing for compliance to IEC 60601-1-2
- Testing for compliance with IEC 60601-2-10 ●
Animal Testing:
No animal testing was performed.
Clinical Testing Summary:
No clinical testing was performed.
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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 26, 2016
Biegler Gmbh % Paul Dryden Consultant Promedic, Inc. 24301 Woodsage Drive Bonita Springs, Florida 34134
Re: K152571
Trade/Device Name: Stivax System Regulation Number: N/A Regulation Name: N/A Regulatory Class: Unclassified Product Code: BWK Dated: April 24, 2016 Received: April 26, 2016
Dear Paul Dryden,
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. Isting 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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, | |
|---|---|
| William J. | |
| Heetderks -A | Digitally signed by William J. Heetderks -A |
| DN: c=US, o=U.S. Government, ou=HHS, ou=NIH, | |
| ou=People, | |
| 0.9.2342.19200300.100.1.1=0010149848, | |
| cn=William J. Heetderks -A | |
| Date: 2016.05.26 11:24:18 -04'00' |
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
2
Indications for Use
510(k) Number (if known)
Device Name
Stivax System
Indications for Use (Describe)
Stivax is an electro-acupuncture device 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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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3
510(k) Summary Page 1 of 5 5/26/2016
| Official Contact: | Friedrich Netauschek
Biegler GmbH
Allhangstrasse 18a
3001 Mauerbach Austria
Tel - (0043)1979210515
Fax - (0043)1979210516 |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary or Trade Name: | Stivax System |
| Common/Usual Name: | Electro-acupuncture device |
| Classification Name: | Not classified (pre-amendment) |
| Predicate Device: | Biegler P-Stim System - K140788 |
| Device: | Stivax System |
Device Description:
The Stivax is a single use, battery-powered, electrical nerve stimulator which is used for the stimulation of the vagus nerve via the ear. The device connects an electrode cable to two sterile (radiation) acupuncture needles that have been applied by a healthcare practitioner. The stimulator connects to a clip holder on medical grade adhesive tape. The stimulator (with tape) adheres to the patient, behind the ear.
The STIVAX and the sterile (radiation) stimulation double needle are intended for single use.
The device consists of the stimulator and a stimulation double needle. The device cannot be recharged. The device has no connection to any external devices except the electrode.
The stimulator is housed in plastic. It is connected through a plug to the stimulation double needle (needles made of titanium, insulated wire). The power is supplied by a 3 V battery (type CR1220).
The dimensions of the device are W x H x D 34 x 7 x 20 mm, the weight is 4.41 g with battery.
The device is activated by connecting the stimulation double needle.
Intended User Clinician
Patient Population
This device is intended for use on adults.
Indications for Use:
Stivax is an electro-acupuncture device for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
Environment of Use:
Clinics, hospital and home environments
4
510(k) Summary Page 2 of 5 5/26/2016
Contraindications:
- Use of cardiac pacemakers because no clinical data are available ●
- Hemophilia ●
- Psoriasis vulgaris ●
Predicate Device Comparison:
The Stivax System from Biegler was compared to the predicate P-Stim System - K140788 in the device comparison table below.
Device Comparison
| | STIVAX | Predicate P-STIM
K140788 |
|--------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Biegler GmbH | Biegler GmbH |
| Power source | 3 V battery (CR1220) | 3x 1.4 V- zinc air batteries |
| Line Current Isolation | NA - Internally powered only. No
connection to mains or any other
equipment | NA - Internally powered only. No
connection to mains or any other
equipment |
| Indications for Use | Stivax is an electro-acupuncture
device for use in the practice of
acupuncture by qualified
practitioners of acupuncture as
determined by the states | P-STIM is an electro-acupuncture
device for use in the practice of
acupuncture by qualified
practitioners of acupuncture as
determined by the states |
| Patient Population | Adults | Adults |
| Environment of use | Clinics, hospital and home
environments | Clinics, hospital and home
environments |
| Contraindications - | Use of cardiac pacemakers
because no clinical data are
available | Use of cardiac pacemakers
because no clinical data are
available
• Hemophilia
• Psoriasis vulgaris |
| Number of Output modes | 1 | 1 |
| Number of Output channels | 1 | 1 |
| Waveform | Monophasic | Biphasic |
| Waveform Shape | Rectangular | Rectangular |
| 5/26/2016 | | |
| | STIVAX | Predicate P-STIM
K140788 |
| Maximum Output Voltage (max)
- 500 Ω
- 1000 Ω
- 2 kΩ
- 10 kΩ | 0.56 V
1.09 V
2.05 V
8.40 V | 2.74 V
3.31 V
3.56 V
3.75 V |
| Maximum Output Current (max) - 500 Ω
- 1000 Ω
- 2 kΩ
- 10 kΩ | 1.12 mA
1.09 mA
1.025 mA
0.84 mA | 5.52 mA
3.31 mA
1.75 mA
0.38 mA |
| Maximum Phase charge (500 Ω) | 0.224 µC | 3.31 µC |
| Contact Area (needle electrode) | 3.796 mm²
(2 needles x 1.898 mm²) | 1.898 mm²
(1 needle) |
| Maximum Current Density (500 Ω) | 0.59 mA/mm² | 0.97 mA/mm² |
| Pulse Duration | 200 µs | 1 ms |
| Maximum Average Current (500 Ω) | 1.12 mA | 5.52 mA |
| Maximum Power Density (500 Ω) | $0.3310-3$ W/mm² | $2.6610-3$ W/mm² |
| Frequency (Hz) | 1 Hz | 1 Hz |
| Burst Mode | None | None |
| Timer range (min) | Fixed 40 min on / 20 min off | Fixed 3 h on / 3 h off |
| Indication display - On/Off status
- Low battery
- Voltage / Current level
- Output mode
- Time to cut-off
- | No
No
No
No
No | No
No
No
No
No |
| Dimensions | 34 x 7 x 20 mm | 63 x 28 x 8 mm |
| Weight | 4.41 g | 5 g |
| Microprocessor control | Yes | Yes |
| Electrode cable | Yes | Yes |
5
510(k) Summary Page 3 of 5 5/26/2016
Differences Between Other Legally Marketed Predicate Devices:
There are some differences between the subject device and the predicate P-Stim (K140788). They are:
- . Difference in electrode configuration
- o P-STIM has the pad as the ground the 3 needles are connected to the same stimulation signal, effectively also acting as 2 electrodes. Whereas the STIVAX also has 2 electrodes, a ground and stimulator.
- . Waveform shape
6
510(k) Summary Page 4 of 5 5/26/2016
- Biphasic stimulation is used for the predicate P-STIM because of the electrode о configuration.
- . Maximum Output Current
- The constant current stimulation of the Stivax allows us to use a lower maximum O output current.
- Maximum Pulse Duration
- o A pulse duration of 200 us is enough to deliver the energy.
- . Treatment protocol
- User feedback suggested that the shorter pause of 20 min is less disruptive to the о user when they are sleeping.
These differences were found to not raise any new safety or risks and thus the Biegler Stivax System can be viewed as substantially equivalent to the predicate device.
Indications -
Stivax is an electro-acupuncture device for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states Discussion - These indications are identical to the predicate
Prescriptive - The Stivax and predicate are prescriptive devices.
Performance and Specifications - The Stivax has equivalent specifications of performance when compared to the predicate.
Compliance with standards –The Stivax System and predicate comply with AAMI ANSI ES6060-1 and IEC 60601-1-2. Additionally Stivax complies with IEC 60601-2-10 for electrical stimulators.
Materials -
Materials inclusive of patient contacting materials of the Stivax system are similar to the predicate. The patient contact needles are of identical titanium allow. A similar medical tape is used to affix the device.
Patient Population -
The Stivax and predicate are indicated for adults
Environment of Use -
Clinics, hospital and home environments, identical to the predicate.
Non-Clinical Testing Summary:
We have performed bench tests and found that the Stivax System met all requirements specifications and standards requirements. Testing includes the following:
- Verification Testing to insure the device meets its specifications .
- . Testing of hazard mitigations
- . Testing for compliance to AAMI ANSI ES60601-1
- . Testing for compliance to IEC 60601-1-2
- Testing for compliance with IEC 60601-2-10 ●
7
Animal Testing:
No animal testing was performed.
Clinical Testing Summary:
No clinical testing was performed.
Substantial Equivalence Conclusion:
Biegler maintains the Stivax System is substantially equivalent to the predicate device in indications for use, patient population, and environment for use, technology characteristics, specifications / performance and compliance with the same international standards