(260 days)
Stivax is an electro-acupuncture device for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
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.
This document is a 510(k) premarket notification for the Stivax System, an electro-acupuncture device. The core of this submission is to demonstrate substantial equivalence to a predicate device, the Biegler P-Stim System (K140788), rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria and performance studies for an AI/algorithm-based device is not directly applicable or available in this document.
However, I can extract the information that is present concerning the device's technical specifications and the non-clinical testing performed for its substantial equivalence claim.
Here's the breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present "acceptance criteria" in the typical sense for an AI/algorithm where specific metrics (e.g., sensitivity, specificity) are defined and then performance against those metrics is reported. Instead, it relies on demonstrating that the subject device (Stivax) has equivalent or comparable specifications and performance to its legally marketed predicate device (P-Stim).
| Feature | Acceptance Criteria (Implied by Predicate) | Reported Stivax Performance (Comparison to Predicate) |
|---|---|---|
| General Characteristics | The Stivax System is described as a single-use, battery-powered, electrical nerve stimulator for vagus nerve stimulation via the ear, similar in principle to the predicate. It connects an electrode cable to two sterile acupuncture needles. The stimulator (with tape) adheres to the patient, behind the ear. Dimensions: 34 x 7 x 20 mm, Weight: 4.41 g. | |
| Power Source | 3x 1.4 V zinc-air batteries (Predicate) | 3 V battery (CR1220) |
| Output Modes | 1 (Predicate) | 1 |
| Output Channels | 1 (Predicate) | 1 |
| Waveform | Biphasic (Predicate) | Monophasic (Difference noted, but deemed not to raise new safety/risks. Deemed substantially equivalent.) |
| Waveform Shape | Rectangular (Predicate) | Rectangular |
| Maximum Output Voltage | Variable, e.g., 2.74 V (500 Ω), 3.75 V (10 kΩ) for Predicate | Variable, e.g., 0.56 V (500 Ω), 8.40 V (10 kΩ) (The Stivax has a different maximum output voltage and current profile compared to the predicate, with a lower current for constant current stimulation, which is deemed acceptable.) |
| Maximum Output Current | Variable, e.g., 5.52 mA (500 Ω), 0.38 mA (10 kΩ) for Predicate | Variable, e.g., 1.12 mA (500 Ω), 0.84 mA (10 kΩ) (The Stivax has a constant current stimulation with a lower maximum output current than the predicate, considered acceptable because "constant current stimulation allows us to use a lower maximum output current.") |
| Maximum Phase Charge | 3.31 µC (500 Ω) for Predicate | 0.224 µC (500 Ω) |
| Contact Area (needle electrode) | 1.898 mm² (1 needle) for Predicate | 3.796 mm² (2 needles x 1.898 mm²) (Difference in electrode configuration, but deemed not to raise new safety/risks. Deemed substantially equivalent.) |
| Maximum Current Density | 0.97 mA/mm² (500 Ω) for Predicate | 0.59 mA/mm² (500 Ω) |
| Pulse Duration | 1 ms (Predicate) | 200 µs (Difference noted, but deemed acceptable as "200 us is enough to deliver the energy.") |
| Maximum Average Current | 5.52 mA (500 Ω) for Predicate | 1.12 mA (500 Ω) |
| Maximum Power Density | 2.66 x 10⁻³ W/mm² (500 Ω) for Predicate | 0.33 x 10⁻³ W/mm² (500 Ω) |
| Frequency (Hz) | 1 Hz (Predicate) | 1 Hz |
| Timer Range | Fixed 3 h on / 3 h off (Predicate) | Fixed 40 min on / 20 min off (Difference noted based on "user feedback suggested that the shorter pause of 20 min is less disruptive to the user when they are sleeping." Deemed not to raise new safety/risks and substantially equivalent.) |
| Indication Display | No status indicators (Predicate) | No status indicators (e.g., On/Off, low battery, voltage/current, etc.) |
| Microprocessor Control | Yes (Predicate) | Yes |
| Electrode Cable | Yes (Predicate) | Yes |
| Compliance with Standards | AAMI ANSI ES6060-1 and IEC 60601-1-2 (Predicate) | Stivax complies with AAMI ANSI ES6060-1, IEC 60601-1-2, AND IEC 60601-2-10 (for electrical stimulators). |
| Materials | Identical titanium alloy patient contact needles. Similar medical tape to affix the device. (Implied similarity to predicate) | Materials inclusive of patient contacting materials of the Stivax system are similar to the predicate. The patient contact needles are of identical titanium alloy. A similar medical tape is used to affix the device. |
| Basic Safety and Essential Performance | Met all requirements and specifications (through non-clinical testing against standards and internal specifications) | Verification Testing to ensure the device meets its specifications. Testing of hazard mitigations. Testing for compliance to AAMI ANSI ES60601-1, IEC 60601-1-2, and IEC 60601-2-10. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
No test set for evaluating algorithm performance (clinical or otherwise) is mentioned. This is a medical device 510(k) submission, not an AI/ML algorithm submission that requires such a test set. The submission relies entirely on non-clinical (bench) testing and comparison to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No ground truth establishment by experts for an algorithm's performance is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable.
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:
Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. The "ground truth" here is compliance with electrical safety and performance standards, and comparison to the predicate device's established safety and effectiveness.
8. The sample size for the training set:
Not applicable. This device is a hardware electrical stimulator, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established:
Not applicable.
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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
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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 -ADN: c=US, o=U.S. Government, ou=HHS, ou=NIH,ou=People,0.9.2342.19200300.100.1.1=0010149848,cn=William J. Heetderks -ADate: 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
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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)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Summary Page 1 of 5 5/26/2016
| Official Contact: | Friedrich NetauschekBiegler GmbHAllhangstrasse 18a3001 Mauerbach AustriaTel - (0043)1979210515Fax - (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
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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-STIMK140788 | |
|---|---|---|
| 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. Noconnection to mains or any otherequipment | NA - Internally powered only. Noconnection to mains or any otherequipment |
| Indications for Use | Stivax is an electro-acupuncturedevice for use in the practice ofacupuncture by qualifiedpractitioners of acupuncture asdetermined by the states | P-STIM is an electro-acupuncturedevice for use in the practice ofacupuncture by qualifiedpractitioners of acupuncture asdetermined by the states |
| Patient Population | Adults | Adults |
| Environment of use | Clinics, hospital and homeenvironments | Clinics, hospital and homeenvironments |
| Contraindications - | Use of cardiac pacemakersbecause no clinical data areavailable | Use of cardiac pacemakersbecause no clinical data areavailable• 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-STIMK140788 | |
| Maximum Output Voltage (max)- 500 Ω- 1000 Ω- 2 kΩ- 10 kΩ | 0.56 V1.09 V2.05 V8.40 V | 2.74 V3.31 V3.56 V3.75 V |
| Maximum Output Current (max)- 500 Ω- 1000 Ω- 2 kΩ- 10 kΩ | 1.12 mA1.09 mA1.025 mA0.84 mA | 5.52 mA3.31 mA1.75 mA0.38 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) | $0.33*10-3$ W/mm² | $2.66*10-3$ 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- | NoNoNoNoNo | NoNoNoNoNo |
| 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 |
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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
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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 ●
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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
N/A