(217 days)
The STIMPOD ST2-3010 is a nerve stimulation device designed to be used for the purpose of nerve locating using invasive electrodes or needles (not supplied)
The STIMPOD ST2-3010 device is a battery powered peripheral nerve stimulator that can be used for the purpose of nerve locating using invasive electrodes or needles (not supplied). The STIMPOD ST2-3010 is a precision nerve locating tool used for localizing specific neural pathways. Localization of nerves by electrical stimulation involves connecting the nerve stimulator to a conducting needle. The stimulus is generated by a constant current source. The waveform is a monophasic square wave with 3 options for pulse width. These are: 0.1, 0.2 and 0.3 milliseconds. The unit dimensions are 145mm x 90mm x 30mm with a weight of 130 g
I'm sorry, but the provided text does not contain the information needed to answer your request about acceptance criteria and study details for a medical device. The document is a 510(k) premarket notification for a nerve stimulator, focusing on demonstrating substantial equivalence to a predicate device. It details the device's technical characteristics, intended use, and comparison to a predicate, but it does not describe specific acceptance criteria and the results of a study (like a clinical trial or performance study) to prove the device meets those criteria.
In particular, the document lacks information on:
- A table of acceptance criteria and reported device performance.
- Sample size used for a test set or data provenance.
- Number of experts or their qualifications for establishing ground truth.
- Adjudication method for a test set.
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size.
- Whether a standalone (algorithm only) performance study was done.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document discusses "safety testing" and references IEC standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10), indicating that the device passed these electrical and electromagnetic compatibility tests. However, these are general device safety standards, not specific performance criteria for a diagnostic or AI-based device's clinical accuracy that would require the kind of study details you've requested.
Therefore, I cannot fill in the table or provide the requested study details based on the provided text.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 6, 2014
Xavant Technology (Pty) Limited Mr. Roche van Rensburg Chairman Ravello 1st Floor, Delmondo Office Park 169 Garsfontein Road Ashlea Gardens Pretoria, Gauteng 0081 SOUTH AFRICA
Re: K140853
Trade/Device Name: Stimpod ST2-3010 Nerve Stimulator Regulation Number: 21 CFR 868.2775 Regulation Name: Electrical Peripheral Nerve Stimulator Regulatory Class: II Product Code: BXN Dated: October 1, 2014 Received: October 10, 2014
Dear Mr. Rothman:
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.
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Page 2 - Mr. Rothman
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 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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ATTACHMENT 2
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: STIMPOD ST2-3010 nerve stimulator
Indications for Use:
The STIMPOD ST2-3010 is a nerve stimulation device designed to be used for the purpose of nerve locating using invasive electrodes or needles (not supplied)
X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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ATTACHMENT 4
510(k) SUMMARY
[As required by 21CFR807.92]
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4.1 Date Prepared [21CFR807.92(a)(1)]
July 28, 2014
4.2 Submitter's Information [21CFR807.92(a)(1)]
| Company Name: | XAVANT Technology (Pty) LTD |
|---|---|
| Street Address: | Ravello, 1st Floor. Delmondo Office Park |
| 169 Garstfontein Road | |
| Ashlea Gardens | |
| City: | Pretoria |
| State/Province: | Gauteng |
| Country: | South Africa |
| Telephone: | +27(0) 12 755 9491 |
| Facsimile: | +27(0) 12 346 7271 |
| Contact Person: | Brian Rothman |
| Contact Title: | Quality Assurance and Regulatory |
| Compliance Officer | |
| Contact Email: | brian@xavant.com |
4.3 Trade Name, Common Name, Classification [21CFR807.92(a)(2)]
| Trade Name: | STIMPOD ST2-3010 nerve stimulator |
|---|---|
| Common Name: | Battery Powered Peripheral Nerve Stimulator |
| Classification Name: | Anesthesiologyper 21 CFR § 868.2775 |
| Device Class: | Class II |
| Product Code: | BXN |
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4.4 Identification of Predicate Device(s) [21CFR807.92(a)(3)]
PREDICATE DEVICES
Xavant Technology, STIMPOD NMS450 (K102084)
There are no significant differences between the STIMPOD ST2-3010 Nerve Stimulator and the predicate devices which would adversely affect the use of the product. It is substantially equivalent to the device in design, function, materials, operational principles and intended use.
The STIMPOD NMS450 is a battery powered peripheral nerve stimulator that can be used for
- general anesthesia, for the purpose of establishing the efficacy of a � Neuromuscular Blocking Agent using non-invasive surface electrodes (not supplied)
- nerve mapping using the non-invasive Nerve Mapping Probe (supplied) �
- nerve locating using invasive electrodes/needles (not supplied) �
The stimulus is generated by a constant current source. The waveform is a square wave with various pulse width options.
The units will continuously check for a closed circuit. Once a closed circuit is detected, the unit will deliver a stimulus until an open circuit is detected.
Once operational the unit will flash an LED when the circuit with the patient is a closed circuit and the stimulation was successfully delivered. In the case that the circuit with the patient is an open circuit, a stimulus will not be delivered.
The anode comprises of an ECG electrode (not supplied). The cathode comprises a permanently attached nerve mapping probe (supplied), and/or a separate nerve locating needle (not supplied), and/or an ECG electrode (not supplied), depending on the mode of the unit
This product is a nerve stimulation device designed to be used by an anaesthetist. durina
-
- General anaesthesia, for the purpose of establishing the efficacy of a Neuromuscular Blocking Agent using non-invasive surface electrodes (not supplied)
-
- Regional anaesthesia for the purpose of
- a) nerve mapping using the non-invasive Nerve Mapping Probe (supplied) and
- b) nerve locating using invasive electrodes/needles (not supplied)
4.5 Description of the Device [21CFR807.92(a)(4)]
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The STIMPOD ST2-3010 device is a battery powered peripheral nerve stimulator that can be used for
- the purpose of nerve locating using invasive electrodes or needles (not supplied) .
The STIMPOD ST2-3010 is a precision nerve locating tool used for localizing specific neural pathways. Localization of nerves by electrical stimulation involves connecting the nerve stimulator to a conducting needle.
The stimulus is generated by a constant current source. The waveform is a monophasic square wave with 3 options for pulse width. These are: 0.1, 0.2 and 0.3 milliseconds.
The unit dimensions are 145mm x 90mm x 30mm with a weight of 130 g
4.6 Intended Use [21CFR807.92(a)(5)]
This product is a nerve stimulation device designed to be used for the purpose of nerve locating using invasive electrodes or needles (not supplied).
The difference in intended use is not critical to its use and does not affect the safety and efficacy of the subject device. Both subject and predicate device are nerve stimulators. Where as the predicate device has three (3) indications for use, the subject device has only one. This is to be used for the purpose of nerve locating using invasive electrodes or needles (not supplied). The predicate device has this use listed and already has clearance.
The intended use of the subject device is limited to within the currently cleared indications of the predicate device.
4.7 Technological Characteristics [21CFR807.92(a)(6)]
Operating Modes:
| Current Range: | 0.00 – 10.00mA ±5%adjustable in 0.1mA increments. |
|---|---|
| Pulse Width Options: | 100µs, 200µs, 300µs |
| Stimulus: | Monophasic square wave |
| Stimulating Frequency: | 20Hz, 50Hz and 100Hz |
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Waveform:
Constant Current Monophasic Square wave
Technical Specifications
| Device Classification: | Class Ila, Type BF |
|---|---|
| Power Supply: | 4x AAA alkaline batteries |
| Power Consumption: | 18mA |
| Maximum Stimulation Voltage: | 70V |
| Weight: | 130g |
| Dimensions: | 145mm x 90mm x 30mm |
| Load Impedance: | 0 kOhm – 7 kOhm |
| Operating Temperature: | 10 - 40 Degrees Celsius (°C) |
| Storage and Transport Temperature: | 0 - 50 Degrees Celsius (°C) |
| Operating Humidity: | 90% Relative Humidity |
Summary of technical characteristics between predicate device (STIMPOD NMS450) and new device (STIMPOD ST2-3010)
| Device Name: | STIMPOD ST2-3010 | STIMPOD NMS450 | AffectsIndicationsfor Use /Technology | Comments |
|---|---|---|---|---|
| ProductComponents: | 1. Nerve Stimulator2. Stimulation Cable3. IFU | 1. Nerve Stimulator2. Nerve Locating Cable3. Nerve Mapping/Locating Cable4. NMBA Monitoring Cable5. IFU | NO (e) | Both contain a nerve stimulator and a cable.The NMS450 has additional cables for additional functions |
| Indications forUse: | This product is a nerve stimulation device designed to be used for the purpose of nerve locating using invasive electrodes or needles (not supplied) | This product is a nerve stimulation device designed to be used by an anesthetist during1. general anesthesia, for the purpose of establishing the efficacy of a Neuromuscular Blocking Agent using non-invasive surface electrodes | NO - In this case, the indications for use are limited to within the cleared indications for use of the predicate device (a) (c) | Essentially, both devices are for nerve localization using invasive electrodes/needles (not supplied) |
| Device Name: | STIMPOD ST2-3010 | STIMPOD NMS450 | Affects Indications for Use / Technology | Comments |
| (not supplied2. regional anesthesiafor the purpose ofa. nerve mappingusing the non-invasive NerveMapping Probe(supplied) andb. nerve locatingusing invasiveelectrodes/needles (notsupplied) | ||||
| Current Ranges | 0 -10mA | Nerve Locating: 0-5mANerve mapping: 0-20mANMBA Mode: 0-80mA | NO (d) | The currentrange iscovered |
| Energy Type(1) | 4 X AAA alkaline batteries, 6V | 4 X AAA alkaline batteries, 6V | NO (e) | Both unitsare batterypowered |
| ActivationLabeling: | ON/OFF Power buttonAccording to ISO 15223 | ON/OFF Power buttonAccording to ISO 15223 | NO (e)NO (d) | |
| Anatomicalsite of useTesting | Location of peripheralnervesSAFETY TESTING | Location of peripheralnervesSAFETY TESTING | NO (a) , (b),(c) | |
| Passed(IEC 60601-1) 3rd edition | Passed(IEC 60601-1) 3rd edition | NO (b) , (h) | ||
| RADIATED RADIOFREQUENCYELECTROMAGNETICFIELD 80 MHz TO 2500MHzIEC61000-4-3Passed | RADIATED RADIOFREQUENCYELECTROMAGNETICFIELD 80 MHz TO 2500MHzIEC61000-4-3Passed | NO (b) , (h) | ||
| ELECTROMAGNETICCOMPATIBILITYPassed(IEC 60601-1-2) | ELECTROMAGNETICCOMPATIBILITYPassed(IEC 60601-1-2) | NO (b) , (h) | ||
| Medical electricalequipment. Particularrequirements for the | Medical electricalequipment. Particularrequirements for the | NO(b) , (h) | ||
| Device Name: | STIMPOD ST2-3010 | STIMPOD NMS450 | AffectsIndicationsfor Use /Technology | Comments |
| safety of nerve andmuscle stimulators | safety of nerve andmuscle stimulators | |||
| PASSED(IEC 60601-2-10) | PASSED(IEC 60601-2-10) | |||
| Weight (5) | 130g | 130g | NO (e) | Same weight |
| Size (unit) (5) | 145mm x 90mm x 30mm | 145mm x 90mm x 30mm | NO (e) | Identicalenclosures |
| Enclosure (4) | Manufactured from ABS | Manufactured from ABS | NO (i) | Identicalenclosures |
| Dial (4) | Tactile membrane withcapacitive sensing wheel.Manufactured frompolycarbonate | Tactile membrane withcapacitive sensing wheel.Manufactured frompolycarbonate | NO (e) | Samekeypads,differentcoloring andfunction |
| LCD (4) | Not covered | Not covered | NO (e) | |
| Cable (4) | KE-PVC mouldingConnector – Gold plated | KE-PVC mouldingConnector – Gold plated | NO (e), (l) | Similar cableconstruction, |
| Packaging (7) | Non-sterileMultiple UsePackaging in apolypropylene carry case | Non-SterileMultiple UsePackaging in apolypropylene carry case | NO (e), (f) | Packaged inthe sameway |
| Software (6) | Language: CArchitecture | Language: CArchitecture | ||
| - User Inputs• Keypad• Dial | - User Inputs• Keypad• Dial | |||
| - External Inputs• Open circuitdetection Lowvoltage• No Open circuitdetection Highvoltage• Battery Voltage• Cable ID x 1• No accelerometer | - External Inputs• Open circuitdetection Lowvoltage• Open circuitdetection Highvoltage• Battery Voltage• Cable ID x 3• Accelerometer | NO (d), (g) | ||
| - Outputs• Display Menu• Display MainScreen | - Outputs• Display Menu• Display MainScreen | |||
| Device Name: | STIMPOD ST2-3010 | STIMPOD NMS450 | AffectsIndicationsfor Use /Technology | Comments |
| (Closed Circuit)○ Red LED (OpenCircuit)○ Buzzer Alarm○ Square WaveStimulation LowVoltage○ No Square WaveStimulation Highvoltage | (Closed Circuit)○ Red LED (OpenCircuit)○ Buzzer Alarm○ Square WaveStimulation Lowvoltage○ Square WaveStimulation Highvoltage | |||
| WaveformPulse Width(3) | Monophasic Square Wave0.1, 0.2, 0.3ms | Monophasic Square Wave0.05, 0.1, 0.3, 0.5, 1ms | NO (h) | Similar andwithin therange of thepredicate |
| Shelf Life (7) | 5 Years | 5 Years | NO (e) | |
| ControlMechanism(3) | Digitally controlled by amicroprocessor | Digitally controlled by amicroprocessor | NO (g) | |
| Electronics | PCB:2 layer boardPOWER SOURCE:: 4 xAAAPOWER SUPPLY: SwitchModeMAX POWERCONSUMPTION: ± 40mAMAX VOLTAGE: 100V | PCB:2 layer boardPOWER SOURCE:: 4 xAAAPOWER SUPPLY: SwitchModeMAX POWERCONSUMPTION: 79mAMAX VOLTAGE: 400V | NO (h) | |
| DeviceCleaning | Cleaning: Soap and water,applied with a damp cloth issuitable to clean anddisinfect the STIMPOD. It isimperative that no moisturepenetrates the STIMPOD.Disinfecting: Anycommercially availablemethanol - free disinfectantin an ethyl alcohol basecan be used for disinfection | Cleaning: Soap and water,applied with a damp cloth issuitable to clean anddisinfect the STIMPOD. It isimperative that no moisturepenetrates the STIMPOD.Disinfecting: Anycommercially availablemethanol - free disinfectantin an ethyl alcohol base canbe used for disinfection. | NO (e) | |
| 510(k) | This submission. | K102084 |
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A detailed comparison has provided the following conclusions:
The bolded letters reference the relevant section on the table above. This is indicated in the column "affects indications for use / Technology"
Clinical Use
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The target populations on which product usage would occur are the same as those of the cited predicate device.
The Stimpod ST2-3010 employs a subset of the indications for use of the Stimpod NMS450, the same contraindications for use, and the same warnings and precautions within labelling
Each of the above devices:
- used for the same clinical condition or purpose; (a) ●
- . have similar relevant critical performance according to expected clinical effect for specific intended use. (b)
Technical Characteristics
The STIMPOD ST2-3010 is equivalent to the identified predicate in design and utilized materials of construction of the currently marketed aforementioned predicate devices.
Also, the principles of operation of the subject device are directly equivalent to those of the cited predicate
Each of the above devices:
- are used under similar conditions of use; (c) ●
- have similar specifications and properties; (d)
- are of similar design; (e) ●
- use similar deployment methods; (f) ●
- have similar principles of operation; (g) and ●
- have similar electrical performance. (h) .
As indicated in the table above, the ST2-3010 and the NMS450 are exact matches on technical characteristics, with the following exceptions:
-
- Current Range 0-10 compared to Current Range 0-5 (Nerve Locating)
- a. The ST2-3010 can adjust the current up to 10mA. The NMS450 however can only adjust the current to 5mA. However, the NMS450 can adjust pulse width up to 1ms, whereas the ST2-3010 can only adjust pulse width up to 0.3ms. That concludes that the maximum charge output of the ST2-3010 is 3uC, which is only 60% of the maximum charge output (5uC) of the NMS450. Thus patient safety is not affected by this change.
-
- Pulse width options 0.1, 0.2, 0.3ms compared to 0.05, 0.1, 0.3, 0.5, 1.0ms
- a. The pulse width options of the ST2-3010 are a subset of the pulse width options of the NMS450, and therefor do not affect patient safety.
-
- No High Voltage stimulation vs. High Voltage Stimulation
- a. As the ST2-3010 is only a nerve location device, it only employs the low voltage section of the electrical circuit, exactly the same as the Nerve Locating mode on the NMS450
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Biological Characteristics
Each of the above devices has:
- no known biocompatibility issues; (i) and
- no known effect on the environment, or to other devices. .
Contents ST2-3010 Peripheral Nerve Stimulator Kit.
The Kit will include the following parts:
- Peripheral Nerve Stimulator a.
- b. Stimulation Adaptor Cable
- Carrying Case C.
- Instructions for Use d.
Note: Needles, ECG electrodes and batteries are not supplied
§ 868.2775 Electrical peripheral nerve stimulator.
(a)
Identification. An electrical peripheral nerve stimulator (neuromuscular blockade monitor) is a device used to apply an electrical current to a patient to test the level of pharmacological effect of anesthetic drugs and gases.(b)
Classification. Class II (performance standards).