(147 days)
Interferential Stimulation (INF) is used for symptomatic relief and management of chronic (Iongterm) intractable pain and/or as an adjunctive treatment in the management of postsurgical and post-traumatic acute pain.
External electrical neuromuscular stimulation (NMES) using biphasic output is indicated as therapeutic adjunct for: prevention or retardation of muscle disuse atrophy; relaxation of muscle spasm; muscle reeducation; maintaining and increasing the range of motion; increasing local blood circulation and as immediate postsurgical stimulation of caff muscles to prevent venous thrombosis.
Transcutaneous Electrical Nerve Stimulation (TENS) is used for the symptomatic relief and management of chronic (long-term) intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain problems.
The Impulse 3 is a portable two channel, battery operated combination electrical neuromuscular stimulator (NMES), interferential stimulator (INF), and transcutaneous electrical nerve stimulator (TENS) unit for pain control, and muscle stimulation. This device, supporting symmetric biphasic, pulsed sine, and asymmetrical biphasic waveforms can be used with the preprogrammed protocols or can be manually configured. A graphical display is provided to provide the user a verbose interface to assist in programming the configurable protocols.
The device is supplied with electrodes and electrode leads, non-replaceable batteries, wall adapter, instruction manual, and carrying case.
The provided text describes a 510(k) premarket notification for the Sterling Medical Impulse 3 Stimulator. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving enhanced effectiveness through clinical studies. Therefore, the information typically found in a clinical study report for an AI/ML device (e.g., sample size, expert qualifications, adjudication methods, effect size of AI assistance, standalone performance) is not directly applicable or available in this document.
Instead, the acceptance criteria for this device are based on demonstrating that its technological characteristics and performance are substantially equivalent to existing predicate devices, and that any differences do not raise new questions of safety or effectiveness. The study that proves this is a non-clinical performance summary based on bench testing and comparison to the specifications of predicate devices.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the parameters of the predicate devices. The device performance is reported by comparing its specifications directly against those of the predicate devices. Due to the extensive nature of the comparison, only a summary of key parameters is provided below. The full details are elaborated in the tables within the original document.
| Parameter Category | Acceptance Criteria (based on predicate ranges/values) | Reported Device Performance (Impulse 3) |
|---|---|---|
| General Device Parameters | ||
| Power Source (Primary) | Comparable to predicate lithium-ion/AA/9V batteries | 2x 750mA, 3.7V, Li-ion, rechargeable |
| Patient Leakage Current (Normal Condition) | ≤ 11µA (predicate range) | 7µA |
| Patient Leakage Current (Single Fault) | ≤ 116µA (predicate range) | 98µA |
| Avg DC Current (device on, no pulses) | ≤ 1µA (predicate) | 1µA |
| Output Modes | TENS, NMES, INF (combination of predicates) | 3 (TENS, NMES, INF) |
| Number of Output Channels | 2 or 4 (predicate range) | 2 |
| Regulated Current/Voltage | Regulated Current (all predicates) | Regulated Current |
| Software/Firmware/Microprocessor Control | Yes (all predicates) | Yes |
| Automatic No-Load Trip | Yes or No (some predicates have it) | Yes (turns off after 1 minute) |
| Automatic Shut Off | Yes (all predicates) | Yes (after prescribed program) |
| User Override Control | Yes (all predicates) | Yes |
| Indicator Displays | On/Off, Low Battery, Voltage/Current (all predicates) | Yes (all) |
| Timer Range | 1-60 minutes (all predicates) | 1-60 minutes |
| Compliance to Voluntary Standards | Yes (all predicates) | Yes |
| Compliance to 21 CFR 898 | Yes (all predicates) | Yes |
| Weight | 4.48 oz. to 11.4 oz. (predicate range) | 6.50 oz. |
| Dimensions | Comparable to predicate devices | 3.1" x 4.8" x 1.3" |
| Housing Materials | Plastic, ABS plastic | ABS 94 HB Plastic Body |
| TENS Mode Parameters | ||
| Waveform | Pulsed asymmetrical biphasic (predicates) | Pulsed asymmetrical biphasic |
| Shape | Rectangular (predicates) | Rectangular |
| Max Output Voltage | Varies, e.g., 27.5V-96V @ 500Ω (predicate range) | 40.6V @ 500Ω (within range) |
| Max Output Current | Varies, e.g., 43mA-96mA @ 500Ω (predicate range) | 81.3mA @ 500Ω (within range) |
| Pulse Duration | 10-450µs (predicate range) | 50-300µs |
| Frequency | 1-120 pps (all predicates) | 1-120 pps |
| Max Phase Charge | 16.5µC - 24.0µC @ 500Ω (predicate range) | 21.7µC @ 500Ω (within range) |
| Max Current Density | 0.42mA/cm² - 0.74mA/cm² @ 500Ω (predicate range) | 0.70mA/cm² @ 500Ω (within range) |
| Max Avg Current | 1.98mA - 3.60mA (predicate range) | 2.61mA (within range) |
| Max Avg Power Density | 2.18mW/cm² - 6.91mW/cm² (predicate range) | 4.81mW/cm² (within range) |
| Burst Mode (Pulses per burst, Bursts per second, Burst duration, Duty Cycle) | Comparable to Sterling TENS & QuadStar II | Comparable |
| Effect of battery/charger voltage variations | None, output not affected (QuadStar II baseline) | None, output not affected |
| INF Mode Parameters | ||
| Waveform | Symmetrical biphasic (predicates) | Symmetrical biphasic |
| Shape | Sinusoidal, Square (predicates) | Sinusoidal |
| Max Output Voltage | Varies, e.g., 17.1V-40.6V @ 500Ω (predicate range) | 26.7V @ 500Ω (within range) |
| Max Output Current | Varies, e.g., 34mA-66mA @ 500Ω (predicate range) | 53mA @ 500Ω (within range) |
| Pulse Duration | 250µs (predicates) | 250µs |
| Frequency | 4000-4150Hz (predicates) | 4000-4150Hz |
| Max Phase Charge | 4.28µC-5.73µC @ 500Ω (predicate range) | 4.72µC @ 500Ω (within range) |
| Max Current Density | 1.37mA/cm² - 1.92mA/cm² @ 500Ω (predicate range) | 1.92mA/cm² @ 500Ω (within range) |
| Max Avg Current | 34.2mA - 45.8mA (predicate range) | 37.8mA (within range) |
| Max Avg Power Density | 23.4mW/cm²-42.0mW/cm² (predicate range) | 36.3mW/cm² (within range) |
| NMES AC Mode Parameters | ||
| Waveform | Pulsed symmetrical biphasic (predicates) | Pulsed symmetrical biphasic |
| Shape | Rectangular (predicates) | Rectangular |
| Max Output Voltage | Varies, e.g., 28.6V-66.4V @ 500Ω (predicate range) | 26.4V @ 500Ω (comparable) |
| Max Output Current | Varies, e.g., 53mA-64mA @ 500Ω (predicate range) | 53mA @ 500Ω (comparable) |
| Pulse Duration | 50-400µs (predicate range) | 50-300µs |
| Frequency | 1-120 pps (predicates) | 1-120 pps |
| Max Phase Charge | 31.7µC-34.3µC @ 500Ω (predicate range) | 31.7µC @ 500Ω (within range) |
| Max Current Density | 0.62mA/cm² - 0.72mA/cm² @ 500Ω (predicate range) | 0.72mA/cm² @ 500Ω (within range) |
| Max Avg Current | 3.8mA - 4.13mA (predicate range) | 3.8mA (within range) |
| Max Avg Power Density | 4.74mW/cm² - 5.11mW/cm² (predicate range) | 5.11mW/cm² (within range) |
| Burst Mode ON/OFF Time | 0-99 seconds / 0-99 seconds (predicates) | 1-99 seconds / 0-99 seconds |
| NMES Russian Mode Parameters | ||
| Waveform | Gated symmetrical biphasic (predicates) | Gated symmetrical biphasic |
| Shape | Rectangular (predicates) | Rectangular |
| Max Output Voltage | Varies, e.g., 28.7V-36.6V @ 500Ω (predicate range) | 26.4V @ 500Ω (comparable) |
| Max Output Current | Varies, e.g., 57mA-17.3mA @ 500Ω (predicate range) | 53mA @ 500Ω (comparable) |
| Pulse Duration | 400µs (predicates) | 400µs |
| Frequency | 50Hz (predicates) | 50Hz |
| Max Phase Charge | 21.1µC-23.0µC @ 500Ω (predicate range) | 21.1µC @ 500Ω (within range) |
| Max Current Density | 1.6mA/cm² - 1.9mA/cm² @ 500Ω (predicate range) | 1.9mA/cm² @ 500Ω (within range) |
| Max Avg Current | 26.4mA - 28.7mA (predicate range) | 26.4mA (within range) |
| Max Avg Power Density | 33.0mW/cm²-35.5mW/cm² (predicate range) | 35.5mW/cm² (within range) |
| Burst Mode ON/OFF Time | 1-99 seconds / 0-99 seconds (predicates) | 1-99 seconds / 0-99 seconds |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not applicable in the context of an electrical stimulator 510(k) submission based on bench testing. The "test set" here refers to the device itself and its measured output parameters.
- Data Provenance: The data comes from the technical specifications and measurements of the Sterling Medical Impulse 3 Stimulator and the predicate devices. This is non-clinical, controlled bench testing data, not human patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. The "ground truth" for electrical stimulation parameters is established through engineering measurements and adherence to industry standards, not expert medical opinion.
- Qualifications of Experts: N/A.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. The "test set" involves comparing technical specifications and measurements, which are quantitative and objectively verifiable, not subjective interpretations requiring adjudication.
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
- MRMC Study: No. This is not a diagnostic device involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This device is an electrical stimulator, not an algorithm, and does not have "human-in-the-loop" performance in the sense of a diagnostic AI. Its performance is inherent in its electrical output and functional controls.
7. The type of ground truth used
- Ground Truth Type: Engineering specifications, measured electrical parameters (voltage, current, pulse duration, frequency, etc.), and compliance with voluntary standards (e.g., IEC 60601-1). The "ground truth" is established by these objective, quantifiable technical measures.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This device does not use an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not applicable, as there is no training set for an AI/ML algorithm.
{0}------------------------------------------------
K12/305
SEP 2 5 2012
510(k) Summary 5
ADMINISTRATIVE INFORMATION
| Manufacturer Name: | Armstrong Industries, Inc. |
|---|---|
| Contact Person: | Ralph Armstrong, President and CEO |
| Official Correspondent: | John Stanley, Vice President and General Manager |
| Establishment Registration Number: | K121305 |
| Performance Standard(s): | Guidance Document for Powered Muscle Stimulator510(k), issued June 9, 1999. |
| Name of Device: |
| Trade Name: | Sterling Medical Impulse 3 Stimulator |
|---|---|
| Common Name: | TENS, NMES, and INF External stimulator |
| Regulation Numbers: | 21 CFR 882.5890 |
| Regulation Class: | II |
| Panel Name: | Neurology |
| Product Code: | GZJ, IPF, LIH |
ldentification of Predicate Device(s):
| Manufacturer | Device | 510(k) Number |
|---|---|---|
| Biomedical Life Systems, Inc. | BMLS04-1 (QuadStar II) | K041388 |
| Newwave Medical, LLC | Smartwave IF 2000 | K003631 |
| Newwave Medical, LLC | Smartwave MS 2000 | K041063 |
| Armstrong Industries, Inc. | Sterling TENS | K891118 |
Intended Use Statement
The Impulse 3, when in interferential stimulation (INF) mode, may be used for symptomatic relief and management of chronic (long-term) intractable pain and/or as an adjunctive treatment in the management of postsurgical and post-traumatic acute pain.
The Impulse 3, when in neuromuscular stimulation (NMES) mode, may be used as therapeutic adjunct for: prevention or retardation of muscle disuse atrophy; relaxation of muscle spasm; muscle reeducation; maintaining and increasing the range of motion; increasing local blood
{1}------------------------------------------------
K12/305
circulation and as immediate postsurgical stimulation of calf muscles to prevent venous thrombosis.
The Impulse 3, when in Transcutaneous Electrical Nerve Stimulation (TENS) mode, may be used for the symptomatic relief and management of chronic (long-term) intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain problems.
This is a prescription device and should be used under medical supervision.
Device Description
The Impulse 3 is a portable two channel, battery operated combination electrical neuromuscular stimulator (NMES), interferential stimulator (INF), and transcutaneous electrical nerve stimulator (TENS) unit for pain control, and muscle stimulation. This device, supporting symmetric biphasic, pulsed sine, and asymmetrical biphasic waveforms can be used with the preprogrammed protocols or can be manually configured. A graphical display is provided to provide the user a verbose interface to assist in programming the configurable protocols.
The device is supplied with electrodes and electrode leads, non-replaceable batteries, wall adapter, instruction manual, and carrying case.
Predicate Device Comparison
The Impulse 3 unit has similar intended use, operating principles, and modes of operation. Based on the predicate product comparison, Sterling Medical has determines that no new issues of safety and effectiveness have been raised with this 510(k) submission.
| Parameter | This submission | Predicate device | Predicate device | Predicate device | Predicate device |
|---|---|---|---|---|---|
| 510(k) Number | K121305 | K041388 | K041063 | K891118 | K003631 |
| Device Name and Model | SterlingMedicalImpulse 3 | QuadStar II | Smartwave MS2000 | Sterling TENS | Smartwave IF2000 |
| Manufacturer | ArmstrongIndustries, Inc. | BioMedical LifeSystems, Inc. | NewwaveMedical, LLC | ArmstrongIndustries, Inc. | NewwaveMedical, LLC |
| Primary Power Source: Number, Size,and Type of Batteries | 2x 750mA,3.7V, LC14500,Li-ion,rechargeable,not userreplaceable | 4x AA Batteries,LR6 | 9V Battery | 9V Battery | 9V Battery |
| Optional Power Source and BatteryCharger | Wall adapter,In: 100-240vac,50-60Hz,Out: 9V, 1.3A,UL60601approved | Wall adapter,In: 120vac,60Hz,Out: 9V, 1.0A | Wall adapter,In: 100 -120vac, 50-60Hz,Out: 9V, 1.0A | N/A | Wall adapter,In: 100 -120vac, 50-60Hz,Out: 9V, 1.0A |
| Method of Line Current Isolation | Transformercoupled | - | Transformercoupled | - | - |
| Patient Leakage Current- Normal Condition | $7\mu A$ | $11\mu A$ | $3.2\mu A$ | N/A | $3.2\mu A$ |
Comparison to the 510(k) Cleared Predicate Devices:
{2}------------------------------------------------
| Single fault condition | $98μA$ | $116μA$ | $6.5μA$ | $6.5μA$ | |
|---|---|---|---|---|---|
| Average DC current through electrodeswhen device is on but no pulses arebeing applied (µA) | $1μΑ$ | $1μΑ$ | $1μA$ | $1 μΑ$ | |
| Number of Output Modes | 3, TENS, NMES,and INF | 3, TENS, NMES,and INF | 1, NMES | 1, TENS | 1, INF |
| Number of output channels | 2 | 4 | 2 | 2 | 2 |
| Output Channels: Synchronous orAlternating? | TENS -SynchronousINF -SynchronousNMES - Both | TENS -SynchronousINF -SynchronousNMES - Both | NMES - Both | TENS -Synchronous | INF -Synchronous |
| Output Channels: Method of Channelisolation | TransformerCoupled | TransformerCoupled | TransformerCoupled | TransformerCoupled | TransformerCoupled |
| Regulated Current or RegulatedVoltage? | RegulatedCurrent | RegulatedCurrent | RegulatedCurrent | RegulatedCurrent | RegulatedCurrent |
| Software/Firmware/MicroprocessorControl? | Yes | Yes | Yes | Yes | Yes |
| Automatic Overload Trip? | No | No | No | No | No |
| Automatic No-Load Trip? | Yes, If the unitis not used, itwill turn itselfoff after 1minute. | No | Yes, If the unitis not used, itwill turn itselfoff after 10minutes. | No | Yes, If the unitis not used, itwill turn itselfoff after 10minutes. |
| Automatic Shut Off? | Yes, the unitturns off afterthe prescribedprogram. | Yes, the unitturns off afterthe prescribedprogram. | Yes, the unitturns off afterthe prescribedprogram. | Yes, the unitturns off afterthe prescribedprogram. | Yes, the unitturns off afterthe prescribedprogram. |
| User Override Control? | Yes, the usercan turn theunit off | Yes, the usercan turn theunit off | Yes, the usercan turn theunit off | Yes, the usercan turn theunit off | Yes, the usercan turn theunit off |
| Indicator Display: On/Off Status? | Yes | Yes | Yes | Yes | Yes |
| Indicator Display: Low Battery? | Yes | Yes | Yes | Yes | Yes |
| Indicator Display: Voltage/CurrentLevel ? | Yes | Yes | Yes | Control dialsare numbered | Yes |
| Timer Range (minutes) | 1 to 60 minutes | 1 to 60 minutes | 1 to 60 minutes | 1 to 60 minutes | 1 to 60 minutes |
| Compliance with Voluntary Standards? | Yes | Yes | Yes | Yes | Yes |
| Compliance with 21 CFR 898? | Yes | Yes | Yes | Yes | Yes |
| Weight (lb., oz) | 6.50 oz. | 11.4 oz. | 6.24 oz. | 4.48 oz. | 6.24 oz. |
| Dimensions (in.) [W x H x D] | 3.1" x 4.8" x1.3" | 6.3" x 2.75" x1.25" | 4.7" x 2.8" x1.0" | 3.66" x 2.44" x1.10" | 4.7" x 2.8" x1.0" |
| Housing Materials and Construction | ABS 94 HBPlastic BodyWith MoldedRubber Sides | Plastic | ABS plasticinjectionmolded | Plastic | ABS plasticinjectionmolded |
Table for the Comparison of Output Specifications for TENS Mode:
.
| Parameter | Impulse 3 | QuadStar II | Smartwave MS2000 | Sterling TENS | Smartwave IF2000 |
|---|---|---|---|---|---|
| Mode or Program Name | TENS | TENS | N/A | TENS | N/A |
| Waveform (e.g., pulsed monophasic,biphasic) | Pulsedasymmetricalbiphasic | Pulsedasymmetricalbiphasic | N/A | Pulsedassymetricalbiphasic | N/A |
| Shape (e.g., rectangular, spike, rectifiedsinusoidal) | Rectangular | Rectangular | N/A | Rectangular | N/A |
| Maximum Output Voltage (volts)(+/-5%) | 40.6V @ 500Ω50.2V @ 2kΩ53.4V @ 10kΩ | 48V @ 500Ω86V @ 2kΩ96V @ 10kΩ | N/A | 27.5V @ 500Ω | N/A |
| Maximum Output Current (specifyunits) (+/- 5%) | 81.3mA @500Ω25.1mA @ 2kΩ5.3mA @ 10kΩ | 96mA @ 500Ω43mA @ 2kΩ9.6mA @ 10kΩ | N/A | 55mA @ 500Ω | N/A |
| Duration of primary (depolarizing) | 50 to 300µs in | 10 to 250µs in | N/A | 50 to 450µs, > | N/A |
{3}------------------------------------------------
| phase (µs) | steps of 5µs | steps of 5µs | 300µs limitsVoltage |
|---|---|---|---|
| Pulse Duration (µs) | 50 to 300µs insteps of 5µs | 10 to 250µs insteps of 5µs | 50 to 450µs, >300µs limitsVoltage |
| Frequency (Hz) [or Rate (pps)] | 1 to 120 pps insteps of 1 pps | 1 to 120 pps insteps of 1 pps | 1 to 120 pps |
| For multiphasic waveforms only:Symmetrical phased? | No | No | No |
| For multiphasic waveforms only: PhaseDuration (include units) (state range, ifapplicable)(both phases, ifasymmetrical) | 2ms | 20 to 500µs | 100 to 1000µs |
| Net Charge (microcoulombs (µC) perpulse (If zero, state method ofachieving 0 net) | 0 net DC, + and- pulses cancel | 0 net DC, + and- pulses cancel | 0 net DC, + and- pulses cancel |
| Maximum Phase Charge (µC) | 21.7µC @ 500Ω | 24.0µC @ 500Ω | 16.5µC |
| Maximum Current Density (mA/cm2,r.m.s.) | 0.70mA/cm2 @500 Ω | 0.74mA/cm2 @500 Ω | 0.42mA/cm2 @500 Ω |
| Maximum Average Current (averageabsolute value), mA | 2.61mA | 3.60mA | 1.98mA |
| Maximum Average Power Density(W/cm2), (using smallest electrodeconductive surface area) | 4.81mW/cm2 | 6.91mW/cm2 | 2.18mW/cm2 |
| Burst Mode: Pulses per burst | 7 | 8 | 7 |
| Burst Mode: Bursts per second | 2 | 2 | 2 |
| Burst Mode: Burst duration (seconds) | 0.085ms (7pulses @ 85Hz) | 0.250ms (8pulses @ 32Hz) | 0.085ms (7pulses @ 85Hz) |
| Burst Mode: Duty Cycle | 0.42% | 0.4% | 0.42% |
| Burst Mode: ON Time (seconds) | If selected,burst mode isconstant | If selected,burst mode isconstant | If selected,burst mode isconstant |
| Burst Mode: OFF Time (seconds) | N/A | N/A | N/A |
| Effect on Maximum Phase Charge(representative) as battery voltagevaries from 5.5V to 8.4V | None, outputnot affected bybatteryvariations | ||
| Effect on Maximum Phase Charge(representative) as charger voltagevaries from 6.75V to 11.25V, nobatteries. | None, outputnot affected bybatteryvariations | ||
| Additional Features (specify, ifapplicable) |
Table for the Comparison of Output Specifications for INF Mode:
1999 - 1999 - 1999
:
| Parameter | Impulse 3 | QuadStar II | Smartwave MS 2000 | Sterling TENS | Smartwave IF 2000 |
|---|---|---|---|---|---|
| Mode or Program Name | INF | INF | N/A | N/A | INF |
| Waveform (e.g., pulsed monophasic, biphasic) | Symmetrical biphasic | Symmetrical biphasic | N/A | N/A | Symmetrical biphasic |
| Shape (e.g., rectangular, spike, rectified sinusoidal) | Sinusoidal | Square | N/A | N/A | Sinusoidal |
| Maximum Output Voltage (volts)(+/- 5%) | 26.7V @ 500Ω33.2V @ 2kΩ35.4V @ 10kΩ | 17.1V @ 500Ω26.4V @ 2kΩ29.2V @ 10kΩ | N/A | N/A | 32.4V @ 500Ω38.0V @ 2kΩ40.6V @ 10kΩ |
| Maximum Output Current (specify units) (+/- 5%) | 53mA @ 500Ω16.6mA @ 2kΩ3.5mA @ 10kΩ | 34mA @ 500Ω13.2mA @ 2kΩ2.9mA @ 10kΩ | N/A | N/A | 66mA @ 500Ω19.1mA @ 2kΩ4.1mA @ 10kΩ |
| Duration of primary (depolarizing) phase (μs) | 125μs | 125μs | N/A | N/A | 125μs |
| Pulse Duration (μs) | 250μs | 250μs | N/A | N/A | 250μs |
| Frequency (Hz) [or Rate (pps)] | 4000Hz – 4150Hz in steps | 4000Hz – 4150Hz in steps | N/A | N/A | 4000Hz – 4150Hz in steps |
.
{4}------------------------------------------------
| of 1Hz | of 1Hz | of 1Hz | |
|---|---|---|---|
| For multiphasic waveforms only:Symmetrical phased? | Yes | Yes | Yes |
| For multiphasic waveforms only: PhaseDuration (include units) (state range, ifapplicable)(both phases, ifsymmetrical) | 250 $\mu$ s | 250 $\mu$ s | 250 $\mu$ s |
| Net Charge (microcoulombs ( $\mu$ C) perpulse (If zero, state method ofachieving zero net charge) | 0 net DC, + and- pulses cancel | 0 net DC, + and- pulses cancel | 0 net DC, + and- pulses cancel |
| Maximum Phase Charge ( $\mu$ C) | 4.72 $\mu$ C @ 500 $\Omega$ | 4.28 $\mu$ C @ 500 $\Omega$ | 5.73 $\mu$ C @ 500 $\Omega$ |
| Maximum Current Density (mA/cm $²$ , r.m.s.) | 1.92mA/cm $²$ @500 $\Omega$ | 1.37mA/cm $²$ @500 $\Omega$ | 1.83mA/cm $²$ @500 $\Omega$ |
| Maximum Average Current (averageabsolute value), mA | 37.8mA | 34.2mA | 45.8mA |
| Maximum Average Power Density(W/cm $²$ ), (using smallest electrodeconductive surface area) | 36.3mW/cm $²$ | 23.4mW/cm $²$ | 42.0mW/cm $²$ |
| Burst Mode: Pulses per burst | N/A | N/A | N/A |
| Burst Mode: Bursts per second | N/A | N/A | N/A |
| Burst Mode: Burst duration (seconds) | N/A | N/A | N/A |
| Burst Mode: Duty Cycle | N/A | N/A | N/A |
| Burst Mode: ON Time (seconds) | N/A | N/A | N/A |
| Burst Mode: OFF Time (seconds) | N/A | N/A | N/A |
| Effect on Maximum Phase Charge(representative) as battery voltagevaries from 5.5V to 8.4V | None, outputnot affected bybatteryvariations | ||
| Effect on Maximum Phase Charge(representative) as charger voltagevaries from 6.75V to 11.25V, nobatteries. | None, outputnot affected bybatteryvariations | ||
| Additional Features (specify, ifapplicable) |
1121305
Table for the Comparison of Output Specifications for NMES AC Mode:
·
| Parameter | Impulse 3 | QuadStar II | Smartwave MS2000 | *Sterling TENS | Smartwave IF2000 |
|---|---|---|---|---|---|
| Mode or Program Name | NMES | NMES | NMES | N/A | N/A |
| Waveform (e.g., pulsed monophasic,biphasic) | Pulsedsymmetricalbiphasic (AC) | Pulsedsymmetricalbiphasic (AC) | Pulsedsymmetricalbiphasic (AC) | ||
| Shape (e.g., rectangular, spike, rectifiedsinusoidal) | Rectangular | Rectangular | Rectangular | ||
| Maximum Output Voltage (volts)(+/-5%) | 26.4V @ 500Ω36.4V @ 2kΩ40.8V @ 10kΩ | 32V @ 500Ω60V @ 2kΩ66.4V @ 10kΩ | 28.6V @ 500Ω35.5V @ 2kΩ38.3V @ 10kΩ | ||
| Maximum Output Current (specifyunits) (+/- 5%) | 53mA @ 500Ω18.2mA @ 2kΩ4.1mA @ 10kΩ | 64mA @ 500Ω30.0mA @ 2kΩ6.6mA @ 10kΩ | 57.2mA @ 500Ω17.8mA @ 2kΩ3.8mA @ 10kΩ | ||
| Duration of primary (depolarizing)phase (µs) | 50 to 300µs insteps of 5µs | 50 to 400µs insteps of 5µs | 50 to 300µs insteps of 50µs | ||
| Pulse Duration (µs) | 50 to 300µs insteps of 5µs | 50 to 400µs insteps of 5µs | 50 to 300µs insteps of 50µs | ||
| Frequency (Hz) [or Rate (pps)] | 1 to 120 pps insteps of 1 pps | 1 to 120 pps insteps of 1 pps | 1 to 120 pps insteps of 1 pps | ||
| For multiphasic waveforms only:Symmetrical phased? | Yes | Yes | Yes |
:
{5}------------------------------------------------
| For multiphasic waveforms only: Phase Duration (include units) (state range, if applicable)(both phases, if asymmetrical) | Second phase identical in width and shape but opposite polarity. | Second phase identical in width and shape but opposite polarity. | Second phase identical in width and shape but opposite polarity. | ||
|---|---|---|---|---|---|
| Net Charge (microcoulombs (µC) per pulse (If zero, state method of achieving zero net charge) | Zero net DC, + and - pulses cancel | Zero net DC, + and - pulses cancel | Zero net DC, + and - pulses cancel | ||
| Maximum Phase Charge (µC) | 31.7µC @ 500Ω | 32.0µC @ 500Ω | 34.3µC @ 500Ω | ||
| Maximum Current Density (mA/cm², r.m.s.) | 0.72mA/cm2 @ 500 Ω | 0.63mA/cm² @ 500 Ω | 0.62mA/cm² @ 500 Ω | ||
| Maximum Average Current (average absolute value), mA | 3.8mA | 3.84mA | 4.13mA | ||
| Maximum Average Power Density (W/cm²), (using smallest electrode conductive surface area) | 5.11mW/cm2 | 4.92mW/cm² | 4.74mW/cm² | ||
| Burst Mode: Pulses per burst | N/A | N/A | N/A | ||
| Burst Mode: Bursts per second | N/A | N/A | N/A | ||
| Burst Mode: Burst duration (seconds) | N/A | N/A | N/A | ||
| Burst Mode: Duty Cycle | N/A | N/A | N/A | ||
| Burst Mode: ON Time (seconds) | 1 to 99 seconds | 0 to 99 seconds | 1 to 99 seconds | ||
| Burst Mode: OFF Time (seconds) | 0 to 99 seconds | 0 to 99 seconds | 0 to 99 seconds | ||
| Effect on Maximum Phase Charge (representative) as battery voltage varies from 5.5V to 8.4V | None, output not affected by battery variations | None, output not affected by battery variations | |||
| Effect on Maximum Phase Charge (representative) as charger voltage varies from 6.75V to 11.25V, no batteries. | None, output not affected by battery variations | ||||
| Additional Features (specify, if applicable) |
Table for the Comparison of Output Specifications for NMES Russian Mode:
| Parameter | Impulse 3 | QuadStar II | MS2000 | Sterling TENS | Smartwave IF 2000 |
|---|---|---|---|---|---|
| Mode or Program Name | NMES | NMES | NMES | N/A | N/A |
| Waveform (e.g., pulsed monophasic, biphasic) | Gated symmetrical biphasic (Russian) | Does not support | Gated symmetrical biphasic (Russian) | N/A | N/A |
| Shape (e.g., rectangular, spike, rectified sinusoidal) | Rectangular | N/A | Rectangular | N/A | N/A |
| Maximum Output Voltage (volts)(+/- 5%) | 26.4V @ 500Ω36.4V @ 2kΩ40.8V @ 10kΩ | N/A | 28.7V @ 500Ω34.6V @ 2kΩ36.6V @ 10kΩ | N/A | N/A |
| Maximum Output Current (specify units) (+/- 5%) | 53mA @ 500Ω18.2mA @ 2kΩ4.1mA @ 10kΩ | N/A | 57mA @ 500Ω17.3mA @ 2kΩ3.7mA @ 10kΩ | N/A | N/A |
| Duration of primary (depolarizing) phase (μs) | 200μs | N/A | 200μs | N/A | N/A |
| Pulse Duration (μs) | 400μs | N/A | 400μs | N/A | N/A |
| Frequency (Hz) [or Rate (pps)] | 50Hz | N/A | 50Hz | N/A | N/A |
| For multiphasic waveforms only: Symmetrical phased? | Yes | N/A | Yes | N/A | N/A |
| For multiphasic waveforms only: Phase Duration (include units) (state range, if applicable)(both phases, if asymmetrical) | Second phase identical is width and shape but opposite polarity. | N/A | Second phase identical is width and shape but opposite polarity. | N/A | N/A |
| Net Charge (microcoulombs (μC) per | Zero net DC, + | N/A | Zero net DC. + | N/A | N/A |
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K12/305
| pulse (If zero, state method ofachieving zero net charge) | and - pulsescancel | and - pulsescancel | |
|---|---|---|---|
| Maximum Phase Charge (μC) | 21.1μC @ 500Ω | 23.0μC @ 500Ω | |
| Maximum Current Density (mA/cm², r.m.s.) | 1.9mA/cm² @ 500Ω | 1.6mA/cm² @ 500Ω | |
| Maximum Average Current (average absolute value), mA | 26.4mA | 28.7mA | |
| Maximum Average Power Density (W/cm²), (using smallest electrode conductive surface area) | 35.5mW/cm2 | 33.0mW/cm² | |
| Burst Mode: Pulses per burst | 50 | 50 | |
| Burst Mode: Bursts per second | 50 | 50 | |
| Burst Mode: Burst duration (seconds) | 10mSec | 10mSec | |
| Burst Mode: Duty Cycle | 50% | 50% | |
| Burst Mode: ON Time (seconds) | 1 to 99 seconds | 1 to 99 seconds | |
| Burst Mode: OFF Time (seconds) | 0 to 99 seconds | 0 to 99 seconds | |
| Effect on Maximum Phase Charge (representative) as battery voltage varies from 5.5V to 8.4V | None, output not affected by battery variations | ||
| Effect on Maximum Phase Charge (representative) as charger voltage varies from 6.75V to 11.25V, no batteries. | None, output not affected by battery variations | ||
| Additional Features (specify, if applicable) |
Performance Summary (non-clinical)
Compliance to applicable voluntary standards includes IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety, 1988, Amendment 1, 1991-11, Amendment 2, 1995.
Testing has been included in the premarket notification to demonstrate equivalence to the predicate devices and meets the "Guidance Document for Powered Muscle Stimulators," dated June 9, 1999.
Conclusion
The Sterling Medical Impulse 3 combination stimulator has the same intended use and similar technological characteristics as the BMLS04-1 (K041388) marketed by Biomedical Life Systems, Inc. In addition, the Impulse 3 supports three modes and has the same intended use and similar technological characteristics as the single mode predicate devices. The Impulse 3 in neuromuscular (NMES) mode has the same intended use and similar technological characteristics as the MS 2000 (K041063) marketed by Newwave Medical, LLC. The Impulse 3 in interferential (INF) mode has the same intended use and similar technological characteristics as the IF 2000 (K003631) marketed by Newwave Medical, LLC. The Impulse 3 in transcutaneous electrical nerve stimulator (TENS) mode has the same intended use and similar technological characteristics as the Sterling TENS (K891118) marketed by Armstrong Industries, Inc.
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Bench testing contained in this submission demonstrates that any differences in their technological characteristics to not raise any new questions of safety or effectiveness. Therefore, the Sterling Medical Impulse 3 is substantially equivalent to the predicate devices.
and the same of the same of the same of
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:
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Children Children Children
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Image /page/8/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. The bottom half of the circle contains the words "OF HEALTH & HUMAN" on the left and "SERVICES • USA" on the right. Inside the circle is an abstract image of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP 25 2012
Armstrong Industries, Inc. c/o Mr. Ralph Armstrong President and CEO 7290 Virginia Pkwy, Suite 3000 McKinney, TX 75071
Re: K121305
Trade/Device Name: Sterling Medical Impulse 3 Stimulator Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: II Product Code: GZJ, IPF, LIH Dated: Not Dated Received: September 6, 2012
Dear Mr. Armstrong:
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
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Page 2 - Mr. Ralph Armstrong
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Kesia Alexander
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement 4
510(k) Number (if known): __K121305
Device Name: Sterling Medical Impulse 3 Stimulator
Indications for Use:
Interferential Stimulation (INF) is used for symptomatic relief and management of chronic (Iongterm) intractable pain and/or as an adjunctive treatment in the management of postsurgical and post-traumatic acute pain.
External electrical neuromuscular stimulation (NMES) using biphasic output is indicated as therapeutic adjunct for: prevention or retardation of muscle disuse atrophy; relaxation of muscle spasm; muscle reeducation; maintaining and increasing the range of motion; increasing local blood circulation and as immediate postsurgical stimulation of caff muscles to prevent venous thrombosis.
Transcutaneous Electrical Nerve Stimulation (TENS) is used for the symptomatic relief and management of chronic (long-term) intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain problems.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use · (Part 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 (ØDE)
Elll Cl
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
Page 1 of 1
ﺴﻌ
510(k) Number K121305
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).