(147 days)
Not Found
No
The summary describes a standard electrical stimulator with preprogrammed and manual configuration options, and there is no mention of AI or ML capabilities in the device description, intended use, or the sections specifically checked for AI/ML terms.
Yes
The "Intended Use / Indications for Use" section explicitly states that Interferential Stimulation (INF), External electrical neuromuscular stimulation (NMES), and Transcutaneous Electrical Nerve Stimulation (TENS) are used for various therapeutic purposes, including pain relief, management of chronic pain, prevention of muscle disuse atrophy, relaxation of muscle spasm, and increasing local blood circulation.
No
The provided text explicitly states the device is used for symptomatic relief, management of pain, prevention of muscle disuse atrophy, relaxation of muscle spasms, muscle reeducation, maintaining and increasing the range of motion, increasing local blood circulation, and as immediate postsurgical stimulation to prevent venous thrombosis, all of which are therapeutic or rehabilitative functions, not diagnostic ones.
No
The device description explicitly states it is a "portable two channel, battery operated combination electrical neuromuscular stimulator (NMES), interferential stimulator (INF), and transcutaneous electrical nerve stimulator (TENS) unit" and lists hardware components like "electrodes and electrode leads, non-replaceable batteries, wall adapter, instruction manual, and carrying case." This indicates it is a physical hardware device with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses described (pain relief, muscle stimulation, preventing muscle atrophy, etc.) are all related to treating or managing conditions within the body. IVDs are used to examine specimens taken from the body (like blood, urine, tissue) to diagnose or monitor conditions.
- Device Description: The device is an electrical stimulator that applies electrical currents to the body via electrodes. This is a therapeutic device, not a diagnostic one that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
Therefore, the Impulse 3 is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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 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.
Interferential Stimulation (INF) is used for symptomatic relief and management of chronic (longterm) 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.
Product codes (comma separated list FDA assigned to the subject device)
GZJ, IPF, LIH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Bench testing contained in this submission demonstrates that any differences in their technological characteristics to not raise any new questions of safety or effectiveness.
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.
K041388, K003631, K041063, K891118
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
§ 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).
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 Stimulator |
| 510(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 | Sterling | ||||
| Medical | |||||
| Impulse 3 | QuadStar II | Smartwave MS | |||
| 2000 | Sterling TENS | Smartwave IF | |||
| 2000 | |||||
| Manufacturer | Armstrong | ||||
| Industries, Inc. | BioMedical Life | ||||
| Systems, Inc. | Newwave | ||||
| Medical, LLC | Armstrong | ||||
| Industries, Inc. | Newwave | ||||
| Medical, LLC | |||||
| Primary Power Source: Number, Size, | |||||
| and Type of Batteries | 2x 750mA, | ||||
| 3.7V, LC14500, | |||||
| Li-ion, | |||||
| rechargeable, | |||||
| not user | |||||
| replaceable | 4x AA Batteries, | ||||
| LR6 | 9V Battery | 9V Battery | 9V Battery | ||
| Optional Power Source and Battery | |||||
| Charger | Wall adapter, | ||||
| In: 100-240vac, | |||||
| 50-60Hz, | |||||
| Out: 9V, 1.3A, | |||||
| UL60601 | |||||
| approved | 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 | Transformer | ||||
| coupled | - | Transformer | |||
| coupled | - | - | |||
| 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 electrodes | |||||
| when device is on but no pulses are | |||||
| being 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 or | |||||
| Alternating? | TENS - | ||||
| Synchronous | |||||
| INF - | |||||
| Synchronous | |||||
| NMES - Both | TENS - | ||||
| Synchronous | |||||
| INF - | |||||
| Synchronous | |||||
| NMES - Both | NMES - Both | TENS - | |||
| Synchronous | INF - | ||||
| Synchronous | |||||
| Output Channels: Method of Channel | |||||
| isolation | Transformer | ||||
| Coupled | Transformer | ||||
| Coupled | Transformer | ||||
| Coupled | Transformer | ||||
| Coupled | Transformer | ||||
| Coupled | |||||
| Regulated Current or Regulated | |||||
| Voltage? | Regulated | ||||
| Current | Regulated | ||||
| Current | Regulated | ||||
| Current | Regulated | ||||
| Current | Regulated | ||||
| Current | |||||
| Software/Firmware/Microprocessor | |||||
| Control? | Yes | Yes | Yes | Yes | Yes |
| Automatic Overload Trip? | No | No | No | No | No |
| Automatic No-Load Trip? | Yes, If the unit | ||||
| is not used, it | |||||
| will turn itself | |||||
| off after 1 | |||||
| minute. | No | Yes, If the unit | |||
| is not used, it | |||||
| will turn itself | |||||
| off after 10 | |||||
| minutes. | No | Yes, If the unit | |||
| is not used, it | |||||
| will turn itself | |||||
| off after 10 | |||||
| minutes. | |||||
| Automatic Shut Off? | Yes, the unit | ||||
| turns off after | |||||
| the prescribed | |||||
| program. | Yes, the unit | ||||
| turns off after | |||||
| the prescribed | |||||
| program. | Yes, the unit | ||||
| turns off after | |||||
| the prescribed | |||||
| program. | Yes, the unit | ||||
| turns off after | |||||
| the prescribed | |||||
| program. | Yes, the unit | ||||
| turns off after | |||||
| the prescribed | |||||
| program. | |||||
| User Override Control? | Yes, the user | ||||
| can turn the | |||||
| unit off | Yes, the user | ||||
| can turn the | |||||
| unit off | Yes, the user | ||||
| can turn the | |||||
| unit off | Yes, the user | ||||
| can turn the | |||||
| unit off | Yes, the user | ||||
| can turn the | |||||
| unit off | |||||
| Indicator Display: On/Off Status? | Yes | Yes | Yes | Yes | Yes |
| Indicator Display: Low Battery? | Yes | Yes | Yes | Yes | Yes |
| Indicator Display: Voltage/Current | |||||
| Level ? | Yes | Yes | Yes | Control dials | |
| are 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" x | ||||
| 1.3" | 6.3" x 2.75" x | ||||
| 1.25" | 4.7" x 2.8" x | ||||
| 1.0" | 3.66" x 2.44" x | ||||
| 1.10" | 4.7" x 2.8" x | ||||
| 1.0" | |||||
| Housing Materials and Construction | ABS 94 HB | ||||
| Plastic Body | |||||
| With Molded | |||||
| Rubber Sides | Plastic | ABS plastic | |||
| injection | |||||
| molded | Plastic | ABS plastic | |||
| injection | |||||
| molded |
Table for the Comparison of Output Specifications for TENS Mode:
.
| Parameter | Impulse 3 | QuadStar II | Smartwave MS
2000 | Sterling TENS | Smartwave IF
2000 |
|-----------------------------------------------------------|--------------------------------------------------|-------------------------------------------|----------------------|------------------------------------|----------------------|
| Mode or Program Name | TENS | TENS | N/A | TENS | N/A |
| Waveform (e.g., pulsed monophasic,
biphasic) | Pulsed
asymmetrical
biphasic | Pulsed
asymmetrical
biphasic | N/A | Pulsed
assymetrical
biphasic | N/A |
| Shape (e.g., rectangular, spike, rectified
sinusoidal) | Rectangular | Rectangular | N/A | Rectangular | N/A |
| Maximum Output Voltage (volts)(+/-
5%) | 40.6V @ 500Ω
50.2V @ 2kΩ
53.4V @ 10kΩ | 48V @ 500Ω
86V @ 2kΩ
96V @ 10kΩ | N/A | 27.5V @ 500Ω | N/A |
| Maximum Output Current (specify
units) (+/- 5%) | 81.3mA @
500Ω
25.1mA @ 2kΩ
5.3mA @ 10kΩ | 96mA @ 500Ω
43mA @ 2kΩ
9.6mA @ 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 limits
Voltage |
|------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|-------------------------------------------|-------------------------------------------|
| Pulse Duration (µs) | 50 to 300µs in
steps of 5µs | 10 to 250µs in
steps of 5µs | 50 to 450µs, >
300µs limits
Voltage |
| Frequency (Hz) [or Rate (pps)] | 1 to 120 pps in
steps of 1 pps | 1 to 120 pps in
steps of 1 pps | 1 to 120 pps |
| For multiphasic waveforms only:
Symmetrical phased? | No | No | No |
| For multiphasic waveforms only: Phase
Duration (include units) (state range, if
applicable)(both phases, if
asymmetrical) | 2ms | 20 to 500µs | 100 to 1000µs |
| Net Charge (microcoulombs (µC) per
pulse (If zero, state method of
achieving 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 (average
absolute value), mA | 2.61mA | 3.60mA | 1.98mA |
| Maximum Average Power Density
(W/cm2), (using smallest electrode
conductive 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 (7
pulses @ 85Hz) | 0.250ms (8
pulses @ 32Hz) | 0.085ms (7
pulses @ 85Hz) |
| Burst Mode: Duty Cycle | 0.42% | 0.4% | 0.42% |
| Burst Mode: ON Time (seconds) | If selected,
burst mode is
constant | If selected,
burst mode is
constant | If selected,
burst mode is
constant |
| Burst Mode: OFF Time (seconds) | N/A | N/A | N/A |
| 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) | | | |
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 @ 500Ω | ||||
| 33.2V @ 2kΩ | |||||
| 35.4V @ 10kΩ | 17.1V @ 500Ω | ||||
| 26.4V @ 2kΩ | |||||
| 29.2V @ 10kΩ | N/A | N/A | 32.4V @ 500Ω | ||
| 38.0V @ 2kΩ | |||||
| 40.6V @ 10kΩ | |||||
| Maximum Output Current (specify units) (+/- 5%) | 53mA @ 500Ω | ||||
| 16.6mA @ 2kΩ | |||||
| 3.5mA @ 10kΩ | 34mA @ 500Ω | ||||
| 13.2mA @ 2kΩ | |||||
| 2.9mA @ 10kΩ | N/A | N/A | 66mA @ 500Ω | ||
| 19.1mA @ 2kΩ | |||||
| 4.1mA @ 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: Phase | |||
| Duration (include units) (state range, if | |||
| applicable)(both phases, if | |||
| symmetrical) | 250 $\mu$ s | 250 $\mu$ s | 250 $\mu$ s |
| Net Charge (microcoulombs ( $\mu$ C) per | |||
| pulse (If zero, state method of | |||
| achieving 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 (average
absolute value), mA | 37.8mA | 34.2mA | 45.8mA |
| Maximum Average Power Density
(W/cm $²$ ), (using smallest electrode
conductive 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 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) | | | |
1121305
Table for the Comparison of Output Specifications for NMES AC Mode:
·
| Parameter | Impulse 3 | QuadStar II | Smartwave MS
2000 | *Sterling TENS | Smartwave IF
2000 |
|-----------------------------------------------------------|---------------------------------------------|---------------------------------------------|-----------------------------------------------|----------------|----------------------|
| Mode or Program Name | NMES | NMES | NMES | N/A | N/A |
| Waveform (e.g., pulsed monophasic,
biphasic) | Pulsed
symmetrical
biphasic (AC) | Pulsed
symmetrical
biphasic (AC) | Pulsed
symmetrical
biphasic (AC) | | |
| Shape (e.g., rectangular, spike, rectified
sinusoidal) | Rectangular | Rectangular | Rectangular | | |
| Maximum Output Voltage (volts)(+/-
5%) | 26.4V @ 500Ω
36.4V @ 2kΩ
40.8V @ 10kΩ | 32V @ 500Ω
60V @ 2kΩ
66.4V @ 10kΩ | 28.6V @ 500Ω
35.5V @ 2kΩ
38.3V @ 10kΩ | | |
| Maximum Output Current (specify
units) (+/- 5%) | 53mA @ 500Ω
18.2mA @ 2kΩ
4.1mA @ 10kΩ | 64mA @ 500Ω
30.0mA @ 2kΩ
6.6mA @ 10kΩ | 57.2mA @ 500Ω
17.8mA @ 2kΩ
3.8mA @ 10kΩ | | |
| Duration of primary (depolarizing)
phase (µs) | 50 to 300µs in
steps of 5µs | 50 to 400µs in
steps of 5µs | 50 to 300µs in
steps of 50µs | | |
| Pulse Duration (µs) | 50 to 300µs in
steps of 5µs | 50 to 400µs in
steps of 5µs | 50 to 300µs in
steps of 50µs | | |
| Frequency (Hz) [or Rate (pps)] | 1 to 120 pps in
steps of 1 pps | 1 to 120 pps in
steps of 1 pps | 1 to 120 pps in
steps 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 @ 500Ω | ||||
| 36.4V @ 2kΩ | |||||
| 40.8V @ 10kΩ | N/A | 28.7V @ 500Ω | |||
| 34.6V @ 2kΩ | |||||
| 36.6V @ 10kΩ | N/A | N/A | |||
| Maximum Output Current (specify units) (+/- 5%) | 53mA @ 500Ω | ||||
| 18.2mA @ 2kΩ | |||||
| 4.1mA @ 10kΩ | N/A | 57mA @ 500Ω | |||
| 17.3mA @ 2kΩ | |||||
| 3.7mA @ 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 |
6
K12/305
| pulse (If zero, state method of
achieving zero net charge) | and - pulses
cancel | and - pulses
cancel | |
|---------------------------------------------------------------------------------------------------------------|-------------------------------------------------|------------------------|--|
| 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.
7
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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Children Children Children
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8
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
9
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
10
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
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510(k) Number K121305