(494 days)
(A) Interferential current stimulation, Premodulated Bipolar Mode and Faradic Stimulation Mode is indicated for:
- Symptomatic relief and management of chronic (long term) intractable pain.
- Adjunctive treatment in the management of post-surgical and post-traumatic, acute pain conditions.
(B) Electrical Muscle Stimulation ( Russian and Galvanic-Interrupted ) is indicated for: - Relaxation of Muscle spasm.
- Prevention or Retardation of disuse atrophy.
- Increasing local blood circulation.
- Muscle re-education.
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
- Maintaining or increasing range of motion.
( C) Galvanic-DC Continuous mode is indicated for :- - Relaxation of muscle spasm.
ANALGESIC PULSER AP-439 is an electrical nerve muscle stimulator with two outputs and four channels. It offers various waveforms including Monophasic, Biphasic, Sinewave & D.C. Line. It has different modes of stimulation such as Faradic, Interferential, DC continuous, and DC Interrupted, with specified maximum output current and voltage for each. It also provides different modulation options for amplitude and frequency.
The provided text is a 510(k) summary for the "Analgesic Pulser AP-439," an Electrical Nerve Muscle Stimulator. This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study to prove performance against specific acceptance criteria in the manner one would typically expect for a modern AI/ML device.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the traditional sense of performance metrics for an AI/ML device (e.g., sensitivity, specificity, AUC). Instead, the acceptance criteria are implicitly that the device's technical specifications and intended uses are substantially equivalent to legally marketed predicate devices.
| Feature | PREDICATE DEVICE (Sys Stim 226) (selected specifications) | PREDICATE DEVICE (Sys Stim 206) (selected specifications) | PREDICATE DEVICE (Sportx) (selected specifications) | PROPOSED DEVICE (AP-439) Technical Specifications (selected specifications) |
|---|---|---|---|---|
| Primary Indication | Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute post surgical pain. | (Not explicitly detailed as primary, but indications generally align with other predicate) | Symptomatic relief and management of chronic, intractable pain or as an adjunctive treatment in the management of acute post-surgical or post-traumatic pain. | Symptomatic relief and management of chronic (long term) intractable pain. Adjunctive treatment in the management of post-surgical and post-traumatic, acute pain conditions. |
| Waveform | Sinewave and biphasic rectangular pulse | Biphasic, monophasic pulse, DC. | Multiplexed symmetrical rectangular biphasic and unbalanced symmetrical rectangular triphasic. | Monophasic, Biphasic, Sinewave & D.C. Line |
| Max Output Current | 65 mA RMS at 1K load (interferential mode) | 100 mA peak, All pulsed Waveforms. 30 mA max. in DC continuous. | 100 mA at load of 500 ohms. | Faradic - 100 mA pp at 500 Ohm Load; Interferential - 72mA RMS at 500 Ohm Load; DC continuous - 30 mA at 500 Ohm Load; DC Interrupted - 92 mA at 500 Ohm Load |
| Max Output Voltage | 65 V RMS at 1K load (interferential mode) | 0 -- 102 VDC | 100 V at load of 2 K ohms. | Faradic - 132 V peak to peak at load of 10K ohms; Interferential - 50 V RMS at load of 10K ohms; DC continuous - 28 V at load of 10K ohms; DC Interrupted - 60 V at load of 10K ohms. |
| Max Current Density (under 2" electrode) | 3.2 mA/cm² (interferential mode) | Not explicitly listed, but 3.2mA/cm² given for Sys Stim 226 | Not explicitly listed | Interferential: 3.55mA/Sq. cm; Galvanic (D.C. continuous): 1.5 mA/Sq. cm; Galvanic Interrupted: 2.1mA/ Sq.cm; Faradic: 0.592 mA/Sq. cm |
| Phase Duration | 125 us (interferential mode), 50-300 us (biphasic mode) | Narrow pulse: 100 us; Wide pulse: 300 us; AC: 300 us; DC: DC Continuous | Symmetrical biphasic: 1800 us; Unbalanced triphasic: 1800 us and 900 us | Faradic: 100-400 (selectable); IFT: 125 micro sec. phase interval; Russian: 200 micro seconds; Galvanic: D.C. |
Study Description:
The document describes a submission for a 510(k) premarket notification. This process is not a clinical study in the sense of a trial designed to prove device effectiveness or safety through statistical analysis against specific acceptance thresholds. Instead, it's a demonstration that the new device is "substantially equivalent" to one or more devices already legally marketed (predicate devices) in terms of intended use, technological characteristics, and safety and effectiveness.
The "study" here is a comparison of technical specifications and intended uses between the proposed device (Analgesic Pulser AP-439) and three predicate devices: Sys stim 226, Sys stim 206 (both from Mettler Electronics Corp.), and Sportx (from Staodyn). The document argues that the AP-439 has the same intended use as the predicates and its technical specifications are comparable, thus ensuring similar safety and effectiveness.
2. Sample Size for Test Set and Data Provenance
Not applicable. This is not a study involving a test set of patient data, but rather a technical and functional comparison of a new device to existing ones.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. Ground truth, in the context of clinical expert consensus or pathology for diagnostic devices, is not a concept applied in this 510(k) submission for an electrical stimulator. The "ground truth" here is the established safety and effectiveness of the predicate devices as determined by their prior clearance.
4. Adjudication Method for the Test Set
Not applicable. There is no test set of patient data requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a comparison for an electrical stimulation device, not an image-reading or diagnostic AI system that would typically undergo an MRMC study.
6. Standalone (Algorithm Only) Performance Study
Not applicable. The device is a physical electro-mechanical product, not an algorithm. Its performance is demonstrated by its adherence to technical specifications that are comparable to previously cleared devices.
7. Type of Ground Truth Used
The "ground truth" implicitly used is the regulatory clearance and established safety/effectiveness of the predicate devices. The submission argues that because the AP-439 operates on similar principles, has comparable technical specifications, and shares the same intended use as these legally marketed devices, it can be considered substantially equivalent.
8. Sample Size for the Training Set
Not applicable. This is not an AI/ML device that learns from a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
{0}------------------------------------------------
MAR - 2 2001
510 (K):K993229(Revised submission)
。
SUMMARY
JOHARI ELECTRO TECH CO.
EC-2, Electronics Complex, Light Industrial Arca, Jodhpur 342003 (INDIA) PHONE: -91-291-741183 (F), 430028 (R) I AX: 91-291-742289 E-mail: joharis@ndf.vsnl.net.in
"510(k) Summary"
| Submitter's name | JOHARI ELECTRO TECH CO. |
|---|---|
| Address | EC-2, Electronics ComplexLight Industrial AreaJodhpur 342003INDIA |
| Phone | 91-291-741183 |
| FAX | 91-291-742289 |
| joharis@ndf.vsnl.net.in | |
| Contact Person | Mrs. Nisha JOHARI |
| Date of Summaryis submitted | Resubmitting on August 9th 2000 |
{1}------------------------------------------------
Device for which clearance is required
| Trade Name : | Analgesic Pulser AP-439 |
|---|---|
| Common Name : | Electrical Nerve Muscle Stimulator |
| Classification Name : | Physical Medicine (Per 21 CFR Section 890) andNeurology (Per 21 CFR Section 882.5890). |
Legally Marketed Device I
| (a) Sys stim 226(b) Sys stim 206 | : | Muscle Stimulator | 510(k) Number K964028 |
|---|---|---|---|
| Manufacturer | : | Mettler Electronics Corp. | |
| Address | : | 1333 S. Claudia St. Anaheim Ca. 92805 | |
| Tel. | : | 001 (714) 533 2221 |
AP-439 has same intended use as predicate. Both the electrical stimulators are to be used in Physical Medicine by Clinicians and Therapists.
Intended Use of Sys Stim 226 and 206
-
- Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute post surgical pain (Interferential or Premodulated Waveforms).
- Temporary relaxation of muscle spasm. 2.
-
- Prevention of post-surgical phlebo-thrombosis through immediate stimulation of calf muscies.
-
- Increase of blood flow in the treatment area.
-
- Prevention or retardation of disuse atrophy in post-injury type conditions.
-
- Muscle re-education.
-
- Maintaining or increasing range of motion.
Legally Marketed Device II:
Sportx
: Pulsed Direct Current (Muscle) and Nerve Stimulator
Manufacturer : Staodyn
{2}------------------------------------------------
ANNEXURE 'VIT
: 1225 Florida Avenue, Longmont, Colorado 80502-1379, 1-800-Address: 343-0488 or 1-800-525-2114
The predicate Device Sportx from Staodyn is indicated for
Pulsed Direct Current (PDC) has been used successfully for many years for the reduction of edema, increase or decrease in blood flow, increase in range of motion and relief of muscle spasm. Transcutaneous Electrical Nerve Stimulation (TENS) has been used successfully for many years in the symptomatic relief and management of chronic, intractable pain or as an adjunctive treatment in the management of chronic, intractable pain or as an adjunctive treatment in the management of acute post-surgical or post-traumatic pain.
AP-439 --------
Indication for Use_(A) Interferential current stimulation, Premodulated Bipolar Mode and Faradic Stimulation Mode is indicated for:
- Symptomatic relief and management of chronic (long 1. term) intractable pain.
- Adjunctive treatment in the management of post-2. surgical and post-traumatic, acute pain conditions.
(B) Electrical Muscle Stimulation ( Russian and Galvanic-Interrupted ) is indicated for:
- Relaxation of Muscle spasm. 1.
- Prevention or Retardation of disuse atrophy. 2.
- Increasing local blood circulation. 3.
- Muscle re-education. 4.
- Immediate post-surgical stimulation of calf muscles ળં to prevent venous thrombosis.
- Maintaining or increasing range of motion 6.
( C) Galvanic-IX Continuous mode is indicated for :-
- Relaxation of muscle spasm. 1.
{3}------------------------------------------------
ANNEXURE 'VIT
TECHNICAL SPECIFICATIONS
ANALGESIC PULSER AP-439
| Power Source | : 110V AC +/- 50Hz - 60Hz |
|---|---|
| Number of outputs | : Two |
| Channels | : Four |
| Synchronous | : Yes |
| Max out put current | : Faradic - 100 mA pp at 500 Ohm LoadInterferential - 72mA RMS (Root Mean Square)at 500 Ohm LoadDC continuous - 30 mA at 500 Ohm LoadDC Interrupted - 92 mA at 500 Ohm Load |
| Max out put voltage | : Faradic - 132 V peak to peak at load of 10K ohmsInterferential - 50 V RMS at load of 10K ohmsDC continuous - 28 V at load of 10K ohmsDC Interrupted - 60 V at load of 10K ohms. |
| Channel isolation | : Yes, confirm to ANSI 3.2.3.2 , 1985. |
| Waveform | : Monophasic, Biphasic, Sinewave & D.C. Line |
| Current densityon 2" diameterelectrodes | : Interferential3.55mA/Sq. cm on 500 ohm loadGalvanic (D.C. continuous)1.5 mA/Sq. cm on 500 ohm loadGalvanic Interrupted2.1mA/ Sq.cm on 500 Ohm LoadFaradic (Narrow Low Freq,Wide Low Freq., Dual, Ramp BurstPaired, Surge)0.592 mA/Sq. cm on 500 ohm load |
| Power densityon 2" diameterelectrodes | Interferential0.127 W/Sq. cm on 500 ohm loadGalvanic (DC Continuos)0.022 W/Sq. cm on 500 ohm loadGalvanic (DC Interrupt)0.095 W/Sq. cm on 500 ohm loadFaradic (Narrow Low Freq,Wide Low Freq., Dual, Ramp BurstPaired, Surge)0.029 W/Sq. cm on 500 ohm load |
| Max. phase charge | Interferential (Quadipolar, vector, premod) |
| at 500 Ohm | 4.5 micro coulomb |
| at 2 K Ohm | 1.5micro coulomb |
| at 10 K Ohm | 0.3micro coulomb |
| Interferential (Russian) | |
| at 500 Ohm | 7.2 micro coulomb |
| at 2 K Ohm | 2.4micro coulomb |
| at 10 K Ohm | 0.5 micro coulomb |
| Galvanic (DC interrupted) | |
| at 500 Ohm | 40 micro coulomb |
| at 2 K Ohm | 15 micro coulomb |
| at 10 K Ohm | 3.2 micro coulomb |
| Faradic (Narrow Low Freq,Wide Low Freq., Dual, Ramp BurstPaired, Surge) | |
| at 500 Ohm | 20 micro coulomb |
| at 2 K Ohm | 9.6 micro coulomb |
| at 10 K Ohm | 3 micro coulomb |
| Modulation Options | |
| Amplitude | Preset IFT only |
| Frequency | IFT section only |
| Mechanical Specifications | Weight 5.5 Lb, 12.2" (l)X 3.5" (h)X 7.5" (d) |
| Pulse width | Faradic: 100-400 (selectable)IFT : 125 micro sec. phase intervalRussian :200Micro SecondsGalvanic : D.C. |
{4}------------------------------------------------
ANNEXURE 'VII
510 (K):K993229(Revised submission)
{5}------------------------------------------------
ANNEXURE 'VIT
DC interrupted: At values greater than 50%power the on DC interrupted. An values go the total time is 3.5 milli secs. At values lower than the 50 % power the on time is 800 micro secs. and total time is 3.5 millisecs.
Sys stim: 226
| Waveform: | Sinewave and biphasic rectangular pulse |
|---|---|
| Volts: | 65 V RMS at 1 K load (interferrential mode), 99 V pp at load of 1K ohms.(biphasic mode) 0-50 V RMS at 1 K ohms load.(Russian ,premodulated mode) |
| Current: | 65 mA RMS at 1 K load (interferrential mode), 99 mA peak at load of 1K ohms.(biphasic mode).0-50 mA RMS at 1 K ohms load.(Russian ,premodulated mode |
| Average current atMax. intensity & freq.: | 65 mA (interferrential mode), 7.2 mA(biphasic mode)50 mA.(Russian ,premodulated mode) |
| Max. current density :Under 2" diameterElectrode: | 3.2 mA/cm2 (interferrential mode), 0.36 mA/cm2(biphasic mode)2.5 mA/cm2.(Russian ,premodulated mode |
| Phase duration: | 125 us (interferrential mode) ,50 -- 300 us (biphasic mode)200 mA.(Russian ) |
| Sys Stim 206 | |
| Waveform: | Biphasic,monophasic pulse,DC. |
| Volts: | 0 -- 102 VDC |
| Current: | 100 mA peak, All pulsed Waveforms.30 mA max. in Dc continuos. |
Average current at: Max. intensity and freq.
{6}------------------------------------------------
ANNEXURE 'VIT
510 (K):K993229(Rcviscd submission)
:
Max. current density: Under 2" diameter Electrode:
| Phase duration: | Narrow pulse: 100 us followed by 400 us at ¼ amplitude of reverse polarity.Wide pulse: 300 us followed by 1200 us at ¼ amplitude of reverse polarity.AC: 300 us in each polarityDC: DC Continuous |
|---|---|
| ----------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
Sports
| Waveform: | Multiplexed symmetrical rectangular biphasic and unbalancedsymmetrical rectangular triphasic. |
|---|---|
| Volts: | 100 V at load of 2 K ohms. |
| Current : | 100 mA at load of 500 ohms. |
| Average current at:Max. intensity & freq. | ---- |
| Max. current densityUnder 2" diameterElectrode: | ---- |
| Phase duration: | Symmetrical biphasic: 1800 usUnbalanced triphasic 1800 us and 900 us |
{7}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/7/Picture/2 description: The image shows a black and white logo. The logo features a stylized depiction of an eagle or bird in flight, composed of three curved lines. The bird is encircled by text, which appears to be part of the logo's design. The text is arranged in a circular fashion around the bird, completing the overall design of the logo.
MAR - 2 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Nisha Johari Director of Marketing Johari Electro-Tech Company Vandana, 28 Nehru Park Jodhpur-342003, India
Re: K993229 Trade Name: Analgesic Pulser, Model AP-439 Regulatory Class: II Product Code: GZJ, IPG and LIH Dated: December 1, 2000 Received: December 5, 2000
Dear Ms. Johari:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have heve hour your books. Is substantially equivalent (for the indications for use above and we have active as marketed in interstate commerce prior to May 28, 1976, the shared in the onemales) to concession incents, or to devices that have been reclassified in enacinent daily of the Modical Dortes Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general therefore, mainer and act reasyode requirements for annual registration, listing of devices, Controlis of the rest the receive, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations (1 remarker ripp. over device the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to mispections) the Food and Date in any result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nredicate device results in a classification for your device and thus, permits your device to proceed to the market.
{8}------------------------------------------------
Page 2 - Ms. Nisha Johari
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Miriam C. Provost
for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{9}------------------------------------------------
ANNEXURE VIT
DEVICE NAME: ANALGESIC PULSER AP-439
INDICATION FOR USE . (A) Interferential current stimulation , Premodulated Bipolar Mode and Faradic Stimulation Mode is indicated for,
1 Symptomatic relief and management of chronic (long term) intractable pain.
2 Adjunctive treatment in the management of post-surgical and post-traumatic, acute pain conditions.
(B) Flectrical Muscle Stimulation ( Russian and Galvanic-Interrupted ) is indicated for:
- Relaxation of Muscle spasm. 1.
- Prevention or Retardation of disuse atrophy. 2.
- Increasing local blood circulation. 3.
- Muscle re-education. 4.
Immediate post-surgical stimulation of calf muscles న్న to prevent venous thrombosis.
-
Maintaining or increasing range of motion 6.
( C) Galvanic-DC Continuous mode is indicated for:- -
Relaxation of muscle spasm. 1.
Concurrence of CDRH, Office of Device Evaluation (ODE)
V Prescription Use Over-The-Counter-Use __________ :
. OR
NISSAS
rav
(Per 21CFR 801.109)
(Optional Hormat 1-2-96)
Murani C. Provost
8.1
(Division Sign-Off) Division of General, Restorative and Neurological Devices
1993229 510(k) Number _
§ 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).