(30 days)
Interferential Current Mode: Symptomatic relief and management of chronic pain and/or as an adjunctive treatment for the management of post surgical and post traumatic pain.
Neuromuscular Stimulator Mode: Relaxation of muscle spasm, increasing local blood circulation, maintaining and increasing range of motion, preventing or retarding disuse atrophy, muscle re-education, and immediate post surgical stimulation of calf muscles to prevent venous thrombosis.
The PMD-2000 Interferential Stimulator is a battery or AC wall adapter powered device intended for clinic, and outpatient use. Once prescribed by a physician it gives the clinician a variety of electrotherapy modes to treat a range of indications. The PMD-2000 is designed for clinician and patient ease of use and provides safe and effective dispensing of the desired electrotherapy treatment. The PMD-2000 incorporates the following features:
- Two independent stimulation channels, which provide true interferential current and neuromuscular stimulation.
- Continuous or pulsed stimulation. Various sweep and ramp times.
- Adjustable amplitude and frequency.
- Fifteen preset therapy protocols.
- Pause button to allow temporary suspension of treatment and a resume button to allow the resumption of treatment. When a treatment session is paused, the timer does not countdown. Upon resumption of treatment, the timer resumes its countdown and the amplitude (intensity) is reset to zero.
- Easy to connect, easy to handle, patient lead wire/cable assembly with a "one way" connector and color coded lead wires contribute to improved patient experience and improved therapy outcomes.
- Timed therapy sessions.
- Double A (AA) battery system accommodates standard alkaline, NiCad and Nickel Metal Hydride batteries.
- The PMD-2000 user interface incorporates a 16 character (8x2) Liquid Crystal Display (LCD) and tactile switches for menu navigation.
Here's a breakdown of the acceptance criteria and study information for the PMD-2000 Interferential Stimulator, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in a quantitative manner for specific performance metrics (e.g., "output frequency must be within +/- X%"). Instead, the acceptance criteria are implicitly defined by the demonstration of "substantial equivalence" to a legally marketed predicate device (CS3101 Interferential Stimulator) through qualitative and comparative bench testing.
| Acceptance Criterion (Implicit) | Reported Device Performance (PMD-2000) |
|---|---|
| Safety: Device operates without unsafe energy levels. | Improved safety due to device software and hardware working together at several "checkpoints" to protect the patient from unsafe energy levels. Very low operating temperatures due to the removal of the battery charging system. |
| Effectiveness: Provides intended therapy. | "Provides the intended therapy in a safe and effective manner." Both devices offer "near-identical preprogrammed treatment protocols." Bench testing confirmed "therapy output and performance characteristics for both units was substantially equivalent." |
| Design, Features, and Function: Similar to predicate device. | "Similar in design, features and function." Both have two independent stimulation channels, continuous or pulsed stimulation, various sweep and ramp times, adjustable amplitude and frequency, and timed therapy sessions. PMD-2000 has specific improvements like a simplified battery system, lower operating temperatures, improved safety features, and a simplified user interface. |
| Treatment Protocols: Offers comparable preprogrammed options. | Both devices offer "near-identical preprogrammed treatment protocols" (PMD-2000 has fifteen preset therapy protocols). |
| User Interface/Experience: Ease of use. | Designed for clinician and patient ease of use. Easy to connect, easy to handle, patient lead wire/cable assembly. Simplified user interface with a minimum number of steps to begin therapy. Easy to read interface screens. Large "Pause" and "Stop" buttons. |
| Indications for Use: Matches predicate device. | The stated indications for use for the PMD-2000 are consistent with those typically found for interferential and neuromuscular stimulators and would have been compared to the predicate device during the substantial equivalence review. (Interferential Current Mode: symptomatic relief/management of acute/chronic pain, adjunctive treatment for post-traumatic/post-surgical pain. Neuromuscular Stimulation Mode: relaxation of muscle spasms, prevention/retardation of disuse atrophy, increasing local blood circulation, muscle re-education, post-surgical calf muscle stimulation to prevent venous thrombosis, maintaining/increasing range of motion.) |
2. Sample Size for the Test Set and Data Provenance
- Sample Size: The document does not specify a numerical sample size for the test set used in a clinical study. Instead, it mentions "Bench testing was performed on the marketed device and the PMD-2000." This indicates that the comparison was likely done on a limited number of physical units of both the PMD-2000 and the predicate device (CS3101).
- Data Provenance: The data provenance is from bench testing. No information is provided regarding country of origin or whether it was retrospective or prospective, as it was a technical comparison of device outputs, not patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The "ground truth" for this device's performance seems to be established by physical measurements and comparisons against the known operational characteristics of the predicate device, rather than expert interpretation of complex data (like medical images).
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided. Given that the evaluation was based on bench testing of device outputs, there would be no need for an adjudication method involving human interpretation.
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
- No, an MRMC comparative effectiveness study was not done.
- This device is an electrical stimulator, not an AI-powered diagnostic or assistive tool for human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not relevant to this product.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, a standalone performance assessment was done in the form of bench testing. The document states: "Bench testing was performed on the marketed device and the PMD-2000 and the therapy output and performance characteristics for both units was substantially equivalent." This constitutes a standalone evaluation of the device's functional output without human interaction in the loop determining its primary effectiveness.
7. The Type of Ground Truth Used
The ground truth used for assessing the PMD-2000's performance was the measured therapy output and performance characteristics of the legally marketed predicate device (CS3101 Interferential Stimulator). Essentially, the predicate device defined the acceptable "truth" for output waveform, frequency, amplitude, etc., which the PMD-2000 had to match or be substantially equivalent to.
8. The Sample Size for the Training Set
This information is not applicable and therefore not provided. The PMD-2000 is an electrical stimulator and is not described as involving machine learning or AI algorithms that would require a "training set" in the conventional sense. Its design and functions are based on established biophysical principles of electrical stimulation.
9. How the Ground Truth for the Training Set was Established
This information is not applicable and therefore not provided, as there is no mention of a "training set" for an AI model.
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Image /page/0/Picture/1 description: The image shows the logo for Phoenix Medical Devices. The logo features a stylized phoenix bird with its wings spread wide, positioned above the company name. The text "PHOENIX" is in a larger, serif font, while "MEDICAL DEVICES" is in a smaller font below it.
NOV 1 8 2004
510(k) Summary for the PMD-2000 Interferential Stimulator
1. Sponsor
Phoenix Medical Devices, LLC 620 Newport Center Drive, Suite 1100 Newport Beach, Ca 92660
Registration Number: 3004620982
Contact Person: Jim Klett Telephone: (800) 689-9892 Fax: (949) 266-5928
Date Prepared: September 15, 2004
2. Device Name
Proprietary Name: PMD-2000 Interferential Stimulator Common/Usual Name: Electrical Muscle and Nerve Stimulator Classification Names: Interferential Current Stimulator, Powered Muscle Stimulator Classification Panel: Physical Medicine Panel/Product Code: 890.5850 / IPF and LiH
3. Legally Marketed Device to Which Equivalence is Claimed
Proprietary Name: CS3101 Interferential Stimulator Common/Usual Name: Electrical Muscle and Nerve Stimulator Classification Names: Interferential Current Stimulator, Powered Muscle Stimulator Classification Panel: Physical Medicine Panel/Product Code: 890.5850 / IPE
| Phoenix Medical Devices, LLC | PMD-2000 510(k) Summary | ||
|---|---|---|---|
| Document No.:10-08-002 | Process Owner:President | Revision:A | File name:10-08-002 PMD-2000 510(k) 510(k) Summary.doc |
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K042 881
4. Intended Use
The PMD-2000 Interferential Stimulator is a multifunction device intended to be used for muscle and nerve stimulation using either of its two therapy modes. Interferential Current Stimulation or Neuromuscular Electrical Stimulation.
In the Interferential Current Mode the PMD-2000 is indicated for the following conditions:
- . Symptomatic relief of acute pain
- t Symptomatic management and relief of chronic pain
- Adjunctive treatment for the management of post traumatic and . Post-surgical pain
In the Neuromuscular Stimulation Mode, the PMD-2000 is indicated for the following conditions:
- . Relaxation of muscle spasms:
- . Prevention or retardation of disuse atrophy:
- Increasing local blood circulation;
- . Muscle re-education:
- Immediate post surgical stimulation of calf muscles to prevent venous thrombosis; o
and
- Maintaining or increasing range of motion. .
5_ Device Description
The PMD-2000 Interferential Stimulator is a battery or AC wall adapter powered device intended for clinic, and outpatient use. Once prescribed by a physician it gives the clinician a variety of electrotherapy modes to treat a range of indications. The PMD-2000 is designed for clinician and patient ease of use and provides safe and effective dispensing of the desired electrotherapy treatment. The PMD-2000 incorporates the following features:
- Two independent stimulation channels, which provide true interferential current and . neuromuscular stimulation.
| Phoenix Medical Devices, LLC | PMD-2000 510(k) Summary | ||
|---|---|---|---|
| Document No.:10-08-002 | Process Owner:President | Revision:A | File name:10-08-002 PMD-2000 510(k) 510(k) Summary.doc |
{2}------------------------------------------------
- Continuous or pulsed stimulation. Various sweep and ramp times.
- Adjustable amplitude and frequency .
- . Fifteen preset therapy protocols
- . Pause button to allow temporary suspension of treatment and a resume button to allow the resumption of treatment. When a treatment session is paused, the timer does not countdown. Upon resumption of treatment, the timer resumes its countdown and the amplitude (intensity) is reset to zero.
- Easy to connect, easy to handle, patient lead wire/cable assembly with a "one way" . connector and color coded lead wires contribute to improved patient experience and improved therapy outcomes.
- Timed therapy sessions. .
- . Double A (AA) battery system accommodates standard alkaline, NiCad and Nickel Metal Hydride batteries.
- The PMD-2000 user interface incorporates a 16 character (8x2) Liquid Crystal . Display (LCD) and tactile switches for menu navigation.
6. Basis for Substantial Equivalence
The PMD-2000 is substantially equivalent to the legally marketed device and is similar in design, features and function and provides the intended therapy in a safe and effective manner. Both devices offer near-identical preprogrammed treatment protocols and the clinician or patient can choose one or more of these pre-set options.
Bench testing was performed on the marketed device and the PMD-2000 and the therapy output and performance characteristics for both units was substantially equivalent.
7. Differences Between the Marketed Device and the PMD-2000
The PMD-2000 incorporates several improvements over the legally marketed device, including:
- Simplified battery system. There is no need to exclusively use rechargeable AA . batteries. This provides great freedom of mobility and battery choice to the user. This feature greatly reduces therapy down time. The simplified battery system also lowers the weight of the device by 50% and results in a more economically priced device.
- Very low operating temperatures due to the removal of the battery charging system. .
| Phoenix Medical Devices, LLC | PMD-2000 510(k) Summary | ||
|---|---|---|---|
| Document No.:10-08-002 | Process Owner:President | Revision:A | File name:10-08-002 PMD-2000 510(k) 510(k) Summary.doc |
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- Improved safety due to the device software and hardware working together at . several "checkpoints" to protect the patient from unsafe energy levels.
- Greatly simplified user interface with a minimum number of steps to begin therapy . treatment.
- Easy to read interface screens of available options and settings. .
- Large "Pause" and "Stop" buttons on the interface ensure quick suspension of . treatment.
| Phoenix Medical Devices, LLC | PMD-2000 510(k) Summary | ||
|---|---|---|---|
| Document No.: | 10-08-002 | Process Owner: | President |
| Revision: | A | File name: | 10-08-002 PMD-2000 510(k) 510(k) Summary.doc |
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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with outstretched wings, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 8 2004
Phoenix Medical Devices, LLC c/o Mr. Ned E. Devine, Jr. Entela, Inc. 3033 Madison Avenue S.E. Grand Rapids, Michigan 49548
Re: K042881
Trade/Device Name: PMD-2000 Interferential Stimulator Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: II Product Code: IPF Dated: November 3, 2004 Received: November 5, 2004
Dear Mr. Devine:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
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Page 2 - Mr. Ned E. Devine, Jr.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Mark A. Mckesson
B. Sc., M. Witts., Ph.D., M.D.
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
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Indications for Use
510(k) Number (if known): K04288)
Device Name: PMD-2000 Interferential Stimulator
Indications for Use:
Interferential Current Mode: Symptomatic relief and management of chronic pain and/or as an adjunctive treatment for the management of post surgical and post traumatic pain.
Neuromuscular Stimulator Mode: Relaxation of muscle spasm, increasing local blood circulation, maintaining and increasing range of motion, preventing or retarding disuse atrophy, muscle re-education, and immediate post surgical stimulation of calf muscles to prevent venous thrombosis.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
A. Mark A. Millhurn
Division of General, Restorative
and Neurological Devices
Page __ of ___________________________________________________________________________________________________________________________________________________________________
510(k) Number K042881
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).