(25 days)
No
The description focuses on electrical stimulation and does not mention any AI/ML components or functionalities.
Yes.
The device's intended use is for "symptomatic relief of chronic intractable pain" and "adjunctive treatment for the management of post-traumatic or post-surgical pain," which are therapeutic applications. Additionally, it is described as an "Interferential Current Therapy device," explicitly indicating its therapeutic function.
No
The device description states its purpose is for "symptomatic relief of chronic intractable pain" and "adjunctive treatment for the management of post-traumatic or post-surgical pain" through electrical stimulation. It does not mention any function related to identifying, analyzing, or determining a medical condition.
No
The device description explicitly states it is a "rechargeable battery operated Interferential Current Therapy device" that utilizes an "output circuit" and delivers current via "patient cable and lead wires to electrodes placed on the skin," indicating it is a hardware device that delivers electrical stimulation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The Chronic Pain Suppressor CPS-2000 is an electrical stimulation device that delivers current through the skin to activate nerves for pain relief. It does not involve testing samples from the body.
- Intended Use: The intended use is for symptomatic relief of pain, not for diagnosing or detecting a condition based on bodily samples.
Therefore, based on the provided information, the Chronic Pain Suppressor CPS-2000 is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The intended uses of the Chronic Pain Suppressor are:
- Symptomatic relief of chronic intractable pain
- Adjunctive treatment for the management of post-traumatic or post-surgical pain .
Indications for Use:
- Symptomatic relief of chronic intractable pain. ●
- Adjunctive treatment for the management of post-traumatic or post-surgical pain.
Product codes
LIH
Device Description
The Chronic Pain Suppressor CPS-2000 is a rechargeable battery operated Interferential Current Therapy device that utilizes an output circuit to generate a symmetric monophasic sine or square waveform of electrical current. Delivered along a patient cable and lead wires to electrodes placed on the skin. The physician prescribed and programmed output passes through the skin and actives the underlying nerves. The symptomatic relief from chronic intractable pain can be obtained from this electrical stimulation.
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
Not Found
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)
The descriptive characteristics presented are thorough to ensure the substantial equivalence of the Chronic Pain Suppressor CPS-2000 to the legally marketed predicate devices. The descriptive characteristics include the data provided in the Substantial Equivalence Comparison Table within this premarket notification submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
NOV 1 4 2003
Image /page/0/Picture/1 description: The image shows a sequence of alphanumeric characters, specifically the string 'K033358'. The characters are written in a bold, sans-serif font, and they appear to be handwritten or generated with a slightly rough edge. The sequence consists of an uppercase 'K' followed by six numerical digits.
8.0 Chronic Pain Suppressor CPS-2000 510(k) Summary (as required by section 807.92(c))
| Submitter's Name: | SurgiTech, Inc.
2424 Vista Way, Suite 300
Oceanside, CA 92054 |
|------------------------------------|---------------------------------------------------------------------|
| Contact Person: | Chris Crowell
Phone: (760) 450-0194
Fax: (760) 721-4290 |
| Date Prepared: | October 10, 2003 |
| Trade or Proprietary Name: | Chronic Pain Suppressor |
| Common or Usual Name: | Interferential Current Therapy |
| SurgiTech Model Number: | CPS-2000 |
| Establishment Registration Number: | 2032724 |
| Device Class: | II |
| Classification Name: | Interferential Current Therapy |
| CFR #: | Unclassified |
| Product Code: | LIH |
Description of Device:
The Chronic Pain Suppressor CPS-2000 is a rechargeable battery operated Interferential Current Therapy device that utilizes an output circuit to generate a symmetric monophasic sine or square waveform of electrical current. Delivered along a patient cable and lead wires to electrodes placed on the skin. The physician prescribed and programmed output passes through the skin and actives the underlying nerves. The symptomatic relief from chronic intractable pain can be obtained from this electrical stimulation.
Intended Use:
The intended uses of the Chronic Pain Suppressor are:
- Symptomatic relief of chronic intractable pain
- Adjunctive treatment for the management of post-traumatic or post-surgical pain .
1
Predicate Device Information:
| Device | Applicant | 510(k) # |
|---|---|---|
| SD-730 | Skylark Device | K992652 |
| HMP 4000 | HMP 4000, Inc. | K924961 |
Substantial Equivalence:
The Chronic Pain Suppressor CPS-2000 is equivalent in basic form and function to almost any other Class II Interferential Current Therapy device. A difference to the legally marketed predicate devices is the "Patient-Lock" feature. This difference in no way affects the safety or effectiveness of the device. Ultimately, the safety is raised as the prescribed treatment parameters programmed by the physician are protected from alteration. The patient may only initiate and stop treatment at designated time intervals, adjust the intensity, and view the session countdown timer for the next treatment.
Performance Data:
The descriptive characteristics presented are thorough to ensure the substantial equivalence of the Chronic Pain Suppressor CPS-2000 to the legally marketed predicate devices. The descriptive characteristics include the data provided in the Substantial Equivalence Comparison Table within this premarket notification submission.
Conformance to Voluntary Standards:
- UL 60601-1 Medical Electrical Equipment, Part 1: General Requirements for . Safety
- IEC 60601-1-2 Medical Electrical Equipment Part 1-2: General requirements for . Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests
- AAMI/ANSI NS4:1986/(R)2002 Transcutaneous Electrical Nerve Stimulators -● specifically items 3.1-3.1.2.1, 3.1.3-3.2.5, 4.1-4.2.3.2
Conclusion:
The Chronic Pain Suppressor CPS-2000 is as safe and effective, and performs as well as the predicate devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three curved lines representing its wings.
NOV 1 4 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Christopher Crowell Ouality Assurance Manager SurgiTech, Inc. 2424 Vista Way, Suite 300 Oceanside, California 92054
Re: K033358
Trade/Device Name: Chronic Pain Suppressor CPS-2000 Regulatory Class: Unclassified Product Code: LIH Dated: October 10, 2003 Received: October 20, 2003
Dear Mr. Crowell:
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. Christopher Crowell
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 (301) 594-4659. 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. Milliken
Celia M. Witten, PhD, MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page of of
510(k) Number:
Device Name: ___ Chronic Pain Suppressor CPS-2000
Indications for Use:
- Symptomatic relief of chronic intractable pain. ●
- Adjunctive treatment for the management of post-traumatic or post-. surgical pain.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
R. Mark N. Milkerson
(Division Sign-Off) Division of General, Restorative and Neurological Devices
(Optional Format 3-10-98)