(169 days)
The CP Relief Wand® CP-1000 is a TENS Device and is intended for use as an adjunctive therapy for pain management for medical purposes such as symptomatic relief of chronic intractable pain and relief of acute post-surgical and post-traumatic pain.
The CP Relief Wand® Model CP-1000 is a portable hand held TENS device with self-contained electrodes. The device is powered by a standard 9 volt alkaline battery. In operation, the electrode end of the CP-1000 is covered by a gel pad and positioned to touch the skin over the pain center. The electrical pulses travel from one electrode, through the skin, through the underlying nerve tissue, and back through the skin to the other electrode to desensitize the underlying nerves within the current path. Convenient controls on the unit are provided for power, intensity, pulse width, and pulse polarity. The materials comprising the gel pad and CP1000 electrodes are comparable to the materials comprising Axelgaard's PALS® Neurostimulation Electrodes cleared per K132422.
The provided 510(k) summary for the CP Relief Wand® Model CP-1000 describes performance testing for functional and design verification and validation, as well as side-by-side comparison with a predicate device. However, it does not present a typical clinical study with specific acceptance criteria that would include metrics often seen in AI/diagnostic device submissions, such as sensitivity, specificity, or AUC.
Instead, the submission focuses on demonstrating substantial equivalence through adherence to recognized consensus standards related to electrical safety and electromagnetic compatibility for medical devices, as well as by comparing waveforms to a predicate device.
Here's an breakdown based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Electrical Safety | Conformance with IEC60601-1 (Edition 2:1988 (A1:1991 + A2:1995)) | Device shown to be in compliance with IEC60601-1 |
| Conformance with IEC60601-2-10 (1987) and Amendment 1 (2001) | Device shown to be in compliance with IEC60601-2-10 | |
| Electromagnetic Compatibility | Conformance with IEC60601-1-2:2007 (Third Edition) | Device shown to be in compliance with IEC60601-1-2 |
| Functional/Design | (Implied) Functional and design verification and validation | Performance testing conducted for functional and design verification and validation, indicating substantial equivalence. |
| Waveform Comparison | (Implied) Waveforms comparable to the predicate device | Side-by-side testing performed, indicating waveforms are comparable and overall substantial equivalence. |
| Safety & Effectiveness | (Implied) Differences from predicates do not affect safety and effectiveness | "These differences between the CP Relief Wand® Model CP-1000 and the predicates do not affect the safety and effectiveness of the device." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a "test set" in the context of a clinical study involving patients or pathological samples. The testing described focuses on engineering and electrical performance. Therefore, typical sample size and data provenance information for a clinical test set are not applicable here. The testing appears to have been conducted on the device itself and possibly in a lab setting.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. The device is a Transcutaneous Electrical Nerve Stimulator (TENS), and its substantial equivalence is primarily demonstrated through engineering standards compliance and performance characteristics, not through interpretation of diagnostic images or physiological signals that would require expert adjudication.
4. Adjudication Method for the Test Set
This information is not applicable, as there was no clinical test set requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The submission is for a TENS device and relies on engineering standards and comparison to predicate devices, not on human interpretation or diagnostic accuracy where an MRMC study would be relevant. There is no mention of AI assistance in the context of improving human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable to the device described. The CP Relief Wand® Model CP-1000 is a physical TENS device, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for this device's safety and effectiveness relies on:
- Compliance with recognized consensus standards: IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-10.
- Comparison to predicate devices: Demonstration that its technological characteristics (including waveforms and materials) are substantially equivalent to the TENS 3000 Stimulator (K102014) and InterX5000 (K042912), and that any differences do not impact safety or effectiveness.
8. The Sample Size for the Training Set
This information is not applicable because the submission does not describe an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there was no training set.
K133779 - CP Relief Wand® Model CP-1000 - 510(k) Summary
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K133779/S002 23MAY2014 Additional Deficiencies Request Response Page 1 of 2
510(k) SUMMARY
MAY 30 2014
(per 21 CFR 807.92)
Date: December 11, 2013
Premarket Notification: K133779
Trade Name: CP Relief Wand® Model CP-1000
Sponsor: Mid-America Medical Innovations, LLC
1709 Honey Creek Road
Jefferson City, MO 65101
Contact Person: Norm Schroeder
Mid-America Medical Innovations, LLC
2704 Industrial Drive
Jefferson City, MO 65109
Phone: 573-496-3213
Fax: 573-496-4015
Common Name: Transcutaneous Electrical Nerve Stimulator
Classification Name: Stimulator, Nerve, Transcutaneous. For pain relief
Device Classification: Class II
Regulation: 21 CFR 882.5890
Device Product Code: GZJ
Device Description: The CP Relief Wand® Model CP-1000 is a portable hand held TENS device with self-contained electrodes. The device is powered by a standard 9 volt alkaline battery. In operation, the electrode end of the CP-1000 is covered by a gel pad and positioned to touch the skin over the pain center. The electrical pulses travel from one electrode, through the skin, through the underlying nerve tissue, and back through the skin to the other electrode to desensitize the underlying nerves within the current path. Convenient controls on the unit are provided for power, intensity, pulse width, and pulse polarity. The materials comprising the gel pad and CP1000 electrodes are comparable to the materials comprising Axelgaard's PALS® Neurostimulation Electrodes cleared per K132422.
Intended Use: The CP Relief Wand® CP-1000 is a TENS Device and is intended for use as an adjunctive therapy for pain management for medical purposes such as symptomatic relief of chronic
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K133779/S002 23MAY2014 Additional Deficiencies Request Response Page 2 of 2
intractable pain and relief of acute post-surgical and post-traumatic pain.
Predicate Devices: TENS 3000 Stimulator (K102014)
InterX5000 (K042912)
Technological Characteristics: The CP Relief Wand® Model CP-1000 possesses similar technological characteristics as the predicate device, including intended use, basic design, use of materials established as safe, and performance. The primary differences are in the use of fewer modes, fewer channels, and slight differences in performance parameters. These differences between the CP Relief Wand® Model CP-1000 and the predicates do not affect the safety and effectiveness of the device. The differences in design result in a less complex device than the predicates and do not affect safety and effectiveness of the device. The slight differences in performance parameters are negligible and do not affect safety and effectiveness of the device. Performance testing was conducted to compare the waveforms and to establish conformance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-10.
Performance Data: Performance testing of the CP-1000 has been conducted for functional and design verification and validation. Side by side testing was also performed for comparison with the predicate device. The testing indicates the device is substantially equivalent to the predicate device and is in compliance with the following recognized consensus standards:
- IEC60601-1 Edition 2:1988 (A1:1991 + A2:1995) Medical Electrical Equipment; Part 1: General Requirements for Safety and Essential Performance
- IEC60601-1-2:2007 Third Edition, Medical electrical equipment - Section 1.2 Collateral standard: Electromagnetic compatibility - Requirements and tests
- IEC60601-2-10 (1987) and Amendment 1 (2001) Medical Electrical Equipment - Part 2-10: Particular requirement for the basic safety and essential performance of nerve and muscle stimulators
Conclusion: The CP Relief Wand® is substantially equivalent to the TENS 3000 Stimulator and InterX5000
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
10903 New Hampshire Avenue
Document Control Center - W066-G609
Silver Spring, MD 20993-0002
May 30, 2014
Mid-American Medical Innovations, LLC
Norm Schroeder
Co-Manager
2704 Industrial Drive
Jefferson City, MO 65109
Re: K133779
Trade/Device Name: CP Relief Wand® Model CP-1000
Regulation Number: 21 CFR 882.5890
Regulation Name: Transcutaneous Electrical Nerve Stimulator
Regulatory Class: Class II
Product Code: GZJ
Dated: April 28, 2014
Received: April 29, 2014
Dear Mr. Schroeder:
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 – Norm Schroeder
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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Felipe Aguel -S
for Carlos L. Peña, PhD, MS
Director
Division of Neurological and Physical Medicine Devices
Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known)
K133779
Device Name
CP Relief Wand® Model CP-1000
Indications for Use (Describe)
The CP Relief Wand® CP-1000 is a TENS Device and is intended for use as an adjunctive therapy for pain management for medical purposes such as symptomatic relief of chronic intractable pain and relief of acute post-surgical and post-traumatic pain.
Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Felipe Aguel -S Date: 2014.05.30 16:11:40 -04'00'
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
Indications for Use
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FORM FDA 3881 (1/14) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
§ 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).