(91 days)
The device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic pain and/or as an adjunctive treatment for the management of post-surgical and post-traumatic acute pain.
The IF-100507 generates small pulses of electrical current. Delivered along lead cables to electrodes placed on your skin, these pulses pass through the skin and activated underlying nerves. The relief from chronic and acute pain that the IF-100507 can provide results from this electrical stimulation.
Here's an analysis of the provided text regarding the acceptance criteria and study for the EVERLIFE Interferential Current Therapy, IF-100507:
It is critical to note that the provided documentation is a 510(k) summary for a medical device cleared via the substantial equivalence pathway. This means there was no clinical study explicitly performed to prove the device meets specific performance acceptance criteria defined by the manufacturer for this submission. Instead, the clearance is based on demonstrating equivalence to a predicate device that was already legally marketed.
Therefore, many of the requested sections below will reflect the absence of a direct clinical study for this specific device model.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) submission based on substantial equivalence, there are no specific quantitative "acceptance criteria" for clinical performance established for this device within this document. The device's performance is implicitly accepted as equivalent to the predicate device.
| Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance (Implied by Substantial Equivalence) |
|---|---|
| Safety: | The device is as safe as the predicate device (APEX Interferential Current Therapy, IF-4000, K952683). Non-clinical tests were conducted for electrical safety, electromagnetic compatibility, and particular requirements for safety of nerve and muscle stimulators. Accessories also meet safety requirements. |
| Effectiveness: | The device is as effective as the predicate device for its intended use. Provides symptomatic relief and management of chronic pain and/or as an adjunctive treatment for the management of post-surgical and post-traumatic acute pain. |
| Functionality: | The device functions in a manner equivalent to the predicate device. System-level testing including waveform testing was performed. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: Not applicable. No clinical test set data was provided or generated for this 510(k) submission.
- Data Provenance: Not applicable. No clinical data was used.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. No clinical test set requiring expert-established ground truth was performed for this 510(k) submission.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set was performed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. A multi-reader multi-case (MRMC) comparative effectiveness study was not done for this device as part of the 510(k) submission. The clearance is based on substantial equivalence to a predicate device, not a comparative clinical trial.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
While the device itself is a standalone stimulator, no standalone performance study (in the context of an algorithm's output or diagnostic accuracy) was done. The non-clinical tests focused on electrical safety, EMC, and waveform generation.
7. The Type of Ground Truth Used
Not applicable for a clinical performance study. The "ground truth" for this submission is based on the established safety and effectiveness of the legally marketed predicate device (APEX Interferential Current Therapy, IF-4000, K952683).
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device, and no "training set" in that context was used or described. The device's design and functionality are based on established engineering principles for interferential current therapy.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set was used.
{0}------------------------------------------------
Ko70890
SUMMARY OF SAFETY AND EFFECTIVENESS for Interferential Current Therapy, IF-100507
JUN 2 9 2007
DATE OF SUBMISSION: February 15, 2007 EVERLIFE MEDICAL EQUIPMENT CO., LTD. SUBMITTER: NO 58, FU-CHIUN ST. HSIN-CHU CITY, CHINA (TAIWAN) 30067 TEL: 886-3-5208829 FAX:886-3-5209783
ESTABLISHMENT
REGISTRATION NO: 3004753827
OFFICIAL CONTACT: Dr. JEN, KE-MIN NO 58, FU-CHIUN ST. HSIN-CHU CITY, CHINA (TAIWAN) 30067 TEL: 886-3-5208829 FAX:886-3-5209783
TRADE NAME: EVERLIFE Interferential Current Therapy, IF-100507
COMMON/USUAL Interferential Current Therapy
NAME:
Interferential Current Therapy
NAME:
REGULATION NUMBER:
CLASSIFICATION
Pre-Amendment
PREDICATED DEVICE:
APEX Interferential Current Therapy, IF-4000. K952683
- INTENDED USE: The device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic pain and/or as an adjunctive treatment for the management of post-surgical and post-traumatic acute pain.
$\frac{P}{M}$ 42 1/2
{1}------------------------------------------------
| Description ofDevice: | The IF-100507 generates small pulses of electricalcurrent. Delivered along lead cables to electrodesplaced on your skin, these pulses pass through theskin and activated underlying nerves. The relief fromchronic and acute pain that the IF-100507 can provideresults from this electrical stimulation. |
|---|---|
| Non-Clinical TestsSubmitted: | The IF-100507 has been tested in accordance withapplicable standards for medical device electricalsafety, electromagnetic compatibility, and theparticular requirements for safety of nerve and musclestimulators.Accessories also meet safety requirements: 510(k)electrodes are specified, and the patient cable utilizesshrouded connectors to meet lead wire safetyrequirements.System level testing including waveform testing wasperformed in combination the IF-100507 stimulator. |
| Clinical TestsSubmitted: | None |
| Conclusion: | As the product description and tests as above, thenew device: EVERLIFE Interferential CurrentTherapy, IF-100507 is as safe and effective as, and |
the function in a manner equivalent to the predicate device: APEX Interferential Current Therapy, IF-4000, K952683.
Thus the new device is substantially equivalent to the predicate devices in this aspect.
N ત્રીશ્ 7
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
JUN 2 9 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Everlife Medical Equipment Co., Ltd. % Ms. Shu-Chen Cheng 2064 Tamarin Drive Columbus. Ohio 43235
Re: K070890
Trade/Device Name: EVERLIFE Interferential Current Therapy, Model IF-100507 Regulatory Class: Unclassified Product Code: LIH Dated: May 23, 2007 Received: May 23, 2007
Dear Ms. Cheng:
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.
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
{3}------------------------------------------------
Page 2 - Ms. Shu-Chen Cheng
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) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Fur
Mark N. Melkerson
Director
DEP DIASLON
Chalet
Division of General Restorative
Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosurc
{4}------------------------------------------------
Indications for Use
510(k) Number:
K 070890
Device Name:
EVERLIFE Interferential Current Therapy, IF-100507
Indications for Use :
The device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic pain and/or as an adjunctive treatment for the management of post-surgical and post-traumatic acute pain.
Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
Page 1 of 1
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).