(548 days)
K893874B
K893874B
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on mimicking the electrical parameters of a predicate device.
Yes
The device is intended for symptomatic relief and management of chronic intractable pain, as well as an adjunctive treatment for acute pain problems, which are therapeutic uses.
No
The device's intended use is for symptomatic relief and management of pain, not for diagnosing conditions.
No
The device description explicitly compares the electrical parameters of the ENDOR 2000 to a legally marketed product, the model 804S III, which is a hardware device (likely a TENS unit based on the intended use). The comparison of electrical parameters strongly suggests the ENDOR 2000 is also a hardware device with electrical outputs, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the symptomatic relief and management of pain. This is a therapeutic application, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is described as mimicking the electrical parameters of a legally marketed product used for pain management. This further supports its therapeutic nature.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, image processing, AI/ML for diagnostic purposes, or any other characteristics typically associated with IVDs.
Therefore, the ENDOR 2000, as described, is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Symptomatic relief and management of chronic (long-term) intractable pain and as an adjunctive treatment in the management of post surgical and post traumatic acute pain problems.
Product codes
84 GZJ
Device Description
Not Found
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
Non clinical data submitted (Basic Design Description of submission) compares the specifications of the ENDOR 2000 with a legally marketed product, the model 804S III (K893874B) sold by Altoona Medical Supply and manufactured by the manufacturer of the ENDOR 2000. Because the electrical parameters mimic those of the 804S III, it is claimed that the ENDOR 2000 is substantially equivalent to an existing, legally marketed product. Clinical tests: No clinical tests were performed. Conclusion: It is concluded that because the ENDOR 2000 was designed like the 804S III keeping all electrical parameters alike (and even using similar circuitry), that it is substantially equivalent to the 804S III. It is reasonable to conclude that the ENDOR 2000 is as safe and effective as the 804S III. One however cannot claim that the ENDOR 2000 is better.
Key Metrics
Not Found
Predicate Device(s)
K893874B
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
510K Summary: Non clinical data submitted (Basic Design Description of submission) compares the specifications of the ENDOR 2000 with a legally marketed product, the model 804S III (K893874B) sold by Altoona Medical Supply and manufactured by the manufacturer of the ENDOR 2000.
Because the electrical parameters mimic those of the 804S III, it is claimed that the ENDOR 2000 is substantially equivalent to an existing, legally marketed product.
Clinical tests: No clinical tests were performed.
Conclusion: It is concluded that because the ENDOR 2000 was designed like the 804S III keeping all electrical parameters alike (and even using similar circuitry), that it is substantially equivalent to the 804S III. It is reasonable to conclude that the ENDOR 2000 is as safe and effective as the 804S III. One however cannot claim that the ENDOR 2000 is better.
1
Image /page/1/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 design featuring three parallel lines that curve and taper towards the right, resembling a stylized representation of a human form or a symbol of health and well-being.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 7 2000
Mr. Lincoln Ong President TC Medical, Inc. 14710 Orchard Road Minnetonka, Minnesota 55345
K984376/S3 Re: Trade Name: EnDor™ 2000 TENS Device Regulatory Class: II Product Code: 84 GZJ Dated: April 5, 2000 Received: April 13, 2000
Dear Mr. Ong:
We have reviewed your Section 510(k) notification of intent to market the device referenced above we have reviewed your beeness is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to the closed of the enactment date of the Medical Device Amendments, or to devices that have been rear 20, 1976, the charge with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, therefere, manno 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your I tpp. o war, a may of our of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 comply with the GMP regulation may 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 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at
2
Page 2 - Mr. Lincoln Ong
(301) 594-4648. 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" (21CFR 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/dsma/dsmamain.html".
Sincerely yours,
une R. lochner-
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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Page 1 of 1
K984376 510(k) Number:
Device Name: EnDor™ 2000 TENS Device
Indications For Use:
Symptomatic relief and management of chronic (long-term) intractable pain and as an adjunctive treatment in the management of post surgical and post traumatic acute pain problems.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Donna R. Vachner.
(D. Brion Sign-Off) Di of General Restorative Devices 51. Number K 98437
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)