(548 days)
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.
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.
Based on the provided 510K summary, the Endor 2000 TENS Device was not subjected to clinical testing or acceptance criteria. Instead, it relied on a claim of substantial equivalence to a legally marketed predicate device, the model 804S III (K893874B).
Here's a breakdown of the information requested, based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as performance criteria but implied by substantial equivalence claim: Electrical parameters mimic 804S III. | Endor 2000 was designed with all electrical parameters alike and using similar circuitry to the 804S III. |
2. Sample size used for the test set and the data provenance
- Sample size: Not applicable. No clinical tests or test sets were used.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No ground truth for a test set was established as no clinical tests were performed.
4. Adjudication method for the test set
- Not applicable. No test set or clinical study was conducted.
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
- Not applicable. This device is a TENS device, not an AI-powered diagnostic tool, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a TENS device, not an algorithm, and no standalone performance study was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. No clinical ground truth was established for the Endor 2000. Its "ground truth" for regulatory purposes was based on its design and electrical parameters mirroring those of the predicate device.
8. The sample size for the training set
- Not applicable. There was no training set, as no machine learning algorithm was involved.
9. How the ground truth for the training set was established
- Not applicable. There was no training set.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The "study" that proved the Endor 2000 met its "acceptance criteria" (which were implicit in the substantial equivalence argument) was a comparison of the device's electrical parameters and design specifications with those of a legally marketed predicate device, the model 804S III.
The 510K summary explicitly states: "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)... 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."
The conclusion further reinforces this: "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."
No clinical trials, human subject testing, or performance data were submitted or required for this 510(k) clearance, as explicitly stated: "Clinical tests: No clinical tests were performed."
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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.
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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
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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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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)
§ 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).