(27 days)
EPX-Impla is a computed tomography x-ray system that acquires a 360° rotational sequence of the head and neck areas, including the ENT and dentomaxillofacial area for use in diagnostic support. The device is operated and used by physicians, dentists, and x-ray technologists.
E-Woo Dental Imaging System Model EPX-Impla is a computed tomography x-ray system.
The provided text describes an FDA 510(k) clearance letter for the "E-WOO Dental Imaging System Model EPX Impla." This document is notification of substantial equivalence, not a study report. Therefore, it does not contain the detailed information about acceptance criteria, device performance, study design, or ground truth establishment that would typically be found in a clinical study report or a pre-market approval application (PMA).
The letter indicates that the device has been found substantially equivalent to legally marketed predicate devices, meaning that "the device is at least as safe and effective as the predicate device." However, it does not provide specific performance metrics or the study that demonstrates this.
Therefore, I cannot provide the requested information from the given text. The text does not elaborate on:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method for the test set.
- Whether an MRMC comparative effectiveness study was done or its effect size.
- Whether a standalone performance study was done.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
{0}------------------------------------------------
Image /page/0/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract, wavy lines that resemble human figures or flowing water.
APR 5 - 2007
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
E-WOO Technology Co., Ltd. % Mr. Stephen T. Mlcoch President North American Technical Services (NATS) Corp. 30 Northport Road SOUND BEACH NY 11789
Re: K070658
Trade/Device Name: E-WOO Dental Imaging System Model EPX Impla Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: November 15, 2007 Received: March 9, 2007
Dear Mr. Mlcoch:
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 (Premarket Approval), 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.
Image /page/0/Picture/10 description: The image is a circular emblem with the text "1800-1900" at the top and "Centennial" at the bottom. The letters "PA" are prominently displayed in the center of the emblem. Three stars are arranged in a horizontal line below the word "Centennial". The emblem appears to be a commemorative seal or logo, possibly related to a centennial celebration of Pennsylvania.
Protecting and Promoting Public Health
{1}------------------------------------------------
Page 2 -
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 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 one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
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/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
{2}------------------------------------------------
E-Woo Dental Imaging System Model EPX-Impla 510K Notification
INDICATIONS FOR USE
510(k) Number (if known):
KO706 58
Device Name:
Indications for Use:
E-Woo Dental Imaging System Model EPX-Impla
EPX-Impla is a computed tomography x-ray system that acquires a 360° rotational sequence of the head and neck areas, including the ENT and dentomaxillofacial area for use in diagnostic support. The device is operated and used by physicians, dentists, and x-ray technologists.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Ehristha Iverson
Division Sign-Off) Division of Reproductive, Abdominal and Radiological Device
510(k) Number K070658
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.