(46 days)
Not Found
No
The summary does not mention AI, ML, or related terms, and the description of image processing is standard for fluoroscopic systems.
No.
The device is used for fluoroscopic examination and imaging, which are diagnostic purposes, not therapeutic (treatment) purposes.
Yes
The "Device Description" states that Vert-X is designed to "acquire, process, display, and store x-ray images, for image diagnosis." This explicitly indicates its use for diagnostic purposes.
No
The device description explicitly states it is a "mobile fluoroscopic system" and a "compact, mobile fluoroscopic system," which are descriptions of hardware. It also mentions acquiring x-ray images, which requires hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Vert-X Function: The description clearly states that Vert-X is a mobile apparatus used for fluoroscopic examination of a patient. This involves using X-rays to image the inside of the body directly, not analyzing samples taken from the body.
Therefore, based on the provided information, Vert-X falls under the category of an imaging device, not an IVD.
N/A
Intended Use / Indications for Use
Vert-X is a mobile apparatus used for fluoroscopic examination of a patient.
Product codes
90 JAA
Device Description
Vert-X is a compact, mobile fluoroscopic system designed for general fluoroscopic imaging. Vert-X acquires, processes, displays, and stores x-ray images, for image diagnosis.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
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
No clinical tests were performed
Key Metrics
Not Found
Predicate Device(s)
Direx 3Dscope (K053640)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
Section 5: 510(k) Summary
[Submitted pursuant to 21 CFR 807.92(a). All data included in this document are accurate and complete to the best of DSC's knowledge.]
1. Submitter Information
AUG 1 8 2006
Kanga
| Submitter: | | Direx Systems Corporation
437 Turnpike Street
Canton
MA 02021 |
|--------------------------------------|--|------------------------------------------------------------------------|
| Telephone:
Fax:
Contact Person | | (339) 502-6013
(339) 502-6018
Larisa Gershtein
QA Manager |
| Contact Person e-mail address: | | Igershtein@direxusa.com |
| 2. Device | | |
| Trade/Proprietary Name: | | Vert-X |
| Classification Name: | | System, x-ray, fluoroscopic, image-intensified |
| Regulation Number: | | 21 CFR 892.1650 |
| Regulatory Class: | | Class II (special controls) |
| Product code: | | 90 JAA |
| Panel: | | Radiology |
3. Predicate Devices
Direx 3Dscope (K053640)
1
4. Intended Use:
Vert-X is a mobile apparatus used for fluoroscopic examination of a patient.
5. Description
Vert-X is a compact, mobile fluoroscopic system designed for general fluoroscopic imaging. Vert-X acquires, processes, displays, and stores x-ray images, for image diagnosis.
6. Clinical Tests
No clinical tests were performed
7. Performance Testing
Vert-X was tested according to the following standards: IEC 60601-1 (1998) + A1(1991) + A2(1995) IEC 60601-1-1 (2000) IEC 60601-1-2 (2001) + A1 (2004) IEC 60601-1-3 (1994) IEC 60601-2-7 (1998) IEC 60601-1-4 (1996) + A1 (1999) ISO 14971 (2000) FDA CDRH 21CFR 1020.30 FDA CDRH 21CFR 1020.32
6. Substantial Equivalence
Vert-X is meets the requirements for a special 510(k) by the virtue of being a minor modification, which does not change the intended use, fundamental technology or reduce safety and effectiveness, of the Company's predicate device, 3Dscope.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
AUG 1 8 2006
Ms. Larisa Gershtein QA Manager Direx Systems Corp. 437 Turnpike Street CANTON MA 02021
Re: K061873
Trade/Device Name: Vert-X Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: JAA Dated: June 27, 2006 Received: July 3, 2006
Dear Ms. Gershtein:
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/2/Picture/10 description: The image is a black and white circular logo. The logo has the letters "PA" in a bold, sans-serif font in the center. Above the letters "PA" are the numbers "1906 - 2006". Below the letters "PA" is the word "Centennial" in a cursive font. There are three stars below the word "Centennial".
Protecting and Promoting Public Health
3
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/cdrh/industry/support/index.html.
Sincerely yours,
Nancy Cbrogdon
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows the logo for Direx Systems Corp. The logo is in black and white, with the word "Direx" in large, bold letters. Below the word "Direx" is a horizontal line, and below that is the text "Systems Corp." in smaller letters. The logo is simple and modern, and it is likely used to represent the company in a variety of contexts.
Section 4: Indications for Use Statement
Indications for Use STATEMENT
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name:
Vert-X
Indications for Use:
Vert-X is a mobile apparatus used for fluoroscopic examination of a patient.
Prescription Use __ _ _ _ (Per 21 CFR § 801.109) OR
Over the Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
David A. Syverson
(Division Sign-O Division of Reproductive, and Radiological Devic 510(k) Number
437 Turnpike Street • Canton, MA 02021 Phone: (339) 502-6013 ♦ Fax: (339) 502-6018 e - mail p r o m o @ @ d i r e x u s a . c o m