(206 days)
Not Found
No
The document does not mention AI, ML, deep learning, or any related terms, and the description focuses on standard X-ray imaging technology.
No
The device is described as a "universal diaging system for radiographic and fluoroscopic examinations" and its function is to "perform fluoroscopy/radiography" to obtain "image information...for medical diagnosis". This indicates a diagnostic purpose rather than a therapeutic one.
Yes
The device is described as obtaining "image information... for medical diagnosis and treatment," and its intended use includes "diagnostic and fluoroscopic exposures."
No
The device description explicitly states it performs fluoroscopy/radiography using fluorescent scintillation effects of X-rays, which is a hardware-based process involving an X-ray detector. The testing also mentions installation of a detector and comparing performance between the predicate and modified device, further indicating hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis. The device description clearly states that the KALARE (DREX-KL80) uses X-rays that have passed through the patient's body to obtain image information. This is a direct imaging technique of the patient's internal structures, not an analysis of a biological sample.
- The intended use and device description focus on radiographic and fluoroscopic examinations of the patient's body. This involves generating images of internal anatomy using X-rays.
- There is no mention of analyzing biological samples or performing tests on specimens.
Therefore, the KALARE (DREX-KL80) is a medical imaging device, specifically an X-ray system, and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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Intended to be used as a universal diaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations.
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Intended for use by a qualified/trained doctor or technologist on both and pediatric subjects taking diagnostic and fluoroscopic exposures of the whole body, skull, spinal column, extremities and other body parts. Applications can be performed with the patient sitting, standing, or lying in prone or supine position.
Product codes
JAA
Device Description
The main function of the KALARE (DREX-KL80) is to perform fluoroscopy/radiography of the examinations of the gastrointestinal tract examination, support for endoscopy, nonvascular contrast study, general abdominal radiography and general skeletal radiography. Using fluorescent scintillation effects of X-rays that have passed through the patient's body, image information is obtained for medical diagnosis and treatment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
X-ray
Anatomical Site
whole body, skull, spinal column, chest, abdomen, extremities and other body. parts.
Indicated Patient Age Range
adult and pediatric subjects
Intended User / Care Setting
qualified/trained doctor or technologist
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing was done to confirm that the installation of the detector met the stated specifications of the component manufacturer. Additional testing was done to compare the performance between the predicate device and the modified device that included testing directed at image quality, artifacts and motion/dynamic capabilities. The conclusion of this testing demonstrated that substantial equivalence to the predicate device could be proven without the use of clinical images. Additionally, in support of this conclusion the detector component has been the subject of other 510k Premarket Notifications where the clinical aspects of the component have been addressed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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JUN 1 3 2014
Image /page/0/Picture/1 description: The image shows the text "K1335553 Page 1 of 3" in a handwritten style. The text appears to be a page number or document identifier. The handwriting is somewhat stylized, with distinct loops and curves in the letters and numbers.
510(k) - SUMMARY OF SAFETY AND EFFECTIVENESS
1. CLASSIFICATION and DEVICE NAME:
| Classification Name: | System, X-ray, Fluoroscopic, Image-Intensified |
|---|---|
| Regulation Number: | 21 CFR 892.1650 (Class II) |
| Product Code | JAA – Image Intensified Fluoroscopic X-ray System |
| Trade Proprietary Name: | KALARE |
| Model Number: | DREX-KL80 |
2. ESTABLISHMENT REGISTRATION: 2020563
3. CONTACT PERSON, U.S. AGENT and ADDRESS:
Contact Person:
Charlemagne Chua Manager, Regulatory Affairs (714) 669-7896
U.S. Agent: Paul Biggins Director, Regulatory Affairs
(714) 730-5000
Establishment Name and Address:
Toshiba America Medical Systems, Inc. (TAMS) 2441 Michelle Drive Tustin, Ca. 92780
4. MANUFACTURING SITE
Toshiba Medical Systems Corporation (TMSC) 1385 Shimoishigami Otawara-shi, Tochigi 324-8550, Japan
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- Date OF SUBMISSION: November 18, 2013
6. PERFORMANCE STANDARD:
21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard
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- PREDICATE DEVICE: KALARE (DREX-KL80) , K110785
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- REASON FOR SUBMISSION: Modification of a cleared device
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- SUBMISSION TYPE:
Traditional 510(k)
10. DEVICE DESCRIPTION:
The main function of the KALARE (DREX-KL80) is to perform fluoroscopy/radiography of the examinations of the gastrointestinal tract examination, support for endoscopy, nonvascular contrast study, general abdominal radiography and general skeletal radiography. Using fluorescent scintillation effects of X-rays that have passed through the patient's body, image information is obtained for medical diagnosis and treatment.
11. SUMMARY OF INTENDED USES:
- a. Intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations
- b. Intended for use by a qualified/trained doctor or technologist on both adult and pediatric subjects taking diagnostic radiographic and fluoroscopic exposures of the whole body, skull, spinal column, chest, abdomen, extremities and other body. parts. Applications can be performed with the patient sitting, standing, or lying in prone or supine position.
12. SUMMARY OF CHANGE(S)
- a. Addition of a previously cleared FPD.
13. SUBSTANTIAL EQUIVALENCE:
This device is substantially equivalent to the KALARE, K110785, marketed by Toshiba America Medical Systems. KALARE includes modifications to the cleared device which adds FPD (in addition to I.I). The basic system configuration, method of operation, base software and manufacturing process remain unchanged from the cleared device.
14. SAFETY:
The device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820 and ISO 13485 Standards. This device is in conformance with the applicable parts of the IEC60601-1 standards, its collateral standards and particular standards; IEC 60601-2-7, IEC60601-2-28 and IEC 60601-2-32. All requirements of the Federal Diagnostic Equipment Standard, as outlined in 21 CFR §1020, that apply to this device, will be met and reported via product report.
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K B35553
Page 3 of 3
15. TESTING
Testing of the modified system was conducted in accordance with the applicable standards published by the International Electromechanical Commission (IEC) for Medical Devices and XR Systems. Bench testing was done to confirm that the installation of the detector met the stated specifications of the component manufacturer. Additional testing was done to compare the performance between the predicate device and the modified device that included testing directed at image quality, artifacts and motion/dynamic capabilities. The conclusion of this testing demonstrated that substantial equivalence to the predicate device could be proven without the use of clinical images. Additionally, in support of this conclusion the detector component has been the subject of other 510k Premarket Notifications where the clinical aspects of the component have been addressed.
16. CONCLUSION
The modifications incorporated into the KALARE, do not change the indications for use or the intended use of the device. Safety and effectiveness have been verified via risk management and the application of design controls to the modifications.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 13, 2014
Toshiba Medical Systems Corporation % Mr. Paul Biggins Director Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN CA 92780
Re: K133553
Trade/Device Name: KALARE (DREX-KL80) with FPD Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: JAA Dated: May 15, 2014 Received: May 16, 2014
Dear Mr. Biggins:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
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Page 2-Mr. Biggins
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known)
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Indications for Use (Describe)
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Intended to be used as a universal diaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations.
-
Intended for use by a qualified/trained doctor or technologist on both and pediatric subjects taking diagnostic and fluoroscopic exposures of the whole body, skull, spinal column, extremities and other body parts. Applications can be performed with the patient sitting, standing, or lying in prone or supine position.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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