(8 days)
The CSCS-001A is a non-invasive post processing package that can be used to evaluate calcified plaques in the coronary arteries, which may be a risk factor for coronary artery disease. This software can be used to generate both DiCOM reports and hard copy reports for the purpose of monitoring disease state over time.
This device is a non-invasive post processing package that allows the user to process volume sets to evaluate calcified plaque in the coronary arteries. These regions of interest can be selected manually or semi-automatically. Using multiple algorithms this software will calculate the calcium score. The software also provides hard copy reports or adds the data to the DiCOM file to allow tracking of the patient,
The provided document is a 510(k) Pre-market Notification for the Toshiba America Medical Systems, Inc. CSCS-001A Calcium Scoring Package. It outlines the device description, indications for use, and a statement of substantial equivalence to predicate devices. However, it does not contain the detailed information required to answer the specific questions about acceptance criteria and the study proving the device meets them.
Here's a breakdown of what's missing and why it cannot be extracted from the provided text:
- Acceptance Criteria and Reported Device Performance: This information is typically found in a clinical or performance evaluation section, often with specific metrics (e.g., accuracy, sensitivity, specificity, inter-observer variability) and target values. The document only mentions "performance standard" as 21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard, which is a general regulatory standard, not specific performance criteria for calcium scoring.
- Sample size and data provenance for test set: The document does not describe any specific test set used for validating the device's performance.
- Number of experts and qualifications for ground truth: No information is provided about experts or ground truth establishment.
- Adjudication method for test set: No test set is described, so no adjudication method is mentioned.
- Multi-reader multi-case (MRMC) comparative effectiveness study: There is no mention of such a study or any effect size related to human reader improvement with AI assistance.
- Standalone performance study: The document focuses on the regulatory submission and substantial equivalence, not on a detailed performance study of the algorithm in a standalone capacity.
- Type of ground truth used: Since no test set or performance study is described, the type of ground truth is not specified.
- Sample size for training set: No training set information is included.
- How ground truth for training set was established: No training set information is included.
Conclusion:
The provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices and adherence to general regulatory standards. It does not present the detailed clinical or performance study data, acceptance criteria, or ground truth establishment methods that would be necessary to answer your specific questions. These details are typically found in a separate performance study report or a more comprehensive technical document that might be referenced but is not included here.
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Toshiba America Medical Systems, Inc. 510(k) Pre-market Notification; CSCS-001A Calcium Scoring Package
510(k) Summary
| OCT 5 2007 | ||
|---|---|---|
| Date: | September 24, 2007 | |
| Submitter's Name: | Toshiba America Medical Systems, Inc. | |
| Submitter's Address: | P.O. Box 2068, 2441 Michelle Drive,Tustin, CA 92781-2068 | |
| Submitter's Contact: | Paul Biggins, Director Regulatory Affairs(714)730-5000 | |
| Establishment RegistrationNumber: | 2020563 | |
| Device Proprietary Name: | CSCS-001A Calcium Scoring Package | |
| Common Name: | Scanner, Computed Tomography, X-Ray[Fed. Reg. No. 892.1750, Pro. Code: 90JAK] | |
| Regulatory Class: | II (per 21 CFR 892.1750) | |
| Performance Standard: | 21 CFR Subchapter J,Federal Diagnostic X-ray Equipment Standard | |
| Predicate Device(s): | GE Smart Score (K020929)Siemens Syngo Calcium Scoring (K990436)Vital Images Vscore (K001682) | |
| Reason For Submission | New device |
Description of this Device:
This device is a non-invasive post processing package that allows the user to process volume sets to evaluate calcified plaque in the coronary arteries. These regions of interest can be selected manually or semi-automatically. Using multiple algorithms this software will calculate the calcium score. The software also provides hard copy reports or adds the data to the DiCOM file to allow tracking of the patient,
Indication for Use:
The CSCS-001A is a non-invasive post processing package that can be used to evaluate calcified plaques in the coronary arteries, which may be a risk factor for coronary artery disease. This software can be used to generate both DiCOM reports and hard copy reports for the purpose of monitoring disease state over time.
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Toshiba America Medical Systems, Inc. 510(k) Pre-market Notification; CSCS-001A Calcium Scoring Package
Technological Characteristics:
This device is similar to the predicate device in uses and applications. The primary difference is in the method used to obtain final results. This device and the predicate devices are post processing software packages.
Safety and Effectiveness Concerns:
This device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820. Additionally this device is in conformance with the applicable parts of the IEC 60601-1 international safety standard.
Substantial Equivalence:
Based upon the above considerations TAMS believes that this device, CSCS-001A, Cardiac Scoring software, is substantially equivalent to the predicate devices and other devices already marketed in the US. This device and other similar marketed devices are post processing software that provide visual and numeric data. Additionally, this device has the same indications of previously marketed devices.
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Image /page/2/Picture/0 description: The image shows a circular logo with text around the perimeter and a stylized eagle in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The eagle is depicted with three curved lines representing its wings and a flowing line for its body.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Toshiba America Medical Systems, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K072737
Trade/Device Name: CSCS-001A, Calcium Scoring Package Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: September 26, 2007 Received: September 27, 2007
Dear Mr. Job:
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/9 description: The image is a circular logo with the text "1906-2006" at the top. The letters "PA" are in the center of the logo, with the word "Centennial" underneath. There are three stars below the word "Centennial". The logo appears to be a commemorative emblem for a centennial celebration.
classing and Promoting Public Scaller
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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/odriv/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
Enclosure
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Toshiba America Medical Systems, Inc. Pre-Market Notification 510(k) for CSCS-001A Cardiac Scoring Package
Indications for Use
510(k) Number (if known):
CSCS-001A, Calcium Scoring Package Device Name:
Indications for Use
The CSCS-001A is a non-invasive post processing package that can be used to evaluate calcified plaques in the coronary arteries, which may be a risk factor for coronary artery disease. This software can be used to generate both DiCOM reports and hard copy reports for the purpose of monitoring disease state over time.
Prescription Use (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)
Herbert Perman
Page 1 of
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
§ 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.