(30 days)
The AN5150 is a digital X-ray chest system intended for use by qualified/trained doctor or technician and is designed to perform radiographic chest examinations.
The AN7150 is a digital X-ray general radiography system intended for use by qualified/trained doctor or technician and is designed to perform radiographic exposures of the whole body including skull, spinal column, chest, abdomen, extremities and other body parts excluding mammography. Radiographic exposures may be taken with the patient in the sitting, standing, or lying in the prone or supine position.
Images from the AN5150 or AN7150 become available for preview by the doctor /x-ray technician on the operator's workstation seconds after the x-ray exposure. After acceptance digital (DICOM) images can be stored on electronic media, or exported to a (DICOM/PACS) network, clinical review station or to a film printer.
The AN5150 is a digital X-ray chest system intended for use by qualified/trained doctor or technician and is designed to perform radiographic chest examinations.
The AN7150 is a digital X-ray general radiography system intended for use by qualified/trained doctor or technician and is designed to perform radiographic exposures of the whole body including skull, spinal column, chest, abdomen, extremities and other body parts excluding mammography. Radiographic exposures may be taken with the patient in the sitting, standing, or lying in the prone or supine position.
Images from the AN5150 or AN7150 become available for preview by the doctor /x-ray technician on the operator's workstation seconds after the x-ray exposure. After acceptance digital (DICOM) images can be stored on electronic media, or exported to a (DICOM/PACS) network, clinical review station or to a film printer.
The provided text describes Analogic Corporation's AN5150 and AN7150 Digital Radiology Systems and their 510(k) submission (K033345). However, this submission does not include a clinical study with acceptance criteria, reported device performance, or details about ground truth, expert adjudication, or reader studies.
The document focuses on demonstrating substantial equivalence to predicate devices (Analogic DR 5000, DR 9000, and Sterling Diagnostic DirectRay Operator Console) through non-clinical testing.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from non-clinical tests) | Reported Device Performance |
|---|---|
| IEC 60601-1 (Safety of medical electrical equipment) | Passed |
| EN 55011, Group 1, Class B emissions limits (Electromagnetic Emissions) | Compliant |
| IEC 60601-1-2 (Electromagnetic Compatibility) | Passed |
| Line Dropout and Variation Susceptibility (per FDA Reviewer Guidance, Nov 1993) | Tested, Passed |
| Mechanical Shock and Vibration Tests | Passed |
| Shipping Container Transportation Test | Passed |
2. Sample size used for the test set and the data provenance
- Not applicable. No clinical test set or data provenance from a clinical study is described. The validation was based on unit and system-level non-clinical tests.
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 established by experts for a test set is described.
4. Adjudication method for the test set
- Not applicable. No adjudication method for a test set is described.
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
- No. An MRMC comparative effectiveness study was not done. The device is a digital radiology system, not an AI-powered diagnostic tool as described in this document.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. No standalone algorithm performance study was done as the device is a digital radiology system, not an algorithm being evaluated in isolation.
7. The type of ground truth used
- Not applicable. For the non-clinical tests, the "ground truth" was compliance with established engineering and safety standards and specifications, rather than clinical ground truth (e.g., pathology, expert consensus).
8. The sample size for the training set
- Not applicable. The device is a digital radiology system, not an AI-based system that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. No training set ground truth was established for this device.
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510(k) Summary For Analogic Corporation AN5150 and AN7150 Digital Radiology Systems
DATE THIS SUMMARY WAS PREPARED:
October 14, 2003
SUBMITTER'S NAME AND ADDRESS:
Analogic Corporation 8 Centennial Drive Peabody, MA 01960
CONTACT PERSON:
| Marvin Rosenbaum, Regulatory Affairs Manager | |
|---|---|
| Telephone | (978) 977-3000 extension 3049 |
| Facsimile | (978) 977-6808 |
DEVICE NAME:
Proprietary or Trade Name: AN5150 and AN7150 Digital Radiology Systems Digital Radiology Systems Common Name: Digital Radiology Systems and Accessories Classification Name:
PREDICATE DEVICE:
The legally marketed devices to which equivalence is being claimed is:
The Analogic DR 5000 and DR 9000 Digital Radiology Systems that was cleared under Premarket Notification K001341 & K001336 respectively and the Sterling Diagnostic DirectRay Operator Console cleared under Premarket Notofication K980970.
DEVICE DESCRIPTION: INTENDED USE
The AN5150 is a digital X-ray chest system intended for use by qualified/trained doctor or technician and is designed to perform radiographic chest examinations.
The AN7150 is a digital X-ray general radiography system intended for use by qualified/trained doctor or technician and is designed to perform radiographic exposures of the whole body including skull, spinal column, chest, abdomen, extremities and other body parts excluding mammography. Radiographic exposures may be taken with the patient in the sitting, standing, or lying in the prone or supine position.
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Images from the AN5150 or AN7150 become available for preview by the doctor /x-ray technician on the operator's workstation seconds after the x-ray exposure. After acceptance digital (DICOM) images can be stored on electronic media, or exported to a (DICOM/PACS) network, clinical review station or to a film printer.
COMPARISION OF TECHNOLICICAL CHARACTERISTICS:
The design of the AN5150 and AN7150 Digital Radiology Systems is derived from the design of the Digital Radiology Systems The DR 5000 and DR 9000.
NONCLINICAL TEST USED IN DETERMINATION OF SUBSTANIAL EQUIVALENCE:
The design of the AN5150 and AN7150 Digital Radiology Systems has been thoroughly validated at the unit and system level and meets all element of its Requirements Specification. This included the following non-clinical tests:
- . IEC 60601-1, an FDA recognized consensus standard for safety of medical electrical equipment.
- Electromagnetic Emissions Tests to determine if it was in compliance with the EN 55011, Group 1, and Class B emissions limits.
- . IEC 60601-1-2, an FDA recognized consensus standard for electromagnetic compatibility.
- Line Dropout and Variation Susceptibility were tested according to the . FDA Reviewer Guidance for PreMarket Notification Submissions, November 1993 Mechanical Shock and Vibration Tests
- Shipping Container Transportation Test .
All tests passed the stated criteria.
CONCLUSIONS FROM NONCLINCAL TESTING
The testing of the AN5150 and AN7150 Digital Radiology Systems demonstrates that the performance is substantially equivalent to the predicate devices cited above.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized lines forming its body and wings. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 9 2003
Mr. Marvin Rosenbaum Regulatory Affairs Manager Analogic Corporation 8 Centennial Drive PEABODY MA 01960
Re: K033345
Trade/Device Name: AN5150 and AN7150 Digital Radiology Systems Regulation Number: 21 CFR§ 892.1680 Regulation Name: Stationary X-ray System Regulatory Class: II Product Code: 90 KPR Dated: October 10, 2003 Received: October 20, 2003
Dear Mr. Rosenbaum:
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 (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); 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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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 the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,
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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510(k) Number Ko3334 >
Device Name: AN5150 and AN7150 Digital Radiology Systems
Indications For Use:
The AN5150 is a digital X-ray chest system intended for use by qualified/trained doctor or technician and is designed to perform radiographic chest examinations.
The AN7150 is a digital X-ray general radiography system intended for use by qualified/trained doctor or technician and is designed to perform radiographic exposures of the whole body including skull, spinal column, chest, abdomen, extremities and other body parts excluding mammography. Radiographic exposures may be taken with the patient in the sitting, standing, or lying in the prone or supine position.
Images from the AN5150 or AN7150 become available for preview by the doctor /x-ray technician on the operator's workstation seconds after the x-ray exposure. After acceptance digital (DICOM) images can be stored on electronic media, or exported to a (DICOM/PACS) network, clinical review station or to a film printer.
David A. Segura
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use J OR Over-The-Counter Use (Per 21 CFR 801.109)
Analogic Corporation AN5150 and AN7150 Digital Radiology Systems 510(k) October 14, 2003 Page vii of xi
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. 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). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary 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.