(39 days)
The AN6150 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 AN6150 are available for preview by the doctor / x-ray technician on the operator's workstation within seconds of the x-ray exposure. After acceptance, by the operator the 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 AN6150 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 AN6150 are available for preview by the doctor / x-ray technician on the operator's workstation within seconds of the x-ray exposure. After acceptance, by the operator the digital (DICOM) images can be stored on electronic media, or exported to a (DICOM/PACS) network, clinical review station or to a film printer.
This 510(k) summary for the Analogic Corporation AN6150 Digital Radiology System primarily focuses on its substantial equivalence to predicate devices based on non-clinical testing. It does not contain information about clinical performance studies, reader studies, or detailed acceptance criteria related to diagnostic accuracy or reader improvement with AI assistance.
Therefore, many of the requested sections about clinical performance, training sets, and ground truth cannot be filled from the provided text.
Here's what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|
| Compliance with recognized safety standards: - IEC 60601-1:1988, +A1:1991, +A2:1995 (safety of medical electrical equipment) - IEC 60601-1-1 - IEC 60601-1-3:1994 (radiation protection) - IEC 60601-2-7 - IEC 60601-2-28 - IEC 60601-2-32 - IEC 60601-1-2:2001 (electromagnetic compatibility) - FDA Reviewer Guidance (Nov 1993) for Line Dropout and Variation Susceptibility - Mechanical Shock and Vibration Tests - Shipping Container Transportation Test | "All tests passed the stated criteria." "The testing of the AN6150 Digital Radiology System demonstrates that the performance is substantially equivalent to the predicate devices cited above." |
| Functional Performance (implicitly expected for digital radiography system comparable to predicate) | Images available for preview on operator's workstation within seconds of x-ray exposure. Digital (DICOM) images can be stored, exported to DICOM/PACS network, clinical review station, or film printer. |
2. Sample size used for the test set and the data provenance:
- Not provided. The document refers to "nonclinical testing" and validation "at the unit and system level," which implies hardware and software engineering tests rather than clinical image evaluations. There is no mention of a "test set" in the context of diagnostic performance or clinical image data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No clinical test set or ground truth establishment by experts is mentioned.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No clinical test set is mentioned.
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. The AN6150 Digital Radiology System is described as a general digital X-ray system, not an AI-assisted diagnostic device. Therefore, no MRMC study or AI-related performance metrics are relevant or mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is a hardware and software system for acquiring and processing X-ray images, not an AI algorithm. Standalone algorithm performance is not relevant here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. No clinical ground truth is mentioned. The "ground truth" for the non-clinical tests would be the specifications and requirements of the standards themselves (e.g., passing specific voltage tolerances, radiation leakage limits, or electromagnetic compatibility thresholds).
8. The sample size for the training set:
- Not applicable. This device is not an AI/machine learning model, so there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable. As there is no AI/machine learning model or training set, this question is not relevant.
Summary of what the document does provide:
The document describes the AN6150 Digital Radiology System and its substantial equivalence to predicate devices (Analogic AN5150 and AN7150). The proof of meeting acceptance criteria primarily comes from non-clinical testing against a series of recognized international and FDA-specific standards for safety, radiation protection, and electromagnetic compatibility. The conclusion drawn is that the device "passed the stated criteria" for these engineering and safety tests, demonstrating its performance is "substantially equivalent" to its predecessors. This type of submission focuses on regulatory compliance for a new version of an established technology rather than demonstrating new clinical diagnostic capabilities or AI performance.
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Image /page/0/Picture/0 description: The image shows a handwritten alphanumeric string. The string appears to be "K040995". The characters are written in a bold, somewhat stylized font, with some variation in stroke thickness. The overall impression is that of a quickly written or stylized code or identifier.
Image /page/0/Picture/2 description: The image shows the word "ANALOGIC" in a bold, sans-serif font. The letters are black and appear to be slightly distressed, giving them a textured look. To the right of the word is a black square, which is a part of the company's logo. The registered trademark symbol is present next to the "C" in "ANALOGIC."
510(k) Summary For Analogic Corporation AN6150 Digital Radiology System
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92
Submitter's Name and Address:
Analogic Corporation 8 Centennial Drive Peabody, MA 01960
Date this Summary was Prepared:
April 15, 2004
Contact Person:
| Donald J Sherratt, Regulatory Affairs Manager | |
|---|---|
| Tel: | (978) 977-3000 extension 3049 |
| Fax: | (978) 977-6808 |
Device Name:
| Proprietary or Trade Name: | AN6150 Digital Radiology System |
|---|---|
| Common Name: | Digital Radiology Systems |
| Classification Name: | Digital Radiology Systems and Accessories |
Predicate Device:
The legally marketed devices to which equivalence is being claimed are:
The Analogic AN5150 and AN7150 Digital Radiology Systems. These systems were cleared under Premarket Notification K033345.
Device Description:
Intended Use
The AN6150 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 AN6150 are available for preview by the doctor / x-ray technician on the operator's workstation within seconds of the x-ray exposure. After acceptance, by the operator the digital (DICOM) images can be stored on electronic media, or exported to a (DICOM/PACS) network, clinical review station or to a film printer.
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Comparison of Technological Characteristics:
The design of the new AN6150 Digital Radiology System is derived from the design of the Digital Radiology Systems AN5150 and AN7150.
Voluntary Standards Used in Determination of Substantial Equivalence:
The design of the AN6150 Digital Radiology System has been thoroughly validated at the unit and system level and meets all elements of its Requirements Specification. This included the following non-clinical tests:
- IEC 60601-1:1988, +A1:1991, +A2:1995, an FDA recognized consensus . standard for safety of medical electrical equipment.
- IEC 60601-1-1: .
- . IEC 60601-1-3:1994, Medical electrical equipment - Part 1: General requirements for safety - 3. Collateral standard: General requirements for radiation protection in diagnostic X-ray equipment
- . IFC 60601-2-7:
- IEC 60601-2-28 .
- IEC 60601-2-32: .
- IEC 60601-1-2:2001, an FDA recognized consensus standard for electromagnetic . compatibility.
- Line Dropout and Variation Susceptibility were tested according to the FDA . Reviewer Guidance for Remarket 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 AN6150 Digital Radiology System 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 U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol of medicine and health. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 5 2004
Mr. Donald J. Sherratt Regulatory Affairs Manager Analogic Corporation 8 Centennial Drive PEABODY MA 01960
Re: K040995 Trade/Device Name: AN6150 Digital Radiology System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: 90 KPR Dated: April 15, 2004 Received: April 26, 2004
Dear Mr. Sherratt:
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 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.
Please be advised that I'DA'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 (OS) 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) I ms lotter will and in your to begin finding of substantial equivalence of your device to a legally premaired predicated 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 If you desire spoolite 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 Additionally, for questions of (301) 594-4639. Also, please note the regulation entitled, "Misbranding Other of Othphanes an ( 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 11anakaotarero, Int at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Boyden
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
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ANALOGIC®
510(k) Number:
Device Name: AN6150 Digital Radiology System
Indications For Use:
The AN6150 is a digital X-ray general radiography system intended for use by qualified/trained The FINOTS Is a dignal ITTLy gollers 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 AN6150 are available for preview by the doctor /x-ray technician on the operator's workstation within seconds of the x-ray exposure. Digital (DICOM) images can be stored on electronic media, or exported to a (DICOM/PACS) network, clinical review station or to a film printer.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| Prescription Use | OR | Over-The-Counter Use ______ |
| (Per 21 CFR 801.109) |
| Nancy Brogdon | |
|---|---|
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, | |
| and Radiological Devices | |
| 510(k) Number | K040995 |
§ 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.