(107 days)
The Dry Laser Imager, DRYPRO Model 793 is intended to be used to acquire images from diagnostic equipment such as CT, MRI, DSA or FDA-approved Full Field Digital Mammography System and print the images on medical dry-film.
The Dry Laser Imager, DRYPRO Model 793 is a Laser Imager to acquire images from diagnostic equipment such as CT, MRI, DSA or Full Field Digital Mammography System and print them on medical dry-film. The device consists of film supplying unit and film transferring unit and exposing unit and heat developing unit and operating unit and power supplying unit and main control unit. This product employs semiconductor laser scanning, but it complies with the Federal Performance Standard 21 CFR Part 1040.10.
The provided text is for a 510(k) summary for a medical image hardcopy device, the Dry Laser Imager, DRYPRO Model 793. This document focuses on the substantial equivalence of the new device to a predicate device and outlines its intended use and compliance standards. However, it does not contain the specific information requested about acceptance criteria for device performance and a detailed study proving the device meets those criteria.
A 510(k) summary typically establishes substantial equivalence, often by comparing technical characteristics to an already-cleared device. It does not usually include detailed performance studies with acceptance criteria, ground truth establishment, or multi-reader studies in the way you've outlined for AI/standalone algorithm performance.
Therefore, many of your requested points cannot be answered from the provided text. I will answer the questions that can be inferred or directly addressed from the document.
Summary of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria:
The provided 510(k) summary for the Dry Laser Imager, DRYPRO Model 793, does not detail specific acceptance criteria for image quality or performance metrics (like sensitivity, specificity, or accuracy) in the way one would find for a diagnostic algorithm. It primarily focuses on establishing substantial equivalence to a predicate device based on technical characteristics and compliance with general standards.
The "study" referenced in this type of document is a comparison to a predicate device to demonstrate substantial equivalence, rather than a clinical performance study with specific acceptance criteria that demonstrate diagnostic accuracy or efficacy.
Here's an attempt to address your points based on the available information:
1. A table of acceptance criteria and the reported device performance:
This information is not available in the provided 510(k) summary. The document does not specify quantitative acceptance criteria for image quality or other performance metrics, nor does it report specific performance data for the device against such criteria. The closest information is the "Comparison of the principal characteristics of the two devices" mentioned, but its content is not included.
2. Sample size used for the test set and the data provenance:
This information is not available in the provided 510(k) summary. There is no mention of a test set, sample size, or data provenance as would be relevant for a performance study of a diagnostic algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not available in the provided 510(k) summary. Ground truth establishment is not discussed as there is no performance study described.
4. Adjudication method for the test set:
This information is not available in the provided 510(k) summary.
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:
This information is not applicable and not available in the provided 510(k) summary. The device is a "Medical Image Hardcopy Device" (a printer for medical images), not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device type.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable and not available in the provided 510(k) summary. The device is a physical printer, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
This information is not applicable and not available in the provided 510(k) summary. Ground truth is not relevant for a hardcopy device approval based on substantial equivalence.
8. The sample size for the training set:
This information is not applicable and not available in the provided 510(k) summary. There is no mention of a training set as the device is not an AI algorithm.
9. How the ground truth for the training set was established:
This information is not applicable and not available in the provided 510(k) summary.
Information that is available or inferable from the document:
- Intended Use: The device is "intended to be used to acquire images from diagnostic equipment such as CT, MRI, DSA or Full Field Digital Mammography System and print the images on medical dry-film."
- Compliance Standards: The device complies with UL60601-1, IEC60601-1, IEC60601-1-2, IEC60825, 21 CFR 1040.10, and DICOM. These standards serve as compliance criteria, though not specific performance metrics.
- Predicate Device: The Dry Laser Imager, DRYPRO Model 793, is substantially equivalent to DRYVIEW 8900 manufactured by Eastman Kodak Company (510(k) No. K033821). This comparison forms the basis of the "study" for 510(k) clearance.
- Performance Equivalence: The document states that a "Comparison of the principal characteristics of the two devices which are pertinent to Specification performance is attached below" (though the attachment itself is not provided in the excerpt). This implies that the performance aspects considered for equivalence are likely related to imaging specifications (e.g., resolution, density, contrast, print speed) of the output film, which would be compared to the predicate.
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NOV 2 4 2004
510(k) Summary as required by 807.92
12042193
1. Company Identification
Konica Minolta Medical & Graphic Inc. 2970 Ishikawa-cho, Hachioji-shi, Tokyo, 192-8505 Japan :011-81-426-60-9607 Tel Fax : 011-81-426-60-9588
2. Official Correspondent
Koji Kubo (Mr.) Assistant Manager Technical Support Group
3. Date of Submission
August 6, 2004
4. Establishment Registration No.
3003769120
5. Device Trade name
Dry Laser Imager, DRYPRO Model 793
6. Common Name
Medical Image Hardcopy Device
7. Classification
Medical image hardcopy device was reviewed by the Radiology Panel and classified in Class II per 21 CFR 892. 2040.
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- Product Code
90 LMC
- Product Code
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9. Predicate Device
The Dry Laser Imager, DRYPRO Model 793 is substantially equivalent to DRYVIEW 8900 manufactured by Eastman Kodak Company, 510(k) No.i K033821.
Comparison of the principal characteristics of the two devices which are pertinent to Specification performance is attached below.
10. Description of Device
The Dry Laser Imager, DRYPRO Model 793 is a Laser Imager to acquire images from diagnostic equipment such as CT, MRI, DSA or Full Field Digital Mammography System and print them on medical dry-film.
The device consists of film supplying unit and film transferring unit and exposing unit and heat developing unit and operating unit and power supplying unit and main control unit.
This product employs semiconductor laser scanning, but it complies with the Federal Performance Standard 21 CFR Part 1040.10.
11. Intended Use
The Dry Laser Imager, DRYPRO Model 793 is intended to be used to acquire of images from diagnostic equipment such as CT, MRI, DSA or Full Field Digital Mammography System and print the images on medical dry film.
The devices are intended to be used by trained medical personnel in a clinic or hospital environment.
12. Compliance Standard
UL60601-1 (expected to be approved by the end of October, 2004), IEC60601-1. IFC60601・1・2, IEC60825, 21 CFR 1040.10, DICOM
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wavy lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 4 2004
Konica Minolta Medical & Graphics, Inc. Re: K042133 % Mr. Shinichi Yamanaka Progress Section Cosmos Corporation 319 Akeno, Obata-cho Watarai-gun, Mie-ken 519-0501 JAPAN
Trade/Device Name: Dry Laser Imager, DRYPRO Model 793 Regulation Number: 21 CFR 892.2040 Regulation Name: Medical image hardcopy device Regulatory Class: II Product Code: 90 LMC
Dated: October 28, 2004
Received: October 29, 2004
Dear Mr. Yamanaka:
ﺮ ﻣﻦ
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 (Premárket 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.
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 this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (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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Indications for Use
510(k) Number (if known) : Dry Laser Imager, DRYPRO Model 793 Device Name
Indications For Use:
The Dry Laser Imager, DRYPRO Model 793 is intended to be used to acquire images from diagnostic equipment such as CT, MRI, DSA or FDA-approved Full Field Digital Mammography System and print the images on medical dry-film.
The devices are intended to be used by trained medical personnel in a clinic or hospital environment.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy L. Brogdon
Division Sign-Off
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
§ 892.2040 Medical image hardcopy device.
(a)
Identification. A medical image hardcopy device is a device that produces a visible printed record of a medical image and associated identification information. Examples include multiformat cameras and laser printers.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.