(29 days)
Not Found
No
The description focuses on the printing technology and connectivity, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is a printer used to produce hard copies of medical images for viewing, not to directly treat or diagnose a medical condition.
No
Explanation: The device is a printer used to print diagnostic images, but it does not perform any diagnostic function itself. It creates hard copies of images generated by other medical imaging devices.
No
The device description clearly states it is a "free-standing printer" and a "dry process, B/W medical image printer," indicating it is a physical hardware device.
Based on the provided information, the Drystar 5300 is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to print diagnostic images on film for viewing. This is a physical output of an image generated by a medical imaging device, not a test performed on a biological sample in vitro (outside the body).
- Device Description: The description focuses on the printing process and the type of film used. It doesn't mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of analytes
- Diagnosis or monitoring of diseases based on biological markers
The Drystar 5300 is a medical image printer, which is a different category of medical device than an IVD.
N/A
Intended Use / Indications for Use
The Drystar 5300 is a free-standing printer used to print diagnostic images on transparent film for viewing on a standard view box. It may be used in any situation in which a hard copy of an image generated by a medical imaging device is required or desirable.
Product codes
90 LMC
Device Description
The Drystar 5300 is a dry process, B/W medical image printer, using the direct thermal printing principle to establish continuous-tone images with medical diagnostic image quality. The printer has one film input tray, which can contain either 11x14 or 14x17 film. The printer is a networkonly printer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
The device was tested for electrical safety according to EN 60601-1-1 and UL-2601, as was described in the 510(k) for the Drystar 4500. The electrical systems are the same across the different models of the Drystar family of printers.
The device was tested for electromagnetic compatibility according to EN 60601-1-2, as described in the 510(k) for the Drystar 4500. The electrical systems and chassis are the same across the models of the Drystar family of printers.
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
Not Found
§ 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.
0
510(k) Summary
Drystar 5300M
Common/Classification Name: Medical Image Hard Copy Device 21 CFR 892.2040
Agfa Corporation 10 South Academy Street Greenville, SC 29602-9048
Contact: Jeff Jedlicka, Prepared: August 11, 2003
LEGALLY MARKETED PREDICATE DEVICES A.
This 510(k) Premarket Notification will demonstrate that the Drystar 5300 medical printer is substantially equivalent to the Drystar 5500 and Drystar 2000/3000 printers. The 2000/3000 was cleared for marketing by FDA under K943602 on May 12, 1995, and the 5500 was cleared for marketing under K023287 on October 22, 2002.
B. DEVICE DESCRIPTION
The Drystar 5300 is a dry process, B/W medical image printer, using the direct thermal printing principle to establish continuous-tone images with medical diagnostic image quality. The printer has one film input tray, which can contain either 11x14 or 14x17 film. The printer is a networkonly printer.
C. INTENDED USE
The Drystar 5300 is a free-standing printer used to print diagnostic images on transparent film for viewing on a standard view box. It may be used in any situation in which a hard copy of an image generated by a medical imaging device is required or desirable.
SUBSTANTIAL EQUIVALENCE SUMMARY D.
The Drystar 5300 is a medical device and it has the same indications for use as the legally marketed Drystar 5500. The Drystar 5300 has the same technological characteristics to the Drystar 5500. This premarket notification will describe the characteristics of the Drystar 5300 in sufficient detail to assure substantial equivalence. For a few
1
characteristics, performance data is provided to demonstrate equivalence.
ய் TECHNOLOGICAL CHARACTERISTICS
The Drystar 5300 has the "same technological characteristics" as the currently marketed Drystar 3000 and 5500 printer. All use a thermal process to produce medical images.
TESTING ட்
The device was tested for electrical safety according to EN 60601-1-1 and UL-2601, as was described in the 510(k) for the Drystar 4500. The electrical systems are the same across the different models of the Drystar family of printers.
The device was tested for electromagnetic compatibility according to EN 60601-1-2, as described in the 510(k) for the Drystar 4500. The electrical systems and chassis are the same across the models of the Drystar family of printers.
G. CONCLUSIONS
This pre-market submission has demonstrated Substantial Equivalence as defined and understood in Sections 513(f)(1) and 513(l)(1) of the Federal Food Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health.
2
Image /page/2/Picture/1 description: The image shows a black and white logo. The logo features a stylized bird with three lines forming its body and wings. The bird is facing left. Encircling the bird is text, which is difficult to read due to the image quality. The logo appears to be a seal or emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 4 2003
Mr. Jeffery A. Jedlicka Manager of Regulatory Affairs AGFA Corporation 10 South Academy Street Mail Stop 100 GREENVILLE SC 29601
Re: K032635
Trade/Device Name: Drystar 5300 Imager Regulation Number: 21 CFR 892.2040 Regulation Name: Medical image hardcopy device Regulatory Class: II Product Code: 90 LMC Dated: August 26, 2003 Received: August 26, 2003
Dear Mr. Jedlicka:
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.
3
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
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
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to proceed to the market.
Enclosure
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STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:
Indications For Use:
The Drystar 5300 is a free-standing printer used to print diagnostic images on transparent film for viewing on a standard view box. It may be used in any situation in which a hard copy of an image generated by a medical imaging device is required or desirable.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
Daniel A. Layson
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
000032