(77 days)
The Marosis™ PACS System is a device that receives digital images and data from various sources (including but not limited to CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations.
The Marosis™ PACS product handles various objects in a Picture Archive and Communication System (PACS) environment. These objects can be images, requests, patients, examination etc. Marosis™ PACS transmits digital electronic images and generates reports over a high-speed network to centralized storage. After transmission, patient information and images are available throughout the facility to many users simultaneously.
This 510(k) summary (K012844) describes the Marosis™ PACS (Picture Archiving Communications System). As a PACS system, its primary function is to receive, store, communicate, process, and display digital medical images and data.
Here's an analysis of the provided text regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not contain any explicit acceptance criteria or specific performance metrics for the Marosis™ PACS system. It focuses on demonstrating substantial equivalence to a predicate device (MEDIFACE™ PACS, K010259) rather than presenting quantitative performance data against predefined criteria.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
The submission states: "The 510(k) Pre-Market Notification for Marosis™ PACS contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device." This implies the "acceptance" was based on demonstrating similar functionality and safety profiles to the predicate, rather than specific numerical performance targets.
2. Sample Size Used for the Test Set and Data Provenance
The document does not mention any specific test set, sample size, or data provenance (e.g., country of origin, retrospective/prospective). The submission relies on a comparison to a predicate device, which usually involves a review of the predicate's technical specifications and intended use, rather than a new comparative study with a dedicated test set for the new device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
No information is provided regarding experts used to establish ground truth. As no specific test set or clinical study is described, there would be no need for expert ground truth establishment for a new device's performance.
4. Adjudication Method for the Test Set
No adjudication method is mentioned as no specific test set or clinical study requiring adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. The submission focuses on substantial equivalence to a predicate device based on its technical characteristics and indications for use.
6. Standalone Performance Study
No standalone performance study is explicitly described. The document emphasizes that "A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed." This highlights the human-in-the-loop nature of interpretation with a PACS system, rather than a standalone AI algorithm producing diagnoses.
7. Type of Ground Truth Used
No specific type of ground truth is mentioned, as the submission does not detail a clinical study where ground truth would be established for measuring diagnostic accuracy or similar performance metrics.
8. Sample Size for the Training Set
No information is provided regarding a training set sample size. PACS systems, like the one described, are primarily software platforms for managing and displaying existing medical images. They are not typically AI/ML systems that undergo "training" in the traditional sense of learning from a dataset to perform specific diagnostic tasks.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set or AI/ML model requiring ground truth for training is described.
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NOV 0 82001 510(k) Summary of Safety and Effectiveness
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
Date Prepared: August 15, 2001
Submitter's Information: 21 CFR 807.92(a)(1) Marotech, Inc. 7F Boryung B/D, 66-21 Wonnam-Dong, Jongro-Gu, Seoul, 110-750, Korea
Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2) Trade Name: Marosis™ PACS Picture Archiving Communications System Common Name: Device Classification: 892.2050 System, Image Processing Name:
Predicate Device: 21 CFR 807. 92(a)(3)
| Manufacturer: | MEDIFACE CO., LTD. |
|---|---|
| Device: | MEDIFACE™ PACS |
| 510(k) Number: | K010259 |
| Decision Date: | 04/26/2001 |
| Decision: | Substantially Equivalent |
| Panel Code device reviewed by: | Radiology |
| Panel Code device classified by: | Radiology |
| Product Code: | LLZ |
| Device Classification Name: | SYSTEM, IMAGE PROCESSING, RADIOLOGICAL |
| Regulation Number: | Class II, 892.2050 |
Device Description: 21 CFR 807 92(a)(4)
The Marosis™ PACS product handles various objects in a Picture Archive and Communication System (PACS) environment. These objects can be images, requests, patients, examination etc. Marosis™ PACS transmits digital electronic images and generates reports over a high-speed network to centralized storage. After transmission, patient information and images are available throughout the facility to many users simultaneously.
Indications for Use: 21 CFR 807 92(a)(5)
Marosis™ PACS is a device that receives digital images and data from various sources (including but not limited to CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture
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devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Typical users of this system are trained professionals, including but not limited to physicians, nurses, and technicians.
Technological Characteristics: 21 CFR 807 92(a)(6)
The device does not contact the patient, nor does it control any life sustaining devices. A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed.
Conclusion: 21 CFR 807 92(b)(1)
The 510(k) Pre-Market Notification for Marosis™ PACS contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device.
The Marosis™ PACS device has been and will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey. The submission contains the results of a hazard analysis and the "Level of Concern for potential hazards have been classified as "minor".
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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an emblem that resembles a stylized human figure or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 0 82001
Marotech, Inc. % Mr. Carl Alletto OTech, Inc. 2001 East Oakshores Drive CROSSROADS TX 76227 Re: K012844
Trade/Device Name: Marosis™ PACS System Medical Image Management Device Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: August 15, 2001 Received: August 23, 2001
Dear Mr. Alletto:
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 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:
| 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" (21 CFR Part 807.97). 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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marotech
Kol2844
NOV 0 82001
(Indications for Use Form)
Page 1 of -1
(012844 510(k) Number:
Device Name: Marosis™ PACS System
Indications for Use:
The Marosis™ PACS System is a device that receives digital images and data from various sources (including but not limited to CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations.
Typical users of this system are trained professionals, including but not limited to physicians, nurses, and technicians.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF
NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use L
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
Nancy C. Hodgson
of Reproductive. A and Radiological Devic 510(k) Number
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§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(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).