(86 days)
The Digital Imaging Systems (BSR), are intended for use in acquiring diagnosic quality images during cardiac, angiographic, vascular and neurovascular applications.
Digital Imaging System (BSR)
The provided text describes a 510(k) premarket notification for a medical device called the "Digital Imaging System (BSR)". This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than performing a de novo study with acceptance criteria and a detailed study proving performance against those criteria.
Therefore, many of the requested sections regarding acceptance criteria, specific study designs, sample sizes, expert involvement, and ground truth establishment are not applicable or explicitly mentioned in this document. The document focuses on demonstrating that the new device has the same intended use and similar technological characteristics as existing, legally marketed devices.
Here's an attempt to answer the questions based only on the provided text, noting where information is not available:
1. A table of acceptance criteria and the reported device performance
This document does not specify quantitative acceptance criteria or a dedicated performance study with reported metrics against those criteria. The core assertion is substantial equivalence to predicate devices. The "performance" is implicitly deemed acceptable if it matches that of the predicate.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as quantitative metrics. The overarching "acceptance criterion" for a 510(k) is Substantial Equivalence to legally marketed predicate devices. | The device is "intended for use in acquiring diagnostic quality images during cardiac, angiographic, vascular and neurovascular applications." This implicitly assumes its image quality will be comparable to predicate devices. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document describes a 510(k) submission for substantial equivalence, not a performance study with a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No explicit ground truth establishment process for a test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set adjudication 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
Not applicable. This device is an "Angiographic x-ray system" / "digital imaging system," not an AI-powered diagnostic tool. There is no mention of AI or human reader improvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a hardware imaging system, not an algorithm, and the concept of "standalone performance" in this context is not relevant as described in the document.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The document assesses substantial equivalence to predicate devices, not performance against an independent ground truth for diagnostic accuracy.
8. The sample size for the training set
Not applicable. This is a hardware system, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is a hardware system, not a machine learning model.
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Image /page/0/Picture/0 description: The image shows the date "SEP 1 1999". The month is September, the day is the 1st, and the year is 1999. The text is in a simple, sans-serif font and is easy to read.
Summary Of Safety and Effectiveness
| I. | General Information | |
|---|---|---|
| Classification Name: | Angiographic x-ray system | |
| Common/Usual Name: | digital imaging system | |
| Device Trade Name: | Digital Imaging System (BSR) | |
| Classification: | Class II Medical Device | |
| Intended Use: | Intended for use in acquiring diagnostic qualityimages during cardiac, angiographic, vascularand neurovascular applications. | |
| Establishment Nameand Address: | Siemens Medical Systems, Inc.Nuclear Medicine Group2501 North Barrington RoadHoffman Estates, IL 60195-5203 | |
| Establishment RegistrationNumber: | 1423253 (Owner/Operator 9010023) | |
| Performance Standard: | None established under Section 514 of the FoodDrug and Cosmetic Act |
II Safety and Effectiveness Information Supporting the Substantial Equivalence Determination
General Safety and Effectiveness Concerns:
The device labeling contains instructions for use. It includes indications for use and cautions. This information assures safe and effective use of the device.
Substantial Equivalence:
The Digital Imaging System (BSR), is substantially equivalent to currently marketed Siemens Medical Systems, Inc. Polytron TOP (K933664) and Phillips Integris Series (K984545).
Contact:
Robert W. Callahan Manager of Regulatory Affairs Siemens Medical Systems, Inc. Nuclear Medicine Group 2501 North Barrington Road Hoffman Estates, IL 60195-5203 Tel: (847) 304-7516 Fax: (847) 304-6023 E-Mail: robert.callahan@nmg.sms.siemens.com
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 1999
Mr. Robert W. Callahan Manager of Regulatory Affairs Siemens Medical Systems, Inc. 2501 North Barrington Road Hoffman Estates, IL 60195-5203
Dear Mr. Callahan:
Re: K991922 Digital Imaging System (BSR) Dated: June 4, 1999 Received: June 7, 1999 Requlatory Class: Il (two) Product Code: 90 IZI 21 CFR 892.1600
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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 redassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class III (Premarket 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Dan Petit
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Form
510(k) Number (if known)_ k99 ) 922
Device Name: Digital Imaging System (BSR)
Indication for Use:
The Digital Imaging Systems (BSR), are intended for use in acquiring diagnosic quality images during cardiac, angiographic, vascular and neurovascular applications.
PLEASE DO NOT WRITE BELOW THIS LINE Concurrence of the CDRH, Office of Device Evaluation (ODE)
David A. Leipson
(Division Sign-Off) (Division Sign-Oil)
Division of Reproductive, Abdominal, EN and Radiological Devic 510(k) Number
Prescription Use (Per 21 CFR 801.109)
ﮯ۔
Or
Over-The-Counter Use_
0001 76
§ 892.1600 Angiographic x-ray system.
(a)
Identification. An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.