(90 days)
To detect or image the distribution of radionuclides in the body or organ, using the following technique(s).
A. Planar Imaging
B. Whole Body Imaging
E. Positron imaging without coincidence
MULTISPECT 2 511keV Collimator
The provided text, K972360, is a 510(k) submission for a device called "MULTISPECT 2 511 keV Collimator" by Siemens Medical Systems, Inc. This submission focuses on demonstrating substantial equivalence to a predicate device rather than rigorously proving performance against pre-defined acceptance criteria through a dedicated study.
Therefore, most of the requested information regarding acceptance criteria, device performance tables, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC/standalone studies is NOT present in the provided document.
The document details the administrative aspects of the 510(k) submission, including classification, intended use, establishment information, and the formal approval letter from the FDA. It declares the device to be "substantially equivalent to legally marketed devices," which is the core of a 510(k) process. This means its performance is considered comparable to existing, approved devices, and a separate, detailed performance study with specific acceptance criteria is typically not required for this type of submission.
Here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable/Not provided. The document is a 510(k) submission demonstrating substantial equivalence, not a performance study against specific acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
Not provided. No specific test set or data provenance (country of origin, retrospective/prospective) is mentioned, as a formal performance study with a test set is not described.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not provided. No experts are mentioned in the context of establishing ground truth for a test set.
4. Adjudication Method for the Test Set
Not provided. No test set is described, so no adjudication method 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
Not applicable/Not provided. This device is a collimator (a physical component of a nuclear medicine imaging system), not an AI-powered diagnostic tool. Therefore, an MRMC study related to AI assistance is not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable/Not provided. This device is a collimator, not a standalone algorithm.
7. The Type of Ground Truth Used
Not provided. Since no specific performance study or test set is described, no ground truth type is mentioned.
8. The Sample Size for the Training Set
Not applicable/Not provided. This device is a physical component, not a trainable algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable/Not provided. This device is a physical component, not a trainable algorithm.
In summary, the provided document is a 510(k) premarket notification whose purpose is to demonstrate substantial equivalence to a legally marketed predicate device. It does not contain information about a dedicated performance study with specific acceptance criteria, test sets, ground truth establishment, or expert-based evaluations as would be found in a clinical trial or a study for novel device performance.
{0}------------------------------------------------
Siemens Medical Systems, Inc., Nuclear Medicine Group MULTISPECT 2 511 ke V Collimator
SUMMARY OF SAFETY AND EFFECTIVENESS June 20, 1997
| I. General Information | SEP 23 1997 |
|---|---|
| Classification Name: | System, Tomography, Computed Emission |
| Product Code: | 90KPS |
| Device Trade Name: | MULTISPECT 2 511keV Collimator |
| Classification: | Class II Medical Device |
| Intended Uses: | Anatomical Region: AllDiagnostic Uses: Imaging |
| Establishment Name and Address: | Siemens Medical Systems, Inc.Nuclear Medicine Group2501 N. Barrington RoadHoffman Estates, Illinois 60195-7372 |
| Establishment Registration Number: | Owner/Operator No. 9010023 |
| Performance Standard: | None established under Section 514 of theFood, Drug 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 Siemens MULTISPECT 2 511keV Collimator is a product which is substantially equivalent to legally marketed devices.
{1}------------------------------------------------
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Paul G. Oris Manager, Regulatory Affairs SIEMENS Medical Systems, Inc. Nuclear Medicine Group 2501 North Barrington Road Hoffman Estates, IL 60195-5203 SEP 2 3 1997
Re: K972360 Siemens MULTISPECT 2 511 keV Collimator Dated: September 4, 1997 Received: September 5, 1997 Regulatory Class: II 21 CFR 892.1200/Procode: 90 KPS
Dear Mr. Oris:
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 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). You may, therefore, 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 (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 requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 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 question 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/dsmamain.html".
Sincerely yours.
W. Hiau Yu
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
510(k) Number (If Known): __ K 912360
Siemens MULTISPECT 2 511 Kev Collimator Option Device Name
Nuclear Medicine Device
Indications For Use: To detect or image the distribution of radionuclides in the body or organ, using the following technique(s).
| YES | NO | Energy Range (keV) | ||
|---|---|---|---|---|
| A. | Planar Imaging | X | ||
| B. | Whole Body Imaging | X | ||
| C. | Tomographic Imaging (SPECT) for non | X | ||
| Positron emitter | ||||
| D. | Positron imaging by coincidence | X | ||
| E. | Positron imaging without coincidence | X | Camera rangeincreases to 588 keV | |
| F. | Other |
(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
(Optional Format 1-2-96)
David A. Ingram
(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Devices
510(k) Number
Siemens Medical Systems, Inc., Nuclear Medicine Group MS2 511 KeV Collimator 510(k) Submission
510(k) Submission Section 2 - Page 2
N/A