E.CAM EXTRA HIGH ENERGY COLLIMATOR

• K Number: K982387
• Device Name: E.CAM EXTRA HIGH ENERGY COLLIMATOR
• Manufacturer: SIEMENS MEDICAL SOLUTIONS USA, INC.
• Date Cleared: 1998-10-06 ( 89 days)
• Product Code: KPS
• Regulation Number: 892.1200
• Type: Traditional
• Panel: Radiology
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

To detect or image the distribution of radionuclides in the body or organ, using the following techinique(s): Planar Imaging, Whole Body Imaging, Positron imaging with out coincidence. Camera range increases to 588 keV.

Device Description

E.CAM Extra High Energy Collimator

AI/ML Overview

This 510(k) submission for the Siemens E.CAM Extra High Energy Collimator does not contain information regarding objective performance criteria or a study demonstrating the device meets such criteria.

The document primarily focuses on establishing substantial equivalence to legally marketed predicate devices, which is a common pathway for 510(k) clearances. This means the manufacturer is asserting their device is as safe and effective as a device already on the market, rather than needing to prove new safety and effectiveness through extensive clinical trials with pre-defined acceptance criteria.

Here's a breakdown of why the requested information cannot be provided from the given text:

1. A table of acceptance criteria and the reported device performance: This information is not present. The submission focuses on product description and comparison to existing devices, not on quantitative performance metrics against pre-defined criteria.

2. Sample size used for the test set and the data provenance: No test set is described. The device is a "collimator," an accessory for a nuclear medicine camera, not a diagnostic algorithm or a device that processes patient data in a way that requires specific "test sets" for performance evaluation in the context of this submission. The "study" mentioned in the prompt usually refers to clinical performance studies, which are not detailed here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no described test set or ground truth establishment process.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for the same reasons as above.

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 a collimator, not an AI-powered diagnostic tool. MRMC studies are typically for evaluating the impact of AI on human interpretation of medical images.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a hardware component (collimator), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as there's no described performance evaluation against a "ground truth."

8. The sample size for the training set: Not applicable, as this is a hardware component. Training sets are relevant for machine learning algorithms.

9. How the ground truth for the training set was established: Not applicable.

In summary, the provided documents indicate a 510(k) clearance based on substantial equivalence, not on a detailed performance study against specific acceptance criteria. The "Summary of Safety and Effectiveness" (K982387) states:

• "The Siemens E.CAM Extra High Energy Collimator is a product which is substantially equivalent to legally marketed devices."
• "The device labeling contains instructions for use. It includes indications for use and cautions. This information assures safe and effective use of the device."

These statements highlight the regulatory strategy chosen by the manufacturer, which relies on demonstrating similarity to already approved devices rather than presenting novel performance data.

Summary

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Redical Systems, Inc., Nuclear Medicine Group E.CAM Extra High Energy Collimator

OCT

K982387

SUMMARY OF SAFETY AND EFFECTIVENESS July 8, 1998

I. General Information
Classification Name:	System, Tomography, Computed Emission
Product Code:	90KPS
Device Trade Name:	E.CAM 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 E.CAM Extra High Energy Collimator is a product which is substantially equivalent to legally marketed devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 6 1998

Andrea DiSani Regulatory Affairs Associate Siemens Medical Systems, Inc. 2501 North Barrington Road Hoffman Estates, IL 60195-7372 Re:

K982387

E.CAM Extra High Energy Collimator Dated: July 8, 1998 Received: July 9, 1998 Regulatory class: II 21 CFR 892.1200/Procode: 90 KPS

Dear Mr. DiSani:

We have reviewed your Section $10(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 Beckeral Food, Drug, and Cosmetion of Act (Act). You may, therefore, market the device, subject to the general controls provisions of the general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing gractice, labeling; and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or 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 ecuivalience compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices of cenerative (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 regult in regulatory action. In addition, FDA may publish further announcements concerning your device in the Rederal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 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 viro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address "http://www.ida.govedrividsmaldsmamain.html".

Sincerely yours,

Lillian Yip, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal. Ear. Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Siemens Medical Systems, Inc., Nuclear Medicine Group E.CAM Extra High Energy Collimator

ﺎ

510(k) Number (If known): K982387

Siemens E.CAM Extra High Energy 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 techinique(s):

		YES	NO	Energy Range (keV)
A.	Planar Imaging	X
B.	Whole Body Imaging	X
C.	Tomographic Imaging (SPECT) for nonPositron emitter		X
D.	Positron imaging by coincidence		X
E.	Positron imaging with out coincidence	X		Camera range increasesto 588 keV

(Please do not write below this line - Continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Perscription Use_ (per 21 CFR 801.109)

OR

Over-the counter Use

(Optional Format 1-2-96)

David L. Severson

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(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological De 510(k) Number

510(k) Submission Section 1 - Page 2

Regulation Number and Section

N/A