The Notebook Imager™ is a gamma camera system which is intended for use in the generation of clinical images in Nuclear Medicine applications. Specifically, the Notebook Imager™ is intended to image the distribution of radionuclides in the body. In so doing, the system produces images depicting the anatomical distribution of radioisotopes within the human body for interpretation by authorized medical personnel.

For Nuclear Medicine Imaging Device
A. Planar imaging Yes Energy Range (KeV) 30-300
F. Other indication(s) in the device label, but not included in above list To image the distribution of radionuclide in the human body.

Device Description

The Notebook Imager™ system is a gamma camera which consists of an Imaging Head, an Arm and Cart assembly, and SITCO Nuclear Medicine software. The computer consists of a PC, Video Display Terminal, Keyboard, optional Printer and processing Software. The Imaging Head consists of a two-dimensional array of room-temperature, solid-state gamma-ray detectors with readout circuitry for constructing planar images of the emission from radiopharmaceuticals. This array consists of from 1 to 64 identical one-inchby-one-inch imaging modules, each containing 64 (8x8) cadmium-zinctelluride (CZT) semi-conductor detector elements mounted on a multichip submodule. The multichip submodule provides amplification of the input signals and identifies the address of the detector element in which each incoming photon is absorbed.

AI/ML Overview

The provided document does not contain information regarding detailed acceptance criteria, device performance, or a study specifically designed to prove the device meets such criteria. It explicitly states that "No clinical testing was necessary."

However, based on the information provided, I can infer what would typically be considered as the "acceptance criteria" and "performance" in the context of a 510(k) submission for a gamma camera, and how the document addresses the "study" (or lack thereof) to meet those criteria.

Here's an interpretation based on the provided text, recognizing the inherent limitations of the data for the requested level of detail:

1. Table of Acceptance Criteria and Reported Device Performance

Since no specific numerical acceptance criteria or detailed performance metrics are provided, I will construct this table based on the statement of "substantial equivalence" and the performance characteristics mentioned in comparison to predicate devices. The "performance" here refers to the claimed improvements over predicate devices.

Acceptance Criteria Category (Inferred)	Specific Criteria (Inferred)	Reported Device Performance (Inferred from "Substantial Equivalence" and Device Description)
Intended Use	The device should be intended for use in the generation of clinical images in Nuclear Medicine applications, specifically to image the distribution of radionuclides in the body for interpretation by authorized medical personnel.	The Notebook Imager™ has the same intended use as the predicate devices: "to image the distribution of radionuclides in the body" and "produces images depicting the anatomical distribution of radioisotopes within the human body for interpretation by authorized medical personnel." It is intended for planar imaging within 30-300 KeV range.
Principle of Operation	The device should use a radiation detection principle similar to predicate gamma cameras.	The Notebook Imager™ "uses the same principle of radiation detection" as the predicate devices (gamma camera operation).
Performance Characteristics	Performance characteristics should be similar to or better than predicate devices, particularly regarding aspects like spatial resolution, which is a key imaging quality metric for gamma cameras.	The Notebook Imager™ has "very similar performance characteristics" to predicate devices. Crucially, it "improves substantially the spatial resolution" compared to conventional cameras by using CdZnTe semiconductor detector elements.
Safety	The device should not introduce new safety risks or should decrease existing risks compared to predicate devices.	The changes (CdZnTe elements, eliminating NaI crystal/PMTs) "will have either no effect on the patient's safety, or rather decrease the risk to the patients, because of the reduced weight of the detector."
Energy Range	Capable of detecting isotopes within typical nuclear medicine energy ranges.	Indicated for Planar imaging with an energy range of 30-300 KeV.

Summary of the "Study" that Proves the Device Meets Acceptance Criteria:

The core "proof" of meeting the acceptance criteria for this 510(k) submission is based on demonstrating substantial equivalence to existing predicate devices, rather than a clinical study with detailed performance metrics. The document explicitly states: "No clinical testing was necessary."

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size: Not applicable. No clinical or performance test set data is provided or referenced, as "No clinical testing was necessary." The submission relies on comparative claims to predicate devices and inherent design advantages.
Data Provenance: Not applicable.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Number of Experts: Not applicable. No test set was used requiring expert ground truth establishment.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. No test set requiring adjudication was used.

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

MRMC Study: No. This device is a gamma camera (hardware), not an AI-assisted diagnostic software.
Effect Size of AI Improvement: Not applicable.

6. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) Was Done

Standalone Performance: Not applicable. This is a hardware device.

7. The Type of Ground Truth Used

Type of Ground Truth: Not applicable for a direct performance study. The "ground truth" for the substantial equivalence claim rests on the established performance and safety profiles of the predicate devices. The claim is that the Notebook Imager™ performs at least as well as, and in some aspects better than (e.g., spatial resolution), the predicate devices for its intended use.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This is a hardware device submission, not a software algorithm requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Ground Truth Establishment for Training Set: Not applicable.

In summary, for K961104, the "study" demonstrating meeting acceptance criteria was primarily a regulatory comparison to predicate devices, asserting substantial equivalence based on engineering design and principle of operation, rather than new clinical trials or performance testing. The key argument was that the new technology (CdZnTe detectors) offered benefits (improved spatial resolution, reduced weight) without compromising safety or intended use, thereby making clinical trials unnecessary for this 510(k) submission.

Summary

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K96/1104

MAY 28 1997

510(k) Notification for Notebook Imager™

Appendix VII, Page 25

Appendix VII

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS DATA

This Summary of 510(k) Safety and Effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

General Information L

A. Submitted By:	DIGIRAD Corporation7408 Trade StreetSan Diego, CA 92121-2410
Contact Person:	Clinton L. Lingren
B. Classification Name:	Scintillation (gamma) camera
Common/Usual Name:	Gamma Camera
Trade Name:	Notebook Imager™

C. Predicate Devices:

Sponsor	Product	510(k) No.
ADAC	Transcam	K921296
ELSCINT	APEX SPX-4	KAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA
SCINTICOR	SIM 400	K885054

D. Device Description:
The Notebook Imager™ system is a gamma camera which consists of an Imaging Head, an Arm and Cart assembly, and SITCO Nuclear Medicine software. The computer consists of a PC, Video Display Terminal, Keyboard, optional Printer and processing Software. The Imaging Head consists of a two-dimensional array of room-temperature, solid-state gamma-ray detectors with readout circuitry for constructing planar images of the emission from radiopharmaceuticals. This array consists of from 1 to 64 identical one-inchby-one-inch imaging modules, each containing 64 (8x8) cadmium-zinctelluride (CZT) semi-conductor detector elements mounted on a multichip submodule. The multichip submodule provides amplification of the input signals and identifies the address of the detector element in which each incoming photon is absorbed.

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E. Intended Use:

Substantial Equivalence: F.
The Notebook Imager™ has the same intended use, uses the same principle of radiation detection, and has very similar performance characteristics as the predicate devices; the ADAC Transcam, K921296, the Elscint APEX SPX-4, and the SCINTICOR SIM-400, K885054. The main difference is that the Notebook Imager™ uses CdZnTe semiconductor detector elements, which eliminate the conventional Nal crystal, the PMTs, and, as a result, most of the volume and weight of those camera heads and improves substantially the spatial resolution. When compared to the conventional camera system, these changes will have either no effect on the patient's safety, or rather decrease the risk to the patients, because of the reduced weight of the detector.

II. Clinical Tests:

No clinical testing was necessary.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH HUMAN SERVICES USA" around the perimeter. In the center of the circle is an abstract symbol that resembles three stylized human figures.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Clinton L. Lingren Regulatory and Patent Liaison Officer DIGIRAD 7408 Trade Street San Diego, CA 92121-2410

MAY 2 8 1997

Re: K961104 Notebook Imager™ (Gamma Camera) Dated: February 26, 1997 Received: February 27, 1997 Regulatory Class: I 21 CFR 892.1100/Procode: 90 IYX ...

Dear Mr. Lingren:

We have reviewed your Section 510k) notification of intent to market the device referenced above and we have decembed 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 Amendances or to devices that have been reclassified 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, listing of devices, good manufacturing practice, labeling, and problibitions 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 England Register. Please note: this response to your premation submission does not affect any obligation you might have under sections 51 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 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predication 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 80) and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591 for Radiology devices, or 594-4613 for Ear, Nose and Throat devices. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misterance 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,

William Yu

Lillian Yin, Ph.D. Division 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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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indication For Use:

For Nuclear Medicine Imaging Device

		Yes	No	Energy Range (KeV)
A.	Planar imaging	X	-	30-300
B.	Whole Body imaging	-	X
C.	Tomographic imaging (SPECT) for non-Positron emitter	-	X
D.	Positron imaging by coincidence	-	X
E.	Positron imaging without coincidence	-	X

Other indication(s) in the device label, F. but not included in above list

To image the distribution of
radionuclide in the human body.

(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_

David A. Symm
(Division Sign-Off)

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

Regulation Number and Section

§ 892.1100 Scintillation (gamma) camera.

(a)
Identification. A scintillation (gamma) camera is a device intended to image the distribution of radionuclides in the body by means of a photon radiation detector. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class I (general controls).