The D-SPECT™ Cardiac Scanner System is an emission computed tomography system intended to detect the location and distribution of gamma ray radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. The D-SPECTTM Cardiac Scanner System includes display equipment, patient and equipment supports, component parts, and accessories.

D-SPECT™ Cardiac Scanner System is primarily intended, but not limited to, cardiac applications.

D-SPECT™ Cardiac Scanner System supports radionuclides within the energy range of 40-170 keV.

The D-SPECT™ Cardiac Scanner System supports acquisition and imaging modes such as, but not limited to, SPECT (Single Photon Emission Computed Tomography), Multi-Gated SPECT and features low count rate (low dose) acquisition, with no lose in image quality.

D-SPECT™ Cardiac Scanner System is intended for Processing, Reporting, Archiving, Display, Communication and analysis of SPECT data, using tools for imaging and fully automated review and quantification of Cardiac SPECT data including Quantitative Perfusion SPECT (QPS), Quantitative Gated SPECT (QGS) and Quantitative Blood Pool Gated SPECT (QBS).

Device Description

Spectrum Dynamics' D-SPECT™ Cardiac Scanner System is a SPECT device, which is designed to perform myocardial perfusion imaging. The device is comprised of a detector head, gantry, and patient chair. Device operation is controlled from an acquisition station console. The system is supported by use of data-transfer accessories (RFID tags), which are attached to the patient's wrist, for patient and radiopharmaceutical agent positive identification. The cardiac gamma camera is designed such that there are no external moving parts that surround the patient. Detector modules rotate within the closed detector head. The special scanning geometry and detector technology enable shorter scan times. Additionally, a new revision of software was developed, adding Archiving, Display and Communication capabilities (NEMA standard DICOM protocol) with external processing stations PACS systems. The new software package also features correction of insignificant bugs discovered since last release. The modified D-SPECT™ Cardiac Scanner System include a Processing workstation. The Processing Workstation, which is part of the imaging system, is equipped with software package for Processing, Archiving, Display, Communication and analysis of emission computerized tomography data using tools for imaging and fully automated review and quantification of Cardiac SPECT data including the Cedars Sinai Quantitative Perfusion SPECT (QPS), Quantitative Gated SPECT (QGS) and Quantitative Blood Pool Gated SPECT (QBS) software.

AI/ML Overview

The provided text is a 510(k) summary for the D-SPECT™ Cardiac Scanner System. Its primary focus is on demonstrating substantial equivalence to previously marketed predicate devices, rather than presenting a detailed study proving the device meets specific acceptance criteria in a quantitative sense.

Therefore, many of the requested sections (e.g., specific acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth for training) cannot be extracted from this document as such detailed performance study information is not included. The document emphasizes that the intended use, indications, and technological features are similar to predicate devices, implying that the risks and benefits are comparable.

Here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

Cannot be extracted. The document does not provide a table of acceptance criteria or specific quantitative performance metrics beyond stating that "low count rate (low dose) acquisition, with no lose in image quality" is a feature. The core argument is substantial equivalence to predicates, not meeting new, specific quantitative performance thresholds.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Cannot be extracted. No studies or test sets are described in the document.

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)

Cannot be extracted. No studies or test sets are described in the document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Cannot be extracted. No studies or test sets are described in the document.

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

Cannot be extracted. The document describes a SPECT cardiac scanner system and its associated software for processing and analysis. It does not describe an AI-assisted interpretation system or an MRMC comparative effectiveness study. The software features "fully automated review and quantification," but an MRMC study comparing human performance with and without this automation is not mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Cannot be extracted. While the software includes "fully automated review and quantification," the document does not describe a standalone performance study for these automated features. The focus is on the device as a whole system being substantially equivalent.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Cannot be extracted. No studies (and thus no ground truth definition) are described in the document.

8. The sample size for the training set

Cannot be extracted. No training sets are mentioned.

9. How the ground truth for the training set was established

Cannot be extracted. No training sets are mentioned.

Summary of what the document does convey regarding "acceptance criteria" and "study":

The "study" or evidence provided is the Rational for Substantial Equivalency. The "acceptance criteria" for this 510(k) submission are implicitly demonstrating that the modified D-SPECT™ Cardiac Scanner System is substantially equivalent to legally marketed predicate devices, meaning it does not raise new questions of safety or effectiveness.

Key points from the document regarding "acceptance criteria" through substantial equivalence:

Intended Use & Indications: The modified device's intended use and indications are "identical to the legally marked devices" (K072468, K003264, K980715, K080784). The "widened indications" for the modified D-SPECT™ (K110507) compared to the older D-SPECT™ (K072468) are aligned with the indications of the other predicate devices (PACS, automated review/quantification).
Technological Features & Performance: "The technology, performance and most of the specifications of the proposed modified D-SPECT™ Cardiac Scanner System are similar to the legally marketed predicate devices."
Risks & Benefits: Because of the similarity in intended use, indications, and technological features, the document asserts that "the risks and benefits are comparable to the predicate devices."
No New Questions of Safety or Effectiveness: The ultimate "acceptance criterion" for a 510(k) is that "there are no new questions of safety or effectiveness raised by the introduction of modified D-SPECT™ Cardiac Scanner System."

In essence, this 510(k) relies on the regulatory pathway of substantial equivalence, where the "proof" is the detailed comparison to legally marketed predicate devices, rather than a de novo performance study against pre-defined quantitative acceptance criteria.

Summary

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JUL 1 3 2011

110567

510(k) Summary

This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990. The contents of the 510(k) summary have been provided in conformance with 21 CFR §807.92

Submitter Information

Spectrum Dynamics (Israel) Ltd. 22 Bareket Street North Industrial Park POB 3033 Caesarea 30889, Israel Tel: (+972) 73 7374500, Fax: (+972) 73 737450 Submission contact person: Ilan Sharon P.O.Box 4262, Zichron Yaacov 30900, Israel TEL: (+972) 52 8704904, Fax: (+972) 73 737450

Device Classification

	Proprietary Device Name:	D-SPECT™ Cardiac Scanner System
	Common name:	Emission Computed Tomography System
	Product Code:	KPS (subsequent code LLZ)
	Classification Name:	Emission computed tomography system (Subsequent – Picture archiving and communications system
	Classification Regulation:	21 CFR §892.1200 (subsequent 21 CFR §892.2050)
	Regulatory Class:	II

Identification of Legally Marketed Predicate Devices

Spectrum Dynamics: D-SPECT™ Cardiac Scanner System -	K072468
ELGEMS: eNTEGRA workstation -	K003264
ADAC Laboratories: AutoQUANT -	K980715
UltraSPECT: WBR Half Dose -	K080784

Device Description

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Intended Use of Device

The D-SPECT™ Cardiac Scanner System is primarily intended for cardiac applications.

The D-SPECT™ Cardiac Scanner System supports radionuclides within the energy range of 40 -170 keV. The D-SPECT™ Cardiac Scanner System supports acquisition and imaging modes such as, but not limited to, SPECT (Single Photon Emission Computed Tomography), Multi-Gated SPECT and is featuring low count rate (low dose) acquisition, with no lose in image quality.

The D-SPECT™ Cardiac Scanner System is intended for Processing, Reporting, Archiving, Display, Communication and analysis of emission computerized tomography data using tools for imaging and fully automated review and quantification of Cardiac SPECT data including Quantitative Perfusion of CCT (QPS), Quantitative Gated SPECT (QGS) and Quantitative Blood Pool Gated SPECT (QBS).

Safety & Effectiveness

The intended use and indications of the submitted modified D-SPECT™ Cardiac Scanner is identical to the legally marked devices: Spectrum Dynamics: D-SPECT™ Cardiac Scanner System (K072468), ELGEMS: eNTEGRA workstation (K003264), ADAC Laboratories: AutoQUANT (K980715) and UltraSPECT: WBR Half Dose (K080784).

Similarity of intended use, indications and technological features demonstrated, therefore, the risks and benefits are comparable to the predicate devices.

We therefore believe that there are no new questions of safety or effectiveness raised by the introduction of modified D-SPECTTM Cardiac Scanner System.

Rational for Substantial Equivalency

Similarities:

The intended use and indications of the proposed modified D-SPECT™ Cardiac Scanner System are similar to the legally marketed predicate devices.

The technology, performance and most of the specifications of the proposed modified D-SPECT™ Cardiac Scanner System are similar to the legally marketed predicate devices Differences:

The proposed modified system includes wider indications in reference to legally marked D-SPECT™ Cardiac Scanner System (K072468) indication for use that was limited to Cardina SPECT aquicition and reconstruction.

The proposed System intended use and indications for use are similar to the above mentioned predicate devices (Adding PACS and fully automated review and quantification of Cardiac SPECT data).

Substantial Equivalence Statement

Based on the above, it is Spectrum Dynamics's opinion that the proposed modified D-SPECT™ Cardiac Scanner System is substantially equivalent in terms of design, functional features and safety & effectiveness to the unmodified D-SPECT™ Cardiac Scanner System (K072468) legally marketed device and to the legally marked predicate devices.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Spectrum Dynamics (Israel) Ltd. % Mr. Ilan Sharon QA & RA Consultant Ilan Sharon - Regulatory Affairs Consultant 1 Ha'rakefet St. Zichron Yaacov, 30900 ISRAEL

JUL 1 3 2011

Re: K110507

Trade/Device Name: D-SPECT™ Cardiac Scanner System Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS Dated: February 20, 2011 Received: February 22, 2011

Dear Mr. Sharon:

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office

of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Mary Patel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: D-SPECTTM Cardiac Scanner System

Indications for Use:

The D-SPECT™ Cardiac Scanner and System is an emission computed tomography system intended to detect the location and distribution of gamma ray radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. The D-SPECTTM Cardiac Scanner System includes display equipment, patient and equipment supports, component parts, and accessories.

D-SPECT™ Cardiac Scanner System is primarily intended, but not limited to, cardiac applications.

D-SPECT™ Cardiac Scanner System supports radionuclides within the energy range of 40-170 keV.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mary S. Patel

Division of Radiologica Vitro Diagnostic D

510K K110507

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Regulation Number and Section

§ 892.1200 Emission computed tomography system.

(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. 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 II.