BEACON, MODEL 211060

• K Number: K983948
• Device Name: BEACON, MODEL 211060
• Manufacturer: PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
• Date Cleared: 1999-04-16 ( 162 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 technique(s): C. Tomographic imaging (SPECT) for non Positron emitter

Device Description

The Beacon system is a new option for non-uniform attenuation correction on the Axis or Irix gamma camera systems. This device is intended to be used for diagnostic imaging of organs and lesions. This device includes adding hardware and software to a gamma camera system.

AI/ML Overview

This 510(k) premarket notification for the "Beacon S System" does not contain information typically found in acceptance criteria or a study proving device performance in the way modern AI/software as a medical device (SaMD) submissions do. This submission is for a hardware and software upgrade to a gamma camera system for non-uniform attenuation correction, not an AI diagnostic algorithm.

Therefore, many of the requested fields cannot be directly answered from the provided text.

Here's an analysis based on the information provided:

PICKER INTERNATIONAL 510(k) NOTICE - K983948 BEACON S SYSTEM

This submission does not detail acceptance criteria or a study in the context of an AI/SaMD diagnostic device with performance metrics like sensitivity, specificity, or AUC. Instead, it describes an upgrade (hardware and software) to existing gamma camera systems to improve non-uniform attenuation correction. The "study" here refers to the engineering development and compliance with quality systems, rather than a clinical performance study with statistical endpoints.

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1. A table of acceptance criteria and the reported device performance
   • Acceptance Criteria: Not explicitly stated in terms of diagnostic performance metrics for a specific clinical task. The acceptance criteria appear to be related to functional specifications, electrical safety standards (IEC-601 or UL-544), and adherence to Picker's internal quality system (OI 2300) and ISO-9001.
   • Reported Device Performance: The document states, "The Beacon system is substantially equivalent to legally marketed devices." This is the core "performance" claim for a 510(k) – that its performance is comparable to a predicate device, rather than providing novel performance metrics. The stated purpose is for "non-uniform attenuation correction" to be used for "diagnostic imaging of organs and lesions," which implies improved image quality or diagnostic accuracy compared to uncorrected images, but no specific metrics are provided.

Acceptance Criteria (Inferred)	Reported Device Performance (Inferred)
Functional specifications met	Device developed to quality system (OI 2300, ISO-9001), implying functional requirements were met. Full documentation provided.
Electrical safety standards met (IEC-601 or UL-544)	Device "will be certified to electrical safety standards... by a third party organization prior to use on human patients." (Future tense)
Substantial equivalence to predicate device	"The Beacon system is substantially equivalent to legally marketed devices." No specific metrics provided, but implies comparable safety and effectiveness.
Intended Use: Diagnostic imaging of organs and lesions	Intended use is consistent with predicate device. Focus on "non-uniform attenuation correction."
Operable by trained health care professionals	Yes, operated by trained professionals.

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

   • Not Applicable. This submission does not describe a clinical test set in the context of diagnostic performance evaluation for an AI/SaMD. The "study" mentioned pertains to internal quality system compliance and substantial equivalence claims, not a clinical trial.

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 ground truth establishment is described for a clinical test set.

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

   • Not Applicable. No test set or related 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

   • No. This device is an attenuation correction system for gamma cameras, not an AI diagnostic algorithm for image interpretation that would typically involve human reader performance studies.

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

   • Not Applicable/No. This device is described as an "option for non-uniform attenuation correction" and "includes adding hardware and software to a gamma camera system." It's an integral component of an imaging system, not a standalone diagnostic algorithm. Its performance is intrinsically linked to the overall imaging process.

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

   • Not Applicable. No explicit ground truth is mentioned in the context of evaluating a diagnostic algorithm's accuracy. The "ground truth" for the device's function would be the physical reality of the radionuclide distribution, which the attenuation correction is trying to represent more accurately. However, this is not described in terms of a clinical validation study's ground truth for disease diagnosis.

8. The sample size for the training set

   • Not Applicable. This is not an AI/ML algorithm that requires a "training set" in the modern sense. It's a software/hardware component for image correction.

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

   • Not Applicable. As above, no training set for an AI/ML algorithm is used.

Summary

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PICKER INTERNATIONAL 510(k) NOTICE

K983948

BEACON S SYSTEM

E: SUMMARY OF SAFETY AND EFFECTIVENESS

This is a summary of the information submitted by Picker International, Inc. to the Office of Device Evaluation (DRAERD) of the FDA as required by the Federal Food, Drug, and Cosmetic Act as amended on November 18, 1990 in section 807.92(c) for the Beacon system.

The Beacon system is a new option for non-uniform attenuation correction on the Axis or Irix gamma camera systems. This device is intended to be used for diagnostic imaging of organs and lesions. There is no change of intended use from that of the predicate device. This device includes adding hardware and software to a gamma camera system.

Functional specifications and operator's instructions (preliminary) are included in the attachments. Final documentation will be provided with productions units.

The Beacon system is substantially equivalent to legally marketed devices. Trained health care professionals who are responsible for Nuclear Medicine diagnostic examinations will operate the system. The Beacon system will be certified to electrical safety standards (IEC-601 or UL-544) by a third party organization prior to use on human patients. Labeling (Product Bulletin and Operator's Guide) will be provided to the user of the equipment.

This device will be developed to our quality system which includes design controls. The quality standard procedure OI 2300 "Program Planning and Control System" defines how an engineering project goes from concept to closure. This procedure complies with the FDA-OSR regulation and the ISO-9001 standard.

Picker has reviewed all known information and performed an investigation as to the causes of safety and effectiveness concerning the Beacon. In addition, all information contained in this 510(k) Notice is accurate and complete.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 6 1999

Norman J. Yager Manager, OA/Regulatory Picker International, Inc. Nuclear Medicine Division 595 Miner Road Highland Heights. Ohio 44143 Re:

K983948

Beacon-S Model 211060 Dated: February 26, 1999 Received: March 1, 1999 Regulatory class: II 21 CFR 892.1200/Procode: 90 KPS

Dear Mr. Yager:

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 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 prohibitions against misbranding and adulteration.

If vour 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 requlations,

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the requlation 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.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

APT 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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K983948 510(k) Number (if known): BEACON-S Device Name: ._

..............................................................................................................................................................................

Nuclear Medicine Device

Indication For Use: To detect or image the distribution of radionuclides in the body or organ, using the following tochnique(s).

		YES	NO	Energy Range (keV)
	A. Planar imaging		X
B.	Whole body imaging		X
	C. Tomographic imaging (SPECT) for non Positron emitter	X		50-550
	D. Positron imaging by coincidence		X
E.	Po-itron imaging without coincidence		X
F.	Other indication(s) in the device label, but not included in above list		N.A.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

F'rescription Lise
(Per 21 CFR 801.109)

OR

Over-the-Counter Use

(Optional Formx 1-2-96)

(Division Sign-Of)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K983948

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.