The intended use of the Dyna Camera 2 series collimator is to detect and image the distribution of high energy photons from an administered positron emitting radioactive agent in the human body. Same as predicate.

Device Description

Not Found

AI/ML Overview

This document describes the 510(k) summary for Park Medical Systems' 511 KeV collimator for their ISOCAM I and ISOCAM II nuclear imaging systems. The submission aims to demonstrate substantial equivalence to a predicate device, the Dyna camera 2 series high energy collimators, rather than proving the device meets specific acceptance criteria through a dedicated study with statistical endpoints.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of a clinical trial or performance study with defined thresholds for sensitivity, specificity, etc. Instead, it presents a comparison table of technological characteristics and performance metrics against a predicate device to demonstrate substantial equivalence.

Feature/Spec.	Predicate (Dyna Camera 2 Series High Energy Collimator)	Park 511 KeV Collimator (ISOCAM I/II)	Acceptance Criteria (Implied by Substantial Equivalence to Predicate)
Intended Use	Detect and image the distribution of high energy photons from an administered positron emitting radioactive agent in the human body.	Same as predicate.	Be suitable for the same intended use.
Physical Description:
1) Name	High Energy Collimator	Ultra High Energy Collimator	Be a collimator for high energy imaging.
2) No. of holes	1,100 (round)	7,500 (hex)	Number and shape of holes is a design choice, not a direct performance criterion for equivalence.
3) Energy Range	44 - 525 KeV	50 - 562 KeV	Operate within a similar high-energy range.
4) Thickness	2.5 inches = 63.5 mm	76 mm	Have a physical thickness suitable for high-energy attenuation.
5) Hole Size	0.20 inches = 5.08 mm	4 mm	Hole size is a design choice affecting resolution and sensitivity trade-offs.
6) Septa thickness	0.156 inches = 3.94 mm	2 mm	Septa thickness is a design choice affecting resolution and septal penetration.
7) Field Size	11.8 inches = 300 mm (diameter)	419 mm × 566 mm (rectangular)	Have a field size suitable for nuclear imaging.
Performance	Resolution	Resolution	Resolution performance comparable to the predicate.
FWHM 99mTc (surface)	5.59 mm	N/A	< 5.59 mm (implied, or at least not significantly worse)
FWHM 18F (surface)	5.70 mm	5.74 mm	Comparable to 5.70 mm (within acceptable limits for equivalence)
FWHM 99mTc (3" from surface)	11.76 mm	N/A (measured at 10 cm, which is ~3.94 inches)	Comparable to 11.76 mm (adjusted for distance difference)
FWHM 18F (3" from surface)	13.20 mm	N/A (measured at 10 cm, which is ~3.94 inches)	Comparable to 13.20 mm (adjusted for distance difference)
FWHM 99mTc (10 cm from surface)	N/A (measured at 3")	10.1 mm	Comparable to 11.76 mm (at 3") when considering different distances. (e.g., 10.1mm at 10cm is better than 11.76mm at 7.62cm given resolution degrades with distance).
FWHM 18F (10 cm from surface)	N/A (measured at 3")	11.8 mm	Comparable to 13.20 mm (at 3") when considering different distances. (e.g., 11.8mm at 10cm is better than 13.20mm at 7.62cm).

Note on Acceptance Criteria: The "acceptance criteria" here are implied by the substantial equivalence framework. The device is "accepted" if its performance and characteristics are comparable to a legally marketed predicate device, especially considering the NEMA NU 1-1994 standard for performance measurements. The specific numerical values for resolution are directly compared, and the new device generally performs within or better than the predicate's reported values, especially when adjusting for measurement distances.

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

The document does not describe a "test set" in the context of human data or a clinical study. The performance data (e.g., resolution) appears to be derived from device characterization measurements according to NEMA standards, not from a clinical test set involving patients or data sets. Therefore, there is no information on sample size for a test set or data provenance (country of origin, retrospective/prospective).

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 "test set" with ground truth established by experts is described as this is a device performance characterization against a predicate, not a clinical diagnostic study.

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

Not applicable. No "test set" requiring 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

Not applicable. This submission is for a physical medical device (collimator for a gamma camera) and does not involve AI or human reader performance studies.

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

Not applicable. This is not an algorithm, but a physical component of an imaging system. The performance data presented (e.g., resolution) represents the standalone performance characteristics of the collimator itself.

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

The "ground truth" for the performance metrics like resolution (FWHM) would be based on physical phantom measurements according to the NEMA NU 1-1994 standard for performance measurements of scintillation cameras. This involves standardized radioactive sources and measurement setups to objectively quantify resolution.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device. The document describes a physical medical device and its characteristics.

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

Not applicable. This is not a machine learning or AI device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for PARK Systemes Medical System. The logo consists of a circular graphic on the left, the word "PARK" in bold black letters in the center, and the words "SYSTEMES MEDICAL SYSTEM" stacked on top of each other on the right. The circular graphic appears to be a stylized representation of a spiral or vortex.

K970128

510(K) SUMMARY

1. SUBMITTER IDENTIFICATION

Submitter's Name and Street Address:

Park Medical Systems Inc. 3195 Louis A. Amos Lachine, Quebec, Canada H8T 1C4

Contact Person: Peter Schultz, Manager Quality and Regulatory

Telephone and Fax Numbers of Contact Person: T- (514) 633-9988, F- (514) 633-8674

Date of Summary: January 10, 1997

분

11.000

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510(k) Premarket Notification Summary

2. DEVICE NAME

Device Name: 511 KeV Collimator

ISOCAM I (Single Head Gamma Camera) Proprietary Name: ISOCAM II (Dual Head Gamma Camera)

System, Tomography, Computed, Emission Classification Name:

....

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510(k) Premarket Notification Summary

3. INTRODUCTION

We manufacture single and dual detector gamma cameras, hereafter, called ISOCAM I and ISOCAM II respectively, which recently underwent FDA review.

At the request of the FDA, this 510(K) is being submitted specifically for the 511 KeV collimator option for the Park Medical Systems ISOCAM I and ISOCAM II nuclear imaging systems.

The format for this submission follows the FDA document entitled, "Premarket Notification 510(k) Regulatory Requirements for Medical Devices". In addition to the information in our previous 510(k) which included high energy imaging with 511 KeV collimators, the information requested in the recent FDA letter to industry concerning 511 KeV collimators, has also been included in this submission.

This submission shows substantial equivalence of Park 511 KeV collimators to the pre-ammendment high energy collimators used with the Dyna camera.

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510(k) Premarket Notification Summary

4. DETERMINATION OF SUBSTANTIAL EQUIVALENCE -SAFETY AND EFFECTIVINESS

The ISOCAM I and ISOCAM II imaging systems have been deemed by Park Medical Systems Inc. to be safe and effective. With regard to safety, they have been designed (as a minimum) using the following safety standards:

CAN/CSA-C22.2 No 114-M90

Canadian Standards Association Diagnostic Imaging and Radiation Therapy Imaging

IEC 601-1

International Electrotechnical Commission Medical Electrical Equipment - General Requirements for Safety

UL544

Underwriters Laboratories Inc. Standard for Medical and Dental Equipment

Although no applicable performance standards have been issued under Section 514 of the FD and C Act, the following is the basis for the performance specifications for the 511 KeV collimators for the ISOCAM I and ISOCAM II systems:

NEMA NU 1-1994 National Electrical Manufactures Association Performance Measurements of Scintillation Cameras

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510(k) Premarket Notification Summary

5. SUBSTANTIAL EQUIVALENCE COMPARISON

Introduction

Based upon the following comparison, Park 511 KeV collimators for the ISOCAM I and II imaging systems have the same characteristics as the predicate device, the Dyna camera 2 series high energy collimators. The comparison table is given in the following pages. The product data sheets for the predicate device are included following the comparison table.

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5. SUBSTANTIAL EQUIVALENCE COMPARISON (Continued)

Comparison Table (Technological Characteristics)

Feature/Spec.	Predicate	Park 511 KeV Collimator
Intended Use	The intended use of the Dyna Camera 2 seriescollimator is to detect and image the distributionof high energy photons from an administeredpositron emitting radioactive agent in the humanbody.	Same as predicate.
PhysicalDescription:
1) Name	High Energy Collimator	Ultra High Energy Collimator
2) No. of holes	1,100 (round)	7,500 (hex)
3) Energy Range	44 - 525 KeV	50 - 562 KeV
4) Thickness	2.5 inches = 63.5 mm	76 mm
5) Hole Size	0.20 inches = 5.08 mm	4 mm
6) Septa thickness	0.156 inches = 3.94 mm	2 mm
7) Field Size	11.8 inches = 300 mm (diameter)	419 mm × 566 mm (rectangular)
Performance	ResolutionFWHM = 5.59 mm 99mTc (surface)= 5.70 mm 18F (surface)FWHM = 11.76 mm 99mTc (3" from surface)= 13.20 mm 18F (3" from surface)(3" = 7.62 cm)	ResolutionFWHM = N/A 99mTc (surface)= 5.74 mm (surface)FWHM = 10.1 mm 99mTc (10 cm from surface)= 11.8 mm 18F (10 cm from surface)

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.