The Premica™-CT Contrast Media Delivery System is indicated for the controlled automatic administration, on the venous side, of contrast media (CM) for computed tomography scan. The System consists of the Premica™-CT instrument, the Bottle Spike, the Day Set, the Patient Set, and accessories. The System is not intended for injection of CM for coronary arteriography, or for any other use for which the device is not indicated. The Premica™-CT Contrast Media Delivery System is not intended for use with children under 16 years of age.

Device Description

The Premica™-CT Contrast Media Delivery System consists of the following components:

the console consisting of the pump, the main control panel, and the power . supply,
. the remote control panel,
the remote test injection trigger (handswitch), and .
associated cables. .
. bottle insulators, and
pedestal, connector, and wheels. .
The printer is provided as an accessory.

AI/ML Overview

The Premica™-CT Contrast Media Delivery System is a contrast media injector for CT scans. The acceptance criteria and supporting studies are based on demonstrating substantial equivalence to a predicate device, the MEDRAD® ENVISION CT™ Injector System (K934086), with a focus on safety and effectiveness, particularly concerning differences in multi-patient use and disposables.

Here's a breakdown of the information requested:

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

The submission does not explicitly state "acceptance criteria" in a quantitative, pass/fail manner as might be seen for a new device's clinical performance. Instead, it relies on demonstrating that the differences from the predicate device do not raise new issues of safety and effectiveness, primarily through functional equivalence and specific testing related to the identified differences.

Characteristic (Acceptance Area)	Acceptance Criteria (Implied)	Reported Device Performance / Justification
Bacterial Contamination (Multi-patient use)	Normal use of disposables does not introduce microbial contamination.	Bacteriological testing demonstrated that normal use of the disposables of the Premica™-CT System does not introduce microbial contamination into the contrast, and that Sets are not susceptible to microbial contamination when the System is used according to instructions for normal operation.
Cross-Contamination (Infected Patient)	Risk of cross-contamination from an infected patient is negligible.	Studies demonstrated that the risk of cross-contamination from an infected patient is negligible, as the retrograde migration of microorganisms and viruses was limited solely to the distal end of the Patient Set.
Prevention of Disposable Re-use (Bottle Spike)	Design prevents re-use of the Bottle Spike.	The design of the Bottle Spike prevents re-use since the tip breaks off within the bottle upon Spike removal.
Prevention of Disposable Re-use (Day Set & Patient Set)	Software control prevents re-use of Day Set and Patient Set past intended durations.	Software control prevents re-use of the Day Set and Patient Set, past their intended durations of use. Validation activities demonstrated that the System fulfills this specification.
Functional Equivalence	Performance characteristics are comparable to the predicate or differences do not impact safety/effectiveness.	See Table J-1 and J-1 (Continued) in the 510(k) summary (Characteristics like flow rate range, injection volume, pressure limit, test injection defaults, injection capabilities, interphase delay, protocol storage, saline flush, and audible scan delay signal were either similar to the predicate or the differences were not considered to raise new issues of safety or effectiveness. For example, the Premica™-CT has an air sensor where the predicate does not, which implies an improvement in safety rather than a new risk.)

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not explicitly stated in terms of patient numbers or specific sample sizes for each test mentioned (bacteriological testing, cross-contamination studies, validation activities). The information focuses on the type of testing performed rather than detailed sample sizes.
Data Provenance: The studies were conducted by Nycomed Amersham Imaging. The specific country of origin for the studies is not mentioned, but it's part of a US regulatory submission. The studies appear to be prospective in nature, as they involve testing the device's performance under simulated or controlled conditions related to its use and re-use prevention.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This device is a contrast media injector, a hardware device. The "ground truth" for its performance would typically involve engineering specifications, microbiology testing, and functional validation against established standards or protocols. It does not involve human interpretation of medical images, so there isn't a concept of "experts establishing ground truth" in the way it applies to diagnostic AI.
The bacteriologic and cross-contamination studies would have been overseen by microbiology experts, and the validation activities by engineering/quality assurance experts, but no specific number or qualifications are provided in the summary.

4. Adjudication method for the test set

Not applicable as the tests relate to device function and microbiology, not human diagnostic interpretation requiring adjudication of discrepancies. The results of the tests (e.g., presence/absence of contamination, functionality of re-use prevention) would be objectively measurable.

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 MRMC study was done. This device is a medical device for delivering contrast media, not a diagnostic imaging AI algorithm. Therefore, there is no concept of "human readers" or "AI assistance" in the context of diagnostic interpretation. The studies focused on physical and microbiological performance.

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

Yes, in spirit. The performance evaluations mentioned, such as the bacteriological testing, cross-contamination studies, and validation of software control for re-use prevention, are assessments of the device (or its components/software) performing its intended function without direct human intervention in the outcome being measured for that specific test (e.g., observing if bacteria migrate, or if the spike breaks). While a human operates the device, the performance being tested is intrinsic to the device's design.

7. The type of ground truth used

Microbiological assays: For bacterial and cross-contamination studies (e.g., standard microbiological culture techniques to detect presence or absence of contamination, or specific assays for viral detection).
Engineering specifications and functional testing: For device re-use prevention mechanisms (e.g., physical inspection for spike breakage, software logs/testing for duration limits).
Industry standards/guidelines: For general device safety and performance.

8. The sample size for the training set

Not applicable. This is a hardware device, not a machine learning model that requires a training set in the conventional sense. The "training" of the device is its design and manufacturing process, validated through the testing described.

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

Not applicable. As above, there is no "training set" for this type of device. The "ground truth" for its design and manufacturing would be established through engineering principles, regulatory standards, scientific research in materials and microbiology, and testing protocols.

Summary

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K983314

510(k) Summary Nycomed Amersham Imaging Premica™-CT Contrast Media Delivery System (per 21 CFR 807.92)

SUBMITTER NAME AND ADDRESS 1.

Nycomed Amersham Imaging 101 Carnegie Center Princeton, NJ 08540-9998

Ms. Kathy Patterson Contact Person: Telephone: (847) 593-6300, Extension 341

DEVICE NAME 2.

Proprietary Name:	Premica™-CT Contrast Media Delivery System
Common/Usual Name:	Automatic injector for contrast media
Classification Name:	Injector, contrast medium, automatic

3. PREDICATE DEVICE/S

74 - DXT MEDRAD® ENVISION CT™ Injector System - K934086

4. DEVICE DESCRIPTION

The Premica™-CT Contrast Media Delivery System consists of the following components:

the console consisting of the pump, the main control panel, and the power . supply,
. the remote control panel,
the remote test injection trigger (handswitch), and .
associated cables. .
. bottle insulators, and
pedestal, connector, and wheels. .

The printer is provided as an accessory.

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INTENDED USE 5.

BASIS FOR SUBSTANTIAL EQUIVALENCE 6.

Information supplied in this premarket notification includes descriptive information about the intended use, operation, and technological characteristics. A side-by-side comparison of the Premica™-CT Contrast Media Delivery System with the MEDRAD® ENVISION CT™ Injector System is provided in Table J-1. below.

Table J-1. Comparison of Premica™-CT Contrast Media Delivery System
with the MEDRAD® ENVISION CT™ Injector System

Characteristic	Premica™-CT ContrastMedia Delivery System	MEDRAD®ENVISION CT™K934086
Indications
Indicated for controlledadministration of contrast mediafor computed tomography scans	Yes	Yes
Physical design
Remote Panel	Yes	Yes
Weight (kg)	Pump 8 (17.6 pounds)Panel 1.7 (3.7 pounds)	Display 4.4 (9.7 pounds)Console 5.8 (12.8 pounds)Head Control 3.0 (6.7 pounds)
Temperature Control	Bottle Insulators	Syringe heater
Single Patient Use Disposables	Patient Set	Syringe
Connecting Tubing	1.5 meters	60 inches (1.52 meters)
Access Types	Rigid and flexible	Rigid and flexible
Access Gauge	16 to 20	Not specified
Multiple Patient Use CM	Yes	No

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Table J-1, Comparison of Premica™-CT Contrast Media Delivery System with the MEDRAD® ENVISION CT™ Injector System (Continued)

Characteristic	Premica™-CT ContrastMedia Delivery System	MEDRAD®ENVISION CT™K934086
Designed to prevent reuse ofdisposables?	Yes	No
Operational Characteristics
Flow Rate (ml/s)	0.2 to 9.9	0.1 to 9.9
Injection Volume/Injection	0 to 300 ml	1 ml to syringe capacity
Maximum Injection Duration	10 s to 9 min 59 sec;Depends on injection volume	Up to 33:20; Depends onvolume, rate, and syringe size
CM Container Volume (ml)	0 to 500	Syringe sizes:125 or 200 ml
Air Sensor	Yes (One for each bottle andone for the Patient Set)	No (Requires monitoring bythe Operator)
Pressure Sensor	Yes	Yes
Pressure Limit	8 bar	Programmable from 25 to 300psi in 5 psi increments
Test Injection Default	Default: 5 ml; 1 ml/s;increments of 0.1 ml/s	Default: 5 ml; 1.5 ml/sec;Volume: 1 - 10 ml; 1 mlincrementsFlow rate: 0.1 ml/sec to 9.9ml/sec in 0.1 ml increments
Injection Capabilities	Up to 2 phases	1 to 8 phases
Interphase Delay (sec)	0-99	Optional
Protocol Storage	Up to 100 of 2 phases each	Up to 50 of 8 phases each
Saline Flush	Yes	No
Audible Scan Delay Signal	0 to 99 sec	0 to 99 sec

The major differences between the two systems are the ability of the Premica™-CT to be used for multiple patients without changing the reservoir of contrast medium, and System design which prevents disposables reuse. Nycomed Amersham Imaging has conducted testing to demonstrate that these differences do not raise new issues of safety and effectiveness. Bacteriological testing demonstrates that

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normal use of the disposables of the Premica™-CT System does not introduce Sets are not susceptible to microbial contamination into the contrast. contamination when the System is used according to instructions for normal operation. Studies also demonstrate that the risk of cross contamination from an infected patient is negligible since the retrograde migration of the microorganisms and viruses was limited solely to the distal end of the Patient Set. The design of the Bottle Spike prevents re-use since the tip breaks off within the bottle upon Spike removal. Software control prevents re-use of the Day Set and Patient Set, past their intended durations of use. Validation activities demonstrate that the System fulfills this specification.

Nycomed Amersham Imaging believes that the information provided within this premarket notification and summarized above demonstrates that the Premica™-CT Contrast Media Delivery System is substantially equivalent to the MEDRAD® ENVISION CT™ Injector System. Testing demonstrates that the procedural difference, specifically multiple dose versus single dose, is safe and raises no new issues of safety or effectiveness.

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Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 9 1999

Nycomed Amerham Imaging, Inc. c/o Rosina Robinson, RN, MED, RAC Senior Staff Consultants Medical Device Consultants, Inc. 49 Plain Street North Attleboro, MA 02760

Re:

K983314

Premica™ CT Contrast Media Delivery System Dated: January 6, 1999 Received: January 7, 1999 Regulatory class: II 21 CFR 870.1650/Procode: 74 IZQ

Dear Ms. Robinson:

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). 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 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 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 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 vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notfication"(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/dsma/dsmamain.html".

Sincerely yours,

sct

Capt. 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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510(k) Number (if known): K 90 3314

Device Name: Nycomed Amersham Imaging Premica" -CT Contrast Media Delivery System

Indications For Use:

The Premica™-CT Contrast Media Delivery System is indicated for the controlled automatic administration, on the venous side, of contrast media (CM) for computed tomography scan. The System consists of the Premica™-CT instrument, the Bottle Spike, the Day Set, the Patient Set, and accessories. The System is not intended for injection of CM for coronary arteriography, or for any other use for which the device is not indicated. The Premica™ -CT Contrast Media Delivery System is not intended for use with children under 16 years of age.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use	✓
(Per 21 CFR 801.109)	(Division Sign-Off)
	Division of Reproductive, Abdominal, ENT,
	and Radiological Devices
510(k) Number	K983314

	Over-The-Counter Use

Nycomed Amersham Imaging Inc 510(k) 9/18/98 CONFIDENTIALNycomed Amersham Imaging Inc. 510(k) Premica™-CT Contrast Media Delivery System

CONFIDENTIAL

Page vi

Regulation Number and Section

§ 870.1650 Angiographic injector and syringe.

(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
Classification. Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.