The Optistar Elite Injection System is a contrast delivery system and is designed to inject MR contrast media and flushing solutions into a patient's vascular system to obtain diagnostic images when used with Magnetic Resonance Imaging equipment.

Device Description

The Optistar Elite is a delivery system designed to inject image enhancing MR contrast media and flushing solutions into the vascular system for the purpose of obtaining enhanced diagnostic images. The Optistar Elite consists of 4 main components and syringes, just like the predicate device: Power Head, Console, Power Control, and Power Supply. Syringes accommodated include Mallinokrodt Optimark pre-filled syringes (10 ml, 15 ml, 20 ml, 30 ml), Mallinckrodt pre-filled saline syringes (50ml and 125 ml), and empty disposable 60 ml Mallinckrodt syringes.

AI/ML Overview

The provided document is a 510(k) Summary for the Optistar Elite Injection System, which is a premarket notification to the FDA for a medical device. This type of document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone comprehensive study with detailed acceptance criteria and performance reports in the format requested.

Therefore, much of the requested information regarding detailed acceptance criteria, sample sizes for test/training sets, number and qualifications of experts for ground truth, adjudication methods, MRMC studies, or specific effect sizes from AI assistance is not present in this document. This is because the context is not a clinical trial or performance study designed to prove device efficacy against predetermined statistical thresholds for acceptance. Instead, it's about demonstrating that the new device is as safe and effective as a previously cleared device.

However, I can extract the available information to address as much of your request as possible.

Description of Acceptance Criteria and Study Findings for the Optistar Elite Injection System

The Optistar Elite Injection System's acceptance criteria and demonstrated performance are primarily evaluated through comparison to a predicate device (Optistar MR Injection System, K984088) to establish substantial equivalence. The performance testing largely focuses on verification steps against recognized standards and confirming that the new features are conveniences that do not negatively impact safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

As explicit, quantifiable "acceptance criteria" are not formally presented in the same way a clinical trial would define them, the table below reflects the comparison of features and capabilities between the Optistar Elite and its predicate device. "Reported Device Performance" here refers to the capabilities and specifications listed for the Optistar Elite. The "Acceptance Criteria" implicitly are that these features are equivalent or improved without compromising safety or fundamental function compared to the predicate, especially within the expanded MR environment.

Feature	Acceptance Criteria (Implicitly, equivalent or improved w/o safety compromise vs. Predicate)	Reported Device Performance (Optistar Elite)
Intended Use	Same as predicate	Intended for injecting MR contrast agents and flushing solutions for the purpose of enhancing diagnostic imaging of humans. (Same as predicate)
MR Environment	≥ 1.5 Tesla of predicate, safe and functional	Up to 3 Tesla. (Validated for use in magnetic field strengths up to 3.0 Tesla with various scanners.)
Multi-phasic Injections	Same as predicate	Yes - multiple phases per protocol (Same as predicate)
Protocol Storage	Same or improved vs. predicate	40 protocols (Same as predicate)
Injection History	Same or improved vs. predicate	Stores last 48 injection results (Improved vs. predicate's 12 results)
Syringe Sizes	Support for relevant sizes, including pre-filled	Prefilled Contrast 10ml, 15ml, 20ml, 30ml syringes; Prefilled Saline 50ml & 125 ml syringes; 60 ml disposable syringes (Slight variation from predicate, e.g., 50ml & 125ml saline vs 25ml & 60ml disposable)
Single/Dual Syringe Modality	Same as predicate	Single syringe and Dual syringe capability (Same as predicate)
Syringe Drive System	Same as predicate	Piezoelectric (Same as predicate)
Syringe Heater	Same as predicate	No (Same as predicate)
Flow Rate (A side: MR contrast)	0.1-8.0 ml/sec for 10-30ml; 0.1-10 ml/sec for 60ml (equivalent or improved)	10, 15, 20, 30ml syringes: 0.1-8.0 ml/sec; 60 ml syringes: 0.1-10 ml/sec (Equivalent to predicate)
Flow Rate (B side: Saline)	0.1-7.0 ml/sec for 60ml (equivalent or improved)	60 ml syringes: 0.1-8.0 ml/sec; 50 & 125 ml syringes: 0.1-8.0 ml/sec (Improved for 60ml, new sizes supported)
Max Pressure Limit	Same as predicate	200 psi (Same as predicate)
Pressure Limit Control	Same as predicate	User-settable, 10 psi increments (Same as predicate)
Flushing System	Same as predicate	Manual or via injector (Same as predicate)
Ability to check patency	Present, ideally more convenient	Yes - Manual or using Patency Check (Improved functionality compared to predicate's manual only)
Ability to run Test Injection	Present, ideally more convenient	Yes - Using Timing Bolus feature (Improved functionality compared to predicate's running 2 separate injections)
Remote Start	Same as predicate	Yes (Same as predicate)
Scan Delay	Same as predicate	0 - 60 seconds (Same as predicate)
Phase Delays	Ideally present	Yes (New feature compared to predicate)
Inject Delay	Ideally present	Yes (New feature compared to predicate)
Console Controls	Same as predicate in type (touch screen color LCD)	Touch screen Color LCD (Same as predicate)
Power head Controls	Equivalent functionality (keypad/buttons)	Keypad (Slight difference in interface type from predicate's "Buttons" but functionally equivalent)
Post Injection Readout	Same as predicate	Yes (Same as predicate)
Enable Sequence	Same as predicate	Yes (Same as predicate)
Check for Air Button	Same as predicate	Yes (Same as predicate)
Volume Remaining Display	Same as predicate	Displayed on Console (Same as predicate)
Mode for keeping fluid path open	Same as predicate	Yes - Drip Mode (Same as predicate)
Ram Retraction	Same or improved vs. predicate	Manual or automatic (Improved vs. predicate's manual only)
Materials	Same as predicate	Plastic and non-ferrous (Same as predicate)
Sterility	Injectors not sterile, disposables sterile (same as predicate)	Injectors are not sterile products. Syringes and Disposables are provided sterile (Same as predicate)

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

The document does not detail specific "test set" sample sizes in the context of clinical data for performance evaluation. The verification and validation activities mentioned are primarily engineering and software testing.

For the MR environment testing:

Data Provenance: The Optistar LE injector (mechanically and electrically equivalent to Optistar Elite) was tested "with a variety of MR scanners from various manufacturers." The document does not specify the country of origin of this data or if it was retrospective or prospective, but the context implies prospective engineering and compatibility testing.
Sample Size: The number of scanners or tests performed is not quantified beyond "a variety."

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

This information is not provided in the document. The testing described is technical verification and validation, not a clinical study requiring expert ground truth for diagnostic accuracy.

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

This information is not provided in the document, as it is not a clinical study based on expert interpretation of diagnostic images.

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

An MRMC study was not done, nor is there any mention of AI assistance in this medical device. The device is a power injector for contrast media, not an image analysis or diagnostic aid involving AI.

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

This concept is not applicable to this device. The Optistar Elite Injection System is a physical contrast delivery system that requires a human operator for programming and initiation. There is no "algorithm only" performance that stands alone in the way an AI diagnostic algorithm might.

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

For the software verification, "Validation testing was performed by customers on production equivalent units in simulated clinical conditions." This suggests user feedback and internal performance metrics against "defined customer needs" and "intended use" serve as a form of "ground truth" for software functionality and usability, rather than clinical ground truth like pathology for diagnostic accuracy.

For hardware performance (e.g., in the MR environment), the "ground truth" was that "the injector performed as specified, delivering accurate volume, flow and pressures" and "did not interfere with the operation of the MR systems." This implies measurement against engineering specifications and non-interference as the ground truth.

8. The sample size for the training set

This information is not applicable and therefore not provided. The device does not employ machine learning or AI that would necessitate a "training set" in the conventional sense. Software verification involved unit, integration, exploratory, and system-level testing, which are standard software development practices, not AI model training.

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

This information is not applicable and therefore not provided, as there is no training set for machine learning for this device.

Summary

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K073592

MAY - 7 2008

COVIDIE

510(k) Summary

1. Company Identification

Mallinckrodt Inc., Liebel-Flarsheim Business 2111 East Galbraith Road Cincinnati, OH 45237

Establishment Registration: 1518293

2. Contact Person

Dale Moore Quality Manager Phone: (513) 948-5771 Fax: (513) 948-5708 Email: Dale.Moore@Covidien.com

3. 510(k) Preparation Date

12/19/07

4. Device Name

Optistar Elite Injection System Trade Name: Common Name: Power Injector Classification Name Iniector and Syringe, Angiographic (21 CFR 870.1650, product code DXT)

5. Device Classification

Class II

6. Indications for Use

7. Description of Device

Power Head- Contains two piezoelectric motors that drive two lead screw rams, the syringe holding mechanisms, the main microprocessor, two sets of forward and reverse keys, one set of accelerator keys, check air key, start key, stop kev, syringe size sensors and indication lamps, and pivot adjustment knob. The Optistar Elite uses a drive system that is similar to the existing Mallinckrodt MR injector in the marketplace. The piezoelectric motors drive the rams that are designed to push against the syringe pushrods (or plunger in 125 ml syringes) to expel the fluid from the barrel of the syringe.

LIEBEL FLARSHEIM BUSINESS 2111 EAST GALBRAITH ROAD CINCINNATI, OH 45237

Page 52 of 78

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Console - The console is the main user interface for the injector system. It allows the user to input injection parameters via a touch screen as well as view the results of an injection. The console incorporates a remote hand switch for starting or stopping an injection. It communicates with the Power Head to program and initiate injection protocols, displays the injection status, and displays a timer. The console contains the system on/off control.

Power Control - The power control is the interface between the console and the power head. The power control processes the information input by the user at the console and relays this information to the power head. The power control also supplies DC voltage to the power control receives its power from the power supply. The power control is the servo drive for the motors in the power head.

Power Supply - The power supply converts AC line voltage to power the Console and Power Control. It also passes communications from the console to power control.

Syringes - The Optistar Elite Injection System accommodates the Mallinokrodt Optimark pre-filled syringes (10 ml, 15 ml, 20 ml, 30 ml), the Mallinckrodt pre-filled saline syringes (50ml and 125 ml) and the empty disposable 60 ml Mallinckrodt syringes.

8. Substantial Equivalence

The predicate injector to the Optistar Elite Injection System is the Optistar MR Injection System, 510(k) number K984088

The Optistar Elite Injector System maintains the same intended use as the predicate device. The Optistar Elite is intended for injecting MR contrast and flushing solutions for the purpose of enhancing diagnostic imaging of humans. The stated Indications for Use differ from those of the predicate device, in that the predicate device included the magnetic field strength limitation of 1.5 Tesla in the Indications statement itself. The proposed device has been validated for use in a magnetic field strength up to 3.0 Testing it with a variety of scanners with field strengths up to 3.0 Tesla. This limitation has been removed from the Indications statement, and will be addressed in the Warnings and Precautions.

The Optistar Elite Injector System consists of four main components and syringes in the same mamer as the predicate device: a Power Head, a Console, a Power Control and Syringes. Both the Optistar Elite Injector System and the predicate device consist of the same fundamental technology. They are piezoelectric mechanical devices which are software controlled.

The Optistar Elite Injector System is similar to the predicate device in that it contains a second identical drive system as a feature to conveniently inject a flushing solution (i.e. saline) in conjunction with the MR contrast injection.

The primary difference between the Optistar Elite and the predicate device is the addition of several features that make the Elite more user friendly. The addition of a patency check function and timing bolus are the main examples of functionality that was present in the predicate device, but is much more convenient in the Elite. The graphical user interface on the Elite is easier to program and has a more modern look.

Below is a table that compares the predicate device to the proposed Optistar Elite Injection System.

LIEBEL FLARSHEIM BUSINESS 2111 EAST GALBRAITH ROAD Cincinnati, OH 45237

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	Optistar Elite Injection System	Optistar MR Injection SystemInjection SystemPredicate Device(K984088)
Feature
Intended Use	Intended for injecting MR contrast agentsand flushing solutions for the purpose ofenhancing diagnostic imaging of humans.	Intended for injecting MR contrast agentsand flushing solutions for the purpose ofenhancing diagnostic imaging of humans.
MR Environment	Up to 3 Tesla.	Up to 1.5 Tesla.
Multi-phasic Injections	Yes - multiple phases per protocol	Yes - multiple phases per protocol
Protocol Storage	40 protocols	40 protocols
Injection History	Stores last 48 injection results	Stores last 12 injection results
Syringe Sizes	Prefilled Contrast 10ml, 15ml, 20ml, 30mlsyringesPrefilled Saline 50ml & 125 ml syringes60 ml disposable syringes	Prefilled Contrast 10ml, 15ml, 20ml,30ml syringes25ml & 60 ml disposable syringes
Single or Dual SyringeModality	Single syringe and Dual syringe capability	Single syringe and Dual syringecapability
Syringe Drive System	Piezoelectric	Piezoelectric
Syringe Heater	No	No
Flow Rate	A side: MR contrast media10, 15, 20, 30ml syringes: 0.1-8.0 ml/sec60 ml syringes: 0.1-10 ml/secB side: Saline60 ml syringes: 0.1-8.0 ml/sec50 & 125 ml syringes: 0.1-8.0 ml/sec	A side: MR contrast media10, 15, 20, 25, 30ml syringes: 0.1-8.0ml/sec60 ml syringes: 0.1-10 ml/secB side: Saline60 ml syringes: 0.1-7.0 ml/sec
Max Pressure Limit	200 psi	200 psi
Pressure Limit Control	User-settable10 psi increments	User-settable10 psi increments
Flushing System	Manual or via injector	Manual or via injector
Ability to checkpatency	Yes - Manual or using Patency Check	Yes - Manual
Ability to run a TestInjection	Yes - Using Timing Bolus feature	Yes - Running 2 separate injections
Remote Start	Yes	Yes
Scan Delay	0 - 60 seconds	0-60 Seconds
Phase Delays	Yes	No
Inject Delay	Yes	No
Console Controls	Touch screen Color LCD	Touch screen Color LCD
Power head Controls	Keypad	Buttons
Post Injection Readout	Yes	Yes
Enable Sequence	Yes	Yes
Check for Air Button	Yes	Yes
Volume RemainingDisplay	Displayed on Console	Displayed on Console
Mode for keeping fluidpath open	Yes - Drip Mode	Yes -- Drip Mode
Ram Retraction	Manual or automatic	Manual
Materials	Plastic and non-ferrous	Plastic and non-ferrous
Sterility	Injectors are not sterile products. Syringesand Disposables are provided sterile	Injectors are not sterile products. Syringesand Disposables are provided sterile.

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LIEBEL FLARSHEIM BUSINESS 2111 EAST GALBRAITH ROAD CINCINNATI, OH 45237

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9. Performance Testing

Substantial equivalence between the subject device (Optistar Elite) and the predicate device (Optistar MR) can be demonstrated mostly through verification steps. The following steps were taken:

Evaluation of Conformity to Standards The Optistar MR and the Optistar Elite both conform 1. to recognized consensus standards, specifically: IEC 60601-1 IEC 60601-1-2 IEC 60601-1-4
Software Verification and Validation as can be seen by reviewing the Safety and 2. Effectiveness comparison chart, the software differences between the Optistar MR and the Optistar Elite do not impact the safety and effectiveness of the contrast media injector. They have been implemented as conveniences to the user. Software implemented for the Optistar Elite has been verified and validated.
- Verification testing was accomplished through unit, integration, exploratory, and o system level testing. Production equivalent software passed all acceptance criteria in the verification protocol.
- Validation testing was performed by customers on production equivalent units in o simulated clinical conditions. Based on the results, it can be concluded that the Optistar Elite software meets its intended use and meets defined customer needs when thoroughly assessed against the product's Customer Requirements.
1. Non-Software Verification
- The product requirements were verified by reviewing the part (or assembly) drawing, . bill of material, labeling and manuals, or other form of data. The Optistar Elite is mechanically and electrically equivalent to Optistar LE, and therefore documentation for Optistar LE was used to provide verification for the Elite.
- When the Optistar MR was introduced, it was validated in a 1.5 Tesla environment, . which represented the standard MR scanner found in imaging facilities at that time. Since then, MR scanners having a higher field strength have been introduced to the market. The Optistar LE injector has been tested with a variety of MR scanners from various manufacturers. These MR systems had magnetic field strengths up to 3.0 Tesla. In this environment, the injector performed as specified, delivering accurate volume, flow and pressures. The power consumption of the injector did not change when operating in this environment. The scanner manufacturers verified that the presence of the Optistar LE injector near the MR scanner did not interfere with the operation of the MR systems.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 7 2008

Mr. Dale Moore Quality Manager Mallinckrodt Inc., Liebel-Flarsheim Business 2111 East Galbraith Road Cincinnati, OH 45237

Re: K073592

Trade/Device Name: Optistar Elite Injector System Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector and Syringe Regulatory Class: Class II (two) Product Code: DXT Dated: April 11, 2008 Received: April 14, 2008

Dear Mr. Moore:

We have reviewed your Section 510(k) premarket notification of intent to market the device w oneve and have 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 I ou may, atores or visions 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 (PMA), it If your device to such additional controls. Existing major regulations affecting your device can may or subject to back academic egulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Dale Moore

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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

D. Vachner

A Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

KOZ 3592

510(k) Number (if known): KXXXXX

Device Name: Optistar Elite Injection System

Indications For Use:

Prescription Use _ X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

vmer R., v. Ames

vision Sian-Of Division of Cardiovascular Devices

510(k) Number_k073592

Page 15 of 78

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.