(139 days)
Not Found
No
The summary describes a contrast delivery system with standard components and performance testing focused on safety, accuracy of delivery, and compatibility with MR systems. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is used to inject contrast media for diagnostic imaging, not to treat a disease or condition.
No
The device is a contrast delivery system designed to inject contrast media and flushing solutions to obtain diagnostic images, not directly produce them or diagnose. It works with imaging equipment for diagnostic purposes, making it an accessory rather than a diagnostic device itself.
No
The device description explicitly lists multiple hardware components (Power Head, Console, Power Control, Power Supply, syringes) and the performance studies include non-software verification and testing with MR scanners, indicating it is a hardware device with integrated software.
Based on the provided information, the Optistar Elite Injection System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to inject contrast media and flushing solutions into a patient's vascular system to obtain diagnostic images using MRI equipment. This is a direct interaction with the patient's body for imaging purposes, not for testing samples in vitro (outside the body).
- Device Description: The device is described as a delivery system for injecting substances into the vascular system. This aligns with a medical device used for patient treatment or diagnosis through imaging, not for laboratory testing.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (blood, urine, tissue, etc.) or performing tests in vitro.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Optistar Elite's function is to facilitate imaging within the body.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DXT
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- 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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging
Anatomical Site
Patient's vascular system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 to recognized consensus standards, specifically: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4.
- Software Verification and Validation: 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 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 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.
- 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.
- The Optistar LE injector has been tested with a variety of MR scanners from various manufacturers with 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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
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.
7. Description of Device
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- 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 System
Injection System
Predicate Device
(K984088) |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | | |
| Intended Use | Intended for injecting MR contrast agents
and flushing solutions for the purpose of
enhancing diagnostic imaging of humans. | Intended for injecting MR contrast agents
and flushing solutions for the purpose of
enhancing 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, 30ml
syringes
Prefilled Saline 50ml & 125 ml syringes
60 ml disposable syringes | Prefilled Contrast 10ml, 15ml, 20ml,
30ml syringes
25ml & 60 ml disposable syringes |
| Single or Dual Syringe
Modality | Single syringe and Dual syringe capability | Single syringe and Dual syringe
capability |
| Syringe Drive System | Piezoelectric | Piezoelectric |
| Syringe Heater | No | No |
| Flow Rate | A side: MR contrast media
10, 15, 20, 30ml syringes: 0.1-8.0 ml/sec
60 ml syringes: 0.1-10 ml/sec
B side: Saline
60 ml syringes: 0.1-8.0 ml/sec
50 & 125 ml syringes: 0.1-8.0 ml/sec | A side: MR contrast media
10, 15, 20, 25, 30ml syringes: 0.1-8.0
ml/sec
60 ml syringes: 0.1-10 ml/sec
B side: Saline
60 ml syringes: 0.1-7.0 ml/sec |
| Max Pressure Limit | 200 psi | 200 psi |
| Pressure Limit Control | User-settable
10 psi increments | User-settable
10 psi increments |
| Flushing System | Manual or via injector | Manual or via injector |
| Ability to check
patency | Yes - Manual or using Patency Check | Yes - Manual |
| Ability to run a Test
Injection | 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 Remaining
Display | Displayed on Console | Displayed on Console |
| Mode for keeping fluid
path 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. Syringes
and Disposables are provided sterile | Injectors are not sterile products. Syringes
and 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.
-
- 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.
4
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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
6
Indications for Use
KOZ 3592
510(k) Number (if known): KXXXXX
Device Name: Optistar Elite Injection System
Indications For Use:
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.
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
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