(147 days)
Not Found
No
The description mentions "microprocessor control" for basic injection parameters (flow rate, volume, pressure, timing) and "programmability" via a touch screen. There is no mention of AI, ML, or any advanced algorithms that learn or adapt based on data. The performance studies focus on verification and validation against specifications, not on the performance of an AI/ML model.
No
The device is designed 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 for diagnostic imaging, not to perform the diagnosis itself.
No
The device description clearly outlines hardware components such as a Powerhead, Console, and Power Supply, which are integral to the device's function of injecting contrast media. This indicates it is a hardware-based medical device with software control, not a software-only device.
Based on the provided information, the OptiOne Single-Head Contrast Delivery System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This testing is performed outside of the living body (in vitro).
- OptiOne's Function: The OptiOne system is designed to inject a substance (contrast media) into a patient's vascular system. This is an in vivo procedure, meaning it takes place within the living body.
- Intended Use: The intended use is to obtain diagnostic images with CT equipment, not to analyze biological samples.
Therefore, the OptiOne Single-Head Contrast Delivery System is a medical device used for image acquisition during a diagnostic procedure performed on a living patient, not an IVD device used for testing biological samples.
N/A
Intended Use / Indications for Use
The OptiOne Single-Head Contrast Delivery System is a contrast delivery system and is designed to inject radiopaque contrast media into a patient's vascular system to obtain diagnostic images with computed tomography (i.e. "CT") equipment.
Product codes (comma separated list FDA assigned to the subject device)
IZQ
Device Description
The OptiOne Single-Head Contrast Delivery System (OptiOne) is intended to inject radiopaque contrast media into a patient's vascular system to obtain diagnostic images when used in conjunction with computed tomography equipment. Each injection is accomplished with a motor-driven syringe mechanism with microprocessor control of the flow rate, volume, pressure and timing. The OptiOne consists of the following key components: a Powerhead, a Console, and a Power Supply. The Power Supply delivers power to the Powerhead and Console. The Console provides remote control and programmability of the injection through a touch screen display system. The Powerhead contains the components to perform the actual injection such as motor control circuits, ball screw and syringe push ram.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
computed tomography (i.e. "CT") equipment
Anatomical Site
patient's vascular system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The OptiOne is intended for use by doctors, radiology technologists and other licensed medical practitioners in a healthcare facility or hospital with computed tomography equipment.
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)
Extensive verification and validation activities were performed to ensure the OptiOne Single-Head Contrast Delivery System design outputs met all design inputs and the customer requirements were successfully met. The testing confirms the OptiOne Single-Head Contrast Delivery System meets the required specifications.
The OptiOne Single-Head Contrast Delivery System was also tested in conformance to the following recognized standards:
IEC ISO 14971 Second edition 2007-03-01 Application of Risk Management to Medical Devices
ISO 15223-1 Second Edition 2012-07-01 Medical Devices - Symbols to be Used with Medical Device Labels, Labelling, and Information to be Supplied - Part 1
AAMI / ANSI ES60601-1:2005/(R)2012 and C1:2009/(R)2012 and, a2:2010/(r)2012 Medical Electrical Equipment -- Part 1: General Requirements for Basic Safety and Essential Performance
IEC 60601-1-2 Edition 4.0 2014-02 Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements and Tests
IEC 60601-1-6 Edition 3.1 2013-10 Medical Electrical Equipment - Part 1-6: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Usability
IEC 62304 First Edition 2006-05 Medical Device Software - Software Life Cycle Processes. (Software/Informatics)
IEC 62366 Edition 1.1 2014-01 Medical Devices - Application of Usability Engineering to Medical Devices. (General I)
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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Image /page/0/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol of medicine and healing. The caduceus is composed of three human profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circle around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 14, 2016
Liebel-Flarsheim Company, LLC Craig Buehler Sr. Regulatory Affairs Specialist 2111 East Galbraith Rd Cincinnati, Ohio 45237
Re: K152361
Trade/Device Name: OptiOne Single-Head Contrast Delivery System Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector And Syringe Regulatory Class: Class II Product Code: IZQ Dated: December 14, 2015 Received: December 15, 2015
Dear Craig Buehler:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above 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 general controls provisions of the Act include requirements for annual registration, listing of devices. good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kenneth J. Cavanaugh -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K152361
Device Name
OptiOne Single-Head Contrast Delivery System
Indications for Use (Describe)
The OptiOne Single-Head Contrast Delivery System is a contrast delivery system and is designed to inject radiopaque contrast media into a patient's vascular system to obtain diagnostic images with computed tomography (i.e. "CT") equipment.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for Mallinckrodt Pharmaceuticals. The logo consists of a geometric shape on the left, made up of overlapping cubes in shades of green, blue, and purple. To the right of the shape is the company name, "Mallinckrodt" in a bold, dark blue font, with the word "Pharmaceuticals" underneath in a lighter blue, smaller font.
Section 5: 510(k) Summary
I. SUBMITTER
Liebel-Flarsheim Company LLC 2111 East Galbraith Rd. Cincinnati. OH 45237 Establishment Number: 1518293
| Contact: | Mr. Craig Buehler |
|---|---|
| Title: | Sr. Regulatory Affairs Specialist |
| Telephone: | (314) 654-3188 |
| Fax: | (314) 654-3344 |
| Date Prepared: | 19 August 2015 |
II. DEVICE
Name of Device: OptiOne Single-Head Contrast Delivery System Common or Usual Name: Power Injector Classification Name: Injector, Contrast Medium, Automatic (21 CFR 870.1650) Regulatory Class: II Product Code: IZQ
| Model Number | Description |
|---|---|
| 847002 | Injector, OptiOne Base System |
| S8472 | OptiOne Single-Head Contrast Delivery System with Pedestal |
| S8473 | OptiOne Single-Head Contrast Delivery System with Ceiling |
| Suspension |
III. PREDICATE DEVICE
OptiVantage DH Injector System with Enhanced Communication (K063503)
IV. DEVICE DESCRIPTION:
The OptiOne Single-Head Contrast Delivery System (OptiOne) is intended to inject radiopaque contrast media into a patient's vascular system to obtain diagnostic images when used in conjunction with computed tomography equipment. Each injection is accomplished with a motor-driven syringe mechanism with microprocessor control of the flow rate, volume, pressure and timing. The OptiOne consists of the following key components: a Powerhead, a Console, and a Power Supply. The Power
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Image /page/4/Picture/0 description: The image shows the Mallinckrodt Pharmaceuticals logo. The logo consists of a geometric shape on the left and the company name on the right. The geometric shape is made up of several overlapping cubes in shades of green, blue, and purple. The company name is written in a dark blue font, with the word "Mallinckrodt" on top and the word "Pharmaceuticals" below.
Supply delivers power to the Powerhead and Console. The Console provides remote control and programmability of the injection through a touch screen display system. The Powerhead contains the components to perform the actual injection such as motor control circuits, ball screw and syringe push ram.
The OptiOne is intended for use by doctors, radiology technologists and other licensed medical practitioners in a healthcare facility or hospital with computed tomography equipment.
The OptiOne incorporates the same materials as its predicate device and will not contact the patient under normal operation conditions.
V. INDICATIONS FOR USE
The OptiOne Single-Head Contrast Delivery System is a contrast delivery system and is designed to inject radiopaque contrast media into a patient's vascular system to obtain diagnostic images when used with computed tomography (i.e. "CT") equipment.
The OptiOne and the OptiVantage predicate device both have the same indication for use.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The OptiOne Single-Head Contrast Delivery System (OptiOne) was developed using the predicate device, OptiVantage DH Injector System with Enhanced Communication (OptiVantage), as the basis for the injector design. Many of the same components and accessories found in and used with the OptiVantage are also found and used with the OptiOne. The main difference between the OptiOne and its predicate is the OptiVantage is a dual head injector and the OptiOne is a single head injector.
The OptiOne has the same technological characteristics as the predicate OptiVantage. These similarities and the differences reducing the powerhead from the predicate device's dual head to a single head are described in the table beginning on the next page.
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Image /page/5/Picture/0 description: The image shows the logo for Mallinckrodt Pharmaceuticals. The logo consists of a geometric design on the left, made up of overlapping cubes in shades of green, blue, and purple. To the right of the geometric design is the company name, "Mallinckrodt," in a bold, dark blue font, with the word "Pharmaceuticals" underneath in a smaller, lighter blue font.
| Feature | OptiOne Single-Head Contrast
Delivery System | OptiVantage DH Injector System
with Enhanced Communication
(K063503) |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| Indication for Use | is a contrast delivery system and is
designed to inject radiopaque
contrast media into a patient's
vascular system to obtain
diagnostic images when used with
computed tomography (i.e. "CT")
equipment. | Same |
| Number of Phases | 4 phases per protocol maximum | 6 phases per protocol maximum |
| Protocol Storage | 40 protocols | Same |
| Syringe Sizes | 125 mL, 100 mL, 75 mL, 50 mL
pre-filled
200 mL empty | Same |
| Single or Dual Syringe
Modality | Single Syringe Capability | Single and Dual Syringe Capability |
| Syringe Drive System | Electromechanical | Same |
| Syringe Heater | 98° ± 6° F (37° ± 3° C) nominal.
Maintains the temperature of pre-
heated contrast (not intended to
heat cold/room temperature
contrast). | Same |
| Auto Syringe Fill Rate | 7.0 mL/s
Tolerance: +/-5% | Same |
| Manual Fill Rate | 2.0 - 15 mL/s
Tolerance: +/- 1 mL/s | Same |
| Flow Rate | 0.1 - 10 mL/s adjustable in
increments of 0.1 mL/s
Tolerance: +/-0.05 mL/s for Flow
Rates less than 1 mL/s
+/-5 % for Flow Rates 1 mL/s to
10 mL/s | Same |
| Peak Pressure Limit | Pounds per Square Inch (psi):
50 - 325 adjustable in 5 psi
increments
kPa: 345 – 2240 adjustable in
34 kPa increments | Same |
| Feature | OptiOne Single-Head Contrast
Delivery System | OptiVantage DH Injector System
with Enhanced Communication
(K063503) |
| Remote Start | Use of the remote hand switch
allows the operator to perform
injections from outside the area of
direct radiation. | Same |
| Scan Delay | 0 - 600 seconds adjustable in
increments of 1 second | Same |
| Phase Delay | 0 – 600 seconds adjustable in
increments of 1 second or
permanent pause | Same |
| Inject Delay | 0 - 600 seconds adjustable in
increments of 1 second | Same |
| OptiBolus | Yes - The OptiBolus feature is
used to deliver an exponentially
decaying flow rate injection that
optimizes the contrast usage and
provides an extended period of
uniform enhancement of the area
of interest. | Same |
| Universal Console | 12.25 W x 2.5 H x 8.5 D inches
(311 W x 64 H x 216 D mm)
5.8 lbs (2.6 kg) | Same |
| Powerhead | 7 W x 6 H x 12.25 D inches
(178 W x 152 H x 311 D mm)
10.4 lbs (4.7 kg) | 12.5 W x 6 H x 8 D inches
(318 W x 152 H x 203 D mm)
14.5 lbs (6.57 kg) |
| Power Supply | 10 W x 4 H x 9 D inches
(267 W x 102 H x 228 D mm)
6 lbs (2.7 kg) | Same |
| Post Injection
Readout | Displayed on Powerhead and
Console | Same |
| OEM Interface | Available Via Relays and Optical
Couplings / Serial (CAN) | Same |
| Safety Stop
Mechanism | Electrical Stop When Injection
Parameters are Out of
Specification | Same |
| Volume Remaining
Display | Displayed on Powerhead and
Console | Same |
| Materials | Plastic and Metal | Same Plastic and Metal |
| Target Population | Humans | Same |
| Feature | OptiOne Single-Head Contrast
Delivery System | OptiVantage DH Injector System
with Enhanced Communication
(K063503) |
| Sterility (Syringe) | Injectors are not sterile products,
but syringes and disposables are
provided sterile. | Same |
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Image /page/6/Picture/0 description: The image shows the logo for Mallinckrodt Pharmaceuticals. The logo consists of a geometric shape made up of overlapping cubes in shades of green, blue, and purple. To the right of the geometric shape is the company name, "Mallinckrodt" in a bold, dark blue font, with the word "Pharmaceuticals" underneath in a lighter, thinner font.
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Image /page/7/Picture/0 description: The image shows the logo for Mallinckrodt Pharmaceuticals. On the left is a geometric design of overlapping cubes in shades of green, blue, and purple. To the right of the design is the company name, "Mallinckrodt" in large, bold, navy blue font, with the word "Pharmaceuticals" underneath in a smaller, lighter blue font.
VII. PERFORMANCE DATA
Extensive verification and validation activities were performed to ensure the OptiOne Single-Head Contrast Delivery System design outputs met all design inputs and the customer requirements were successfully met. The testing confirms the OptiOne Single-Head Contrast Delivery System meets the required specifications.
The OptiOne Single-Head Contrast Delivery System was also tested in conformance to the following recognized standards:
| Standard |
|---|
| IEC ISO 14971 Second edition 2007-03-01 Application of Risk Management to |
| Medical Devices |
| ISO 15223-1 Second Edition 2012-07-01 Medical Devices - Symbols to be |
| Used with Medical Device Labels, Labelling, and Information to be Supplied - |
| Part 1 |
| AAMI / ANSI ES60601-1:2005/(R)2012 and C1:2009/(R)2012 and, |
| a2:2010/(r)2012 Medical Electrical Equipment -- Part 1: General Requirements |
| for Basic Safety and Essential Performance |
| IEC 60601-1-2 Edition 4.0 2014-02 Medical Electrical Equipment - Part 1-2: |
| General Requirements for Basic Safety and Essential Performance - Collateral |
| Standard: Electromagnetic Disturbances - Requirements and Tests |
| IEC 60601-1-6 Edition 3.1 2013-10 Medical Electrical Equipment - Part 1-6: |
| General Requirements for Basic Safety and Essential Performance - Collateral |
| Standard: Usability |
| IEC 62304 First Edition 2006-05 Medical Device Software - Software Life |
| Cycle Processes. (Software/Informatics) |
| IEC 62366 Edition 1.1 2014-01 Medical Devices - Application of Usability |
| Engineering to Medical Devices. (General I) |
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Image /page/8/Picture/0 description: The image shows the Mallinckrodt Pharmaceuticals logo. The logo consists of a geometric design on the left and the company name on the right. The geometric design is made up of overlapping cubes in shades of green, blue, and purple. The company name is written in a dark blue font, with "Mallinckrodt" on the top line and "Pharmaceuticals" on the bottom line.
VIII. CONCLUSIONS
The OptiOne Single-Head Contrast Delivery System was developed under the Liebel-Flarsheim Company LLC Design Control processes. The verification and validation activities ensure the OptiOne meets all customer requirements and product specifications. The OptiOne Single-Head Contrast Delivery System has the same intended use as its predicate. The powerhead and software was modified from the predicate device to reflect the clinical use of a single head contrast delivery system from a dual head injector. Based on the data contained in this submission, Liebel-Flarsheim Company LLC believes the OptiOne Single-Head Contrast Delivery System is substantially equivalent to its predicate.