(144 days)
The CT Exprés III™ Contrast Media Delivery System (CMDS) is indicated for controlled automatic administration, on the venous side, of contrast media (CM) to human subjects while undergoing examination by means of a computed tomography (CT) scanner.
The system consists of the CT Exprés III™ Instrument, the Bottle Spike, the Day Set III, the Patient Set, accessories and detachable parts.
This device is not intended for injection of CM for coronary arteriography, or for any other use for which the device is not indicated.
This device is only to be operated by and under quasi-continuous supervision of qualified medical staff in an appropriate licensed health care facility.
The CT Exprés III™ Contrast Media Delivery System (CMDS) is a programmable, software driven, electromechanical, high-pressure contrast media injection system.
The positive pressure necessary for the injection is generated by a disposable rotary peristaltic cassette, located inside one of the disposable (Patient Set).
The CT Exprés III™ Contrast Media Delivery System consists of the main following elements:
- . The instrument, i.e. the main unit (injector unit and power supply), the main control panel, and associated cables.
- . Accessories, i.e. the handswitch.
- Detachable parts, i.e. the remote control panel, the bottle insulators, and the pedestal pole. .
- Three associated proprietary disposables creating a complete fluidic pathway from the . bottle of CM to the patient, i.e. the "Bottle Spike", the "Day Set III" and the "Patient Set".
The printer and ceiling mount are provided as optional devices for use in combination with the CT Exprés III™.
The provided document is a 510(k) summary for the CT Exprés III™ Contrast Media Delivery System (CMDS). It details the device's intended use and compares it to a predicate device (Premica™-CT CMDS). However, it does not contain information about specific acceptance criteria or a study designed to prove the device meets those criteria, typically found in detailed performance study reports.
The document primarily focuses on establishing substantial equivalence to the predicate device by comparing:
- Intended Use: Both are for controlled administration of contrast media for CT scans. The CT Exprés III™ expands usage to all patients, unlike the predicate device which excluded those under 16 years.
- Physical Design: Similar components (remote panel, single-patient disposables, multi-dose container compatibility, prevention of reuse features), with slight weight differences.
- Operational Characteristics: Similar programmable flow rates (0.5 - 9.9 mL/s vs 0.2 - 9.9 mL/s), identical programmable injection volume (0 - 300 mL), 9 min 59 sec maximum injection duration, identical pressure limit (8 bar/120 psi), test injection, saline flush, connecting tubing length, and storage for 100 protocols.
- Differences:
- Injection Capabilities: CT Exprés III™ can handle up to 5 phases (Saline pre-flush, CM phase one, Saline intermediate flush, CM phase two, Saline post-flush), while the predicate device could only handle up to 3 phases (CM phase one, CM phase two, Saline post-flush).
- Fluid Containers: CT Exprés III™ can simultaneously accommodate two contrast media bottles and one saline container, whereas the predicate handled only two fluid containers.
- Access Gauge: CT Exprés III™ accepts 16-27 G, including smaller needles (23-27 G), with an automatic safety feature to prevent injection if the programmed rate exceeds limits for small gauges. The predicate only accepted 16-22 G.
The document states, "These differences are explained for in the CT Exprés III™ operator's manual and software programming capabilities and do not raise any new questions of safety or effectiveness." This implies that the differences observed are not considered substantial enough to warrant extensive new clinical or performance studies for regulatory approval in the context of a 510(k) submission.
Due to the nature of this 510(k) summary, much of the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication, MRMC study, standalone performance, ground truth details, training set size) is not explicitly present because the submission hinges on substantial equivalence rather than a de novo clinical validation study with specific performance metrics against pre-defined acceptance criteria.
Here's an attempt to answer based on the available information, noting where information is absent:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission seeking substantial equivalence to a predicate device, explicit "acceptance criteria" for novel performance metrics are not typically defined in the same way as for a PMA (Premarket Approval) or a de novo submission. Instead, the "acceptance criteria" are implied to be that the new device performs at least as well as, or introduces only minor differences from, the predicate device without raising new safety or effectiveness concerns.
| Characteristic | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (CT Exprés III™ CMDS) |
|---|---|---|
| Intended Use | Controlled administration of contrast media for CT scans, with no new safety/effectiveness concerns. Potential to broaden patient population without adverse impact. | Indicated for controlled automatic administration of CM to human subjects undergoing CT scans. Can be used with all patients (unlike predicate's age restriction). |
| Flow Rate | Functionally equivalent to 0.2 - 9.9 mL/s. | Programmable 0.5 - 9.9 mL/s. (Slightly narrower low end, but deemed equivalent; also acknowledges flow rate may be limited with very small needles due to pressure limit). |
| Injection Volume | Equivalent to 0 - 300 mL per injection. | Programmable 0 - 300 mL per injection. |
| Maximum Injection Duration | Equivalent to 9 min 59 sec. | 9 min 59 sec. |
| Pressure Limit | Equivalent to 8 bar (ca. 120 psi) for safety alarms. | 8 bar (ca. 120 psi). Incorporated with pressure sensors for occlusion alarms. |
| Injection Phases | At least up to 3 phases. | Up to 5 phases: Saline (pre-flush), CM (phase one), Saline (intermediate flush), CM (phase two), Saline (post-flush). (Improved capability over predicate). |
| Number of Fluid Containers | Accommodate at least two fluid containers. | Can simultaneously accommodate two bottles of contrast media and one container with saline. (Improved capability over predicate). |
| Access Gauge | Accept 16-22 G needles. | Accepts 16-27 G needles. Includes very small sizes (23-27 G) with a safety feature: automatically displays information and prevents function if an unsafe injection rate is programmed for small gauges. (Improved capability and safety over predicate for smaller gauges). |
| Safety Features | Presence of pressure sensors and Air-In-Line sensors. | Incorporates pressure sensors (8 bar alarm) and Air-In-Line sensors for patient safety. |
| Disposables | Single patient use, designed to prevent reuse. | Single patient use ("Patient Set"). Disposables have design features that prevent their reuse. |
| Temperature Control | Passive temperature control for heated contrast. | Bottle insulators for passive temperature control. |
| Storage Protocols | Equivalent to 100 protocols. | Stores 100 protocols. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable/Not provided. The 510(k) submission does not describe a clinical test set with human or animal subjects for performance evaluation against specific criteria. It relies on a comparison of technical specifications and design features to a legally marketed predicate device.
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/Not provided. No "test set" requiring expert ground truth establishment is described in this 510(k) summary. The comparison is based on engineering specifications and design.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/Not provided. No test set or adjudication process is detailed.
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/Not provided. This device is an electromechanical contrast media injector, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study or AI-related effectiveness assessment is not relevant to its regulatory submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable/Not provided. This device is a hardware system with software controls, not a standalone algorithm. Its performance is inherent in its electromechanical function, not an "algorithm-only" assessment.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable/Not provided. The ground truth in this context would be the predicate device's established performance and the engineering specifications used for the new device. No clinical outcomes data or pathology reviews are presented here.
8. The sample size for the training set
Not applicable/Not provided. This is not a machine learning or AI-driven device, so there is no concept of a "training set" for an algorithm.
9. How the ground truth for the training set was established
Not applicable/Not provided. As there is no training set mentioned, the establishment of its ground truth is not applicable.
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Swiss Medical Care -
510(k) SUMMARY SWISS MEDICAL CARE S.A. CT EXPRÉS III ™ CONTRAST MEDIA DELIVERY SYSTEM (PER 21 CFR 807.92)
1. SUBMITTER NAME AND ADDRESS
Swiss Medical Care S.A. Avenue de Sévelin 28 CH-1004 Lausanne SWITZERLAND Tel: +41 (0)21 623 60 30 Fax: +41 (0)21 623 60 31
Contact Person: Ms. Cécile Boyer, Manager, Regulatory Affairs Email: c.boyer@swissmedcare.com
2. DEVICE NAME
CT Exprés III™ Contrast Media Delivery System (CMDS) Trade Name: Common/Usual Name: Automatic injector for contrast media Iniector Classification Name: Injector, Contrast medium, automatic (21 CFR 870.1650, Product Code IZQ)
3. PREDICATE DEVICE/S
Premica™-CT Contrast Media Delivery System - K983314
DEVICE DESCRIPTION 4.
The CT Exprés III™ Contrast Media Delivery System (CMDS) is a programmable, software driven, electromechanical, high-pressure contrast media injection system.
The positive pressure necessary for the injection is generated by a disposable rotary peristaltic cassette, located inside one of the disposable (Patient Set).
The CT Exprés III™ Contrast Media Delivery System consists of the main following elements:
- . The instrument, i.e. the main unit (injector unit and power supply), the main control panel, and associated cables.
- . Accessories, i.e. the handswitch.
- Detachable parts, i.e. the remote control panel, the bottle insulators, and the pedestal pole. .
- Three associated proprietary disposables creating a complete fluidic pathway from the . bottle of CM to the patient, i.e. the "Bottle Spike", the "Day Set III" and the "Patient Set".
The printer and ceiling mount are provided as optional devices for use in combination with the CT Exprés III™.
DEC 26 2006
:
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INTENDED USE 5.
The CT Exprés III™ Contrast Media Delivery System (CMDS) is indicated for controlled automatic administration, on the venous side, of contrast media (CM) to human subjects while undergoing examination by means of a computed tomography (CT) scanner.
The system consists of the CT Exprés III™ Instrument, the Bottle Spike, the Day Set III, the Patient Set, accessories and detachable parts.
This device is not intended for injection of CM for coronary arteriography, or for any other use for which the device is not indicated.
This device is only to be operated by and under quasi-continuous supervision of qualified medical staff in an appropriate licensed health care facility.
6. BASIS FOR SUBSTANTIAL EQUIVALENCE
Information supplied in this premarket notification includes descriptive information about the intended use, operation, and technological characteristics. A side-by-side comparison of the CT Exprés III™ Contrast Media Delivery System with the CT Exprés™ Contrast Media Delivery System is provided in Table J-1 below:
| Characteristics | CT Exprés III™ CMDS | Premica™-CT CMDS(K983314) |
|---|---|---|
| Indication | ||
| Indicated for controlledadministration of contrast media forcomputed tomography scans | Yes | Yes |
| Not intended for use with childrenunder 16 years of age | No | Yes |
| Physical Design | ||
| Remote panel | Yes | Yes |
| Weight (without fluid containers) | Injector : 8.5 kg (18 lbs)Console : 1.7 kg (3.7 lbs) | Injector : 8 kg (17.6 lbs)Console : 1.7 kg (lbs) |
| Contrast media temperature control | Bottle insulators | Bottle insulators |
| Single patient use disposables | Patient Set | Patient Set |
| Multiple patient solutions | Yes | Yes |
| Designed to prevent reuse ofdisposables | Yes | Yes |
| Operational Characteristics | ||
| Programmable flow rate | 0.5 - 9.9 mL/s | 0.2 - 9.9 mL/s |
| Programmable injection volume perinjection | 0 - 300 mL | 0 - 300 mL |
| Maximum injection duration | 9 min 59 sec | 9 min 59 sec |
Table H-1: Comparison of CT Exprés III™ Contrast Media Delivery System with CT Exprés™ Contrast Media Delivery System
CONFIDENTIAL Appendix H, page 2
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Table H-1: Comparison of CT Exprés III™ Contrast Media Delivery System with CT Exprés TM Contrast Media Delivery System (Continued)
| Characteristics | CT Exprés III™ CMDS | Premica™-CT CMDS(K983314) |
|---|---|---|
| Contrast media container volume | 50-500 mL | 50-500 mL |
| Pressure limit | 8 bar (ca. 120 psi) | 8 bar (ca. 120 psi) |
| Test injection default | Yes | Yes |
| Injection capabilities | Up to 3 phases | Up to 5 phases |
| Saline flush | Yes | Yes |
| Connecting tubing | Length = 1.5 m | Length = 1.5 m |
| Access types | Flexible | Flexible |
| Access gauge | 16-27 G | 16-22 G |
| Interphase delay | 0-99 sec | 0-99 sec |
| Scan delay | 0-99 sec | 0-99 sec |
| Injection protocol storage | 100 protocols | 100 protocols |
Indications for use
Both the CT Exprés III™ and Premica™-CT contrast media delivery system are indicated for the controlled administration of contrast media for computed tomography scans.
The CT Exprés III™ can be used with all patients. The Premica™-CT labelling indicates that the device can not be used with patients under 16 years of age.
Physical design
Both systems consist of several elements.
Both systems have remote panels to allow easier user control of the systems.
Both systems provide single patient use disposables ("Patient Set"). Both systems have disposables with design features that prevent their reuse.
Both systems draw their contrast media or saline from multi-dose containers (bottles or soft pouches). Contrast media container volumes are identical for the two systems (50 - 500 mL).
Operational characteristics
Programmable flow rate ranges are nearly identical for both systems (0.5 - 9.9 mL/s for the CT Exprés III™, 0.2-9.9 mL/s).
The programmable volume of contrast media per injection is also identical (0 - 300 mL/injection).
Programmable flow rate ranges and programmable volume ranges being identical, the injection durations are also identical for the two systems.
July 17, 2006
CONFIDENTIAL Appendix H, page 3
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Swiss Medical Care = =
The CT Exprés III™ can be programmed for injection sequences of one to five steps:
-
- Saline (pre-flush)
-
- Contrast media (phase one)
-
- Saline (intermediate flush)
-
- Contrast media (phase two)
-
- Saline (post-flush)
The Premica™-CT can be programmed for injection sequences of up to three steps:
-
- Contrast media (phase one)
-
- Contrast media (phase two)
-
- Saline (post-flush)
Both systems incorporate pressure sensors with the limit for triggering a pressure alarm (occlusion alarm) at 8 bar (ca. 120 psi).
Both systems incorporate Air-In-Line sensors for patient safety.
Since contrast media temperature can change the fluid viscosity, both systems provide for passive temperature control in the form of bottle insulators to reduce temperature loss from the heated contrast.
One difference between the two systems is the ability of the CT Exprés III™ to simultaneously accommodate two bottles of contrast media and one container with saline, whereas the Premica™-CT can accommodate only two fluid containers (two bottles of contrast media OR one bottle with contrast media and one container with saline).
Another difference between the two systems is the ability of the CT Expres III™ to accept not only the range of needle sizes (16-22 G) normally used for injecting contrast media, but also very small needle sizes (23-27 G). Note that, when using the very small needle sizes (23-27 G). the programmable injection rates may be limited to values of only a few mL/s because the injection pressure that CT Exprés III™ is generating is limited to 8 bar (ca. 120 psi). As a safety feature, CT Exprés III™ will automatically display information for the user when an injection rate is programmed above the limit injection rate. Under these circumstances, the CT Expres III™ will not function. This makes the CT Expres III™ suitable for use with patients or injection conditions where very small needle sizes are preferred.
The Premica™-CT can only accept needle sizes in the range of 16 - 22 G, making it unsuitable for use with patients or injection conditions where very small needle sizes are preferred.
These differences are explained for in the CT Exprés III™ operator's manual and software programming capabilities and do not raise any new questions of safety or effectiveness.
7. PREPARATION DATE OF 510(K) SUMMARY
July 26, 2006
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Image /page/4/Picture/0 description: The image shows a circular logo with text around the perimeter and a stylized eagle in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN". The eagle is depicted with three thick, curved lines forming its body and wings, giving it a modern and abstract appearance.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Swiss Medical Care S.A. % Mr. Robert L. Aromando, Jr. Managing Partner K Street Associates, LLC PMB 237, 203 Main Street FLEMINGTON NJ 08822
Re: K062265
Trade/Device Name: Swiss Medical Care S.A. CT EXPRESS III™ Contrast Media Delivery System Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector and Syringe Regulatory Class: II Product Code: IZQ
Dated: December 7, 2006 Received: December 8, 2006
Dear Mr. Aromando:
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.
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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/4/Picture/11 description: The image shows a circular logo with the text "1906-2006" at the top. The letters "FDA" are prominently displayed in the center, with the word "Centennial" written below. Three stars are arranged in a row beneath the word "Centennial", and the phrase "Science in Service of Health" is written along the bottom curve of the circle. The logo appears to commemorate the centennial of the Food and Drug Administration.
Protecting and Promoting Public Health
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Page 2 --
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I loase of actived that i Drimination that your device complies with other requirements of the Act that I Dri hes intact and regulations administered by other Federal agencies. You must or any I catal statutes and regerements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI K I at 607), lacemig (21 OFF regulation (21 CFR Part 820); and if applicable, the electronic form in the quint) of ovisions (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) I his icher will anow you to oogin mains of substantial equivalence of your device to a legally premarket notheadon: "The President 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 If you desire specific at Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under (21 CF F at 60 : 377): " roo 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/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: SWISS MEDICAL CARE S.A. CT EXPRÉS III™ CONTRAST MEDIA DELIVERY SYSTEM
Indications for Use:
The CT Exprés III™ Contrast Media Delivery System (CMDS) is indicated for controlled automatic administration, on the venous side, of contrast media (CM) to human subjects while undergoing examination by means of a computed tomography (CT) scanner.
The system consists of the CT Exprés III™ Instrument, the Bottle Spike, the Day Set III, the Patient Set, accessories and detachable parts.
This device is not intended for injection of CM for coronary arteriography, or for any other use for which the device is not indicated.
This device is only to be operated by and under quasi-continuous supervision of qualified medical staff in an appropriate licensed health care facility.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Buchholz for NCB
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K061265
Swiss Medical Care S.A. 510(K) July 28, 2006
CONFIDENTIAL
§ 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.