(31 days)
The EmpowerCTA Injector system is intended for the vascular administration of contrast and flushing media and the EmpowerCT Injector system is intended for vascular administration of contrast. Both injector systems are used in conjunction with computed tomography (CT) scanning of the body with an optional interface to a CT scanner.
The EmpowerCT and EmpowerCTA Injector Systems are currently marketed as injection systems that use one or two consumable syringe(s) to displace contrast media and flushing media (EmpowerCTA only) to the patient. A motor driven linear actuator mechanism controls displacement of the syringe piston.
The currently marketed injector systems consist of four components. These include the Injector, Remote Control, EDA and Power Supply.
Consistent with currently marketed devices, the proposed device will allow the user to administer the contrast media to the patient by specifying the following variables at the remote control.
Volume- Volume is selectable from 1 ml to 200 ml in 1 ml increments.
Flow Rate- Flow rates are selectable from 0.1 to 10 ml/sec in increments of 0.1ml/sec.
Pressure- Maximum syringe pressure is selectable from 40-300 psi in increments of 1 psi
The provided text is a 510(k) summary for a medical device (EmpowerCT/EmpowerCTA Injector System) and focuses on comparing the modified device to its predicate devices for substantial equivalence. It does not contain information about acceptance criteria or a study proving that the device meets those criteria, as typically found in clinical trial reports or validation studies.
Here's a breakdown of what can be extracted and what is missing based on your request:
1. A table of acceptance criteria and the reported device performance
The document provides performance specifications for the injector systems, which can be considered acceptance criteria based on their current marketing status and regulatory approval. However, it does not explicitly present these as "acceptance criteria" against which a new study's results are being compared to prove the device meets them. Instead, it describes "Proposed Devices" and "Currently marketed devices" with identical performance specifications, indicating that the modification (connectivity) does not alter these core performance aspects.
| Performance Characteristic | Acceptance Criteria (from "Proposed Devices" column, implying "met") | Reported Device Performance (Implied as "Same as Proposed") |
|---|---|---|
| Flow Rate | 0.1 to 10 mL/sec in user specified increments of 0.1 ml/sec. Accuracy: ±5% of programmed rate +0.1 mL/sec | Same as Proposed |
| Delivery Volume | 1 to 200 mL in user specified increments of 1 mL. Accuracy: ±2% of programmed volume +1ml) | Same as Proposed |
| Maximum Pressure | 40 to 300 psi in user specified increments of 1 psi. Accuracy: ±10% of programmed pressure limit + 10 psi | Same as Proposed |
| Connectivity | Yes either via a CT Trigger port or via a data communication method. The data communication method was developed in accordance with the CAN-CIA specification DSP 425. | Yes via a CT Trigger port only. (For currently marketed predicate) |
Missing Information (Not Available in the Provided Text):
The document describes a special 510(k) submission for a device modification (adding scanner connectivity) to a previously cleared device. It establishes substantial equivalence by demonstrating that the performance characteristics of the modified device are identical to the predicate device, except for the new connectivity feature. It does not present a new study with explicit acceptance criteria and corresponding results proving the device meets those criteria for the entire device system in the context of this submission. The focus is on the impact of the modification.
Therefore, the following points cannot be answered from the provided text:
- Sample sized used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method
- 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
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
Summary of what is present:
The document is a regulatory submission demonstrating substantial equivalence for a modification to an existing device. It highlights that the core performance parameters (flow rate, volume, pressure) remain the same as the predicate devices, and the modification is primarily related to connectivity. Therefore, it relies on the previously established performance of the predicate devices rather than presenting new studies to re-prove these fundamental aspects.
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K0630229
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1
EmpowerCT/EmpowerCTA Injector System Special 510(k) Summary
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ﺚ ..
| Contact Information: | Tracey CampbellE-Z-EM, Inc.Director of Regulatory Affairs1111 Marcus Avenue, suite LL-26Lake Success, NY 11042Phone: 516-333-8230, ext. 3407Fax: 516-302-2911 |
|---|---|
| NOV - 2 2006 | |
| Steven HartmanE-Z-EM, Inc.Director of Engineering750 Summa AvenueWestbury, NY 11590Phone: 516-333-8230, ext. 2345Fax: 516-333-2334 | |
| Trade Name: | EmpowerCT and EmpowerCTA Injector Systems |
| Common Name: | Radiographic CT Injector for Contrast Medium, Automatic |
| Classification: | System, X-Ray, Tomography, ComputedPlethysmograph, ImpedanceCardiovascular/Radiology/Injector, Contrast medium,Automatic21 CFR 892.1750 (Product Code JAK)21 CFR 870.2770 (Product Code DSB)21 CFR 870.1650 (Product Code IZQ) |
| Currently MarketedDevices: | E-Z-EM EmpowerCTA Injector System (K031571)EmpowerCT Injector System (K011160) |
| New Indications for Use: | The EmpowerCTA Injector system is intended for thevascular administration of contrast and flushing media andthe EmpowerCT Injector system is intended for vascularadministration of contrast. Both injector systems are usedin conjunction with computed tomography (CT) scanning ofthe body with an optional interface to a CT scanner. |
| Description ofModification: | The EmpowerCT and EmpowerCTA Injector Systems havebeen modified to allow for connection to a CT scanner.This connection will allow data and state information to besynchronized between the scanner and injector systems.The EmpowerCT and EmpowerCTA Injector Systems arecurrently marketed as injection systems that use one ortwo consumable syringe(s) to displace contrast media and |
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flushing media (EmpowerCTA only) to the patient. A motor driven linear actuator mechanism controls displacement of the syringe piston.
The currently marketed injector systems consist of four components. These include the Injector, Remote Control, EDA and Power Supply.
Consistent with currently marketed devices, the proposed device will allow the user to administer the contrast media to the patient by specifying the following variables at the remote control.
| Volume- | Volume is selectable from 1 ml to 200 ml in 1 ml increments. |
|---|---|
| Flow Rate- | Flow rates are selectable from 0.1 to 10 ml/sec in increments of0.1ml/sec. |
| Pressure- | Maximum syringe pressure is selectable from 40-300 psi inincrements of 1 psi |
Accessories:
There is no change to the accessories available with the CT or CTA Injector Systems.
- The EmpowerCT is currently available with or without the E-Z-EM EDA . Device (K961845, K974621). The EmpowerCT Injector System is designed specifically for use with the following currently approved dedicated E-Z-EM disposables:
- Fast*Load CT Syringe (K933846) .
- EDA Electrode Patch (K961845, K974621) .
- Empower Transfer Set (K041178)· .
- · The EmpowerCTA Injector System is also currently available with or without the E-Z-EM EDA device (K961845, K974621) The EmpowerCTA Injector System is designed specifically for use with the currently approved dedicated E-Z-EM disposables:
Comparative Summary:
In the proposed device modification, the EmpowerCT and EmpowerCTA Injectors in addition to having a CT Trigger option, will now have a mechanism to synchronize data and state information communication between the CT Injector System and the CT Scanner. The connectivity is the only modification being made to the EmpowerCT and EmpowerCTA Injector Systems.
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A comparison between the proposed E-Z-EM EmpowerCTA and EmpowerCT Injector A companser botwoon the proposeeed Injector System devices are presented in the following tables.
| Performance (Injector) | Proposed DevicesE-Z-EM EmpowerCT andEmpowerCTA Injector withoptional scanner interconnect | Currently marketeddevicesE-Z-EM EmpowerCT(K011160) andEmpowerCTA Injector(K031571) |
|---|---|---|
| Design | Syringe type injector, softwarecontrolled, venous side, low pressureinjector. | Same as Proposed |
| Anatomical Sites | Inject contrast and flushing mediainto a peripheral vein | Same as Proposed |
| Flow Rate | 0.1 to 10 mL/sec in user specifiedincrements of 0.1 ml/secA Accuracy: ±5% of programmedrate +0.1 mL/sec | Same as Proposed |
| Delivery Volume | 1 to 200 mL in user specifiedincrements of 1 mLAccuracy: ±2% of programmedvolume +1ml) | Same as Proposed |
| Maximum Pressure | 40 to 300 psi in user specifiedincrements of 1 psiAccuracy: ±10% of programmedpressure limit + 10 psi | Same as proposed |
| Pressure Limiting | Yes | Yes |
| Operating Principle | Electric Motor Linear ActuatedSyringe Piston | Same as Proposed |
| Power Supply | Medical Grade Switching PowerSupply | Same as Proposed |
| Remote Start Switch | Yes | Yes |
| Air Detection | User Observed | Same as Proposed |
| Display | Color Touch screen | Same as Proposed |
| Maximum Number of InjectionPhases per Protocol | 8 (Contrast Only)or2 (1 Contrast followed by 1 Saline)or3 (2 Contrast followed by 1 Saline) | Same as Proposed |
| Maximum Number of StoredInjection Protocols | 50 | Same as Proposed |
| Programmed Pause | Yes | Yes |
| Connectivity | Yes either via a CT Trigger port orvia a data communication method.The data communication methodwas developed in accordance withthe CAN-CIA specification DSP 425. | Yes via a CT Trigger portonly. |
| Target Population | Humans | Same as Proposed |
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is a common symbol associated with healthcare and medicine.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
NOV - 2 2006
Ms. Tracey Campbell Director, Regulatory Affairs E-Z-EM, Inc. 750 Summa Avenue WESTBURY NY 11590
Re: K063029
Trade/Device Name: E-Z-EM Empower CT/CTA Injector System with optional EDA Regulation Number: 21 CFR §892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Codes: JAK, DSB and IZQ Dated: September 29, 2006 Received: October 2, 2006
Dear Ms. Campbell:
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/3/Picture/10 description: The image shows a circular logo with the text "1906-2006 FDA Centennial" inside. The logo is surrounded by a ring of stars. The text "FDA" is prominently displayed in the center of the logo. The logo appears to be a commemorative emblem for the 100th anniversary of the Food and Drug Administration.
Protecting and Promoting Public St
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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 Office of 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 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/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
| Number: | K063029 |
|---|---|
| 510(k) Application: | Special 510(k) Device Modification |
| Device Name: | E-Z-EM EmpowerCT/CTA Injector System with optional EDA |
| Indications for Use: | |
| Injector: | Administration of contrast and flushing media in conjunction with computed tomography (CT) scanning of the body with an optional interface to a CT scanner. |
| EDA: | The Extravasation Detection Accessory is indicated for the detection of extravasations of contrast media during CT using a power injector. |
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, and
Radiological Devices
| 510(k) Number | K063029 |
|---|---|
| --------------- | --------- |
| Prescription Use (Per 21 CFR 801.109) | OR | Over-the-Counter Use | |
|---|---|---|---|
| --------------------------------------- | --------------------------------------------- | ---- | ---------------------- |
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.