(14 days)
The SyneRad Impact 60, SyneRad Impact 72 and Analogic AMS1600 are Computed Tomography X-ray Systems intended to produce images of the head and whole body by computer reconstruction of X-ray transmission data at different angle and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
The SyneRad IMPACT 60, SyneRad IMPACT 72 and Analogic AMS1600 Multislice Computed Tomography Systems consist of a gantry, a patient table and an operator console. All three CT Systems are virtually identical. The physical size of all three systems is the same and they use the same control console, operating system and software. The Analogic AMS1600 is the platform from which the two Anexa systems are built and is identical in construction (except for cosmetics created by the covers) to the SyneRad IMpact 72. The difference between the SyneRad IMPACT 60 and the SyneRad IMpact 72 is the output rating of the High Voltage Power Supply mounted on the gantry. The SyneRad IMPACT 60 has a 60 kW PSU whereas the SyneRad IMpact 72 has a 72 kW PSU. The kVp levels are the same for both systems. The upper mA setting for the 60 kW system is 500 mA. The upper mA setting for the 72 kW system is 600 mA. The High Voltage Power Supply provides feedback to the control computer which selects the upper mA limit. These 16-slice CT scanners have a gantry aperture opening of 70 centimeters. They are based on proven Analogic computed tomography technology. They have a 16-row detector and a 0.50 second minimum scan time. High-speed image reconstruction is from an innovative reconstruction engine. The operator console is supplied with two 20-inch high resolution monitors. 3D software is standard. Workflow and patient throughput requirements are supported by local archiving and DICOM-based interconnectivity features.
The provided document describes the Analogic Corporation's SyneRad IMPACT 60, SyneRad IMPACT 72, and Analogic AMS1600 Computed Tomography X-ray systems. It is a 510(k) submission, meaning the company is seeking to demonstrate substantial equivalence to previously cleared devices, rather than conducting new clinical trials for effectiveness. Therefore, the information typically associated with acceptance criteria being met by a study might not be present in the same format as for novel devices.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative performance metric sense (e.g., sensitivity, specificity for a diagnostic task). Instead, it relies on demonstrating comparable technological characteristics and performance (measured on phantoms) to predicate devices.
The key performance comparison is presented in the "Key Parameters Comparison Chart":
| Characteristic | Anexa IMPACT72 | Anexa IMPACT 60 | G. E. Healthcare LightSpeed 6.0 (LightSpeed Pro16) | G. E. Healthcare LightSpeed 5.0 (LightSpeed 16) | Toshiba AQUILION 16 CFX |
|---|---|---|---|---|---|
| High Contrast Spatial Res. | |||||
| 0% MTF, lp/cm | 17.25 lp/cm | 17.25 lp/cm | 15.4 lp/cm | 15.4 lp/cm | 18 lp/cm |
| 50% MTF, lp/cm | 8+ lp/cm | 8+ lp/cm | 8.5 lp/cm | 8.5 lp/cm | 9.4 lp/cm |
| Low-contrast res., mm @ % @ 4 rads | 5 mm @ 0.30%, 8" CATPHAN | 5 mm @ 0.30%, 8" CATPHAN | 5 mm @ 0.30%, 8" CATPHAN | 5 mm @ 0.30%, 8" CATPHAN | 5 mm @ 0.3% @ 21.8 mGy (per MHRA) |
| Weighted CTDI shown on console | Yes | Yes | Yes | Yes | Yes |
| Dose Length Product shown on console | Yes | Yes | Yes | Yes | Yes |
| Geometric Efficiency displayed | Yes | Yes | Yes | Yes | Yes |
Acceptance Criteria (Implicit via Substantial Equivalence): The implicit acceptance criterion is that the new devices perform as well as or better than the predicate devices in the listed image quality parameters, and share similar functional characteristics and intended uses.
Reported Device Performance: As seen in the table, the SyneRad systems show comparable or slightly better high-contrast spatial resolution (e.g., 0% MTF of 17.25 lp/cm vs. 15.4 lp/cm for GE, 50% MTF of 8+ lp/cm vs. 8.5 lp/cm for GE) and identical low-contrast resolution (5 mm @ 0.30%) to the predicate devices. Other features like displaying CTDI and DLP are also matched.
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Their X-ray power and technique factors are comparable to the predicate devices. They also have comparable image quality performance (measured on phantoms) as the predicate devices."
- Sample Size for Test Set: Not explicitly stated as a number of patients or cases. The testing was conducted on phantoms, which are inanimate objects designed to simulate human tissue for specific measurements. The specific number of times each phantom was scanned or the variety of phantoms used is not detailed.
- Data Provenance: The data appears to be prospective bench testing conducted internally by Analogic Corporation on their new devices in comparison to characteristics of predicate devices. There is no mention of country of origin for patient data as no patient data was used for performance comparison.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. Ground truth for phantom-based image quality measurements is typically established by physical measurements and the inherent design parameters of the phantoms themselves, not by human expert interpretation in the same way as clinical diagnostic studies.
4. Adjudication Method for the Test Set
Not applicable. As no human expert interpretation or clinical decision-making was involved in establishing the "ground truth" for the phantom testing, no adjudication was necessary.
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
No. This is a 510(k) submission for a new CT scanner system, not an AI-powered diagnostic algorithm. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or is relevant to this submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, in a way. The performance evaluation was essentially "standalone" in that it focused on the device's technical specifications and image quality capabilities (phantom-based measurements) without involving human interpretation or clinical outcomes. The "algorithm" here is the CT reconstruction and imaging process itself.
7. The type of ground truth used
The ground truth for the core image quality metrics (High Contrast Spatial Resolution, Low-Contrast Resolution) was established through phantom measurements. These phantoms (e.g., "CATPHAN") have known physical properties and are used in a standardized way to objectively quantify imaging performance.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set of data. The "training" for the device, if one could apply the term, would be its engineering design, calibration, and manufacturing processes.
9. How the ground truth for the training set was established
Not applicable, as there is no training set in the context of this traditional medical imaging device.
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Kos 2447
SEP 2 1 2005
510(k) SUMMARY
FOR
Analogic Corporation
SyneRad IMPACT 60, SyneRad IMpact 72 and Analogic AMS1600 Submitter's Name and Address
| Submitter's Name: | Analogic Corporation | ||
|---|---|---|---|
| Address: | 8 Centennial Drive | ||
| City, State, and Zip: | Peabody, MA, 01960 |
Contact Person
| Name: | Donald J Sherratt |
|---|---|
| Title: | Director of Regulatory Affairs |
| Telephone: | ( 978 ) 977-3000 extension 4075 |
| Facsimile: | ( 978 ) 977-6808 |
| E-mail: | dsherratt@analogic.com |
Manufacturing Facility Address
| Manufacturer: | Analogic Corporation |
|---|---|
| Address: | 8 Centennial Drive |
| City, State, and ZIP: | Peabody, MA, 01960 |
Establishment Registration Number
Est. Registration Number: 1220672
New Device Details
Proprietary of Trade Names
| Proprietary or TradeName: | SyneRad IMPACT 60SyneRad Impact 72 andAnalogic AMS1600 |
|---|---|
| ------------------------------- | ---------------------------------------------------------------- |
New Device Common Name
Common Name:
Computed Tomography X-ray system
New Device Class
Device Class:
Class II
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New Device Product Code
Device Procode:
| New Device CFR | |
|---|---|
| Device CFR: | 892.1750 |
| New Device Classification Panel | |
| Classification Panel: | Radiology |
| New Device Classification Name | |
| Classification Name: | System, X-ray, Tomography, Computed |
| Reason for submission | |
| Reason for submission | New Devices |
| Comparison with predicates | |
| Predicate #1K033502 | GE Lightspeed 6.0 CT Scanner System |
| Predicate #2K030420 | GE Lightspeed 5.0 CT Scanner System |
90JAK
Description of These Devices
The SyneRad IMPACT 60, SyneRad IMPACT 72 and Analogic AMS1600 Multislice Computed Tomography Systems consist of a gantry, a patient table and an operator console.
Predicate #3 K020385, K022050 Toshiba Aquilion 16 CFX
All three CT Systems are virtually identical. The physical size of all three systems is the same and they use the same control console, operating system and software. The Analogic AMS1600 is the platform from which the two Anexa systems are built and is identical in construction (except for cosmetics created by the covers) to the SyneRad IMpact 72. The difference between the SyneRad IMPACT 60 and the SyneRad IMpact 72 is the output rating of the High Voltage Power Supply mounted on the gantry. The SyneRad IMPACT 60 has a 60 kW PSU whereas the SyneRad IMpact 72 has a 72 kW PSU. The kVp levels are the same for both systems. The upper mA setting for the 60 kW system is 500 mA. The upper mA setting for the 72 kW system is 600 mA. The High Voltage Power Supply provides feedback to the control computer which selects the upper mA limit.
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These 16-slice CT scanners have a gantry aperture opening of 70 centimeters. They are based on proven Analogic computed tomography technology. They have a 16-row detector and a 0.50 second minimum scan time. High-speed image reconstruction is from an innovative reconstruction engine. The operator console is supplied with two 20-inch high resolution monitors. 3D software is standard. Workflow and patient throughput requirements are supported by local archiving and DICOM-based interconnectivity features.
Summary of Intended Uses
The SyneRad IMPACT 60, SyneRad IMPACT 72 and Analogic AMS 1600 are Computed Tomography X-ray Systems intended to produce images of the head and whole body by computer reconstruction of X-ray transmission data at different angle and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
Comparison of Technological Characteristics
The SyneRad IMPACT 60, SyneRad IMPACT 72 and Analogic AMS1600 Multislice Computed Tomography Systems utilize the same technological characteristics and operating principles, are comparable in key safety and effectiveness and QA features, and uses the same basic design, construction and materials.
They also have the same intended use and modes of operation (CT scanning throughout the whole body including Spiral, Axial, Dynamic, Scout modes, additional optional scan modes like CT fluoro and ECG gated acquisition). Their X-ray power and technique factors are comparable to the predicate devices. They also have comparable image quality performance (measured on phantoms) as the predicate devices. The control console displays weighted CTDI, Dose Length Product and geometric efficiency in a method similar to the predicate devices.
In the opinion of Analogic Corporation, the SyneRad IMPACT 60, SyneRad IMPACT 72 and Analogic AMS1600 are of comparable type and substantially equivalent to the currently marketed head and whole body X-ray computed tomography systems that comply with the same or equivalent standards and have the same intended use. These new devices will be certified to comply with the X-ray requirements of 21CFR1020.30 and 1020.33 as well as the safety requirements of UL 60601-1 and IEC 60601-1 and associated collateral and particular standards.
| Anexa | G. E. Healthcare | Toshiba | |||
|---|---|---|---|---|---|
| Model | IMPACT72 | IMPACT 60 | LightSpeed 6.0(LightSpeed Pro16) | LightSpeed 5.0(LightSpeed 16) | AQUILION 16 CFX |
| K Number | New Devices | K033502 | K030420 | K020385 and K022050 | |
| Spiral, Axiel, Dynamic and Scout Scanning | Yes | Yes | Yes | Yes | |
| CT fluoro end ECG gated scan mode | Optional | Optional | Optional | Optional | |
| kW output | 72 kW | 60 kW | 100 kW | 53.2 kW | 60 kW |
| kVp Range | 80, 100, 120, 140 kVp | 80, 100, 120, 140 kVp | 80, 100, 120, 140 kVp | 80, 100, 120, 140 kVp | 80, 100, 120, 135 kVp |
| mA Range | 10 - 600 mA | 10 - 500 mA | 10 - 800 mA | 10 - 440 mA | 10 - 500 mA |
| High Contrast Spatial Res. | |||||
| 0% MTF, lp/cm | 17.25 lp/cm | 17.25 lp/cm | 15.4 lp/cm | 15.4 lp/cm | 18 lp/cm |
| 50% MTF, lp/cm | 8+ lp/cm | 8+ lp/cm | 8.5 lp/cm | 8.5 lp/cm | 9.4 lp/cm |
| Low-contrast res., mm @ % @ 4 rads | 5 mm @ 0.30%,8" CATPHAN | 5 mm @ 0.30%,8" CATPHAN | 5 mm @ 0.30%,8" CATPHAN | 5 mm @ 0.30%,8" CATPHAN | 5 mm @ 0.3% @ 21.8 mGy (per MHRA) |
| Weighted CTDI shown on console | Yes | Yes | Yes | Yes | |
| Dose Length Product shown on console | Yes | Yes | Yes | Yes | |
| Geometric Efficiency displayed on console when < 70% | Yes | Yes | Yes | Yes |
Key Parameters Comparison Chart
September 1, 2005 APPENDIX E Analogic Corporation SyneRad IMPACT 60, SyneRad IMPACT 72 and Analogic AMS1600CT Systems 510(k) Page 3 of 4
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Compliance with Voluntary Standards
Before final market release, the SyneRad IMPACT 60, SyneRad IMPACT 72 and Analogic AMS1600 Multislice Computed Tomography Systems will be thoroughly validated at the unit and system level to meet all elements of its Requirements Specification. This includes the following non-clinical tests:
| StandardsNo. | StandardsOrganization | Standards Title | Version | Date |
|---|---|---|---|---|
| 60601-1-1 | IEC | Medical electrical equipment - Part 1-1:General requirements for safety -Collateral standard: Safetyrequirements for medical electricalsystems | 2 | 2000 |
| 60601-1 | IEC | Medical Electrical Equipment- Part 1:General Requirements for Safety | 2 +A1, +A2 | 1988, 1991, 1995 |
| 60601-1 | UL | Medical Electrical Equipment- Part 1:General Requirements for Safety | 1 | 2003 |
| 60601-1-2 | IEC | Medical electrical equipment - Part 1-2:General requirements for safety -Collateral standard: Electromagneticcompatibility - Requirements and tests | 2 | 2001 |
| 60601-1-3 | IEC | Medical electrical equipment - Part 1:General requirements for safety - 3.Collateral standard: Generalrequirements for radiation protection indiagnostic X-ray equipment | 1 | 1994 |
| 60601-2-32 | IEC | Medical electrical equipment - Part 2:Particular requirements for the safety ofassociated equipment of X-rayequipment | 1 | 1994 |
| 60601-2-44 | IEC | Medical electrical equipment - Part 2-44: Particular requirements for thesafety of X-ray equipment for computedtomography | 2.1 | 2002 |
Conclusion
Based on similarity in technology, characteristics and the same intended use as the predicates, and compliance with the Radiological Safety Regulations supported by bench testing, Analogic Corporation considers the SyneRad IMPACT 60, SyneRad IMPACT 72 and the Analogic AMS1600 substantially equivalent.
Bench testing demonstrates that the SyneRad IMPACT 60, SyneRad IMPACT 72 and the Analogic AMS1600 comply with 21CFR Subchapter J.
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Image /page/4/Picture/2 description: The image shows a logo with a stylized bird figure. The bird is depicted with three curved lines representing its body and wings. The logo is surrounded by text arranged in a circular pattern, with the words following the curve of the circle. The text is in a simple, sans-serif font.
SEP 2 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Analogic Corporation c/o Mr. Neil E. Devine, Jr. Responsible Third Party Official Intertek Testing Services NA, Inc. 70 Codman Hill Road BOXBOROUGH MA 01719
Re: K052447
K052447
Trade/Device Name: SyneRad Impact 60 and 72, and Analogic AMS1600
Trade/Device Name: 1200 and 720 Regulation Number: 21 CFR §892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: September 6, 2005 Received: September 7, 2005
Dear Mr. Devine:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced We have reviewed your Section 310(x) preniance institution indications for use stated in
above and have determined the device is substant in interstate commerce prior to above and have determined the devices is stessurites marketed in interstate commerce prior to
the enclosure) to legally marketed predicated in interses or to devices that hav the enclosure) to legally marketed predical Device Amendments, or to devices that have been May 28, 1976, the enactment aske of the Nical Dough and Cosmetic Act (Act) that the reclassified in accordance with the provisions of any a 125 a 125 and the election, market the do not require approval of a premance applivar a phical controls provisions of the Act
device, subject to the general controls provisions of the Act. The energing practice, f device, subject to the general controls provisions of die rear of
include requirements for annual registration, listing of devices, good manufacturing practice, labeling, mclude requirements.
and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Prematket If your device is classified (see above) into clice in (ciccial major regulations affecting your
Approval), it may be subject to such additions leises "Tele 21 Parts 800 to 8 Approval), it may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA
device can be found in the Code of Federal Regulations of the Rederel Register device can be found in the Code of I cacial regaring your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that Please be advised that FDA's issuance of a substances crequirements of the Act or any
FDA has made a determination that your device complex with answering with all FDA has made a determination that your developed with of the Packs. You must comply with all the Federal statutes and regulations administered of cessistation (21 CFR Part 807); labeling.
Act's requirements, including, but not limited to registration as set forth a the q Act's requirements, including, but not minuted to reguletents as torth in the quality systems (QS)
(21 CFR Part 801); good manufacturing practice requirements as set fortugul (21 CFR Part 801); good manufacturity practice the electronic product radiation control provisions
regulation (21 CFR Part 820); and if applicable, the electronic product rad (Sections 531-542 of the Act): 21 CFR 1000-1050.
{5}------------------------------------------------
This letter will allow you to begin marketing your device as described in your Section 510(k)
The are and the more The RD to fine of substantial courvalence of your device t This letter will allow you to begin marketing your device of your device of your device to a legally
premarket notification. The FDA finding of substantial equivalevice and t rine seen and the month of substantial equivalence of your device of your device to any good your device to proceed to the market.
If you desire specific advice on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your device on our labeling regulation (1) in 1977 in 1977 in 1977 at
contact the Office of Compliance at one of the following numbers, base the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entitled, "Misoration on your responsibilities under the Act from the 807.97). You may obtain other general information on your responsible in total and the more of the marker (800)
Division of Small Manufacturers, International and Consumer A Division of Sinall Manafactures, internet address
638-2041 of (501) 445-6597 or w/support/index.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Naticy C. Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Office of Docvices and Radiological Health
Enclosure
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Indications For Use Statement
| 510(k) Number (if known): | K052447 |
|---|---|
| Device Name: | SyneRad IMPACT 60 and SyneRad IMpact 72 and Analogic AMS1600 |
| Indications For Use: | The SyneRad Impact 60, SyneRad Impact 72 and Analogic AMS1600 areComputed Tomography X-ray Systems intended to produce images of thehead and whole body by computer reconstruction of X-ray transmissiondata at different angle and planes. This device may include signal analysisand display equipment, patient, and equipment supports, componentsand accessories. |
Prescription Use (Per 21 CFR 801 Subpart D) AND/OR
X
Over-The-Counter Use
(Per 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Leyson
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number.
Analogic Corporation Amalogio Octporation.
SyneRad IMPACT 60, SyneRad IMPACT 72 and Analogic AMS1600 CT Systems 510(k)
September 1, 2005 Page xii of xvii
§ 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.