(85 days)
The Advantx LCN+ angiographic imaging system is intended for general purpose diagnostic angiographic fluoroscopy and radiography study.
The Advantx LCLP+ angiographic imaging system is intended for general purpose diagnostic angiographic fluoroscopy and cardiography study.
The Advantx LCN+ is a biplane x-ray system consisting of a floor mounted three-axis C-arm and a ceiling suspended C-arm that addresses all angiographic procedures that require a 32 cm Image Intensifier.
The Advantx LCLP+ is a biplane x-ray system consisting of a floor mounted three-axis C-arm and a ceiling suspended C-arm that addresses all angiographic procedures that require a 22 cm Image Intensifier.
The Advantx LCN+ angiographic imaging system is an angiographic and radiographic biplane positioner for use with the x-ray system Advantx. It consists of an angiographic biplane positioner, a vascular table and an x-ray system.
The Advantx LCLP+ angiographic imaging system is an angiographic and cardiographic biplane positioner for use with the x-ray system Advantx. It consists of an angiographic biplane positioner, a vascular table and an x-ray system.
The provided text describes two angiographic imaging systems, the Advantx LCN+ and Advantx LCLP+, and their substantial equivalence to existing devices. However, it does not include detailed acceptance criteria or a study proving the device meets specific performance metrics in the way typically expected for a medical device performance study (e.g., diagnostic accuracy, sensitivity, specificity, or image quality assessments with quantitative metrics and statistical analysis).
Instead, the documentation focuses on:
- Safety and regulatory compliance: Demonstrating that the devices comply with 21CFR and UL 187 standards, have risk management in place (FMEA), and do not pose added safety risks.
- Substantial Equivalence: Asserting that the devices are substantially equivalent to currently marketed angiographic imaging systems for their stated intended uses. This is a regulatory pathway, not a performance study in the clinical sense.
Therefore, many of the requested sections (Table of acceptance criteria and reported performance, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, training set details) cannot be extracted from the provided text because such a detailed performance study with quantitative acceptance criteria and results is not present. The document focuses on regulatory clearance through substantial equivalence based on safety and existing device types.
Here's a breakdown of what can be inferred or explicitly stated based on the given information:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, specific, quantifiable performance acceptance criteria (e.g., minimum sensitivity, detection rate, image resolution targets) and their corresponding reported device performance metrics are not explicitly stated. The "performance" described is primarily related to safety, design, and regulatory compliance.
| Acceptance Criteria Category | Specific Criteria (as inferred) | Reported Device Performance (as stated) |
|---|---|---|
| Safety | Compliance with regulatory standards (21 CFR, UL 187) | "The Advantx LCN+/LCLP+ angiographic imaging system complies with 21CFR and UL 187." "This system poses no added safety risk." |
| Risk Management | Identification and control of potential hazards (unintended x-ray emission, excessive radiation, mechanical/electrical hazards) | Hazards identified in Risk Management Summary; controlled by FMEA, system evaluation, adherence to Industrial Standards (UL). |
| Design Integrity | Prevention of single-point failures causing unintended motion | "There are hardware and software redundancies to prevent single point failures that could cause unintended motion." |
| Substantial Equivalence | Equivalence to currently marketed devices regarding standards and intended uses | "The Advantx LCN+/LCLP+ x-ray angiographic system is substantially equivalent to currently marketed angiographic imaging systems that comply with the same or equivalent standards and have the same intended uses." |
| Manufacturing/Materials | Compliance with UL 187 for construction and materials | "All construction and materials are compliant with UL 187." |
2. Sample size used for the test set and the data provenance
Not specified. The document does not describe a performance "test set" in the context of clinical or image quality evaluation. The evaluation appears to be a review of design, construction, and safety documentation for regulatory clearance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not specified. Ground truth establishment by experts for a test set is not mentioned, as no such test set or study is described in detail.
4. Adjudication method for the test set
Not applicable/Not specified. No adjudication method is mentioned.
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. The document does not describe an MRMC study, nor does it refer to AI or human-in-the-loop performance. This is an X-ray angiographic system, not an AI-powered diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
No. This is an imaging acquisition system, not an algorithm, so standalone performance in the context of AI or image analysis is not relevant.
7. The type of ground truth used
Not applicable/Not specified. The concept of "ground truth" as used in performance studies (e.g., pathology for a lesion, outcomes data for a diagnosis) is not relevant or addressed in the provided documentation, which focuses on device safety and regulatory compliance.
8. The sample size for the training set
Not applicable/Not specified. No training set is mentioned as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable/Not specified. No training set ground truth is relevant or mentioned.
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FEB 1 3 1998
Image /page/0/Picture/2 description: The image shows the text "GE Medical Systems" in bold, black font. The text is stacked on one line. The font appears to be sans-serif.
P.O. Box 414, W-709 Milwaukee, WI 53201 USA
510(K) SUMMARY OF SAFETY and EFFECTIVENESS
This 510(k) summary of safety and effectiveness is submitted in accordance with the requirements of 21CFR part 807.87(h).
Identification of Submitter
Larry A. Kroger, Ph.D. Senior Manager of Regulatory Programs Telephone: (414)544-3894 Date Prepared: October 31, 1997
Identification of the Product
| Name: | Advantx LCN+ angiographic imaging system |
|---|---|
| Manufacturer: | GE Medical Systems - Europe |
| 283, rue de la Miniere | |
| 78533 Buc Cedex, FRANCE | |
| Distributed by: | GE Medical Systems, Milwaukee, WI |
Marketing History
The Advantx LCN+ x-ray angiographic system is substantially equivalent to currently marketed angiographic imaging systems that comply with the same or equivalent standards and have the same intended uses.
Device Descriptions
The Advantx LCN+ angiographic imaging system is an angiographic and radiographic biplane positioner for use with the x-ray system Advantx. It consists of an angiographic biplane positioner, a vascular table and an x-ray system.
| Materials: | All construction and materials are compliant with UL 187. |
|---|---|
| Design: | There are hardware and software redundancies to prevent singlepoint failures that could cause unintended motion. |
| Energy Source: | 220 V AC 50/60 Hz |
Indications for Use
The Advantx LCN+ angiographic imaging system is intended for general purpose diagnostic angiographic fluoroscopy and radiography study.
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GE Medical Systems
P.O. Box 414, W-709 Milwaukee, WI 53201 USA
510(K) SUMMARY OF SAFETY and EFFECTIVENESS
Adverse Effects on Health
The potential hazards (unintended emission of x-rays, excessive radiation, mechanical and electrical hazards) are identified in a Risk Management Summary and controlled by:
- Failure Mode and Effects Analysis (FMEA) to demonstrate the non-existence . or extremely low probability of unwanted events.
- System evaluation to insure performance to specification and Federal . Regulations.
- Adherence to Industrial Standards (UL) .
Conclusions
100
The Advantx LCN+ angiographic imaging system complies with 21CFR and UL 187. This system poses no added safety risk.
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GE Medical Systems
P.O. Box 414, W-709 Milwaukee, WI 53201 USA
510(K) SUMMARY OF SAFETY and EFFECTIVENESS
This 510(k) summary of safety and effectiveness is submitted in accordance with the requirements of 21CFR part 807.87(h).
Identification of Submitter
Larry A. Kroger, Ph.D. Senior Manager of Regulatory Programs Telephone: (414)544-3894 Date Prepared: October 31, 1997
Identification of the Product
Advantx LCLP+ angiographic imaging system Name:
GE Medical Systems - Europe Mfg.: 283, rue de la Miniere 78533 Buc Cedex, FRANCE
Marketing History
The Advantx LCLP+ x-ray angiographic system is substantially equivalent to currently marketed angiographic x-ray systems that comply with the same or equivalent standards and have the same intended uses.
Device Descriptions
The Advantx LCLP+ angiographic imaging system is an angiographic and cardiographic biplane positioner for use with the x-ray system Advantx. It consists of an angiographic biplane positioner, a vascular table and an x-ray system. All construction and materials are compliant with UL 187. Materials: There are hardware and software redundancies to prevent single Design: point failures that could cause unintended motion.
Energy Source: 220 V AC 50/60 Hz
Indications for Use
The Advantx LCLP+ angiographic imaging system is intended for general purpose diagnostic angiographic fluoroscopy and cardiography study.
Image /page/2/Picture/16 description: The image shows the fraction 3/4. The number 3 is above a horizontal line, and the number 4 is below the horizontal line. This is a common way to represent fractions in mathematics.
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P.O. Box 414. W-709 Milwaukee, WI 53201 USA
510(K) SUMMARY OF SAFETY and EFFECTIVENESS
Adverse Effects on Health
The potential hazards (unintended emission of x-rays, excessive radiation, mechanical and electrical hazards) are identified in a Risk Management Summary and controlled by:
- Failure Mode and Effects Analysis (FMEA) to demonstrate the non-existence . or extremely low probability of unwanted events.
- System evaluation to insure performance to specification and Federal . Regulations.
- Adherence to Industrial Standards (UL) .
Conclusions
The Advantx LCLP+ angiographic imaging system complies with 21CFR and UL 187. This system poses no added safety risk.
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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird with three curved lines representing its wings or feathers. The bird is positioned above a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 3 1998
Larry A. Kroger, Ph.D. Regulatory Affairs Program Manager GE Medical Systems, Inc. P.O. Box 414 Milwaukee, WI 53201
Dear Dr. Kroger:
:
Re:
K974367 Advantx LCN+ & Advantx LCLP+ Dated: November 18, 1997 Received: November 20, 1997 Regulatory class: II 21 CFR 892.1600/Procode: 90 IZI
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the ise stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predication 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdcbdsmamain.html"...............................................................................................
Sincerely yours.
h.7. liau Yu.
Lillian Yin. Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name: Advantx LCN+ and Advantx LCLP+ angiographic x-ray systems
Indications for Use
The Advantx LCN+ is a biplane x-ray system consisting of a floor mounted three-axis C-arm and a ceiling suspended C-arm that addresses all angiographic procedures that require a 32 cm Image Intensifier.
The Advantx LCLP+ is a biplane x-ray system consisting of a floor mounted three-axis C-arm and a ceiling suspended C-arm that addresses all angiographic procedures that require a 22 cm Image Intensifier.
(PLESE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801-109)
OR Over-The-Counter Use_
David C. Segerson
Division Sign Off
ivision Sign-Off) Division of Reproductive,
510(k) Number K974367
§ 892.1600 Angiographic x-ray system.
(a)
Identification. An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.