(198 days)
The intended use of the NOGA system is catheter-based cardiac mapping.
The NOGA system allows real-time display of cardiac maps in a number of different formats. Maps may be displayed as cardiac electrical activation maps, cardiac electrical propagation maps, cardiac electrical potential maps, cardiac chamber geometry maps, cardiac dynamic maps, cardiac hemodynamic maps, and cardiac electromechanical maps. The acquired patient signals, including body surface ECG, intracardiac electrograms and intracavity or intravascular blood pressure may also be displayed in real time on the display screen.
The Biosense NOGA system is designed to acquire, and display electro-mechanical maps of the human heart. The maps are reconstructed using the combination of information gathered from the integration of a plurality of intracardiac electrograms with their respective endocardial locations. In the NOGA system the location information needed to create the cardiac maps is acquired simultaneously with the local electrogram using locatable-tip catheters equipped with a Biosense sensor. The NOGA system also allows presentation of electroanatomical maps as a function of time over the cardiac cycle (electromechanical maps).
The NOGA system enables cardiac mapping using a non-fluoroscopic catheter tip location technology. The NOGA system also uses this technology to collect additional information about the heart chamber geometry as a function of time over the cardiac cycle.
The provided text is a 510(k) summary for the Biosense NOGA system. It describes the device, its intended use, regulatory compliance, and a statement regarding testing. However, it does not contain specific information on acceptance criteria, a detailed study proving performance, sample sizes for test and training sets, expert qualifications, ground truth establishment methods, or whether MRMC or standalone studies were conducted.
The document states:
"The non-clinical bench and animal testing show that the device is as safe and as effective as the previously marketed device to which it is being compared and does not raise any new questions of safety or effectiveness."
This is a general statement of equivalence to a predicate device (Biosense NOGA system 510(k) No. K960542), but it does not provide the specifics requested in your prompt.
Therefore, I cannot fulfill your request for the following information based on the provided text:
- A table of acceptance criteria and the reported device performance: Not provided.
- Sample sized used for the test set and the data provenance: Not provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
- Adjudication method: Not provided.
- 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 provided. The NOGA system is a cardiac mapping system, not an AI-assisted diagnostic tool that would typically involve human readers in this context.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not explicitly detailed, though the "non-clinical bench and animal testing" would likely include standalone performance evaluations. No specifics are given.
- The type of ground truth used: Not provided.
- The sample size for the training set: Not provided.
- How the ground truth for the training set was established: Not provided.
The document is a regulatory submission for premarket notification (510(k)), which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed scientific study report with all the specifics requested.
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Image /page/0/Picture/0 description: The image shows the word "Biosense" in a bold, sans-serif font. To the left of the word is a square divided into four smaller squares, with the top left and bottom right squares filled in with a dark color. A horizontal line underlines the word "Biosense".
Einstein Building, Etgar St., New Industrial Zone, POB 2009, Tirat HaCarmel 39120 ISRAEL Tel: +972-4-8576057 Fax: +972-4-8571071 e-mail: mail@biosense.co.il
510(k) summary for the NOGA system
| 510(k) Notification submitted by: | Biosense Ltd.Einstein Building, 7 Etgar Street, New Industrial ZonePOB 2009, Tirat HaCarmel, 39120 ISRAELTel: +972-4-8576057 Fax: +972-4-8571071 |
|---|---|
| Contact person: | Lisa Wells, Regulatory Affairs Specialist |
| Proprietary device name: | NOGATM |
| Classification name: | Programmable diagnostic computer(per 21 CFR 870.1425) |
| Common device name: | Cardiac mapping system |
| Cleared unmodified device | Biosense NOGA system510(k) No. K960542 |
The Biosense NOGA system is designed to acquire, and display electro-mechanical maps of the human heart. The maps are reconstructed using the combination of information gathered from the integration of a plurality of intracardiac electrograms with their respective endocardial locations. In the NOGA system the location information needed to create the cardiac maps is acquired simultaneously with the local electrogram using locatable-tip catheters equipped with a Biosense sensor. The NOGA system also allows presentation of electroanatomical maps as a function of time over the cardiac cycle (electromechanical maps).
Currently, cardiac mapping is performed using a roving mapping catheter, a computerized mapping system, and fluoroscopy to determine the location of the mapping catheter. In the conventional procedure both the patient and the physician are exposed to harmful ionizing radiation during the course of the lengthy procedure.
The NOGA system enables cardiac mapping using a non-fluoroscopic catheter tip location technology. The NOGA system also uses this technology to collect additional information about the heart chamber geometry as a function of time over the cardiac cycle. Conventionally, such information would be collected using fluoroscopy or cine while injecting a radiopaque contrast agent into the heart chamber (ventriculography).
The NOGA system complies with the European EMC directive; 89/336/EEC as amended by 92/31/EEC and 93/68/EEC and the CE mark has been affixed to the product.
The NOGA system complies with the following standards:
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Image /page/1/Picture/0 description: The image shows the logo for Biosense, a Johnson & Johnson company. The logo consists of a stylized "B" symbol made up of four squares, followed by the word "Biosense" in a bold, sans-serif font. Below the word "Biosense" is a thin, horizontal line, and below that is the text "a Johnson & Johnson company" in a smaller, serif font.
Einstein Building, Etgar St., New Industrial Zone, POB 2009, Tirat HaCarmel 39120 ISRAEL Tel: +972-4-8576057 Fax: +972-4-8571071 e-mail: mail@biosense.co.il
IEC 601-1/1988 IEC 601-1 A1/1991 IEC 601-1 A2/1995 IEC 601-2-27/1994 EN 60601-1-2/1993
The non-clinical bench and animal testing show that the device is as safe and as effective as the previously marketed device to which it is being compared and does not raise any new questions of safety or effectiveness. The use of the non-fluoroscopic location technology may reduce the exposure to dangerous ionizing radiation to the both the physician and the patient.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing or protecting another figure, represented by three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
13 1999
Marcia Leatham, M.D. VP, Clinical and Regulatory Biosense, Inc. 3333 Diamond Canyon Road Diamond Bar, CA 91765
K990494 Re: Modification to NOGA Requlatory Class: Class II Product Code: DOK Dated: Auqust 2, 1999 Received: August 4, 1999
Dear Dr. Leatham:
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 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). 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 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 requlation may result in requlatory 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 the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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Page 2 - Marcia Leatham, M.D.
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 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion 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" (21CFR 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/cdrh/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callanan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) No: K960542
Device Name: NOGA System
Indications For Use:
The intended use of the NOGA system is catheter-based cardiac mapping.
The NOGA system allows real-time display of cardiac maps in a number of different formats. Maps may be displayed as cardiac electrical activation maps, cardiac electrical propagation maps, cardiac electrical potential maps, cardiac chamber geometry maps, cardiac dynamic maps, cardiac hemodynamic maps, and cardiac electromechanical maps. The acquired patient signals, including body surface ECG, intracardiac electrograms and intracavity or intravascular blood pressure may also be displayed in real time on the display screen.
N. Qalh Tilla
ivision Sign-Off) Division of Cardiovascular, Rest and Neurological De 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).