(332 days)
The RefStar™ RMT External Reference Patch is indicated for use with the NAVI-STAR™ RMT catheter and the CARTO™ RMT system to provide catheter tip location as well as electrogram information.
The RefStar RMT is an external reference catheter designed to be placed on the patient's back in order to compensate for movement during electrophysiology mapping of the heart. The back of the distal end of the RefStar RMT External Reference Patch has an adhesive backing, designed to be placed externally on the patient's back. The catheter contains a location sensor, that, when used together with the CARTO RMT system and the , NAVISTAR RMT Catheter provides catheter tip location information to construct a 3D electrophysiological maps of the human heart in the Stereotaxis Magnetic Navigation System magnetic field (K013484 and K021555) in real-time.
The provided text describes a 510(k) premarket notification for the RefStar RMT External Reference Patch. This device is seeking clearance based on substantial equivalence to a predicate device, not by proving efficacy via clinical trials with specific acceptance criteria. This means the submission doesn't contain a detailed study with acceptance criteria and device performance results in the way a novel device might.
Here's a breakdown of the requested information based on the provided text:
1. Table of acceptance criteria and the reported device performance
Based on the provided text, no specific quantitative acceptance criteria or detailed performance results (e.g., accuracy, precision) are explicitly stated for the RefStar RMT. The submission focuses on demonstrating substantial equivalence.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as quantitative acceptance criteria for the RefStar RMT. The primary criteria is "substantial equivalence" to the predicate device. | Bench testing demonstrates that the devices are functionally equivalent. RefStar RMT complies with multiple external electrical and performance standards. |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of a clinical performance study. The testing mentioned is "bench testing under simulated use conditions." Therefore, no information on sample size for a test set or data provenance (country of origin, retrospective/prospective) is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The document does not describe a clinical study requiring expert-established ground truth.
4. Adjudication method for the test set
Not applicable. The document does not describe a clinical study requiring adjudication.
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. This device is a surface reference patch for an electrophysiology system, not an AI-powered diagnostic tool. Therefore, an MRMC study or AI assistance is not relevant to its clearance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a hardware component of a larger electrophysiology system and does not operate as a standalone algorithm.
7. The type of ground truth used
Not applicable in the context of a clinical performance study with "ground truth." The "truth" for this submission is the established performance and safety of the predicate device. The performance of the RefStar RMT was likely assessed against established engineering specifications and functional requirements to ensure it matched the predicate.
8. The sample size for the training set
Not applicable. The document does not describe a training set as this is not an AI/machine learning model.
9. How the ground truth for the training set was established
Not applicable. The document does not describe a training set or its associated ground truth.
Summary of the Study (Bench Testing and Substantial Equivalence):
The RefStar RMT was cleared based on proving substantial equivalence to a predicate device, the Cordis-Webster RefStar™ External Surface Reference Device (K980961). The study described is bench testing under simulated use conditions. The core argument for safety and efficacy relies on:
- Identical Indication for Use: Both the RefStar RMT and the predicate device have the same indication for use: "to provide catheter tip location as well as electrogram information" when used with specific catheter and system components.
- Similar Design Requirements and Technological Characteristics: The new device meets the same design requirements and shares similar technological characteristics with the predicate.
- Functional Equivalence: Bench testing demonstrated that the devices are functionally equivalent. This would typically involve verifying that the new device performs its intended functions (e.g., providing location signals, electrical properties) within acceptable tolerances and in a manner consistent with the predicate.
- Compliance with Standards: The RefStar RMT complies with multiple external electrical and performance standards, although the specific standards are not listed.
Essentially, the "study" for this 510(k) was a comparison to an already cleared device, demonstrating that the new device performs its intended function similarly and does not raise new questions of safety or effectiveness.
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SEP 29 2005
K042998
11. SUMMARY OF SAFETY AND EFFICACY
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| APPLICANT | Biosense Webster, Inc.3333 Diamond Canyon RdDiamond Bar, CA 91765phone: (800) 729-9010fax: (909) 839-8804 |
|---|---|
| TRADE NAME: | RefStar RMT External Reference Patch |
| COMMON NAME: | Surface Reference Device |
| CLASSIFICATIONNAME: | Electrode Recording Catheter |
| DEVICECLASSIFICATION: | Class II, 21 CFR §870.1220 |
| PRODUCT CODE | 74 DRF |
| PREDICATEDEVICE: | The RefStar RMT is substantially equivalent to the Cordis-WebsterRefStar™ External Surface Reference Device, cleared formarketing under K980961. |
SUBSTANTIALLY EQUIVALENT TO:
The Biosense Webster, Inc. RefStar RMT External Reference Patch is substantially equivalent to the Cordis-Webster RefStar™ External Surface Reference Device, (cleared under K980961).
. . . . . . .
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The RefStar RMT is an external reference catheter designed to be placed on the patient's back in order to compensate for movement during electrophysiology mapping of the heart.
INDICATION FOR USE:
The RefStarTM RMT is indicated for use with the NAVI-STARTM RMT catheter and the CARTOTM RMT system to provide catheter tip location as well as electrogram information.
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TECHNICAL CHARACTERISTICS:
The back of the distal end of the RefStar RMT External Reference Patch has an adhesive backing, designed to be placed externally on the patient's back. The catheter contains a location sensor, that, when used together with the CARTO RMT system and the , NAVISTAR RMT Catheter provides catheter tip location information to construct a 3D electrophysiological maps of the human heart in the Stereotaxis Magnetic Navigation System magnetic field (K013484 and K021555) in real-time.
PERFORMANCE DATA:
The RefStar RMT was tested under simulated use conditions, and complies with multiple external electrical and performance standards.
BASIS FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE:
The Biosense Webster, Inc. RefStar RMT Exterence Patch is substantially equivalent to the Cordis-Webster RefStar™ External Surface Reference Device, cleared for marketing under K980961. The indication for use is the same for both devices. The catheters meet the same design requirements and have similar technological characteristics. Bench testing demonstrates that the devices are functionally equivalent.
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Public Health Service
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SEP 2 9 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Biosense Webster, Inc. c/o Mr. Mark O'Donnell Director, Regulatory Affairs 3333 Diamond Canyon Rd. Diamond Bar, CA 91765
Re: K042998
Trade Name: RefStar RMT External Reference Patch Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Regulatory Class: Class II (two) Product Code: DRF Dated: September 1, 2005 Received: September 2, 2005
Dear Mr. O'Donnell:
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 (PMA), 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.
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Page 2 - Mr. Mark O'Donnell
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 (240) 276-0295. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Bhimman per
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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RefStar RMT Special 510(k)
- INDICATIONS FOR USE
510(k) Number (if known): K042988
Page 1 of 1
Device Name: REFSTARTM RMT External Reference Patch
Indications for Use:
The RefStar™ RMT External Reference Patch is indicated for use with the NAVI-STAR™ RMT catheter and the CARTO™ RMT system to provide catheter tip location as well as electrogram information.
Prescription Use x _ x
(Part 21 CFR 801 Subpart D)
OR
(21 CFR 807 Subpart C)
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
B. Zimmerman
(Division Sign-Off) Division of Cardiov
Biosense Webster, Inc. Confidential
Page 19 of 47
fidential
§ 870.1220 Electrode recording catheter or electrode recording probe.
(a)
Identification. An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.(b)
Classification. Class II (performance standards).