(28 days)
The intended use of the New Device is to provide a reference location relative to the mapping/diagnostic catheter when used in conjunction with the CARTO and NOGA equipment.
The Cordis Webster REF-STAR External Reference Patch is indicated for the use with the NAVI-STAR and NOGA-STAR catheters and the CARTO and NOGA systems to provide catheter tip location as well as electrogram information.
The REF-STAR External Reference Patch (ERP) is an integral part of a nonfluoroscopic catheter tip location and electrogram capture technology called CARTO and NOGA. When used with the CARTO and NOGA systems, the intracardiac location of the NAVI-STAR or NOGA-STAR mapping catheter tip is compared to the location of this reference patch. This reference device consists of a sensor embedded in an adhesive patch, which is connected to an handle that houses the printed circuit board.
The ERP, like the Predicate Device the Ex Surface Reference Device, is an external device placed on the patient's back by an adhesive patch. The adhesive patch is located on the distal end of the reference device and sandwiches a Biosensor in-between two hypoallergenic adhesive foam pads. The patch is permanently fixed to the shaft and acts as protection for the Biosensor in addition to providing a way to attach the sensor to the patient. The shaft is an Estane material which is radiolucent and houses the electrical cables for the Biosensor. The Biosensor is connected to a PC board which amplifies the electrical signal before it is transferred to the CARTO or NOGA system. The PC board also contains calibration data for the X, Y and Z axis of the sensor. The strain relief for the shaft as it enters the Barrel Cone is made up of two layers of Polyolefin heat shrink tubing. The Barrel Cone is made of Delrin and is attached to the Barrel Extension which is also made of Delrin. The Barrel Extension houses the PC board and connector. The PC board is surrounded by a Mu Metal Shield to protect it from electromagnetic interference.
The provided document describes a 510(k) summary for the REF-STAR External Reference Patch. It is a submission for substantial equivalence to a predicate device, not a study proving a novel device meets specific acceptance criteria in a clinical setting with human subjects. Therefore, many of the requested categories are not applicable or cannot be extracted from this type of regulatory submission.
However, I can extract the information that is present:
1. Table of Acceptance Criteria and Reported Device Performance
The submission describes "Verification testing" to confirm the device's characteristics against a predicate. It does not list specific numerical acceptance criteria or performance metrics directly from the testing. The statement is broad, indicating the new device's technological characteristics are the same as the predicate.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Structural Integrity | Verified (compared to Predicate Device) |
| Electrical Integrity | Verified (compared to Predicate Device) |
| Adhesive Durability | Verified (compared to Predicate Device) |
| Technological Characteristics | Same as Predicate Device |
| Intended Use | Provides reference location with CARTO and NOGA systems for catheter tip location and electrogram information. |
2. Sample size used for the test set and the data provenance
The document does not specify a sample size for any test set or provide details on data provenance (e.g., country of origin, retrospective/prospective). It refers to "Verification testing" but doesn't elaborate on the methodology or data collection.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a regulatory filing for a device, not a study involving expert-established ground truth. The device's function is purely technical in providing a reference location.
4. Adjudication method for the test set
Not applicable. This does not involve adjudication by experts.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, an MRMC study was not done. This device is a passive external reference patch, not an AI or diagnostic tool that would typically undergo such a study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a hardware component. Its performance is inherent to its physical and electrical properties when integrated into the CARTO and NOGA systems. It does not have an "algorithm only" mode.
7. The type of ground truth used
"Verification testing" was conducted against the "Predicate Device." The ground truth for proving the new device's performance is essentially the established performance and characteristics of the existing, legally marketed predicate device.
8. The sample size for the training set
Not applicable. This device is not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This device is not an AI algorithm.
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1982415
Appendix A: 510(k) Summary of Safety and Effectiveness
Information supporting claims of substantial equivalence, as defined under the Statement Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness is summarized below.
For the convenience of the Reviewer, this summary is formatted in accordance with the Agency's final rule "... 510(k) Summaries and 510(k) Statements ... " (21 CFR §807) and can be used to provide a substantial equivalence summary to anyone requesting it from the Agency.
Device description
The REF-STAR External Reference Patch (ERP) is an integral part of a nonfluoroscopic catheter tip location and electrogram capture technology called CARTO and NOGA. When used with the CARTO and NOGA systems, the intracardiac location of the NAVI-STAR or NOGA-STAR mapping catheter tip is compared to the location of this reference patch. This reference device consists of a sensor embedded in an adhesive patch, which is connected to an handle that houses the printed circuit board.
The ERP, like the Predicate Device the Ex Surface Reference Device, is an external device placed on the patient's back by an adhesive patch. The adhesive patch is located on the distal end of the reference device and sandwiches a Biosensor in-between two hypoallergenic adhesive foam pads. The patch is permanently fixed to the shaft and acts as protection for the Biosensor in addition to providing a way to attach the sensor to the patient. The shaft is an Estane material which is radiolucent and houses the electrical cables for the Biosensor. The Biosensor is connected to a PC board which amplifies the electrical signal before it is transferred to the CARTO or NOGA system. The PC board also contains calibration data for the X, Y and Z axis of the sensor. The strain relief for the shaft as it enters the Barrel Cone is made up of two layers of Polyolefin heat shrink tubing. The Barrel Cone is made of Delrin and is attached to the Barrel Extension which is also made of Delrin. The Barrel Extension houses the PC board and connector. The PC board is surrounded by a Mu Metal Shield to protect it from electromagnetic interference.
Intended use
The intended use of the New Device is to provide a reference location relative to the mapping/diagnostic catheter when used in conjunction with the CARTO and NOGA equipment.
Continued on next page
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| Indicationsstatement | The Cordis Webster REF-STAR External Reference Patch is indicated for theuse with the NAVI-STAR and NOGA-STAR catheters and the CARTO andNOGA systems to provide catheter tip location as well as electrograminformation. |
|---|---|
| Technologicalcharacteristics | The technological characteristics of the New Device are the same as thePredicate Device. |
| Performancedata | Verification testing of the New Device was conducted to verify the structuralintegrity, electrical integrity and adhesive durability of the External ReferencePatch and to compare the applicable results to the Predicate Device. |
| Conclusion | Based on the 510(k) summaries and the 510(k) statements (21 CFR §807) andthe information provided herein, we conclude that the New Device issubstantially equivalent to the Predicate Device under the Federal Food, Drugand Cosmetic Act. |
| Contact | Mary AdamsRegulatory Affairs ManagerCordis Webster, Inc.4750 Littlejohn StreetBaldwin Park, CA 91706 |
| Date | July 10, 1998 |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Mary Adams Regulatory Affairs Manager Cordis Webster, Inc. 4750 Littlejohn Street Baldwin Park, CA 91706
AUG 1 0 1998
Re: K982415 Cordis Webster REF-STARTM External Reference Patch Regulatory Class: II (two) Product Code: DRF Dated: July 10, 1998 Received: July 13, 1998
Dear Ms. Adams:
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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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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This letter will allow you to beqin 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,
DA Saylor
Thomas J. Callahan, 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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Appendix B: Indications for Use Statement
Statement
Indications for Use Statement:
| 510(k) Number: K | 982415 |
|---|---|
| ------------------ | -------- |
Device Name: REF-STAR External Reference Patch
Indications for Use: The REF-STAR External Reference Patch is indicated for use with the NAVI-STAR and NOGA-STAR catheters and the CARTO and NOGA systems to provide catheter tip location as well as electrogram information.
Prescription Use
(Per 21 CFR 801.109)
Qe th tllh
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological De 510(k) Number
§ 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).