(62 days)
REFSTAR® PLUS with QWIKPATCH® External Reference Patch: The Biosense Webster REFSTAR® or REFSTAR® PLUS External Reference Patch is indicated for use with the Biosense Webster navigation catheters and the CARTO® and NOGA® Systems to provide a reference point for catheter tip location.
REFSTAR® PLUS Cable: The REFSTAR® PLUS Cable provides a means to connect between a Biosense Webster electrophysiology REFSTAR® PLUS with QWIKPATCH® External Reference Patch and the Patient Interface Unit (PIU). This cable may be re-used.
The Biosense Webster REFSTAR® PLUS with QWIKPATCH® External Reference Patch is an integral part of a non-fluoroscopic catheter tip location and electrogram capture technology called CARTO® and NOGA®. When used with the CARTO® and NOGA® svstems, the location of the navigation catheter tip is compared to the location of this reference patch. This reference device consists of a sensor embedded in an adhesive patch at the distal end of a shaft, which connects to a connector at the proximal end of the shaft. The connector connects to the REFSTAR® PLUS Cable, which houses a printed circuit board and an EEPROM (Electrically Erasable Programmable Read Only Memory). The REFSTAR® PLUS Cable connects the REFSTAR® PLUS with QWIKPATCH® External Reference Patch to the Patient Interface Unit (PIU) of CARTO® and NOGA® EP Navigation Systems.
The provided text describes a 510(k) premarket notification for the REFSTAR® PLUS with QWIKPATCH® External Reference Patch and REFSTAR® PLUS Cable. This submission focuses on establishing substantial equivalence to a predicate device, rather than a clinical study proving performance against acceptance criteria in the typical sense of AI/algorithm performance.
Therefore, many of the requested categories are not applicable to this type of submission. However, I will extract the available information and indicate where information is not present.
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical integrity (Implicit) | Passed bench testing to validate mechanical integrity. |
| Electrical integrity (Implicit) | Passed bench testing to validate electrical integrity. |
| Performance with CARTO® and NOGA® Systems (Implicit: "provide a reference point for catheter tip location") | Passed bench testing to validate performance with CARTO® and NOGA® Systems. |
| Substantial Equivalence to Predicate Device (Explicit requirement for 510(k) clearance) | Found substantially equivalent to the predicate REFSTAR® with QWIKPATCH® External Reference Patch and Interface cable in terms of intended use, operating principles, fundamental scientific technology, design and performance. |
2. Sample size used for the test set and the data provenance
This section is not applicable. The submission describes "bench testing" for mechanical and electrical integrity and performance with systems. It does not refer to a test set of data derived from patients or human subjects. The provenance of any data used for bench testing is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable. Ground truth for a clinical or AI performance study is not relevant here as it's a device safety and performance validation through bench testing, not a clinical trial or AI algorithm evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable. There was no clinical test set 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
This section is not applicable. This is not an AI device, and no MRMC study was conducted or referenced. The device provides a reference point for catheter tip location within existing navigation systems (CARTO® and NOGA®), rather than AI assistance to human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. This device is an external reference patch and cable, not a standalone algorithm. Its function is to provide an input (reference point) to the CARTO® and NOGA® systems, which are themselves non-fluoroscopic navigation systems.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This section is not applicable in the context of clinical "ground truth." The "ground truth" for the bench testing would have been established by engineering specifications, calibration standards, and expected performance parameters when integrated with the CARTO® and NOGA® systems.
8. The sample size for the training set
This section is not applicable. This is not an AI/machine learning device, so there is no concept of a training set.
9. How the ground truth for the training set was established
This section is not applicable, as there is no training set for this device.
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14. 510(K) SUMMARY
| Applicant: | Biosense Webster, Inc.3333 Diamond Canyon Rd.Diamond Bar, CA 91765,USAPhone: 800-839-8599Fax: 909-839-8804 |
|---|---|
| Date: | January 19, 2009 |
| Contact Person: | Balaka DasSenior Specialist, Regulatory Affairs |
| Proprietary Device Name,Manufacturing Part Number: | REFSTAR® PLUS with QWIKPATCH® External ReferencePatch, D-1210-03REFSTAR® PLUS Cable, M-4700-106 |
| Common Device Name: | Surface Reference Device |
| Classification Name: | Electrode Recording Catheter(per 21 CFR 870.1220, Product code DRF |
| Predicate Device: | REFSTAR® External Reference Patch (K061468)Interface Cable (K982415) |
| Manufacturing Facilities: | REFSTAR® PLUS with QWIKPATCH® External ReferencePatchBiosense Webster, Inc.Circuito Interior Norte #1820Parque Industrial SalvacarJuarez Chihuahua |
Biosense Webster, Inc. 15715 Arrow Highway Irwindale, CA 91706
Mexico 32599
CONFIDENTIAL
MAR 2 4 2009
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Special 510(k) RefStar Plus with QwikPatch External Reference Patch RefStar Plus Cable
REFSTAR® PLUS Cable Biosense Webster (Israel) Ltd. POB 2009 4 Etgar Street, Einstein Bldg. Tirat HaCarmel, 39120 Israel
14.1 Description of Device
The Biosense Webster REFSTAR® PLUS with QWIKPATCH® External Reference Patch is an integral part of a non-fluoroscopic catheter tip location and electrogram capture technology called CARTO® and NOGA®. When used with the CARTO® and NOGA® svstems, the location of the navigation catheter tip is compared to the location of this reference patch. This reference device consists of a sensor embedded in an adhesive patch at the distal end of a shaft, which connects to a connector at the proximal end of the shaft. The connector connects to the REFSTAR® PLUS Cable, which houses a printed circuit board and an EEPROM (Electrically Erasable Programmable Read Only Memory). The REFSTAR® PLUS Cable connects the REFSTAR® PLUS with QWIKPATCH® External Reference Patch to the Patient Interface Unit (PIU) of CARTO® and NOGA® EP Navigation Systems.
14.2 Indications for Use
REFSTAR® PLUS with QWIKPATCH External Reference Patch:
The Biosense Webster REFSTAR® PLUS External Reference Patch is indicated for use with the Biosense Webster navigation catheters and the CARTO® and NOGA® Systems to provide a reference point for catheter tip location.
REFSTAR® PLUS Cable:
The REFSTAR® PLUS Cable provides a means to connect between a Biosense Webster electrophysiology REFSTAR® PLUS with QWIKPATCH® External Reference Patch and the Patient Interface Unit (PIU). This cable may be re-used.
14.3 Summary of Testing
The REFSTAR® PLUS with QWIKPATCH® External reference Patch and REFSTAR® PLUS Cable have passed bench testing to validate the mechanical and electrical integrity of the devices and the performance of the devices with the CARTO® and NOGA® Systems.
14.4 Substantial Equivalence
The REFSTAR® PLUS with QWIKPATCH® External Reference Patch and REFSTAR® PLUS Cable are substantially equivalent to the predicate REFSTAR® with QWIKPATCH® External Reference Patch and Interface cable in terms of intended
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use, operating principles, fundamental scientific technology, design and performance.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three legs and a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is written around the border of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
. MAR 2 4 2009
Biosense Webster, Inc. c/o Mr. Balaka Das Senior Specialist, Regulatory Affairs 3333 Diamond Canyon Road Diamond Bar, CA 91765
Re: K090120
Trade Name: REFSTAR(6) PLUS with OWIKPATCH(8) External Reference Patch REFSTAR(6) PLUS Cable Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Regulatory Class: Class II (two) Product Code: DRF Dated: March 4, 2009 Received: March 5, 2009
Dear Mr. Das:
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. Balaka Das
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 (OS) 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) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
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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5. INDICATIONS FOR USE
510(k) No (if known): _ K 096120
Device Name: REFSTAR® PLUS with QWIKPATCH® External Reference Patch REFSTAR® PLUS Cable
Indications for Use:
REFSTAR® PLUS with QWIKPATCH® External Reference Patch:
The Biosense Webster REFSTAR® or REFSTAR® PLUS External Reference Patch is indicated for use with the Biosense Webster navigation catheters and the CARTO® and NOGA® Systems to provide a reference point for catheter tip location.
REFSTAR® PLUS Cable:
The REFSTAR® PLUS Cable provides a means to connect between a Biosense Webster electrophysiology REFSTAR® PLUS with QWIKPATCH® External Reference Patch and the Patient Interface Unit (PIU). This cable may be re-used.
Prescription Use ﻠﻴ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | Page 1 of 1 | |
|---|---|---|
| (Division Sign-Off) | ||
| Division of Cardiovascular Devices | ||
| 510(k) Number K090120 | ||
| Biosense Webster, Inc. | CONFIDENTIAL | Page 13 of 188 |
§ 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).