(80 days)
Not Found
No
The description focuses on a physical mapping catheter and a navigation system based on magnetic field technology. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is strictly for mapping and diagnostic purposes, providing only location information of the esophagus relative to the heart during ablation procedures. It does not exert any therapeutic effect.
No.
The device is used for anatomical mapping of the esophagus to determine its relative position to the heart, which is a navigational and mapping function, not a diagnostic one that identifies diseases or conditions. The "Indications for Use" states it is for "catheter-based anatomic mapping of the esophagus." While it's used during an electrophysiology ablation procedure, its explicit purpose is location information, not diagnosis. The predicate device K954390 is a "Diagnostic Catheter" but the "Intended Use" of the ESOPHASTAR is anatomical mapping, not disease diagnosis.
No
The device description explicitly states it is a "mapping catheter" with a "flexible polyurethane shaft," an "atraumatic tip section," and a "magnetic location sensor embedded in the tip." These are physical hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Biosense Webster ESOPHASTAR™ Esophageal Mapping Catheter is a physical device that is inserted into the body (esophagus) to perform anatomical mapping. It uses a location sensor and navigation system to determine the position of the esophagus relative to the heart.
- No Sample Analysis: The device does not analyze any biological samples taken from the patient. Its function is based on physical location and mapping within the body.
Therefore, the device's intended use and description clearly indicate it is an in vivo (within the living body) device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Biosense Webster ESOPHASTAR™ Esophageal Mapping Catheter and related accessory devices are indicated for catheter-based anatomic mapping of the esophagus. When used during an electrophysiology ablation procedure, the EsophaStar is intended to be used in addition to other tools and techniques used to assist the physician in obtaining generalized location information of the esophagus with respect to the heart. The device is not intended to provide absolute esophageal wall location information. The Biosense Webster ESOPHASTARTM Esophageal Mapping Catheter is placed in the esophagus via the transpharyngeal or transnasal approach.
Product codes
DRF
Device Description
The Biosense Webster ESOPHASTAR™ Esophageal Mapping Catheter is a mapping catheter to be used exclusively for anatomically mapping points within the esophagus using CARTO™ Navigation System technology to indicate the relative anatomical relationship between the esophagus and posterior wall of the left atrium. The EsophaStar is intended to be used in addition to other tools and techniques used to assist the physician in obtaining generalized location information of the esophagus with respect to the heart. The device is introduced through the patient's nose or throat into the esophagus. Once in the desired position, the device's location sensor is used to "map" the 3-D position of the catheter in the esophagus, using Biosense Webster's location software and hardware system, as the device is slowly pulled towards the initial entry port.
The ESOPHASTAR™ Esophageal Mapping Catheter is 8 F in diameter and is 125 cm long. The catheter has a flexible polyurethane shaft with an atraumatic tip section. This catheter has a magnetic location sensor embedded in the tip and, therefore, is used with the CARTO™ EP Navigation System (a magnetic field location technology) and a REFSTAR™ with QWIKPATCH™ External Reference Patch to tag the esophagus.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
esophagus, posterior wall of the left atrium
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The ESOPHASTAR™ underwent bench testing and was also tested under simulated use conditions in animals. The Catheter passed all intended criteria in accordance with appropriate test criteria and standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
a) NaviStar Diagnostic Catheter (K954390), b) ENTRIFLEX Feeding Tube (K833621)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
5. 510(K) SUMMARY
| Applicant: | Biosense Webster, Inc.
3333 Diamond Canyon Rd.
Diamond Bar, CA 91765
USA
Phone: +1-800-729-7272
Fax: +1-909-839-8804 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Date: | May 25th, 2006 |
| Contact Person: | Natalie Bennington
Project Manager, Regulatory Affairs |
| Proprietary Device Name: | ESOPHASTARTM Esophageal Mapping Catheter |
| Common Device Name: | Electrophysiologic Mapping Catheter |
| Classification Name: | Electrode Recording Catheter
(per 21 CFR 870.1220, Product Code DRF) |
| Predicate Devices: | a) Star Diagnostic Catheter (K954390) (later renamed
NaviStar Diagnostic Catheter) |
| | b) ENTRIFLEX Feeding Tube (K833621) |
| Manufacturer: | Biosense Webster, Inc.
3333 Diamond Canyon Rd.
Diamond Bar, CA 91765 |
5.1 Substantially Equivalent To:
The Biosense Webster, Inc. ESOPHASTAR™ Esophageal Mapping Catheter is substantially equivalent to the Biosense Webster NaviStar Diagnostic Catheter (K954390, cleared Dec. 21, 1995) and the ENTRIFLEX Feeding Tube (K833621, cleared Nov. 28, 1983).
5.2 Description of the Device Subject to Premarket Notification:
The Biosense Webster ESOPHASTAR™ Esophageal Mapping Catheter is a mapping catheter to be used exclusively for anatomically mapping points within the esophagus
1
using CARTO™ Navigation System technology to indicate the relative anatomical relationship between the esophagus and posterior wall of the left atrium. The EsophaStar is intended to be used in addition to other tools and techniques used to assist the physician in obtaining generalized location information of the esophagus with respect to the heart. The device is introduced through the patient's nose or throat into the esophagus. Once in the desired position, the device's location sensor is used to "map" the 3-D position of the catheter in the esophagus, using Biosense Webster's location software and hardware system, as the device is slowly pulled towards the initial entry port.
The ESOPHASTAR™ Esophageal Mapping Catheter is 8 F in diameter and is 125 cm long. The catheter has a flexible polyurethane shaft with an atraumatic tip section. This catheter has a magnetic location sensor embedded in the tip and, therefore, is used with the CARTO™ EP Navigation System (a magnetic field location technology) and a REFSTAR™ with QWIKPATCH™ External Reference Patch to tag the esophagus.
For further description of the CARTO™ EP Navigation System, refer to the operating instructions for this system.
5.3 Indications for Use:
The Biosense Webster ESOPHASTAR™ Esophageal Mapping Catheter and related accessory devices are indicated for catheter-based anatomic mapping of the esophagus. When used during an electrophysiology ablation procedure, the EsophaStar is intended to be used in addition to other tools and techniques used to assist the physician in obtaining generalized location information of the esophagus with respect to the heart. The device is not intended to provide absolute esophageal wall location information. The Biosense Webster ESOPHASTARTM Esophageal Mapping Catheter is placed in the esophagus via the transpharyngeal or transnasal approach.
5.4 Performance Data:
The ESOPHASTAR™ underwent bench testing and was also tested under simulated use conditions in animals. The Catheter passed all intended criteria in accordance with appropriate test criteria and standards.
5.5 Overall Performance Conclusions:
The nonclinical studies demonstrate that the ESOPHASTAR™ Esophageal Mapping Catheter is safe and effective for anatomic mapping of the esophagus and establish equivalence of the ESOPHASTAR™ Esophageal Mapping Catheter to the predicate devices, the NaviStar Diagnostic Catheter and the ENTRIFLEX Feeding Tube.
2
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the Department of Health and Human Services (HHS) in the USA. The logo features the department's name encircling a stylized graphic. The graphic consists of three parallel lines that curve and flow together, resembling a human form or a symbol of health and well-being.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 4 2006
Biosense Webster, Inc. c/o Ms. Natalie Bennington Project Manager, Regulatory Affairs 3333 Diamond Canyon Rd. Diamond Bar, CA 91765
Re: K061463 Trade/Device Name: ESOPHASTARTM Esophageal Mapping Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter or Electrode Recording Probe Regulatory Class: Class II Product Code: DRF Dated: May 25, 2006 Received: May 26, 2006
Dear Ms. Bennington:
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.
3
Page 2 - Ms. Natalie Bennington
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease oc advised that I Driseantes syour device complies with other requirements of the Act that I Dri has made a actor regulations administered by other Federal agencies. You must or any I call 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 CFR I art 6077, idoomig (21 CFR Part 820); and if applicable, the electronic form in the quality by by selling (Sections 531-542 of the Act); 21 CFR 1000-1050. product familion only of probegin marketing your device as described in your Section 510(k) I mis letter with anon yours ough finding of substantial equivalence of your device to a legally premaired predicated 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 if you desire specific darroliance 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 other general informational and Corpumer Assistance at its toll-free number (800) 638-2041 or ivandracturers, Internationaryana ddress 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
4
4. INDICATIONS FOR USE STATEMENT
510(k) No (if known):
Device Name: ESOPHASTAR™ Esophageal Mapping Catheter
Indications for Use:
The Biosense Webster ESOPHASTAR™ Esophageal Mapping Catheter and related accessory devices are indicated for catheter-based anatomic mapping of the esophagus. When used during an electrophysiology ablation procedure, the EsophaStar is intended to be used in addition to other tools and techniques used to assist the physician in obtaining generalized location information of the esophagus with respect to the heart. The device is not intended to provide absolute esophageal wall location information. The Biosense Webster ESOPHASTAR™ Esophageal Mapping Catheter is placed in the esophagus via the transpharyngeal or transnasal approach.
Prescription Use (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)
(Division Sign-Off) Division of Cardiovascu
510(k) Number
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