(249 days)
The catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only. The LASSO 2515 NAV Variable Catheter is designed to obtain electrograms in the atrial regions of the heart.
The LASSO 2515 NAV Variable Catheter provides location information when used with compatible Carto EP Navigation Systems version 1.0 or higher.
The LASSO 2515 NAV Variable Catheter has been designed to facilitate electrophysiological mapping of the atria of the heart with the Carto 3 Navigation System and a reference device. It is deployed in the right or left atrium through an 8F guiding sheath. This deflectable catheter consists of a 4F circular spine on its distal tip, with platinum / iridium electrodes that can be used for stimulation and recording.
The LASSO 2515 NAV Variable Catheter features a Nitinol loop design that allows the expansion and contraction of the loop to custom-fit veins with different sizes, ranging from 25mm to 15mm diameter (± 15%).
The catheter interfaces with standard recording equipment via interface cables with the appropriate connectors.
Here's a breakdown of the acceptance criteria and the study information for the Lasso 2515 NAV Variable Catheter, based on the provided text:
Important Note: The provided 510(k) summary is for a medical device (catheter) used for electrophysiological mapping, not an AI/ML powered device. Therefore, many of the requested fields (e.g., sample size for AI test/training sets, number of experts for ground truth, MRMC study, standalone algorithm performance) are not applicable to this type of traditional medical device submission. The information below focuses on what is available in the document for a physical medical device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and effectiveness | "The nonclinical studies demonstrate that the Lasso 2515 NAV Variable Catheter is safe and effective for anatomic mapping of the heart." |
| Equivalence to predicate devices (Variable Lasso 2515 Circular Mapping Catheter and NaviStar Diagnostic Catheter) | "establish equivalence of the Lasso 2515 NAV Variable Catheter to the predicate devices..." |
| Performance in accordance with appropriate test criteria and standards | "The Catheter passed all intended criteria in accordance with appropriate test criteria and standards." |
| Ability to facilitate electrophysiological mapping of atria with Carto 3 Navigation System and reference device | "designed to facilitate electrophysiological mapping of the atria of the heart with the Carto 3 Navigation System and a reference device." |
| Expandable and controllable loop diameter (25mm to 15mm ± 15%) | "features a Nitinol loop design that allows the expansion and contraction of the loop to custom-fit veins with different sizes, ranging from 25mm to 15mm diameter (± 15%)." |
| Ability to obtain electrograms in atrial regions | "is designed to obtain electrograms in the atrial regions of the heart." |
| Provide location information with compatible Carto EP Navigation Systems version 1.0 or higher | "provides location information when used with compatible Carto EP Navigation Systems version 1.0 or higher." |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "bench and animal testing" but does not provide specific sample sizes for these tests.
- Data Provenance: Not explicitly stated. The testing was conducted by or for Biosense Webster, Inc., with manufacturing sites in the USA and Mexico. The regulatory submission is to the US FDA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- N/A. This is a physical medical device; the concept of "ground truth" established by experts in the context of an algorithmic diagnostic performance is not directly applicable. Performance was likely evaluated against engineering specifications, physiological measurements, and comparison to predicate devices by qualified engineers and scientists.
4. Adjudication method for the test set
- N/A. Not applicable for this type of device and testing.
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
- No. This is not an AI-powered device.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
- N/A. This is not an AI-powered device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Bench and Animal Testing Results/Engineering Specifications/Predicate Device Performance Comparison. The document states: "The Lasso 2515 NAV Variable Catheter underwent bench and animal testing. The Catheter passed all intended criteria in accordance with appropriate test criteria and standards." This implies the "ground truth" was based on established engineering specifications, performance metrics validated in preclinical (bench and animal) settings, and ultimately, by demonstrating equivalence to previously cleared predicate devices.
8. The sample size for the training set
- N/A. This is not an AI/ML powered device, so there is no "training set."
9. How the ground truth for the training set was established
- N/A. This is not an AI/ML powered device, so there is no "training set" or "ground truth" for it in this context.
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510(K) SUMMARY 5.
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| Applicant: | Biosense Webster, Inc.3333 Diamond Canyon Rd.Diamond Bar, CA 91765USAPhone: +1-800-729-7272Fax: +1-909-839-8804 | JAN - 6 2009 |
|---|---|---|
| Date: | May 1, 2008 | |
| Contact Person: | Natalie BenningtonManager, Regulatory Affairs | |
| Proprietary Device Name: | Lasso 2515 NAV Variable Catheter, D-1290-01 &D-1290-02 | |
| Common Device Name: | Electrophysiologic Mapping Catheter | |
| Classification Name: | Electrode Recording Catheter(per 21 CFR 870.1220, Product Code DRF) | |
| Predicate Devices: | 1. Variable Lasso 2515 Circular Mapping Catheter[510(k) K031161]2. Star Diagnostic Catheter ([510(k) K954390] (laterrenamed NaviStar Diagnostic Catheter) |
Manufacturer:
Manufacturing Sites:
Biosense Webster, Inc. 3333 Diamond Canyon Rd. Diamond Bar, CA 91765
Biosense Webster Inc. 15715 Arrow Highway Irwindale, CA 91706
Biosense Webster, Inc. Cordis de Mexico Circuito Interior Norte #1820 Parque Industrial Salvarcar 32599 Juarez, Chihuahua, Mexico
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5.1 Substantially Equivalent To:
The Biosense Webster, Inc. Lasso 2515 NAV Variable Catheter is substantially equivalent to the Biosense Webster Variable Lasso 2515 Circular Mapping Catheter [510(k) K031161, cleared July 22, 2003] and the Biosense Webster NaviStar Diagnostic Catheter [510(k) K954390, cleared Dec. 21, 1995].
5.2 Description of the Device Subject to Premarket Notification:
The LASSO 2515 NAV Variable Catheter has been designed to facilitate electrophysiological mapping of the atria of the heart with the Carto 3 Navigation System and a reference device. It is deployed in the right or left atrium through an 8F guiding sheath. This deflectable catheter consists of a 4F circular spine on its distal tip, with platinum / iridium electrodes that can be used for stimulation and recording.
The LASSO 2515 NAV Variable Catheter features a Nitinol loop design that allows the expansion and contraction of the loop to custom-fit veins with different sizes, ranging from 25mm to 15mm diameter (± 15%).
The catheter interfaces with standard recording equipment via interface cables with the appropriate connectors.
5.3 Indications for Use:
The catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only. The LASSO 2515 NAV Variable Catheter is designed to obtain electrograms in the atrial regions of the heart.
The LASSO 2515 NAV Variable Catheter provides location information when used with compatible Carto EP Navigation Systems version 1.0 or higher.
5.4 Performance Data:
The Lasso 2515 NAV Variable Catheter underwent bench and animal testing. The Catheter passed all intended criteria in accordance with appropriate test criteria and standards.
Overall Performance Conclusions: ર્સ્ડ
The nonclinical studies demonstrate that the Lasso 2515 NAV Variable Catheter is safe and effective for anatomic mapping of the heart and establish equivalence of the Lasso 2515 NAV Variable Catheter to the predicate devices, the Variable Lasso 2515 Circular Mapping Catheter and the NaviStar Diagnostic Catheter.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 6 2009
Biosense Webster, Inc. c/o Ms. Natalie Bennington Manager, Regulatory Affairs 3333 Diamond Canyon Rd. Diamond Bar, CA 91765
K081258 Re:
Trade/Device Name: Lasso 2515 NAV Variable Catheter, D-1290-01 and D-1290-02 Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter or Electrode Recording Probe Regulatory Class: Class II (two) Product Code: DRF Dated: November 25, 2008 Received: November 26, 2008
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.
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Page 2 – Ms. Natalie Bennington
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,
Qame
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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Indications for Use
510(k) Number (if known): K081258
Device Name: Lasso 2515 NAV Variable Catheter, D-1290-01 & D-1290-02
Indications For Use:
The catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only. The LASSO 2515 NAV Variable Catheter is designed to obtain electrograms in the atrial regions of the heart.
The LASSO 2515 NAV Variable Catheter provides location information when used with compatible Carto EP Navigation Systems version 1.0 or higher.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW 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 |
KOBI258 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).