(56 days)
The IntellaMap Orion™ High Resolution Mapping Catheter is indicated for electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart.
The IntellaMap Orion High Resolution Mapping Catheter is an 8.5 French (Ø 2.82mm), 115 cm working length, and a 64-electrode steerable catheter. The basket-shaped distal region consists of 8 splines that compose the electrode array. The proximal end has a handle that extends to a cable with a connector. The handle includes bi-directional articulation controls and a deployment slider that activates the electrode array into a basket shape once inside the heart. A flushing port extends from the back of the connector for connection to a continuous pressurized saline drip. The catheter is supplied with an 8.5F insertion sleeve for insertion through the hemostasis valve on an introducer sheath. A sensor in the catheter tip enables the position of the distal region of the catheter to be tracked in space when used with the RHYTHMIA HDx™ Mapping System.
The provided text describes a medical device, the IntellaMap Orion™ High Resolution Mapping Catheter, and its clearance process with the FDA. It does not contain information about the acceptance criteria or a study that specifically proves the device meets those criteria, as typically found in a clinical trial report or a performance study for AI/software devices. The document focuses on establishing substantial equivalence to a predicate device through design verification and biocompatibility testing.
However, I can extract the information that is present and indicate what is not available based on your request.
Here's the breakdown of the available and unavailable information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in terms of quantitative metrics for mapping performance. The goal is to be "as safe, as effective, and performs as well as the predicate device." | Design Verification Bench Testing: - Electrical Testing: Pass - Reliability Testing: Pass - Catheter Joint Strength: Pass - Tip Buckle: Pass - Visual Inspections and Dimensions: Pass - Simulated Use: Pass Biocompatibility Testing: - Cytotoxicity: Pass - Hemolysis Direct Contact and Extract Methods: Pass - Sensitization Maximization: Pass - Intracutaneous Irritation: Pass - Acute Systemic Toxicity: Pass - Materials Mediated Rabbit Pyrogen: Pass - Partial Thromboplastin Time: Pass - In Vitro Hemocompatibility: Pass - Complement Activation: Pass - USP Physicochemical Test: Pass - Latex Assay: Pass |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable in the context of electrical, reliability, mechanical, simulated use, and biocompatibility bench testing as described. There are no "test sets" of patient data in the sense of a clinical or image-based AI study.
- Data Provenance: The data comes from internal Boston Scientific Corporation design verification and biocompatibility testing. The country of origin for this data is not specified but is implicitly internal to the manufacturer's testing processes. This is retrospective in the sense of being an assessment of the manufactured device's characteristics rather than a prospective clinical trial.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth, in this context, refers to established engineering standards, material science properties, biological responses, and simulated use protocols rather than expert clinical consensus on patient data.
4. Adjudication method for the test set:
- Not applicable. The "Pass" results indicate that the device met pre-defined internal specifications and regulatory requirements for each test, which serves as the "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:
- No MRMC comparative effectiveness study was done. This device is a mapping catheter, a hardware device, not an AI software intended to assist human readers with diagnostic interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware medical device, not an algorithm.
7. The type of ground truth used:
- The "ground truth" for the performance claims comes from established engineering specifications, material science testing standards (e.g., ISO 10993-1 for biocompatibility), and simulated use protocols.
8. The sample size for the training set:
- Not applicable. There is no AI component requiring a "training set."
9. How the ground truth for the training set was established:
- Not applicable. There is no AI component requiring a "training set."
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
October 25,2019
Boston Scientific Corporation Nicole Lyden Senior Regulatory Affairs Specialist 4100 Hamline Ave North St. Paul, Minnesota 55112
Re: K192360
Trade/Device Name: IntellaMap Orion High Resolution 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: August 29, 2019 Received: August 30, 2019
Dear Nicole Lyden:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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
{1}------------------------------------------------
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark Fellman Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K192360
Device Name
IntellaMap Orion™ High Resolution Mapping Catheter
Indications for Use (Describe)
The IntellaMap Orion™ High Resolution Mapping Catheter is indicated for electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☒Prescription Use (Part 21 CFR 801 Subpart D) | ☐Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image contains the logo for Boston Scientific. The logo is in blue and features the words "Boston" and "Scientific" stacked on top of each other. The font is a serif typeface, and the overall design is simple and professional.
Boston Scientific Corporation 300 Boston Scientific Way Marlborough, MA 01752 (508) 683-4000
510(k) Summary for IntellaMap Orion™ High Resolution Mapping Catheter K192360
1. Submitter
Boston Scientific Corporation Electrophysiology Division 4100 Hamline Ave North St. Paul, MN 55112
Contact:
Benjamin Dollins, JD Senior Regulatory Affairs Specialist Phone: 651-582-6150 Fax: 651-582-5134 E-mail: benjamin.dollins@bsci.com
Nicole Lyden Senior Regulatory Affairs Specialist Phone: 651-582-6344 Fax: 651-582-5134 E-mail: nicole.lyden@bsci.com
Date Prepared: August 29, 2019
2. Device
Trade Name: IntellaMap Orion™ Common Name: IntellaMap Orion High Resolution Mapping Catheter Classification Name: Electrode Recording Catheter or Electrode Recording Probe Product Code: DRF Device Class and Panel: Class II, Cardiovascular Classification Regulation: 21 CFR Part 870.1220
3. Predicate Device
Trade Name: IntellaMap Orion™ Manufacturer: Boston Scientific Corporation Clearance Number: K143481 Common Name: IntellaMap Orion High Resolution Mapping Catheter Classification Name: Electrode Recording Catheter or Electrode Recording Probe Product Code: DRF
{4}------------------------------------------------
Device Class and Panel: Class II, Cardiovascular Classification Regulation: 21 CFR Part 870.1220
4. Device Description
The IntellaMap Orion High Resolution Mapping Catheter is an 8.5 French (Ø 2.82mm), 115 cm working length, and a 64-electrode steerable catheter. The basket-shaped distal region consists of 8 splines that compose the electrode array. The proximal end has a handle that extends to a cable with a connector. The handle includes bi-directional articulation controls and a deployment slider that activates the electrode array into a basket shape once inside the heart. A flushing port extends from the back of the connector for connection to a continuous pressurized saline drip. The catheter is supplied with an 8.5F insertion sleeve for insertion through the hemostasis valve on an introducer sheath. A sensor in the catheter tip enables the position of the distal region of the catheter to be tracked in space when used with the RHYTHMIA HDx™ Mapping System.
5. Indications for Use
The IntellaMap Orion High Resolution Mapping Catheter is indicated for electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart.
6. Technological Characteristics
The IntellaMap Orion High Resolution Mapping Catheter incorporates substantially equivalent design, packaging, fundamental technology, manufacturing processes, sterilization process and intended use as those featured in the predicate device.
7. Substantial Equivalence
The proposed modifications to the IntellaMap Orion High Resolution Mapping Catheter flexible printed circuit assembly, feeder tube, feed tube strain relief, and insertion sleeve do not impact the device's substantial equivalence to the previously cleared version of this device. The modified device is as safe, as effective, and performs as well as the predicate device. The indications for use, intended use, classification, product functions, materials, configuration, and sterility are substantially equivalent to the predicate device.
8. Performance Data
The technological differences between the subject and predicate devices have been evaluated through biocompatibility and design verification tests to provide evidence of substantial equivalence for the IntellaMap Orion High Resolution Mapping Catheter. The device has been verified through the following:
{5}------------------------------------------------
Design Verification Bench Testing The Design Verification Bench Testing included:
| Test | Results |
|---|---|
| Electrical Testing | Pass |
| Reliability Testing | Pass |
| Catheter Joint Strength | Pass |
| Tip Buckle | Pass |
| Visual Inspections and Dimensions | Pass |
| Simulated Use | Pass |
Biocompatibility Testing
The following Biocompatibility Testing was completed on the IntellaMap Orion High Resolution Mapping Catheter in compliance with the requirements of ISO 10993-1: 2018 - Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within a risk management process.
| Test | Results |
|---|---|
| Cytotoxicity | Pass |
| Hemolysis Direct Contact and Extract Methods | Pass |
| Sensitization Maximization | Pass |
| Intracutaneous Irritation | Pass |
| Acute Systemic Toxicity | Pass |
| Materials Mediated Rabbit Pyrogen | Pass |
| Partial Thromboplastin Time | Pass |
| In Vitro Hemocompatibility | Pass |
| Complement Activation | Pass |
| USP Physicochemical Test | Pass |
| Latex Assay | Pass |
The test results demonstrate that the IntellaMap Orion High Resolution Mapping Catheter is considered safe and effective for its intended use.
9. Conclusion
The proposed IntellaMap Orion High Resolution Mapping Catheter is equivalent in indications for use, intended use, classification, product functions, materials, configuration, and sterility to the predicate device. Therefore, Boston Scientific asserts the proposed
{6}------------------------------------------------
IntellaMap Orion High Resolution Mapping Catheter to be substantially equivalent to the predicate IntellaMap Orion High Resolution Mapping Catheter (cleared in K143481).
§ 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).