The Reprocessed IntellaMap Orion High Resolution Mapping Catheter is indicated for electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart.

Device Description

The Reprocessed IntellaMap Orion High Resolution Mapping Catheter is an 8.5F(ø 2.82 mm), 115 cm working length, 64-electrode steerable catheter. The basket-shaped distal reqion consists of 8 splines that comprise 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 of 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 Mapping System.

AI/ML Overview

The provided text describes the regulatory clearance of a reprocessed medical device, the Reprocessed IntellaMap Orion High Resolution Mapping Catheter, and lists the types of functional and safety testing conducted to demonstrate its performance. However, it does not provide specific acceptance criteria or detailed results of a study designed to prove the device meets those criteria.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, nor can I detail a study that proves the device meets specific acceptance criteria based on the information given. The document focuses on regulatory equivalence to a predicate device rather than presenting a performance study with detailed metrics against defined acceptance criteria.

Based on the provided text, here's what can be inferred regarding the request:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated as quantifiable metrics. The document broadly indicates that the reprocessed device's performance (safety and effectiveness) needs to be demonstrated and that its purpose, design, materials, function, and intended use are "identical to the predicate device."
- Reported Device Performance: No specific numerical performance metrics are reported in this document. The document lists the types of tests performed (e.g., Biocompatibility, Cleaning Validation, Functional testing, Electrical Safety Testing, Packaging Validation), but not their outcomes or criteria for success.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- This information is not provided. The document mentions "Bench and laboratory testing" but does not specify sample sizes or data provenance for these tests.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- This information is not provided. The testing described is primarily laboratory and bench testing, not clinical studies requiring expert ground truth establishment in the context of diagnostic interpretation.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not applicable and not provided, as the testing described does not involve expert adjudication of a diagnostic output.
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 is mentioned. This device is a physical medical instrument (catheter), not an AI diagnostic tool, so this type of study is not relevant to its clearance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable as the device is a physical medical instrument, not an algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- For the functional and safety testing, "ground truth" would be established through engineering specifications, material standards, and validated testing methodologies (e.g., sterilization validation based on established microbial inactivation levels, biocompatibility based on ISO standards, electrical safety based on IEC standards). No expert consensus, pathology, or outcomes data is mentioned as a "ground truth" for these tests in this document.
The sample size for the training set:
- This is not applicable. The device is a reprocessed physical instrument, not an AI model, so there is no "training set."
How the ground truth for the training set was established:
- This is not applicable for the reasons stated above.

In summary, the provided document is a regulatory clearance letter focused on substantial equivalence based on a comparison to a predicate device and a list of performed functional and safety tests. It does not contain the detailed performance data, acceptance criteria, or study specifics that would be expected for an AI/diagnostic software clearance, or a clinical study on a novel device.

Summary

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November 18, 2021

Innovative Health, LLC. Amanda Babcock Regulatory Affairs Manager 1435 N. Hayden Road, Suite 100 Scottsdale, AZ 85257

Re: K211662

Trade/Device Name: Reprocessed 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: NLG Dated: October 19, 2021 Received: October 20, 2021

Dear Amanda Babcock:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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 (QS) 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,

Aneesh Deoras Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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The Item number in the scope of this submission is as follows:

Item Number	Description	UsableLength(cm)	FrenchSize	Curve	Electrodes
M004RC64S0	ReprocessedIntellaMap OrionHigh ResolutionMapping Catheter	115	8.5F	180,Bidirectional	64

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Indications for Use

510(k) Number (if known) K211662

Device Name

Reprocessed IntellaMap Orion High Resolution Mapping Catheter

Indications for Use (Describe)

The Reprocessed 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)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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SECTION 5: 510(k) SUMMARY

As required by 21 CFR 807.92

Submitter's Name and Address:

Innovative Health, LLC. 1435 N. Hayden Road, Suite 100 Scottsdale, AZ 85257

Contact Name and Information:

Amanda Babcock Regulatory Affairs Manager Innovative Health, LLC. (480) 525-5911 (office) (888) 965-7705 (fax) ababcock@innovative-health.com

Date prepared:

May 28, 2021

Device Information:

Trade/Proprietary Name:	Reprocessed IntellaMap Orion High Resolution Mapping Catheter
	Catheter
Common or Usual Name:	Diagnostic Electrophysiology Mapping Catheter
Classification Name:	Electrode Recording Catheter or Electrode Recording Probe
	Probe
Classification Number:	Class II, 21 CFR 870.1220
Product Code:	NLG

Predicate Device:

510(k) Number	Device	Manufacturer
K192360	IntellaMap Orion High Resolution MappingCatheter	Boston ScientificCorporation

Reference Device:

510(k) Number	Device	Manufacturer
K200212	Reprocessed Advisor HD Grid MappingCatheter, Sensor Enabled	Innovative Health, LLC.

Device Description:

The item number in scope of this submission is as follows:

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Item Number	Description	Usable Length (cm)	French Size	Curve	Electrodes
M004RC64S0	ReprocessedIntellaMap OrionHigh ResolutionMapping Catheter	115	8.5F	180,Bidirectional	64

Table 5.1: Device Scope

Indications for Use:

The Reprocessed IntellaMap Orion High Resolution Mapping Catheter is indicated for electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart.

Technological Characteristics:

The purpose, design, materials, function, and intended use of the Reprocessed IntellaMap Orion High Resolution Mapping Catheter are identical to the predicate device. There are no changes to the claims, clinical applications, patient populations, performance specifications, or method of operation. In addition, Innovative Health's reprocessing of the Catheter includes removal of visible soil and decontamination of the device and lumen. Each device (including the lumen) is inspected, and function tested prior to packaging and labeling.

Functional and Safety Testing:

Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Reprocessed IntellaMap Orion High Resolution Mapping Catheter. This included the following:

Biocompatibilitv ●
Cleaning Validation ●
Sterilization Validation
Functional testing
- Visual Inspection .
- . Dimensional Verification
- . Dynamic Continuity
- Simulated Use .
- . Leak/Occlusion
- Inner lumen occlusion ■
- . Mechanical Characteristics
Electrical Safety Testing
- Dielectric and Current .
  - Leakage
Packaging Validation ●

The Reprocessed IntellaMap Orion High Resolution Mapping Catheter is reprocessed no more than one (1) time. Each device is marked, serialized and tracked. After the device has reached the maximum number of reprocessing cycles, the device is rejected from further reprocessing. Reprocessing is performed only by Innovative Health. Innovative Health restricts its reprocessing to exclude devices previously reprocessed by other reprocessors.

Conclusion:

Innovative Health concludes that the Reprocessed IntellaMap Orion High Resolution Mapping Catheter is substantially equivalent to the predicate devices described herein.

Regulation Number and Section

§ 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).