K Number
K181618
Device Name
Reprocessed Torqr Diagnostic EP Catheter
Date Cleared
2018-10-18

(121 days)

Product Code
Regulation Number
870.1220
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Reprocessed Torqr Catheter is intended for use in diagnostic electrophysiologic procedures. The catheter is designed for recording intracardiac electrograms and temporary pacing associated with electrophysiology studies.
Device Description
The Reprocessed Torqr Diagnostic EP Catheter is a flexible, radiopaque catheter constructed of extruded polyurethane over stainless steel braid and platinum electrodes. The catheter is of high torque construction to aid in precise catheter placement.
More Information

Not Found

No
The summary describes a physical catheter for diagnostic procedures and does not mention any software or algorithms that would incorporate AI/ML.

No.
The device is intended for diagnostic purposes (recording intracardiac electrograms and temporary pacing associated with electrophysiology studies), not for treating a disease or condition.

Yes
The "Intended Use / Indications for Use" section explicitly states, "The Reprocessed Torqr Catheter is intended for use in diagnostic electrophysiologic procedures."

No

The device description clearly states it is a physical catheter constructed of materials like polyurethane, stainless steel braid, and platinum electrodes, indicating it is a hardware device. The performance studies also focus on hardware-related testing like biocompatibility, sterilization, and electrical safety.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states "diagnostic electrophysiologic procedures" and "recording intracardiac electrograms and temporary pacing associated with electrophysiology studies." This describes a procedure performed within the body (in vivo) to gather electrical signals from the heart.
  • Device Description: The description details a catheter designed to be inserted into the body.
  • Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body (in vitro) to provide information about a patient's health. The description and intended use of this catheter do not involve the analysis of such specimens.

Therefore, this device is an in vivo diagnostic device, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

The Reprocessed Torqr Catheter is intended for use in diagnostic electrophysiologic procedures. The catheter is designed for recording intracardiac electrograms and temporary pacing associated with electrophysiology studies.

Product codes (comma separated list FDA assigned to the subject device)

NLH

Device Description

The Reprocessed Torqr Diagnostic EP Catheter is a flexible, radiopaque catheter constructed of extruded polyurethane over stainless steel braid and platinum electrodes. The catheter is of high torque construction to aid in precise catheter placement.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

intracardiac

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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)

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

  • Biocompatibility
  • Cleaning Validation
  • Sterilization Validation
  • Functional testing
    • Visual Inspection
    • Dimensional Verification
    • Electrical Continuity and Resistance
    • Simulated Use
    • Mechanical Characteristics
  • Electrical Safety Testing
    • Dielectric and Current Leakage
  • Packaging Validation

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K923915

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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

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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 18, 2018

Innovative Health, LLC. Amanda Babcock Principal Regulatory Affairs Specialist 1435 North Hayden Road. Suite 100 Scottsdale, Arizona 85257

Re: K181618

Trade/Device Name: Reprocessed Torqr Diagnostic EP Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Or Electrode Recording Probe Regulatory Class: Class II Product Code: NLH Dated: September 7, 2018 Received: September 10, 2018

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

1

devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely

Mada Jellman
for

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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| Description | Item
Number | Length
(cm) | Curve | French
Size | No. of
Electrodes | Spacing
(mm) |
|------------------------------------|----------------|----------------|-----------|----------------|----------------------|-----------------|
| Torqr
Diagnostic EP
Catheter | 04122JM | 110 | Josephson | 5F | 4 | 2-5-2 |
| 04125JM | 110 | Josephson | 5F | 4 | 5-5-5 | |
| 04122UM | 110 | Cournand | 5F | 4 | 2-5-2 | |
| 04125UM | 110 | Cournand | 5F | 4 | 5-5-5 | |
| 04130DS | 110 | Damato | 5F | 4 | 2-2-2 | |
| 041002JM | 110 | Josephson | 6F | 4 | 2-5-2 | |
| 041005JM | 110 | Josephson | 6F | 4 | 5-5-5 | |
| 041002UM | 110 | Cournand | 6F | 4 | 2-5-2 | |
| 041005UM | 110 | Cournand | 6F | 4 | 5-5-5 | |
| 041005DM | 110 | Damato | 6F | 4 | 5-5-5 | |
| 041565CS | 65 | CS | 5F | 10 | 2-5-2 | |
| 041865CS | 65 | CS | 5F | 10 | 2-8-2 | |
| 041590CS | 90 | CS | 5F | 10 | 2-5-2 | |

The item numbers included in the scope of this submission K181618 are as follows:

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Indications for Use

510(k) Number (if known) K181618

Device Name

Reprocessed Torqr Diagnostic Electrophysiology (EP) Catheter

Indications for Use (Describe)

The Reprocessed Torqr Catheter is intended for use in diagnostic electrophysiologic procedures. The catheter is designed for recording intracardiac electrograms and temporary pacing associated with electrophysiology studies.

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(c)

Submitter's Name and Address:

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

Contact Name and Information:

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

Date prepared:

June 18, 2018

Device Information:

Trade/Proprietary Name:Reprocessed Torqr Diagnostic EP Catheter
Common or Usual Name:Diagnostic Electrophysiology Catheter
Classification Name:Electrode Recording Catheter or Electrode Recording Probe
Classification:Class II, 21 CFR 870.1220
Product Code:NLH

Predicate Device:

510(k) Number510(k) TitleManufacturer
K923915Torqr Series Diagnostic EP CathetersMedtronic (CardioRhythm)

Device Description:

The Reprocessed Torqr Diagnostic EP Catheter is a flexible, radiopaque catheter constructed of extruded polyurethane over stainless steel braid and platinum electrodes. The catheter is of high torque construction to aid in precise catheter placement.

The item numbers in scope of this submission are as follows:

| Description | Item
Number | Length
(cm) | Curve | French
Size | No. of
Electrodes | Spacing
(mm) |
|------------------------------------|----------------|----------------|-----------|----------------|----------------------|-----------------|
| Torqr
Diagnostic EP
Catheter | 04122JM | 110 | Josephson | 5F | 4 | 2-5-2 |
| | 04125JM | 110 | Josephson | 5F | 4 | 5-5-5 |
| | 04122UM | 110 | Cournand | 5F | 4 | 2-5-2 |
| | 04125UM | 110 | Cournand | 5F | 4 | 5-5-5 |
| | 04130DS | 110 | Damato | 5F | 4 | 2-2-2 |

5

041002JM110Josephson6F42-5-2
041005JM110Josephson6F45-5-5
041002UM110Cournand6F42-5-2
041005UM110Cournand6F45-5-5
041005DM110Damato6F45-5-5
041565CS65CS5F102-5-2
041865CS65CS5F102-8-2
041590CS90CS5F102-5-2

Table 5.1: Device Scope

Indications for Use:

The Reprocessed Torgr Catheter is intended for use in diagnostic electrophysiologic procedures. The catheter is designed for recording intracardiac electrograms and temporary pacing associated with electrophysiology studies.

Technological Characteristics:

The purpose, design, materials, function, and intended use of the Reprocessed Torqr Catheter are identical to the predicate devices. 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. Each device 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 Reprocessed Catheter. This included the following:

  • Biocompatibilitv .
  • Cleaning Validation .
  • Sterilization Validation 0
  • Functional testing 0
    • . Visual Inspection
    • = Dimensional Verification
    • . Electrical Continuity and Resistance
    • Simulated Use
    • . Mechanical Characteristics
  • Electrical Safety Testing ●
    • . Dielectric and Current Leakage
  • o Packaging Validation

The Reprocessed Torqr Catheter is reprocessed no more than one (1) time. Each device is marked 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.

6

Conclusion:

Innovative Health concludes that the Reprocessed Torqr Catheter is as safe and effective as the predicate devices described herein.