Reprocesses Umbilical Cable

K221854 · Innovative Health, LLC · NLH · Aug 6, 2022 · Cardiovascular

Device Facts

• Record ID: K221854
• Device Name: Reprocesses Umbilical Cable
• Applicant: Innovative Health, LLC
• Product Code: NLH · Cardiovascular
• Decision Date: Aug 6, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1220
• Device Class: Class 2

Intended Use

The reprocessed cable provides an electrical connection between the IntellaMap Orion Mapping Catheter and the Signal Station of the Rhythmia Mapping System. The reprocessed Umbilical Cable is intended to be used with an Orion Mapping Catheter during electrophysiology procedures, electroanatomical mapping, intracardiac stimulation (pacing) and/or recording of electrical potentials.

Device Story

Reprocessed Umbilical Cable serves as electrical interface between IntellaMap Orion Mapping Catheter and Rhythmia Mapping System Signal Station; facilitates signal transmission for electroanatomical mapping, intracardiac stimulation, and recording of electrical potentials. Used in clinical electrophysiology settings by trained medical professionals. Device is insulated, multi-conductor cable (200 cm) with multi-pin connectors. Innovative Health performs reprocessing, including cleaning, decontamination, inspection, and functional testing (electrical continuity, HiPOT). Device is serialized, tracked, and limited to one reprocessing cycle. Output is raw electrical signal data transmitted to mapping system for clinician visualization and diagnostic decision-making.

Clinical Evidence

Bench testing only. Validation included cleaning, sterilization, packaging, visual inspection, dimensional verification, electrical continuity testing, and High Potential (HiPOT) testing.

Technological Characteristics

Insulated, multi-conductor cable, 200 cm length, 78-pin connectors. Passive electrical connection. Reprocessed via cleaning and decontamination. Sterilization validation performed. No active electronic components or software algorithms.

Indications for Use

Indicated for patients undergoing electrophysiology procedures, electroanatomical mapping, intracardiac stimulation (pacing), and/or recording of electrical potentials using the IntellaMap Orion Mapping Catheter.

Regulatory Classification

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.

Predicate Devices

• Reprocessed Achieve Catheter Connecting Cable (K193263)

Reference Devices

• Reprocessed IntellaMap Orion High Resolution Mapping Catheter (K211662)

Submission Summary (Full Text)

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August 6, 2022

Innovative Health, LLC. Meerna Muradvich Regulatory Affairs Engineer 1435 North Hayden Road, Suite 100 Scottsdale, Arizona 85257

Re: K221854

Trade/Device Name: Reprocessed Umbilical Cable Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Or Electrode Recording Probe Regulatory Class: Class II Product Code: NLH Dated: June 24, 2022 Received: June 27, 2022

Dear Meerna Muradvich:

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

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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 ([e-mail]) or phone [phone] 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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# K221854 - Meerna Muradvich

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

| Item Number | Device Description | Length (Ft) | Number of<br>Pins |
|-------------------|-----------------------------|-------------|-------------------|
| M004RAUMBILICAL20 | Reprocessed Umbilical Cable | 6.6 | 78 |

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# Indications for Use

510(k) Number (if known) K221854

Device Name Reprocessed Umbilical Cable

#### Indications for Use (Describe)

The reprocessed cable provides an electrical connection between the IntellaMap Orion Mapping Catheter and the Signal Station of the Rhythmia Mapping System. The reprocessed Umbilical Cable is intended to be used with an Orion Mapping Catheter during electrophysiology procedures, electroanatomical mapping, intracardiac stimulation (pacing) and/or recording of electrical potentials.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|---------------------------------------------|
| > Prescription Use (Part 21 CER 801 Subnart D) | Over-The-Counter Use (21 CER 801 Subnart C) |

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# K221854 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:

Meerna Muradvich Requlatory Affairs Enqineer Innovative Health, LLC. [phone] (office) [phone] (fax) [e-mail]

#### Date prepared:

June 24, 2022

#### Device Information:

| Trade/Proprietary Name: | Reprocessed Umbilical Cable |
|-------------------------|--------------------------------------------------------|
| Common Name: | Diagnostic Electrophysiology Catheter Connecting Cable |
| Classification Name: | Catheter, Recording, Electrode, Reprocessed |
| Classification Number: | Class II, 21 CFR 870.1220 |
| Product Code: | NLH |

## Predicate Device:

| 510(k) Number | 510(k) Device | Manufacturer |
|---------------|--------------------------------------------------|-------------------------|
| K193263 | Reprocessed Achieve Catheter<br>Connecting Cable | Innovative Health, LLC. |

#### Reference Device:

| 510(k) Number | 510(k) Device | Manufacturer |
|---------------|------------------------------------------------------------------|-------------------------|
| K211662 | Reprocessed IntellaMap Orion High<br>Resolution Mapping Catheter | Innovative Health, LLC. |

#### Device Description:

The reprocessed umbilical cable is an insulated, multi-conductor cable that us 200 cm (6.6 ft) in length with multi-pin connectors at each end.

Note: Only the Umbilical Cable is the subject of this submission. Any other related equipment is not included in the scope of this submission.

## Indications for Use:

The reprocessed cable provides an electrical connection between the IntellaMap Orion Mapping Catheter and the Signal Station of the Rhythmia Mapping System. The reprocessed Umbilical Cable is intended to be used with an Orion Mapping Catheter during electrophysiology procedures, electroanatomical mapping, intracardiac stimulation (pacing) and/or recording of electrical potentials.

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

| Item Number | Device Description | Length<br>(Ft) | Number of Pins |
|-------------------|-----------------------------|----------------|----------------|
| M004RAUMBILICAL20 | Reprocessed Umbilical Cable | 6.6 | 78 |

Table 5.1: Device Scope

# Technological Characteristics:

The purpose, design, materials, function, and intended use of the Reprocessed Umbilical Cable is identical to the predicate device. There are no changes to the claims, clinical applications, patient population, performance specifications, or method of operation. In addition, Innovative Health's reprocessing of this device 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 the Reprocessed Umbilical Cable. This included the following:

- Cleaning Validation ●
- Sterilization Validation ●
- . Functional Testing
- · Visual Inspection
- Dimensional Verification .
- . Electrical Continuity Testing
- High Potential (HiPOT) Testing ●
- Packaging Validation ●

The Reprocessed Umbilical Cable 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 Umbilical Cable is as safe and effective as the predicate device described herein.