NAUTILUS DELTA

K141634 · Romedex International Srl · LJS · Jan 27, 2015 · General Hospital

Device Facts

• Record ID: K141634
• Device Name: NAUTILUS DELTA
• Applicant: Romedex International Srl
• Product Code: LJS · General Hospital
• Decision Date: Jan 27, 2015
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.5970
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

Intended Use

The intended use of Nautilus DeltaTM is to support navigation and tip positioning of central venous access devices. Nautilus DeltaTM can be used as an alternative method to fluoroscopy and chest X-ray for central venous catheter tip placement confirmation.

Device Story

Nautilus Delta system facilitates real-time central venous access device (CVAD) tip positioning. System inputs: patient cardiac electrical activity (ECG) via sterile extension cable connected to catheter stylet/guidewire. Patient module acquires/processes ECG data; transmits wirelessly (Bluetooth) to mobile medical application. Application displays surface ECG, R-peak markers, heart rate, and navigation signal to guide catheter from access point to cavo-atrial junction (CAJ). Used in clinical settings by healthcare providers; replaces/augments traditional fluoroscopy or chest X-ray. Provides visual feedback on graphical user interface; assists clinicians in accurate tip placement; reduces radiation exposure by minimizing need for imaging.

Clinical Evidence

Clinical data from European post-market use in hundreds of patients across multiple hospitals. No adverse events reported. Side-by-side clinical comparisons with predicate devices demonstrated substantial equivalence. Bench testing confirmed compliance with standards including ES60601-1, IEC 60601-1-2, IEC 60601-2-27, IEC 62304, IEC 62366, ISO 11737-1, ISO 11135-1, ISO 11135-2, EN 55022, and EN 300328.

Technological Characteristics

System includes sterile ECG extension cable, non-sterile ECG cable, patient module, and mobile application. Uses Bluetooth for wireless data transmission. Features include real-time ECG acquisition, R-peak detection, heart rate calculation, and navigation signal computation. Complies with IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60601-2-27 (ECG monitoring), IEC 62304 (software), and ISO 11135 (sterilization).

Indications for Use

Indicated for navigation/positioning of CVADs (≥3 Fr) using cardiac electrical activity as alternative to X-ray/fluoroscopy. Population: Adults/adolescents (>12-21y) with PICCs, CVCs, ports, hemodialysis catheters; children (>2-12y) with PICCs/CICCs; infants (>1mo-2y) and neonates (birth-1mo) with CICCs. Contraindicated/limited in patients with altered cardiac rhythm (atrial fibrillation, flutter, severe tachycardia, pacemaker-driven rhythm); additional confirmation method required for these patients.

Regulatory Classification

Identification

A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.

Special Controls

*Classification.* Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”

Predicate Devices

• Epidural Catheter Connector (K973371)
• Sherlock 3CG Tip Confirmation System (K113808)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is a stylized image of three faces in profile, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 27, 2015

Romedex International SRL Sorin Grunwald, PhD. Managing Director 625 Clayton Street San Francisco, CA 94117

Re: K141634

Trade/Device Name: Nautilus Delta™ Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, implanted, long- term intravascular catheter Regulatory Class: II Product Code: LJS Dated: December 15, 2015 Received: December 17, 2015

Dear Dr. Grunwald:

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. 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.

{1}------------------------------------------------

Page 2 - Sorin Grunwald, Ph.D.

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina
Kiang -S

for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known) K141634

Device Name Nautilus Delta

#### Indications for Use (Describe)

Nautilus Delta is indicated for navigation and positioning of central venous access devices (CVADs) of at least 3 Fr in size. Nautilus Delta provides real-time catheter tip location by using the patient's cardiac electrical activity and is indicated for use as an alternative method to chest X-ray and fluoroscopy for CVAD tip placement confirmation. In adult patients and in adolescents (greater than 12 through 21 years of age), Nautilus Delta can be used with CVADs such as peripherally inserted central catheters (PICCs), central venous catheters (CVCs), implantable ports, and hemodialysis catheters; in children (greater than 2 to 12 years of age), Nautilus Delta can be used with centrally inserted central catheters (CICCs); in infants (greater than 1 month to 2 years of age) and in neonates (from birth to 1 month of age), Nautilus Delta can be used with CICCs. In each specific age group, the CVAD type and size must be chosen and the CVAD must be used according to the CVAD's indications for use. Limiting but not contraindicated situations for this method are in patients where alterations of cardiac rhythm change the presentation of the P wave as in atrial fibrillation, atrial flutter, severe tachycardia, and pacemaker driven rhythm. In such patients, who are easily identifiable prior to central venous catheter insertion, the use of an additional method is required to confirm catheter tip location.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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}------------------------------------------------

# 510(k) Summary

| Proprietary Name: | Nautilus Delta™ also known as Handy Nautilus™ |
|-------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Trade Name: | Nautilus Delta™ |
| Applicant Name: | Romedex International SRL |
| Applicant Address: | 74 Fundeni Str., 022325, Bucharest, Romania<br>+40.21.255.0385, [e-mail], www.romedex.com |
| Contact person: | Sorin Grunwald PhD, 625 Clayton Str., San Francisco, CA 94117<br>[e-mail], Tel: [phone], Fax: [phone] |
| Date of Preparation: | June 16, 2014 |
| Product Classification: | Class II, 21 CFR §880.5970<br>LJS - Accessory to Percutaneous, Implanted, Long-Term<br>Intravascular Catheters |
| Classification Panel: | General Hospital |
| Predicate devices: | Epidural Catheter Connector (K973371)<br>Sherlock 3CG Tip Confirmation System (K113808) |
| Device Description: | The Nautilus Delta™ system consists of the following elements:<br>single use sterile ECG extension cable (also known as Nautilus<br>Electrical Adaptor also known as NautilusE), non-sterile ECG<br>cable, patient module (ECG data acquisition and processing and<br>integrated remote control), and mobile medical application<br>running on any mobile platform which complies with the minimum<br>requirements. Nautilus Delta™ provides real-time catheter tip<br>location information by using the patient's cardiac electrical<br>activity (ECG). This information can be used to position any<br>central venous access devices (CVADs) at or around the cavo-<br>atrial junction (CAJ). Nautilus Delta supports navigation of central<br>venous catheters from the vascular access point towards the CAJ<br>by computing and displaying a navigation signal. Nautilus Delta<br>also displays on its graphical user interface the surface (skin) ECG<br>signal, a marker identifying the R-peak, and the patient's heart<br>rate. In order to obtain intravascular ECG information at the tip<br>(distal end) of a catheter, a stylet or a guidewire inserted in the<br>catheter can be connected to Nautilus Delta patient module via the<br>sterile Nautilus Delta ECG extension cable. Nautilus Delta and<br>NautilusE do not have any direct or indirect contact with the<br>patient. |
| Intended Use: | The intended use of Nautilus DeltaTM is to support navigation and<br>tip positioning of central venous access devices. Nautilus DeltaTM<br>can be used as an alternative method to fluoroscopy and chest X-<br>ray for central venous catheter tip placement confirmation. |
| Indications for Use: | Nautilus Delta is indicated for navigation and positioning of central<br>venous access devices (CVADs) of at least 3 Fr in size. Nautilus<br>Delta provides real-time catheter tip location information by using<br>the patient's cardiac electrical activity and is indicated for use as an<br>alternative method to chest X-ray and fluoroscopy for CVAD tip<br>placement confirmation.<br>In adult patients and in adolescents (greater than 12 through 21<br>years of age), Nautilus Delta can be used with CVADs such as<br>peripherally inserted central catheters (PICCs), central venous<br>catheters (CVCs), implantable ports, and hemodialysis catheters;<br>in children (greater than 2 to 12 years of age), Nautilus Delta can<br>be used with PICCs and with centrally inserted central catheters<br>(CICCs); in infants (greater than 1 month to 2 years of age) and<br>in neonates (from birth to 1 month of age), Nautilus Delta can be<br>used with CICCs. In each specific age group, the CVAD type and<br>size must be chosen and the CVAD must be used according to the<br>CVAD's indications and instructions for use.<br>Limiting but not contraindicated situations for this method are in<br>patients where alterations of cardiac rhythm change the<br>presentation of the P wave as in atrial fibrillation, atrial flutter,<br>severe tachycardia, and pacemaker driven rhythm. In such patients,<br>who are easily identifiable prior to central venous catheter<br>insertion, the use of an additional method is required to confirm<br>catheter tip location. |
| Summary of Technological<br>Characteristics compared<br>to Predicate Devices: | Nautilus Delta has features, materials and technological<br>characteristics which are similar to the ones of the predicate<br>devices. The most notable differences are:<br>a) Nautilus Delta uses wireless technology (Bluetooth) instead of<br>an USB cable for the ECG data transmission between the<br>Patient and the Operator modules.<br>b) Nautilus Delta uses a mobile platform instead of a netbook PC.<br>c) Nautilus Delta provides a Bluetooth remote control integrated<br>in the Patient Module instead of a standalone Bluetooth remote<br>control.<br>d) Nautilus Delta provides an additional optional navigation<br>signal to support catheter tip navigation from the vascular<br>access point towards the cavo-atrial junction.<br>e) Nautilus Delta displays the patient's heart rate and markers to<br>identify the R-peak of the QRS complex of the ECG<br>waveform. |

{4}------------------------------------------------

{5}------------------------------------------------

Summary of Romedex has performed extensive testing in order to demonstrate Performance Testing: that the new characteristics do not affect safety and effectiveness when compared to the predicate devices and to demonstrate compliance with the following standards: ES60601-1, IEC 60601-1-2, IEC 60601-2-27, IEC 62304, IEC 62366, ISO 11737-1, ISO 11135-1, ISO 11135-2, EN 55022, and EN 300328. Summary of Since obtaining the CE mark, Nautilus Delta also known as Handy Nautilus was successfully used in Europe in hundreds of patients in Clinical Data: several hospitals in several countries by many different users of different backgrounds and experience levels. No adverse events were reported. Side-by-side comparisons with legally marketed similar devices, including the predicate devices, were performed in clinical settings to demonstrated substantial equivalence of Nautilus Delta with the predicate devices. Summary of Based on the analysis of the indications for use, intended use, Substantial Equivalence: technological characteristics, performance tests, and post-market clinical experience, Romedex International has concluded that the new characteristics of the subject device do not affect the safety or effectiveness of the subject device as compared to the predicate devices. Romedex International considers that the new device Nautilus Delta is substantially equivalent to the predicate devices K973371 and K113808.