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 PICCs and 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 and instructions 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.

Device Description

The Nautilus Delta™ system consists of the following elements: single use sterile ECG extension cable (also known as Nautilus Electrical Adaptor also known as NautilusE), non-sterile ECG cable, patient module (ECG data acquisition and processing and integrated remote control), and mobile medical application running on any mobile platform which complies with the minimum requirements. Nautilus Delta™ provides real-time catheter tip location information by using the patient's cardiac electrical activity (ECG). This information can be used to position any central venous access devices (CVADs) at or around the cavo-atrial junction (CAJ). Nautilus Delta supports navigation of central venous catheters from the vascular access point towards the CAJ by computing and displaying a navigation signal. Nautilus Delta also displays on its graphical user interface the surface (skin) ECG signal, a marker identifying the R-peak, and the patient's heart rate. In order to obtain intravascular ECG information at the tip (distal end) of a catheter, a stylet or a guidewire inserted in the catheter can be connected to Nautilus Delta patient module via the sterile Nautilus Delta ECG extension cable. Nautilus Delta and NautilusE do not have any direct or indirect contact with the patient.

AI/ML Overview

The provided text is a 510(k) Summary for the Nautilus Delta™ device, which is an accessory to percutaneous, implanted, long-term intravascular catheters. Its intended use is to support navigation and tip positioning of central venous access devices (CVADs) by using the patient's cardiac electrical activity (intracardiac ECG) as an alternative to chest X-ray and fluoroscopy for CVAD tip placement confirmation.

The document states that Romedex International SRL submitted this 510(k) after obtaining CE mark approval, and that the device "was successfully used in Europe in hundreds of patients in 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."

However, the document does NOT contain explicit acceptance criteria (e.g., target accuracy, sensitivity, specificity values) for device performance, nor does it detail a specific study proving the device meets quantified acceptance criteria. The submission focuses on demonstrating substantial equivalence to predicate devices (Epidural Catheter Connector K973371 and Sherlock 3CG Tip Confirmation System K113808) through a comparison of technological characteristics, performance testing against various 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), and post-market clinical experience from Europe.

Since the input document does not contain the specific information requested, I will state that the information is not provided.

Here's a breakdown of the requested information based on the provided text:

A table of acceptance criteria and the reported device performance:
- Not provided. The document states that "Romedex has performed extensive testing in order to demonstrate 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." It does not, however, list specific performance metrics (e.g., accuracy, sensitivity, specificity for tip placement) or their corresponding acceptance thresholds.
Sample size used for the test set and the data provenance:
- The document states: "Since obtaining the CE mark, Nautilus Delta also known as Handy Nautilus was successfully used in Europe in hundreds of patients in several hospitals in several countries..." This indicates a retrospective collection of real-world use data from Europe. A precise sample size for a formal "test set" demonstrating performance is not explicitly provided, beyond "hundreds of patients."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not provided. The document mentions "many different users of different backgrounds and experience levels" using the device, but it does not specify how ground truth was established for these "hundreds of patients" for comparison purposes (e.g., if chest X-ray or fluoroscopy was used as ground truth for tip placement confirmation and adjudicated by experts).
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not provided.
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:
- Not provided. The device is not an AI/ML algorithm that assists human readers; it's a device that provides real-time catheter tip location information using cardiac electrical activity as an alternative method to chest X-ray and fluoroscopy. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable in the typical sense for this device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The device provides real-time information to a human operator. The document describes it as a system with a patient module, cables, and a mobile application for display. Performance would inherently involve the device generating a "navigation signal" and displaying information for a human to interpret and act upon. The text does not describe a "standalone algorithm-only" performance evaluation independent of human interaction or interpretation of the displayed information for tip placement confirmation.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated for the "hundreds of patients" data. For CVAD tip placement, the common ground truth methods are chest X-ray or fluoroscopy. The device is indicated as an alternative to these. While "side-by-side comparisons with legally marketed similar devices" (which would presumably use standard confirmation methods) were performed, the specific type of ground truth used to validate the Nautilus Delta's performance in terms of tip placement accuracy is not detailed.
The sample size for the training set:
- Not applicable / Not provided. The Nautilus Delta as described is a medical device that measures and processes ECG signals to determine catheter tip location using established physiological principles. It is not an AI/ML device that requires a "training set" in the context of machine learning model development.
How the ground truth for the training set was established:
- Not applicable / Not provided. As it's not an AI/ML device in the sense of needing a training set, the methodology for establishing ground truth for a training set is not pertinent here.

Summary

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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.

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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

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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)

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FOR FDA USE ONLY

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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+40.21.255.0385, info@romedex.com, www.romedex.com
Contact person:	Sorin Grunwald PhD, 625 Clayton Str., San Francisco, CA 94117sorin@romedex.com, Tel: +1.650.209.4838, Fax: +1.650.636.9666
Date of Preparation:	June 16, 2014
Product Classification:	Class II, 21 CFR §880.5970LJS - Accessory to Percutaneous, Implanted, Long-TermIntravascular Catheters
Classification Panel:	General Hospital
Predicate devices:	Epidural Catheter Connector (K973371)Sherlock 3CG Tip Confirmation System (K113808)
Device Description:	The Nautilus Delta™ system consists of the following elements:single use sterile ECG extension cable (also known as NautilusElectrical Adaptor also known as NautilusE), non-sterile ECGcable, patient module (ECG data acquisition and processing andintegrated remote control), and mobile medical applicationrunning on any mobile platform which complies with the minimumrequirements. Nautilus Delta™ provides real-time catheter tiplocation information by using the patient's cardiac electricalactivity (ECG). This information can be used to position anycentral venous access devices (CVADs) at or around the cavo-atrial junction (CAJ). Nautilus Delta supports navigation of centralvenous catheters from the vascular access point towards the CAJby computing and displaying a navigation signal. Nautilus Deltaalso displays on its graphical user interface the surface (skin) ECGsignal, a marker identifying the R-peak, and the patient's heartrate. In order to obtain intravascular ECG information at the tip(distal end) of a catheter, a stylet or a guidewire inserted in thecatheter can be connected to Nautilus Delta patient module via thesterile Nautilus Delta ECG extension cable. Nautilus Delta andNautilusE do not have any direct or indirect contact with thepatient.
Intended Use:	The intended use of Nautilus DeltaTM is to support navigation andtip positioning of central venous access devices. Nautilus DeltaTMcan be used as an alternative method to fluoroscopy and chest X-ray for central venous catheter tip placement confirmation.
Indications for Use:	Nautilus Delta is indicated for navigation and positioning of centralvenous access devices (CVADs) of at least 3 Fr in size. NautilusDelta provides real-time catheter tip location information by usingthe patient's cardiac electrical activity and is indicated for use as analternative method to chest X-ray and fluoroscopy for CVAD tipplacement confirmation.In adult patients and in adolescents (greater than 12 through 21years of age), Nautilus Delta can be used with CVADs such asperipherally inserted central catheters (PICCs), central venouscatheters (CVCs), implantable ports, and hemodialysis catheters;in children (greater than 2 to 12 years of age), Nautilus Delta canbe used with PICCs and with centrally inserted central catheters(CICCs); in infants (greater than 1 month to 2 years of age) andin neonates (from birth to 1 month of age), Nautilus Delta can beused with CICCs. In each specific age group, the CVAD type andsize must be chosen and the CVAD must be used according to theCVAD's indications and instructions for use.Limiting but not contraindicated situations for this method are inpatients where alterations of cardiac rhythm change thepresentation 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 catheterinsertion, the use of an additional method is required to confirmcatheter tip location.
Summary of TechnologicalCharacteristics comparedto Predicate Devices:	Nautilus Delta has features, materials and technologicalcharacteristics which are similar to the ones of the predicatedevices. The most notable differences are:a) Nautilus Delta uses wireless technology (Bluetooth) instead ofan USB cable for the ECG data transmission between thePatient and the Operator modules.b) Nautilus Delta uses a mobile platform instead of a netbook PC.c) Nautilus Delta provides a Bluetooth remote control integratedin the Patient Module instead of a standalone Bluetooth remotecontrol.d) Nautilus Delta provides an additional optional navigationsignal to support catheter tip navigation from the vascularaccess point towards the cavo-atrial junction.e) Nautilus Delta displays the patient's heart rate and markers toidentify the R-peak of the QRS complex of the ECGwaveform.

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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.

Regulation Number and Section

§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.

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