The C3 Wave System is indicated for use in the positioning of Peripherally Inserted Central Catheters (PICC). The C3 Wave provides real-time catheter tip location information by displaying changes in the patient's cardiac electrical activity. The C3 Wave is indicated for use as an alternative method to chest X-ray or fluoroscopy confirmation of PICC tip placement in adult patients.

Note: Limiting, but not contraindicated, situations for this technique are patients where cardiac rhythms may change presentation of the P-Wave:
-Atrial fibrillation
-Atrial flutter

Severe tachycardia
-Pacemaker-Driven Rhythm
-Chronic obstructive pulmonary disease (COPD)
Such patients are easily identified prior to PICC insertion. Use of additional method is necessary to confirm catheter tip location.

Device Description

C3 Wave is designed to provide a continuous display of electrocardiograph [ECG] waveform to be used as a quide in placement of peripherally-inserted central catheters [PICC] in the lower third of the Superior Vena Cava [SVC] of a patient. The principle for operation of this system uses three ECG leads placed on the patient's chest and generates a third ECG lead by switching from RA to PICC stylet. The ECG waveform is wirelessly transmitted to a tablet which allows the operator to view and record changes to the ECG waveform as the tip of the catheter approaches the heart. As the PICC catheter approaches the atrium of the heart, the P wave in the ECG waveform shows substantial changes. This system is designed to aid the visualization of changes in P wave amplitude.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the C3 Wave System, based on the provided text:

Acceptance Criteria and Device Performance

The document doesn't explicitly list "acceptance criteria" as a separate table with specific numerical targets. However, the outcome of the clinical study serves as the primary performance metric for the expanded indications for use.

Table 1: Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Successful demonstration of clinical acceptance between the MedComp C3 Wave System ECG Tip Confirmation System positioning results and traditional portable chest x-ray in determining proper distal tip location during a PICC procedure, to support its use as an alternative method to X-ray or fluoroscopy.	98% success rate when the Bundle Protocol Parameters were met.
No critical task failures during human factors testing for PICC tip confirmation.	No critical task failures were observed.

Study Details

Here's a breakdown of the study information as requested:

2. Sample size used for the test set and the data provenance:

Sample Size: 303 PICCs were placed. Each PICC placement likely represents a single case in the test set.
Data Provenance: Retrospective, as indicated by the completion of "Clinical Surveys" and data collection from "two healthcare facilities." The study design involved obtaining an X-ray after the C3 Wave System was used, implying a comparison against established practice. Given it's a 510(k) submission, the data is typically from a clinical trial conducted for regulatory purposes. The specific country of origin is not mentioned, but "two healthcare facilities" implies clinical settings.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts: Not explicitly stated how many individual experts independently reviewed each X-ray for ground truth. However, the process refers to "established hospital protocol (e.g., Chest X-Ray, Fluoroscopy)," which implies that the interpretation of the chest X-rays to determine "acceptable tip location" was performed by qualified medical professionals as part of standard clinical practice. This would typically involve radiologists or trained clinicians responsible for interpreting such images.
Qualifications of Experts: Not specifically detailed. It can be inferred that the chest X-rays were interpreted by clinicians or radiologists according to "clinical judgement and established hospital protocol."

4. Adjudication method for the test set:

Adjudication Method: Not explicitly detailed. The study mentions that a "subsequent portable chest x-ray was to be obtained... to ascertain acceptable tip location of PICC." This implies that the chest X-ray served as the gold standard against which the C3 Wave System's positioning results were compared. There's no mention of a formal adjudicated consensus process if multiple readers were involved in interpreting the X-rays; it likely followed standard clinical practice for X-ray interpretation.

5. 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:

MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done in the context of human readers improving with AI vs without AI assistance.
Nature of Study: This study evaluated the C3 Wave System as a standalone alternative to chest X-ray or fluoroscopy, not as an AI-assistance tool for human readers. The "success rate" refers to the device's ability to correctly identify tip placement compared to the X-ray, not an improvement in human reader performance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Standalone Performance: Yes, the clinical study primarily evaluated the C3 Wave System for its standalone ability to determine PICC tip location. The system provides real-time electrical activity display, and the "clinician was to complete an electronic survey document to capture specific data points within each procedure including insertion related assessments" which implies the system's output (ECG display) was used by the clinician to guide placement, and then the system's output was judged against the X-ray. The 98% success rate reflects the system's performance in guiding tip placement without requiring an X-ray for initial confirmation.

7. The type of ground truth used:

Ground Truth: Expert Consensus (implied by clinical practice) / Imaging (Chest X-ray). The "acceptable tip location of PICC" was ascertained by a "subsequent portable chest x-ray," which is then interpreted by medical professionals according to "clinical judgement and established hospital protocol." The X-ray image and its interpretation serve as the ground truth.

8. The sample size for the training set:

Training Set Sample Size: The document does not provide information about the sample size used for training the C3 Wave System's algorithms. As it's an ECG-based system, its "training" might involve developing and refining the algorithms that interpret ECG changes to infer catheter tip position, which could be based on prior physiological models or data, but specific data for algorithmic training is not present in this summary.

9. How the ground truth for the training set was established:

Training Set Ground Truth Establishment: This information is not provided in the document. Without details on the training set, how its ground truth was established cannot be determined from this summary.

Summary

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December 6, 2017

Medical Components, Inc (dba Medcomp) Courtney Nix Regulatory Affairs Manager, North American and Europe 1499 Delp Drive Harleysville, Pennsylvania 19438

Re: K170934

Trade/Device Name: C3 Wave System Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, implanted, long-term intravascular catheter Regulatory Class: Class II Product Code: LJS Dated: October 27, 2017 Received: November 6, 2017

Dear Courtney Nix:

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.

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov

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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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-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,

Tina Kiang -

Tina Kiang, Ph.D. Acting 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) K170934

Device Name C3 Wave System

Indications for Use (Describe)

The C3 Wave System is indicated for use in the positioning of Peripherally Inserted Central Catheters (PICC). The C3 Wave provides real-ime cather tip location information by displaying changes in the patient's cardiac electrical activity. The C3 Wave is indicated for use as an alternative method to chest X-ray or fluoroscopy confirmation of PICC tin placement in adult patients.

Note: Limiting, but not contraindicated, situations for this technique are patients where cardiac rhythms may change presentation of the P-Wave:

-Atrial fibrillation

-Atrial flutter

Severe tachycardia

-Pacemaker-Driven Rhythm

-Chronic obstructive pulmonary disease (COPD)

Such patients are easily identified prior to PICC insertion. Use of additional method is necessary to confirm catheter tip location.

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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510(k) Summary: K170934

A. Submitter Information:

Submitter:	Medcomp®1499 Delp DriveHarleysville, PA 19438Tel: (215) 256-4201, x 2285Fax: (215) 256-9191
Registration Number:	2518902
Contact:	Courtney NixCnix@Medcompnet.comRegulatory Affairs Manager: North America and EU
Date Prepared:	November 28, 2017
Proposed or Subject Device Information:
Trade Name:	C3 Wave System
Device:	Catheter, intravascular, Therapeutic Long-TermGreater Than 30 Days
Product Code:	LJS
Regulation Description:	Percutaneous, implanted, long-term intravascularcatheter
C.F.R. Section:	880.5970
Class:	ll
Regulation MedicalSpecialty and ReviewPanel:	General Hospital
Predicate Device Information:
510(k) Number:	K143238
510(k) Holder:	Medcomp®
Trade Name:	C3 Wave System
Device:	Catheter, intravascular, Therapeutic Long-TermGreater Than 30 Days
Product Code:	LJS

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Regulation Description:	Percutaneous, implanted, long-term intravascularcatheter
C.F.R. Section:	880.5970
Class:	II
Regulation MedicalSpecialty and ReviewPanel:	General Hospital

E. Purpose for Submission:

The primary purpose of this submission is to revise the indications for use for the C3 Wave System. The indications currently included, cleared by C3 Wave System K143238, "Confirmation of tip placement should be verified according to clinical judgement and established hospital protocol (e.q., Chest X-Ray, Fluoroscopy)." The proposed indications will revise this statement to read "for use as an alternative method to chest X-ray or fluoroscopy confirmation of PICC tip placement in adult patients."

The proposed C3 Wave System is equivalent to the cleared C3 Wave System, K143238, in device design, materials and materials. The changes to the cleared device include the hardware to the hub portion of the system, software, and the indications for use.

E. Device Description:

The C3 Wave system must only be operated by a skilled nurse, physician, or trained medical professional who has been qualified in placement of PICC's and trained in the proper use of this device.

G. Indications for Use:

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Note: Limiting, but not contraindicated, situations for this technique are patients where cardiac rhythms may change presentation of the P-Wave:

-Atrial fibrillation
-Atrial flutter
Severe tachycardia
-Pacemaker-Driven Rhythm
-Chronic obstructive pulmonary disease (COPD)

Such patients are easily identified prior to PICC insertion. Use of additional method is necessary to confirm catheter tip location.

H. Intended Use:

C3 Wave System is intended to provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave changes as the tip approaches the right atrium of the heart via the superior vena cava.

l. Comparison to Predicate Device:

The C3 Wave system is substantially equivalent to the predicate device.

Device	Proposed Device:	Predicate Device:	SubstantiallyEquivalentComparison
	The C3 Wave System	The C3 Wave System
	K170934	(K143238)
Indicationsfor Use	The C3 Wave System isindicated for use in thepositioning of PeripherallyInserted Central Catheters(PICC). The C3 Waveprovides real-time cathetertip location information bydisplaying changes in thepatient's cardiac electricalactivity. The C3 Wave isindicated for use as analternative method to chestX-ray or fluoroscopyconfirmation of PICC tipplacement in adult patients.Note: Limiting, but notcontraindicated, situationsfor this technique arepatients where cardiacrhythms may changepresentation of the P-Wave:-Atrial fibrillation-Atrial flutter- Severetachycardia-Pacemaker-Driven Rhythm	The C3 Wave System isindicated for use as asupplemental aid inpositioning for PeripherallyInserted Central Catheters(PICC) in adult patients. Itprovides real-time cathetertip location information byusing the patient's cardiacelectrical activity.Confirmation of tipplacement should beverified according to clinicaljudgement and establishedhospital protocol (e.g.,Chest XRay, Fluoroscopy).Note: Limiting, but notcontraindicated, situationsfor this technique arepatients where cardiacrhythms may changepresentation of the P wave:atrial fibrillation, atrialflutter, severetachycardia, pacemakerdriven rhythm, and chronic	The subjectdevice isindicated as analternativemethod to chestx-ray orfluoroscopyconfirmation ofPICC tipplacement inadult patients,subject to thenoted limitations.The differencesbetween thesubject andpredicate deviceindications for usedo not raisedifferentquestions ofsafety andeffectiveness.Performance datawas provided toverify the design
		-Chronic obstructivepulmonary disease (COPD)Such patients are easilyidentified prior to PICCinsertion. Use of additionalmethod is necessary toconfirm catheter tiplocation.	obstructive pulmonarydisease (COPD).Such patients are easilyidentified prior to PICCinsertion. Use of additionalconfirmation method isnecessary to confirmcatheter tip location.	and labelingadequatelysupport therevisedindications foruse.
User/Setting		Prescription Use –Hospital/Clinical Setting	Prescription Use –Hospital/Clinical Setting	Equivalent
Patient/UserInterface		iPad	iPad	Equivalent
System		iPad, C3 Wave Hub, ECGLeads, C3 Wave Remote	iPad, C3 Wave Hub, ECGLeads, C3 Wave Remote	Equivalent
SterilizationMethod		Sterile Accessory Packs – EO	Sterile Accessory Packs – EO	Equivalent
Energy Source		Mains power (batterybacked)	Mains power (batterybacked)	Equivalent
EMC & ElectricalSafety		IEC 60601-1IEC 60601-1-2	IEC 60601-1IEC 60601-1-2	Equivalent
ATTRIBUTE		C3 Wave (Proposed Device)		C3 Wave System (K143238)
OperatingPrinciple/Technology:		The C3 Wave system consistsof an iPad® monitor, a C3 hub,and remote control.First, the hub, which can beplaced on the patient's chest,collects the ECG signal fromthe surface ECG (via ECGchest pad electrode leads)and the intravascular ECG(lead connected to thecatheter stylet).Next, the waveform is sentwirelessly by Bluetooth™technology from the hub to themobile application.Then, the C3 mobileapplication, installed on aniPad®, displays the ECGwaveform. Hence, themedical professional canmonitor the location of thePICC catheter through theECG waveform and,specifically, monitor the P-wave shape and amplitudewhich indicates tip positionrelative to the sinoatrial node.Further, sterility can be		The C3 Wave system consistsof an iPad® monitor, a C3 hub,and remote control.First, the hub, which can beplaced on the patient's chest,collects the ECG signal fromthe surface ECG (via ECGchest pad electrode leads) andthe intravascular ECG (leadconnected to the catheterstylet).Next, the waveform is sentwirelessly by Bluetooth™technology from the hub to themobile application.Then, the C3 mobileapplication, installed on aniPad®, displays the ECGwaveform. Hence, the medicalprofessional can monitor thelocation of the PICC catheterthrough the ECG waveformand, specifically, monitor the P-wave shape and amplitudewhich indicates tip positionrelative to the sinoatrial node.Further, sterility can be
		maintained during the entire		maintained during the entire

510(K) Summary: Comparison Table

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	process as the C3 Wavesystem is controlled using aremote control.	system is controlled using aremote control.

The proposed C3 Wave System is equivalent to the cleared C3 Wave System, K143238, in device design, materials and materials. The changes to the proposed device from the predicate are in the hardware to the hub portion of the system, software and the expanded indications for use.

Through performance bench testing, the subject device has demonstrated that it is substantially equivalent to the predicate.

J. Non-Clinical Performance Testing

Standards	PerformanceTesting
IEC 60601-1:2006+A12:2014 Medical electrical equipment -Part 1: General requirements for basic safety and essentialperformance	IEC 60601-1 TestReport (E468297-D1-IT-1)
IEC 60601-1-2:2007 Medical electrical equipment - Part 1-2:General requirements for basic safety and essentialperformance - Collateral standard: Electromagneticcompatibility - Requirements and tests	IEC 60601-1-2 TestReport (R-2642P)
IEC 62304:2006 Medical device software — Software life cycleprocesses	IEC 62304 Test Report
	Equipment Interaction
	C3 Wave Remote –Updated Firmware
	C3 Wave ApplicationSoftware - EquipmentInteraction “SoftwareDriven Warnings”
	C3 Wave – EquipmentInteraction (C3 WaveApplication iPadSoftware)
	Lextech - Medcompfunctionality checklistVPI - Hub firmware test
	VPI - Remote firmwaretest
ISTA-2A Partial simulation performance test procedure	Non-Sterile C3 WaveAccessory Pack- ECGElectrodes TestSummary
ISTA-1A Non-simulation integrity performance test procedure	C3 Wave NavigationSystem w/ iPad – ISTA-2A Shipping TestSummary
IEC 62133:2013 Secondary cells and batteries containingalkaline or other non-acid electrolytes - Safety requirements forportable sealed secondary cells, and for batteries made fromthem, for use in portable applications	C3 Wave Hub - ISTA-1A Shipping TestIEC 62133 CB TestCertificate (4307556.50)
47 CFR Part 15, Subpart C Intentional Radiators	Bluetooth Low EnergyCertification TestReport (10463456A)
	Bluetooth Low EnergyCertification TestReport (10463456B)
	EN 300 328 V1.8.1Certification TestReport (14L18625-E1)(Remote)
	EN 300 328 V1.8.1Certification TestReport (14L18625-E2)(Hub)
RSS-210 License-Exempt Radio Apparatus: Category IEquipment	Bluetooth Low EnergyCertification TestReport (10463456A)
	Bluetooth Low EnergyCertification TestReport (10463456B)
	EN 300 328 V1.8.1Certification TestReport (14L18625-E1)
	EN 300 328 V1.8.1Certification TestReport (14L18625-E2)
ETSI EN 300 328 V1.8.1 Electromagnetic compatibility andRadio spectrum Matters (ERM); Wideband transmissionsystems; Data transmission equipment operating in the 2,4 GHzISM band and using wide band modulation techniques;Harmonized EN covering the essential requirements of article3.2 of the R&TTE Directive	EN 300 328 V1.8.1Certification TestReport (14L18625-E1)
	EN 300 328 V1.8.1Certification TestReport (14L18625-E2))
ETSI EN 301 489-17 V2.2.1 Electromagnetic compatibility andRadio spectrum Matters (ERM); ElectroMagnetic Compatibility(EMC) standard for radio equipment; Part 17: Specificconditions for Broadband Data Transmission Systems	Bluetooth Low EnergyCertification TestReport (10463456A)
	Bluetooth Low EnergyCertification TestReport (10463456B)
Bluetooth 4.1	Low Energy RF PHYTest Specification (TS):Test Suite Structure(TSS) and TestPurposes (TP) RF-PHY.TS.4.1.0 (UL-BQT-RP10522414JD01AV2.0) (Hub)
	Low Energy RF PHYTest Specification (TS):Test Suite Structure(TSS) and TestPurposes (TP) RF-PHY.TS.4.1.0 UL-BQT-RP10522414JD02AV2.0 (Remote)

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In addition to demonstrating performance in accordance with these standards, the submission contained information recommended in FDA quidance documents for software and cybersecurity:

Content of Premarket Submissions for Software Contained in Medical Devices. ●
. Content of Premarket Submissions for Management of Cybersecurity in Medical Devices

The current released version of the C3 Wave app is 2.0.3. The current released remote firmware is version 16. The current released hub firmware is version 39.

Clinical and Human Factors Testing

Clinical and human factors studies were collected/performed to evaluate the C3 Wave System.

Clinical Study

Clinical Surveys were completed to demonstrate that various PICC line nurses of different years of experience can successfully insert the PICC Line based on their ability to read the ECG display on the iPad

. Objective: To demonstrate clinical acceptance between the MedComp C3 Wave System ECG Tip Confirmation System positioning results and traditional portable chest xray in determining proper distal tip location during a PICC procedure.
Methods: A total of 303 PICCs were to be placed at two healthcare facilities using the C3 Wave System ECG Tip Confirmation System in accordance with the instructions for use. A subsequent portable chest x-ray was to be obtained, with the patient position similar of PICC placement, to ascertain acceptable tip location of PICC. The clinician was to complete an electronic survey document to capture specific data points within each procedure including insertion related

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assessments and final catheter functionality questions referred to as the Bundle Protocol.

Outcome: The C3 Wave System has demonstrated a 98% success rate when the Bundle Protocol Parameters were met.

Human Factors

Human Factors Testing has been conducted to evaluate the application of the C3 Wave System when used to confirm PICC tip position as an alternative method to chest X-ray or fluoroscopy confirmation. Participants in the study were representative of the population who place PICC lines in the clinical environment where the product is intended to be used, e.g., hospital wards, acute care centers, extended care centers, alternate care centers, and outpatient clinics. Clinicians with experience in the placement of PICC lines were recruited for the study. No critical task failures were observed in the study.

K. Summary/Conclusion of Substantial Equivalence:

In conclusion, the proposed device, C3 Wave System, is equivalent to the predicate device, C3 Wave System (K143238).

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.”