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 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 contrindicated, 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 guide 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.

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.

AI/ML Overview

This document details the substantial equivalence review for the Medcomp C3 Wave System (K180567), which is an update to a previously cleared device (K170934). The current submission focuses on expanding accessory pack offerings, specifically adding a larger drape and revising the packaging system. Therefore, the "study" described relates to the testing performed to ensure the safety and effectiveness of these modifications, rather than a clinical efficacy study of the core device functionality.

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

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Related to Modifications)	Reported Device Performance (Related to Modifications)
Biocompatibility (ISO 10993-1, -5, -10)	Biocompatibility was performed and met for skin-contacting surface, limited exposure.
Cytotoxicity (ISO 10993-5:2009)	Testing performed. (Implied successful if SE is granted)
Sensitization (ISO 10993-10)	Testing performed. (Implied successful if SE is granted)
Irritation (ISO 10993-10)	Testing performed. (Implied successful if SE is granted)
Sterilization Cycle Development (ANSI/AAMI/ISO 11135-1:2014, Annex B)	Developed using Overkill Approach.
Microbiological Performance Qualification (ANSI/AAMI/ISO 11135-1:2014, Section 9.4.2)	Performed in accordance with standard.
Physical Performance Qualification (ANSI/AAMI/ISO 11135-1:2014, Section 9.4.3)	Performed in accordance with standard.
Ethylene Oxide Sterilization Residuals (AAMI/ANSI/ISO 10993-7:2008)	Residuals for C3 ECG Cable Accessory Pack (MRC3RD004) were in accordance with the standard, with a maximum level of 4/mg/device.
Packaging Integrity (ASTM F 1929-15)	Validated with a dye test.
Packaging Seal Strength (ASTM F1140/F1140M-13)	Validated with a compressed air burst test.
Shipping/Transit Testing	ISTA 2A performed. (This is listed under "Testing (Accessory Packs)" in Table 6.1 and section "Non-Clinical Testing")

Note: The document states that "All testing was completed and is the subject of this submission" and concludes that the device raises "no new questions of safety or effectiveness compared to the predicate device." This implies that all acceptance criteria for the non-clinical testing performed on the modified accessory pack were met. Specific numerical performance metrics for each test (beyond the EO residuals) are not detailed in this summary.

2. Sample Size Used for the Test Set and Data Provenance

The provided text describes non-clinical laboratory testing performed on the modified accessory pack. It does not mention a "test set" in the context of patient data or clinical performance. Therefore, information on sample size for a test set and data provenance (country of origin, retrospective/prospective) is not applicable or not provided for this specific submission, as it focuses on accessory modifications rather than the primary device's clinical performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable or not provided as the submission focuses on non-clinical testing of device accessories (drape and packaging), not on clinical performance requiring expert ground truth for interpretation of patient data.

4. Adjudication Method for the Test Set

This information is not applicable or not provided for the same reasons as point 3.

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

An MRMC comparative effectiveness study was not performed or described in this document. The C3 Wave System is an ECG-based positioning aid for PICC lines, not an AI-assisted diagnostic tool that would typically involve human readers interpreting images. This submission specifically addresses modifications to accessory packs.

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

A standalone performance study of an algorithm is not discussed or applicable to this submission. The C3 Wave System is a device that provides real-time data to a human operator (skilled nurse, physician, or trained medical professional) to aid in PICC placement. The submission pertains to modifications to non-electronic accessories.

7. The Type of Ground Truth Used

For the non-clinical testing of accessories, the "ground truth" would be established by standardized laboratory testing procedures and the specifications of relevant international and national consensus standards (e.g., ISO 10993 for biocompatibility, ANSI/AAMI/ISO 11135 for sterilization, ASTM F1929 and F1140 for packaging). This is not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

This information is not applicable or not provided. Since the submission refers to modifications of accessories and non-clinical testing, there is no "training set" in the context of machine learning or AI algorithms.

9. How the Ground Truth for the Training Set was Established

This information is not applicable or not provided as there is no "training set" in the context of this submission.

Summary

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April 12, 2018

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

Re: K180567

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: March 12, 2018 Received: March 15, 2018

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.

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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 -
s

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) K180567

Device Name

C3 Wave System

Indications for Use (Describe)

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)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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K180567		510(k) SUMMARY	Special 510K
	A. Submitter Information:
	Submitter:	Medical Components Inc.(dba Medcomp®)1499 Delp DriveHarleysville, PA 19438Tel: (215) 256-4201 x 2285Fax: (215) 256-9191
	Registration Number:	2518902
	Contact Person:	Courtney NixRegulatory Affairs Manager,North America and Europe
	Date of Preparation:	03/02/2018
	B. Subject Device
	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:	II
	Regulation MedicalSpecialty and ReviewPanel:	General Hospital
	C. Predicate Device
	510(k) Number:	K170934
	510(k) Holder:	Medcomp®
	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:	II
	Regulation MedicalSpecialty and ReviewPanel:	General Hospital

Medcomp®: C3 Wave System
K180567 510(k) Summary

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D. Subject of Submission:

The purpose of this submission is to expand the accessory packs offerings for the C3 Wave System. The K170394 clearance includes three accessory packs. The submission is to add an accessory code that contains a large drape. As a result, the packaging system had to be revised to a larger header bag. All testing was completed and is the subject of this submission.

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.

F. Indications for Use:

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.

G. Intended Use:

Medcomp®: C3 Wave System K180567 510(k) Summary

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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.

H. Comparison to Predicate Devices:

Device	Proposed Device:C3 Wave System(MRC3RD004)	Predicate Device:C3 Wave System(MRC3RD000)	SubstantiallyEquivalentComparison
Indicationsfor Use	The C3 Wave Systemis indicated for use inthe positioning ofPeripherally InsertedCentral Catheters(PICC). The C3 Waveprovides real-timecatheter tip locationinformation bydisplaying changes inthe patient's cardiacelectrical activity. TheC3 Wave is indicatedfor use as analternative method tochest X-ray orfluoroscopyconfirmation of PICCtip placement in adultpatients.Note: Limiting, but notcontraindicated,situations for thistechnique are patientswhere cardiac rhythmsmay changepresentation of the P-Wave:-Atrial fibrillation-Atrial flutter- Severetachycardia-Pacemaker-DrivenRhythm-Chronic obstructivepulmonary disease(COPD)Such patients are	The C3 Wave Systemis indicated for use inthe positioning ofPeripherally InsertedCentral Catheters(PICC). The C3 Waveprovides real-timecatheter tip locationinformation bydisplaying changes inthe patient's cardiacelectrical activity. TheC3 Wave is indicatedfor use as analternative method tochest X-ray orfluoroscopyconfirmation of PICCtip placement in adultpatients.Note: Limiting, but notcontraindicated,situations for thistechnique are patientswhere cardiac rhythmsmay changepresentation of the P-Wave:-Atrial fibrillation-Atrial flutter- Severetachycardia-Pacemaker-DrivenRhythm-Chronic obstructivepulmonary disease(COPD)Such patients areeasily identified prior	Unchanged
	to PICC insertion. Useof additional method isnecessary to confirmcatheter tip location.	to PICC insertion. Useof additional method isnecessary to confirmcatheter tip location.
User/Setting	Prescription Use –Hospital/ClinicalSetting	Prescription Use –Hospital/ClinicalSetting	Unchanged
Patient/UserInterface	iPad	iPad	Unchanged
System	iPad, C3 Wave Hub,ECG Leads, C3 WaveRemote	iPad, C3 Wave Hub,ECG Leads, C3 WaveRemote	Unchanged
OverallSystemComponents(incl.AccessoryPacks)	iPad, iPad Case,Remote, RemoteBattery, Hub, HubBattery, Hub PowerSupply, Leads, Base,ECG Clip Cable,Remote Cover,Electrodes, Skip Prep,Drape	iPad, iPad Case,Remote, RemoteBattery, Hub, HubBattery, Hub PowerSupply, Leads, Base,ECG Clip Cable,Remote Cover,Electrodes, Skip Prep,Drape	Equivalent; Changeto Dimension ofDrape
SterileAccessoryPackComponents	ECG Clip Cable,Remote Cover, andDrape	ECG Clip Cable,Remote Cover, andDrape	Equivalent; Changeto Dimension ofDrape
DrapeDimensions	100" x 86"	45" x 40"	Equivalent; Changeto Dimension ofDrape
SterilizationMethod	Sterile AccessoryPacks – EO	Sterile AccessoryPacks – EO	Unchanged
PackagingSystems	12.250"x18.500"Tyvek Headerbag	17.500"x10.750"Tyvek Headerbag	Equivalent; Changeto Dimension ofHeaderbag toaccommodate largerdrape
	CSR wrapped kitplaced inside aTyvek /LLDPEheaderbag andshipped within acorrugated shippingcarton	CSR wrapped kitplaced inside aTyvek /LLDPEheaderbag andshipped within acorrugated shippingcarton
Testing(AccessoryPacks)	ISTA 2A, Endotoxin,EO Residuals, andLAL	ISTA 2A, Endotoxin,EO Residuals, andLAL	Unchanged

Table 6.1: 510(K) Summary: Design Comparison Matrix

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Non-Clinical Testing l.

The Following non-clinical testing was completed on the modified accessory pack (larger drape and headerbag). Testing was performed as a result of the risk assessment and design control activities based on the subject device modifications from the cleared predicate.

Medcomp®: C3 Wave System K180567 510(k) Summary

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Biocompatibility:

Biocompatibility was performed for the device modifications per ISO 10993-1 for a skin contacting surface device, with limited exposure (i.e. less than 24 hours).

CYTOTOXICITY:

ISO 10993-5: 2009; Biological Evaluation of Medical Devices – Part 5: Tests for In Vitro Cytotoxicity

SENSITIZATION:

ISO 10993-10; Biological Evaluation of Medical Devices – Part 10: Tests for Irritation and Skin Sensitization

IRRITATION:

ISO 10993-10; Biological Evaluation of Medical Devices – Part 10: Tests for Irritation and Skin Sensitization

Sterilization testing on the modified subject device:

The sterilization cycle was developed using the Overkill Approach defined in ANSI/AAMI/ISO 11135-1: 2014, Annex B. The Microbiological Performance Qualification was performed in accordance with ANSI/AAMI/ISO 11135-1: 2014, section 9.4.2 and the Physical Performance Qualification was performed in accordance with section 9.4.3.

The residuals for C3 ECG Cable Accessory Pack (MRC3RD004) were in accordance with AAMI/ANSI/ISO 10993-7:2008, Biological Evaluation of Medical Devices- Part 7: Ethylene Oxide Sterilization Residuals, the maximum level is 4/mg/device.

The packaging integrity of the pouch seal was validated with a dye test per ASTM F 1929-15.

The strength of the packaging seal was validated with a compressed air burst test per ASTM F1140/F1140M-13.

J. Summary of Substantial Equivalence:

Based on the indications for use, design, and performance testing results, the modified subject device raises no new questions of safety or effectiveness compared to the predicate device and is substantially equivalent to the predicate device, C3 Wave System (K170934).

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.”