The Celerity 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.

The Celerity System is indicated for use as a supplemental aid in positioning of Peripherally Inserted Central Catheters (PICC) in adult patients. It provides real-time catheter tip location information by using the patient's cardiac electrical activity. Confirmation of tip placement should be verified according to clinical judgment and established hospital protocol (e.g., chest x-ray, fluoroscopy).

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 confirmation method is necessary to confirm catheter tip location.

Device Description

The Celerity System includes the Celerity Monitor/Software, ECG Patient Cable, Remote Control Cable, Battery, Power Supply Cord and ECG Clip Cable (alligator clip). Procedural accessories including ECG Snap Leads, ECG Electrodes, Cable Cover and Prep Pads are provided as a convenience for the clinician.

AI/ML Overview

The Medcomp Celerity System is a device intended to provide real-time tip location information of a central venous catheter by utilizing ECG to observe P-wave changes as the tip approaches the right atrium. The device's performance was evaluated through design verification and validation activities in accordance with 21 CFR 820.30 and testing per IEC 60601 standards.

Here's the breakdown of the acceptance criteria and the supporting study information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list specific numerical acceptance criteria for device performance (e.g., accuracy percentages, sensitivity/specificity thresholds for tip location). Instead, it states that "Design Verification and Validation activities were performed in accordance with Design Control requirements per 21 CFR 820.30 and demonstrate that the subject Celerity System meets predetermined performance specifications."

The performance evaluation focused on demonstrating safety and essential performance through compliance with recognized electrical safety and electromagnetic compatibility standards.

Acceptance Criteria Category	Specific Criteria (Implicit from document)	Reported Device Performance
Safety	Compliance with IEC 60601-1	Met (as per design verification and validation activities)
Essential Performance	Compliance with IEC 60601-1-2	Met (as per design verification and validation activities)
Functional Equivalence	Operating principles/technology equivalent to predicate device	Demonstrated (one of the bases for substantial equivalence)
Intended Use	Device supports stated intended use	Demonstrated
No New Questions of Safety/Effectiveness	Differences from predicate device do not raise new questions of safety or effectiveness	Demonstrated

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

The document does not explicitly state the sample size used for any specific performance test set related to the accuracy of P-wave changes or tip location. It broadly mentions "Design Verification and Validation activities" and "safety and performance testing."

Furthermore, there is no information provided regarding the country of origin of the data or whether the data was retrospective or prospective.

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

This information is not provided in the document. The document refers to "clinical judgment and established hospital protocol (e.g., chest x-ray, fluoroscopy)" for confirming tip placement, but it does not detail how ground truth was established for the device's own performance evaluation.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for establishing ground truth or evaluating the test set.

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

No MRMC comparative effectiveness study is mentioned in the document. The Celerity System is described as a "supplemental aid" to assist clinicians in positioning PICCs using ECG, but there's no study comparing human performance with and without the device. The device itself is not an "AI" in the modern sense but rather a real-time monitoring system.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The document describes the Celerity System as providing "real time tip location information" by utilizing ECG to observe P-wave changes. While this implies a standalone algorithm for processing ECG data and identifying P-wave changes, there is no separate "algorithm only" performance study detailed with specific metrics for accuracy or reliability of its ECG analysis in isolation from a clinical user. Its function is inherently presented as an aid for the clinician.

7. The Type of Ground Truth Used

The document states that "Confirmation of tip placement should be verified according to clinical judgment and established hospital protocol (e.g., chest x-ray, fluoroscopy)." This suggests that the ultimate ground truth for actual tip location in clinical practice (and presumably in any validation studies) would be based on imaging methods (chest x-ray, fluoroscopy) and expert clinical judgment. However, the specifics of how this ground truth was applied to prove the device meets its acceptance criteria are not detailed.

8. The Sample Size for the Training Set

The document does not provide any information about a training set or its sample size. This type of information is typically associated with machine learning or AI algorithms, which are not explicitly mentioned for the Celerity System's core function.

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

As no training set is mentioned, information on how its ground truth was established is not applicable.

Summary

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May 9th, 2014 Medcomp Traditional Premarket Notification Celerity System

510(k) Summary

K140799

Date Prepared: May 9th, 2014

JUN 1 3 2014

Submitter Information A.

Submitter:	MEDCOMP®
	1499 Delp Drive
	Harleysville, PA 19438
Tel:	(215) 256-4201, x2271
Fax:	(215) 256-9191
Contact:	Jessica Leo, Regulatory Associate

1499 Delp Drive Harleysville, PA 19438 Tel:215-256-4201 Fax:215-256-1787 www.medcompnet.com

Trade Name	Celerity™ System
Common Name:	PICC placement accessory
Classification Name:	Percutaneous, implanted, long-term intravascular Catheter
Product Code:	LJS,
CFR:	21CFR880.5970
Class:	II
Predicate Devices	K093775;
	Sapiens ™ Tip Location System
	Romedex International Srl
Common Name:	PICC placement accessory
Classification Name:	Percutaneous, implanted, long- term intravascular Catheter
Product Code:	LJS,
CFR:	21CFR880.5970
Class:	II

D. Device Description

E. Intended Use

Image /page/0/Picture/12 description: The image shows the ISO 13485 Certified Quality System logo. The text "ISO 13485" is in large, bold font. Below it, the words "Certified Quality System" are in a smaller font. The logo is black and white.

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May 9th, 2014 Medcomp Traditional Premarket Notification Celerity System

F. Indications for Use

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 confirmation method is necessary to confirm catheter tip location.

G. Technological Characteristics

Technological Characteristics of the Celerity System are equivalent with respect to the basic system design and function to that of the predicate device. The differences between the predicate and proposed devices do not raise new questions of safety or effectiveness.

H. Safety and Performance

Design Verification and Validation activities were performed in accordance with Design Control requirements per 21 CFR 820.30 and demonstrate that the subject Celerity System meets predetermined performance specifications.

The performance evaluation plan included testing per the following recognized standards to assess conformance to IEC 60601 (3rd Edition).

IEC 60601-1	Medical Electrical Equipment - Part 1: General Requirementsfor Safety
IEC 60601-1-2	Medical Electrical Equipment - Part 2: General Requirementsfor Basic Safety and Essential Performance - CollateralStandard Electro Magnetic Compatibility - Requirements andTest

Substantial Equivalence Conclusion

The proposed device is substantially equivalent to the predicate device based on:

The Intended Use .
I.
Operating principles/technology .
. Results of safety and performance testing
Responses to questions raised in the FDA 510(k) decision tree .

ર-3

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W066-G609 Silver Spring, MD 20993-0002

June 13, 2014

Medcomp® C/O Ms. Lorraine M. Hanley Medical Components, Inc., d.b.a Medcomp 25 Forest Drive Marlborough, MA 01752

Re: K140799

Trade/Device Name: Celerity TM System Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: May 27, 2014 Received: May 27, 2014

Dear Ms. Hanley:

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 - Ms. Hanley

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 devicerelated 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/ResourcesforYou/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,

MarySTBper-S

Erin I. Keith. M.S. Division 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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	DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug AdministrationIndications for Use		Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement below.

510(k) Number (if known)
Device NameCelerity PICC Tip Confirmation System

Indications for Use (Describe)activity. Confirmation of tip placement should be verified according to clinical judgement and established hospitalprotocol (e.g., chest x-ray, flouroscody).			The Celerity System is indicated for use as a supplemental aid in positioning of Peripherally Inserted Central Catheters(PICC) in adult patients. It provides real-time catheter tip location information by using the patient's cardiac electrical
Note: Limiting, but not contraindicated, situations for this technique, are patients where cardiac rhythms may changepresentation 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 an additional confirmation method is necessary toconfirm 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)
			PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
		FOR FOA USE ONLY2000 11 11 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
		Digitally signed byRichard C. Chapman -S
		Date: 2014.06.13
		14:50:17 -04'00'
		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."
		of this information collection, including suggestions for reducing this burden, to:	The burden time for this collection of information is estimated to average 79 hours per response, including thetime to review instructions, search existing data sources, gather and maintain the data needed and completeand review the collection of information. Send comments regarding this burden estimate or any other aspect
		Department of Health and Human ServicesFood and Drug AdministrationOffice of Chief Information Officer
	PRAStaff@fda:hhs.gov	Paperwork Reduction Act (PRA) Staff
		"An agency may not;conduct or sponsor, and;a person is not required to respond to, a collection ofinformation unless it displays a currently valid OMB number."
FORM FDA 3881 (1/14)		Page 1 of 1

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.”