Celerity PICC Tip Confirmation System

K142889 · AngioDynamics, Inc. · LJS · Jan 27, 2015 · General Hospital

Device Facts

• Record ID: K142889
• Device Name: Celerity PICC Tip Confirmation System
• Applicant: AngioDynamics, Inc.
• Product Code: LJS · General Hospital
• Decision Date: Jan 27, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5970
• Device Class: Class 2

Intended Use

The Celerity System is indicated for the 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. The Celerity System is indicated for use as an alternative method to chest X-ray or fluoroscopy confirmation of PICC tip placement in adult patients.

Device Story

The Celerity System is an ECG-based tip confirmation system used during PICC insertion to verify catheter tip location in the superior vena cava/right atrium. It inputs cardiac electrical signals via an ECG patient cable and surface electrodes; the system monitors P-wave morphology changes as the catheter tip approaches the heart. The device provides real-time visual feedback to the clinician, allowing for immediate tip positioning without immediate reliance on chest X-ray or fluoroscopy. It is intended for use in clinical settings by trained healthcare providers. By providing real-time guidance, the system aims to reduce the need for post-procedural imaging, potentially decreasing radiation exposure and procedural time. The system includes a monitor, software, and various cables/accessories.

Clinical Evidence

Bench testing only. Performance evaluation included design verification and validation per 21 CFR 820.30, and testing to IEC 60601-1 (General Safety) and IEC 60601-1-2 (EMC). Human factors/simulated use testing was conducted to evaluate the system as an alternative to X-ray/fluoroscopy, confirming safe and effective use.

Technological Characteristics

System includes monitor, software, ECG patient cable, remote control cable, battery, and accessories (electrodes, snap leads). Operates via ECG signal processing to detect P-wave changes. Complies with IEC 60601-1 and IEC 60601-1-2 standards. Standalone system.

Indications for Use

Indicated for positioning PICCs in adult patients. Provides real-time tip location via cardiac electrical activity as an alternative to chest X-ray or fluoroscopy. Not contraindicated but limited for patients with atrial fibrillation, atrial flutter, severe tachycardia, pacemaker-driven rhythm, or COPD; additional confirmation 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

• Celerity™ System (K140799)
• Sapiens™ Tip Location System (K093775)

Submission Summary (Full Text)

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

February 5, 2015

AngioDynamics Inc. Mr. Michael P. Hanley Specialist, Global Regulatory Affairs 26 Forest Street Marlborough, MA 01752

Re: K142889

Trade/Device Name: CelerityTM PICCTip Confirmation System Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, implanted, long-term intravascular catheter Regulatory Class: II Product Code: LJS Dated: December 12, 2014 Received: December 15, 2014

Dear Mr. Hanley:

This letter corrects our substantially equivalent letter of January 27, 2015.

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. Drue, 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. 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

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Page 2 - Mr. Michael P. Hanley

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/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 [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

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### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K142889

Device Name Celerity PICC Tip Configuration System

### Indications for Use (Describe)

The Celerity System is indicated for the positioning of Peripherally Inserted Catheters (PICC) in adult patients. It provides real-time catheter tip location by using the patient's cardiac electrical activity. The Celerity System is indicated for use as an alternative nethod to chest x-ray or fluoroscopy confirmation of PICC tip placement in adult patients.

Note: In general, devices that utilize ECG technique to observe P-Wave are limited, but not contraindicated, for patients where cardiac rhythms may change presentation of the P-Wave; including,

-Atrial fibrillation

-Atrial flutter

-Severe tachycardia

-Pacemaker-driven rhythm

- Chronic obstructive pulmonary disease (COPD)

Such patients are easily identified prior to PCC insertion. Use of an additional confirmation 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)

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

10 - 11 - 11 FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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# 510(k) Summary : K142889

:

### Date Prepared: October 01, 2014

| A. | Submitter Information | | | |
|----|---------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|------------------------------------|
| | | Submitter: | | Angiodynamics Inc.<br>26 Forest St |
| | | | | Marlborough, MA 01752 |
| | | Tel: | | [phone] |
| | | Fax: | | [phone] |
| | | Contact: | | Michael Hanley, Specialist, Global |
| | | Regulatory Affairs | | |
| | | Email: | | [e-mail] |
| | | Or: | | |
| | | | | Linda Varroso |
| | | | | AngioDynamics, Inc. |
| | | | | 26 Forest Street |
| | | | | Marlborough, MA 01752 |
| | | | Tel: | [phone] |
| | | | Fax: | [phone] |
| | | | Email: | [e-mail] |
| B. | Trade Name | Trade Name: | Celerity™ PICC Tip Confirmation System | |
| | | Common Name: | | PICC placement accessory |
| | | Classification Name:<br>intravascular Catheter | | Percutaneous, implanted, long-term |
| | | Product Code: | LJS, 21CFR 880.5970 | |
| | | Class: | II | |
| C. | Predicate Devices | K140799 Celerity™ System | | |
| | | K093775 Sapiens ™ Tip Location System | | |
| | | Common Name: PICC placement accessory | | |
| | | Classification Name: Percutaneous, implanted, long-term intravascular | | |
| | | Catheter | | |
| | | Product Code: LJS, 21CFR 880.5970 | | |
| | | Class: II | | |
| D. | Device Description | | | |
| | | The Celerity System includes the Celerity Monitor/Software, ECG Patient<br>Cable, Remote Control Cable, Battery, Power Supply Cord and ECG Clip | | |
| | | Cable (alligator clip). Procedural accessories including ECG Snap Leads,<br>Surface Electrodes, Cable Cover and Prep Pads are provided as a | | |
| | | convenience for the clinician. | | |
| E. | Intended Use | | | |
| | The Celerity System is intended to provide real time tip location | | | |
| | information of a central venous catheter by utilization of ECG to observe | | | |

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P-wave changes as the tip approaches the right atrium of the heart via the superior vena cava.

#### F. Indications for Use

The Celerity System is indicated for the 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. The Celerity System is indicated for use as an alternative method to chest X-ray or fluoroscopy confirmation of PICC tip placement in adult patients.

Note: In general, devices that utilize ECG technique to observe P-wave are limited, but not contraindicated, for 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 an additional confirmation method is necessary to confirm catheter tip location.

#### Technological Characteristics G.

:

Technological Characteristics of the subject Celerity 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

The results of 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 (300 Edition).

- IEC 60601-1 Medical Electrical Equipment – Part 1: General Requirements for Safety Medical Electrical Equipment – Part 2: General IEC 60601-1-2 Requirements for Basic Safety and Essential Performance – Collateral Standard Electro Magnetic Compatibility - Requirements and Test

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December 12, 2014 Re: K142889-Supplement

> Human Factors Evaluation - Simulated Use Testing alternate to chest xray and fluoroscopy:

Simulated Use / Human Factors Testing has been conducted to evaluate the application of the Celerity electrocardiogram (ECG)-Based Tip Confirmation System (i.e., Celerity System) when used to confirm PICC tip position as an alternative method to chest X-ray or fluoroscopy confirmation. The use related events noted in the studies have been adequately reviewed and addressed in order to ensure the safe, effective use of the device as an alternate to x-ray techniques for confirmation of tip location of PICC. Based on the content of the proposed Celerity System's Risk Analysis / Use and Design FMEAs, and the content of the Instructions for Use, the Celerity System has demonstrated its suitability for its intended purpose.

### l. Substantial Equivalence Conclusion

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

- The Intended Use and Indications for Use
- . Operating principles/technology
- Results of safety and performance testing ●
- Responses to questions posed in FDA 510(k) "Substantial Equivalence" Decision-Making Flowchart