SAPIENS TIP CONFIRMATION SYSTEM

K112744 · C.R. Bard, Inc. · LJS · Oct 20, 2011 · General Hospital

Device Facts

• Record ID: K112744
• Device Name: SAPIENS TIP CONFIRMATION SYSTEM
• Applicant: C.R. Bard, Inc.
• Product Code: LJS · General Hospital
• Decision Date: Oct 20, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5970
• Device Class: Class 2

Intended Use

The Sapiens* Tip Confirmation System (TCS) is indicated for guidance and positioning of Peripherally Inserted Central Catheters (PICCs). The Sapiens* TCS provides real-time PICC tip location information by using the patient's cardiac electrical activity. Sapiens* TCS is indicated for use as an alternative method to chest X-ray and fluoroscopy for PICC tip placement confirmation in adult patients. Limiting but not contraindicated situations for this technique 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 PICC insertion, the use of an additional method is required to confirm catheter tip location.

Device Story

System consists of PC netbook, ECG module, leads, and optional printer/remote. Intravascular stylet inserted into PICC connects to ECG module to capture cardiac electrical signals; body electrodes provide reference ECG waveforms. System displays real-time intravascular ECG waveforms to guide catheter tip placement. Used by clinicians during PICC insertion procedures. Output allows real-time visualization of P-wave changes to confirm tip location, potentially reducing reliance on post-procedural chest X-ray or fluoroscopy.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing and verification/validation activities demonstrating adherence to predetermined performance specifications and safety standards (IEC 60601-1, IEC 60601-1-2).

Technological Characteristics

System includes PC netbook, ECG module, and leads. Sensing principle: intravascular ECG signal acquisition via catheter stylet. Standards: IEC 60601-1 (safety), IEC 60601-1-2 (EMC). Connectivity: wired ECG lead connection. Software: proprietary TCS software for waveform display.

Indications for Use

Indicated for guidance and positioning of PICCs in adult patients as an alternative to chest X-ray/fluoroscopy. Contraindicated/limited in patients with cardiac rhythm alterations (atrial fibrillation, atrial flutter, severe tachycardia, pacemaker-driven rhythm) where P-wave presentation is changed; requires additional confirmation method in these cases.

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

• Sapiens* Tip Confirmation System (K093775)

Submission Summary (Full Text)

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K112744

Bard Access Systems, Inc. Sapiens* Tip Confirmation System (TCS) Special 510(k) Premarket Notification

## 510(k) Summary
21 CFR 807.92

## Sapiens* Tip Confirmation System

| General<br>Provisions | Submitter Name:<br>Submitter Address: | Bard Access Systems, Inc.<br>605 North 5600 West<br>Salt Lake City, UT 84116 |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | Henry Boland<br>Regulatory Affairs Specialist<br>[e-mail]<br>801.522.5000 ext. 5428<br>801.522.5425 fax |
| | Date of Preparation: | 20 September 2011 |
| Subject Device | Trade Name: | Sapiens* Tip Confirmation System |
| | Classification Name: | 21 CFR 880.5970 - Class II<br>LJS - Accessory to percutaneous, implanted, long-<br>term intravascular catheter |
| Predicate<br>Device | Trade Name: | Sapiens* Tip Confirmation System |
| | Classification Name: | 21 CFR 880.5970 - Class II<br>LJS - Accessory to percutaneous, implanted, long-<br>term Intravascular catheters |
| | Premarket Notification: | K093775, concurrence date 15 July 2010 |
| | Manufacturer: | Bard Access Systems, Inc. |
| Device<br>Description | The Sapiens* TCS consists of the following elements: PC netbook running<br>Sapiens* TCS software, Sapiens* TCS ECG module, ECG leads connection,<br>printer (optional), and remote control (optional). A stylet inserted into a central<br>venous catheter can be connected to the Sapiens* TCS system via the<br>Sapiens* TCS ECG leads connection, establishing a direct electrical<br>connection to the catheter distal tip for ECG signal measurement. When the<br>central venous catheter stylet is connected to Sapiens* TCS, the Sapiens*<br>TCS PC netbook displays a cardiac electrical signal from the four ECG<br>electrodes, including the catheter stylet (intravascular electrode) and three<br>body electrodes, which provide ECG waveforms. The intravascular ECG<br>waveforms provided by the Sapiens* TCS can be used for guiding and<br>positioning of the central venous catheter. These ECG waveforms can be<br>printed using an optional printer to document the procedural record for the<br>patient's file. | |

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Bard Access Systems, Inc. Sapiens* Tip Confirmation System (TCS) Special 510(k) Premarket Notification

The Sapiens* Tip Confirmation System (TCS) is indicated for guidance and Indications for positioning of Peripherally Inserted Central Catheters (PICCs). The Sapiens* TCS Use / Intended provides real-time PICC tip location information by using the patient's cardiac Use electrical activity. Sapiens* TCS is indicated for use as an alternative method to chest X-ray and fluoroscopy for PICC tip placement confirmation in adult patients. Limiting but not contraindicated situations for this technique 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 PICC insertion, the use of an additional method is required to confirm catheter tip location. Technological characteristics of the subject Sapiens* TCS are equivalent with Technological respect to the basic system design and function to that of the predicate device. Characteristics Differences do not raise any new questions regarding safety and effectiveness. Verification and validation activities were designed and performed to Safety & demonstrate that the subject Sapiens* TCS met predetermined performance Performance specifications. The following standards in conjunction with in-house protocols Tests were used to determine appropriate methods for evaluating the performance of the device: IEC 60601-1:1988/1991/1995 Medical Electrical Equipment - Part 1: General Requirements for Safety IEC 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance -Collateral standard: Electromagnetic compatibility -Requirements and tests The subject device met all pre-determined acceptance criteria and demonstrated substantial equivalence as compared to the predicate device. Based on the indications for use, technological characteristics, and safety and Summary of performance testing, the subject Sapiens* TCS, met the minimum Substantial Equivalence requirements that are considered adequate for its intended use and is substantially equivalent in design, materials, principles of operation and indications for use to the predicate Sapiens* TCS.

* Sapiens is the trademark and/or registered trademark of C.R. Bard, Inc. or an affiliate.

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

OCT 2 0 2011

Mr. Henry Boland Regulatory Affairs Specialist C.R. Bard, Inc. Bard Access Systems 605 North 5600 West Salt Lake City, Utah 84116

Re: K112744

Trade/Device Name: Sapiens Tip Confirmation System Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: September 20, 2011 Received: September 21, 2011

Dear Mr. Boland:

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 - Mr. Boland

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Anthony D. Watson

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Bard Access Systems, Inc. Sapiens* Tip Confirmation System (TCS) Special 510(k) Premarket Notification

## Indications for Use Statement

510(k) Number (if known):

Device Name: Sapiens™ Tip Confirmation System

Indications for Use:

The Sapiens* Tip Confirmation System (TCS) is indicated for guidance and positioning of Peripherally Inserted Central Catheters (PICCs). The Sapiens* TCS provides real-time PICC tip location information by using the patient's cardiac electrical activity. Sapiens* TCS is indicated for use as an alternative method to chest X-ray and fluoroscopy for PICC tip placement confirmation in adult patients.

Limiting but not contraindicated situations for this technique 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 PICC insertion, the use of an additional method is required to confirm catheter tip location.

Prescription Use × Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anthony D. attacher

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K112744