(29 days)
Not Found
No
The description focuses on standard ECG signal processing and analysis, with no mention of AI or ML techniques for interpretation or guidance.
No.
The device is for guidance and positioning of PICCs and confirmation of tip placement, not for treating a disease or condition.
Yes
The device provides "real-time PICC tip location information" and is explicitly indicated "for use as an alternative method to chest X-ray and fluoroscopy for PICC tip placement confirmation in adult patients," which are diagnostic activities.
No
The device description explicitly lists hardware components including a PC netbook, ECG module, ECG leads connection, and optional printer and remote control.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The Sapiens* TCS works by measuring the patient's cardiac electrical activity directly from within the body via a stylet inserted into a catheter. It does not analyze blood, urine, tissue, or other bodily fluids or substances in vitro (outside the body).
- The intended use is for guiding and positioning a medical device (PICC). While it uses a physiological signal (ECG), its purpose is to aid in a medical procedure on the patient, not to diagnose a condition or provide information about a patient's health status based on a sample.
The device is a medical device that utilizes physiological signals for real-time guidance during a medical procedure.
N/A
Intended Use / 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.
Product codes
LJS
Device Description
The Sapiens* TCS consists of the following elements: PC netbook running Sapiens* TCS software, Sapiens* TCS ECG module, ECG leads connection, printer (optional), and remote control (optional). A stylet inserted into a central venous catheter can be connected to the Sapiens* TCS system via the Sapiens* TCS ECG leads connection, establishing a direct electrical connection to the catheter distal tip for ECG signal measurement. When the central venous catheter stylet is connected to Sapiens* TCS, the Sapiens* TCS PC netbook displays a cardiac electrical signal from the four ECG electrodes, including the catheter stylet (intravascular electrode) and three body electrodes, which provide ECG waveforms. The intravascular ECG waveforms provided by the Sapiens* TCS can be used for guiding and positioning of the central venous catheter. These ECG waveforms can be printed using an optional printer to document the procedural record for the patient's file.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Verification and validation activities were designed and performed to demonstrate that the subject Sapiens* TCS met predetermined performance specifications. The following standards in conjunction with in-house protocols 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
0
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
Provisions | Submitter Name:
Submitter Address: | Bard Access Systems, Inc.
605 North 5600 West
Salt Lake City, UT 84116 |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | Henry Boland
Regulatory Affairs Specialist
henry.boland@crbard.com
801.522.5000 ext. 5428
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
LJS - Accessory to percutaneous, implanted, long-
term intravascular catheter |
| Predicate
Device | Trade Name: | Sapiens* Tip Confirmation System |
| | Classification Name: | 21 CFR 880.5970 - Class II
LJS - Accessory to percutaneous, implanted, long-
term Intravascular catheters |
| | Premarket Notification: | K093775, concurrence date 15 July 2010 |
| | Manufacturer: | Bard Access Systems, Inc. |
| Device
Description | The Sapiens* TCS consists of the following elements: PC netbook running
Sapiens* TCS software, Sapiens* TCS ECG module, ECG leads connection,
printer (optional), and remote control (optional). A stylet inserted into a central
venous catheter can be connected to the Sapiens* TCS system via the
Sapiens* TCS ECG leads connection, establishing a direct electrical
connection to the catheter distal tip for ECG signal measurement. When the
central venous catheter stylet is connected to Sapiens* TCS, the Sapiens*
TCS PC netbook displays a cardiac electrical signal from the four ECG
electrodes, including the catheter stylet (intravascular electrode) and three
body electrodes, which provide ECG waveforms. The intravascular ECG
waveforms provided by the Sapiens* TCS can be used for guiding and
positioning of the central venous catheter. These ECG waveforms can be
printed using an optional printer to document the procedural record for the
patient's file. | |
1
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.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the upper half of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines above a set of wavy lines.
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.
3
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 (800) 638-2041 or (301) 796-7100 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
4
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