(29 days)
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.
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.
The provided document, K112744, is a 510(k) Premarket Notification for the Sapiens* Tip Confirmation System (TCS). It describes the device, its intended use, and its substantial equivalence to a predicate device. However, the document does not contain specific acceptance criteria or details of a study proving the device meets those criteria, as typically presented in clinical trial results or performance studies with defined endpoints.
The document states: "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."
This indicates that performance specifications were established and met, likely related to safety and electromagnetic compatibility based on the listed standards. However, the document does not provide a table of these acceptance criteria or specific performance values for the device. It also does not describe a clinical study focused on diagnostic accuracy or clinical effectiveness to demonstrate its ability to confirm PICC tip placement.
Therefore, many of the requested details about a study proving acceptance criteria cannot be extracted from this document because such a study, with the specific elements requested (e.g., sample size for test sets, expert ground truth, MRMC study, standalone performance), is not described.
Summary based on the provided document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Compliance with IEC 60601-1:1988/1991/1995 (Medical Electrical Equipment - Safety) | "The subject device met all pre-determined acceptance criteria" |
| Compliance with IEC 60601-1-2:2007 (Electromagnetic Compatibility) | "The subject device met all pre-determined acceptance criteria" |
| Substantial Equivalence to predicate Sapiens* TCS | "demonstrated substantial equivalence as compared to the predicate device." |
| Functional equivalence to predicate device | "Technological characteristics of the subject Sapiens* TCS are equivalent with respect to the basic system design and function to that of the predicate device." |
| Safety equivalence to predicate device | "Differences do not raise any new questions regarding safety and effectiveness." |
Note: The document states "Verification and validation activities were designed and performed to demonstrate that the subject Sapiens TCS met predetermined performance specifications" and "The subject device met all pre-determined acceptance criteria." However, it does not detail what those specific performance specifications or acceptance criteria were in terms of diagnostic accuracy or clinical outcomes, beyond general safety and EMC standards and substantial equivalence.*
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to "Verification and validation activities" and "in-house protocols" but does not detail any specific clinical test set, its size, or provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. Since no specific clinical test set for diagnostic performance is described, there is no mention of experts establishing ground truth for such a test.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
This information is not provided in the document. The Sapiens* TCS is described as a system for guiding and positioning PICCs using the patient's cardiac electrical activity, not a system involving "human readers" to interpret images or AI assistance in the way typically discussed for MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document describes the device as providing "real-time PICC tip location information by using the patient's cardiac electrical activity" and displaying a cardiac electrical signal. It is an instrument that aids a clinician during a procedure. The concept of "standalone performance" for an algorithm in a diagnostic context is not directly applicable or described in this document. The device's performance is inherently tied to being used by an operator to guide placement.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not explicitly stated in the document for the purpose of demonstrating diagnostic accuracy. The device "is indicated for use as an alternative method to chest X-ray and fluoroscopy for PICC tip placement confirmation." This implies that the standard ground truth for PICC tip confirmation would be chest X-ray or fluoroscopy. However, the document does not describe a study comparing the Sapiens* TCS results against such ground truth data in a formal performance study.
8. The sample size for the training set
This information is not provided in the document. The Sapiens* TCS works by measuring the patient's cardiac electrical activity and is not described as an AI/machine learning system that requires a "training set" in the conventional sense.
9. How the ground truth for the training set was established
This information is not provided in the document for the reasons stated in point 8.
{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
| GeneralProvisions | Submitter Name:Submitter Address: | Bard Access Systems, Inc.605 North 5600 WestSalt Lake City, UT 84116 |
|---|---|---|
| Contact Person: | Henry BolandRegulatory Affairs Specialisthenry.boland@crbard.com801.522.5000 ext. 5428801.522.5425 fax | |
| Date of Preparation: | 20 September 2011 | |
| Subject Device | Trade Name: | Sapiens* Tip Confirmation System |
| Classification Name: | 21 CFR 880.5970 - Class IILJS - Accessory to percutaneous, implanted, long-term intravascular catheter | |
| PredicateDevice | Trade Name: | Sapiens* Tip Confirmation System |
| Classification Name: | 21 CFR 880.5970 - Class IILJS - Accessory to percutaneous, implanted, long-term Intravascular catheters | |
| Premarket Notification: | K093775, concurrence date 15 July 2010 | |
| Manufacturer: | Bard Access Systems, Inc. | |
| DeviceDescription | The Sapiens* TCS consists of the following elements: PC netbook runningSapiens* TCS software, Sapiens* TCS ECG module, ECG leads connection,printer (optional), and remote control (optional). A stylet inserted into a centralvenous catheter can be connected to the Sapiens* TCS system via theSapiens* TCS ECG leads connection, establishing a direct electricalconnection to the catheter distal tip for ECG signal measurement. When thecentral venous catheter stylet is connected to Sapiens* TCS, the Sapiens*TCS PC netbook displays a cardiac electrical signal from the four ECGelectrodes, including the catheter stylet (intravascular electrode) and threebody electrodes, which provide ECG waveforms. The intravascular ECGwaveforms provided by the Sapiens* TCS can be used for guiding andpositioning of the central venous catheter. These ECG waveforms can beprinted using an optional printer to document the procedural record for thepatient'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
§ 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.”