(87 days)
The Sherlock 3CG™ Tip Confirmation System (TCS) is indicated for guidance and positioning of Peripherally Inserted Central Catheters (PICCs). The Sherlock 3CG TCS provides real-time PICC tip location information by using passive magnet tracking and the patient's cardiac electrical activity (ECG). When relying on the patient's ECG signal, the Sherlock 3CG 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 catheter insertion, the use of an additional method is required to confirm PICC tip location.
The Sherlock 3CG* TCS is indicated for guidance and positioning of PICCs during insertion and placement. The Sherlock 3CG* TCS provides real-time catheter tip location information by using passive magnet tracking and the patient's cardiac electrical activity (ECG). The Sherlock 3CG* TCS displays the location of the PICC tip using a magnetic stylet and magnetic sensors. The Sherlock 3CG* TCS also displays ECG waveforms received from the patient's skin (baseline ECG) and from the tip of the catheter (intravascular ECG) on the graphical user interface.
The provided text does not contain information on specific acceptance criteria and detailed study results with quantitative performance metrics for the Sherlock 3CG* Tip Confirmation System. The document is a 510(k) summary for premarket notification, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting a full clinical trial report with detailed performance data against predefined acceptance criteria.
However, based on the available information, here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly provided in the document. The document states:
- "Verification and validation activities were designed and performed to demonstrate that the subject Sherlock 3CG* TCS met predetermined performance specifications."
- "The subject device met all pre-determined acceptance criteria and demonstrated substantial equivalence as compared to the predicate device."
While these statements confirm that acceptance criteria existed and were met, the actual criteria (e.g., accuracy percentages, specificity, sensitivity, failure rates for specific outcomes) and the corresponding reported performance values are not detailed.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The 510(k) summary does not include details about the clinical study design, patient numbers, or data collection methodology (retrospective/prospective, country of origin) that would typically be found in a full study report.
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. Details on how ground truth was established, including the number and qualifications of experts, are absent.
4. Adjudication Method for the Test Set
This information is not provided in the document. The adjudication method (e.g., 2+1, 3+1, none) for the test set is not described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This information is not provided in the document. The Sherlock 3CG* TCS is a device that provides real-time tip location using magnetic tracking and ECG, functioning as an alternative to chest X-ray/fluoroscopy for PICC tip confirmation; it is not presented as an AI-assisted diagnostic tool that human readers would interpret. Therefore, an MRMC study comparing human readers with and without AI assistance would not be applicable in this context based on the device description.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device itself is a "Tip Confirmation System" that "provides real-time PICC tip location information" and "displays the location... using a magnetic stylet and magnetic sensors" and "displays ECG waveforms." The phrasing suggests that the device provides direct information, and its performance would inherently be "standalone" in generating tip location guidance. However, the document does not present a specific "standalone study" with detailed results. The device's "without human-in-the-loop performance" could be inferred from its function as a direct measurement and display system, but no data is presented to quantify this.
7. The Type of Ground Truth Used
While not explicitly stated for the "test set," the device's indications for use state that "When relying on the patient's ECG signal, the Sherlock 3CG TCS is indicated for use as an alternative method to chest X-ray and fluoroscopy for PICC tip placement confirmation in adult patients." This strongly implies that chest X-ray and/or fluoroscopy would be the ground truth comparators for confirming PICC tip placement in any validation studies. However, the specific method used for establishing ground truth in the actual performance studies is not detailed.
8. The Sample Size for the Training Set
This information is not provided in the document. The 510(k) summary does not mention a "training set" or "validation set" in the context of device development or performance testing, as it is primarily focused on demonstrating substantial equivalence rather than detailing an AI/machine learning model's development.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided as there is no mention of a "training set" in the context of device development in the provided document.
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K113808 page. 1 of 2
Bard Access Systems, Inc. Sherlock 3CG* Tip Confirmation System (TCS) Traditional 510(k) Premarket Notification
MAR 1 9 2012
:
510(k) Summary 21 CFR 807.92
Sherlock 3CG* 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: | 22 December 2011 | |
| Subject Device | Trade Name: | Sherlock 3CG* Tip Confirmation System |
| Classification Name: | 21 CFR 880.5970 - Class IILJS - Percutaneous, implanted, long-termintravascular catheter | |
| PredicateDevice | Trade Name: | Sapiens* Tip Confirmation System |
| Classification Name: | 21 CFR 880.5970 - Class IILJS - Percutaneous, implanted, long-termIntravascular catheters | |
| Premarket Notification: | K112744, concurrence date 20 October 2011 | |
| Manufacturer: | Bard Access Systems, Inc. | |
| PredicateDevice | Trade Name: | Sherlock 3CG* Tip Positioning System |
| Classification Name: | 21 CFR 880.5970 - Class IILJS - Percutaneous, implanted, long-termIntravascular catheters | |
| Premarket Notification: | K091324, concurrence date 07 August 2009 | |
| Manufacturer: | Bard Access Systems, Inc. | |
| DeviceDescription | The Sherlock 3CG* TCS is indicated for guidance and positioning of PICCsduring insertion and placement. The Sherlock 3CG* TCS provides real-timecatheter tip location information by using passive magnet tracking and the | |
| patient's cardiac electrical activity (ECG). The Sherlock 3CG* TCS displaysthe location of the PICC tip using a magnetic stylet and magnetic sensors.The Sherlock 3CG* TCS also displays ECG waveforms received from thepatient's skin (baseline ECG) and from the tip of the catheter (intravascularECG) on the graphical user interface. | ||
| Indications forUse / IntendedUse | The Sherlock 3CG* Tip Confirmation System (TCS) is indicated for guidance andpositioning of Peripherally Inserted Central Catheters (PICCs). The Sherlock 3CGTCS provides real-time PICC tip location information by using passive magnettracking and the patient's cardiac electrical activity (ECG). When relying on thepatient's ECG signal, the Sherlock 3CG TCS is indicated for use as an alternativemethod to chest X-ray and fluoroscopy for PICC tip placement confirmation inadult patients. | |
| Limiting but not contraindicated situations for this technique are in patients wherealterations of cardiac rhythm change the presentation of the P wave as in atrialfibrillation, atrial flutter, severe tachycardia, and pacemaker driven rhythm. In suchpatients, who are easily identifiable prior to catheter insertion, the use of anadditional method is required to confirm PICC tip location. | ||
| TechnologicalCharacteristics | Technological characteristics of the subject Sherlock 3CG* TCS are equivalentwith respect to the basic system design and function to that of the predicatedevices, Sapiens* Tip Confirmation System and Sherlock 3CG* Tip PositioningSystem. Differences do not raise any new questions regarding safety andeffectiveness. | |
| Safety &PerformanceTests | Verification and validation activities were designed and performed todemonstrate that the subject Sherlock 3CG* TCS met predeterminedperformance specifications. The following standards in conjunction with in-house protocols were used to determine appropriate methods for evaluatingthe 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 safetyand essential performance - Collateralstandard: Electromagnetic compatibility- Requirements and tests | |
| The subject device met all pre-determined acceptance criteria anddemonstrated substantial equivalence as compared to the predicate device. | ||
| Summary ofSubstantialEquivalence | Based on the indications for use, technological characteristics, and safety andperformance testing, the subject Sherlock 3CG* TCS met the minimumrequirements that are considered adequate for its intended use and issubstantially equivalent in design, materials, principles of operation andindications for use to the predicate devices, Sapiens* Tip Confirmation Systemand Sherlock 3CG* Tip Positioning System. |
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K113808 page
ge 2 of 2
Bard Access Systems, Inc.
Sherlock 3CG* Tip Confirmation System (TCS)
Traditional 510(k) Premarket Notification
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle, depicted with flowing lines to represent its wings and body.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAR 1 9 2012
Mr. Henry Boland Regulatory Affairs Specialist C.R. Bard, Inc. 605 North 5600 West Salt Lake City, Utah 84116
Re: K113808
Trade/Device Name: Sherlock 3CGTM Tip Confirmation System Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: December 22, 2011 Received: December 23, 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 Eederal 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
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. Sherlock 3CG* Tip Confirmation System (TCS) Traditional 510(k) Premarket Notification
Indications for Use Statement
510(k) Number (if known): __
Device Name: Sherlock 3CG™ Tip Confirmation System
Indications for Use:
The Sherlock 3CG™ Tip Confirmation System (TCS) is indicated for guidance and positioning of Peripherally Inserted Central Catheters (PICCs). The Sherlock 3CG TCS provides real-time PICC tip location information by using passive magnet tracking and the patient's cardiac electrical activity (ECG). When relying on the patient's ECG signal, the Sherlock 3CG 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 catheter insertion, the use of an additional method is required to confirm PICC tip location.
Over-The-Counter Use Prescription 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)
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K113808
14
§ 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.”