(87 days)
Not Found
No
The description focuses on passive magnet tracking and ECG analysis, with no mention of AI or ML terms or concepts.
No
The device is used for guiding and positioning PICCs and confirming their tip location, serving a diagnostic and navigational purpose rather than providing direct therapy.
Yes
The device uses ECG and magnetic tracking to provide real-time information about PICC tip location and can be used as an alternative to chest X-ray for placement confirmation, which are diagnostic activities.
No
The device description explicitly mentions using "passive magnet tracking and magnetic sensors" and receiving "ECG waveforms from the patient's skin and from the tip of the catheter," indicating the presence of hardware components beyond just software.
Based on the provided information, the Sherlock 3CG™ Tip Confirmation System (TCS) is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The Sherlock 3CG TCS works by tracking a magnetic stylet within the patient's body and analyzing the patient's cardiac electrical activity (ECG). It does not analyze blood, tissue, or other bodily fluids or substances in vitro (outside the body).
- The intended use is for guiding and positioning a medical device (PICC) within the patient's body. This is an in vivo (within the living organism) procedure.
- The device description focuses on magnetic tracking and ECG analysis from the patient. This further supports its in vivo function.
Therefore, the Sherlock 3CG TCS is a medical device used in vivo for guiding and confirming the placement of a PICC, not an IVD.
N/A
Intended Use / 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.
Product codes
LJS
Device Description
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.
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 Sherlock 3CG* 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
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
| 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: | 22 December 2011 |
| Subject Device | Trade Name: | Sherlock 3CG* Tip Confirmation System |
| | Classification Name: | 21 CFR 880.5970 - Class II
LJS - Percutaneous, implanted, long-term
intravascular catheter |
| Predicate
Device | Trade Name: | Sapiens* Tip Confirmation System |
| | Classification Name: | 21 CFR 880.5970 - Class II
LJS - Percutaneous, implanted, long-term
Intravascular catheters |
| | Premarket Notification: | K112744, concurrence date 20 October 2011 |
| | Manufacturer: | Bard Access Systems, Inc. |
| Predicate
Device | Trade Name: | Sherlock 3CG* Tip Positioning System |
| | Classification Name: | 21 CFR 880.5970 - Class II
LJS - Percutaneous, implanted, long-term
Intravascular catheters |
| | Premarket Notification: | K091324, concurrence date 07 August 2009 |
| | Manufacturer: | Bard Access Systems, Inc. |
| Device
Description | 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. | | |
| Indications for
Use / Intended
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. | |
| Technological
Characteristics | Technological characteristics of the subject Sherlock 3CG* TCS are equivalent
with respect to the basic system design and function to that of the predicate
devices, Sapiens* Tip Confirmation System and Sherlock 3CG* Tip Positioning
System. Differences do not raise any new questions regarding safety and
effectiveness. | |
| Safety &
Performance
Tests | Verification and validation activities were designed and performed to
demonstrate that the subject Sherlock 3CG* 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. | |
| Summary of
Substantial
Equivalence | Based on the indications for use, technological characteristics, and safety and
performance testing, the subject Sherlock 3CG* TCS met the minimum
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 devices, Sapiens* Tip Confirmation System
and Sherlock 3CG* Tip Positioning System. | |
1
K113808 page
ge 2 of 2
Bard Access Systems, Inc.
Sherlock 3CG* Tip Confirmation System (TCS)
Traditional 510(k) Premarket Notification
2
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.
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/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
4
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