(31 days)
Not Found
No
The description focuses on passive magnet tracking and ECG analysis, with no mention of AI or ML techniques for data processing or interpretation.
No.
The device is used for guiding and positioning PICCs and confirming their tip placement, which are diagnostic and procedural guidance functions, not therapeutic.
No
The device provides guidance and positioning for PICC insertion and confirmation of PICC tip placement, which are procedural functions rather than diagnostic functions that identify a disease or condition.
No
The device description explicitly mentions using "passive magnet tracking and the patient's cardiac electrical activity (ECG)" and "magnetic stylet and magnetic sensors," 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) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Sherlock 3CG™ TCS Function: The Sherlock 3CG™ TCS works by using a magnetic stylet and magnetic sensors to track the position of a PICC line within the body. It also uses the patient's cardiac electrical activity (ECG) to help confirm the tip location.
- No Specimen Analysis: The device does not analyze any specimens taken from the patient's body. It interacts directly with the patient's internal anatomy (via the PICC line and ECG leads) and physiological signals.
Therefore, the Sherlock 3CG™ TCS falls under the category of a medical device used for guidance and positioning during a medical procedure, rather than an in vitro diagnostic device.
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 (comma separated list FDA assigned to the subject device)
LJS
Device Description
The Sherlock 3CGTM TCS is indicated for guidance and positioning of PICCs during insertion and placement. The Sherlock 3CGTM TCS provides real-time catheter tip location information by using passive magnet tracking and the patient's cardiac electrical activity (ECG). The Sherlock 3CGTM TCS displays the location of the PICC tip using a magnetic stylet and magnetic sensors. The Sherlock 3CGTM 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 guidance documents in conjunction with in-house protocols were used to determine appropriate methods for evaluating the performance of the device. Design Control Guidance for Medical Device Manufacturers, March 11, 1997 Draft Guidance - Applying Human Factors and Usability Engineering to Optimize Medical Device Design, June 22, 2011 The subject device met all pre-determined acceptance criteria and demonstrated substantial equivalence as compared to the predicate device.
The results of the testing performed demonstrate the subject device is as safe, as effective, and performs as well as or better than the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Sherlock 3CG Tip Confirmation System (TCS)
·
Bard Access Systems, Inc.
510(k) Summary 21 CFR 807.92
Sherlock 3CG Tip Confirmation System
| | Submitter Name:
Address: | Bard Access Systems, Inc.
605 North 5600 West
Salt Lake City, UT 84116 |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| General
Provisions | Contact Person | James R. Davis
Regulatory Affairs Specialist
james.davis2@crbard.com
801.522.5000 ext 5456
801.522.5425 |
| | Date of Preparation: | 07 February 2014 |
| Subject
Device | Trade Name:
Common/Usual Name:
Classification Name: | Sherlock 3CGTM Tip Confirmation System
Sherlock 3CGTM Tip Confirmation System
Percutaneous, implanted, long-term intravascular
catheter |
| | Product Code/
Regulation: | LJS - 21 CFR 880.5970 |
| Predicate
Device | Trade Name:
Classification Name: | Sherlock 3CGTM Tip Confirmation System
Percutaneous, implanted, long-term intravascular
catheter |
| | Premarket Notification:
Manufacturer: | K113808
Bard Access Systems, Inc. |
| Device
Description | The Sherlock 3CGTM TCS is indicated for guidance and positioning of PICCs
during insertion and placement. The Sherlock 3CGTM TCS provides real-time
catheter tip location information by using passive magnet tracking and the
patient's cardiac electrical activity (ECG). The Sherlock 3CGTM TCS displays the
location of the PICC tip using a magnetic stylet and magnetic sensors. The
Sherlock 3CGTM 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 Sherlock 3CG
TCS. 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 guidance documents in conjunction with in-house
protocols were used to determine appropriate methods for evaluating the
performance of the device. Design Control Guidance for Medical Device Manufacturers, March 11, 1997 Draft Guidance - Applying Human Factors and Usability Engineering to
Optimize Medical Device Design, June 22, 2011 The subject device met all pre-determined acceptance criteria and demonstrated
substantial equivalence as compared to the predicate device. | |
| Testing
Conclusion | The results of the testing performed demonstrate the subject device is as safe, as
effective, and performs as well as or better than 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 Sherlock 3CG™ TCS. | |
1
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:
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002
March 14, 2014
Bard Access Systems, Incorporated Mr. James Davis Regulatory Affairs Specialist 605 North 5600 West Salt Lake City, UT 84116
Re: K140345
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: February 7, 2014 Received: February 14, 2014
Dear Mr. Davis:
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. Davis
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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,
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Erin 1. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K140345
Device Name
Sherlock 3CG Tip Confirmation System (TCS)
Indications for Use (Describe)
The Sherlock 3CG Tip Confirmation System (TCS) is indicated for guidance and positioning of Peripherally Inserted Central Catheters (PICCs). The Sherlock 3CGTM 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 3CGTM 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 catherer insertion, the use of an additional method is required to confirm PICC tip location.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FOR FOR FOR FOR FOR THE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Digitally signed by Richard C. Chapman Date: 2014.03.12 18:00:56 -04′00″
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
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