(94 days)
Not Found
No
The description focuses on passive magnet and cardiac electrical signal detection for real-time catheter tip location, with no mention of AI or ML algorithms for data processing or interpretation.
No
The device aids in catheter placement by providing real-time tip location information, but it does not directly treat or prevent a disease or condition.
No
The device is used for catheter guidance and positioning during placement, providing real-time location information, rather than diagnosing a disease or condition.
No
The device description explicitly states that the system consists of a sensor, stylet, and connection assembly, which are hardware components.
Based on the provided information, the Sherlock 3CG™ Tip Positioning System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Sherlock 3CG™ Function: The Sherlock 3CG™ system is used during a medical procedure (central venous catheter placement) to guide and position the catheter tip within the patient's body. It uses real-time signals (magnetic and electrical) from the patient's body to determine the catheter's location.
- No Specimen Examination: The system does not involve the collection or examination of any specimens taken from the patient.
Therefore, the Sherlock 3CG™ Tip Positioning System falls under the category of a medical device used for procedural guidance, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Sherlock 3CG™ Tip Positioning System Sensor: The Sherlock 3CG™ Tip Positioning System (TPS) is indicated for central venous catheter guidance and positioning during catheter placement. The Sherlock 3CG™ TPS provides real time catheter tip location information through the use of passive magnet and cardiac electrical signal detection.
Sherlock 3CG™ Tip Positioning System Stylet: Catheter stylets provide internal reinforcement to aid in catheter placement. When used with the Sherlock 3CG™ Tip Positioning System (TPS), the Sherlock 3CG™ TPS stylet also provides the placer rapid feedback on catheter tip location and orientation through the use of passive magnets and cardiac electrical signal detection.
Product codes (comma separated list FDA assigned to the subject device)
LJS
Device Description
The Sherlock 3CG™ Tip Positioning System (TPS) consists of a sensor, stylet, and connection assembly. The system is designed to aid in central venous catheter tip positioning through magnet tracking and ECG signal information. The Sherlock 3CG™ TPS System detects and displays the position of the magnet-tipped stylet relative to the sensor. In addition, the Sherlock 3CG™ TPS System detects and displays a cardiac electrical signal from the three ECG electrodes, including the Sherlock 3CG™ TPS Stylet and two body electrodes, which provide catheter tip positioning information.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
central venous
Indicated Patient Age Range
Not Found
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 tests have been performed in accordance with Design Controls per 21 CFR §820.30.
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.
K061240, K063240, K081626, K081625
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
K09324
Section 5 - 510(k) Summary
Page 20 of 128
1 of 1
510(k) Summary
| 510(k) Summary
| AUG 07 2009 | |
|---|---|
| Device trade name: | Sherlock 3CG™ Tip Positioning System Sensor |
| Sherlock 3CG™ Tip Positioning System Stylet | |
| Device class and panel: | Class II, 21 CFR §880.5970 |
| LJS - Accessory to Percutaneous, Implanted, Long-Term Intravascular Catheters | |
| Applicant name: | Rick Gaykowski |
| Bard Access Systems, Inc. [wholly owned subsidiary of C.R. Bard, Inc.] | |
| 605 North 5600 West, Salt Lake City, UT 84116 | |
| (801) 522-0700, x5432 | |
| Predicate devices: | K061240 - Sherlock™ II Tip Location System Detector |
| K063240 - Sherlock™ Tip Location System Stylet | |
| K081626 - FlowPICC™ Console | |
| K081625 - FlowPICC™ Stylet | |
| Performance | |
| Standards: | Performance standards have not been established by the FDA under |
| §514 of the Federal Food, Drug and Cosmetic Act. | |
| Indications for Use: | Sherlock 3CG™ Tip Positioning System Sensor: The Sherlock 3CG™ Tip |
| Positioning System (TPS) is indicated for central venous catheter guidance | |
| and positioning during catheter placement. The Sherlock 3CG™ TPS provides | |
| real time catheter tip location information through the use of passive magnet | |
| and cardiac electrical signal detection. | |
| Sherlock 3CG™ Tip Positioning System Stylet: Catheter stylets provide | |
| internal reinforcement to aid in catheter placement. When used with the | |
| Sherlock 3CG™ Tip Positioning System (TPS), the Sherlock 3CG™ TPS stylet | |
| also provides the placer rapid feedback on catheter tip location and orientation | |
| through the use of passive magnets and cardiac electrical signal detection. | |
| Device description: | The Sherlock 3CG™ Tip Positioning System (TPS) consists of a sensor, stylet, |
| and connection assembly. The system is designed to aid in central venous | |
| catheter tip positioning through magnet tracking and ECG signal information. | |
| The Sherlock 3CG™ TPS System detects and displays the position of the | |
| magnet-tipped stylet relative to the sensor. In addition, the Sherlock 3CG™ | |
| TPS System detects and displays a cardiac electrical signal from the three | |
| ECG electrodes, including the Sherlock 3CG™ TPS Stylet and two body | |
| electrodes, which provide catheter tip positioning information. | |
| Technological | |
| Characteristics: | Technological similarities between the subject Sherlock 3CG™ Tip Positioning |
| System Sensor and Sherlock 3CG™ Tip Positioning System Stylet and the | |
| predicate devices remain identical. There are no new questions raised | |
| regarding safety or efficacy of these devices. | |
| Safety & Performance | |
| Tests: | Verification and validation tests have been performed in accordance |
| with Design Controls per 21 CFR §820.30. | |
| Summary of Substantial | |
| Equivalence: | Based on the indications for use, technological characteristics, and |
| safety and performance testing, the subject Sherlock 3CG™ TPS System, | |
| consisting of the Sherlock 3CG™ TPS Sensor and Sherlock 3CG™ TPS Stylet | |
| met the minimum requirements that are considered adequate for its intended | |
| use and are substantially equivalent in design, materials, sterilization, | |
| principles of operation and indications for use to the current commercially | |
| available Sherlock™ II Tip Location System, which consists of the Sherlock ™ | |
| II Tip Location System Detector and Sherlock™ Tip Location System Stylet; | |
| and the FlowPICC™ System, which consists of the FlowPICC™ Console and | |
| FlowPICC™ Stylet. |
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three wings, representing health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Mr. Rick Gaykowski Vice President, Regulatory Affairs Bard Access Systems, Incorporated C.R. Bard, Incorporated 605 North 5600 West Salt Lake, Utah 84116
AUG 0 7 2009
Re: K091324
Trade/Device Name: Sherlock 3CGTM Tip Positioning System Stylet, Sherlock 3CGTM Tip Positioning System Sensor Regulation Number: 880.5970 Regulation Name: Percutaneous Implanted Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS
Dated: July 6, 2006 Received: July 8, 2009
Dear Mr. Gaykowski:
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.
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.
2
Page 2- Mr. Gaykowski
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.
ph for
Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page 18 of 128
510(k) Number (if known): _
Device Name:
Sherlock 3CG™ Tip Positioning System Stylet
Indications for Use:
Catheter stylets provide internal reinforcement to aid in catheter placement. When used with the Sherlock 3CG™ Tip Positioning System (TPS), the Sherlock 3CG™ TPS Stylet also provides the placer rapid feedback on catheter tip location and orientation through the use of passive magnets and cardiac electrical signal detection.
Prescription: Use (Part 21 CFR §801 Subpart D)
AND/OR
Over-The-Counter Use (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: K091324
4
510(k) Number (if known):
Device Name:
Sherlock 3CG™ Tip Positioning System Sensor
Indications for Use:
The Sherlock 3CG™ Tip Positioning System (TPS) is indicated for central venous catheter guidance and positioning during catheter placement. The Sherlock 3CG™ TPS provides real time catheter tip location information through the use of passive magnet and cardiac electrical signal detection.
Prescription Use (Part 21 CFR §801 Subpart D)
AND/OR
Over-The-Counter Use (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)
vision of Anesthesiology, General Hospital mection Control, Dental Devices
10(k) Number: K091324