(63 days)
Not Found
No
The summary describes a physical device (stylet) used for catheter placement and tip confirmation via passive magnets and cardiac electrical signal detection. There is no mention of AI or ML in the device description, intended use, or performance studies.
No.
The device is a catheter stylet designed to aid in the placement of catheters and provide tip location information, not to directly treat or diagnose a disease or condition.
Yes
The device aids in catheter placement and, when used with the Sherlock 3CG® Tip Confirmation System (TCS), provides "rapid feedback on catheter tip location and orientation through the use of passive magnets and cardiac electrical signal detection." This function of providing information about the internal state (tip location and orientation) of the body (specifically, a catheter within the body) for medical purposes constitutes a diagnostic function.
No
The device description explicitly states it is a "sterile, single use device" made of "specially-formulated materials" with specific dimensions, indicating it is a physical hardware component. It also mentions working with a "Tip Confirmation System (TCS)" which likely involves hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to aid in catheter placement and provide feedback on catheter tip location and orientation using passive magnets and cardiac electrical signal detection. This is a procedural aid and monitoring function, not a diagnostic test performed on biological samples in vitro.
- Device Description: The description focuses on the physical characteristics of the stylet and its function in supporting catheter placement and working with a tip confirmation system. It doesn't mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: The text does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Detection of specific analytes or biomarkers
- Diagnostic interpretation of results
The device is clearly intended for use in vivo during a medical procedure to assist with the physical placement and positioning of a catheter.
N/A
Intended Use / Indications for Use
The Sherlock 3CG® TPS Stylet provides real time catheter tip location information through the use of passive magnet and cardiac electrical signal detection.
Catheter stylets provide internal reinforcement to aid in catheter placement. When used with the Sherlock 3CG® Tip Confirmation System (TCS), 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
Bard Access Systems, Inc.'s Sherlock 3CG® Tip Positioning System (TPS) Stylet is a sterile, single use device 0.49 mm (0.019 in) outer diameter x 78.5 cm, made of specially-formulated materials designed to aid in the placement of specific Bard catheters, as well as any open-ended, non-valved, polyurethane, peripherally inserted central catheters (PICCs) that meet the dimensional specifications of the stylet. The Sherlock 3CG® TPS Stylet is designed to work with catheters containing a minimum lumen diameter of 0.51mm (0.020 in). The stylet provides internal reinforcement to aid in catheter placement. The Sherlock 3CG® TPS Stylet may be used with the Sherlock 3CG® Tip Confirmation System (TCS) to provide catheter tip placement information during the procedure.
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
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 as per 21 CFR §820.30. The following guidance documents and standards in conjunction with in-house protocols were used to determine appropriate methods for evaluating the performance of the device:
• Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, March 16, 1995
• BS/EN/ISO 10555-1: 1997, Sterile, single-use intravascular catheters, Part 1. General Requirements /ISO 10555-1:2004 Amendment
• BS/EN/ISO 10555-3:1997, Sterile, single-use intravascular catheters, Part 3. Central venous catheters
• ISO 594-2: 1998, Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment– Part 2: Lock Fittings
• AAMI/ANSI/ISO 11135-1:2007 Sterilization of health care products – Ethylene oxide — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - First Edition
• AAMI/ANSI/ISO 10993-1:2009, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, and the FDA Modified ISO 10993 Test Profile
The subject devices met all predetermined acceptance criteria derived from the above listed references and demonstrated substantially equivalent performance as compared to the cited predicate devices.
Risk management, including a failure modes and effects analysis (FMEA), of the subject device was conducted in accordance with ISO 14971:2012, Medical Devices – Risk Management for Medical Devices.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 13,2014
Bard Access Systems, Incorporated Brvan Stone Regulatory Affairs Specialist 605 North 5600 West Salt Lake City, UT 84116
RE: K142267
Sherlock 3CG® Tip Positioning System (TPS) Stylet Regulation Number: 21 CFR 880.5970 Regulation Name: Accessory to Percutaneous, Implanted Long-Term Intravascular Catheter Regulatory Class: Class II Product Code: LJS Dated: August 14, 2014 Received: August 15, 2014
Dear Mr. Stone:
This letter corrects our substantially equivalent letter of October 17, 2014.
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.
1
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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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,
Susan Runno DDS, MA
Erin I. Keith, M.S Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/2 description: The image shows the logo for BARD ACCESS SYSTEMS. The word "BARD" is in large, bold, sans-serif font. Below the word "BARD" is the phrase "ACCESS SYSTEMS" in a smaller, bold, sans-serif font.
Indications for Use
510(k) Number (if known):
Device Name:
Sherlock 3CG® Tip Positioning System (TPS) Stylet
Indications for Use:
Sherlock 3CG® Tip Positioning System Stylet
Catheter stylets provide internal reinforcement to aid in catheter placement. When used with the Sherlock 3CG® Tip Confirmation System (TCS), 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 V (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)
Page 1 of 1
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Image /page/3/Picture/0 description: The image shows the logo for BARD ACCESS SYSTEMS. The word "BARD" is in large, bold, sans-serif font, with each letter connected to the next. Below the word "BARD" is the phrase "ACCESS SYSTEMS" in a smaller, sans-serif font.
Device
510(k) Summary 21 CFR 807.92(a)
| | Submitter Name:
Address: | Bard Access Systems, Inc.
605 North 5600 West
Salt Lake City, UT 84116 |
|------------------------------|----------------------------------------------------------|---------------------------------------------------------------------------------------------|
| General
Provisions | Contact Person: | Bryan Stone
Regulatory Affairs Specialist |
| | Telephone Number:
Fax Number:
Date of Preparation: | (801) 522-5876
(801) 522-5425
8 August 2014 |
| | Subject
Device | Trade Name:
Common Name:
Classification Name: |
| Product Code/
Regulation: | | LJS/21 CFR §880.5970 |
| Predicate
Devices | Predicate Trade Name: | Sherlock 3CG® Tip Positioning System Stylet,
Sherlock 3CG® Tip Positioning System Sensor |
| | Classification Name: | Accessory to Percutaneous, Implanted, Long-Term
Intravascular Catheter |
| | Premarket Notification:
Manufacturer: | K091324
Bard Access Systems, Inc. |
Bard Access Systems, Inc.'s Sherlock 3CG® Tip Positioning System (TPS) Stylet is a sterile, single use device 0.49 mm (0.019 in) outer diameter x 78.5 cm, made of specially-formulated materials designed to aid in the placement of specific Bard catheters, as well as any open-ended, non-valved, polyurethane, peripherally inserted central catheters (PICCs) that meet the dimensional specifications of the stylet. The Sherlock 3CG® TPS Stylet is Description designed to work with catheters containing a minimum lumen diameter of 0.51mm (0.020 in). The stylet provides internal reinforcement to aid in catheter placement. The Sherlock 3CG® TPS Stylet may be used with the Sherlock 3CG® Tip Confirmation System (TCS) to provide catheter tip placement information during the procedure.
4
| Intended Use | The Sherlock 3CG® TPS Stylet provides real time catheter tip location
information through the use of passive magnet and cardiac electrical signal
detection. |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications For
Use | Catheter stylets provide internal reinforcement to aid in catheter placement.
When used with the Sherlock 3CG® Tip Confirmation System (TCS), 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. |
| Technological
Characteristics | Technological characteristics including design, materials and function of the
subject Sherlock 3CG® TPS Stylet are identical with respect to those of the
predicate Sherlock 3CG® TPS Stylet. The subject device may now be used
with specific Bard catheters as well as any open-ended, non-valved,
polyurethane peripherally inserted central catheter that meets the dimensional
specifications of the stylet (0.020 in minimum lumen diameter). |
5
| Safety &
Performance
Tests | Verification and validation tests have been performed in accordance with
Design Controls as per 21 CFR §820.30. The following guidance documents
and standards in conjunction with in-house protocols were used to determine
appropriate methods for evaluating the performance of the device:
• Guidance on Premarket Notification [510(k)] Submission for Short-
Term and Long-Term Intravascular Catheters, March 16, 1995
• BS/EN/ISO 10555-1: 1997, Sterile, single-use intravascular
catheters, Part 1. General Requirements /ISO 10555-1:2004
Amendment
• BS/EN/ISO 10555-3:1997, Sterile, single-use intravascular
catheters, Part 3. Central venous catheters
• ISO 594-2: 1998, Conical fittings with a 6% (Luer) taper for
syringes, needles and certain other medical equipment– Part 2:
Lock Fittings
• AAMI/ANSI/ISO 11135-1:2007 Sterilization of health care products
– Ethylene oxide — Part 1: Requirements for development,
validation and routine control of a sterilization process for medical
devices - First Edition
• AAMI/ANSI/ISO 10993-1:2009, Biological Evaluation of Medical
Devices Part 1: Evaluation and Testing, and the FDA Modified ISO
10993 Test Profile
The subject devices met all predetermined acceptance criteria derived from
the above listed references and demonstrated substantially equivalent
performance as compared to the cited predicate devices.
Risk management, including a failure modes and effects analysis (FMEA), of
the subject device was conducted in accordance with ISO 14971:2012,
Medical Devices – Risk Management for Medical Devices. |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary of
Substantial
Equivalence | Based on the intended use, technological characteristics, and safety and
performance testing, the subject Sherlock 3CG® TPS Stylet met the
requirements that are considered sufficient for its intended use and is as safe
and as effective as predicate devices cited. |