(52 days)
Not Found
No
The description focuses on passive magnets and cardiac electrical signal detection for tip confirmation, with no mention of AI or ML algorithms for data processing or interpretation. The performance studies described are standard verification tests for packaging and tip tracking based on predetermined criteria, not machine learning model validation.
No.
The device acts as an aid for catheter placement and tip confirmation, providing structural support and feedback on tip location, rather than directly treating a medical condition or restoring function.
Yes
The "Intended Use" section states that the device provides "rapid feedback on catheter tip location and orientation" through the use of "passive magnets and cardiac electrical signal detection." This indicates that the device is used to diagnose/determine the position of the catheter tip within the body.
No
The device description explicitly states it is a "stylet," which is a physical, internal reinforcement for a catheter. It also mentions "passive magnets" and "cardiac electrical signal detection," indicating hardware components are involved. The performance studies focus on physical characteristics like packaging and tip tracking, not software validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The primary intended use is to provide internal reinforcement for catheter placement and, when used with a specific system, to provide feedback on catheter tip location and orientation using passive magnets and cardiac electrical signal detection. This describes a device used in vivo (within the body) for a procedural aid and monitoring, not for testing samples in vitro (outside the body) to diagnose a condition.
- Device Description: The description reinforces the use of the stylet within the patient's venous system to aid in catheter placement.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
The device is clearly intended for use during a medical procedure within the patient's body.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
LJS
Device Description
The Sherlock 3CG® TPS Stylet has been developed to aid in the placement of Bard Access Systems' catheters using current placement techniques. The stylets are designed to give the catheters added support and stiffness while traversing the patient's venous system. Also, should the clinician choose to do so, the stylets have been designed to be used in conjunction with Sherlock 3CG® Tip Confirmation System to allow for rapid feedback of catheter tip placement.
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 tests were designed and performed in accordance with Design Controls per 21 CFR §820.30. The only modification made to the subject device when compared to the predicate device is a change in the packaging tray and the addition of a second size offering for the stylet. The packaging tray was modified to include a cavity recess containing two magnets beneath the preloaded stylet and catheter. No other changes were made to the Sherlock 3CG® TPS Stylet or packaging. Additionally, the sylet will now be offered in the following sizes: 0.019 in outer diameter x 78.5 cm and 0.019 in outer diameter x 62.5 cm.
The following tests were conducted per guidance documents and standards in conjunction with in-house protocols to establish the performance of the device:
- Ship Testing
- Tip Tracking Testing
The verification method for ship testing was executed in accordance with ISO 11607-1:2006, Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems. The Tip Tracking testing was executed per internal test methods and protocols. All testing passed the predetermined acceptance criteria.
The subject device met all design requirements derived from the above listed references and demonstrated substantial equivalence as compared to the cited predicate device.
Risk management, including a failure modes and effects analysis (FMEA), of the subject device was conducted in accordance with BS EN ISO 14971:2012, Medical Devices – Application of Risk Management to Medical Devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Tip Tracking Testing: Normal: x_bar + k * s = k/3
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 seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, composed of three intertwined figures. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The seal is presented in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 29, 2017
C.R. Bard, Inc. Ms. Mona Shahrebani Regulatory Affairs Specialist 605 North 5600 West Salt Lake City, Utah 84116
Re: K172397
Trade/Device Name: Sherlock 3CG Tip Positioning System (TPS) Stylet Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, implanted, long-term intravascular catheter Regulatory Class: Class II Product Code: LJS Dated: August 30, 2017 Received: August 31, 2017
Dear Ms. Mona Shahrebani:
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. Isting 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,
Tina Kiang
-s
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Change Control Table, Change History
Change Control Table
| Version | Document Author | Document Approver | Date Approved |
|---|---|---|---|
| 1.00 | Name, Title, Office | Name, Title, Office | MM/DD/YYYY |
Complete Change Control Table (all versions) retained in SWIFT Docs.
3
Indications for Use
510(k) Number (if known)
Device Name
Sherlock 3CG® Tip Positioning System (TPS) Stylet
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☒Prescription Use (Part 21 CFR 801 Subpart D) | ☐Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Image /page/4/Picture/0 description: The image shows the word "BARD" in a stylized, bold, sans-serif font. The letters are outlined in black, creating a hollow effect. The design is simple and modern, with a focus on the geometric shapes of the letters.
ACCESS SYSTEMS
510(k) Summary
21 CFR 807.92(a)
| General
| Provisions | Submitter Name: | Bard Access Systems, Inc. |
|---|---|---|
| Submitter Address: | 605 North 5600 West | |
| Salt Lake City, UT 84116 | ||
| Contact Person: | Mona Shahrebani | |
| Regulatory Affairs Specialist | ||
| Telephone Number: | (801) 522-5967 | |
| Fax Number: | (801) 522-4907 | |
| Date of Preparation: | September 27, 2017 | |
| Subject Device | Trade Name(s): | Sherlock 3CG® Tip Positioning System (TPS) Stylet |
| Common Name: | Peripherally Inserted Central Catheter (PICC) | |
| Classification Name: | Percutaneous, Implanted, Long-term Intravascular Catheter | |
| Product Code/Regulation: | LJS/21 CFR §880.5970 | |
| Predicate | ||
| Devices | Predicate Trade Name: | Sherlock 3CG® Tip Positioning System (TPS) Stylet |
| Classification Name: | Percutaneous, Implanted, Long-term Intravascular Catheter | |
| Premarket Notification: | K091324 | |
| Manufacturer: | Bard Access Systems, Inc. |
5
| Device
Description | The Sherlock 3CG® TPS Stylet has been developed to aid in the placement of Bard Access Systems' catheters using current
placement techniques. The stylets are designed to give the catheters added support and stiffness while traversing the
patient's venous system. Also, should the clinician choose to do so, the stylets have been designed to be used in conjunction
with Sherlock 3CG® Tip Confirmation System to allow for rapid feedback of catheter tip placement. | | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 of the subject Sherlock 3CG® TPS Stylet are substantially equivalent with respect to basic
design and function to those of the cited predicate device. | | |
| Technological
Characteristics | | Subject Device:
Sherlock 3CG® Tip Positioning System Stylet | Predicate Device:
Sherlock 3CG® Tip Positioning System Stylet |
| | Primary
Device
Materials | Stylet outer casing
Same as predicate
Core Wire
Same as predicate
Distal Tip
Same as predicate | Stylet outer casing
• Polyimide
Core Wire
• Stainless Steel
Distal Tip
• Magnets: Neodymium-Iron-Boron
• Tip Adhesive: Dymax UV Thermal Epoxy 1184-
M-VT
• Conductive Epoxy: EpoTek H20E |
| | Stylet Distal
Tip
Configuration | Same as predicate | Atraumatic tip |
| | Stylet | 0.019 in outer diameter x 78.5 cm | 0.019 in outer diameter x 78.5 cm |
| Dimensions | 0.019 in outer diameter x 62.5 cm | | |
| Packaging
Configuration | PETG tray with degaussing magnets, sized at
13mm x 5mm x 3.5mm and 13mm x 5mm x
1.5mm, placed in a cavity created within the tray,
wrapped in CSR wrap, sealed in header bag
LLDPE/Nylon film sealed to HCW27 coated 1073B
Tyvek®
Note: Tyvek® is a registered trademark of E. I. du Pont de
Nemours or an affiliate | PETG tray, wrapped in CSR wrap, sealed in
header bag LLDPE/Nylon film sealed to HCW27
coated 1073B Tyvek®
Note: Tyvek® is a registered trademark of E. I. du Pont de
Nemours or an affiliate | |
| The only modification made to the subject device when compared to the predicate device is a change in the packaging tray
and the addition of a second size offering for the stylet. The packaging tray was modified to include a cavity recess containing
two magnets below where the preloaded stylet and catheter rest. No other changes were made to the Sherlock 3CG® TPS
Stylet or packaging. Additionally, the stylet will now be offered in the following sizes: 0.019 in outer diameter x 78.5 cm and
0.019 in outer diameter x 62.5 cm.
The technological differences listed above were evaluated using the same test requirements as the predicate devices, as
defined in the Risk Assessment. Therefore, the difference in packaging design between the subject and predicate device does
not raise different questions of equivalence. | | | |
| Performance
Tests | Verification tests were designed and performed in accordance with Design Controls per 21 CFR §820.30. The only
modification made to the subject device when compared to the predicate device is a change in the packaging tray and the
addition of a second size offering for the stylet. The packaging tray was modified to include a cavity recess containing two
magnets beneath the preloaded stylet and catheter. No other changes were made to the Sherlock 3CG® TPS Stylet or
packaging. Additionally, the sylet will now be offered in the following sizes: 0.019 in outer diameter x 78.5 cm and 0.019 in
outer diameter x 62.5 cm.
The following tests were conducted per guidance documents and standards in conjunction with in-house protocols to establish
the performance of the device: | | |
| | Verification
Method | Risk Acceptability Criteria (Acceptance Criteria of Test) | |
| | Ship Testing | - Visual inspection and Integrity testing of header bag.
- Visual inspection of components.
- Visual inspection of trays. | |
| | Tip Tracking
Testing | - Normal: $\overline{x} + k * s \le 1 \text{ cm or } 10^\circ$ , Non-Normal: $Ppk \ge k/3$ | |
| | The verification method for ship testing was executed in accordance with ISO 11607-1:2006, Packaging for terminally
sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems. The Tip
Tracking testing was executed per internal test methods and protocols. All testing passed the predetermined acceptance
criteria. | | |
| | The subject device met all design requirements derived from the above listed references and demonstrated substantial
equivalence as compared to the cited predicate device. | | |
| | Risk management, including a failure modes and effects analysis (FMEA), of the subject device was conducted in accordance
with BS EN ISO 14971:2012, Medical Devices – Application of Risk Management to Medical Devices. | | |
| Summary of
Substantial
Equivalence | Based on the indications for use, technological characteristics, and results of performance testing, the subject Sherlock 3CG®
Tip Positioning System Stylet met the requirements that are considered sufficient for its intended use and demonstrates
substantial equivalence to the cited predicate device. | | |
6
7