Sherlock 3CG Tip Positioning System Stylet

K172397 · C.R. Bard, Inc. · LJS · Sep 29, 2017 · General Hospital

Device Facts

• Record ID: K172397
• Device Name: Sherlock 3CG Tip Positioning System Stylet
• Applicant: C.R. Bard, Inc.
• Product Code: LJS · General Hospital
• Decision Date: Sep 29, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5970
• Device Class: Class 2

Intended 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.

Device Story

Stylet provides internal reinforcement for catheter placement; used with Sherlock 3CG® Tip Confirmation System (TCS) for real-time tip location/orientation feedback. Input: passive magnetic signals and cardiac electrical signals. Operation: stylet contains magnets and sensors to track tip position within venous system; provides rapid feedback to clinician. Used in clinical settings by healthcare providers. Output: visual feedback on tip location/orientation. Benefit: aids accurate catheter placement; reduces need for post-placement imaging.

Clinical Evidence

Bench testing only. Verification tests performed per 21 CFR 820.30. Ship testing conducted per ISO 11607-1:2006. Tip tracking performance validated against internal protocols with acceptance criteria defined by risk assessment. All testing passed.

Technological Characteristics

Outer casing: Polyimide; Core wire: Stainless steel; Distal tip: Neodymium-Iron-Boron magnets, UV thermal epoxy, conductive epoxy. Dimensions: 0.019 in OD, lengths 62.5 cm and 78.5 cm. Packaging: PETG tray with integrated degaussing magnets, CSR wrap, Tyvek/film header bag. Sterilization: Terminally sterilized. Connectivity: Passive magnetic and electrical signal sensing.

Indications for Use

Indicated for use as an internal reinforcement for catheter placement and to provide real-time catheter tip location and orientation feedback when used with the Sherlock 3CG® Tip Confirmation System.

Regulatory Classification

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.

Special Controls

*Classification.* Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”

Predicate Devices

• Sherlock 3CG® Tip Positioning System (TPS) Stylet (K091324)

Submission Summary (Full Text)

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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

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# 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.

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# Indications for Use

510(k) Number (if known)

K172397

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) | |
|------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><span>☒</span><span>Prescription Use (Part 21 CFR 801 Subpart D)</span></div> | <div style="display:flex; align-items:center;"><span>☐</span><span>Over-The-Counter Use (21 CFR 801 Subpart C)</span></div> |

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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

K172397

## 510(k) Summary

## 21 CFR 807.92(a)

| General<br>Provisions | Submitter Name: | Bard Access Systems, Inc. |
|-----------------------|--------------------------|-----------------------------------------------------------|
| | Submitter Address: | 605 North 5600 West<br>Salt Lake City, UT 84116 |
| | Contact Person: | Mona Shahrebani<br>Regulatory Affairs Specialist |
| | Telephone Number: | [phone] |
| | Fax Number: | [phone] |
| | 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<br>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. |

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| Device<br>Description | The Sherlock 3CG® TPS Stylet has been developed to aid in the placement of Bard Access Systems' catheters using current<br>placement techniques. The stylets are designed to give the catheters added support and stiffness while traversing the<br>patient's venous system. Also, should the clinician choose to do so, the stylets have been designed to be used in conjunction<br>with Sherlock 3CG® Tip Confirmation System to allow for rapid feedback of catheter tip placement. | | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications For<br>Use | Catheter stylets provide internal reinforcement to aid in catheter placement. When used with the Sherlock 3CG® Tip<br>Confirmation System (TCS), the Sherlock 3CG® TPS Stylet also provides the placer rapid feedback on catheter tip location<br>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<br>design and function to those of the cited predicate device. | | |
| Technological<br>Characteristics | | Subject Device:<br>Sherlock 3CG® Tip Positioning System Stylet | Predicate Device:<br>Sherlock 3CG® Tip Positioning System Stylet |
| | Primary<br>Device<br>Materials | Stylet outer casing<br>Same as predicate<br><br>Core Wire<br>Same as predicate<br><br>Distal Tip<br>Same as predicate | Stylet outer casing<br>• Polyimide<br><br>Core Wire<br>• Stainless Steel<br><br>Distal Tip<br>• Magnets: Neodymium-Iron-Boron<br>• Tip Adhesive: Dymax UV Thermal Epoxy 1184-<br>M-VT<br>• Conductive Epoxy: EpoTek H20E |
| | Stylet Distal<br>Tip<br>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<br>Configuration | PETG tray with degaussing magnets, sized at<br>13mm x 5mm x 3.5mm and 13mm x 5mm x<br>1.5mm, placed in a cavity created within the tray,<br>wrapped in CSR wrap, sealed in header bag<br>LLDPE/Nylon film sealed to HCW27 coated 1073B<br>Tyvek®<br><br>Note: Tyvek® is a registered trademark of E. I. du Pont de<br>Nemours or an affiliate | PETG tray, wrapped in CSR wrap, sealed in<br>header bag LLDPE/Nylon film sealed to HCW27<br>coated 1073B Tyvek®<br><br>Note: Tyvek® is a registered trademark of E. I. du Pont de<br>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<br>and the addition of a second size offering for the stylet. The packaging tray was modified to include a cavity recess containing<br>two magnets below where the preloaded stylet and catheter rest. No other changes were made to the Sherlock 3CG® TPS<br>Stylet or packaging. Additionally, the stylet will now be offered in the following sizes: 0.019 in outer diameter x 78.5 cm and<br>0.019 in outer diameter x 62.5 cm.<br>The technological differences listed above were evaluated using the same test requirements as the predicate devices, as<br>defined in the Risk Assessment. Therefore, the difference in packaging design between the subject and predicate device does<br>not raise different questions of equivalence. | | | |
| Performance<br>Tests | Verification tests were designed and performed in accordance with Design Controls per 21 CFR §820.30. The only<br>modification made to the subject device when compared to the predicate device is a change in the packaging tray and the<br>addition of a second size offering for the stylet. The packaging tray was modified to include a cavity recess containing two<br>magnets beneath the preloaded stylet and catheter. No other changes were made to the Sherlock 3CG® TPS Stylet or<br>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<br>outer diameter x 62.5 cm.<br><br>The following tests were conducted per guidance documents and standards in conjunction with in-house protocols to establish<br>the performance of the device: | | |
| | Verification<br>Method | Risk Acceptability Criteria (Acceptance Criteria of Test) | |
| | Ship Testing | - Visual inspection and Integrity testing of header bag.<br>- Visual inspection of components.<br>- Visual inspection of trays. | |
| | Tip Tracking<br>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<br>sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems. The Tip<br>Tracking testing was executed per internal test methods and protocols. All testing passed the predetermined acceptance<br>criteria. | | |
| | The subject device met all design requirements derived from the above listed references and demonstrated substantial<br>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<br>with BS EN ISO 14971:2012, Medical Devices – Application of Risk Management to Medical Devices. | | |
| Summary of<br>Substantial<br>Equivalence | Based on the indications for use, technological characteristics, and results of performance testing, the subject Sherlock 3CG®<br>Tip Positioning System Stylet met the requirements that are considered sufficient for its intended use and demonstrates<br>substantial equivalence to the cited predicate device. | | |

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