(63 days)
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.
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.
The provided document is a 510(k) summary for the Sherlock 3CG® Tip Positioning System (TPS) Stylet. It outlines the intended use, technological characteristics, and safety and performance tests. However, it does not contain the detailed acceptance criteria and study results in the format requested.
The document indicates that "Verification and validation tests have been performed in accordance with Design Controls as per 21 CFR §820.30" and that "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." However, it does not explicitly state what those predetermined acceptance criteria were, nor does it provide specific reported device performance metrics against them.
Therefore, I cannot populate the table or answer most of your detailed questions directly from the provided text.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document states that the devices met predetermined acceptance criteria, but it does not list these criteria or specific performance values. Instead, it lists technical standards and guidance documents (e.g., BS/EN/ISO 10555-1: 1997, ISO 594-2: 1998, AAMI/ANSI/ISO 11135-1:2007) that were used to determine appropriate methods for evaluating performance. It also mentions risk management according to ISO 14971:2012.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. The document mentions "Verification and validation tests" but provides no details on sample size, data provenance, or whether the study was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Cannot be provided. This device is a stylet for a catheter tip positioning system, which uses passive magnets and cardiac electrical signal detection for feedback on catheter tip location. The ground truth for such a device would likely involve direct physical measurement or imaging confirmation (e.g., X-ray) of the catheter tip, not expert review of images for diagnosis. The document does not describe the establishment of a ground truth by experts in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Cannot be provided. As above, the nature of the device and the information provided do not suggest an adjudication method for a test set, which is typically relevant for interpretative tasks often involving human expert readers.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Cannot be provided. The document does not mention an MRMC study. This device is an accessory to a positioning system, which is a tool to aid in placement, not an AI for interpretation that would typically require an MRMC study to evaluate reader improvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be directly answered. The device is described as a "stylet" that "provides the placer rapid feedback." This implies it works with human-in-the-loop (the placer). The document doesn't detail the performance of the "Sherlock 3CG® Tip Confirmation System (TCS)" itself, only the stylet which is an accessory to it. The stylet's function is to provide internal reinforcement and, when used with the TCS, enables the system to provide tip location feedback.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be determined from the text. The document does not specify how the accuracy of the catheter tip location detected by the Sherlock 3CG® TCS (when used with the stylet) was validated or what "ground truth" method was employed for this validation.
8. The sample size for the training set
- Not applicable/Cannot be provided. As this is not an AI/machine learning device in the context of image interpretation or diagnosis (it's a physical medical device accessory), the concept of a "training set" is not relevant in the sense of data used to train an algorithm.
9. How the ground truth for the training set was established
- Not applicable/Cannot be provided. For the same reason as above.
In summary, the provided document is a regulatory submission summary focusing on the equivalence of the device to a predicate based on technological characteristics and general safety/performance testing protocols. It does not contain the detailed study results or acceptance criteria in the requested format.
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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.
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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 (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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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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Device
510(k) Summary 21 CFR 807.92(a)
| Submitter Name:Address: | Bard Access Systems, Inc.605 North 5600 WestSalt Lake City, UT 84116 | |
|---|---|---|
| GeneralProvisions | Contact Person: | Bryan StoneRegulatory Affairs Specialist |
| Telephone Number:Fax Number:Date of Preparation: | (801) 522-5876(801) 522-54258 August 2014 | |
| SubjectDevice | Trade Name:Common Name:Classification Name: | |
| Product Code/Regulation: | LJS/21 CFR §880.5970 | |
| PredicateDevices | Predicate Trade Name: | Sherlock 3CG® Tip Positioning System Stylet,Sherlock 3CG® Tip Positioning System Sensor |
| Classification Name: | Accessory to Percutaneous, Implanted, Long-TermIntravascular Catheter | |
| Premarket Notification:Manufacturer: | K091324Bard 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.
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| Intended Use | The Sherlock 3CG® TPS Stylet provides real time catheter tip locationinformation through the use of passive magnet and cardiac electrical signaldetection. |
|---|---|
| Indications ForUse | Catheter stylets provide internal reinforcement to aid in catheter placement.When used with the Sherlock 3CG® Tip Confirmation System (TCS), theSherlock 3CG® TPS Stylet also provides the placer rapid feedback oncatheter tip location and orientation through the use of passive magnets andcardiac electrical signal detection. |
| TechnologicalCharacteristics | Technological characteristics including design, materials and function of thesubject Sherlock 3CG® TPS Stylet are identical with respect to those of thepredicate Sherlock 3CG® TPS Stylet. The subject device may now be usedwith specific Bard catheters as well as any open-ended, non-valved,polyurethane peripherally inserted central catheter that meets the dimensionalspecifications of the stylet (0.020 in minimum lumen diameter). |
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| Safety &PerformanceTests | Verification and validation tests have been performed in accordance withDesign Controls as per 21 CFR §820.30. The following guidance documentsand standards in conjunction with in-house protocols were used to determineappropriate 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 intravascularcatheters, Part 1. General Requirements /ISO 10555-1:2004Amendment• BS/EN/ISO 10555-3:1997, Sterile, single-use intravascularcatheters, Part 3. Central venous catheters• ISO 594-2: 1998, Conical fittings with a 6% (Luer) taper forsyringes, 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 medicaldevices - First Edition• AAMI/ANSI/ISO 10993-1:2009, Biological Evaluation of MedicalDevices Part 1: Evaluation and Testing, and the FDA Modified ISO10993 Test ProfileThe subject devices met all predetermined acceptance criteria derived fromthe above listed references and demonstrated substantially equivalentperformance as compared to the cited predicate devices.Risk management, including a failure modes and effects analysis (FMEA), ofthe subject device was conducted in accordance with ISO 14971:2012,Medical Devices – Risk Management for Medical Devices. |
|---|---|
| Summary ofSubstantialEquivalence | Based on the intended use, technological characteristics, and safety andperformance testing, the subject Sherlock 3CG® TPS Stylet met therequirements that are considered sufficient for its intended use and is as safeand as effective as predicate devices cited. |
§ 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.”