Turbo-Flo® Peripherally Inserted Central Venous Catheter (PICC) Sets and Trays are intended for venous pressure monitoring, blood sampling and administration of drugs and fluids.

Device Description

The 4 and 5 Fr Turbo-Flo® PICC Sets with single or double lumen configurations are radiopaque polyurethane peripherally inserted central venous catheters for short- or long-term use, and can be inserted over-the-wire or through a Peel-Away® introducer. The set components may include the PICC, obturator, Peel-Away® introducer, entry needles, wire guide, and other convenience components. The set is supplied sterile and is intended for one-time use.

AI/ML Overview

This document describes a 510(k) premarket notification for the Cook Incorporated Turbo-Flo® PICC Sets. The submission aims to demonstrate substantial equivalence to a predicate device (Turbo-Flo® PICC, K041849). It's important to note that the document explicitly states no performance testing was required or conducted for this specific submission because the modifications were deemed minor. Therefore, there are no acceptance criteria or study results demonstrating performance to those criteria for this specific device in this document.

However, based on the provided text, I can infer the context and provide a table reflecting the changes made and the justification for not requiring new performance criteria/studies.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
PICC Catheter Shaft Depth Marking Ink (Visual Readability, Durability)	The new ink (Imaje #5135E black ink) is utilized in Cook Turbo-JeCT® PICC catheters (K072625), which are also manufactured with polyurethane tubing and undergo the same manufacturing and sterilization processes. No new testing was warranted.
Removal of Power Injection Indication (Safety/Effectiveness Implications)	The removal of the power injection indication, an add-on feature, raises no new questions of safety or effectiveness. No new testing was required.
Overall Substantial Equivalence to Predicate Device (Safety and Effectiveness)	The subject device does not raise new questions of safety or effectiveness compared to the predicate device due to the minor modifications.

Explanation: The document does not list explicit quantitative acceptance criteria or corresponding measurement results for the Turbo-Flo® PICC Sets. Instead, it relies on the argument of "substantial equivalence" to a previously cleared predicate device. The changes made (ink type and removal of power injection indication) were considered minor and adequately addressed by previous clearances or by their nature not to introduce new safety or effectiveness concerns.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable. No dedicated performance or clinical testing was conducted for this submission. The rationale for substantial equivalence explicitly states "no testing is warranted" and "no performance testing is required for this submission."
Data Provenance: Not applicable. As no new testing was performed, there is no new test set data. The justification for substantial equivalence relies on the characteristics of the previously cleared predicate device (Turbo-Flo® PICC K041849) and reference device (Turbo-JeCT PICC K072625).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Number of Experts: Not applicable. No new test set requiring expert ground truth establishment was conducted for this submission.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. No new test set requiring adjudication was conducted for this submission.

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

MRMC Study: Not applicable. This device is a physical medical device (catheter), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance is irrelevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Standalone Performance: Not applicable. This is a physical medical device, not a standalone algorithm.

7. The Type of Ground Truth Used

Type of Ground Truth: Not applicable for new testing in this submission. The "ground truth" for the device's safety and effectiveness relies on the prior extensive testing and regulatory clearance of the predicate device (Turbo-Flo® PICC K041849) and the reference device (Turbo-JeCT PICC K072625). For the changes specifically, the ground truth is essentially the established performance of the new ink in the reference device and the inherent safety evaluation of removing a feature.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This is a physical medical device, not an AI/machine learning model that requires a training set.

9. How the Ground Truth for the Training Set was Established

Ground Truth for Training Set: Not applicable. As above, this is a physical medical device, not an AI/machine learning model.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 7, 2016

Cook Incorporated Mr. Steven Lawrie Regulatory Affairs Manager 750 Daniels Way Bloomington, Indiana 47404

Re: K161496

Trade/Device Name: Turbo-Flo® PICC Sets Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: July 11, 2016 Received: July 12, 2016

Dear Mr. Lawrie:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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" (21 CFR 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,

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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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Indications for Use

510(k) Number (if known) K161496

Device Name Turbo-Flo® PICC Sets

Indications for Use (Describe)

Turbo-Flo Peripherally Inserted Central Venous Catheter (PICC) Sets and Trays are intended for venous pressure monitoring, blood sampling and administration of drugs and fluids.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) SUMMARY

K161496 Turbo-Flo® PICC Sets 21 CFR § 807.92 Date Prepared: October 5, 2016

Submitted By:

Submission: Applicant: Contact: Applicant Address:

Contact Phone Number: Contact Fax Number: Email:

Device Information:

Trade Name: Common Name: Regulation Number: Regulation Name: Regulatory Class: Product Code: Classification Panel:

Predicate Device:

Trade Name: 510(k) Number: Common Name: Regulation Number: Regulation Name: Regulatory Class: Product Code: Classification Panel:

Reference Device:

Trade Name: 510(k) Number: Common Name: Regulation Number: Regulation Name: Regulatory Class:

Traditional 510(k) Premarket Notification Cook Incorporated Steven Lawrie Cook Incorporated 750 Daniels Way Bloomington, IN 47404 (812) 335-3575 x104518 (812) 332-0281 RegSubmissions@CookMedical.com

Turbo-Flo® PICC Sets

Catheter, intravascular, therapeutic, long-term greater than 30 days 21 CFR §880.5970 Percutaneous, implanted, long-term intravascular catheter Class II ris General Hospital

Turbo-Flo® PICC

K041848 Catheter, intravascular, therapeutic, long-term greater than 30 days 21 CFR §880.5970 Percutaneous, implanted, long-term intravascular catheter Class II LIS General Hospital

Turbo-JeCT PICC

K072625 Catheter, intravascular, therapeutic, long-term greater than 30 days 21 CFR §880.5970 Percutaneous, implanted, long-term intravascular catheter Class II

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Product Code: LIS Classification Panel: General Hospital

Purpose of the Submission:

Cook is submitting this premarket notification to obtain FDA's determination that the Turbo-Flo® PICC Sets are substantially equivalent to the Turbo-Flo® PICC cleared under K041849. The modifications of the subject device as compared to the predicate include changing the depth marking ink printed on the Turbo-Flo® PICC catheter shaft and the removal of the power injection indication.

Device Description:

Intended Use:

Turbo-Flo® Peripherally Inserted Central Venous Catheter (PICC) Sets and Trays are intended for venous pressure monitoring, blood sampling and administration of drugs and fluids.

Comparison to Predicate Device:

Turbo-Flo® PICC Sets and the predicate device, the Turbo-Flo® PICC (K041849), are substantially equivalent in that these devices have the same design, intended use, technological characteristics, method of placement, and included accessories. Both devices are intended for short- or long-term use for venous pressure monitoring, blood sampling, and administration of drugs and fluids.

The modifications of the subject device as compared to the predicate include changing the depth marking ink printed on the Turbo-Flo® PICC catheter shaft and the removal of the power injection indication, as shown in the following comparison table.

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	Predicate Device	Subject Device	Reference Device
	Turbo-Flo PICC(K041849)	Turbo-Flo PICC	Turbo-JeCT PICC(K072625)
Manufacturer	Cook Incorporated	Cook Incorporated	Cook Incorporated
Regulation	21 CFR §880.5970	Identical	Identical
Class	Class II	Identical	Identical
Product Code	LJS	Identical	Identical
ClassificationName	Percutaneous,implanted, long-termintravascular catheter	Identical	Identical
Intended Use/Indications forUse	Indicated for short- orlong-term use forvenous pressuremonitoring, bloodsampling,administration of drugsand fluids, and for usewith power injectors fordelivery of contrast inCT studies.The maximum pressuresetting/limit of powerinjectors used with theTurbo-Flo PICC maynot exceed 300 psi forthe 5 Fr single lumenand 200 psi for the 4 Frsingle lumen and 5 Frdouble lumen. TheTurbo-Flo PICC isindicated for a singleinjection of contrastmedia through a powerinjection.	Intended for venouspressure monitoring,blood sampling andadministration of drugsand fluids.	Indicated for short- orlong-term use forvenous pressuremonitoring, bloodsampling,administration of drugsand fluids, and for usewith power injectors fordelivery of contrast inCT studies.The Turbo-JeCTPICC is indicated formultiple injections ofcontrast media througha power injector. Themaximum pressurelimit setting for powerinjectors used with theTurbo-Ject PICC maynot exceed 325 psi andthe flow rate may notexceed the maximumflow rate indicated.
Duration ofUse	Short-term or long-term	Identical	Identical
French Size	4, 5	Identical	Identical
Length (cm)	60	Identical	Identical
# of Lumens	Single or Double	Identical	Identical
Shaft Material	Polyurethane	Identical	Identical
Depth	5 cm increments,	1 cm increments,	1 cm increments,
Marking	Imaje #5101 black ink	Imaje #5135E black ink	Imaje #5135E black ink
Sterilization	EtO, SAL 106	Identical	Identical
Shelf Life	3 years	Identical	Identical
Packaging	Tray with Tyveklidstock	Identical	Identical

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Performance Data:

As the ink printed on the subject device is utilized in Cook Turbo-JeCT® PICC catheters (K072625) which are also manufactured with polyurethane tubing and undergo the same manufacturing (including ink printing process) and sterilization processes, no testing is warranted for the minor modification on the subject device. In addition, the removal of the power injection, an add-on feature, raises no new questions of safety or effectiveness. Therefore, no performance testing is required for this submission.

Conclusion:

The subject device does not raise new questions of safety or effectiveness compared to the predicate device. This supports a determination of substantial equivalence.

Regulation Number and Section

§ 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.”