Turbo-Flo PICC Sets

• K Number: K161496
• Device Name: Turbo-Flo PICC Sets
• Manufacturer: COOK INCORPORATED
• Date Cleared: 2016-10-07 ( 128 days)
• Product Code: LJS CLA LIS
• Regulation Number: 880.5970

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.

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.

Predicate Devices

K041848

Reference Devices

K072625

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard medical device (PICC catheter) and its components. There is no mention of AI, ML, or any related technologies in the intended use, device description, or performance studies.

Therapeutic

Yes
The device is described as "intended for venous pressure monitoring, blood sampling and administration of drugs and fluids," which are therapeutic and diagnostic purposes.

Diagnostic

No
The device is intended for administration of drugs and fluids, blood sampling, and venous pressure monitoring, which are therapeutic and monitoring functions, not diagnostic.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical catheter made of polyurethane and includes various hardware components like introducers, needles, and wire guides.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use clearly states the device is for "venous pressure monitoring, blood sampling and administration of drugs and fluids." These are all procedures performed in vivo (within the living body) for direct patient care.
• Device Description: The description details a catheter designed for insertion into the venous system. This is a medical device used for direct intervention and monitoring within the body.
• Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the living body) to provide information for diagnosis, monitoring, or treatment. IVDs typically involve reagents, test strips, analyzers, or software for analyzing biological samples like blood, urine, or tissue.

Therefore, the Turbo-Flo® Peripherally Inserted Central Venous Catheter (PICC) is a medical device used for direct patient care, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes

LJS

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.

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

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.

Key Metrics

Not Found

Predicate Device(s)

K041848

Reference Device(s)

K072625

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.”

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 [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" (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 [phone] or [phone] 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)

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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 [phone] x104518 [phone] [e-mail]

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:

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.

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
Classification
Name	Percutaneous,
implanted, long-term
intravascular catheter	Identical	Identical
Intended Use/
Indications for
Use	Indicated for short- or
long-term use for
venous pressure
monitoring, blood
sampling,
administration of drugs
and fluids, and for use
with power injectors for
delivery of contrast in
CT studies.
The maximum pressure
setting/limit of power
injectors used with the
Turbo-Flo PICC may
not exceed 300 psi for
the 5 Fr single lumen
and 200 psi for the 4 Fr
single lumen and 5 Fr
double lumen. The
Turbo-Flo PICC is
indicated for a single
injection of contrast
media through a power
injection.	Intended for venous
pressure monitoring,
blood sampling and
administration of drugs
and fluids.	Indicated for short- or
long-term use for
venous pressure
monitoring, blood
sampling,
administration of drugs
and fluids, and for use
with power injectors for
delivery of contrast in
CT studies.
The Turbo-JeCT
PICC is indicated for
multiple injections of
contrast media through
a power injector. The
maximum pressure
limit setting for power
injectors used with the
Turbo-Ject PICC may
not exceed 325 psi and
the flow rate may not
exceed the maximum
flow rate indicated.
Duration of
Use	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 Tyvek
lidstock	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.