The VentriClear® Ventricular Drainage Catheter Set with Cook® Spectrum® Antibiotic Impregnation and the VentriClear® II Ventricular Drainage Catheter have been designed for obtaining access to a ventricular cavity of the brain for short-term use to externally drain fluid for the purpose of relieving elevated intracranial pressure or fluid volume.

Device Description

The VentriClear® Ventricular Drainage Catheter Set with Cook® Spectrum® Antibiotic Impregnation consists of a VentriClear® Ventricular Drainage catheter and other components that are used to facilitate the procedure. The VentriClear® Ventricular Drainage Catheter is a 9 French catheter designed with a radiopaque tip which aids in radiographic recognition and has a closed-end configuration with 16 standard and 16 small sideports. The VentriClear® Ventricular Drainage Catheter has markings at 1 cm increments to aid in determining depth and ease of placement and is 33 cm in length. The VentriClear® Ventricular Drainage Catheter consists of silicone elastomer impregnated with the antimicrobial agents minocycline and rifampin.

The VentriClear® II Ventricular Drainage Catheter consists of a VentriClear® II Ventricular Drainage catheter and other components that are used to facilitate the procedure. The VentriClear® II Ventricular Drainage Catheter is a 9 French catheter designed with a radiopaque tip which aids in radiographic recognition and has a closedend configuration with 16 sideports. The VentriClear® II Ventricular Drainage Catheter has markings at 1 cm increments, starting at the 3 cm mark and extending to 33 cm, to aid in determining depth and ease of placement and is 33 cm in length. The VentriClear® II Ventricular Drainage Catheter consists of silicone elastomer impregnated with the antimicrobial agents minocycline and rifampin.

AI/ML Overview

The provided text describes Cook Incorporated's VentriClear Ventricular Drainage Catheter Set with Cook Spectrum Antibiotic Impregnation and VentriClear II Ventricular Drainage Catheter. This document is a 510(k) premarket notification to the FDA, asserting substantial equivalence to previously marketed predicate devices.

However, this document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of device performance metrics such as sensitivity, specificity, accuracy, or any other quantifiable performance indicators.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices (Spectrum® Ventricular Catheter K011812 and VentriClear® II Ventricular Drainage Catheter Set K071640) by comparing device characteristics and indications for use. The only difference noted is the addition of a contraindication for use in pregnant women for both the VentriClear and VentriClear II catheters.

Therefore, I cannot provide the requested information in the format of a table of acceptance criteria and reported device performance, nor can I elaborate on sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as this type of information is not present in the provided text.

The document explicitly states under "Nonclinical Testing": "There were no device changes, so no additional testing was required to support the determination of substantial equivalence to the predicate devices." This further confirms that a new performance study to establish acceptance criteria was not conducted or reported in this submission.

Summary

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

April 8, 2016

Cook Incorporated Mr. Steven Lawrie, MS, MA, RAC Regulatory Affairs Specialist 750 Daniels Way Bloomington, IN 47404

Re: K160223

Trade/Device Name: VentriClear Ventricular Drainage Catheter Set with Cook Spectrum Antibiotic Impregnation and VentriClear II Ventricular Drainage Catheter Regulation Number: 21 CFR 882.4100 Regulation Name: Ventricular Catheter Regulatory Class: Class II Product Code: NHC Dated: March 9, 2016 Received: March 10, 2016

Dear Mr. Steven 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.

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

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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,

Carlos L. Pena -5D/Δ

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K160223

Device Name

VentriClear Ventricular Drainage Catheter Set with Cook Spectrum Antibiotic Impregnation VentriClear II Ventricular Drainage Catheter

Indications for Use (Describe)

The VentriClear Ventricular Drainage Catheter Set with Cook Spectrum Antibiotic Impregnation and the VentriClear II Ventricular Drainage Catheter have been designed for obtaining access to a ventricular cavity of the brain for short-term use to externally drain fluid for the purpose of relieving elevated intracranial pressure or fluid volume.

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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Image /page/3/Picture/14 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in large, white, sans-serif font on a red background. Below the word "COOK" is the word "MEDICAL" in a smaller, white, sans-serif font on a red background.

COOK INCORPORATED 750 DANIELS WAY BLOOMINGTON, IN 47404 USA 812.339.2235 TOLL BREE 800.457.4500 WWW.COOKMEDICAL.COM

510(k) Summary

VentriClear® Ventricular Drainage Catheter Set with Cook® Spectrum® Antibiotic Impregnation VentriClear® II Ventricular Drainage Catheter 21 CFR §882.4100 Date Prepared: February 23, 2016

Submitted By:

Applicant:	Cook Incorporated
Contact:	Steven Lawrie
Applicant Address:	750 Daniels WayBloomington, IN 47404
Contact Phone Number:	(812) 335-3575 x104518
Contact Fax Number:	(812) 332-0281

Device Information

Trade Name:	VentriClear® Ventricular Drainage Catheter Setwith Cook® Spectrum® Antibiotic ImpregnationVentriClear® II Ventricular Drainage Catheter
Common Name:	Ventricular Catheter
Classification Name:	Catheter, Ventricular (Containing Antibiotic OrAntimicrobial Agents)NHC (21 CFR §882.4100)
Class:	Class II

Predicate Devices:

K011812, Spectrum® Ventricular Catheter .
K071640, VentriClear® II Ventricular Drainage Catheter Set .

Device Description:

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Image /page/4/Picture/0 description: The image shows the Cook Medical logo. The word "COOK" is in white, sans-serif font on a red background. Below the word "COOK" is the word "MEDICAL" in white, sans-serif font on a red background.

increments to aid in determining depth and ease of placement and is 33 cm in length. The VentriClear® Ventricular Drainage Catheter consists of silicone elastomer impregnated with the antimicrobial agents minocycline and rifampin.

Indications for Use:

The VentriClear® Ventricular Drainage Catheter Set with Cook® Spectrum® Antibiotic Impregnation and the Ventriclear® II Ventricular Drainage Catheter have been designed for obtaining access to a ventricular cavity of the brain for short-term use to externally drain fluid for the purpose of relieving elevated intracranial pressure or fluid volume.

The indications for use are same as the predicate devices, the Spectrum® Ventricular Catheter (K011812) and the VentriClear® II Ventricular Drainage Catheter Set (K071640).

Comparison to Predicate:

The VentriClear® Ventricular Drainage Catheter Set with Cook® Spectrum® Antibiotic Impregnation and the VentriClear® II Ventricular Drainage Catheter are identical to the predicate devices, the Spectrum® Ventricular Catheter (K011812) and the VentriClear® II Ventricular Drainage Catheter Set (K071640), with the exception of the addition of a contraindication. The following contraindication is added to the IFU for the VentriClear Ventricular Drainage Catheter Set:

"VentriClear catheters are contraindicated for use in pregnant women."

Additionally, the following contraindication is added to the IFU for the VentriClear® II Ventricular Drainage Catheter:

"The VentriClear II is contraindicated for use in pregnant women."

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Table 1 below provides a detailed comparison of the subject and predicate devices.

Table 1: Comparison Table

	PREDICATE DEVICES	PROPOSED DEVICE
	Spectrum®Ventricular Catheter(K011812)	VentriClear® IIVentricular DrainageCatheter Set(K071640)	VentriClear®Ventricular DrainageCatheter Set withCook® Spectrum®AntibioticImpregnation and theVentriClear® IIVentricular DrainageCatheter
Regulation Number	882.4100	882.4100	882.4100
Product Code	NHC	NHC	NHC
Classification	Catheter, Ventricular(Containing AntibioticOr AntimicrobialAgents)	Catheter, Ventricular(Containing AntibioticOr AntimicrobialAgents)	Catheter, Ventricular(Containing AntibioticOr AntimicrobialAgents)
Indications for Use	For obtaining access toa ventricular cavity ofthe brain for short-termuse to externally drainfluid for the purpose ofrelieving elevatedintracranial pressure orfluid volume.	For obtaining access toa ventricular cavity ofthe brain for short-termuse to externally drainfluid for the purpose ofrelieving elevatedintracranial pressure orfluid volume.	Identical
Contraindications	• This device iscontraindicated inpatients having allergyor history of allergy totetracyclines orrifampin.NOTE: Because theVentriClear VentricularDrainage Catheter isimpregnated with acombination of theantimicrobial agentsminocycline (aderivative oftetracycline) andrifampin (a derivative ofrifamycin B), theirassociatedcontraindications,warnings andprecautions (Physician'sDesk Reference) shouldbe considered whenusing this device,	• This device iscontraindicated inpatients having allergyor history of allergy totetracyclines orrifampin.NOTE: Because theVentriClear VentricularDrainage Catheter isimpregnated with acombination of theantimicrobial agentsminocycline (aderivative oftetracycline) andrifampin (a derivativeof rifamycin B), theirassociatedcontraindications,warnings andprecautions (Physician'sDesk Reference) shouldbe considered whenusing this device,	• This device iscontraindicated inpatients having allergyor history of allergy totetracyclines orrifampin.NOTE: Because theVentriClear VentricularDrainage Catheter isimpregnated with acombination of theantimicrobial agentsminocycline (aderivative oftetracycline) andrifampin (a derivative ofrifamycin B), theirassociatedcontraindications,warnings andprecautions (Physician'sDesk Reference) shouldbe considered whenusing this device,
		PREDICATE DEVICES		PROPOSED DEVICE
		Spectrum®Ventricular Catheter(K011812)	VentriClear® IIVentricular DrainageCatheter Set(K071640)	VentriClear®Ventricular DrainageCatheter Set withCook® Spectrum®AntibioticImpregnation and theVentriClear® IIVentricular DrainageCatheter
Contraindications(continued)		although there havebeen no reports ofdetected systemic levelsof minocycline orrifampin in patientsreceiving a VentriClearCatheter.	although there havebeen no reports ofdetected systemic levelsof minocycline orrifampin in patientsreceiving a VentriClearCatheter.	although there havebeen no reports ofdetected systemic levelsof minocycline orrifampin in patientsreceiving a VentriClearCatheter.• [VentriClear catheters/ The VentriClear II] arecontraindicated for usein pregnant women.
	Material	Silicone	Silicone	Identical
	Size	9 Fr	9 Fr	Identical
	Length	33 cm	33 cm	Identical
	Sideports	32	16	32 (VentriClear), 16(VentriClear II)
Catheter	End-hole	Closed	Closed	Identical
	DepthMarks	Yes	Yes	Identical
	Tip	Radiopaque	Radiopaque	Identical
	Antimicro-bial Agents	Minocycline/Rifampin	Minocycline/Rifampin	Identical
Set Components		Pre-loaded stainlesssteel stylet/obturator,stainless steel tunnelingtrocar with proximalfittings, Luer Lock Plug,Female Luer LockAdapter, Snap Fit Cap,and Silicone WingedTie Down	Pre-loaded stainlesssteel stylet/obturator,stainless steel tunnelingtrocar with proximalfittings, Luer LockPlug, Female Luer LockAdapter, Snap Fit Cap,and Silicone WingedTie Down	Identical
Packaging		Tyvek/polyester pouch	Tyvek/polyester pouch	Identical
Sterilization		EtO	EtO	Identical
Shelf Life		2 years	2 years	Identical

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Image /page/6/Picture/0 description: The image shows the logo for Cook Medical. The word "COOK" is in large, white, sans-serif letters. Below the word "COOK" is the word "MEDICAL" in smaller, white, sans-serif letters on a red background.

COOK INCORPORATED 750 DANIELS WAY BLOOMINGTON, IN 47404 USA PHONE: 812.339.2235 TOLL PREE: 800.457.4500 WWW.COOKMEDICAL.COM

Table 1: Comparison Table (continued)

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COOK INCORPORATED 750 DANIELS WAY BLOOMINGTON, IN 47404 USA HONE: 812.339.2235 TOLL FREE 800.457.4500 WWW.COOKMEDICAL.COM

Nonclinical Testing:

There were no device changes, so no additional testing was required to support the determination of substantial equivalence to the predicate devices.

Conclusion:

The subject devices are substantially equivalent to the predicate devices, the Spectrum® Ventricular Catheter (K011812) and the VentriClear® II Ventricular Drainage Catheter Set (K071640).

Regulation Number and Section

§ 882.4100 Ventricular catheter.

(a)
Identification. A ventricular catheter is a device used to gain access to the cavities of the brain for injection of material into, or removal of material from, the brain.(b)
Classification. Class II (performance standards).