(70 days)
Not Found
No
The description focuses on the physical characteristics and materials of a drainage catheter, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended to relieve elevated intracranial pressure or fluid volume, which are therapeutic functions.
No
Explanation: The device is described as a drainage catheter for relieving elevated intracranial pressure or fluid volume, which is a therapeutic function, not a diagnostic one.
No
The device description clearly details physical components such as catheters made of silicone elastomer, radiopaque tips, sideports, and markings, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "externally drain fluid for the purpose of relieving elevated intracranial pressure or fluid volume." This is a therapeutic intervention performed directly on the patient, not a test performed on a sample taken from the patient to provide information about their health status.
- Device Description: The device is a catheter designed to be inserted into the brain's ventricular cavity. This is a medical device used for a procedure, not a reagent, instrument, or system intended for use in vitro.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (like blood, urine, or CSF) in a laboratory setting. There is no mention of assays, reagents, or diagnostic measurements.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to physically drain fluid from the brain, which is a direct treatment or management of a condition, not a diagnostic test.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
NHC
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 closed-end 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ventricular cavity of the brain
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical Testing: There were no device changes, so no additional testing was required to support the determination of substantial equivalence to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement.
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
1
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
2
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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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 Way |
| Bloomington, IN 47404 | |
| Contact Phone Number: | (812) 335-3575 x104518 |
| Contact Fax Number: | (812) 332-0281 |
Device Information
| Trade Name: | VentriClear® Ventricular Drainage Catheter Set
with Cook® Spectrum® Antibiotic Impregnation
VentriClear® II Ventricular Drainage Catheter |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Ventricular Catheter |
| Classification Name: | Catheter, Ventricular (Containing Antibiotic Or
Antimicrobial Agents)
NHC (21 CFR §882.4100) |
| Class: | Class II |
Predicate Devices:
- K011812, Spectrum® Ventricular Catheter .
- K071640, VentriClear® II Ventricular Drainage Catheter Set .
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
4
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.
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.
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® II | |||
| Ventricular Drainage | ||||
| Catheter Set | ||||
| (K071640) | VentriClear® | |||
| Ventricular Drainage | ||||
| Catheter Set with | ||||
| Cook® Spectrum® | ||||
| Antibiotic | ||||
| Impregnation and the | ||||
| VentriClear® II | ||||
| Ventricular Drainage | ||||
| Catheter | ||||
| Regulation Number | 882.4100 | 882.4100 | 882.4100 | |
| Product Code | NHC | NHC | NHC | |
| Classification | Catheter, Ventricular | |||
| (Containing Antibiotic | ||||
| Or Antimicrobial | ||||
| Agents) | Catheter, Ventricular | |||
| (Containing Antibiotic | ||||
| Or Antimicrobial | ||||
| Agents) | Catheter, Ventricular | |||
| (Containing Antibiotic | ||||
| Or Antimicrobial | ||||
| Agents) | ||||
| Indications for Use | 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. | 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. | Identical | |||
| Contraindications | • This device is | |||
| contraindicated in | ||||
| patients having allergy | ||||
| or history of allergy to | ||||
| tetracyclines or | ||||
| rifampin. | ||||
| NOTE: Because the | ||||
| VentriClear Ventricular | ||||
| Drainage Catheter is | ||||
| impregnated with a | ||||
| combination of the | ||||
| antimicrobial agents | ||||
| minocycline (a | ||||
| derivative of | ||||
| tetracycline) and | ||||
| rifampin (a derivative of | ||||
| rifamycin B), their | ||||
| associated | ||||
| contraindications, | ||||
| warnings and | ||||
| precautions (Physician's | ||||
| Desk Reference) should | ||||
| be considered when | ||||
| using this device, | • This device is | |||
| contraindicated in | ||||
| patients having allergy | ||||
| or history of allergy to | ||||
| tetracyclines or | ||||
| rifampin. | ||||
| NOTE: Because the | ||||
| VentriClear Ventricular | ||||
| Drainage Catheter is | ||||
| impregnated with a | ||||
| combination of the | ||||
| antimicrobial agents | ||||
| minocycline (a | ||||
| derivative of | ||||
| tetracycline) and | ||||
| rifampin (a derivative | ||||
| of rifamycin B), their | ||||
| associated | ||||
| contraindications, | ||||
| warnings and | ||||
| precautions (Physician's | ||||
| Desk Reference) should | ||||
| be considered when | ||||
| using this device, | • This device is | |||
| contraindicated in | ||||
| patients having allergy | ||||
| or history of allergy to | ||||
| tetracyclines or | ||||
| rifampin. | ||||
| NOTE: Because the | ||||
| VentriClear Ventricular | ||||
| Drainage Catheter is | ||||
| impregnated with a | ||||
| combination of the | ||||
| antimicrobial agents | ||||
| minocycline (a | ||||
| derivative of | ||||
| tetracycline) and | ||||
| rifampin (a derivative of | ||||
| rifamycin B), their | ||||
| associated | ||||
| contraindications, | ||||
| warnings and | ||||
| precautions (Physician's | ||||
| Desk Reference) should | ||||
| be considered when | ||||
| using this device, | ||||
| PREDICATE DEVICES | PROPOSED DEVICE | |||
| Spectrum® | ||||
| Ventricular Catheter | ||||
| (K011812) | VentriClear® II | |||
| Ventricular Drainage | ||||
| Catheter Set | ||||
| (K071640) | VentriClear® | |||
| Ventricular Drainage | ||||
| Catheter Set with | ||||
| Cook® Spectrum® | ||||
| Antibiotic | ||||
| Impregnation and the | ||||
| VentriClear® II | ||||
| Ventricular Drainage | ||||
| Catheter | ||||
| Contraindications | ||||
| (continued) | although there have | |||
| been no reports of | ||||
| detected systemic levels | ||||
| of minocycline or | ||||
| rifampin in patients | ||||
| receiving a VentriClear | ||||
| Catheter. | although there have | |||
| been no reports of | ||||
| detected systemic levels | ||||
| of minocycline or | ||||
| rifampin in patients | ||||
| receiving a VentriClear | ||||
| Catheter. | although there have | |||
| been no reports of | ||||
| detected systemic levels | ||||
| of minocycline or | ||||
| rifampin in patients | ||||
| receiving a VentriClear | ||||
| Catheter. | ||||
| • [VentriClear catheters | ||||
| / The VentriClear II] are | ||||
| contraindicated for use | ||||
| in 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 |
| Depth | ||||
| Marks | Yes | Yes | Identical | |
| Tip | Radiopaque | Radiopaque | Identical | |
| Antimicro- | ||||
| bial Agents | Minocycline/Rifampin | Minocycline/Rifampin | Identical | |
| Set Components | Pre-loaded stainless | |||
| steel stylet/obturator, | ||||
| stainless steel tunneling | ||||
| trocar with proximal | ||||
| fittings, Luer Lock Plug, | ||||
| Female Luer Lock | ||||
| Adapter, Snap Fit Cap, | ||||
| and Silicone Winged | ||||
| Tie Down | Pre-loaded stainless | |||
| steel stylet/obturator, | ||||
| stainless steel tunneling | ||||
| trocar with proximal | ||||
| fittings, Luer Lock | ||||
| Plug, Female Luer Lock | ||||
| Adapter, Snap Fit Cap, | ||||
| and Silicone Winged | ||||
| Tie 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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Image /page/7/Picture/0 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in white, bold letters on a red background. Below the word "COOK" is the word "MEDICAL" in white, smaller letters on a red background. The red background is a rectangle shape.
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).