Intended 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

Spectrum® VentriClear™ II Ventricular Drainage Catheter Set includes a silicone 2.8 mm (9 Fr.) ventricular catheter available in a 33 cm length with numbered markings and 16 sideports. VentriClear™ II is impregnated with minocycline and rifampin. This device is supplied sterile and is intended for one-time use.

AI/ML Overview

The provided document describes a Special 510(k) Premarket Notification for a medical device (Spectrum® VentriClear™ II Ventricular Drainage Catheter). This type of submission is for modifications to a legally marketed device and primarily focuses on demonstrating substantial equivalence to a predicate device through performance testing. It is not an AI/ML device, and therefore the requested information such as MRMC studies, effect size of human readers with AI assistance, or standalone algorithm performance, and training set details are not applicable to this submission.

Here's a breakdown of the acceptance criteria and study information that is relevant and available in the document:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria with specific threshold values for each test. Instead, it refers to the tests generally assuring "reliable design and performance" and conforming to "requirements necessary for its use." The performance results are described in a qualitative manner.

Acceptance Criteria Category	Reported Device Performance
Material Properties
HPLC testing	Results provide reasonable assurance that the device conforms to requirements.
Tensile testing	Results provide reasonable assurance that the device conforms to requirements.
Biocompatibility	Results provide reasonable assurance that the device conforms to requirements.
Fluid Management
Liquid leakage testing	Results provide reasonable assurance that the device conforms to requirements.
Burst pressure testing	Results provide reasonable assurance that the device conforms to requirements.
Gravity flow rate testing	Results provide reasonable assurance that the device conforms to requirements.

2. Sample size used for the test set and the data provenance

The document does not specify the sample sizes used for any of the described tests (HPLC, Tensile, Liquid Leakage, Burst Pressure, Biocompatibility, Gravity Flow Rate). The data provenance is also not specified, but given that these are physical performance tests of a manufactured medical device, they would typically be conducted in a laboratory setting by the manufacturer (Cook Incorporated) rather than involving human patient data from a specific geographical origin. These tests are prospective in nature, as they are conducted on newly manufactured or modified devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is a physical medical device (catheter), not an AI/ML diagnostic tool requiring expert interpretation for ground truth establishment. The "ground truth" for its performance is determined by physical and chemical testing against engineering specifications and industry standards.

4. Adjudication method for the test set

Not applicable, as ground truth is not established through expert consensus or interpretation. The performance is assessed against predefined physical/chemical standards.

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

Not applicable. This is not an AI-assisted diagnostic device.

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

Not applicable. This is not an AI/ML algorithm.

7. The type of ground truth used

The "ground truth" for the performance of this device is established through:

Engineering Specifications and Standardized Test Methods: Each test (HPLC, Tensile, Leakage, Burst Pressure, Flow Rate, Biocompatibility) would have pre-defined acceptance criteria based on established engineering principles, material science, and relevant industry standards for medical devices of this type.
Predicate Device Performance: The primary method of demonstrating "substantial equivalence" is by showing that the modified device performs comparably to the legally marketed predicate device (Cook Spectrum® Ventricular Drainage Catheter Set - K011812) in terms of these physical and chemical properties.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/ML device that requires a training set.

Summary

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Special 510(k) Premarket Notification: Device Modification Spectrum® VentriClear™ II Ventricular Drainage Catheter Cook Incorporated June 14, 2007

31 -

Ko71640

510(k) Summary

Submitted By:

JUL 1 2 2007

Theodore Heise, Ph.D., RAC Vice President Regulatory Scientific Affairs Cook Incorporated 750 Daniels Way (PO Box 489) Bloomington, IN 47404 (47402) 812-339-2235 June 14, 2007

Device:

Trade Name:

Proposed Classification:

Cook Incorporated Spectrum® VentriClear™ II Ventricular Drainage Catheter Set Catheter, Ventricular (Containing Antibiotic or Antimicrobial Agents) NHC (21 CFR $882.4100)

Indications for Use

The Spectrum® VentriClear™ II Ventricular Drainage Catheter Set is intended 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 device is supplied sterile and is intended for one-time use.

Predicate Devices:

Spectrum® VentriClear™ II Ventricular Drainage Catheter Set is similar in terms of intended use, principles of operation, materials of construction and technological characteristics to the predicate Cook Spectrum® Ventricular Drainage Catheter Set.

Device Description:

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Substantial Equivalence:

The Spectrum® VentriClear™ II Ventricular Drainage Catheter Set is similar to the Cook Incorporated Spectrum® Ventricular Drainage Catheter Set (D.C. # K011812). The similar indications for use, principles of operation, technological characteristics, and performance testing results of VentriClear™ II as compared to the predicate device support a determination of substantial equivalence.

Test Data:

Spectrum® VentriClear™ II Ventricular Drainage Catheter Set was subjected to the following tests to assure reliable design and performance under the specified testing parameters.

1. HPLC testing
1. Tensile testing
Liquid leakage testing 3.
1. Burst pressure testing
న. Biocompatibility
Gravity flow rate testing 6.

The results of these tests provide reasonable assurance that the device conforms to the requirements necessary for its use as a ventricular catheter.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 2 2007

Cooke Incorporated % Theodore Heise, Ph.D., RAC VP, Regulatory Scientific Affairs 750 Daniels Way Bloomington, Indiana 47404

Re: K071640

Trade/Device Name: Spectrum® VentriClear™ II Ventricular Drainage Catheter Set Regulation Number: 21 CFR 882.4100 Regulation Name: Ventricular catheter Regulatory Class: II Product Code: NHC Dated: June 14, 2007 Received: June 15, 2007

Dear Dr. Heise:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2 - Theodore Heise, Ph.D., RAC

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson
Director

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Special 510(k) Premarket Notification: Device Modification Spectrum® VentriClear™ II Ventricular Drainage Catheter Cook Incorporated June 14, 2007

Indications for Use

Kot 164

510(k) Number (if known):

Device Name:

Spectrum® VentriClear™ II Ventricular Drainage Catheter Set.

Indications for Use:

Intended 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.

(Division Sign-Off)

(Division Sign-of-General, Restorative, Division of of of other and Neurological

510(k) Number K671640

Prescription Use XX (Per 21 CFR 801.109)

Over-the-Counter Use

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

-Company Confidential-

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).