The SPECTRUM® Ventricular Catheter 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 will be supplied sterile and is intended for one-time use.

Device Description

The SPECTRUM® Ventricular Catheter is a 9 Fr catheter nominally 33 cm in length. The catheter has a closed-end configuration with nominally 16 sideports, and has markings at 1 cm increments to aid in determining depth of placement. The SPECTRUM® Ventricular Catheter is impregnated with an antimicrobial combination of minocycline and rifampin which may reduce the risk of catheter related infection during use. Based on HPCC analysis, the average amount of minocycline on the catheter is approximately 5 mg (159 Φg/cm), and the average amount of rifampin on the catheter is approximately 4 mg (116 @g/cm). Components supplied with the SPECTRUM® Ventricular Catheter include a pre-loaded stainless steel stylet, a stainless steel tunneling trocar, and proximal fittings, which are included to facilitate placement and use of the Ventricular Catheter.

AI/ML Overview

The SPECTRUM® Ventricular Catheter is a medical device intended for short-term external drainage of fluid from the ventricular cavity of the brain to relieve elevated intracranial pressure or fluid volume. The information provided outlines the device's characteristics, intended use, and the studies conducted to demonstrate its substantial equivalence to predicate devices and ensure its safety and efficacy.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The provided text does not explicitly state numerical acceptance criteria in a typical "Pass/Fail" format. Instead, it describes various tests and a clinical study designed to demonstrate that the SPECTRUM® Ventricular Catheter performs as intended and is as safe and effective as predicate devices. The "reported device performance" is essentially the successful completion of these tests and the favorable outcomes of the clinical study.

Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility	Successfully passed Dermal Sensitization, Cytotoxicity, 7 Day Muscle Implantation with Histopathology, Intracutaneous Toxicity, Systemic Toxicity, Hemolysis, Genotoxicity, and a Two Week Brain Implantation Study.
Physical Performance	Successfully passed physical performance testing.
Antimicrobial Efficacy	Successfully passed HPLC analysis, zone of inhibition testing, and susceptibility testing.
Clinical Efficacy (Reduced Catheter-related Infection)	In a clinical study, the SPECTRUM® Ventricular Catheter group showed a significantly lower incidence of catheter-related infection (1.3%) compared to the standard non-coated catheter group (6.8%) (p<0.05).
Substantial Equivalence	Found to be substantially equivalent to predicate ventricular catheters in terms of intended use, materials, and physical construction. Test results provide reasonable assurance of device performance for its intended use.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size for Clinical Study:
- SPECTRUM® Ventricular Catheter group: 149 patients were followed up.
- Standard non-coated catheter group (control): 139 patients were followed up.
Data Provenance: The clinical study was described as a "prospective, randomized, multicenter clinical trial." The country of origin is not explicitly stated, but the submission is to the U.S. FDA, implying the study was conducted under appropriate regulatory guidelines, likely within the U.S. or internationally with standards acceptable to the FDA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

The document does not specify the number of experts or their qualifications for establishing the ground truth related to the clinical study's outcome (catheter-related infection). The "ground truth" for infection would typically be established by clinical diagnosis, laboratory tests, and potentially microbiological culture results, which would be interpreted by healthcare professionals (physicians, microbiologists). There is no mention of an independent panel of experts reviewing cases in the context of adjudication for ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

The document does not describe a specific adjudication method (like 2+1 or 3+1) for the clinical study's outcomes. Clinical study endpoints, such as catheter-related infection, are typically diagnosed by treating physicians and confirmed by laboratory results, rather than relying on an adjudication panel in the context of device performance claims unless there's a specific nuanced diagnostic challenge. It's presumed that the diagnoses were made by the clinical staff involved in the multicenter trial.

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

No MRMC comparative effectiveness study was done as this device is a physical medical device (catheter), not an AI-powered diagnostic or assistive technology. Therefore, the concept of human readers improving with AI assistance is not applicable here.

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

This question is not applicable. The SPECTRUM® Ventricular Catheter is a physical medical device, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the clinical study, the ground truth was based on outcomes data, specifically the "incidence of catheter-related infection." This would involve clinical diagnosis of infection, potentially supported by laboratory findings (e.g., cerebrospinal fluid analysis, culture results), and clinical follow-up of patients.

For the other non-clinical tests (biocompatibility, physical performance, antimicrobial efficacy), the ground truth was based on established laboratory and test standards defined for each specific test (e.g., ASTM standards for physical tests, ISO standards for biocompatibility, specific microbiological testing protocols).

8. The sample size for the training set

This question is not applicable. This is a physical medical device, not a machine learning model, so there is no concept of a "training set."

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

This question is not applicable for the same reason as point 8.

Summary

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SPECTRUM® Ventricular Catheter - 510(k) Premarket Notification November 1, 2001

NOV 0 82001

510(K) SUMMARY 9

Merry Lee Bain Merry Lee Bain
Vice President/Director Regulatory Affairs & Clinical Services Cook Incorporated 925 South Curry Pike Bloomington, Indiana, 47402 (812) 339-2235

Trade Name: Common/Usual Name: Proposed Classification: SPECTRUM® Ventricular Catheter SPECTRUM - Ventheter, External Drainage Catheter Ventricular Catheter, External Shunt and Components 21 CFR Part 882.5550 (84JXG) Class II

The SPECTRUM® Ventricular Catheter is intended for obtaining access to a ventricular The SPECTRUM" Ventricular Cather is mielled for the puid first the pulpose of relieving
cavity of the brain for short-terra use to externally drain for the public sterile and cavity of the brain for short-term use to externally dram had bor will be supplied sterile and is
elevated intracranial pressure or fluid volume. The device will be supplied intended for one-time use.

intended for one-time use.
The SPECTRUM® Ventricular Catheter is comparable in terms of intended use and The SPECTRUM® Ventricular Catilete Ventricular catheters, including Cook
technological characteristics to predicate Ventricular catheters, including Cook 110 5 = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = Incorporated's Ventricular Catheter and the Cook SPECTRUM //ABRM Catheter for SPECTRUM® Silicone Foley Catheter and the Cook of CCTRON Problem of the Security of Component
intravascular use, the SPECTRUM® Venticious and rifempin intravascular use, the SF BCTROIA - and rifampin.

The SPECTRUM® Ventricular Catheter is a 9 Fr catheter nominally 33 cm in length.
16 sidenticular Cather stime with neminally 16 sidenors, and has The SPECTRUM® Ventricular Catherer is a 711 cansonally 16 sideports, and has
The catheter has a closed-end configuration with admin of placement. The The catheter has a closed-end contriguration was notest of placement. The markings at 1 cm increments to and in determing depth of provincial combination of
SPECTRUM® Ventricular Catheter is impregnated with an antimicrobial of SPECTRUM® Ventricular Catherer is impreglated with artuated infection during
minocycline and rifampin which may reduce the risk of eatheter is minocycline and rifampin which inay reduce are minocycline on the catheter is use. Based on HPCC analysis, the average amount of ifamino of tifampin on the catheter is
approximately 5 mg (159 Φg/cm), and the average amount of the SPECTRUM® approximately 4 mg (116 @g/cm), and alcaretes supplied with the SPECTRUM®
approximately 4 mg (116 @g/cm). I components supplied with the SPECTRUM approximately 4 mg (116 @g/cm). Components steel stylet, a stainless steel tumneling
Ventricular Catheter include a pre-loaded stainless steel tunneling Ventricular Catheter include a pre-loaded stailitess steel by rough bear
trocar, and proximal fittings, which are included to facilitate placement and use of the Ventricular Catheter.

Koll812

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SPECTRUM® Ventricular Catheter - 510(k) Premarket Notification November 1, 2001

The SPECTRUM® Ventricular Catheter is similar with respect to indications for use,
10(k) The SPECTRUM" Ventricular Catheter is summar with simply of section 510(k)
materials and physical construction to predicate devices in terms of section 510(k) materials and physical construction to predicate usevices in retime equivalence.
substantial equivalency, and has undergone testing to support substantial equivalence. substantial equivalent determination under the Federal Food, Drug, and Cosmetic
The substantially equivalent determination under the Federal Food, Drug, and Cosmetic The substantially equivalent determination under une i second and the substant and intended to have and Act IS not intended in other patent matters.

The device will be manufactured according to specified process controls, undergoing The device will be manufactured according to specifical process consembly of the good of the processing, stermization and putching. Of Cook Incorporated.

The SPECTRUM® Ventricular Catheter has undergone biocompatibility testing (Dermal
) in the may of Bear Mass begal from with Histopathology, The SPECTRUM® Venticity, 7 Day Muscle Implantation with Histopathology,
Sensitization, Cytotoxicity, 7 Day Muscles, Genotoxicity, and a T Sensitization, Cytotoxicity, 7 Day Muscle Inplaniansis, Genotoxicity, and a Two Week
Intracutaneous Toxicity, Systemic Toxicity, Hemolysis, Genotoxicity, and a Two of Intracutaneous Toxicity, Systems Toxical performance testing, HPLC analysis, zone of
Brain Implantation Study), physical performance testing, Results of this tes Brain Implantation Study), physical performatice evaluation. Results of this testing
inhibition testing, susceptibility testing, and clinical evaluation. Results of this te inhibition testing, susceptibility testing, and emiled of the intended use.
provide reasonable assurance of device performance for its intended use.

Clinical Study

Clinical Study
To evaluate efficacy of the Cook SPECTRUM® Ventricular Catherer clinical To evaluate efficacy of the Cook SPEC I RUM - Vennondized, multicenter clinical
incidence of catheter-related infection, a prollective, and randomized, multicented to receive incidence of catheter-related intection, a prospective, and randomly assigned to receive
trial was conducted in which patients were enrolled and randomly or a 9 Fr Co trial was conducted in which patients were enrouled alle ransonary of a 9 Fr Cook
either a standard non-coated 9 Fr Cook Venticular Catherts available for either a standard non-coated 9 FF Cook Ventricular Cather (288 patients available for SPECTRUM® Ventricular Cathere (readleth). "Or atterer and 139 patients received
follow-up, 149 received the SPECTRUM® venthere placement was 8 ± 5,8 days in follow-up, 149 received the SPEC I KOive of catherer placement was 8.5 ± 5.8 days in
the control catheter. The average duration of catheren was 8.5 ± 5.8 days in the control cathere. The average duration of cantect proven. Results showed that patients
the treatment group, and 8.2 ± 6.9 days in the control group. Results showed that pa the treatment group, and 8.2 ± 6.9 days in the control groups and receiving the SPECTRUM * Ventricular Catheter had sighthoundy of ************************************************************************************************************* respectively).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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-like symbol with three curved lines representing the body and wings. The symbol is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 0 82001

Ms. April Lavender, RAC Vice President, Regulatory Affairs Cook, Inc. 925 South Curry Pike P.O. Box 489 Bloomington, Indiana 47402

Re: K011812

: K011812
Trade/Device Name: SPECTRUM® Vectricular Catheter FraderDon Number: 21 CFR 882.4100 Regulation Name: Ventricular Catheter Regulatory Class: Class II Product Code: NHC Dated: September 5, 2001 Received: September 10, 2001

Dear Ms. Lavender:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section > IQK premaise is substantially equivalent (for the indications
referenced above and have determined the device is substanted in interstate referenced above and have decimined the nevice to redicate devices marketed in interstate
for use stated in the enclosure) to legally marketed produce Amendments, for use stated in the enclosure) to the enactment date of the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug, commerce prior to May 28, 1976, the enactiven use of the Federal Food, Drug, devices that have been reclassified in accordance with as proval application (PMA).
and Cosmetic Act (Act) that do not require approval control control sonovisions of the Act and Cosmetic Act (Act) that do not require approval on the general controls por isions of the Act. The
You may, therefore, market the device, subject to the general control You may, therefore, market the device, subject of the genting for annual registration, listing of
general controls provisions of the Act include requirements misbranding and general controls provisions of the Act mender requirements seems of the one of the adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) mito entire) and to regular one affecting your device can
may be subject to such additional controls. Existing major regulations aff may be subject to such additional controls: Existing major regals o 898. In addion, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. be found in the Code of Federal Regulations, This DV, Children

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA's issuance of a substantial other requirements of the Act
that FDA has made a determination that your device complies with other requirements Yo that FDA has made a determination inal your dereces by other Federal agencies. You must
or any Federal statutes and regulations administered by other to: registration and li or any Federal statutes and regulations and limited to: registration and listing (21
comply with all the Act's requirements, including, but limited to: reguirements as set comply with all the Act 5 tequirements, including on intecturing matice requirements as set
CFR Part 807); labeling (2) CFR Part 801); good manufacturing practice requirement CFR Part 807); labeling (21 CFR Parl ovi ); good manutetan:) gtd. if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and 1050. forth in the quality systems (QS) regulation (21 -51 R Parveller) - 1 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. April Lavender, RAC

This letter will allow you to begin marketing your device as described in your Section 510(k)
The articles of the RD A. First Finding of substantial equivalence of your devic This letter will allow you to begin marketing your device of your device of your device of your device to a legally
premarket notification. The in a cleasification for your d Premarket notification. The FDA finding of substantial equivalence of 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 and If you desire specific advice for your device on our labelling regulation of the Office of
additionally 21 CFR Part 1150 - Additionally, for questions on the promotion and ad additionally 21 CFR Part 809.10 for in xitten devices), promotions on the promotion of a Compliance at (301) 594-4659. Additionally, for questions of Compliance of College of College of College your device, please contact the Office of Complaatics and fiestion" (21CFR Part 807.97).
regulation entitled, "Misbranding by reference to premaitet morification it a regulation entitled, "Misbranding by responsibilities under the Act may be obtained from the Other general information on your responsionities and Consumer Assistance at its toll-free number
Division of Small Manufacturers, International and Consumer Assistance at it Division of Small Manufacturers, Inc at its Internet address
(800) 638-2041 or (301) 443-6597 or at its Internet an . ht (800) 638-2041 or (301) 445-0597 or at its manam. html

Sincerely yours,

Mark N Millman

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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NOV 0 8 2001

510(k) Number (if known): K01XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX

K.011 812

Device Name: _SPECTRUM® Ventricular Catheter

Indications For Use:

The SPECTRUM® Ventricular Catheter is intended for l he SPECTHolm "None" ventricular cavity of the brain for
obtaining access to a ventricular cavity of the purpose of obtaining access to a von
short-term use to externally drain fluid for the purpose of short-term use to oxtomally
relieving elevated intracranial pressure or fluid volume. The relieving elevated intracturing intended for one-time
device will be supplied sterile and is intended for one-time use.

(Please do not write below this line - continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Walker

(Division Sign-on)
Division of General, Restorative Division of General Devices

510(k) Number -

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use_

11812

(Optional Format 1-2-96

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).