Codman BACTISEAL™ Barium Striped Catheters are intended for use in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated.

Device Description

Codman BACTISEAL™ Barium Striped Catheters are manufactured from barium striped silicone which is impregnated with Clindamycin Hydrochloride and Rifampicin. BACTISEAL™ catheters have been shown in laboratory studies to reduce the colonization of gram positive bacteria on the tubing surface.

AI/ML Overview

The provided text describes a 510(k) submission for the Codman BACTISEAL™ Barium Striped Catheters. The substantial equivalence was based on performance and in-vitro testing. It does not contain information about a study that would produce acceptance criteria and device performance in the way described in the prompt (e.g., using a test set, ground truth, expert opinions, or MRMC studies). The provided document is a regulatory submission for substantial equivalence.

Therefore, many of the requested fields cannot be extracted directly from this document.

However, I will extract what is available and indicate when information is not present.

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

Acceptance Criteria	Reported Device Performance
Substantial equivalence to predicate devices (Codman BACTISEAL™ Catheters, Uni-Shunt Catheters with Elliptical Reservoir, CODMAN HAKIM™ Shunt Systems) in intended use, materials, design, and dimensions.	"All test results demonstrated the substantial equivalence of the product to commercially distributed devices for the same intended use."
Reduced colonization of gram positive bacteria on the tubing surface.	"BACTISEAL™ catheters have been shown in laboratory studies to reduce the colonization of gram positive bacteria on the tubing surface."
Performance testing	Results demonstrated substantial equivalence (specific metrics not provided).
In vitro testing	Results demonstrated substantial equivalence (specific metrics not provided).

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

Sample size for test set: Not specified.
Data provenance: Not specified (presumably from laboratory studies, but country and retrospective/prospective status are not mentioned).

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)

Not applicable as this document refers to physical and in-vitro performance testing, not studies requiring expert ground truth in a clinical or diagnostic image analysis context.

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

Not applicable (see point 3).

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. This type of study (MRMC for AI assistance) was not done, as the device is a physical catheter, not an AI diagnostic tool.

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

No. This is not an algorithm, but a physical medical device.

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

For the physical and in-vitro testing, the "ground truth" would be the established performance metrics and specifications for the predicate devices and general standards for medical devices (e.g., material strength, antibacterial efficacy measurements in lab conditions). The document highlights "laboratory studies" for antibacterial properties.

8. The sample size for the training set

Not applicable, as this is not an AI/machine learning device that requires a training set.

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

Not applicable (see point 8).

Summary

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MAY 1 4 2003

EXHIBIT A

KO3/123

510(k) Summary Codman BACTISEAL™ Barium Striped Catheters

Codman & Shurtleff, Inc. 325 Paramount Drive Raynham, MA 02767-0350

Contact Person

Elizabeth Dolan Regulatory Affairs Specialist Telephone Number: (508) 828-3262 Fax Number: (508) 828-3212

Name of Device

Proprietary Name:	Codman BACTISEAL™ Barium Striped Catheters
Common Name:	Hydrocephalus catheters
Classification Name:	Central Nervous System Fluid Shunt and Components

Device Classification

Class II per 21 CFR & 882.5550 - Central nervous system fluid shunt and components (84 JXG)

Statement of Substantial Equivalence

Codman BACTISEAL™ Barium Striped Catheters are substantially equivalent to Codman BACTISEAL™ Catheters, Uni-Shunt Catheters with Elliptical Reservoir. CODMAN HAKIM™ Shunt Systems based on the subject device's similarity to the predicate devices in intended use, materials, design, and dimensions.

Indications for Use

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Physical Description

Device Testing

Substantial equivalence for this device was based upon performance testing and in vitro testing. All test results demonstrated the substantial equivalence of the product to commercially distributed devices for the same intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human figures, represented by simple lines, facing to the right.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 4 2003

Ms. Elizabeth Dolan Regulatory Affairs Specialist Codman & Shurtleff, Inc. 325 Paramount Drive Raynham, Massachusetts 02767-0350

Re: K031123

Trade/Device Name: Codman BACTISEAL™ Barium Striped Catheters Regulation Number: 21 CFR 882.4100 Regulation Name: Ventricular catheter Regulatory Class: II Product Code: HCA Dated: April 7, 2003 Received: April 14, 2003

Dear Ms. Dolan:

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 - Ms. Elizabeth Dolan

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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Muriam C. Provost

(d 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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510(k) Number (if known):

K 031123

Device Name:

Codman BACTISEAL™ Barium Striped Catheters

Indications For Use:

(Please do not write below this line - Continue on another page if necessary) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR §801.109)

Over-the-Counter Use

iriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K031123

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).