Used for remote afterloading of a radiation source. To be used with the Varian VariSource Remote High Dose Rate Afterloader system, supplied by Varian Oncology Systems of Palo Alto, California.

Device Description

The VRAC High Dose Rate (HDR) Remote Afterloading Catheter is a 4.6 French , 150cm long, single lumen catheter. The distal end of the catheter is closed. The outside diameter of the shaft has placement markings to facilitate accurate pre-treatment positioning of the catheter. The catheter is compatible with the Varian VariSource Remote High Dose Rate Afterloader manufactured by Varian Oncology Systems, Palo Alto, California.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the HDR Applicator Catheter:

Lack of Specific AI/Machine Learning Information:

It's important to note that the provided text is a 510(k) Premarket Notification document from 1998. This predates the widespread use of AI/Machine Learning in medical devices for diagnostic or interpretive purposes as we understand it today. Therefore, the document does not discuss AI/ML specific acceptance criteria, studies, or performance metrics like sensitivity, specificity, AUC, human-in-the-loop performance, or the other AI/ML-centric points you've requested.

The document focuses on the physical and functional safety and effectiveness of a medical device (a catheter) through traditional engineering and biocompatibility testing, with the primary goal of demonstrating substantial equivalence to existing predicate devices.

Interpretation based on the provided text:

Given the context, I will provide the information requested where applicable, interpreting "acceptance criteria" and "study" in the traditional sense of medical device validation for this older, non-AI device. For items related to AI/ML or human interpretation, I will explicitly state that the information is not present in the provided document.

Acceptance Criteria and Study for the HDR Applicator Catheter

The VRAC High Dose Rate (HDR) Remote Afterloading Catheter's acceptance criteria and the studies proving it meets these criteria are centered around its physical integrity, functionality, and biocompatibility. The primary goal of the submission was to demonstrate substantial equivalence to legally marketed predicate devices, meaning its performance characteristics are similar enough not to raise new questions of safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test/Evaluation	Reported Device Performance (Summary)
Functional Performance	Co-Efficient of Friction Comparison/Simulated Use	Assured reliable design and performance under specified parameters. Details not provided, but implies the catheter can be inserted and operated as intended without excessive friction or damage.
Physical Integrity	Tensile Strength	Assured reliable design and performance under specified parameters. Details not provided, but implies appropriate strength for intended use without breakage.
Safety - Fluid Barrier	Ingress of Fluids	Assured reliable design and performance under specified parameters. Details not provided, but implies the catheter prevents fluid ingress into critical areas during use.
Safety - Biocompatibility	Biocompatibility	Assured reliability. Details not provided, but implies the materials are safe for patient contact and do not cause adverse biological reactions.

2. Sample Size Used for the Test Set and the Data Provenance

The document does not specify the exact sample sizes (N numbers) for each individual test (Co-Efficient of Friction, Tensile Strength, Ingress of Fluids, Biocompatibility). The tests are typically performed on a statistically relevant number of device units according to internal quality procedures and industry standards for medical device testing, but these numbers are not detailed in this 510(k) summary.

The data provenance is from internal testing conducted by COOK INCORPORATED, the device manufacturer. The tests described are laboratory-based, non-clinical evaluations. There is no mention of human clinical data or geographical origin of such data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This question is not applicable to the provided document. The "ground truth" for these types of engineering and biocompatibility tests is established through objective measurements against predetermined specifications and adherence to recognized testing standards (e.g., ISO for biocompatibility). There are no "experts" establishing a ground truth in the context of diagnostic interpretation or clinical outcomes for this submission.

4. Adjudication Method for the Test Set

This question is not applicable to the provided document. Adjudication methods like 2+1 or 3+1 refer to agreement among human readers or experts, typically for image interpretation or clinical decision-making, which is not part of this device's validation. The testing described involves objective, measurable physical and chemical properties.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The provided information pertains to the physical and functional characteristics of a medical catheter, not to an AI-assisted diagnostic or interpretive device. The concept of "AI assistance" or "human reader improvement with AI" is not relevant to this 1998 medical device submission.

6. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) Was Done

No, a standalone (algorithm only) performance study was not done. This device is a physical catheter, not an algorithm. Its performance is evaluated through material science, engineering, and biocompatibility testing.

7. The Type of Ground Truth Used

The "ground truth" for the tests described is based on:

Engineering Specifications: Predetermined performance limits and tolerances for parameters like tensile strength and coefficient of friction.
Industry Standards: Compliance with established standards for medical device materials and safety (e.g., ISO standards for biocompatibility).
Predicate Device Characteristics: The performance of the predicate devices implicitly sets a benchmark for acceptable performance.

This is not expert consensus, pathology, or outcomes data in the clinical sense.

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" as this device is not an AI/Machine Learning algorithm.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable. There is no "training set" or "ground truth" establishment in the context of AI/ML for this device.

Summary

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NOV က 1998

510(k) Premarket Notification HDR Applicator Catheter COOK INCORPORATED

VII.2
K98/884

Safety and Effectiveness Information

April Lavender, RAC Submitted By: Vice President, Regulatory Affairs COOK INCORPORATED 925 South Curry Pike P.O. Box 489 Bloomington, In 47402 (812) 339-2235 May 27, 1998

VRAC High Dose Rate (HDR)Remote Trade Name: Device: Afterloading Catheter Remote Controlled Radionuclide Applicator Proposed Classification Name: System

Predicate Devices:

The VRAC High Dose Rate (HDR) Remote Afterloading Catheter is similar in terms of intended use, materials of construction, and technological characteristics to predicate devices reviewed as remote afterloading catheters.

Device Description

Substantial Equivalence

The VRAC High Dose Rate (HDR) Remote Afterloading Catheter is similar to another COOK INCORPORATED remote afterloading catheter which was found substantially equivalent under 510(k) #D.C. K945383. The similar indications for use and technological characteristics of the VRAC High Dose Rate (HDR) Remote Afterloading Catheter as compared to the predicate device supports a determination of substantial equivalency.

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510(k) Premarket Notification HDR Applicator Catheter COOK INCORPORATED

Test Data

The VRAC High Dose Rate (HDR) Remote Afterloading Catheter was subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests include:

Co-Efficient of Friction Comparison/Simulated Use 参
彩 Ingress of Fluids
� Tensile Strength
� Biocompatibility

The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a remote controlled radionuclide applicator.

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Public Health Service

Rockville MD 20850

Food and Drug Administration 9200 Corporate Boulevard

Image /page/2/Picture/15 description: The image shows a partial view of a seal or emblem, featuring the text "DEPARTMENT OF HEALTH & HUMAN". The text is arranged in a circular fashion, suggesting it is part of a larger circular design. To the right of the text, there are three stylized, curved lines, possibly representing a symbol or abstract design element within the emblem.

3 1998 NOV

April Lavender, RAC Vice President Regulatory Affairs Cook Incorporated 925 South Curry Pike P.O. Box 489 Bloomington, IN 47402 Re: K981886

VRAC High Dose Rate (HDR) Remote Afterloading Catheter Dated: August 7, 1998 Received: August 10, 1998 Regulatory class: II 21 CFR 892.5700/Procode: 90 JAO

Dear Ms. Lavender:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitn diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/oddf/dsmadsmam.html".

Sincerely yours,

Lillian Yih, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reproductiv Abdominal, Ear, Nose and Thro and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Premarket Notification HDR Applicator Catheter COOK INCORPORATED

510(k) Number (if known):

981886

High Dose Rate (HDR) Remote Afterloading Catheter Device Name:

Indications for Use:

Used for remote afterloading of a radiation source. To be used with the Varian VariSource Remote High Dose Rate Afterloader system, supplied by Varian Oncology Systems of Palo Alto, California.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

V Prescription Use (Per 21 CFR 801.109)

Over-the-Counter Use

ﺮﺓ، ﻭ

David A. Syreem

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological De 510(k) Number

Regulation Number and Section

§ 892.5700 Remote controlled radionuclide applicator system.

(a)
Identification. A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.(b)
Classification. Class II.