The VariSource iX is indicated, in the treatment of both benign and malignant disease, for both curative and palliative intent, in the delivery of remote-controlled high dose-rate Brachytherapy for conditions anywhere in the body when brachytherapy treatment is indicated.

Device Description

The VariSource iX Series High Dose Rate Afterloader system is a computer controlled remote electro/mechanical system used for medical purposes, for placing a NiTiNol wire incorporating an irradiated iridium seed internally or close by, a malignant tumor or tumor bed in a practice known as brachytherapy. The device has up to 20 channels for treatment.

AI/ML Overview

The provided text is a 510(k) Summary for the VariSource iX HDR Brachytherapy Afterloader. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not include detailed information about acceptance criteria and a study proving the device meets those criteria in the typical format of a performance study with specific metrics, sample sizes, and expert adjudications.

The document primarily focuses on establishing substantial equivalence to the predicate device (VariSource K061582) based on technological characteristics, as indicated in section "6. Summary of the Technological Characteristics: The Substantial Equivalence Comparison Chart provides a comparison of the technological characteristics to those of the predicate device. This chart is located in Tab 9 of the submission."

Therefore, based only on the provided text, I cannot complete all sections of your request. I will fill in what is available and explicitly state where information is missing.

Acceptance Criteria and Device Performance Study Analysis for VariSource iX HDR Brachytherapy Afterloader

The provided 510(k) summary (K071467) does not contain a detailed performance study with explicit acceptance criteria and corresponding reported device performance metrics in the format requested (e.g., sensitivity, specificity, accuracy for a classification task, or specific quantitative performance measures for other device types).

The submission focuses on demonstrating substantial equivalence to a predicate device (VariSource K061582) based on technological characteristics. This typically means that the new device performs in a manner that is as safe and effective as the predicate device, often without requiring extensive new clinical or performance studies if the technological changes are minor. The "acceptance criteria" in this context would implicitly be that the device functions as intended and meets the safety and performance standards of the predicate.

Given the absence of a specific performance study in the provided text, the table below will reflect that information is not available.

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric / Acceptance Criteria	Reported Device Performance
Not Available - Document focuses on substantial equivalence based on technological characteristics rather than a new performance study with specific metrics.	Not Available - No specific quantitative performance metrics are provided in the summary.

Detailed Study Information (Based on provided text, or marked as Not Available if absent):

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 Test Set: Not Available. The document does not describe a performance study with a test set of data.
Data Provenance: Not Available.

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)

Number of Experts: Not Available. No test set or ground truth establishment process is described.
Qualifications of Experts: Not Available.

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

Adjudication Method: Not Available. No test set or adjudication process is described.

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

MRMC Study: Not applicable. The VariSource iX is a brachytherapy afterloader, a medical device for delivering radiation, not an AI-assisted diagnostic tool for "human readers." Therefore, an MRMC study related to human reading improvement with AI is not relevant to this device type.

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

Standalone Performance Study: Not Available. The device is a physical electro/mechanical system. Its performance evaluation would typically involve tests of its mechanical accuracy, radiation delivery precision, software functionality, and safety features, rather than "standalone algorithm performance" in the AI sense. The 510(k) focuses on substantial equivalence of its technological characteristics.

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

Type of Ground Truth: Not Available. No performance study requiring ground truth is described. For a device like this, the "ground truth" for its safety and effectiveness would be established through engineering tests, adherence to design specifications, and comparison to the predicate device's established performance and safety profile.

8. The sample size for the training set

Sample Size for Training Set: Not Available. This device is an electro/mechanical system. The concept of a "training set" in the context of machine learning is not applicable here. Its software and firmware would be developed and tested through traditional software engineering and verification/validation processes.

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

Ground Truth Establishment for Training Set: Not Applicable. See explanation for point 8.

Summary

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K07/467

JUL 16 2007

510(k) Summary

The following information is provided following the format of 21 CFR 807.92 for the VariSource iX HDR Brachytherapy Afterloader.

Submitter: Varian Medical Systems 3100 Hansen Way M/S E-110 Palo Alto, CA 94304-1129 Contact Name: Vy Tran Phone: (650) 424-5731 Fax: (650) 842-5040 Email: vy.tran@varian.com Date summary was prepared: May 25th, 2007

2. Name of the Device:	VariSource iX HDR Afterloader
Trade/Proprietary Name:	VariSource iX HDR Afterloader
Common or Usual Name:	VariSource iX HDR Afterloader
Classification Name:	Radiological Image Processing System21 CFR §892.5700Class IIProduct Code: JAQ

1. Predicate Device to claim substantial equivalence: VariSource K061582
1. Description of the Device: The VariSource iX Series High Dose Rate Afterloader system is a computer controlled remote electro/mechanical system used for medical purposes, for placing a NiTiNol wire incorporating an irradiated iridium seed internally or close by, a malignant tumor or tumor bed in a practice known as brachytherapy. The device has up to 20 channels for treatment.

Hardware Platform and Operating System

The console control application runs on validated PCs under a Microsoft®¹ windows operating system. The firmware controlling the High Dose Rate Afterloader runs on an embedded Intel 188 processor.

Peripherals and Accessories

The iX Series control console provides real time information of wire position and system status and interfaces with a printer in order to provide a hard copy of a treatment prescriptions and delivery records. In addition the iX Series control console can receive treatment plans from a treatment planning application (not part of this submission), this information is transferred either manually using a USB2 drive, or via a network interface.

Registered Trade Mark of Microsoft Corporation

2 USB- Universal Serial Bus

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1. Intended Use Statement: The VariSource iX System is a computer controlled remote HDR Afterloader used to place a high activity radioactive source within a needle(s) or applicator(s) which have previously been placed for a specified clinical purpose in a patient.
  The radioactive source (enclosed within the wire/cable) is driven via coupling catheters (Transfer Guide Tubes) from the Afterloader into needles or applicators within or on the patient.

The length of time and position that the High Dose Rate source spends within the needle or applicator is controlled in accordance with an Irradiation Treatment Prescription.

1. Summary of the Technological Characteristics: The Substantial Equivalence Comparison Chart provides a comparison of the technological characteristics to those of the predicate device. This chart is located in Tab 9 of the submission.

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Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The text is in all caps and appears to be in a sans-serif font. The overall design is simple and conveys a sense of government authority.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

JUL 16 2007

Ms. Vy Tran Corporate Director, Regulatory Affairs Varian Medical Systems 3100 Hansen Way M/S E-110 PALO ALTO CA 94304

Re: K071467

Trade/Device Name: VariSource iX HDR Brachytherapy Afterloader Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radio-nuclide applicator system Regulatory Class: II Product Code: JAQ Dated: May 25, 2007 Received: May 29, 2007

Dear Ms. Tran:

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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/2/Picture/10 description: The image is a circular logo with the text "1906-2006" at the top. The letters "DA" are in the center of the logo in a stylized font. The word "Centennial" is written below the letters "DA" in a cursive font. There are three stars at the bottom of the logo.

Presocing and Promoting Publio Hoath

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Page 2 -

Enclosure

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.

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 promated 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 one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology 240-276-0115
21 CFR 884 xxx ---------------------------------------------------------------------------------------------------------------------------------------------------------------	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

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/cdrl/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

Nancy C. Brogdon Director. Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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PAGE 1 of 1

510(k) Number (if known): K071467
Device Name: VariSource iX HDR Brachytherapy Afterloader

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

Helene Reem

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 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.