The VariSource iX Series is indicated for use in the treatment of both benign and malignant disease, for both curative and palliative intent, in the delivery of remote-controlled High Dose Rate (HDR) brachytherapy.

Device Description

The VariSource iX series afterloader systems are computer controlled remote electro/mechanical systems used for medical purposes, for placing a cable incorporating an irradiated iridium seed internally or close by a malignant tumor or turnor bed in a practice known as brachytherapy.

AI/ML Overview

The provided text is a 510(k) Summary for a medical device called "VariSource iX and VariSource iX(t) Afterloaders." This document primarily focuses on demonstrating substantial equivalence to a predicate device and does not include information about acceptance criteria or a study proving that the device meets those criteria, as typically understood for AI/ML device performance.

Here's an analysis based on the provided text:

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

Acceptance Criteria: Not specified in the provided document. The document states "All the tests that were performed met the applied pass criteria," but it does not detail what those criteria were.
Reported Device Performance: The document only states that "Results of Verification and Validation Testing showed conformance to applicable requirements and specifications and assured hazard safeguards functioned properly." It does not provide specific performance metrics (e.g., accuracy, sensitivity, specificity, or error rates) for the device's functional aspects.

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

Test Set Sample Size: Not applicable. The document explicitly states: "No Clinical Tests have been included in this pre-market submission." The non-clinical tests mentioned are verification and validation of the device's engineering and safety aspects, not performance derived from analyzing patient data.
Data Provenance: Not applicable, as no clinical data was used for testing.

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. Since no clinical tests or human-in-the-loop performance studies were conducted, there was no need for experts to establish ground truth.

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

Not applicable. No clinical test set or adjudication method 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

No. The document explicitly states: "No Clinical Tests have been included in this pre-market submission." This device is a remote-controlled radionuclide applicator system, not an AI/ML-driven diagnostic or assistive tool, so an MRMC study is not relevant to its type.

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

Not applicable. This device is a piece of medical hardware (an afterloader) used for brachytherapy. It is not an algorithm or software-only device in the context of typical AI/ML devices where standalone performance is measured. The "console software" mentioned is for controlling the hardware, not for making independent diagnostic or treatment decisions.

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

Not applicable. For the engineering verification and validation, the "ground truth" would be the device meeting its design specifications and safety requirements, as opposed to clinical ground truth derived from patients.

8. The sample size for the training set

Not applicable. This device is hardware with control software. It does not use machine learning, and therefore does not have a "training set" in the sense of AI/ML models.

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

Not applicable. As there is no training set, this question is not relevant.

Summary from the provided text:

The 510(k) submission for the VariSource iX and VariSource iX(t) Afterloaders focuses on demonstrating substantial equivalence to a predicate device based on intended use, technological characteristics, and non-clinical verification and validation testing. It explicitly states that no clinical tests were included in this pre-market submission. Therefore, the document does not contain the information requested regarding acceptance criteria for clinical performance, details of performance studies involving patient data, ground truth establishment, or sample sizes related to such studies, as these types of studies were not part of this particular submission. The device is a piece of medical equipment for brachytherapy and not an AI-powered diagnostic tool.

Summary

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PREMARKET 'NOTIFICATION

510(k) Summary

VariSource iX and VariSource iX(t) Afterloaders

As required by 21 CFR 807.92

Submitter's Name:

Varian Medical Systems 911 Hansen Way, M/S C-255 Palo Alto CA94304

Contact Name: Ms Vy Tran, Vice President, Regulatory Affairs and Quality Systems Phone: 650/424.5731 Fax:650/842.5040 vy.tran@varian.com Date: 30 April 2012

Proprietry Name:

VariSource iX VariSource iX(t)

Classification Name:

Common/Usual Name:

Predicate Device:

Device Description:

Indications for Use:

Remote controlled radionuclide applicator system 21CFR892.5700 Class II

VariSource iX afterloader, VariSource iX Series afterloaders, VariSource IX series afterloader systems, VariSource iX Series

VariSource iX HDR Afterloader (K071467)

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Substantial Equivalence Discussion

Intended Use

The VariSource iX Series is indicated for use in the treatment of both benign and malignant disease for both curative and palliative intent, in the delivery of remote controlled High Dose Rate (HDR) brachytherapy ..

Differences

The differences with respect to the predicate are listed in the substantial equivalence chart.

With respect to the previous version of this device, which contained Console software Version 1.1, the changes are to Plan Importing, Partial treatment Options, Fraction Editing and Remote Service Access.

Technological Characteristics

Both the current device and the predicate are remote-controlled afterloading devices for brachytherapy. The systems both utilize a small, high activity Iridium-192 source that is fixed to a flexible metal cable and driven via one or more source guide tubes into an applicator(s) or needle(s) inserted for a specified clinical purpose into a patient.

Argument for Substantial Equivalence to the Predicate Device

There are few differences between the VariSource IX Series afterioaders and the predicate. Varian therefore believes that the VariSource iX Series afterloaders are substantially equivalent to the predicate.

Non Clinical Tests

Results of Verification and Validation Testing showed conformance to applicable requirements and specifications and assured hazard safeguards functioned properly.

Clinical Tests

No Clinical Tests have been included in this pre-market submission

Conclusions

All the tests that were performed met the applied pass criteria. Varian considers the device to be safe and effective and to perform as well or better than the predicate

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

NOV 1 6 2012

Ms. Vy Tran Vice President, Regulatory Affairs and Quality Systems Varian Medical Systems, Inc. 3100 Hansen Way PALO ALTO CA 94304

Re: K122236

Trade/Device Name: VariSource iX and VariSource iX(t) Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radio-nuclide applicator system Regulatory Class: II Product Code: JAQ Dated: September 26, 2012 Received: October 4, 2012

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 (PMA), it may be subject to 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

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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Machal D. Offair 11:55:20 -05'00'

Janine M. Morris Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K122236

Device Name: VariSource iX and VariSource iX(t)

Indications for Use:

The VariSource iX and VariSource iX(t) are indicated for use in the treatment of both benign and malignant disease, for both curative and palliative intent, in the delivery of remote-controlled High Dose Rate (HDR) brachytherapy.

Yes Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Michael D. O'Hara 2012.11.16
11:56:44 -05'00'

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

510(k) K122236

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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.