VariSeed 7.0 is a software application used for planning and evaluation of permanent implant brachytherapy procedures. VariSeed 7.0 is a software application for planning and evaluating permanent implant brachytherapy procedures for the treatment of prostate cancer with permanent implants that can be modeled according to AAPM TG-43. It facilitates pre-operative planning and intra-operative planning and evaluation.

Device Description

See the Software Description of the Device, Tab E

AI/ML Overview

This a premarket notification for VariSeed 7.0, a brachytherapy treatment planning system, submitted in 2001. Due to the age of the document and the nature of 510(k) summaries from that period, the detailed information typically expected for acceptance criteria and study designs (especially concerning AI/ML performance) is not present.

Here's a breakdown of what can and cannot be answered based only on the provided text:

What can be extracted:

Device Name: VariSeed 7.0
Intended Use: VariSeed 7.0 is a software application used for planning and evaluation of permanent implant brachytherapy procedures, specifically for prostate cancer, using models conforming to AAPM TG-43. It facilitates pre-operative, intra-operative, and post-operative planning and evaluation.
Predicate Devices: MMS TherapacPLUS B3DTUI (K982821) and Brachyvision (K992762). This implies that the device demonstrated "substantial equivalence" to these existing legally marketed devices, which was the primary regulatory pathway at the time.

What cannot be extracted from the provided text:

The document does not contain any information regarding:

A table of acceptance criteria and reported device performance.
Sample sizes for test sets or training sets.
Data provenance (country of origin, retrospective/prospective).
Number or qualifications of experts for ground truth.
Adjudication methods.
Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
Standalone algorithm performance studies.
The type of ground truth used (e.g., pathology, outcomes data).
How ground truth for the training set was established.

Explanation for missing information:

In 2001, AI/ML-driven medical devices as we understand them today were nascent, and the regulatory framework for them was not developed. 510(k) submissions for software applications like VariSeed (which is a treatment planning system) focused on demonstrating substantial equivalence to predicate devices, primarily through aspects like:

Functional equivalence: Does it perform the same tasks?
Technological equivalence: Does it use similar technology?
Performance equivalence: Does it produce clinically acceptable results, often compared to the predicate device's expected output or clinical standards of the time (like AAPM TG-43 for brachytherapy)?

The concepts of large-scale validation studies with detailed metrics like sensitivity, specificity, AUC, and multi-reader studies to quantify AI's impact on human performance were not standard requirements for this type of device at that time. The approval was based on its similarity to existing, legally marketed systems, rather than proof of meeting specific, quantitatively defined performance criteria in a clinical study as would be expected for a novel diagnostic or AI-powered device today.

Summary

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JUL 1 2 2001

KO12017
VARI
medical sy

Oncology Systems 100 Hansen Way alo Alto, CA 94304-1038 tel +1 650 493 4000 ww.varian.com

Premarket Notification [510K] Summary as required by 21 CFR 807.92

Date Summary was prepared:

June 7, 2001

Submitter's Name:

Varian Medical Systems 3140 Hansen Way F-055 Palo Alto, CA 94304

Contact Person:

Linda S. Nash Corporate Director, Regulatory Affairs and Quality Assurance (650) 424-6990 Phone (650) 842-5051 FAX E-Mail linda.nash(@os.varian.com

Device Name:

VariSeed 7.0

Classification Name:

Source, Brachytherapy, Radionuclide

Predicate Device:

MMS TherapacPLUS B3DTUI, K982821 and Brachyvision, K992762

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Product Description:

See the Software Description of the Device, Tab E

Intended Use:

VariSeed 7.0 is a software application used for planning and evaluation of permanent implant brachytherapy procedures.

Technological Characteristics:

See the "Substantial Equivalence Comparison Chart", Tab F.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

JUL 1 2 2001

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings or feathers. The eagle's head is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Linda Nash Director, Regulatory Affairs and Quality Assurance Varian Medical Systems, Inc. 3100 Hansen Way PALO ALTO CA 94304-1038

Re: K012017

VARISEED 7.0 (Brachytherapy Treatment Planning System) Dated: June 25, 2001 Received: June 28, 2001 Regulatory Class: II 21 CFR 892.5730/Procode: 90 MUJ

Dear Ms. Nash:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the We have is substantially equivalent (for the intications 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). 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 th your device is classimos (so aco regulations affecting your device can be found in the Code of Federal Regulations, to such additional controls. Internally equivalent determination assumes compliance with the Current Good Manufacturing Fride 21, 1 at 5 00 to 099. 11 backed to 1941. System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 1 rache requirements, is set tour in the Quand Drug Administration (FDA) will verify such assumptions. Failure o comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements to comply war the Federal Register. Please note: this response to your premarket notification submission does not offect 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 I his lotter while no 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 vitro If you distic devices), please contact the Office of Compliance at (301) 594-4639. 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 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) 1638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Nancy C. Brogdon

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

Enclosure (s)

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Page | of |

510(k) Number (if known): K012017

Device Name: Vari Seed 7.0_

Indications For Use:

VariSeed 7.0 is a software application for planning and evaluating permanent implant Vanoood 7.0 lo a connate application of prostate cancer with permanent implants braonythorapy procount of to AAPM TG-43. It facilitates pre-operative planning and that our be models a socialing in the operative planning and evaluation.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices,
510(k) Number	K012017

Prescription Use	✓	OR	Over-The-Counter Use
(Per 21 CFR 801.109)			(Optional Format 1-2-96)

Regulation Number and Section

§ 892.5050 Medical charged-particle radiation therapy system.

(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.