(48 days)
The VariSource 200 System is a High Dose Rate Brachytherapy Afterloader used to treat lesions, tumors and conditions in the body where radiation is indicated.
The VariSource 200 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 provided document is a 510(k) summary for the VariSource 200 HDR Brachytherapy Afterloader, which is a medical device used for radiation therapy, specifically brachytherapy. It is not an AI/ML device, and thus the acceptance criteria and study information typically associated with AI/ML device performance (like sensitivity, specificity, MRMC studies, ground truth establishment by experts, training/test set sizes, etc.) are not applicable or provided in this document.
Instead, the document focuses on demonstrating substantial equivalence to a predicate device (VariSource K - K945383) by comparing technological characteristics and meeting relevant safety standards.
Therefore, I cannot provide the requested information regarding AI/ML device performance criteria.
However, I can extract the comparison chart that outlines the device's characteristics and how it compares to its predicate, essentially serving as a form of acceptance criteria for a non-AI medical device.
1. A table of acceptance criteria and the reported device performance
For a traditional medical device like the VariSource 200 HDR Brachytherapy Afterloader, "acceptance criteria" are typically defined by regulatory standards (like IEC 601-2-17) and by demonstrating substantial equivalence to a predicate device. The performance is assessed against these established characteristics and safety thresholds.
| Characteristic / Acceptance Criteria (Predicate Device) | Reported Device Performance (VariSource 200) |
|---|---|
| Intended Use | High Dose Rate Brachytherapy |
| Safe (Maximum source strength) | Tungsten Alloy 370GBq |
| Maximum Surface Dose (IEC 601-2-17: 1µGy/h @ 1m) | <0.5 µGy/h @ 1m |
| Radiation Detector | Installed in room, Built into unit - and connected to system interlocks |
| Dimension (Length) | 635mm |
| Dimension (Width) | 533 mm |
| Dimension (Height) | 1097 mm |
| Weight | 148Kg |
| Power Requirements | 110/220 V +/- 10% |
| Power Consumption | 550 VA, peak |
| UPS | Yes |
| Ambient Temperature | 15 - 35°C |
| Relative Humidity | 30% - 75% |
| Atmospheric Pressure | 70kPa - 110kPa |
| Rotation of head | No (rotate unit) |
| Variable Height head | No |
| Number of patient connection Channels | 20 |
| Channel Indexer Locking Mechanism | Mechanical |
| Method of Correct Catheter connection Detection | LED - Photo Transistor Pair |
| Treatment Length in Catheter | 70 cm to 150cm |
| Authorized Access | Yes (Key Switch, Password - 3 levels) |
| Power Fail | UPS takes over, operator choice to continue/interrupt, can complete interrupted treatment, UPS powers safely for 30 min, new treatment cannot be initiated |
| Emergency Source Retraction (Battery Back-up) | Yes |
| Emergency Source Retraction (Battery test prior to source extension) | Yes |
| Emergency Source Retraction (DC Motor) | Yes |
| Emergency Source Retraction (Separate Motor) | Yes |
| Emergency Source Retraction (Manual Crank) | Yes (On side of unit, handle on wheel) |
| Source Wire No | SL 777V |
| Source Capsule Length | 11mm |
| Source Active Length | 10mm |
| Source Diameter | 0.59mm |
| Source Material | Iridium |
| Source Wire | Solid Nickel-Titanium Alloy |
| Turning Radius | 17 mm in 4.7 Fr thick wall catheter, at 120 cm from turret |
| Source Mechanical Life | Interlocked at 500 extensions |
| QA Tool (Source Position Verification) | Yes - External, allows daily QA of source positioning accuracy, including dummy positioning - recorded on a single sheet of paper |
| User Interface (Graphical User interface) | DOS |
| Operating System | (Not specified for predicate) |
| Prescription Record Transfer | Floppy disk |
| Standard Plans | On floppy disk |
| Prescription & Reports | Printed on Paper |
| PC Hardware | Intel 486 50MHz, IBM Compatible |
| Monitor | 15" CRT |
| Printer | Laser Printer |
| Independent Treatment Control Panel | Yes |
| Regulations (IEC 601-2-17) | Yes |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable to this type of device and is not provided in the document. The submission focuses on hardware and functional equivalence, not data-driven performance.
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)
This information is not applicable to this type of device and is not provided. Ground truth establishment by experts is relevant for diagnostic or AI/ML devices, not for a brachytherapy afterloader.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable to this type of device and is not provided. Adjudication methods are typically used in clinical studies or for establishing ground truth for AI/ML algorithms.
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
This information is not applicable, as the VariSource 200 is a hardware device for delivering radiation therapy, not an AI-assisted diagnostic or treatment planning system. Therefore, no human readers or AI assistance are involved in its primary function as described in this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable, as the VariSource 200 is a hardware device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable. The "ground truth" for this device relates to its engineering specifications, safety performance (e.g., maximum surface dose, emergency retraction functionality), and its ability to accurately deliver radiation as intended, rather than diagnostic accuracy against a clinical ground truth. Compliance with regulatory standards (e.g., IEC 601-2-17) serves as a primary form of "ground truth" for device safety and performance.
8. The sample size for the training set
This information is not applicable. This is a hardware device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable.
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K061582 510(k) Summary
The following information is provided following the format of 21 CFR 807.92 for the VariSource 200 HDR Brachytherapy Afterloader.
- Varian Medical Systems 1. Submitter: 3100 Hansen Way M/S E-110 Palo Alto, CA 94304-1129 Contact Name: Vy Tran Phone: (650) 424-5731 (650) 842-5040 Fax: Email: vy.tran@varian.com Date summary was prepared: June 1, 2006
| 2. Name of the Device: | VariSource 200 HDR Afterloader |
|---|---|
| Trade/Proprietary Name: | VariSource 200 HDR Afterloader |
| Common or Usual Name: | |
| Classification Name: | Radiological Image Processing System21 CFR §892.5700Class IIProduct Code: 90 JAQ |
-
- Predicate Devices to claim substantial equivalence: a. VariSource K(945383)
-
- Description of the Device: The VariSource 200 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.
Hardware Platform and Operating System
The console control application runs on standard Intel PCs under a DOS operating systems. The firmware controlling the High Dose Rate Afterloader runs on an embedded Intel 188 processor.
Peripherals and Accessories
The 200 Series control console provides real time information of wire position and system status and interfaces with a printer in order to provide a hard copies of a treatment prescriptions and delivery records. In addition the 200 Series control
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console can receive treatment plans from a treatment planning application (not part of this submission), this information is transferred via a floppy disk.
- Intended Use Statement: The VariSource 200 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.
Summary of the Technological Characteristics: The Substantial Equivalence 6. Comparison Chart provides a comparison of the technological characteristics to those of the predicate devices. This chart is located in Tab 9 of the submission.
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Image /page/2/Picture/0 description: The image shows the logo for Varian Medical Systems. The logo consists of the word "VARIAN" in bold, uppercase letters. The "I" in "VARIAN" is stylized with a curved line extending above the letter. Below the word "VARIAN" are the words "medical systems" in a smaller font.
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Varian Brachytherapy
HDR Product Comparison Chart
The following table represents information as known to Varian from a review of published information available about competing products and the predicate device.
| Description | Varian VariSourceRemote High Dose RateAfterloader(Predicate Device) | VariSource 200 |
|---|---|---|
| 510(k) Number | K945383 | |
| Intended Use | High Dose RateBrachytherapy | High Dose RateBrachytherapy |
| Safe(Maximum source strength) | Tungsten Alloy370GBq | Tungsten Alloy407GBq. Safe and Unittested to meet SurfaceDose Requirement |
| Maximum Surface Dose(IEC 601-2-17: 1µGy/h @ 1m) | <0.5 µGy/h @ 1m | <0.5 µGy/h @ 1m |
| Radiation Detector | Installed in roomBuilt into unit - andconnected to systeminterlocks | Installed in roomBuilt into unit - andconnected to systeminterlocks |
| DimensionLengthWidthHeight | 635mm533 mm1097 mm | 610 mm560 mm1070 mm |
| Weight | 148Kg | 142 kg |
| Power Requirements | 110/220 V +/- 10% | 110/220 V +/- 10% |
| Power Consumption | 550 VA, peak | 550 VA, peak |
| UPS | Yes | Yes |
| Ambient Temperature | 15 - 35°C | 15 - 35°C |
| Relative Humidity | 30% - 75% | 30% - 75% |
| Atmospheric Pressure | 70kPa - 110kPa | 70kPa - 110kPa |
| Rotation of head | No (rotate unit) | No (rotate unit) |
| Variable Height head | No | No |
| Number of patientconnection Channels | 20 | 20 |
| Channel Indexer LockingMechanism | Mechanical | Electro-Mechanical |
| Method of Correct Catheterconnection Detection | LED - Photo Transistor Pair | LED - Photo Transistor Pair |
| Treatment Length inCatheter | 70 cm to 150cm | 70 cm to 150cm |
| Authorized Access: | Yes | Yes |
| Key Switch | Yes | Yes |
| Password | Yes - 3 levels | Yes - 3 levels |
| Power Fail | UPS takes over - operatorcan choose to continue orinterrupt treatment.An interrupted treatmentmay be completed atoperator option at any time.UPS will power unit safelyfor 30 minutes - new patienttreatment may not beinitiated during power fail | UPS takes over - operatorcan choose to continue orinterrupt treatment.An interrupted treatmentmay be completed atoperator option at any time.UPS will power unit safelyfor 30 minutes - new patienttreatment may not beinitiated during power fail |
| Description | Varian VariSourceRemote High Dose RateAfterloader(Predicate Device) | VariSource 200 |
| Emergency Source Retraction: | ||
| Battery Back-up | Yes | Yes |
| Battery test prior to sourceextension | Yes | Yes |
| DC Motor | Yes | Yes |
| Separate Motor | Yes | Yes |
| Manual Crank | Yes | Yes |
| Manual Crank Access | On side of unit | On side of unit |
| Crank method | Handle on wheel | Handle on wheel |
| Source: | ||
| Source Wire No | SL 777V | VS2000 |
| Source Capsule Length | 11mm | 6 mm |
| Source Active Length | 10mm | 5 mm |
| Source Diameter | 0.59mm | 0.59 mm |
| Source Material | Iridium | Enriched Iridium |
| Source Wire | Solid Nickel-Titanium Alloy | Solid Nickel-Titanium Alloy |
| Turning Radius | 17 mm in 4.7 Fr thick wallcatheter, at 120 cm fromturret | 17 mm in 4.7 Fr thick wallcatheter, at 120 cm fromturret |
| Source Mechanical Life | Interlocked at 500extensions | Interlocked at 1000extensions |
| QA Tool | ||
| Source PositionVerification. Video imagevia frame grabber with plainpaper print out. | Yes - External, allows dailyQA of source positioningaccuracy, including dummypositioning - recorded on asingle sheet of paper. | Yes - Internal, allows dailyQA of source positioningaccuracy, including dummypositioning - recorded on asingle sheet of paper. |
| User Interface | ||
| Graphical User interface | DOS | DOS |
| Operating System | ||
| Prescription RecordTransfer | Floppy disk | Floppy disk |
| Standard Plans | On floppy disk | On floppy disk |
| Prescription & Reports | Printed on Paper | Printed on Paper |
| PC Hardware* | Intel 486 50MHz, IBMCompatible | Intel 486 50MHz, IBMCompatible |
| Monitor* | 15" CRT | 15" CRT |
| Printer* | Laser Printer | Laser Printer |
| Independent TreatmentControl Panel | Yes | Yes |
| Regulations:IEC 601-2-17 | Yes | Yes |
| (:
CTD Section 5
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HDR Product Comparison Chart
Ko61582
*Minimum Specification
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| Department | VBT Project Manager | Date: | 16th December 2005 |
|---|---|---|---|
| Name | Chris Heath | Signature: |
CTD Section 5
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Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of what appears to be a human figure embracing or protecting another figure, possibly representing care or support.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
JUL 25 2006
Ms. Vy Tran Director, Corporate Regulatory Affairs Varian Medical Systems, Inc. 3100 Hansen Way M/S E-110 PALO ALTO CA 94304-1129
Re: K061582
Trade/Device Name: VariSource 200 HDR Brachytherapy Afterloader Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radio-nuclide applicator system Regulatory Class: II Product Code: JAQ Dated: June 2, 2006 Received: June 7, 2006
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/4/Picture/10 description: The image is a black and white circular logo. The logo contains the letters "FDA" in a bold, sans-serif font. Above the letters, the numbers "1906 - 2006" are printed. Below the letters, the word "Centennial" is printed in a cursive font. The logo is surrounded by a circular border with small stars and text.
roting Public J
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Page 2 -
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 form in the quind 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) I mo loket notification. The FDA finding of substantial equivalence of your device to a legally premaince modicate 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/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Hogden
Nancy C. Brogdon Director. Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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PAGE 1 of 1
K061582 510(k) Number (if known): Device Name: VariSource 200 HDR Brachytherapy Afterloader
Indications For Use:
The VariSource 200 System is a High Dose Rate Brachytherapy Afterloader used to treat lesions, tumors and conditions in the body where radiation is indicated.
(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)
Tamye Snugden
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number K061582
Prescription Use _ (Per 21 CFR 801.109)
§ 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.