(258 days)
The Varian VariSource™ Remote High Dose Rate Afterloader [system, including applicators and accessories] is a device intended to be used by properly trained and licensed medical personnel to provide radiation brachytherapy. The VariSource Endometrial applicator which is the subject of this 510(k) is a component of the VariSource system.
Applicators for the Varian VariSource Remote High Dose Rate Afterloader are a part of a remote controlled radionuclide applicator system, including an electromechanical device to enable an operator to apply, by remote control, a radionuclide source of high activity at various internal or surface body locations for radiation brachytherapy. The shape and materials of the applicator determine where it will be utilized for treatment.
The provided text is a 510(k) summary for the Varian VariSource Endometrial Applicator, which is a component of a remote high dose rate afterloader system. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing independent performance data against specific acceptance criteria.
Therefore, many of the requested categories for a study proving acceptance criteria cannot be directly answered from the given text.
Here's an analysis based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
Strict "acceptance criteria" and "device performance" as might be seen for a new, de novo device are not explicitly stated in this 510(k) summary. Instead, the focus is on demonstrating substantial equivalence to a legally marketed predicate device (Mick Radio-Nuclear Instruments, Inc., Hilaris-Nori Endometrial Applicator, K871216).
The comparison provided is primarily a feature-by-feature technological comparison, which serves as the "study" to prove it meets the criteria of substantial equivalence.
| Feature | Predicate Device (MRNI Hilaris-Nori Endometrial Applicator, K871216) | Varian VariSource Endometrial Applicator (K980576) | Acceptance "Criterion" (Substantial Equivalence) | Reported "Performance" (Comparison) |
|---|---|---|---|---|
| Afterloading Method | Manual | Remote HDR | Must be suitable for brachytherapy | Different method, but both achieve brachytherapy |
| Coupling Catheter Fittings | No | Yes | Must allow connection to afterloader | Presence of fittings for remote HDR system |
| Vaginal Cylinder Diameter & Length | 2.5 cm X 6, 7, 8, 10, & 12 cm; 3.0 cm X 6, 7, 8, 10, & 12 cm | 3.1 cm X 10.2 cm | Must be appropriately sized for intended use | Slightly different, but within expected range for endometrial application |
| Vaginal Cylinder Material | Delrin | Polysulfone | Biocompatible, suitable for radiation environment | Both are medical-grade polymers |
| Irradiation Tubes Number | 3: 1 straight, 2 curved | 3: 1 straight, 2 curved | Provides necessary channels for source placement | Identical number and configuration |
| Irradiation Tubes Material | Stainless steel | Stainless Steel | Biocompatible, durable, radiation-transparent | Identical material |
| Irradiation Tubes Diameter & Length | 6 mm X 24 cm | Straight: 3 mm X 38.1 cm; Curved: 3 mm X 36 cm | Suitable dimensions for accurate source delivery | Different dimensions, but designed for specific afterloader system |
| Fixation | Snap Lock | Pivot Assembly Lock | Secure attachment | Different mechanism, but serves same function |
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable as this is a comparison to a predicate device, not a performance study involving a patient test set. The "test" is the comparison of technical characteristics to the predicate device.
The data provenance is the design specifications and materials of the Varian VariSource Endometrial Applicator compared against the known characteristics of the predicate device. It's a review of documentation, not clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This is not applicable. Ground truth in this context refers to the documented specifications of both the proposed and predicate devices. The "experts" are the Varian Oncology Systems team who prepared the 510(k) and the FDA reviewers who assessed the submission. Their qualifications would be in regulatory compliance, engineering, and medical device evaluation, but they are not establishing a "ground truth" for a performance study.
4. Adjudication Method for the Test Set
This is not applicable. There's no "adjudication" in the sense of resolving discrepancies in expert interpretations of data. The comparison is based on documented technical specifications. The FDA's review process serves as the "adjudication" of the substantial equivalence claim.
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 is not applicable. The device is a physical medical applicator for brachytherapy, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. As noted above, this is a physical medical device, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for this 510(k) submission is the documented technical specifications and intended use of both the Varian VariSource Endometrial Applicator and its chosen predicate device, the Mick Radio-Nuclear Instruments, Inc., Hilaris-Nori Endometrial Applicator (K871216). This is a features-based comparison to demonstrate that the new device is as safe and effective as the predicate device.
8. The Sample Size for the Training Set
This is not applicable. There is no training set involved as this is not a machine learning or AI device.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set.
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Attachment 3 Page 1 of 2
NOV 2 1998
510(k) SUMMARY AS REQUIRED BY 21 CFR 807.92
-
- Submitter: Varian Oncology Systems 3045 Hanover Street Palo Alto, CA 94304
Linda S. Nash, Manager Contact: Requlatory Compliance & Radiation Safety Phone (650) 424-6990 FAX (650) 424-4830 linda.nash@os.varian.com
- Submitter: Varian Oncology Systems 3045 Hanover Street Palo Alto, CA 94304
February 12, 1998 Prepared: Revised: July 24, 1998
- VariSource Endometrial Applicator for Varian VariSource™ 2. Device Name: Remote High Dose Rate Afterloader.
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- Predicate Device: Mick Radio-Nuclear Instruments, Inc., Hilaris-Nori Endometrial Applicator, K871216.
- Applicators for the Varian VariSource Remote High Dose Rate 4. Description: Afterloader are a part of a remote controlled radionuclide applicator system, including an electromechanical device to enable an operator to apply, by remote control, a radionuclide source of high activity at various internal or surface body locations for radiation brachytherapy. The shape and materials of the applicator determine where it will be utilized for treatment.
-
- Intended Use: The Varian VariSource Remote High Dose Rate Afterloader [system, including applicators and accessories] is a device intended to be used by properly trained and licensed medical personnel to provide radiation brachytherapy The VariSource Endometrial Applicator which is the subject of this 510(k) is a component of the VariSource system.
-
- Technological See attached comparison chart. Characteristics
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Comparison to Predicate Device
| # | Feature | MRNI Hilaris-Nori EndometrialApplicator, K871216 | VariSource EndometrialApplicatorK980576 |
|---|---|---|---|
| 1 | Afterloading Method | Manual | Remote HDR |
| 2 | Coupling CatheterFittings | No | Yes |
| 3 | Vaginal Cylinder | Yes | Yes |
| Diameter and Length | 2.5 cm X 6, 7, 8, 10, & 12 cm3.0 cm X 6, 7, 8, 10, & 12 cm | 3.1 cm X 10.2 cm | |
| Material | Delrin | Polysulfone | |
| 4 | Irradiation Tubes | 3: 1 straight, 2curved | 3: 1 straight, 2curved |
| Material | Stainless steel | Stainless Steel | |
| Diameter and Length | 6 mm X 24 cm | Straight: 3 mm X 38.1 cmCurved: 3 mm X 36 cm | |
| Fixation | Snap Lock | Pivot Assembly Lock |
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Image /page/2/Picture/0 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles, stacked on top of each other. The profiles are facing to the right and are connected by a flowing line.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 1998
Linda Nash Regulatory Compliance and Radiation Safety Manager Varian Associates, Inc. 3045 Hanover Street Palo Alto, California 94304
Re:
VariSource Endometrial Appliator for VariSource HDR Afterloader Dated: August 13, 1998 Received: August 14, 1998 Regulatory class: II 21 CFR 892.5700/Procode: 90 JAQ
Dear Ms. Nash:
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 vitro 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/cdr/dsmaldsmamain.html".
Sincerely yours,
Kilian Yi
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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varian@
STATEMENT of INDICATIONS for USE*
I state in my capacity as Manager, Regulatory Compliance and Safety, of Varian Oncology Systems that the Product which is the subject of this premarket notification, is intended to be used for the following:
The Varian VariSource™ Remote High Dose Rate Afterloader [system, including applicators and accessories] is a device intended to be used by properly trained and licensed medical personnel to provide radiation brachytherapy. The VariSource Endometrial applicator which is the subject of this 510(k) is a component of the VariSource system.
Charles Seuil
Charles H. Will, Manager Requlatory Compliance & Safety
February 12, 1998 Date
Date
*Suggested language and format to meet the requirements of section 513(i) of the Federal Food, Drug, and Cosmetic Act, as amended, and 21 CFR sections 801.4 and 800.92(a)(5).
K980576
510(k) Number
510(k) Number
Elvin A. Segner
Division Sign-off Office of Device Evaluation
Prescription Use (Per 21 CFR 801.109)
Over-the-Counter Use _
§ 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.