The VariSource Breast Template System is indicated for high-dose rate Brachytherapy irradiation of the breast or chest wall. The system offers a means of performing interstitial implants with a fixed geometry, for the treatment of breast carcinoma. A pair of a series of Templates are fixed in place relative to one another with the Breast Bridge. The Breast Bridge is also used to hold the Templates over the breast during needle insertion and can be adjusted, via a ratchet mechanism to achieve the required template spacing.

Device Description

The Breast Bridge and Template System is designed to make implanting needles, particularly through the breast, in a fixed geometric pattern easily achievable. The design places templates with holes in a triangular pattern (Paris geometry) on either side of the breast. A ratchet mechanism holds these templates in place while needles are implanted through the Breast. The Needles are NOT part of this product. This product is simply a tool to make it easy to insert needles in a fixed pattern.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the "VariSource Breast Template System". This type of document is for medical devices and focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through clinical studies in the same way an AI/ML device would.

Therefore, many of the requested categories for AI/ML device performance and study design are not applicable (N/A) to this 510(k) submission. There is no mention of an algorithm, AI, or machine learning in the document.

Here's the breakdown based on the information provided:

A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The document does not explicitly state "acceptance criteria" in terms of performance metrics like sensitivity, specificity, accuracy, etc. for an AI/ML system. Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device, as per 21 CFR 807.92. The "acceptance" is that the device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness compared to the predicate.
- Reported Device Performance: The document provides a "Specification Comparison Chart" (Tab G, not fully included in the snippets, but summarized in the "SDD FEATURE COMPARISON" table). This chart compares features of the new device (VariSource Breast Template System) to its predicate device (Applicators for Varian VariSource Remote High Dose Rate Afterloader – Interstitial Needle Applicator). Performance is primarily assessed through a comparison of technical characteristics and safety aspects, not through quantifiable performance metrics for an AI system. For example, it compares materials, sterilization methods, and anatomical sites.

Feature	Varian Breast Bridge and Template System (Proposed Device)	Predicate Device
Intended use	HDR Brachytherapy	HDR Brachytherapy
Indications for use	For high-dose rate Brachytherapy irradiation of the breast or chest wall. Offers a means of performing interstitial implants with a fixed geometry for the treatment of breast carcinoma. A pair of templates are fixed relative to one another with the Breast Bridge, which also holds templates over the breast during needle insertion and can be adjusted via a ratchet mechanism to achieve required template spacing.	See above (implied same as new device for the relevant anatomical sites)
Design	Designed to make implanting needles, particularly through the breast, in a fixed geometric pattern easily achievable. Places templates with holes in a triangular pattern (Paris geometry) on either side of the breast. A ratchet mechanism holds these templates in place while needles are implanted through the Breast. Needles are NOT part of this product. This product is simply a tool to make it easy to insert needles in a fixed pattern.	Interstitial Needle Applicators (implies a more direct applicator for needles)
Materials	Stainless Steel ratchet, polycarbonate (USP class VI approved) templates	Stainless Steel
Performance	N/A (No specific performance data beyond design and material properties are provided as per 510(k) requirements for this type of device)	N/A
Sterility	Autoclave (Device not supplied sterile, validated for autoclave sterilization)	Autoclave (Predicate device's needles are supplied sterile via gamma radiation at 10⁻⁶ SAL)
Biocompatibility	Fully biocompatible Stainless Steel and Polycarbonate used.	Fully biocompatible Stainless Steel used.
Anatomical sites	Breast, Chest Wall	Breast, Chest Wall and others including Prostate.
Compatibility with other devices	Uses 18 gauge needles	Includes 18 gauge needles

Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- N/A. This is a mechanical device (template system), not an AI/ML algorithm. There is no "test set" in the context of evaluating algorithm performance. The evaluation is based on structural and functional comparison to a predicate device.
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)
- N/A. No ground truth establishment by experts for a test set is mentioned for this mechanical device.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. No test set or adjudication method outlined for algorithm performance.
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
- N/A. This device is not an AI system. No MRMC study was performed or is applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is a mechanical device, not an algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- N/A. Ground truth for algorithmic evaluation is not applicable here. The "truth" in this submission relates to the equivalence of the device's characteristics and safety profile to the predicate device.
The sample size for the training set
- N/A. There is no training set as this is not an AI/ML device.
How the ground truth for the training set was established
- N/A. No training set or ground truth establishment for a training set.

Summary of the Study/Evaluation:

The "study" in this 510(k) revolves around demonstrating substantial equivalence to a predicate device, not proving performance of an AI/ML system.

Study Type: Substantial Equivalence Comparison (based on design, materials, intended use, and general safety/effectiveness characteristics).
The manufacturer compares the "VariSource Breast Template System" to the "Applicators for Varian VariSource Remote High Dose Rate Afterloader – Interstitial Needle Applicator."
The comparison focuses on technical characteristics, such as:
- Intended Use and Indications for Use (which are stated to be the same, allowing for fixed geometry interstitial implants for breast carcinoma).
- Design (the new device provides a fixed geometric pattern for needle insertion, unlike the predicate's direct needle applicators).
- Materials (both use stainless steel; the new device also uses USP class VI approved polycarbonate for templates).
- Sterility (the new device is autoclavable, the predicate's needles are gamma sterilized).
- Biocompatibility (both use biocompatible materials).
- Anatomical sites (breast and chest wall for both, predicate also prostate).
- Compatibility with other devices (both use/include 18 gauge needles).

The conclusion of the "study" (i.e., the basis for the FDA's clearance) is that the VariSource Breast Template System is substantially equivalent to the predicate device, meaning it has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness.

Summary

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KD23220

Image /page/0/Picture/1 description: The image shows the logo for Varian Medical Systems. The logo is in black and white and features the word "VARIAN" in a serif font, with a stylized "I" that resembles a person. Below "VARIAN" is the text "medical systems" in a smaller, sans-serif font.

cology Systems 0 Hansen Way o Alto, CA 94304-1038 +1 650 493 4000 www.varian.com

OCT 2 5 2002

Premarket Notification [510(k)] Summary as required by 21 CFR 807.92

Date summary was prepared:

September 18, 2002

Submitter's Name:

Varian Medical Systems 3100 Hansen Way Palo Alto, CA 94304

Contact Person:

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

Device Name:

VariSource Breast Template System

Classification Name:

System, Applicator, Radionuclide, Remote-Controlled

Predicate Device:

Applicators for Varian VariSource Remote High Dose Rate Afterloader – Interstital Needle Applicator

Intended Use:

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Templates over the breast during needle insertion and can be adjusted, via a ratchet mechanism to achieve the required template spacing.

Technological Characteristics:

See the attached "Specification Comparison Chart", Tab G

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SDD FEATURE COMPARISON

Feature	Varian Part Description & Number.Breast Bridge and Template System Pt #AL13011000	Predicate DeviceApplicators for Varian VariSourceRemote High Dose RateAfterloader
1. Intended use	HDR Brachytherapy	HDR Brachytherapy
2. Indications for use	See above	See above
3. Target population	N/A	N/A
4. Design	The Breast Bridge and Template System isdesigned to make implanting needles,particularly through the breast, in a fixedgeometric pattern easily achievable. Thedesign places templates with holes in atriangular pattern (Paris geometry) on eitherside of the breast. A ratchet mechanismholds these templates in place whileneedles are implanted through the Breast.The Needles are NOT part of this product.This product is simply a tool to make it easyto insert needles in a fixed pattern.	Interstitial Needle Applicators
5. Materials	Stainless Steel ratchet, polycarbonate (USPclass VI approved) templates	Stainless Steel
6. Performance	N/A	N/A
7. Sterility	Autoclave	Autoclave
8. Biocompatibilty	Fully biocompatible Stainless Steel andPolycarbonate used.	Fully biocompatible Stainless Steelused.
9. Mechanical safety	N/A	N/A
10. Chemical safety	N/A	N/A
11. Anatomical sites	Breast, Chest Wall	Breast, Chest Wall and othersincluding Prostate.
12. Human factors	Controlled through VariSource Afterloader.	Controlled through VariSourceAfterloader.
13. Energy used and/ordelivered	N/A	N/A
14. Compatibility with theenvironment and otherdevices	Uses 18 gauge needles	Includes 18 gauge needles
15. Where used	BrachyTherapy treatment unit	BrachyTherapy treatment unit
16. Standards met	No applicable device standard	No applicable device standard
17. Electrical safety	N/A	N/A
18. Thermal safety	N/A	N/A
19. Radiation safety	N/A	N/A
20. Predicate DeviceClearance number	N/A	K952913
	Varian Part Description & Number.	Predicate Device
Feature	Breast Bridge and Template System Pt #AL13011000	Applicators for Varian VariSourceRemote High Dose RateAfterloader - Interstitial NeedleApplicator
Needle material	Template is constructed from a stainlesssteel ratchet and polycarbonate templatesTemplate facilitates the use of 18 ga.,needles	Stainless steel shaft, Aluminiumcoupling, Nylon suture button.
Needle dimensions		18-21 ga., 10 - 20 cmDia. 0.8 – 1.3 mm
Needle obturator	No	Yes
Needle obturator material	N/A	Tungsten
Needle cap material	N/A	Aluminium
Obturator cap material	N/A	Aluminium
Packaged individually withobturator	N/A	Yes
Sterility	Not supplied sterile	Sterile via gamma radiation
Sterility assurance level	N/A	10⁻⁶
Sterilisation cycle validation	N/A	AAMI guideline for Gamma radiationsterilisation (AAMI ST32 October,1991)
Packaging	Packaged in an Aluminium tray.	Needles are packaged in apolycarbonate tube with end capsplaced in a tyvek/mylar pouch andheat sealed.

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Note: While the template is not supplied sterile is have been validated for efficacy and suitability for autoclave sterilisation.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/2 description: The image shows a logo with a circular border containing text, and an abstract symbol in the center. The symbol appears to be a stylized representation of a bird or a similar shape, composed of three curved lines. The text around the border is not fully legible, but it seems to be part of a title or organization name.

Food and Drug Administration 200 Corporate Boulevard Rockville MD 20850

Ms. Linda S. Nash Corporate Director, Regulatory Affairs and Quality Systems Varian Medical Systems 3100 Hansen Way F-055 PALO ALTO CA 94304

Re: K023220

Trade/Device Name: VariSource Breast Template System Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radio-nuclide applicator system Regulatory Class: II

Product Code: 90 JAQ Dated: September 19, 2002 Received: September 27, 2002

Dear Ms. Nash:

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 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours.

Nancy C. Grigdon

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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XYZ390

Page 1 of 1

510(k) Number (if known). KO23390

Device Name: VariSource Breast Template System

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)

David A. Leggett

(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Device 510(k) Number ________________________________________________________________________________________________________________________________________________________________

Prescription Use

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.