(28 days)
Not Found
No
The description focuses on a mechanical system for guiding needle insertion in a fixed geometric pattern and makes no mention of AI or ML.
No.
The VariSource Breast Template System is described as a "tool to make it easy to insert needles in a fixed pattern" during brachytherapy. It does not deliver therapy itself. The needles, which would deliver the therapy, are explicitly stated as "NOT part of this product." Its predicate device, [K952913](https://510k.innolitics.com/search/K952913); Applicators for Varian VariSource Remote High Dose Rate Afterloader – Interstital Needle Applicator, also seems to be an accessory rather than a therapeutic device itself.
No
No, this device is not a diagnostic device. Its "Intended Use" clearly states it is for "high-dose rate Brachytherapy irradiation of the breast or chest wall" and for "performing interstitial implants... for the treatment of breast carcinoma." It is described as a "tool to make it easy to insert needles in a fixed pattern" during treatment, not for diagnosis.
No
The device description explicitly details physical components like "Breast Bridge," "Templates," "holes," and a "ratchet mechanism," indicating it is a hardware device used for guiding needle insertion. There is no mention of software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for high-dose rate Brachytherapy irradiation of the breast or chest wall. This is a therapeutic procedure, not a diagnostic one.
- Device Description: The device is described as a tool to facilitate the insertion of needles in a fixed pattern for brachytherapy. It does not perform any tests on biological samples or provide diagnostic information.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting markers, or providing diagnostic results.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely related to the delivery of radiation therapy.
N/A
Intended Use / Indications for Use
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.
Product codes
90 JAQ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Breast, Chest Wall
Indicated Patient Age Range
N/A
Intended User / Care Setting
BrachyTherapy treatment unit
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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:
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
1
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
2
SDD FEATURE COMPARISON
| Feature | Varian Part Description & Number.
Breast Bridge and Template System Pt #
AL13011000 | Predicate Device
Applicators for Varian VariSource
Remote High Dose Rate
Afterloader |
|----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| 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 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. | Interstitial Needle Applicators |
| 5. Materials | Stainless Steel ratchet, polycarbonate (USP
class VI approved) templates | Stainless Steel |
| 6. Performance | N/A | N/A |
| 7. Sterility | Autoclave | Autoclave |
| 8. Biocompatibilty | Fully biocompatible Stainless Steel and
Polycarbonate used. | Fully biocompatible Stainless Steel
used. |
| 9. Mechanical safety | N/A | N/A |
| 10. Chemical safety | N/A | N/A |
| 11. Anatomical sites | Breast, Chest Wall | Breast, Chest Wall and others
including Prostate. |
| 12. Human factors | Controlled through VariSource Afterloader. | Controlled through VariSource
Afterloader. |
| 13. Energy used and/or
delivered | N/A | N/A |
| 14. Compatibility with the
environment and other
devices | 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 Device
Clearance number | N/A | K952913 |
| | Varian Part Description & Number. | Predicate Device |
| Feature | Breast Bridge and Template System Pt #
AL13011000 | Applicators for Varian VariSource
Remote High Dose Rate
Afterloader - Interstitial Needle
Applicator |
| Needle material | Template is constructed from a stainless
steel ratchet and polycarbonate templates
Template facilitates the use of 18 ga.,
needles | Stainless steel shaft, Aluminium
coupling, Nylon suture button. |
| Needle dimensions | | 18-21 ga., 10 - 20 cm
Dia. 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 with
obturator | 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 radiation
sterilisation (AAMI ST32 October,
1991) |
| Packaging | Packaged in an Aluminium tray. | Needles are packaged in a
polycarbonate tube with end caps
placed in a tyvek/mylar pouch and
heat sealed. |
3
Note: While the template is not supplied sterile is have been validated for efficacy and suitability for autoclave sterilisation.
4
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.
5
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
6
XYZ390
Page 1 of 1
510(k) Number (if known). KO23390
Device Name: VariSource Breast Template System
Indications For Use:
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.
(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