(120 days)
Not Found
No
The description focuses on a passive, rigid applicator for positioning a radiation source, with verification done through radiographic images and manual measurements. There is no mention of automated analysis, decision-making, or learning from data, which are characteristic of AI/ML.
Yes
The device is described as an applicator for non-invasive brachytherapy, delivering radiation to tissue, which is a form of medical treatment.
No
Explanation: The ART Breast Brachytherapy Applicator is described as a device used to deliver radiation dose for treatment, not to diagnose a condition. It is a therapy delivery device.
No
The device is a physical applicator used for brachytherapy, which is a hardware component. The description focuses on its physical design and use with afterloading equipment.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "non-invasive brachytherapy" and "delivering radiation dose to the underlying tissue." This is a therapeutic application, not a diagnostic one.
- Device Description: The description focuses on its function in positioning a radiation source for treatment.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide information about a patient's health status or disease. IVDs are designed to perform tests on these types of samples to aid in diagnosis, monitoring, or screening.
This device is a medical device used in a therapeutic procedure (brachytherapy), not a diagnostic procedure.
N/A
Intended Use / Indications for Use
The ART Breast Brachytherapy Applicator is a rigid applicator intended for use with Nucletron remote afterloading equipment for non-invasive brachytherapy. The applicator provides a means of positioning the HDR source near the breast to deliver radiation dose to the underlying tissue in areas of intact skin.
Product codes (comma separated list FDA assigned to the subject device)
JAO
Device Description
The Advanced Radiation Therapy (ART) Breast Brachytherapy Applicator is a rigid applicator used for non-invasive HDR treatment of the breast. The applicator is designed to be positioned external to the breast to receive the HDR afterloader source via catheter lumens. The position and placement of the applicator is verified by means of radiographic images and the travel distance of the HDR source in the lumens is determined radiographically by using the check cable of the afterloader equipment. With the applicator properly immobilized on the breast surface, the HDR treatment process can begin according to established protocols.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
The Advanced Radiation Therapy Breast Brachytherapy Applicator is a passive device. Performance testing was not required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
510(k) Summary ART Breast Brachytherapy Applicator
Page 1 of 2
JUN -6 2006
1. Sponsor Name
Advanced Radiation Therapy, LLC 9 Linnell Circle, Billerica, MA 01821 Telephone: 978-663-7300 Fax 978-663-7322 Contact Individual: Raymond J. Bricault Jr., Chief Operating Officer
2. Device Name
ART Breast Brachytherapy Applicator
3. Identification of Predicate or Legally Marketed Device
Mick Nuclear - HAM Applicator - K961601 Nucletron Freiburg Flap Applicator set - K983338 Varian Medical Systems - Catheter Flap - 510(k) unknown but currently advertised and believed to be legally marketed
4. Device Description
The Advanced Radiation Therapy (ART) Breast Brachytherapy Applicator is a rigid applicator used for non-invasive HDR treatment of the breast. The applicator is designed to be positioned external to the breast to receive the HDR afterloader source via catheter lumens. The position and placement of the applicator is verified by means of radiographic images and the travel distance of the HDR source in the lumens is determined radiographically by using the check cable of the afterloader equipment. With the applicator properly immobilized on the breast surface, the HDR treatment process can begin according to established protocols.
ട. Intended Use
The ART Breast Brachytherapy Applicator is a rigid applicator intended for use with Nucletron remote afterloading equipment for non-invasive brachytherapy. The applicator provides a means of positioning the HDR source near the breast to deliver radiation dose to the underlying tissue in areas of intact skin.
6. Comparison of Technological Characteristics
9 Linnell Circle Billerica, MA 01821 Tel 978-663-7300
Page 12 of 19
April 28, 2006
1
K60299
K060299
Page 2 of 2
All the devices use a surface application approach to provide radiation to tissue via a remote afterloader device; all are intended as accessories to remote afterloaders.
7 Performance Testing
The Advanced Radiation Therapy Breast Brachytherapy Applicator is a passive device. Performance testing was not required.
8 Statement of Equivalency
The ART Breast Brachytherapy Applicator is substantially equivalent to the predicates, which provide the same or similar functions. The intended use, statement of indications, and technological and performance characteristics of the ART Breast Brachytherapy Applicator supports the concept of substantial equivalence.
9 Linnell Circle Billerica, MA 01821 Tel 978-663-7300
Page 13 of 19
April 28, 2006
2
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 depiction of an eagle or bird-like figure with outstretched wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird symbol.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
JUN -6 2006
Mr. Raymond J. Bricault Jr. Chief Operating Officer Advanced Radiation Therapy, LLC 9 Linnell Circle BILLERICA MA 01821-3902
Re: K060299
Trade/Device Name: ART Breast Brachytherapy Applicator Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAO Dated: April 28, 2006 Received: May 1. 2006
Dear Mr. Bricault:
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/2/Picture/10 description: The image is a black and white circular logo. The logo has the letters "FDA" in a bold font in the center. Above the letters, the years "1906-2006" are printed. Below the letters, the word "Centennial" is printed in a cursive font. Three stars are printed below the word "Centennial".
Protecting and Promoting Public Health
3
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.
This letter will allow you to begin marketing your device as described in your Section 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:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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
4
Indications for Use
Kubo299
510(k) Number (if known):
Device Name: ART Breast Brachytherapy Applicator
Indications for Use:
The ART Breast Brachytherapy Applicator is a rigid applicator intended for use with Nucletron remote afterloading equipment for non-invasive brachytherapy. The applicator provides a means of positioning the HDR source on the periphery of the breast to deliver radiation dose to the underlying tissue in areas of intact skin.
Prescription Use X
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Legemann
(Division Sign-C Division of Repr and Radiolog 510k) Nut
**
9 Linnell Circle Billerica, MA 01821 Tel 978-663-7300
Page 5 of 1
r
April 28, 2006