(104 days)
No
The device description and performance study summary indicate a passive, physical applicator with no mention of software, algorithms, or data processing that would suggest AI/ML.
Yes
This device is a shielded breast applicator used for non-invasive brachytherapy, which is a form of radiation therapy to treat the breast. This directly indicates a therapeutic purpose.
No
Explanation: The device is an applicator used for non-invasive brachytherapy treatment, not for diagnosing conditions. Its purpose is to deliver radiation, not to identify or characterize diseases.
No
The device description clearly describes a physical applicator with different sizes, indicating it is a hardware device used in brachytherapy.
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 of the breast." This is a therapeutic procedure, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a physical applicator used to deliver radiation to the breast. It doesn't mention analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document doesn't mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other biological samples.
- Detecting or measuring substances in these samples.
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.
This device is a therapeutic medical device used for delivering radiation treatment.
N/A
Intended Use / Indications for Use
The ART Shielded Breast Applicator is intended for use with Nucletron or Varian remote afterloading HDR equipment for non-invasive brachytherapy of the breast in areas of intact skin.
Product codes
JAQ
Device Description
The Advanced Radiation Therapy (ART) Shielded Breast Applicator is used for non-invasive HDR treatment of the breast. The applicator is designed to be positioned either external to a mammography style paddle which immobilizes the breast or directly against the breast with intact skin. Once the target has been immobilized and imaged the applicator is placed such that it is aligned with the target. The exterior shielding of the applicator will reduce dose to the surrounding tissue. The applicator is available in 5 sizes - 4, 5, 6, 7 and 8 cm ID.
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
The Advanced Radiation Therapy Shielded Breast Applicator is a passive device. Performance testing was not required.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Advanced Radiation Therapy
July 25, 2006
ART Shielded Breast Applicator Premarket Notification 510k Summary of Safety and Effectiveness
ART Shielded Breast Applicator
1. Sponsor Name
NOV - 7 2006
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 Shielded Breast Applicator
3. Identification of Predicate or Legally Marketed Device
Advanced Radiation Therapy - ART Breast Brachytherapy Applicator -K060299 Mick Nuclear - HDR-IORT Shielded Applicator - K052351 Varian Medical Systems - Shielded Applicator Set - K033371
ﻬﺎ Device Description
The Advanced Radiation Therapy (ART) Shielded Breast Applicator is used for non-invasive HDR treatment of the breast. The applicator is designed to be positioned either external to a mammography style paddle which immobilizes the breast or directly against the breast with intact skin. Once the target has been immobilized and imaged the applicator is placed such that it is aligned with the target. The exterior shielding of the applicator will reduce dose to the surrounding tissue. The applicator is available in 5 sizes - 4, 5, 6, 7 and 8 cm ID.
5. Intended Use
The ART Shielded Breast Brachytherapy Applicator is intended for use with Nucletron or Varian remote afterloading systems for non-invasive brachytherapy in areas of intact skin.
6. Comparison of Technological Characteristics
The predicate devices and the ART Shielded Applicator are used 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 Shielded Breast Applicator is a passive device. Performance testing was not required.
1
Advanced Radiation Therapy July 25, 2006 ART Shielded Breast Applicator Premarket Notification
Statement of Equivalency
The ART Shielded Breast 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 Shielded Breast Applicator support the concept of substantial equivalence.
2
Image /page/2/Picture/1 description: The image shows a logo for the Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Mr. Ravmond J. Bricault Jr. Chief Operating Officer Advanced Radiation Therapy, LLC 9 Linnell Circle BILLERICA MA 01821-3902
NOV - 7 2006
Re: K062135
Trade/Device Name: ART Shielded Breast Applicator Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAQ Dated: October 6, 2006 Received: October 10, 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 contains the text "1906-2006" at the top, followed by the letters "PA" in a bold, stylized font. Below the letters, the word "Centennial" is written in a cursive font. There are four stars at the bottom of the logo.
Protecting and Promoting Public Health
3
Page 2 -
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r reast be advised that I Driv issually in that your device complies with other requirements of the Act that I DA has made a regulations administered by other Federal agencies. You must of any I cacal surates und regarants, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CITY at 807), adomig (21 OF N P 21 CFR Part 820); and if applicable, the electronic forum in all quality systems (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) This letter will anow you'ls cognitudios of substantial equivalence of your device to a legally premarket notication: "The PDF intems
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 If you desire specific advise to your 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 (21GT K Fall 607.97): "100 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/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
July 25, 2006 Advanced Radiation Therapy ART Shielded Breast Applicator Premarket Notification Indications for Use
510(k) Number (if known):
Device Name: ART Shielded Breast Applicator
Indications for Use:
The ART Shielded Breast Applicator is intended for use with Nucletron or Varian remote afterloading HDR equipment for non-invasive brachytherapy of the breast in areas of intact skin.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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. Leagrom
(Division Sign-Off) Division of Reproductive, Abdominal. and Radiological Devices
510(k) Number K062135