(43 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or related concepts, and the description of the software's function (determining location based on fiducials) does not inherently require AI/ML.
No
The device is used to determine the precise location of a target for radiotherapy or radiosurgery, which are therapeutic procedures, but the device itself is a localization system, not a device that directly performs therapy.
No
The device is used to determine the precise location of a target for treatment, not to diagnose a condition.
Unknown
The provided text is a 510(k) summary, but it lacks the "Device Description" section, which is crucial for determining if the device is software-only. The "Intended Use" mentions a "Breast Localization System" and "implanted fiducials," which strongly suggests a hardware component (the fiducials and potentially a system to interact with them). Without a device description, it's impossible to definitively rule out hardware.
Based on the provided information, the ACCULOC Breast Localization System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- ACCULOC's Function: The provided description states that the ACCULOC system is used for "lesions requiring extracranial stereotactic radiotherapy or radiosurgery to the breast." It uses software to "determine the precise location of the target with respect to implanted fiducials." This describes a system used in vivo (within the living body) for guiding radiation therapy, not for testing samples in vitro.
Therefore, the ACCULOC Breast Localization System falls under the category of a medical device used for treatment planning and delivery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The indications for use of ACCULOC Breast Localization System (formerly MAMMOLOC) are lesions requiring extracranial stereotactic radiotherapy or radiosurgery to the breast. The software is used to determine the precise location of the target with respect to implanted fiducials.
Product codes
IYE
Device Description
Not Found
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)
Not Found
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.
Not Found
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
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Lee Myers, M.D. Director of Operations Northwest Medical Physics Equipment, Inc. 21031 67th Ave W LYNNWOOD WA 98036
DEC 1 2 2006
Re: K063274
Trade/Device Name: ACCULOC Breast Localization System (formerly MAMMOLOC) Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: October 26, 2006 Received: October 30, 2006
Dear Dr. Myers:
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/0/Picture/9 description: The image is a circular seal or logo. The text "1906-2006" is at the top of the seal. The letters "PA" are in the center of the seal in a bold font. The word "Centennial" is below the letters "PA". Three stars are at the bottom of the seal.
Protecting and Promoting Public Health
1
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 (QS) 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.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 the Act from the Division of Small 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. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Section 4. Indications for Use Statement
510 (k) Number (if known): (new product)
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The indications for use of ACCULOC Breast Localization System (formerly MAMMOLOC) are lesions requiring extracranial stereotactic radiotherapy or radiosurgery to the breast.
The software is used to determine the precise location of the target with respect to implanted fiducials.
Prescription Use Over-The-Counter Use Prescription Use
(Part 21 CFR 801 Subpart D) AMD/OR (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Sezerman
(Division Sign-Off) Division of Reproductive, Abdomi and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
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(Posted November 13, 2003)