(22 days)
The Modified 650 Mammography System is intended to produce radiographic images of the breast. Its specific intended use is for screening and diagnostic mammography. Screening mammography involves the production of images for initial examination for breast cancer diagnosis. Diagnosis mammography involves the production of magnified breast images, crease spot compression views, and the thorough examination of breast determined suspicious through screening mammography by a physician in preparation for biopsy.
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This submission describes a mammography system (Modified 650 Mammography System, also referred to as Affinity System), which is a device for producing radiographic images of the breast for screening and diagnostic mammography. It is not an AI/ML device. The provided text details regulatory compliance and clearances, rather than performance studies of an AI algorithm.
Therefore, the requested information elements related to AI/ML device performance and studies cannot be extracted from the provided text.
Here's a breakdown of what can be extracted, and why other elements cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Design Standards/Certifications) | Reported Device Performance |
|---|---|
| UL Standard 187 (Underwriters Laboratories, Inc.) | Designed for classification to this standard. |
| CSA Standard C22.2 No. 114 (Canadian Standards Association) | Designed for classification to this standard. |
| IEC-601-1 (International Electrotechnical Commission) | Designed for certification to this standard. |
| Federal Performance Standards for Ionizing Radiation Emitting Products (21 CFR 1000) | Tested and conforms to these standards. |
| ACR Standards for image quality and radiation dose limits | Designed to meet requirements for ACR accreditation. |
| User-friendly and comprehensive Operator's Manual | Ensures safe and effective operation (mentioned as a design feature). |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Cannot be extracted. This information is relevant for AI/ML device studies, not for the regulatory compliance and design specifications of a mammography imaging system as described.
3. 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)
- Cannot be extracted. This refers to AI/ML ground truth establishment, which is not applicable here.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Cannot be extracted. This refers to AI/ML study methodologies, not applicable here.
5. 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
- Cannot be extracted. This refers to AI/ML comparative studies, not applicable here.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Cannot be extracted. This refers to AI/ML performance, not applicable here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Cannot be extracted. This refers to AI/ML ground truth, not applicable here.
8. The sample size for the training set
- Cannot be extracted. This refers to AI/ML training data, not applicable here.
9. How the ground truth for the training set was established
- Cannot be extracted. This refers to AI/ML training data ground truth, not applicable here.
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Section 1.0
Safety and Effectiveness 510(k) Summary 1.3
- The Modified 650 Mammography System has been designed for classification to 1. Underwriters Laboratories, Inc. (UL) to Standard 187.
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- The Modified 650 Mammography System has been designed for classification by Underwriters Laboratories, Inc. to Canadian Standards Association, CSA Standard C22.2 No. 114.
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- The Modified 650 Mammography System has been designed for certification to International Electrotechnical Commission Standard IEC-601-1
- The Modified 650 Mammography System is tested and conforms to the Federal ধ Performance Standards for Ionizing Radiation Emitting Products, defined in 21 CFR 1000.
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- The American College of Radiology (ACR) in Reston, Virginia, conducts a nationwide program that accredits providers of mammography services. To qualify for ACR accreditation, the mammography device at a provider site must meet ACR standards for image quality and operation within radiation dose limits. The Modified 650 Mammography System has been designed to meet the requirements for ACR accreditation.
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- A comprehensive Operator's Manual provided with each system is user friendly and comprehensive, thus ensuring safe and effective operation of the Modified 650 Mammography System.
This information is provided pursuant to the requirements of the Safe Medical Devices Act of 1990 (SMDA).
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Image /page/1/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES" are arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 4 2001
Ms. Roaida Rizkallah Regulatory Specialist LORAD Hologic Company 36 Apple Ridge Road DANBURY CT 06810
Re: K013290
Trade/Device Name: Affinity System (Modified 650 Mammography System) Regulation Number: 21 CFR 892.1710 Regulation Name: Mammographic x-ray System Regulatory Class: II Product Code: 90 IZH Dated: October 1, 2001 Received: October 2, 2001
Dear Ms. Rizkallah:
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 (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.
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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 vours,
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
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510(k) Number (if known): K013290
Device Name: Modified 650 Mammography System
Intended Use:
The Modified 650 Mammography System is intended to produce radiographic images of The Modified 630 Miammography Dyston screening and diagnostic manmography. the breast. Its specific intended use is for seroning for initial examination for Screening mammography involves the production of inlinges the production of magnified breast cancer diagnosis. Diagnosus manimography Libreast determined suspicious images for more unorough cxammation of crease spot compression views, and the unrough sereeming maniling - physician in preparation for biopsy.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ملك 21 CFR 801.109
OR
Over-the-Counter Use ___
Vassay C. boordon
(Division Sign-on)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K01329
§ 892.1710 Mammographic x-ray system.
(a)
Identification. A mammographic x-ray system is a device intended to be used to produce radiographs of the breast. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.