(22 days)
The MultiCare Platinum device combines the function of a standard x-ray mammography unit with that of a stereotactic lesion localization system to produce a device that has specific application in first localizing, and then giving a physician the capacity of performing Fine Needle Aspiration or core biopsy of lesions determined to be suspicious through prior mammographic examination.
The MultiCare Platinum device combines the function of a standard x-ray mammography unit with that of a stereotactic lesion localization system.
The provided text is a 510(k) summary for the MultiCare Platinum mammographic x-ray system. This document focuses on demonstrating substantial equivalence to predicate devices based on regulatory compliance and design specifications, rather than clinical performance studies using AI algorithms or human reader studies. Therefore, many of the requested elements are not present in the provided text.
Here is an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Design Standards) | Reported Device Performance |
|---|---|
| UL Standard 2601-1 (Electrical Safety) | Designed for classification to, and presumed to meet, this standard. |
| CSA Standard C22.2 No. 601.1-M9 (Electrical Safety - Canada) | Designed for classification by, and presumed to meet, this standard. |
| IEC-601-1 (Medical Electrical Equipment) | Designed for certification to, and presumed to meet, this standard. |
| Federal Performance Standards for Ionizing Radiation Emitting Products (21 CFR 1020) | Tested and conforms to these standards. |
| American College of Radiology (ACR) Accreditation Standards (Image Quality & Dose Limits) | Designed to meet the requirements for ACR accreditation. |
| User-Friendly and Comprehensive Operator's Manual (Ensuring Safe & Effective Operation) | A comprehensive Operator's Manual is provided, ensuring safe and effective operation. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The 510(k) summary focuses on engineering and regulatory compliance, not on clinical performance testing with a specific test set of images or patient data.
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)
This information is not provided in the document. Ground truth establishment with experts is typical for clinical performance studies, which are not detailed here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
There is no indication that an MRMC comparative effectiveness study was done. The device described is a mammographic x-ray system, not an AI-powered diagnostic tool. The submission is a traditional 510(k) for a medical imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is an imaging system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided as there are no clinical performance studies detailed that would require a ground truth. The "ground truth" for this submission revolves around meeting technical and safety standards.
8. The sample size for the training set
This information is not provided. This concept is relevant for AI algorithms, which are not the subject of this 510(k) summary.
9. How the ground truth for the training set was established
This information is not provided. This concept is relevant for AI algorithms, which are not the subject of this 510(k) summary.
Summary of Device and Acceptance Criteria Pertaining to the Provided Text:
The K030666 510(k) submission for the MultiCare Platinum System and Accessories primarily establishes safety and effectiveness by demonstrating compliance with international and national electrical safety standards (UL 2601-1, CSA C22.2 No. 601.1-M9, IEC 601-1), federal radiation performance standards (21 CFR 1020), and design adherence to American College of Radiology (ACR) accreditation requirements for image quality and dose. The "study" proving these criteria are met consists of the design and testing processes undertaken by the manufacturer to ensure the device meets these established engineering and regulatory benchmarks, as well as the provision of a comprehensive operator's manual. No clinical performance studies with patient data, AI algorithms, or human reader evaluations are described in this summary. The FDA's substantial equivalence determination is based on this regulatory and design compliance against predicate devices.
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KD306666
1.3 Safety and Effectiveness 510(k) Summary
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- The Multicare Platinum has been designed for classification to Underwriters Laboratories, Inc. (UL) to Standard 2601-1
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- The Multicare Platinum has been designed for classification by Underwriters Laboratories, Inc. to Canadian Standards Association, CSA Standard C22.2 No. 601.1-M9
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- The Multicare Platinum has been designed for certification to International Electrotechnical Commission Standard IEC-601-1
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- The Multicare Platinum is tested and conforms to the Federal Performance Standards for Ionizing Radiation Emitting Products, defined in 21 CFR 1020
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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 Multicare Platinum 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 Multicare Platinum
This information is provided pursuant to the requirements of the Safe Medical Devices Act of 1990 (SMDA).
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 5 2003
Ms. Gail Yaeker-Daunis Sr. Quality/Regulatory Specialist Lorad, A Hologic Company 36 Apple Ridge Road DANBURY CT 06810
Re: K030666
Trade/Device Name: MultiCare Platinum System and Accessories Regulation Number: 21 CFR 892.1710 Regulation Name: Mammographic x-ray system Regulatory Class: II Product Code: 90 IZH Dated: February 27, 2003 Received: March 3, 2003
Dear Ms. Yaeker-Daunis:
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 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 the 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" (21CFR Part 807.97) you may obtain. 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. 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):
K03066
Device Name: Multicare Platinum
Intended Use:
The MultiCare Platinum device combines the function of a standard x-ray mammography unit with that of a stereotactic lesion localization system to produce a device that has specific application in first localizing, and then giving a physician the capacity of performing Fine Needle Aspiration or core biopsy of lesions determined to be suspicious through prior mammographic examination.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use 21 CFR 801.109
OR
Over-the-Counter Use
Nancyc Burgdon
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ___
§ 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.