(22 days)
Not Found
Not Found
No
The summary describes a standard x-ray mammography unit with stereotactic localization, and explicitly states "Not Found" for mentions of AI, DNN, or ML.
No.
The device is used for localizing lesions and assisting with biopsy procedures, which are diagnostic and interventional, not therapeutic.
No
The device is used for localizing lesions and facilitating biopsies, which are procedures for obtaining samples. While these procedures are critical for determining a diagnosis, the device itself is not described as performing the diagnostic interpretation of those samples, nor is it explicitly stated to diagnose.
No
The device description explicitly states it combines the function of a standard x-ray mammography unit with a stereotactic lesion localization system, indicating it includes hardware components.
Based on the provided information, the MultiCare Platinum device 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.
- MultiCare Platinum function: The description clearly states the device is an x-ray mammography unit combined with a stereotactic lesion localization system. Its purpose is to localize lesions within the body and facilitate procedures like Fine Needle Aspiration or core biopsy. These procedures involve taking samples from the body, but the device itself is used for imaging and guiding the sample collection, not for analyzing the sample in vitro.
The device is a medical imaging and interventional guidance system, not a diagnostic test performed on a sample outside the body.
N/A
Intended Use / Indications for 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.
Product codes
90 IZH
Device Description
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Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray mammography
Anatomical Site
Not Found
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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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Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines that suggest feathers or wings. The overall design is simple and professional, reflecting the official nature of the organization.
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.
2
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 ___