(69 days)
No
The summary describes a digital imaging device for verifying tissue samples from breast biopsies. There is no mention of AI, ML, image processing beyond basic digital imaging, or any data sets or performance metrics typically associated with AI/ML algorithms.
No.
The MammoPath is used for digital imaging of harvested specimens to verify correct tissue excision during biopsy, which is a diagnostic and verification function, not a therapeutic one.
No
The device is used for digital imaging of harvested specimens to verify that the correct tissue has been excised during a biopsy, rather than for diagnosing a condition itself.
No
The description explicitly states the device is used for "digital imaging of the harvested specimen," implying a hardware component for image acquisition. It also mentions being used "as a stand-alone unit," further suggesting a physical device beyond just software.
Based on the provided information, the MammoPath device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens in vitro (outside the body) to provide information for diagnosis, monitoring, or treatment. This typically involves analyzing biological samples like blood, urine, or tissue using chemical, biological, or immunological methods.
- The MammoPath's intended use is for imaging harvested tissue specimens using Mammographic X-Ray. Its purpose is to visually verify that the correct tissue has been excised during a breast biopsy. This is a form of ex vivo imaging, not an in vitro analysis of the biological properties of the tissue.
- The description focuses on the imaging process and its role in confirming the physical presence of the target tissue. It doesn't mention any analysis of the tissue's composition or biological characteristics.
Therefore, the MammoPath falls under the category of a medical imaging device used for specimen verification, rather than an IVD.
N/A
Intended Use / Indications for Use
The MammoPath can be used with Mammotest® (K861692). Mammotest is a breast biopsy system manufactured by Fischer Imaging, Inc., a dedicated Mammographic device for stereotactically - guided needle biopsy of the breast. Mammotest allows the operator to visualize suspicious breast lesions under Mammographic X-Ray and to guide various tissue acquisition devices to the lesion for tissue harvesting. The Mammopath would then be used for digital imaging of the harvested specimen to provide rapid verification that the correct tissue has been excised during biopsy.
The MammoPath can also be used as a stand-alone unit (without Fischer's Mammotest) and would be used to verify correct tissue sampling any given harvested specimen.
Doing the verification directly in the same room enables cases to be completed faster, thus limiting the time the patient needs to be under examination. Specimen radiography can potentially limit number of patient recalls.
Product codes
90 MWP
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Mammographic X-Ray
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
Public Health Service
Image /page/0/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a stylized eagle emblem. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the emblem. The eagle emblem is composed of three curved lines, representing the department's mission to protect the health of all Americans and provide essential human services.
JUN 1 3 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Samir B. Paliwal Director. Regulatory Affairs and Ouality Assurance Fischer Imaging Corporation 12300 North Grant Street DENVER CO 80241
Re: K021113
Trade/Device Name: Mammopath™M Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: 90 MWP Dated: March 31, 2002 Received: April 5, 2002
Dear Mr. Paliwal:
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.
1
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 yours,
Nancy C. Snogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
ATTACHMENT A
510(k) Number: K021113 Product: Mammopath
INDICATIONS FOR USE
The MammoPath can be used with Mammotest® (K861692). Mammotest is a breast biopsy system manufactured by Fischer Imaging, Inc., a dedicated Mammographic device for stereotactically - guided needle biopsy of the breast. Mammotest allows the operator to visualize suspicious breast lesions under Mammographic X-Ray and to guide various tissue acquisition devices to the lesion for tissue harvesting. The Mammopath would then be used for digital imaging of the harvested specimen to provide rapid verification that the correct tissue has been excised during biopsy.
The MammoPath can also be used as a stand-alone unit (without Fischer's Mammotest) and would be used to verify correct tissue sampling any given harvested specimen.
Doing the verification directly in the same room enables cases to be completed faster, thus limiting the time the patient needs to be under examination. Specimen radiography can potentially limit number of patient recalls.
Prescription Use
David A. Severson