(87 days)
To provide a platform to conduct minimally invasive breast biopsy procedures.
A biopsy system, which uses x-ray guidance for stereotactic localization, that allows the physician to accurately place a biopsy needle for the retrieval of tissue samples in the area of concern. The tissue removed will require further evaluation through pathological assessment.
The system, in combination with the Kuske Breast Applicator Set and the Comfort Catheter System, can also be used as a table platform to perform Interstitial Brachytherapy procedures. The Kuske Breast Applicator Set and the Comfort Catheter System are stand alone items that do not attach to the system. The table platform is utilized as a means to image the area of interest and to image the template for placement of the catheters.
Not Found
I am sorry, but the provided text is a 510(k) clearance letter for the MammoTest® device and not a study report. It does not contain the detailed information about acceptance criteria and study results you requested. Therefore, I cannot generate the specific table and answer the questions based on the input.
The document primarily states that the FDA has reviewed the device and found it substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It also lists the indications for use of the MammoTest® system.
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Public Health Service
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OCT 2 9 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Robert G. Schueppert Manager of Regulatory Affairs Fischer Imaging Corp. 12300 North Grant Street DENVER CO 80241
Re: K042095
Trade/Device Name: MammoTest® Regulation Number: 21 CFR 892.1710 and 892.5700 Regulation Name: Mammographic x-ray system Regulatory Class: II Product Code: 90 IZH and JAQ Dated: September 15, 2004 Received: September 21, 2004
Dear Mr. Schueppert:
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.
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 devicc 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.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmaldsmamain.html
Sincerely yours,
Nancy C. Brogdon
Nancy C. I rogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):__K042095
Device Name:__________________________________________________________________________________________________________________________________________________________________ MammoTest ®
Indications For Use:
To provide a platform to conduct minimally invasive breast biopsy procedures.
A biopsy system, which uses x-ray guidance for stereotactic localization, that allows the physician to accurately place a biopsy needle for the retrieval of tissue samples in the area of concern. The tissue removed will require further evaluation through pathological assessment.
The system, in combination with the Kuske Breast Applicator Set and the Comfort Catheter System, can also be used as a table platform to perform Interstitial Brachytherapy procedures. The Kuske Breast Applicator Set and the Comfort Catheter System are stand alone items that do not attach to the system. The table platform is utilized as a means to image the area of interest and to image the template for placement of the catheters.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C Brogdon
(Division Skin-On
Division of Reproductive, Abdominal,
and Radiological Devices K042095
510(k) Number
Page 1 of 1
§ 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.