(33 days)
K9738568
No
The description focuses on using stereo images and geometric calculations to determine lesion location, with no mention of AI/ML terms or processes.
No.
The device is used for guidance in biopsy procedures, not for treating a disease or condition.
No
Explanation: The device is described as a guidance system for biopsy procedures, not for interpreting medical images or diagnosing conditions. It assists in precise needle placement based on pre-determined lesion coordinates.
No
The device description explicitly states it uses "two stereo images on a film" and is used to "position a needle holder". This indicates the device includes hardware components (film reader, needle holder positioning mechanism) in addition to any software used for coordinate determination.
Based on the provided information, the Biopsy-M 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.
- Biopsy-M Function: The Biopsy-M device is used for guiding procedures (fine needle aspiration, needle biopsy, guide wire placement) within the body based on imaging. It does not analyze samples taken from the body.
The device's function is to assist in the localization and targeting of a lesion within the breast using mammographic images, which is an in vivo (within the living body) process.
N/A
Intended Use / Indications for Use
The intended uses of the Biopsy M are mammographic procedures requiring stereotactic guidance, such as fine needle aspiration. needle biopsy and guide wire placement. The intended uses are
identical to those of the predicate device.
Product codes (comma separated list FDA assigned to the subject device)
90IZH
Device Description
The Biopsy-M device uses two stereo images on a film to determine the location of a lesion in three dimensions. Once the coordinates of the lesion are determined by the Biopsy-M they are used to position a needle holder such that when the physician inserts the needle or guide-wire, the tip will be precisely positioned at the pre-determined coordinates.
The Biopsy-M works on the same principle as human binocular vision. Two images of the same object are taken with the x-ray source in two different positions. Objects between the source and film plane appear at a different location as the source is moved from position A to B as shown in the figure below. Since the geometry of the system is fixed, given the apparent position of the object in the two views, shown as C and D in the figure, the true position of the object can be calculated.
Mammography has been demonstrated to be the best imaging choice for screening of women for breast cancer by many studies and is currently recommended as a routine procedure for women over 50 years of age. Mammography, however, has been shown to have a high rate of false positive examinations. Stereotactic needle localization has been shown to be a minimally invasive procedure for obtaining the tissue samples needed determining the lesion type for a positive mammography examination. The procedure removes much less tissue than and produces much less scar tissue than conventional surgical biopsy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
mammographic procedures
Anatomical Site
breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Cytoguide (DC K933430)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Giotto HT (Premarket notification K9738568)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Submitter Information: 1.
- 1.1. Submitter: SITCO Incorporated 3456 N. Ridge Ave. #100 Arlington Heights, IL 60004 Phone: (847) 463-2001 FAX: (847) 463-2011
- Manufacturing Facility: 1.2. Internazionale Medico Scientifica S.r.I. Via Pila, 1/8 - 40044 Pontecchio Marconi Bologna, Italy
- 1.3. Contact: Robert H. McCarthy
- 1.4. Date: May 25, 1998
2. Device Name
| 2.1. | Classification Name: | System Mammographic |
|---|---|---|
| 2.1. | Classification Number: | 901ZH |
- 2.2. Biopsy M Trade/Proprietary Name:
- 2.3. Predicate Device: Cytoguide (DC K933430)
Device Description 3.
- 3.1. Function
The Biopsy-M device uses two stereo images on a film to determine the location of a lesion in three dimensions. Once the coordinates of the lesion are determined by the Biopsy-M they are used to position a needle holder such that when the physician inserts the needle or guide-wire, the tip will be precisely positioned at the pre-determined coordinates.
1
Scientific Concepts: 3.2.
The Biopsy-M works on the same principle as human binocular vision. Two images of the same object are taken with the x-ray source in two different positions. Objects between the source and film plane appear at a different location as the source is moved from position A to B as shown in the figure below. Since the geometry of the system is fixed, given the apparent position of the object in the two views, shown as C and D in the figure, the true position of the object can be calculated.
Image /page/1/Picture/3 description: The image shows the words "C D" and "Film Plane" in a diagram. There is a horizontal line that extends from the letters "C D" to the words "Film Plane". There is a small black dot below the line and to the left of the letters "C D".
B A Source
Physical And Performance Characteristics: 3.3.
Mammography has been demonstrated to be the best imaging choice for screening of women for breast cancer by many studies and is currently recommended as a routine procedure for women over 50 years of age. Mammography, however, has been shown to have a high rate of false positive examinations. Stereotactic needle localization has been shown to be a minimally invasive procedure for obtaining the tissue samples needed determining the lesion type for a positive mammography examination. The procedure removes much less tissue than and produces much less scar tissue than conventional surgical biopsy.
Device Intended Use: 4.
- 4.1. The intended uses of the Biopsy M are mammographic procedures requiring stereotactic guidance, such as fine needle aspiration. needle biopsy and guide wire placement. The intended uses are
2
510(k) Summary
identical to those of the predicate device.
5. Device Technological Characteristics:
- The characteristics of the Biopsy-M system compare substantially 5.1. with the Cytoguide predicate device, in both materials used, technology applied, and functional methodology. Differences of note do not affect safety and effectiveness of the device, intended use, or application methods. The device operates in a manner substantially equivalent to other cleared devices in this category, and performs as well as the predicate Cytoguide.
5.2. Biocompatibility
The components of the Cytoguide that come in direct contact with the patient (paddles, supports, holders, Bucky) are of the same materials as the the Giotto HT (Premarket notification K9738568)
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 4 1998
Robert H. McCarthy Vice President Sitco Incorporated 3456 N. Ridge Ave. Arlington Heights, IL 60004 Re:
K982049 Biopsy M (System Mammographic) Dated: June 1, 1998 Received: June 11, 1998 Regulatory class: II 21 CFR 892.1710/Procode: 90 IZH
Dear Mr. McCarthy:
We have reviewed your Section 510/k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in reculatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Thease note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510%) 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Kiilai Yhi
Lillian Yih, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):_
Biopsy - M Device Name:_
Indications For Use:
The intended uses of the Biopsy M are mammographic procedures requiring The intended uses of the bloppy in as fine needle biopsy and guide wire placement.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David G. Heyman
(Division Sign-Off) 4 Division of Reproductive, Abdominal, EN and Radiological Devices
510(k) Number K982049
Prescription Use_ V (Per 21 CFR 801.109) હત્વ
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)