(624 days)
Not Found
No
The device description and intended use clearly describe a standard mechanical needle and hookwire device for localization, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No
The device is described as a localization tool to identify the location of abnormalities, not to treat them.
No
The device is described as a needle and hookwire device used for localization, which is an interventional tool, not a diagnostic one. Its purpose is to mark a location for subsequent intervention, not to diagnose a condition.
No
The device description explicitly states it is a "standard needle and hookwire device," which are physical hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to identify the location of a soft tissue abnormality using imaging techniques. This is a localization function, not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The device is described as a needle and hookwire, which are instruments used for physical localization within the body, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing chemical or biological tests, or providing diagnostic information based on the analysis of these samples.
IVD devices are typically used to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device's function is purely to mark a location within the body for subsequent procedures or imaging.
N/A
Intended Use / Indications for Use
The device is intended for use to identify by standard radiologic mark or techniques (X-Ray, fluoroscopy, CT, MRI) the location of a soft tissue abnormality such as a cyst, lesion, or tumor.
Product codes
MIG
Device Description
The TumorLocalizer MRI is a standard needle and hookwire device used for the localization of non-palpable lesions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray, fluoroscopy, CT, MRI
Anatomical Site
Soft tissue
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)
K863848, K914941, K915417, K863090, K920816
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image shows the logo for Ferguson Medical. The logo consists of a stylized letter "M" on the left, followed by the words "FERGUSON" and "MEDICAL" stacked on top of each other on the right. The logo is black and white.
962615
916-342-4133 FAX: 916-343-4541
MAR 1 9 1998
15 May 1996
510 (k) SUMMARY
The 510(k) summary information required by 21 CFR 807.92 is as follows:
- Needle, tumor localization, Classification name: A . or guide, surgical, needle, or other.
- Common/usual name: Tumor localizer, lesion marker, and others.
TumorLocalizer MRI Proprietary name:
- equivalence: Manan Breast Tumor B. Substantial Breast Localization Needle (K863848), Simon Lesion Localization Needle (K914941), MD Tech Kopan Target (K915417), E-Z-Em PercuGuide I E-Z-Em PercuGuide Lesion Marking (K863090), device (K920816), and others.
- The TumorLocalizer MRI is a C. Device description: standard needle and hookwire device used for the localization of non-palpable lesions.
- D. Intended Use: The device is intended for use to identify by standard radiologic mark or techniques (X-Ray, fluoroscopy, CT, MRI) the location of a soft tissue abnormality such as a cyst, lesion, or tumor.
1
- Technological characteristics: The TumorLocalizer E. MRI is similar to predicate devices in its design, function, and intended use.
The proposed device is different than some tumor localizers in its wire configuration, sizes and gauges of the wire and needle, and shape and operation of the handpiece.
Submitted, FERGUSON MEDICAL FDA Establishment Registration Number 2937794
Fraule Foye
Frank Ferguson Official Correspondent
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three overlapping human profiles facing to the right, creating a sense of depth and unity.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR | 9 1998
Mr. Frank Ferguson Ferguson Medical 3407 Bay Avenue 95973 Chico, California
K962615 Re: TumorLocalizer MRI Trade Name: Requlatory Class: II Product Code: MIG Dated: December 26, 1997 Received: January 5, 1998
Dear Mr. Ferguson:
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 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 895. ਬੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please 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 requlations.
3
Page 2 - Mr. Ferguson
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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,
Stephen Rhodes
M. Witten, Ph.D., M.D. lirector Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K96261 510(k) Number (if known):
Device Name: TumorLocalizer MRI
Indications For Use:
The device is intended for use to mark or identify, by standard radiologic techniques (X-Ray, fluoroscopy, CT, MRI) the location of a soft tissue abnormality such as a cyst, lesion, or tumor.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Stiphen Rhodes
Prescription Use × (Per 21 CFR 801.109)
OR
Over-The-Counter Use
. .
(Optional Format 1-2-96)