(91 days)
Not Found
No
The summary describes a kit for contrast-enhanced radiography and makes no mention of AI or ML.
No
This device is used for diagnostic imaging (radiography) and not for treating a disease or condition.
Yes
The device is described as performing "contrast media enhanced radiography of the mammary ducts," which is a procedure used to visualize and diagnose conditions of the mammary ducts.
No
The description explicitly refers to a "Galactography kit," which strongly implies the presence of physical components (e.g., instruments, contrast media) in addition to any potential software elements. The description focuses on the procedure and its purpose, not on software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to perform "contrast media enhanced radiography of the mammary ducts." This is a procedure performed on a living patient using imaging, not a test performed on a sample of bodily fluid or tissue in vitro (outside the body).
- Device Description: The description reinforces the intended use of performing a radiographic procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device is used directly on the patient for imaging purposes.
N/A
Intended Use / Indications for Use
The Galactography kit is designed to perform safe and effective, contrast media enhanced radiography of the mammary ducts.
Product codes (comma separated list FDA assigned to the subject device)
FMI
Device Description
The Galactography kit is designed to perform safe and effective, contrast media enhanced radiography of the mammary ducts.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mammary ducts
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): 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.
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.
Not Found
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
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image is a logo for MDTECH MEDICAL DEVICE TECHNOLOGIES INC. The logo is black and white and features the letters "MDTECH" in large, bold font. The letters are stacked on top of each other, with the "MD" on top and the "TECH" on the bottom. The letters are also stylized with horizontal lines running through them. Below the letters, the words "MEDICAL DEVICE TECHNOLOGIES INC" are written in a smaller font.
Gainesville, Florida TEL: 352/338-0440 FAX: 352/338-0662 APR 2 3 1998
510(k) SUMMARY
APPLICANT:
Medical Device Technologies, Inc. 4445-310 SW 35th Terrace Gainesville, FL 32608
§878.4800 Manual surgical instrument
Karl Swartz Quality Assurance Manager
TELEPHONE:
TRADE NAMES:
CONTACT:
(352)338-0440 fax (352)338-0662
Manan™ Galactography Kit
Breast biopsy kit COMMON NAME:
CLASSIFICATION NAME:
SUBSTANTIAL EQUIVALENCE:
| Company Name | Product Name | 510(k) No. |
|---|---|---|
| Manan Medical Products | Galactography Kit | K881671 |
DESCRIPTION OF DEVICE:
The Galactography kit is designed to perform safe and effective, contrast media enhanced radiography of the mammary ducts.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 23 1998
Mr. Karl Schwartz Quality Assurance Manager Medical Device Technologies Inc. 4445-310 SW 35th Terrace Gainsville, Florida 32608
Re: K980227 Trade Name: Manan™ Galactography Kit Regulatory Class: II Product Code: FMI Dated: January 21, 1998 Received: January 22, 1998
Dear Mr. Schwartz:
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 The general controls provisions of the Act of the Act. include requirements for annual reqistration, 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. ਸ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set ... forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements 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 regulations.
2
Page 2 - Mr. Schwartz
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 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.qov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and ... . ... Radiological Health
Enclosure
3
Image /page/3/Picture/0 description: The image is a logo for MDTECH Medical Device Technologies INC. The logo is black and white and features the text "MDTECH" in large, bold letters. Below the text "MDTECH" is the text "MEDICAL DEVICE TECHNOLOGIES INC" in smaller letters. The logo has a rectangular shape with rounded corners.
4445-310 S.W. 35th Terrace Gainesville, Florida 32608 TEL: 352/338-0440 FAX: 352/338-0662
Page_1_of_1_
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Manan™ Galactography Kit
Indications for Use:
The Galactography kit is designed to perform safe and effective, contrast media enhanced radiography of the mammary ducts.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | R980227 |
Prescription Use
(Per 21 CFR 801.109) X
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)