(24 days)
KS09810, K954521
Not Found
No
The description details a mechanical and software-assisted system for needle localization based on user input of coordinates from stereotactic images. There is no mention of automated image analysis, pattern recognition, or learning algorithms that would indicate AI/ML. The software appears to be a calculation and guidance tool based on user-provided data.
No.
The device is an accessory to mammography equipment designed to assist in performing a pre-surgical, stereotactic needle localization procedure. It aids in diagnosis and procedure guidance rather than directly treating a disease or condition.
No
The device is an accessory to mammography equipment designed to assist in pre-surgical stereotactic needle localization procedures. It is used to stabilize the breast and guide needle placement for biopsy or other procedures, not for making a diagnosis itself.
No
The device description explicitly mentions hardware components like a compression unit, guidance frame, and needle holder, which are integral to its function and are not solely software.
Based on the provided information, the TraxyLoc™-1 System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- TraxyLoc™-1 Function: The TraxyLoc™-1 System is an accessory to mammography equipment used during a medical procedure (stereotactic needle localization) on the patient's body. It assists in guiding a needle for subsequent biopsy or other procedures. It does not analyze specimens taken from the body.
The device's function is to aid in a surgical/interventional procedure, not to perform diagnostic testing on biological samples.
N/A
Intended Use / Indications for Use
The TraxyLoc™-1 System is a near-real time, image-guided accessory to mammography equipment designed to stabilize a patient's breast and assist a qualified physician in performing a pre-surgical, stereotactic needle localization procedure to target one or more mammographically previously discovered abnormalities for subsequent biopsy or other procedures.
Product codes
JZH
Device Description
The TraxyLoc™-1 System is designed for, pre-surgical use in a stereotactic needle The TraxyEoo - - ByBoraphically previously discovered breast abnormalities. The 100ailed of mainmostabilization and needle guidance for accurate placement of localization needles at positions of suspected abnormalities in the breast.
The device is intended for appropriately trained and qualified physicians, radiologists, and radiology/medical technicians who have previously performed manual and/or stereotactic needle localizations procedures.
The TraxyLoc™-1 System stabilizes the breast in a compression unit which is attached to the mammography equipment. After obtaining two images sterentactically (horizontal and vertical images) the previously identified breast artifact is identified and located on the Overlay Grids. The view orientation and artifact location data is then entered into the Traxalign™ software and the system settings for performing a needle localization are obtained. The localization needle is southings to personally holder. The needle holder is then placed onto the guidance frame as per the software directions. The needle is inserted into the breast as per a typical manual needle localization procedure. At least one confirmatory mammography image should be taken to ensure the position of the needle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
mammography
Anatomical Site
patient's breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
appropriately trained and qualified physicians, radiologists, and radiology/medical technicians
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
Bench testing was performed to ensure that the device performs as intended. All testing demonstrated satisfactory performance of the device.
- The image quality of the breast artifact with the device is equivalent to current . standards.
- The breast stabilizer compresses the breast comfortably, does not impact . image quality, and does not uncompress during the procedure.
- The software accuracy of the needle placement is +/-1mm. Note this accuracy . is dependent upon accurate user data input, needle straightness, breast density and user attention to needle assembly positioning. At least one and sometimes a pair of post needle localization confirmatory X-ray images are required as part of standard practice.
Key Metrics
software accuracy of the needle placement is +/-1mm.
Predicate Device(s)
Lorad Digital Spot Mammography KS09810, Mammospot Paddle K954521
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
90 JZH 892.1710
Traxyz Medical Inc. TraxyLoc™-1 System 510(k) Summary 10.0
KOSOGG 3 .
APR 8 2005
Company:
Traxyz Medical, Inc. 200 Highland Avenue Suite 301 Needham, MA 02494
Contact:
SON Medical 290 Turnpike Road, #323 Westborough, MA 01581 F. David Rothkopf
Date Prepared:
March 7, 2005
Name of Device:
Traxyz Medical Inc. TraxyLocTM-1 System
Predicate Device:
Lorad Digital Spot Mammography KS09810 Mammospot Paddle K954521
Intended Use:
The TraxyLoc™-1 System is a near-real time, image-guided accessory to mammography equipment designed to stabilize a patient's breast and assist a qualified physician in performing a pre-surgical, stereotactic needle localization procedure to target one or more mammographically previously discovered abnormalities for subsequent biopsy or other procedures.
ાવ
CONFIDENTIAL March 2005
1
Device Description:
The TraxyLoc™-1 System is designed for, pre-surgical use in a stereotactic needle The TraxyEoo - - ByBoraphically previously discovered breast abnormalities. The 100ailed of mainmostabilization and needle guidance for accurate placement of localization needles at positions of suspected abnormalities in the breast.
The device is intended for appropriately trained and qualified physicians, radiologists, and radiology/medical technicians who have previously performed manual and/or stereotactic needle localizations procedures.
The TraxyLoc™-1 System stabilizes the breast in a compression unit which is attached to the mammography equipment. After obtaining two images sterentactically (horizontal and vertical images) the previously identified breast artifact is identified and located on the Overlay Grids. The view orientation and artifact location data is then entered into the Traxalign™ software and the system settings for performing a needle localization are obtained. The localization needle is southings to personally holder. The needle holder is then placed onto the guidance frame as per the software directions. The needle is inserted into the breast as per a typical manual needle localization procedure. At least one confirmatory mammography image should be taken to ensure the position of the needle.
Technological Characteristics:
The technological characteristics of the new device are less than those of the predicate device.
Performance Data:
Bench testing was performed to ensure that the device performs as intended. All testing demonstrated satisfactory performance of the device.
- The image quality of the breast artifact with the device is equivalent to current . standards.
- The breast stabilizer compresses the breast comfortably, does not impact . image quality, and does not uncompress during the procedure.
- The software accuracy of the needle placement is +/-1mm. Note this accuracy . is dependent upon accurate user data input, needle straightness, breast density and user attention to needle assembly positioning. At least one and sometimes a pair of post needle localization confirmatory X-ray images are required as part of standard practice.
This information is provided pursuant to the requirements of the Safe Medical Devices Act of 1990 (SMDA).
Traxyz Medical, Inc. 510(k)
15
2
Image /page/2/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around the edge. In the center of the seal is a stylized image of an eagle with its wings spread.
Public Health Service
APR 8 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Traxyz Medical, Inc. % Mr. F. David Rothkopf President SON Medical 290 Turnpike Road, #323 WESTBOROUGH MA 01581 Re: K050663
Trade/Device Name: TrazyLocTM-1 System Regulation Number: 21 CFR 892.1710 Regulation Name: Mammographic x-ray system
Regulatory Class: II Product Code: IZH Dated: March 9, 2005 Received: March 15, 2005
Dear Mr. Rothkopf:
. Dear Mr. Rothkopt:
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.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin manketing your and equivalence of your device to a legally premarket nothleation. The PDA mianing of backannal system 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 If you desire specific advice for your dories on on 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 notifications the Also, please note the regulation entired, "Theorananages on your responsibilities under the Act from the 807.97). You may obtain outcr general information on your Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Ko50663 510(k) Number (if known):
Device Name: TraxyLocTM-1 System
Intended Use:
The TraxyLoc™-1 System is a near-real time, image-guided accessory to mammography equipment designed to stabilize a patient's breast and assist a qualified physician in performing a pre-surgical, stereotactic needle localization procedure to target one or more mammographically previously discovered abnormalities for subsequent biopsy or other procedures.
(Please do not write below this line – Continue on another page if necessary)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Nancy Brogdon | |
|---|---|
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, | |
| and Radiological Devices | |
| 510(k) Number | K050663 |
| Prescription Use | OR | Over-the-Counter Use |
|---|---|---|
| 21 CFR 801.109 |
7
Traxyz Medical, Inc. 510(k)
CONFIDENTIAL March 2005