(44 days)
Not Found
LUNAR Spine Morphometry Software Option, Radiographic identification of Vertebral Deformities, CT Scout views
No
The summary describes a software option for bone densitometers that allows for visual or quantitative assessment of vertebral deformities. It mentions image processing is "Not Found" and explicitly states "Mentions AI, DNN, or ML: Not Found". There is no indication of AI/ML in the intended use, device description, or any other provided sections.
No.
The device is used for assessment and evaluation of vertebral deformities, which is a diagnostic function, not a therapeutic one. It provides information for diagnosis rather than directly treating a condition.
Yes
The device is intended for "visual or quantitative assessment of vertebral body deformities," which clearly indicates a diagnostic purpose.
Yes
The device is described as a "Software Option" for existing hardware (Hologic X-Ray Bone Densitometers) and its function is solely related to the processing and assessment of images acquired by that hardware. There is no mention of new or modified hardware components being part of this submission.
Based on the provided information, this 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.
- Device Function: The MXA-II Software Option for Hologic X-Ray Bone Densitometers is used for the visual or quantitative assessment of vertebral body deformities based on X-ray images. This is an in vivo diagnostic process, meaning it's performed on the living body, not on a sample taken from the body.
The device analyzes images obtained directly from the patient's body using an X-ray machine, which falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The intended use of the MXA-II Software Option for the Hologic X-Ray Bone Densitometers is to allow the visual or quantitative assessment of vertebral body deformities.
Product codes (comma separated list FDA assigned to the subject device)
90 KGI
Device Description
The imaging protocols and acquisition software of the MXA-II software option are the same as the Hologic Vertebral Morphometry software program. Using the MXA-II option, the patient would be scanned as under the currently distributed vertebral morphometry option. In the MXA-II option, however, the vertebral deformities can be evaluated either quantitatively or visually.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
Vertebral body
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.
Hologic Vertebral Morphometry Software Option
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.
LUNAR Spine Morphometry Software Option, Radiographic identification of Vertebral Deformities, CT Scout views
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
§ 892.1170 Bone densitometer.
(a)
Identification. A bone densitometer is a device intended for medical purposes to measure bone density and mineral content by x-ray or gamma ray transmission measurements through the bone and adjacent tissues. 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
1 1999
OCT
વું વ MXA-II Software Option 510(k) Premarket Notification
510(K) SUMMARY
MXA-II software option for the X-Ray Bone Densitometers
| Submitter Name: | Hologic, Incorporated |
|---|---|
| Submitter Address: | 35 Crosby Drive |
| Bedford, MA 01730 | |
| Contact Person: | Nandini Murthy, Regulatory Scientist |
| Phone Number: | (781) 999-7300 |
| Fax Number: | (781) 280-0662 |
| Date Prepared: | August 17, 1999 |
| Device Trade Name: | Hologic® QDR® X-Ray Bone Densitometers |
| Device Common Name: | X-Ray Bone Densitometer |
| Predicate Devices: | Hologic Vertebral Morphometry Software Option |
| LUNAR Spine Morphometry Software Option | |
| Radiographic identification of Vertebral Deformities | |
| CT Scout views | |
| Device Description: | The imaging protocols and acquisition software of the MXA-II |
| software option are the same as the Hologic Vertebral | |
| Morphometry software program. Using the MXA-II option, the | |
| patient would be scanned as under the currently distributed | |
| vertebral morphometry option. In the MXA-II option, however, | |
| the vertebral deformities can be evaluated either quantitatively | |
| or visually. | |
| Intended Use: | The product is a software option for the Hologic x-ray bone |
| densitometers, allowing the visual or quantitative assessment of | |
| vertebral body deformities |
1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
001 1 1999
Nandini Murthy, RAC Regulatory Scientist Hologic, Inc. 35 Crosby Drive Bedford, MA 01730-1401 RE;
MXA-II Software Dated: August 17, 1999 Received: August 18, 1999 Regulatory Class: II 221 CFR 892.1170/Procode: 90 KGI
Dear Ms. Murthy:
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 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 redassified 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 defermination assumes compliance with the Current Good Manufacturing Practice requirements, 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 Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory 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.
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) 594-4613. 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 requlation entitled. "Misbranding by reference to premarket notification"(21 CFR 807.97). Qther 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/dsma/dsmamain.html".
Sincerely yours,
Dan Detist
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
ਸੀ। Enclosure
2
| Page | |
|---|---|
| of |
510(k) Number (if known): _
Device Name:
Indications For Use:
The intended use of the MXA-II Software Option for the Hologic X-Ray Bone Densitometers is to allow the visual or quantitative assessment of vertebral body deformities.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Javid A. Sygm
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological D 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)