(58 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the software as providing an image for "qualitative visual assessment" and "visual identification," which are manual processes.
No
The device is used for diagnostic assessment (identifying vertebral deformations and estimating vertebral heights) and provides an x-ray image for qualitative visual assessment. It does not provide any therapy or treatment.
Yes
The software provides an x-ray image of the spine for qualitative visual assessment to identify vertebral deformations and estimate vertebral heights (morphometry), which are diagnostic activities. It is also restricted to prescription use by or on the order of a physician, indicating its role in medical diagnosis.
No
The device is described as "Software is used with the Prodigy bone densitometer," indicating it is a software component that operates in conjunction with a hardware device (the bone densitometer), not a standalone software-only medical device.
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 Dual-energy Vertebral Assessment View Software works with a bone densitometer to produce and analyze x-ray images of the spine. This is an in vivo (within the living body) imaging technique, not an in vitro test on a sample.
- Intended Use: The intended use is for qualitative visual assessment of vertebral deformations and estimation of vertebral heights based on the x-ray image. This is a diagnostic process based on imaging, not on analyzing a biological sample.
Therefore, the device falls under the category of medical imaging software used for diagnostic purposes, but it is not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Dual-energy Vertebral Assessment View Software is used with the Prodigy bone densitometer. This software provides an x-ray image of the spine for qualitative visual assessment in order to identify vertebral deformations and estimate vertebral heights (morphometry).
The use of the Prodigy Bone Densitometer is restricted to prescription use only. The operator's manual for the Prodigy contains the following statement:
"United States Federal Law restricts this device to the sale, distribution, and use by or on the order of a physician."
Product codes
90 KGI
Device Description
The Dual-energy Vertebral Assessment View Software enables imaging of the spine for visual identification of vertebral deformities and estimation of vertebral heights (morphometry). Using this software, the patient is scanned as under the currently distributed product. The Dual-energy Vertebral Assessment View Option adds the ability to visually assess the image for identification of vertebral deformations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray image
Anatomical Site
spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription use by or on the order of a 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)
GE Lunar Lateral View software 510(k) K000826, LUNAR EXPERT Morphometry Software 510(k) K950611, Hologic Morphometry II option 510(k) K992775
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image shows the General Electric (GE) logo, which consists of the letters 'G' and 'E' intertwined within a circular frame. The letters are stylized with flowing, cursive-like forms, and the entire logo is presented in black against a white background. The circular frame has three decorative swirls evenly spaced around its perimeter, adding a touch of elegance to the design.
GE Medical Systems LUNAR
GE Lunar Corporation General Electric Company 726 Heartland Trail, Madison, Wi 53717 gemedicalsystems.com
DEC 2 0 2002
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS 10.0
This summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92.
| Contact Person: | James P. Raskob
GE LUNAR Corporation
726 Heartland Trail
Madison, WI 53717 |
|----------------------|-------------------------------------------------------------------------------------|
| Phone:
Fax: | (608) 826-7425
(608) 826-7825 |
| Date: | October 22nd , 2002 |
| Device/Trade Name: | Dual-energy Vertebral Assessment View
Software Option |
| Common Name: | Bone Densitometer |
| Classification Name: | Bone Densitometer
21CFR 892.1170 |
| Predicate Devices: | GE Lunar Lateral View software 510 (k) K000826 |
| | LUNAR EXPERT Morphometry Software
510(k) K950611 |
| | Hologic Morphometry II option
510(k) K992775 |
DESCRIPTION OF THE DEVICE: 10.1
The Dual-energy Vertebral Assessment View Software enables imaging of the spine for visual identification of vertebral deformities and estimation of vertebral heights (morphometry). Using this software, the patient is scanned as under the currently distributed product. The Dual-energy Vertebral Assessment View Option adds the ability to visually assess the image for identification of vertebral deformations.
1
10.2 CONCLUSION
The Prodigy Dual-energy Vertebral Assessment View Software is substantially equivalent to currently marketed software. No new safety and effectiveness questions are raised with the Dual-energy Vertebral Assessment View Software application.
James P. Rasbor
Signed
James P. Raskob Printed Name
Regulatory Affairs/Quality Assurance Manager Title
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized human figure in profile, composed of three curved lines, set within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle.
Public Health Service
ood and Drug Administrat 9200 Corporate Boulevard Rockvilla MD 20050
Mr. James P. Raskob Regulatory Affairs/Quality Assurance Manager GE Lunar Corporation 726 Heartland Trail MADISON WI 53717
Re: K023554
Trade/Device Name: Dual-energy Vertebral Assessment View Software Regulation Number: 21 CFR 892.1170 Regulation Name: Bone densitometer Regulatory Class: II Product Code: 90 KGI Dated: October 21, 2002 Received: October 23, 2002 ·
Dear Mr. Raskob:
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 (PMA). it may be subject to 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 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer 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,
Nancy C. Snogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATION FOR USE FORM
Page 1 of 1
510(k) Number (if known) K023554
Device Name: PRODIGY Dual-energy Vertebral Assessment View Software
Indications for use:
Dual-energy Vertebral Assessment View Software is used with the Prodigy bone densitometer. This software provides an x-ray image of the spine for qualitative visual assessment in order to identify vertebral deformations and estimate vertebral heights (morphometry).
The use of the Prodigy Bone Densitometer is restricted to prescription use only. The operator's manual for the Prodigy contains the following statement:
"United States Federal Law restricts this device to the sale, distribution, and use by or on the order of a physician."
PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109) ✓
OR
Over-the-Counter Use
(Optional Format 1-2-96)
David A. Symm
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _