(30 days)
No
The summary explicitly states that the software integrates previously cleared features and does not mention AI, ML, or related terms.
No
The device is indicated for diagnostic purposes such as "estimation of bone mineral density (BMD)", "comparison of measured variables obtained from a given QDR scan to a database of reference values", "estimation of fracture risk", and "vertebral deformity assessment", rather than directly treating a disease or condition.
Yes
The device is indicated for "estimation of bone mineral density (BMD), comparison of measured variables obtained from a given QDR scan to a database of reference values, the estimation of fracture risk, vertebral deformity assessment, body composition analysis, and discrimination of bone from prosthetics." These are all diagnostic or assessment functions that aid in understanding a patient's health status.
Yes
The device description explicitly states it is a "software system" and integrates features of prior versions of QDR Densitometers, implying it is the software component that runs on existing hardware (the QDR X-Ray Bone Densitometers). The predicate devices also include both software and hardware components, but the description focuses solely on the software package.
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 description clearly states that the device is a software system for X-Ray Bone Densitometers. It uses X-ray imaging to estimate bone mineral density, assess fracture risk, and perform body composition analysis. This is an in vivo (within the living body) diagnostic process, not an in vitro one.
- Input Modality: The input modality is explicitly listed as X-Ray, which is an imaging technique applied directly to the patient, not a laboratory test on a sample.
- Anatomical Site: The anatomical site is Bone, which is being assessed directly within the patient's body.
Therefore, the Discovery Package for QDR X-Ray Bone Densitometers is a medical device used for in vivo diagnostic imaging and analysis, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of the Discovery Package for QDR X-Ray Bone Densitometers is the estimation of bone mineral density (BMD), comparison of measured variables obtained from a given QDR scan to a database of reference values, the estimation of fracture risk, vertebral deformity assessment, body composition analysis, and discrimination of bone from prosthetics using the Hologic QDR® X-Ray Bone Densitometers.
The Discovery Package for QDR X-Ray Bone Densitometers is indicated for the estimation of bone mineral density (BMD), comparison of measured variables obtained from a given QDR scan to a database of reference values, the estimation of fracture risk, vertebral deformity assessment, body composition analysis, and discrimination of bone from prosthetics using the Hologic QDR® X-Ray Bone Densitometers.
Product codes
90 KGI
Device Description
The Discovery Package for QDR Bone Densitometers is a software system that integrates all of the previously cleared features of prior versions of the QDR Densitometers in a Microsoft Windows XP operating environment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
Bone
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
K992677, K992775, K983028, K963363, K941362, K943505, K913321, K894795, K883280, K001812
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
Special 510(k) - SUMMARY
……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………
Discovery Package for Hologic QDR X-Ray Bone Densitometers
| Submitter Name: | Hologic, Incorporated |
|---|---|
| Submitter Address: | 35 Crosby Drive |
| Bedford, MA 01730 | |
| NOV 8 2002 | |
| Contact Person: | Daniel F. Phelan, Senior Regulatory Affairs Specialist |
| Phone Number: | 781-999-7300 |
| Fax Number: | 781-280-0662 |
| Date Prepared: | October 1, 2002 |
| Device Trade Name: | Discovery Package for Hologic QDR X-Ray Bone Densitometers |
| Device Common Name: | X-Ray Bone Densitometer |
| Predicate Devices: | K992677 Windows 98 "Eagle" Software for QDR Densitometers |
| K992775 Assessment of Vertebral Deformities Using QDR Densitometers | |
| K983028 Fracture Risk Estimation for QDR Densitometers | |
| K963363 Reference Databases (NHANES Software) for QDR Densitometers | |
| K941362 Vertebral Morphometry Analysis Software for QDR Densitometers | |
| K943505 QDR 4500 X-Ray Bone Densitometer | |
| K913321 QDR 2000 X-Ray Bone Densitometer | |
| K894795 QDR 1000W X-Ray Bone Densitometer | |
| K883280 QDR 1000 X-Ray Bone Densitometer | |
| K001812 Pediatric Reference Data for Lunar Bone Densitometer | |
| Device Description: | The Discovery Package for QDR Bone Densitometers is a software system that |
| integrates all of the previously cleared features of prior versions of the QDR | |
| Densitometers in a Microsoft Windows XP operating environment. | |
| Intended Use: | The intended use of the Discovery Package for QDR X-Ray Bone |
| Densitometers is the estimation of bone mineral density (BMD), comparison of | |
| measured variables obtained from a given QDR scan to a database of reference | |
| values, the estimation of fracture risk, vertebral deformity assessment, body | |
| composition analysis, and discrimination of bone from prosthetics using the | |
| Hologic QDR® X-Ray Bone Densitometers. |
1
Image /page/1/Picture/1 description: The image shows a black and white logo. The logo features a stylized depiction of an eagle's head, represented by three curved lines that suggest the bird's beak and head feathers. To the left of the eagle's head, there is a partial inscription of the words "DEPARTMENT OF HEALTH". The text is arranged vertically, following the curve of the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
8 2002 NOV
Re: K023398
Mr. Richard L. Follett Vice President, Regulatory Affairs And Quality Assurance HOLOGIC, Inc. 35 Crosby Drive BEDFORD MA 01730
Trade/Device Name: Discovery Package for Hologic QDR X-ray Bone Densitometers Regulation Number: 21 CFR 892.1170 Regulation Name: Bone Densitometers Regulatory Class: II Product Code: 90 KGI Dated: October 1, 2002 Received: October 9, 2002
Dear Mr. Follett:
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.
2
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 vour 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. Brogdon
Nancy C. Progdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use Statement
The Discovery Package for QDR X-Ray Bone Densitometers is indicated for the estimation of bone mineral density (BMD), comparison of measured variables obtained from a given QDR scan to a database of reference values, the estimation of fracture risk, vertebral deformity assessment, body composition analysis, and discrimination of bone from prosthetics using the Hologic QDR® X-Ray Bone Densitometers.
Prescription Use
(Per 21 CFR 801.109)
David A. Flynn
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number