(30 days)
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.
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.
The provided text is a 510(k) summary for the "Discovery Package for Hologic QDR X-Ray Bone Densitometers." This document is a regulatory submission for a software system that integrates previously cleared features of bone densitometers into a new operating environment. As such, the study described focuses on software validation rather than a clinical performance study with acceptance criteria in the typical sense of measuring diagnostic accuracy.
Therefore, the information requested in your prompt regarding acceptance criteria, device performance, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types is not available within this 510(k) summary.
Here's why and what information is available:
- Software System: The device is described as "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." This suggests that the primary validation would involve ensuring the software correctly performs the functions it's designed for, consistent with its predicate devices.
- Predicate Devices: The submission heavily relies on predicate devices (K992677, K992775, K983028, K963363, K941362, K943505, K913321, K894795, K883280, K001812). This typically means the new device is being shown to be "substantially equivalent" to these existing, legally marketed devices. Demonstrating substantial equivalence for a software update often involves comparing the new software's output to the predicate's output without necessarily needing extensive new clinical trials or diagnostic accuracy studies.
- Lack of Clinical Study Details: The summary does not contain any sections detailing a clinical study, performance metrics like sensitivity/specificity, or a comparison against a human expert baseline. The focus is on the integration of existing functionalities into a new operating system.
Therefore, I cannot populate the table or answer most of the questions as the information is not provided in the given text.
Information that can be extracted or inferred:
- Device Trade Name: Discovery Package for Hologic QDR X-Ray Bone Densitometers
- Intended Use: Estimation of bone mineral density (BMD), comparison of measured variables to a reference database, estimation of fracture risk, vertebral deformity assessment, body composition analysis, and discrimination of bone from prosthetics using Hologic QDR X-Ray Bone Densitometers.
- Device Description: A software system integrating previously cleared features of prior QDR Densitometer versions into a Microsoft Windows XP operating environment.
Without a detailed study report within this 510(k) summary focusing on specific performance metrics, it's impossible to describe acceptance criteria or the study proving the device meets them in the context of diagnostic accuracy.
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Special 510(k) - SUMMARY
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Discovery Package for Hologic QDR X-Ray Bone Densitometers
| Submitter Name: | Hologic, Incorporated |
|---|---|
| Submitter Address: | 35 Crosby DriveBedford, 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 DensitometersK992775 Assessment of Vertebral Deformities Using QDR DensitometersK983028 Fracture Risk Estimation for QDR DensitometersK963363 Reference Databases (NHANES Software) for QDR DensitometersK941362 Vertebral Morphometry Analysis Software for QDR DensitometersK943505 QDR 4500 X-Ray Bone DensitometerK913321 QDR 2000 X-Ray Bone DensitometerK894795 QDR 1000W X-Ray Bone DensitometerK883280 QDR 1000 X-Ray Bone DensitometerK001812 Pediatric Reference Data for Lunar Bone Densitometer |
| Device Description: | The Discovery Package for QDR Bone Densitometers is a software system thatintegrates all of the previously cleared features of prior versions of the QDRDensitometers in a Microsoft Windows XP operating environment. |
| Intended Use: | The intended use of the Discovery Package for QDR X-Ray BoneDensitometers is the estimation of bone mineral density (BMD), comparison ofmeasured variables obtained from a given QDR scan to a database of referencevalues, the estimation of fracture risk, vertebral deformity assessment, bodycomposition analysis, and discrimination of bone from prosthetics using theHologic QDR® X-Ray Bone Densitometers. |
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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.
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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
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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
§ 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.