K Number
K080711
Device Name
1.10-YEAR FRACTURE RISK QUESTIONNAIRE OPTION FOR QDR X-RAY BONE DENSITOMETER, MODEL QDR OPTION
Manufacturer
Date Cleared
2008-09-02

(173 days)

Product Code
Regulation Number
892.1170
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Femoral neck BMD and clinical risk factors are used to estimate the patient's 10year risk of hip fracture and 10-year risk of fracture using the World Health Organization (WHO) algorithm (FRAX™). The physician may use the 10-year percent probability of fracture, along with the physician's knowledge of patient history, and apply medical expertise and best practice clinical judgment po the obtained 10-year percent probability results to determine if therapeutic intervention is necessary.
Device Description
Software option for Bone Densitometers
More Information

Not Found

No
The summary explicitly states "Not Found" for mentions of AI, DNN, or ML, and the core functionality described is the application of a known algorithm (FRAX™) to calculate risk based on BMD and clinical factors.

No.
The device estimates fracture risk using the WHO algorithm (FRAX™) to help physicians determine if therapeutic intervention is necessary, but it does not provide therapy itself.

Yes
The device estimates a patient's 10-year risk of hip fracture and overall fracture using the WHO algorithm (FRAX™), which is used by a physician to determine if therapeutic intervention is necessary based on clinical judgment and the obtained probability results. This involves identifying a health condition (risk of fracture), thus qualifying it as a diagnostic device.

No

The device is described as a "Software option for Bone Densitometers," which implies it is a software component that integrates with existing hardware (Bone Densitometers). It is not a standalone software application.

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: This device is a software option for bone densitometers that uses X-ray input to measure femoral neck BMD and calculate fracture risk based on the WHO FRAX™ algorithm. This process involves analyzing data obtained from a medical imaging device (bone densitometer) and patient clinical risk factors, not analyzing samples taken from the body.
  • Intended Use: The intended use clearly describes the estimation of fracture risk using BMD and clinical factors, which is a diagnostic process based on imaging and patient data, not an in vitro test.

Therefore, this device falls under the category of a medical device that aids in diagnosis and risk assessment, but it is not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

Femoral neck BMD and clinical risk factors are used to estimate the patient's 10year risk of hip fracture and 10-year risk of fracture using the World Health Organization (WHO) algorithm (FRAX™). The physician may use the 10-year percent probability of fracture, along with the physician's knowledge of patient history, and apply medical expertise and best practice clinical judgment po the obtained 10-year percent probability results to determine if therapeutic intervention is necessary.

Femoral neck BMD and clinical risk factors are used to estimate 10-year risk of hip fracture and 10-year risk of major osteoporotic fracture using the World Health Organization (WHO) algorithm (FRAX™) in adults. The physician may use the 10-year fracture risk, along with the physician's knowledge of patient history, and apply medical expertise and best practice clinical judgment to determine if therapeutic intervention is indicated.

Product codes

90 KGI

Device Description

Software option for Bone Densitometers

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

X-Ray Bone Densitometers

Anatomical Site

Femoral neck

Indicated Patient Age Range

Adults

Intended User / Care Setting

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)

K983028, K963363

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

Koro7//

Hologic: 10-year Fracture Risk Questionnaire Option 510(k) Premarket Notification

G. 510(k) Summary

SEP - 2 2008

Manufacturing Establishment and Contact Information G.1

G.1.1 Manufacturer Name and Address:

Hologic, Inc. 35 Crosby Drive Bedford, MA 01730

G.1.2 Establishment Registration Number:

1221300

G.1.3 Name, Title, and Telephone Number of Contact:

Bryan Cowell, RAC Regulatory Affairs Specialist Phone: (781) 999-7300, ex. 7085 Fax: (781) 999-0614 Bryan.cowell@hologic.com

G.2 Device Identification

G.2.1 Device Trade Name:

10-year Fracture Risk Questionnaire Option for QDR X-Ray Bone Densitometers

G.2.2 Common / Usual Name:

Software option for Bone Densitometers

G.2.3 Proposed Intended Use:

Femoral neck BMD and clinical risk factors are used to estimate the patient's 10year risk of hip fracture and 10-year risk of fracture using the World Health Organization (WHO) algorithm (FRAX™). The physician may use the 10-year percent probability of fracture, along with the physician's knowledge of patient history, and apply medical expertise and best practice clinical judgment po the obtained 10-year percent probability results to determine if therapeutic intervention is necessary.

G.3 Device Classification

Radiology

G.3.1 Classification:

Class II

1

G.3.2 Classification Name and Rule

Bone Densitometer: 21 CFR 892.1170

G.3.3 Classification Panel

Radiology

G.3.4 Product Code

90 KGI

G.3.5 Predicate Devices

510(k) No.:K963363
Trade Name:NHANES Reference Data Software Option for Hologic QDR Series X-Ray Bone Densitometers
SE Date:November 22, 1996
Manufacturer:Hologic, Inc.
  • . 510(k) No.: K983028 Trade Name: Estimation of Fracture Risk from BMD using Hologic QDR X-Ray Bone Densitometers November 13, 1998 SE Date: Manufacturer: Hologic, Inc.

G.4 Conclusion:

The Hologic 10-year Fracture Risk Questionnaire option is substantially equivalent to the presently marketed predicate devices, the Hologic Estimation of Fracture Risk from BMD using Hologic QDR X-Ray Bone Densitometers (K983028) and the Hologic NHANES Reference Data Software Option for Hologic QDR Series X-Ray Bone Densitometers (K963363), and no new safety or efficacy questions are raised.

2

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 2 2008

Mr. Bryan Cowell Regulatory Affairs Specialist Hologic, Inc. 35 Crosby Drive BEDFORD MA 01730

Re: K080711

Trade/Device Name: 10-year Fracture Risk Questionnaire Option for QDR X-Ray Bone Densitometers

Regulation Number: 21 CFR 892.1170

DEPARTMENT OF HEALTH & HUMAN SERVICES

Regulation Name: Bone densitometer

Regulatory Class: II

Product Code: KGI

Dated: July 10, 2008

Received: July 11, 2008

Dear Mr. Cowell:

. . . . .

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 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.

3

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.

This letter will allow you to begin marketing your device as described in your Section 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of 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
Other240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 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

4

A.2 Indication for Use Statement

510(k) Number (if known):

Device Name: 10-year Fracture Risk Questionnaire Option for QDR X-Ray Bone Densitometers

Indication for Use: Femoral neck BMD and clinical risk factors are used to estimate 10-year risk of hip fracture and 10-year risk of major osteoporotic fracture using the World Health Organization (WHO) algorithm (FRAX™) in adults. The physician may use the 10-year fracture risk, along with the physician's knowledge of patient history, and apply medical expertise and best practice clinical judgment to determine if therapeutic intervention is indicated.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRA, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) NumberK080711