(53 days)
No
The summary describes a software option that performs calculations based on DXA scan data to estimate structural properties. There is no mention of AI, ML, or any learning-based algorithms. The performance studies compare it to existing software, not AI/ML models.
No
The device is described as estimating structural properties of the hip and analyzing bone mineral mass distribution, which falls under diagnostic or analytical functions rather than therapeutic intervention.
Yes
The device is described as measuring the distribution of bone mineral mass and allowing the physician to estimate structural properties of the hip, which aligns with diagnostic purposes for assessing bone health.
No
The device is described as an "Option for QDR X-Ray Bone Densitometers," which are hardware devices. While the HSA component is software, it functions as an add-on or feature to existing hardware, not as 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 description clearly states that the device uses data from DXA scans to measure bone mineral mass and estimate structural properties of the hip. This is an analysis of imaging data obtained from the patient's body, not a test performed on a biological sample taken from the body.
Therefore, this device falls under the category of medical imaging analysis software, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Hip Structural Analysis (HSA) Option for QDR X-Ray Bone Densitometers uses data from conventional Dual Energy X-Ray Absorptiometry (DXA) scans to measure the distribution of bone mineral mass at specific cross sections of the hip and allows the physician to estimate structural properties of the hip, such as CSA, CSMI, Z and Buckling Ratio.
Product codes
90 KGI
Device Description
The Hip Structural Analysis (HSA) Option for QDR X-Ray Bone Densitometers uses data from conventional Dual Energy X-Ray Absorptiometry (DXA) scans to measure the distribution of bone mineral mass at specific cross sections of the hip and allows the physician to estimate structural properties of the hip, such as CSA, CSMI, Z and Buckling Ratio.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Dual Energy X-Ray Absorptiometry (DXA)
Anatomical Site
hip
Indicated Patient Age Range
Not Found
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)
Reference Device(s)
Not Found
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
JUL 2 8 2006
Section G 510(k) Summary
000081
1
H. 510(k) Summary
Manufacturing Establishment and Contact Information H.1
H.1.1 Manufacturer Name and Address:
Hologic, Inc. 35 Crosby Drive Bedford, MA 01730
H.1.2 Establishment Registration Number:
1221300
H.1.3 Name, Title, and Telephone Number of Contact:
Jeanette Schier-Pugsley Regulatory Affairs Manager Phone: (781) 999-7300, ex. 7406 Fax: (781) 999-0614 jschierpugsley@hologic.com
Device Identification H.2
H.2.1 Device Trade Name:
Hip Structural Analysis (HSA) Software Option for the Hologic QDR X-Ray Bone Densitometers.
H.2.2 Common / Usual Name:
Software option for Bone Densitometers
H.2.3 Intended Use:
The Hip Structural Analysis (HSA) Option for QDR X-Ray Bone Densitometers uses data from conventional Dual Energy X-Ray Absorptiometry (DXA) scans to measure the distribution of bone mineral mass at specific cross sections of the hip and allows the physician to estimate structural properties of the hip, such as CSA, CSMI, Z and Buckling Ratio.
Device Classification H.3
H.3.1 Classification:
Class II
H.3.2 Classification Name and Rule
Bone Densitometer: 21 CFR 892.1170
2
H.3.3 Classification Panel
Radiology
H.3.4 Product Code
90 KGI
H.3.5 Predicate Devices
. 510(k) No.: K023398 Trade Name: Discovery Package for QDR Densitometers SE Date: November 8, 2002 Manufacturer: Hologic, Inc.
- . 510(k) No .: K011917
Advanced Hip Assessment (AHA) Software for GE Prodigy x-Trade Name: ray bone densitometers.
August 3, 2001 SE Date:
Manufacturer: GE Lunar Corporation
H.4 Conclusion:
Based on the scientific literature and testing supplied in the 510(k) submission, the Structural Analysis (HSA) Option for QDR X-Ray Bone Densitometers is substantially equivalent to the presently marketed Discovery Package for QDR Densitometers software (K023398) and the Advanced Hip Assessment (AHA) Software for GE Prodigy x-ray bone densitometers (K011917). No new safety and efficacy questions are raised with the HSA Software Option.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three bars above it, representing the department's mission to protect the health of all Americans. The words "DEPARTMENT OF HUMAN SERVICES (USA)" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
JUL 2 8 2006
Ms. Jeanette Schier-Pugsley. RAC Regulatory Affairs Manager HOLOGIC, Inc. 35 Crosby Drive BEDFORD MA 01730
Re: K061561
Trade/Device Name: Hip Structure Analysis (HAS) Software Option for QDR X-Ray Bone Densitometers
Regulation Number: 21 CFR 892.1170 Regulation Name: Bone densitometer Regulatory Class: II Product Code: KGI Dated: June 2, 2006 Received: June 5, 2006
Dear Ms. Pugsley:
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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/3/Picture/11 description: The image is a circular logo or seal. The text "1906-2006" is at the top of the logo. The letters "PA" are in the center of the logo in a large, bold font. The word "Centennial" is below the letters "PA". Three stars are below the word "Centennial".
Protecting and Promoting Public Health
4
Page 2 -
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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 vours.
Nancy C. Brogdon
Nancy C. Brogdon Director. Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
A.2 Indications for Use Statement
510(k) Number (if known): 061561
Hip Structural Analysis (HSA) Software Option for QDR X-Ray Bone Device Name: Densitometers
The Hip Structural Analysis (HSA) Option for QDR X-Ray Bone Densitometers uses data from conventional Dual Energy X-Ray Absorptiometry (DXA) scans to measure the distribution of bone mineral mass at specific cross sections of the hip and allows the physician to estimate structural properties of the hip, such as CSA, CSMI, Z and Buckling Ratio.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
V Prescription Use
OR
Over-The-Counter-Use
(Per 21 CFR 801.109)
(Optional Format 1)
Nancy Bradon
(Division Sign-Off)
Division of Reproductive. Abdo and Radiological Device >10(k) Number
000010