← Product Code [KGI](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KGI) · K061561 # HIP STRUCTURAL ANALYSIS SOFTWARE OPTION FOR THE HOLOGIC QDR X-RAY BONE DENSITOMETERS (K061561) _Hologic, Inc. · KGI · Jul 28, 2006 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KGI/K061561 ## Device Facts - **Applicant:** Hologic, Inc. - **Product Code:** [KGI](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KGI.md) - **Decision Date:** Jul 28, 2006 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.1170 - **Device Class:** Class 2 - **Review Panel:** Radiology ## 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 Story Software option for Hologic QDR X-Ray Bone Densitometers; utilizes existing DXA scan data as input. Transforms bone mineral mass distribution data into structural hip properties; calculates cross-sectional area (CSA), cross-sectional moment of inertia (CSMI), section modulus (Z), and buckling ratio. Used in clinical settings by physicians to assess hip bone structure. Output provides quantitative estimates to assist clinical decision-making regarding bone health and fracture risk assessment. ## Clinical Evidence No clinical data provided; substantial equivalence supported by scientific literature and bench testing. ## Technological Characteristics Software-only option for existing DXA hardware. Performs geometric and structural calculations based on bone mineral mass distribution. Operates on Hologic QDR X-Ray Bone Densitometer platforms. ## Regulatory 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. ## Predicate Devices - Discovery Package for QDR Densitometers ([K023398](/device/K023398.md)) - Advanced Hip Assessment (AHA) Software for GE Prodigy x-ray bone densitometers ([K011917](/device/K011917.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ K061561 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 --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KGI/K061561](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KGI/K061561) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com