INFANT WHOLE BODY SOFTWARE OPTION FOR QDR DENSITOMETERS

{0}------------------------------------------------ ## F. 510/k) Summary of Safety and Effectiveness # OCT 2 9 2004 ### F.1 Manufacturer Name and Address: Hologic, Inc. 35 Crosby Drive Bedford, MA 01730 #### Name, Title, and Telephone Number of Contacts: F.2 - Official Correspondent: Richard L. Follett Vice President, Requlatory Affairs and Quality Assurance (781) 999-7506 Submission Correspondent: Daniel F. Phelan Senior Regulatory Affairs Specialist (781) 999-7538 #### F.3 Date of Submission: September 10, 2004 #### F.4 Device Identification Trade Name: Infant Whole Body Software Option for QDR Densitometers Common Name: Software Option for Bone Densitometer #### E.5 Predicate Device Information K023398 Discovery Package for QDR X-Ray Bone Densitometers K961787 Body Composition Analysis Software for QDR X-Ray Bone Densitometers #### F.6 Device Description and Intended Use The Infant Whole Body software option for QDR X-Ray Bone Densitometers is an optional data acquisition and analysis method that provides estimates of bone mineral content (BMC. in grams), bone mineral density (BMD, in grams/cm²), and body composition (lean body mass and fat mass of non-osseous tissues) in human infants from birth to one year of age. These data may be used at the discretion of a physician where medically necessary. #### F.7 Substantial Equivalence The Infant Whole Body Software Option is performs the same functions as the currently available Hologic Body Composition Software Option for QDR X-Ray Bone Densitometers (K961787) and the Discovery Package for Hologic QDR X-Ray Bone Densitometers (K023398). The Infant Whole Body software option adds an optional scan type to the QDR XP Scan Module, and an optional analysis type to the QDR XP Analysis Module of the QDR for Windows software operating system. The Infant Whole Body Software option performs the same functions as the currently commercialized Whole Body Software Option: the acquisition and analysis of whole body BMC (in grams), BMD (in grams per square centimeter), and body composition (%fat) for use Image /page/0/Picture/21 description: The image shows a sequence of numbers, specifically '00056'. The numbers are printed in a bold, sans-serif font. The image appears to be a close-up of the numbers, possibly extracted from a larger document or display. {1}------------------------------------------------ at the discretion of a physician. The only differences between the Infant Whole Body software option and the adult Whole Body Software Option are: A modification to the Scan Module (data acquisition module) to enable a smaller region of interest (due to smaller subject size), thinner x-ray beam and slower scan speed to improve spatial resolution and bone edge detection, and A modification to the Analysis Module (data analysis module) include an algorithm that employs lower bone and soft tissue detection thresholds suitable for detecting and evaluating low bone densities and low soft tissue masses found in human infants. #### F.8 Tabular Comparison | Attribute | Hologic ® Body<br>Composition<br>Software Option for<br>QDR® X-Ray Bone<br>Densitometers | Hologic ®Discovery<br>Package for QDR | Hologic® Infant Whole Body<br>Software Option | |--------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | K961787 | K023398 | | | Indications for<br>Use | Estimate the lean<br>body mass and fat<br>mass of non-osseous<br>tissues in situations<br>where medically<br>necessary. | Estimation of bone mineral<br>content (BMC), bone<br>mineral density (BMD),<br>comparison of measured<br>variables to a database of<br>reference values, the<br>estimation of fracture risk,<br>vertebral deformity<br>assessment, body<br>composition analysis, and<br>discrimination of bone from<br>prosthetics using Hologic<br>QDR X-Ray Bone<br>Densitometers. | The Infant Whole Body software option<br>for QDR X-Ray Bone Densitometers is<br>an optional data acquisition and<br>analysis method that provides<br>estimates of bone mineral content<br>(BMC, in grams), bone mineral density<br>(BMD, in grams/cm²), and body<br>composition (lean body mass and fat<br>mass of non-osseous tissues) in<br>human infants from birth to one year of<br>age. These data may be used at the<br>discretion of a physician where<br>medically necessary. | | Target<br>Population | Children.<br>Adolescents, Adult | Children, Adolescents, Adult | Infant | | Age Range | 3-80 years of age,<br>depending on scan<br>mode. | 3-80 years of age,<br>depending on scan mode. | Birth -1 year | | Prescription<br>Use | Required. | Same | Same | | Acquisition<br>Technique | Dual X-Ray<br>Absorptiometry | Dual X-Ray Absorptiometry | Same | | Analysis<br>Regions | Spine, Femur, Whole<br>Body | Lumbar Spine, Hip,<br>Forearm, Whole Body, AP<br>Lateral Spine | Spine, Femur, Whole Body | | Operating<br>Platform | Windows 98,<br>Windows XP | Windows XP | Windows 98,<br>Windows XP | | Dual Energy<br>X-Rav<br>Production | Pulsed dual voltage x-<br>ray tube | Same | Same | | Scan Site | Whole Body | Whole Body, Hip, Spine,<br>Forearm | Whole Body | | Measurement<br>Output<br>(Results) | Global and Regional<br>Bone and Body<br>Composition<br>Estimates | Same | Same | | Report<br>Screens | Bone Area, BMC,<br>BMD, and Body<br>Composition Reports | Same | Same | | Attribute | Hologic ® Body<br>Composition<br>Software Option for<br>QDR® X-Ray Bone<br>Densitometers | Hologic ®Discovery<br>Package for QDR | Hologic® Infant Whole Body<br>Software Option | | Calibration<br>System (Bone<br>Results) | Internal Reference<br>system with bone<br>equivalent material | Same | Same | | Calibration<br>System (Body<br>Composition<br>Results) | Aluminum and Acrylic<br>Step Phantom | Same | Same | | Scan Length | up to 77 inches | up to 77 inches | 32 inches | | Scanning<br>Method | Multi-detector array,<br>Indexing table,<br>motorized C-arm | Same | Same | | X-Ray System | Switched pulse dual-<br>energy x-ray tube,<br>operating at 100 and<br>140kV, 2.5mA<br>average at 25% duty<br>cycle, 5.0 mA average<br>at 50% duty cycle<br>(30s maximum),<br>Tungsten target | Same | Same | | Detection<br>System | Multi-channel detector<br>consisting of CdWO4<br>scintillators coupled to<br>Silicon diodes. | Same | Same | | Scatter Dose<br>Rate | Less than 10μGy/hr at<br>2m from the center of<br>the X-Ray beam for<br>BMC/BMD and Body<br>Comp. scans | Same | Same | | Leakage<br>Radiation | Meets requirements of<br>21CFR 1020.30(k) for<br>leakage from an x-ray<br>source. | Same | Same | | Calibration | Automatic Internal<br>Reference System | Same | Same | | Hologic Device<br>Models | Discovery A/C/W,<br>Delphi A/C/W,<br>QDR 4500 A/C/W,<br>Explorer | Discovery A/C/W/SL,<br>Delphi A/C/W/SL,<br>QDR 4500 A/C/W/SL,<br>Explorer | Discovery A,<br>Delphi A,<br>QDR 4500 A | {2}------------------------------------------------ #### F.9 Conclusion Hologic believes that the Infant Whole Body Software Option is substantially equivalent to currently marketed devices. No new issues of safety or effectiveness are raised. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 OCT 2 9 2004 Mr. Daniel F. Phelan Senior Regulatory Affairs Specialist HOLOGIC, Inc. 35 Crosby Drive BEDFORD MA 01730 Re: K042480 Trade/Device Name: Infant Whole Body Software Option for Hologic QDR X-Ray Bone Densitometers Regulation Number: 21 CFR §892.1170 Regulation Name: Bone densitometer Regulatory Class: II Product Code: 90 KGI Dated: September 10, 2004 Received: September 13, 2004 Dear Mr. Phelan: 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. 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. {4}------------------------------------------------ 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.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 | |-----------------|----------------------------------|--------------| | 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 | | 21 CFR 892.xxxx | (Radiology) | 240-276-0120 | | Other | | 240-276-0100 | Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmadsmam.httml 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 Enclosure {5}------------------------------------------------ #### Indications for Use Statement B.3 510(k) Number (if known): KOY2Y 80 Device Name: Infant Whole Body Software Option for QDR X-Ray Bone Densitometers Indications for Use: The Infant Whole Body software option for QDR X-Ray Bone Densitometers is an optional data r ne infant whole Buysis method that provides estimates of bone mineral content (BMC, in acquilition and unaryold motived in grams/cm²), and body composition (lean body mass and grams), bono minford dones) in human infants from birth to one year of age. These data may be used at the discretion of a physician where medically necessary. ## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) < Prescription Use OR Over-The-Counter-Use (Per 21 CFR 801.109) (Optional Format 1) Nancy C Broadon (Division Sigh-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number K042480