(46 days)
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.
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. 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 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.
The provided document is a 510(k) Summary of Safety and Effectiveness for the Hologic Infant Whole Body Software Option for QDR Densitometers, dated October 29, 2004. It describes the device and claims substantial equivalence to predicate devices. However, it does not contain detailed information about specific acceptance criteria or a study proving the device meets those criteria, as typically found in clinical validation studies.
The document focuses on comparing the new device's features and intended use to existing, legally marketed predicate devices (K023398 Discovery Package and K961787 Body Composition Analysis Software). The primary argument for substantial equivalence is that the Infant Whole Body software performs the same functions with minor modifications to optimize for infants (smaller region of interest, thinner x-ray beam, slower scan speed, and lower bone/soft tissue detection thresholds). This is a regulatory filing for premarket notification, not a clinical trial report.
Therefore, many of the requested details are not present in this document.
Here's a breakdown of the information that can be extracted or inferred, and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state specific acceptance criteria (e.g., specific accuracy thresholds for BMC, BMD, or body composition measurements) or numerical device performance results from a validation study. The comparison table (F.8) lists attributes of the devices but does not quantify performance.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. No specific test set or clinical study data is reported.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document, as no specific test set requiring expert ground truth is described.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study is not mentioned or described in the document. This type of study would compare human reader performance with and without AI assistance, which is not the focus of this 510(k) filing.
6. Standalone (Algorithm Only) Performance Study
A standalone performance study for the algorithm itself (demonstrating its accuracy in measuring BMC, BMD, and body composition in infants) is not explicitly detailed or referenced in terms of specific metrics or a study. The document states that the software provides "estimates" and relies on its similarity to predicate devices, which are already cleared for measuring these parameters. The modifications are described as improving spatial resolution and bone edge detection and employing suitable detection thresholds for infants, but no quantitative performance improvement or validation is provided.
7. Type of Ground Truth Used
The document does not specify the type of ground truth used for any performance evaluation, as no such evaluation is detailed. For bone densitometry, "ground truth" would typically involve precise physical measurements, possibly validated by phantoms or alternative highly accurate methods, but no such details are furnished.
8. Sample Size for the Training Set
This information is not provided in the document. The filing describes the product as a "software option," implying algorithmic changes rather than a deep learning model that would typically require a training set in the modern sense. Given the 2004 date, it's more likely referring to adjustments in established algorithms rather than training a machine learning model on a dataset.
9. How Ground Truth for the Training Set Was Established
This information is not provided in the document.
Summary of Document's Content Regarding Performance/Validation:
The document asserts that the Infant Whole Body Software Option is substantially equivalent to predicate devices. It achieves this by:
- Modifying the Scan Module: To enable a smaller region of interest, thinner x-ray beam, and slower scan speed to improve spatial resolution and bone edge detection for smaller subjects.
- Modifying the Analysis Module: To include an algorithm that employs lower bone and soft tissue detection thresholds suitable for infants.
The basis for regulatory clearance (510(k)) is this claim of substantial equivalence, meaning it performs the same essential functions as previously cleared devices, with modifications appropriate for its specific user population (infants), and without raising new issues of safety or effectiveness. The filing does not include a new clinical study to establish specific performance metrics or acceptance criteria for the new software option. It relies on the established safety and effectiveness of the predicate devices and the design modifications tailored for infants.
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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
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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 ® BodyCompositionSoftware Option forQDR® X-Ray BoneDensitometers | Hologic ®DiscoveryPackage for QDR | Hologic® Infant Whole BodySoftware Option |
|---|---|---|---|
| 510(k) Number | K961787 | K023398 | |
| Indications forUse | Estimate the leanbody mass and fatmass of non-osseoustissues in situationswhere medicallynecessary. | Estimation of bone mineralcontent (BMC), bonemineral density (BMD),comparison of measuredvariables to a database ofreference values, theestimation of fracture risk,vertebral deformityassessment, bodycomposition analysis, anddiscrimination of bone fromprosthetics using HologicQDR X-Ray BoneDensitometers. | The Infant Whole Body software optionfor QDR X-Ray Bone Densitometers isan optional data acquisition andanalysis method that providesestimates of bone mineral content(BMC, in grams), bone mineral density(BMD, in grams/cm²), and bodycomposition (lean body mass and fatmass of non-osseous tissues) inhuman infants from birth to one year ofage. These data may be used at thediscretion of a physician wheremedically necessary. |
| TargetPopulation | Children.Adolescents, Adult | Children, Adolescents, Adult | Infant |
| Age Range | 3-80 years of age,depending on scanmode. | 3-80 years of age,depending on scan mode. | Birth -1 year |
| PrescriptionUse | Required. | Same | Same |
| AcquisitionTechnique | Dual X-RayAbsorptiometry | Dual X-Ray Absorptiometry | Same |
| AnalysisRegions | Spine, Femur, WholeBody | Lumbar Spine, Hip,Forearm, Whole Body, APLateral Spine | Spine, Femur, Whole Body |
| OperatingPlatform | Windows 98,Windows XP | Windows XP | Windows 98,Windows XP |
| Dual EnergyX-RavProduction | Pulsed dual voltage x-ray tube | Same | Same |
| Scan Site | Whole Body | Whole Body, Hip, Spine,Forearm | Whole Body |
| MeasurementOutput(Results) | Global and RegionalBone and BodyCompositionEstimates | Same | Same |
| ReportScreens | Bone Area, BMC,BMD, and BodyComposition Reports | Same | Same |
| Attribute | Hologic ® BodyCompositionSoftware Option forQDR® X-Ray BoneDensitometers | Hologic ®DiscoveryPackage for QDR | Hologic® Infant Whole BodySoftware Option |
| CalibrationSystem (BoneResults) | Internal Referencesystem with boneequivalent material | Same | Same |
| CalibrationSystem (BodyCompositionResults) | Aluminum and AcrylicStep Phantom | Same | Same |
| Scan Length | up to 77 inches | up to 77 inches | 32 inches |
| ScanningMethod | Multi-detector array,Indexing table,motorized C-arm | Same | Same |
| X-Ray System | Switched pulse dual-energy x-ray tube,operating at 100 and140kV, 2.5mAaverage at 25% dutycycle, 5.0 mA averageat 50% duty cycle(30s maximum),Tungsten target | Same | Same |
| DetectionSystem | Multi-channel detectorconsisting of CdWO4scintillators coupled toSilicon diodes. | Same | Same |
| Scatter DoseRate | Less than 10μGy/hr at2m from the center ofthe X-Ray beam forBMC/BMD and BodyComp. scans | Same | Same |
| LeakageRadiation | Meets requirements of21CFR 1020.30(k) forleakage from an x-raysource. | Same | Same |
| Calibration | Automatic InternalReference System | Same | Same |
| Hologic DeviceModels | Discovery A/C/W,Delphi A/C/W,QDR 4500 A/C/W,Explorer | Discovery A/C/W/SL,Delphi A/C/W/SL,QDR 4500 A/C/W/SL,Explorer | Discovery A,Delphi A,QDR 4500 A |
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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.
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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.
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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
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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
§ 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.