K Number
K042480
Device Name
INFANT WHOLE BODY SOFTWARE OPTION FOR QDR DENSITOMETERS
Manufacturer
Date Cleared
2004-10-29

(46 days)

Product Code
Regulation Number
892.1170
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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.
Device Description
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.
More Information

No
The description focuses on modifications to existing algorithms and scan parameters for infants, not the introduction of AI/ML. There is no mention of AI, ML, training data, or performance metrics typically associated with AI/ML devices.

No.
The device provides estimates of bone mineral content, bone mineral density, and body composition. It does not treat or prevent a disease or condition. The data it provides "may be used at the discretion of a physician where medically necessary," indicating it aids in diagnosis or monitoring rather than providing therapy itself.

Yes

Explanation: The device is described as providing "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)" for human infants. These data are explicitly stated to be used "at the discretion of a physician where medically necessary," indicating their use in assessing and understanding a patient's health status, which is a diagnostic function. The device also modifies the analysis module to include an algorithm for detecting and evaluating low bone densities and soft tissue masses, which is geared towards identifying conditions.

No

The device is described as a "software option" for existing QDR X-Ray Bone Densitometers, which are hardware devices. The software modifies the operation of the hardware (scan speed, beam thickness) and analyzes data acquired by the hardware. It is not a standalone software 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: This device uses Dual X-Ray Absorptiometry to measure bone mineral content, bone mineral density, and body composition directly from the infant's body. It does not analyze samples taken from the body.
  • Input: The input is X-ray data acquired directly from the patient, not a biological sample.

Therefore, this device falls under the category of a medical device that performs measurements in vivo (within the living body), not in vitro (in glass/outside the body).

N/A

Intended Use / Indications for 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.

Product codes

90 KGI

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Dual X-Ray Absorptiometry

Anatomical Site

Whole Body

Indicated Patient Age Range

Birth -1 year

Intended User / Care Setting

Not Found

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)

K023398, K961787

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.

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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

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.

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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 ® Body
Composition
Software Option for
QDR® X-Ray Bone
Densitometers | Hologic ®Discovery
Package for QDR | Hologic® Infant Whole Body
Software Option |
|--------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K961787 | K023398 | |
| Indications for
Use | Estimate the lean
body mass and fat
mass of non-osseous
tissues in situations
where medically
necessary. | Estimation of bone mineral
content (BMC), bone
mineral density (BMD),
comparison of measured
variables to a database of
reference values, the
estimation of fracture risk,
vertebral deformity
assessment, body
composition analysis, and
discrimination of bone from
prosthetics using Hologic
QDR X-Ray Bone
Densitometers. | 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. |
| Target
Population | Children.
Adolescents, Adult | Children, Adolescents, Adult | Infant |
| Age Range | 3-80 years of age,
depending on scan
mode. | 3-80 years of age,
depending on scan mode. | Birth -1 year |
| Prescription
Use | Required. | Same | Same |
| Acquisition
Technique | Dual X-Ray
Absorptiometry | Dual X-Ray Absorptiometry | Same |
| Analysis
Regions | Spine, Femur, Whole
Body | Lumbar Spine, Hip,
Forearm, Whole Body, AP
Lateral Spine | Spine, Femur, Whole Body |
| Operating
Platform | Windows 98,
Windows XP | Windows XP | Windows 98,
Windows XP |
| Dual Energy
X-Rav
Production | Pulsed dual voltage x-
ray tube | Same | Same |
| Scan Site | Whole Body | Whole Body, Hip, Spine,
Forearm | Whole Body |
| Measurement
Output
(Results) | Global and Regional
Bone and Body
Composition
Estimates | Same | Same |
| Report
Screens | Bone Area, BMC,
BMD, and Body
Composition Reports | Same | Same |
| Attribute | Hologic ® Body
Composition
Software Option for
QDR® X-Ray Bone
Densitometers | Hologic ®Discovery
Package for QDR | Hologic® Infant Whole Body
Software Option |
| Calibration
System (Bone
Results) | Internal Reference
system with bone
equivalent material | Same | Same |
| Calibration
System (Body
Composition
Results) | Aluminum and Acrylic
Step Phantom | Same | Same |
| Scan Length | up to 77 inches | up to 77 inches | 32 inches |
| Scanning
Method | Multi-detector array,
Indexing table,
motorized C-arm | Same | Same |
| X-Ray System | Switched pulse dual-
energy x-ray tube,
operating at 100 and
140kV, 2.5mA
average at 25% duty
cycle, 5.0 mA average
at 50% duty cycle
(30s maximum),
Tungsten target | Same | Same |
| Detection
System | Multi-channel detector
consisting of CdWO4
scintillators coupled to
Silicon diodes. | Same | Same |
| Scatter Dose
Rate | Less than 10μGy/hr at
2m from the center of
the X-Ray beam for
BMC/BMD and Body
Comp. scans | Same | Same |
| Leakage
Radiation | Meets requirements of
21CFR 1020.30(k) for
leakage from an x-ray
source. | Same | Same |
| Calibration | Automatic Internal
Reference System | Same | Same |
| Hologic Device
Models | 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.

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
Other240-276-0100

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)