(91 days)
No
The device description focuses on comparing patient data to a static reference database and calculating standard deviation scores (Z-scores). There is no mention of learning, adaptation, or complex pattern recognition characteristic of AI/ML. The "Mentions AI, DNN, or ML" section is also explicitly marked as "Not Found".
No
The device is a software option that expands the range of bone densitometry reference data for comparative purposes; it does not directly treat or mitigate a disease or condition.
No
Explanation: The device is a software option that provides reference data for bone densitometry measurements, allowing comparison of measured BMD to a database of reference values. While these data "may be used for comparative purposes at the discretion of the physician," the device itself does not make a diagnosis but rather provides data for interpretation. The description emphasizes it "extends the existing, commercially available reference databases' ability to generate a Z-score" and "provides a comparison," supporting its role as a data presentation/reference tool rather than a diagnostic one.
No
The device is described as a "software option used with Hologic QDR Series X-Ray Bone Densitometers," indicating it is an add-on to existing hardware, 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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Pediatric Reference Database software works with a bone densitometer, which is an imaging device that uses X-rays to measure bone mineral density in vivo (within the living body). The software then compares these in vivo measurements to a database of reference values.
- Lack of Sample Analysis: The device does not analyze any biological samples taken from the patient. It processes data obtained directly from the patient's body using an imaging modality.
Therefore, because the device operates on data acquired in vivo through imaging rather than analyzing in vitro biological samples, it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Pediatric Reference Database is a software option used with Hologic QDR Series X-Ray Bone Densitometers. The software expands the range of bone densitometry reference data to include ages 3-20 years of age. The software provides a comparison of measured Bone Mineral Density (BMD) measurements obtained by dual energy x-ray absorptiometry to a database of BMD reference values in children. These data may be used for comparative purposes at the discretion of the physician.
Product codes
90 KGI
Device Description
The Pediatric Reference Database is a software option which simply extends the existing, commercially available reference databases' ability to generate a Z-score for younger subjects.
The Pediatric Reference Database for the Hologic QDR Series X-Ray Bone Densitometers provides AP I lie rediance Reference Batalensitometry reference data for male, white American children. The Spine, This and "Hotel in conjunction with previously existing software in the QDR Series I culaine relevelos band is results to sex, ethnicity and age-matched values. The reference Densitometers while realigate of bone densitometry reference values to include age 3-20 years of age. database is used to exparison of Bone Mineral Density (BMD) measurements obtained by dual energy x-ray absorptiometry to a database of BMD reference values.
Patient results for each analysis region can be compared to reference values both graphically and I uncility to vach allery of the age dependent reference Bone Mineral Density (BMD) values quantitution of + or the sex and ethnicity of the patient are generated with a marker placed at the position corresponding to the estimated patient BMD and age. Deviation "scores," are computed, quantifying (in eorroponants to are estation units) the difference between the patient's estimated BMD and the mean population standated (Z-score) reference data. In addition, the patient BMD is expressed in percent of the age matched mean in percent of the pediatric mean.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
dual energy x-ray absorptiometry
Anatomical Site
Spine, This and "Hotel" (likely meant to be "Hip")
Indicated Patient Age Range
3-20 years of age
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)
Lunar Pediatric Reference Data (K001812), Expanded.LUNAR Reference Data (K964307), NHANES Reference Data for QDR (K963363), Hologic® Discovery Package for QDR (K023398), Hologic® QDR Explorer X-Ray Bone Densitometer (K033224), ODR 4500 X-Ray Bone Densitometer (K943505)
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.
0
Hologic®, Inc. May 10, 2004
AUG 1 1 2004
Hologie Reference Database 510(k) Premarket Notification
Section F.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
510(k) Summary of Safety and Effectiveness:
Pediatric Reference Database
K04H266
| Submitter: | Hologic, Inc. |
|---|---|
| Submitter Address: | 35 Crosby Drive |
| Bedford, MA 01730 | |
| Contact Person: | Richard L. Follett, V.P., Regulatory Affairs and Quality Assurance |
| Phone Number: | (781) 999-7506 |
| Fax: | (781) 280-0669 |
| Date Prepared: | May 7, 2004 |
| Device Trade | |
| Name: | Pediatric Reference Database |
| Device Common | |
| Name: | BoneDensitometer |
| Device Classification | |
| Name: | Bone Densitometer |
| 21 CFR 892.1170 | |
| Predicate Devices: | Lunar Pediatric Reference Data (K001812) |
| Expanded.LUNAR Reference Data (K964307) | |
| NHANES Reference Data for QDR (K963363) | |
| Hologic® Discovery Package for QDR (K023398) | |
| Hologic® QDR Explorer X-Ray Bone Densitometer (K033224) | |
| ODR 4500 X-Ray Bone Densitometer (K943505) |
1
Hologic®. Inc. May 10, 2004
Hologic Reference Database 510(k) Premarket Notification
Device Description:
The Pediatric Reference Database is a software option which simply extends the existing, commercially available reference databases' ability to generate a Z-score for younger subjects.
The Pediatric Reference Database for the Hologic QDR Series X-Ray Bone Densitometers provides AP I lie rediance Reference Batalensitometry reference data for male, white American children. The Spine, This and "Hotel in conjunction with previously existing software in the QDR Series I culaine relevelos band is results to sex, ethnicity and age-matched values. The reference Densitometers while realigate of bone densitometry reference values to include age 3-20 years of age. database is used to exparison of Bone Mineral Density (BMD) measurements obtained by dual energy x-ray absorptiometry to a database of BMD reference values.
Patient results for each analysis region can be compared to reference values both graphically and I uncility to vach allery of the age dependent reference Bone Mineral Density (BMD) values quantitution of + or the sex and ethnicity of the patient are generated with a marker placed at the position corresponding to the estimated patient BMD and age. Deviation "scores," are computed, quantifying (in eorroponants to are estation units) the difference between the patient's estimated BMD and the mean population standated (Z-score) reference data. In addition, the patient BMD is expressed in percent of the age matched mean in percent of the pediatric mean.
Intended Use:
The Pediatric Reference Database is a software option used with Hologic QDR Series X-Ray Bone The roundters. The software expands the range of bone densitometry reference data to include ages 3-20 years of age. The software provides a comparison of measured Bone Mineral Density (BMD) measurements obtained by dual energy x-ray absorptiometry to a database of BMD reference values in children. These data may be used for comparative purposes at the discretion of the physician.
Conclusion:
••
The Pediatric Reference Database is substantially equivalent to currently marketed software. No new safety and effectiveness questions are raised with the inclusion of these expanded reference values.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 1 2004
Ms. Anastasia C. Randall Senior Regulatory Affairs Specialist HOLOGIC, Inc. 35 Crosby Drive BEDFORD MA 01730
Re: K041266
Trade/Device Name: Pediatric Reference Database Regulation Number: 21 CFR 892.1170 Regulation Name: Bone Densitometer Regulatory Class: II Product Code: 90 KGI Dated: July 13, 2004 Received: July 14, 2004
Dear Ms. Randall:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your bection b 10(t) personalially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enorosare) to regary the Medical Device Amendments, or to econimer of they 2011-11-11 11:47 pm accordance with the provisions of the Federal Food, DNA and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmetion (110.) that be neview, subject to the general controls provisions of the Act. The r ou may, therefore, mains 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can may or subject to sales advanced 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 that I DA has made a ceretre and regulations administered by other Federal agencies. You must comply or any I coolar started and 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.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will anow you to ocgin hanteling of substantial equivalence of your device to a legally premarket notification. The PDA miding of dassification 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 If you desire specific advice for your dones to the following numbers, based on the regulation number at the top of the letter:
| 8xx. Ixxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Adultionaly, for questions on the promote the regulation entitled, "Misbranding Office of Comphanos at (2017 97 1000 (21 CFR Part 807.97) you may obtain. Other general by Ference to premarket notified to the Act may be obtained from the Division of Small information on your responsional and Consumer Assistance at its toll-free number (800) 638-2041 or 1901) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Bugdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Hologic®, Inc. May 10, 2004
Section D.
Indications for Use Statement
510(k) Number (if known): _KOU 1266
Device Name: _Pediatric Reference Database
Indications for Use:
The Pediatric Reference Database is a software option used with Hologic QDR Series X-1
1 The Pediatic Reference Database is a soltware openabase is for use in determining Z-Ray Bone Delishometers: The Pears at the discretion of the physician.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE
) (PLEASE DO NOT WRITE SECONDRED) OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use______________________________________________________________________________________________________________________________________________________________
Over-The-Counter-Use
(Per 21 CFR 801.109)
(Optional Format 1)
Vaind C. Syper
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K044 266