(116 days)
No
The summary describes a standard X-ray bone densitometer with a new software option for imaging the femur. There is no mention of AI, ML, or any related technologies in the device description, intended use, or performance studies. The comparison to the predicate device focuses on identical technological characteristics and software.
No
The device is used for visualization and diagnosis (identifying bone deformities), not for treating or rehabilitating a condition.
Yes
The device is described as being used to "visualize focal reaction or thickening along the lateral cortex of the femoral shaft which may be accompanied by a transverse radiolucent line." This visualization aids in the identification of potential "atypical femur fractures," which is a diagnostic purpose.
No
The device description explicitly states it is a software option for a bone densitometer, which is a hardware device (examination table, C-arm, x-ray tube, detector array). The software enables a specific scan type on existing hardware.
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 such as blood, urine, or tissue that have been taken from the human body. They are used to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device is an X-ray bone densitometer used to visualize bone deformities in the femur. It acquires images of the patient's bone using X-rays.
- No Sample Analysis: There is no mention of analyzing any biological samples from the patient. The device directly interacts with the patient's body to acquire images.
Therefore, this device falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Single Energy (SE) Femur Exams are used to visualize focal reaction or thickening along the lateral cortex of the femoral shaft which may be accompanied by a transverse radiolucent line. Clinical correlation is advised as these features may be consistent with atypical femur fractures, a complication associated with long term use of antiresorptive therapy.
Product codes
KGI
Device Description
The proposed Hologic ® Single Energy (SE) Femur scan allows for the visualization of bone deformities of the femur, specifically focal reaction or thickening along the lateral cortex of the femoral shaft which may be accompanied by a transverse radiolucent line.
Hologic's Discovery (K023398) bone densitometer models: Discovery A, C, W, and SL consist of an examination table and a C-arm. At opposite ends of the C-arm an x-ray tube and a linear multi-detector array are mounted. The patient is positioned on the examination table between the x-ray tube and the detector array. The detector and x-ray source scan the patient axially using an x-ray fan beam perpendicular to the direction of movement. The xray source can be pulsed at a constant voltage to acquire exams as in the case of Hologic's Instant Vertebral Assessment (IVA) exams reviewed and cleared by FDA (K060111). Currently, two types of IVA scans are in use on the Discovery A, C, W, and SL bone densitometers; the IVA and the IVA-HD (High Definition). Both scans are used for the visualization of vertebral bone deformities. The IVA scan has a 10 second scan time, whereas the IVA-HD has a 15 second scan time. IVA-HD scans use a thinner aperture resulting in higher resolution and a lower total dose than IVA scans. The high resolution image of the single energy IVA-HD scan makes it ideal for use as a scan to visualize deformities in the femur.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray Fan Beam Scan
Anatomical Site
Femoral shaft
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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
The SE Femur and IVA-HD scans offer the same fundamental device technology, image acquisition mode, acquisition speed, x-ray technique factors, vertical resolution, x-ray aperture, radiation dose, and image display supported by the bone densitometer. The Single Energy (SE) Femur Exam has the same technological characteristics as the predicate device. The identical IVA-HD scan is used for the acquisition of the lumbar and thoracic spine scan as is used for the proposed device for the acquisition of the SE Femur scan. The sole difference is in the positioning of the patient so that the targeted region (spine or femur) is imaged. No changes have been made to the software and both SE Femur and IVA scans can be viewed on the DXA system's screen and a report can be printed.
The information provided in the 510(k) submission is acceptable for the demonstration of substantial equivalence to the predicate device with respect to physical performance and testing
Key Metrics
Not Found
Predicate Device(s)
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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K130277
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Section 5 -510(k) Summary
Date Prepared: January 31, 2013
MAY 3 1 2013
1.0 Manufacturing Establishment and Contact Information
1.1 Manufacturer Name and Address:
Hologic, Inc. 35 Crosby Drive Bedford, MA 01730
1.2 Establishment Registration Number:
1221300
Name, Title, and Telephone Number of Contact: 1.3
Name: Eileen M. Boyle Regulatory Affairs Specialist III Title: Phone: (781) 999-7781 (866) 652-8674 Fax : eileen.boyle@hologic.com Email :
2.0 Device Identification
- 2.1 Device Trade Name: Hologic® Single Energy (SE) Femur Exam
2.2 Common/Usual Name
Software for Bone Densitometers
2.3 Proposed Intended Use:
Single Energy (SE) Femur Exams are used to visualize focal reaction or thickening along the lateral cortex of the femoral shaft which may be accompanied by a transverse radiolucent line. Clinical correlation is advised as these features may be consistent with atypical femur fractures, a complication associated with long term use of antiresorptive therapy.
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2.4 Comparison of the Indication for Use:
The proposed indication for use of the SE Femur scan is substantially equivalent to that of the predicate device. Like the proposed device, the predicate device is indicated for the visualization of bone deformities. The predicate device is indicated for the visualization of vertebral bone deformities (as well as for the visualization of abdominal aortic calcifications), whereas the proposed device is for the visualization of bone deformities of the femur.
Since the identical IVA-HD scan is used, the SE Femur scan and IVA scans offer the same fundamental device technology, image acquisition mode, acquisition speed, x-ray technique factors, vertical resolution, x-ray aperture, radiation dose, and image display supported by the bone densitometer. No changes were made to the image acquisition software, report structure, or performance specifications. No new safety and effectiveness questions were raised following the risk assessment for the proposed expansion of the IVA scan's intended use. Therefore, the expanded indication for use statement has no effect on the bone densitometer's safety or effectiveness.
3.0 Device Classification
- 3.1 Classification: Class II
- 3.2 Classification Name and Rule Bone Densitometer: 21 CFR 892-1170
- 3.3 Classification Panel Radiology
- 3.4 Product Code તે જેવી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામમાં મુખ્યત્વે ખેત-ઉપયોગ વિભાગમાં આવેલું એક ગામના લોકોનો મુખ્યત્વે આવ
- 3.5 Prescription Use The use of the Single Energy (SE) Femur Exam is restricted to prescription use only.
3.6 Predicate Devices
- . 510(k) No: K060111 Trade Name: IVA (MXA-II) software option for the X-Ray bone densitometer SE Date: 4/4/2006 Manufacturer: Hologic, Inc.
2
4.0 Device Description
The proposed Hologic ® Single Energy (SE) Femur scan allows for the visualization of bone deformities of the femur, specifically focal reaction or thickening along the lateral cortex of the femoral shaft which may be accompanied by a transverse radiolucent line.
Hologic's Discovery (K023398) bone densitometer models: Discovery A, C, W, and SL consist of an examination table and a C-arm. At opposite ends of the C-arm an x-ray tube and a linear multi-detector array are mounted. The patient is positioned on the examination table between the x-ray tube and the detector array. The detector and x-ray source scan the patient axially using an x-ray fan beam perpendicular to the direction of movement. The xray source can be pulsed at a constant voltage to acquire exams as in the case of Hologic's Instant Vertebral Assessment (IVA) exams reviewed and cleared by FDA (K060111). Currently, two types of IVA scans are in use on the Discovery A, C, W, and SL bone densitometers; the IVA and the IVA-HD (High Definition). Both scans are used for the visualization of vertebral bone deformities. The IVA scan has a 10 second scan time, whereas the IVA-HD has a 15 second scan time. IVA-HD scans use a thinner aperture resulting in higher resolution and a lower total dose than IVA scans. The high resolution image of the single energy IVA-HD scan makes it ideal for use as a scan to visualize deformities in the femur.
Comparison of Technological Characteristics: 5.0
The Single Energy (SE) Femur Exam is substantially equivalent to that of the predicate device. Like the proposed device, the predicate device is indicated for the visualization of bone deformities. The comparison table summarizes the technological characteristics of the Single Energy Femur Exam and the IVA the predicate device:
| Device Characteristics | Proposed 510(k) Device
Single Energy Femur Exam | Hologic, Inc.
IVA (K060111) |
|-------------------------------------|----------------------------------------------------|---------------------------------------|
| Method of Deformity
Assessment | Visual ) | Same |
| Fundamental Device
Technology | DXA Bone Densitometer | Same |
| Exam Site | Femoral shaft | Lumbar and Thoracic Spine |
| Imaging Scan | IVA-HD | IVA-HD |
| Image Acquisition Mode | Single Energy Fan Beam Scan | Same |
| Acquisition Speed for 15.7"
Scan | 15 seconds | Same |
| X-ray Technique Factors | 140 kVp @ 5 ma | Same |
| Vertical Resolution | 1.4 lp/mm | Same |
| X-ray Aperture | 0.25 mm (W) x 61 mm (L) | Same |
| Entry Dose | 0.025 mGy | Same |
| Image Display | On screen display with image
tools | Same |
| Device Output | Image of femoral shaft | Image of Lumbar and Thoracic
Spine |
Comparison table of the Single Energy Femur Exam and IVA:
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K130277
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6.0 Performance Testing
The SE Femur and IVA-HD scans offer the same fundamental device technology, image acquisition mode, acquisition speed, x-ray technique factors, vertical resolution, x-ray aperture, radiation dose, and image display supported by the bone densitometer. The Single Energy (SE) Femur Exam has the same technological characteristics as the predicate device. The identical IVA-HD scan is used for the acquisition of the lumbar and thoracic spine scan as is used for the proposed device for the acquisition of the SE Femur scan. The sole difference is in the positioning of the patient so that the targeted region (spine or femur) is imaged. No changes have been made to the software and both SE Femur and IVA scans can be viewed on the DXA system's screen and a report can be printed.
The information provided in the 510(k) submission is acceptable for the demonstration of substantial equivalence to the predicate device with respect to physical performance and testing
7.0 Substantial Equivalence
The Single Energy (SE) Femur Exam software is substantially equivalent to commercially IVA software option (K060111) which allows visualization of bone deformities. The predicate device provides substantially equivalent or the same intended use, features and functions as the proposed device.
8.0 Conclusion
The Hologic Single Energy (SE) Femur Exam software allows visualization of bone deformities. The features and functions are substantially equivalent to those of the predicate device.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 31, 2013
Hologic, Inc. % Ms. Eileen M. Boyle Senior Regulatory Affairs Specialist 35 Crosby Drive BEDFORD MA 01730
Re: K130277
Trade/Device Name: Single Energy (SE) Femur Exam Regulation Number: 21 CFR 892.1170 Regulation Name: Bone densitometer Regulatory Class: II Product Code: KGI Dated: May 15, 2013 Received: May 16, 2013
Dear Ms. Boyle:
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 contrôls provisions of the Act include requirements for annual registration, listing of devices, good-manufacturing practice, labeling, and-prohibitions against-misbranding andadulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
5
Page 2 - Ms. Boyle
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/DeviceLabeling/ default.hum. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
· for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
6
Section 4 - Indications for Use
510(k) Number (if known): K130277
Device Name: Single Energy (SE) Femur Exam
Indications for Use:
Single Energy (SE) Femur Exams are used to visualize focal reaction or thickening along the lateral cortex of the femoral shaft which may be accompanied by a transverse radiolucent line. Clinical correlation is advised as these features may be consistent with atypical femur fractures, a complication associated with long term use of antiresorptive therapy.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
سر
Sm.h.7)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off
Office of InVitro Diagnostic Device Evaluation and Safety
K130277 510(k) _______________________________________________________________________________________________________________________________________________________________________
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