(113 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and does not describe any AI/ML-specific components, training data, or performance metrics typically associated with such technologies.
No.
The device estimates visceral fat content to assist healthcare professionals in managing diseases, but it explicitly states that it "does not diagnose disease, or recommend treatment regimens, or quantify treatment effectiveness." Therefore, it is not a therapeutic device.
No
The device description explicitly states, "The Hologic Visceral Fat software does not diagnose disease, or recommend treatment regimens, or quantify treatment effectiveness." Instead, it provides estimated visceral fat content which is "useful to health care professionals in their management of diseases/conditions."
No
The device is described as "Hologic Visceral Fat Software used on Hologic Discovery bone densitometer total body scans". This indicates the software is an add-on or feature of a hardware device (the bone densitometer), not a standalone software-only medical device.
Based on the provided information, the Hologic Visceral Fat Software 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: The Hologic Visceral Fat Software analyzes imaging data (DXA scans) of the human body to estimate visceral fat content. It does not analyze biological samples taken from the body.
- Intended Use: The intended use describes the software as providing an estimate of visceral fat content based on the scan data, to be used by healthcare professionals in managing certain conditions. It explicitly states it "does not diagnose disease, or recommend treatment regimens, or quantify treatment effectiveness."
Therefore, because the device operates on imaging data and not biological samples, it falls outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Hologic Visceral Fat Software used on Hologic Discovery bone densitometer total body scans estimates the visceral adipose tissue (visceral fat) content within the android region in an adult male or female population, excluding pregnant women. The content that is estimated is the Visceral Fat Area, Visceral Fat Mass, and Visceral Fat Volume. These values can be displayed in user-defined statistical formats and trends.
The estimated visceral fat content is useful to health care professionals in their management of diseases/conditions where the disease/condition itself, or its treatment can affect the relative amounts of visceral fat content in the android region. The Hologic Visceral Fat software does not diagnose disease, or recommend treatment regimens, or quantify treatment effectiveness. Only the health care professional can make these judgments. Some of the diseases, conditions for which visceral fat estimation is useful include hypertension, impaired fasting glucose, impaired glucose tolerance, diabetes mellitus, dyslipidemia, and metabolic syndrome.
Product codes
KGI
Device Description
The proposed Hologic® Visceral Fat Software provides an estimate of a patient's visceral fat in the abdominal region of a whole body scan. The results are included in the Adipose Indices section of the Hologic Discovery bone densitometer's body composition report.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
DXA (Dual-energy X-ray Absorptiometry)
Anatomical Site
abdominal region, android region
Indicated Patient Age Range
adult
Intended User / Care Setting
health care professionals
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)
Testing was successfully conducted and demonstrates that the Hologic Visceral Fat Software meets all of its functional requirements and performance specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
0
Hologic Visceral Fat Software 510(k) Premarket Notification
KII 3.356 1 of 3
Section 5 -510(k) Summary
1 Manufacturing Establishment and Contact Information
MAR - 6 2012
Manufacturer Name and Address: 1.1
Hologic, Inc. 35 Crosby Drive Bedford, MA 01730
1.2 Establishment Registration Number:
1221300
1.3 Name, Title, and Telephone Number of Contact:
Name: Eileen M. Boyle Regulatory Affairs Specialist II Title: (781) 999-7781 Phone: (866) 652-8674 Fax : eileen.boyle@hologic.com
Device Identification 2
2.1 Device Trade Name:
Hologic Visceral Fat Software
2.2 Common / Usual Name:
Software for Bone Densitometers
2.3 Proposed Intended Use:
The Hologic Visceral Fat Software used on Hologic Discovery bone densitometer total body scans estimates the visceral adipose tissue (visceral fat) content within the android region in an adult male or female population, excluding pregnant women. The content that is estimated is the Visceral Fat Area, Visceral Fat Mass, and Visceral Fat Volume. These values can be displayed in user-defined statistical formats and trends.
The estimated visceral fat content is useful to health care professionals in their management of diseases/conditions where the disease/condition itself, or its treatment can affect the relative amounts of visceral fat content in the android region. The Hologic Visceral Fat software does not diagnose disease, or recommend treatment regimens, or quantify treatment effectiveness. Only the health care professional can make these judgments. Some of the diseases, conditions for which visceral fat estimation is useful include hypertension, impaired fasting glucose, impaired glucose tolerance, diabetes mellitus, dyslipidemia, and metabolic syndrome.
1
Hologic, Inc .: November 10, 2011
Hologic Visceral Fat Software 510(k) Premarket Notification
KII 3356 2 of
Device Classification 3
3.1 Classification:
Class II
3.2 Classification Name and Rule
Bone Densitometer: 21 CFR 892.1170
Classification Panel 3.3
Radiology
3.4 Product Code
વે જણાવાદ તાલુકામાં આવેલું એક ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામમાં મુખ્યત્વે ખેત
3.5 Predicate Devices
- . 510(k) No.: K103730 Trade Name: GE Lunar Visceral Fat Software SE Date: 5/6/2011 Manufacturer: GE Medical Systems Lunar
- . 510(k) No.: K103265 Hologic NHANES Whole Body DXA Reference Database Trade Name: SE Date: · 3/16/2011 Manufacturer: Hologic, Inc.
Device Description 4
The proposed Hologic® Visceral Fat Software provides an estimate of a patient's visceral fat in the abdominal region of a whole body scan. The results are included in the Adipose Indices section of the Hologic Discovery bone densitometer's body composition report.
5 Performance Testing
Testing was successfully conducted and demonstrates that the Hologic Visceral Fat Software meets all of its functional requirements and performance specifications.
5 Substantial Equivalence
The Hologic® Visceral Fat Software is substantially equivalent to commercially available devices used for the estimation of a patient's visceral fat. The predicate devices selected for comparison are the GE Lunar Visceral Fat Software Option (K103730) and the Hologic NHANES Whole Body DXA Reference Database (K103265). The predicate devices provide substantially equivalent or the same intended use, features and functions as the proposed device.
2
Hologic, Inc.: November 10, 2011
Hologic Visceral Fat Software 510(k) Premarket Notification
Conclusion: 6
KI13356 R 3 of 3
. The Hologic Visceral Fat Software is an extension of the cleared Discovery NHANES Whole Body DXA Reference Database (K103265). The features and functions are substantially equivalent to those of the indicated commercially distributed device (GE Lunar Visceral Fat Software K103730) with regard to intended use, performance, safety and effectiveness
Hologic Proprietary and Confidential
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three wings.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
MAR - 6 2012
Ms. Eileen M. Boyle Regulatory Affairs Specialist II Hologic, Inc. 35 Crosby Drive BEDFORD MA 01730
Re: K113356
Trade/Device Name: Hologic Visceral Fat Software Regulation Number: 21 CFR 892.1170 Regulation Name: Bone densitometer Regulatory Class: II Product Code: KGI Dated: February 29, 2012 Received: March 1, 2012
Dear Ms. Boyle:
We have reviewed your Section 510(k) premarket notification of intent to market the device w one reviewed your 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). and Cosmetic roll (1 ret) that as novice, subject to the general controls provisions of the Act. The I ou may, merelore, market 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 class II (Special Controls), it may be subject to such 11 your device is classified (200 acorregulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 I lease of advisod that I Dr o retime that your device complies with other requirements of the Act that I DA has made a actorized administered by other Federal agencies. You must or any I catales and regarments, including, but not limited to: registration and listing (21 Compy with an the Fee of requirements 801 and 809); medical device reporting (reporting of
4
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket whil anow you to organ maing of substantial equivalence of your device to a legally marketed nothicate 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Janine M. Morris Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Hologic, Inc .: November 10, 2011
Hologic Visceral Fat Software 510(k) Premarket Notification
SECTION 4 - INDICATIONS FOR USE
510(k) Number (if known): Device Name:
The Hologic Visceral Fat Software used on Hologic Discovery bone densitometer total body scans estimates the visceral adipose tissue (visceral fat) content within the android region in an adult male or female population, excluding pregnant women. The content that is estimated is the Visceral Fat Area, Visceral Fat Mass, and Visceral Fat Volume. These values can be displayed in user-defined statistical formats and trends.
The estimated visceral fat content is useful to health care professionals in their management of diseases/conditions where the disease/condition itself, or its treatment can affect the relative amounts of visceral fat content in the android region. The Hologic Visceral Fat software does not diagnose disease, or recommend treatment regimens, or quantify treatment effectiveness. Only the health care professional can make these judgments. Some of the diseases, conditions for which visceral fat estimation is useful include hypertension, impaired fasting glucose, impaired glucose tolerance, diabetes mellitus, dyslipidemia, and metabolic syndrome.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
ffice of Device Evaluation (ODE)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, C
(Division Sign-Off)
Division of Radiological Devices
Office of in Vitro
510K K1133
Hologic Proprietary and Confidential
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Section 4