(240 days)
Yes
The document explicitly states that the device is "AI-powered software" and uses an "AI trained model" for segmentation.
No
The device is described as an AI-powered software intended to measure bone mineral density (BMD) from existing CT scans. Its purpose is to provide assessment of bone density, not to treat or cure a disease or condition. While the information it provides can be used in clinical evaluation, the software itself does not provide therapy.
Yes
The device measures bone mineral density (BMD) from existing CT scans, which is a key parameter used in the diagnosis of conditions like osteoporosis. The output of the device is intended to be reviewed by radiologists and used by healthcare providers in conjunction with clinical evaluation, indicating its role in the diagnostic process.
Yes
The device is described as a "software module" that "works on existing CT scans" and performs "post-processing" of images. There is no mention of any associated hardware component being part of the device itself.
Based on the provided information, the Automated Bone Mineral Density Software Module (ABMD) is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The ABMD software analyzes existing CT scan images, which are medical images, not biological specimens like blood, urine, or tissue.
- The intended use is to measure bone mineral density from existing CT scans. This is an analysis of imaging data, not a test performed on a biological sample.
- The device description explicitly states it's post-processing software that works on existing CT scans. This reinforces that it's processing imaging data.
While the software provides information about a patient's bone density, which is a physiological characteristic, it does so by analyzing imaging data, not by performing a test on a biological sample. This places it outside the definition of an In Vitro Diagnostic device.
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this specific device.
Intended Use / Indications for Use
The Automated Bone Mineral Density Software Module (ABMD) is a post-processing AI-powered software intended to measure bone mineral density (BMD) from existing CT scans by averaging Hounsfield units in the trabecular region of vertebral bones. ABMD is not intended to replace DXA or any other tests dedicated to BMD measurement. It is solely designed for measuring BMD in existing CT scans ordered for reasons other than BMD measurement. In summary, ABMD is an opportunistic AI-powered tool that enables: (1) retrospective assessment of bone density from CT scans acquired for other purposes, (2) assessment of bone density in conjunction with another medically appropriate procedure involving CT scans, and (3) assessment of bone density without a phantom as an independent measurement procedure.
Product codes
KGI
Device Description
The Automated Bone Mineral Density (ABMD) Software is a software module that estimates bone mineral density in the vertebral bones by averaging Hounsfield Units (HU) in the trabecular area. ABMD Software is a post-processing software that works on existing CT scans. ABMD Software measurements are to be reviewed by radiologists and should be used by healthcare providers in conjunction with clinical evaluation.
Mentions image processing
Yes
Mentions AI, DNN, or ML
The Automated Bone Mineral Density Software Module (ABMD) is a post-processing AI-powered software intended to measure bone mineral density (BMD) from existing CT scans by averaging Hounsfield units in the trabecular region of vertebral bones. ABMD is an opportunistic AI-powered tool. The ABMD Software uses an AI trained model to segment out vertebral bones in the field of view.
Input Imaging Modality
CT scans (DICOM format)
Anatomical Site
Vertebral bones / spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Radiologists, healthcare providers.
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
Study 1:
Reference Dataset: 993 quantitative CT (QCT) readings of a cohort of asymptomatic cases who underwent CT scans.
Truthing Process: QCT BMD, T-score, and Z-score values derived from manual measurement by trained operators.
Study 2:
Reference Dataset: 172 asymptomatic cases who underwent whole-body DXA scans as well as CT scans.
Truthing Process: DXA scans derived T-score, and Z-score values plus QCT BMD, T-score, and Z-score values derived from manual measurement by trained operators.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Software Verification and Validation Testing.
Study 1:
Sample size: 993 QCT readings.
Analysis methods: Pearson Correlation, Deming Regressions, and Bland Altman Agreement.
Results: Strong correlations and agreements were found between manual QCT and ABMD Software.
Study 2:
Sample size: 172 cases.
Analysis methods: Pearson Correlation, Deming Regressions, and Bland Altman Agreement.
Results: Strong correlations and agreements were found between manual QCT and ABMD Software. Modest but significant correlations and agreement were found between DXA, and ABMD Software.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
ABMD Software strongly correlated with manual QCT-based BMD measurement (t = 0.97, p
§ 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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July 29, 2022
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HeartLung Corporation % Lauren Lee Regulatory Consultant 1124 W Carson St TORRANCE CA 90502
Re: K213760
Trade/Device Name: ABMD Software Regulation Number: 21 CFR 892.1170 Regulation Name: Bone Densitometer Regulatory Class: Class II Product Code: KGI Dated: June 22, 2022 Received: June 29, 2022
Dear Lauren Lee:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. 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 of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Laurel Burk Assistant Director DHT8B: Division of Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K213760
Device Name ABMD Software
Indications for Use (Describe)
The Automated Bone Mineral Density Software Module (ABMD) is a post-processing AI-powered software intended to measure bone mineral density (BMD) from existing CT scans by averaging Hounsfield units in the trabecular region of vertebral bones. ABMD is not intended to replace DXA or any other tests dedicated to BMD measurement. It is solely designed for measuring BMD in existing CT scans ordered for reasons other than BMD measurement. In summary, ABMD is an opportunistic AI-powered tool that enables: (1) retrospective assessment of bone density from CT scans acquired for other purposes, (2) assessment of bone density in conjunction with another medically appropriate procedure involving CT scans, and (3) assessment of bone density without a phantom as an independent measurement procedure.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image is a logo for a company called HeartLung. The logo features a stylized human figure with a heart in the chest area and lungs represented by horizontal lines. The word "HeartLung" is written in red below the figure. The logo has a modern and clean design.
510(K) Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92:
1. Submitter
HeartLung Corporation 1124 W Carson St. The Lundquist Institute, MRL Building, Floor 3 Torrance, CA 90502 Tel: (650) 448-8089 Contact: Dr. Morteza Naghavi Date Prepared: November 24, 2021
2. Device
Subject Device: Automated Bone Mineral Density Software Trade Name: ABMD Software Common Name: ABMD Software Classification: Class II, 21 CFR 892.1170 Product Code: KGI
3. Predicate Device
Manufacturer: Mindways Trade Name: QCT Bone Mineral Density Analysis Software Predicate 510(k): K894854 Classification: Class II, 21 CFR 892.1170 Product Code: KGI
4. Reference Device
Manufacturer: Mindways Trade Name: QCT Pro Asynchronous Calibration Module, CliniQCT Predicate 510(k): K140342 Classification: Class II, 21 CFR 892.1170 Product Code: KGI
5. Device Description
General Description
The Automated Bone Mineral Density (ABMD) Software is a software module that estimates bone mineral density in the vertebral bones by averaging Hounsfield Units (HU) in the trabecular
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Image /page/4/Picture/0 description: The image is a logo for a company called HeartLung. The logo features a stylized human torso with a heart in place of the lungs. The heart is pink, and the rest of the torso is blue. The logo is set against a white background.
area. ABMD Software is a post-processing software that works on existing CT scans. ABMD Software measurements are to be reviewed by radiologists and should be used by healthcare providers in conjunction with clinical evaluation.
Intended Patient Population
ABMD Software is for post-processing analysis of bone mineral density in people who underwent a CT scan that includes vertebral bone.
Principles of Ops
ABMD Software reads a CT scan (in DICOM format) and extracts patient-specific metadata such as age, gender, and scan specific information like acquisition time, pixel size and scanner type. The ABMD Software uses an AI trained model to segment out vertebral bones in the field of view and subsequently measures the average of the Hounsfield unit, HU, in a cylinder volume within the trabecular tissue of each vertebral bone without including the cortical bone. The bone mineral density (BMD) is calculated by the mean of those averages for vertebral bones found in the field of view. Subsequently, the Z-score and T-scores are calculated based on the age and gender of the person and the calibration factor for the CT scan. The snapshots of the spinal bones and measured area along with the average HU and the scores are exported for review and confirmation by a human expert.
Software will output the segmentation of trabecular bone used in calculation of BMD as determined by the sample volume being a minimum of 1 pixel away from the cortical bone.
Software passes if the sample volume is at least 1 pixel away from the cortical border.
Software fails if the sample volume crosses or intersects with the cortical border.
The end user cannot change or edit the segmentation or results of the device. The end user must accept or reject the region where the BMD measurement is done. If rejected, the end user must conduct an alternate method such as manual measurement using the same methods described in QCT-based manual measurement of BMD.
This device is not intended to replace DXA scanners. It is only intended to be used on the existing CT scans or CT scans ordered for reasons other than measuring BMD so that it will prevent extra radiation dose being introduced to the patients.
Conditions of Use:
The ABMD Software is a post-processing software module that only works on existing CT scans that include spinal bones.
6. Intended Use
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K213760 HeartLung Corporation 1124 W Carson St The Lundquist Institute, MRL Building, Floor 3 Torrance, CA 90502
The Automated Bone Mineral Density (ABMD) Software is a post-processing AI-powered software intended to measure bone mineral density (BMD) from existing CT scans by averaging Hounsfield units in the trabecular region of vertebral bones. ABMD Software is not intended to replace DXA or any other tests dedicated to BMD measurement. It is solely designed for measuring BMD in existing CT scans or CT scans ordered for reasons other than BMD measurement. In summary, ABMD Software is an opportunistic AI-powered tool that enables: (1) retrospective assessment of bone density from CT scans acquired for other purposes, (2) assessment of bone density in conjunction with another medically appropriate procedure involving CT scans, and (3) assessment of bone density without a phantom as an independent measurement procedure.
- Comparison of Technological Characteristics & Intended Use to Predicate Device The table below provides a summary of the technological characteristics of the ABMD Software in comparison to the predicate device. The indications for use for the predicate device are similar to the indications for the use of the ABMD Software. There are no major technological differences between the two systems that raise new issues of safety and/or effectiveness. Thus, the ABMD Software is substantially equivalent to the predicate device.
| Feature | Subject Device
ABMD Software | Predicate
Device
QCT Bone
Mineral Density
Analysis
Software
K894854 | Reference
Device
QCT Pro
Asynchronous
Calibration
Module,
CliniQCT
K140342 | Summary |
|-------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| Indication for
Use/Intended
Use | Estimate bone
mineral density
within the spine. | Estimate bone
mineral density
within the spine. | Estimate bone
mineral density
within the spine. | Equivalent. |
| Modality | CT scan images
(DICOM) | CT scan images
(DICOM) | CT scan images
(DICOM) | Equivalent. |
| Device provides
estimates of | Yes | Yes | Yes | Equivalent. |
| bone mineral
density from the
spine. | | | | |
| Device provides
the bone mineral
density value. | Yes | Yes | Yes | Equivalent. |
| Device provides
Z-score. | Yes | Yes | Yes | Equivalent. |
| Device provides
T-score. | Yes | Yes | Yes | Equivalent. |
| User | Healthcare
Providers | Healthcare
Providers | Healthcare
Providers | Equivalent. |
| Operating
System | Linux | Windows | Windows | Equivalent,
software
function is
independent
from
operating
system. |
| Retrospective
measurements
from CT scans. | CT scan images
can be selected and
inputted to the
software. | CT scan images
can be selected
and inputted to
the software. | CT scan images
can be selected
and inputted to
the software. | Equivalent. |
| Automatic
Averaging
Hounsfield
Units | Software
automatically
measures and
averages
Hounsfield units in
the trabecular | Software
automatically
measures and
averages
Hounsfield units
in the trabecular | Software
automatically
measures and
averages
Hounsfield units
in the trabecular | Equivalent. |
| | region of spinal
bones. | region of spinal
bones. | region of spinal
bones. | |
| Calibration | Inputting CT
scanner-specific
calibration factor is
required. Software
outputs calibrated
BMD score. | Simultaneous
scanning of
calibration
phantom is
required.
Software outputs
calibrated BMD
score. | Asynchronous
scanning of
calibration
phantom is
required.
Software outputs
calibrated BMD
score. | Equivalent.
Software
provides
measurements
corrected for
calibration
data. |
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Image /page/7/Picture/0 description: The image is a logo for an organization called "HeartLung". The logo features a stylized human figure with a heart in the chest area and what appears to be a representation of the lungs. The figure is enclosed in a rounded square shape. The word "HeartLung" is written in red below the figure.
8. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
Sterilization & Shelf-Life Testing
Not applicable for this software as a medical device.
Biocompatibility Testing
Not applicable for this software as a medical device.
Electrical Safety and Electromagnetic Compatibility (EMC)
Not applicable for this software as a medical device.
Software Verification and Validation Testing
Software Verification and Validation testing was completed to demonstrate the safety and effectiveness of the device. Testing demonstrates the ABMD Software meets all its functional requirements and performance specifications.
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Image /page/8/Picture/0 description: The image is a logo for an organization called "HeartLung". The logo features a stylized human figure with a heart in the chest area and lungs surrounding the heart. The heart is colored pink, while the lungs and the rest of the figure are blue. The text "HeartLung" is written in red and blue below the figure.
The ABMD Software strongly correlated with manual QCT-based BMD measurement. The scatter plot and regression lines show the range of bias to be limited and display a very strong correlation between BMD measured by manual method versus ABMD Software (t = 0.97, p