(119 days)
No
The summary describes image processing software that suppresses bone anatomy but does not mention AI, ML, or deep learning. The description of performance studies focuses on clinical acceptability and comparison to predicate devices, not on training or validation of an AI/ML model.
No
The device is described as assisting diagnosis by minimizing anatomical distractions in chest x-ray images and enhancing visualization of chest pathology; it does not explicitly state it treats or prevents a disease or condition.
No
Explanation: The device is described as "Bone Suppression Software" that "assists diagnosis" by "minimizing anatomical distractions" and "enhancing visualization" of pathology in a companion image. While it aids the diagnostic process, it explicitly states it provides a "companion image that is delivered in addition to the original diagnostic image" and uses "image processing" to generate a "bone-suppressed image to aid diagnosis." It does not make a diagnosis itself but rather provides an enhanced view for a human diagnostician.
Yes
The device is described as a "software component" and its function is to process existing digital x-ray images. There is no mention of any hardware being part of the device itself, only that it is used on diagnostic x-ray systems.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The definition of an IVD involves testing samples like blood, urine, tissue, etc., outside of the body to obtain information about a person's health.
- This device processes medical images. The software works with chest x-ray images, which are generated from the patient's body, but the processing happens on the image data itself, not on a biological specimen.
- The intended use is to assist diagnosis by enhancing image visualization. The software's purpose is to improve the clarity of chest x-rays for radiologists to interpret, not to directly analyze biological markers or substances.
The device falls under the category of medical image processing software or radiology software, which are regulated as medical devices but are distinct from IVDs.
N/A
Intended Use / Indications for Use
The software's intended use is to assist diagnosis of chest pathology by minimizing anatomical distractions such as the ribs and clavicle in chest x-ray images.
Product codes
MQB
Device Description
The Bone Suppression Software is a software component for use on diagnostic x-ray systems utilizing digital radiography (DR) or computed radiography (CR) technology. The software option suppresses bone anatomy in order to enhance visualization of chest pathology in a companion image that is delivered in addition to the original diagnostic image.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
chest
Indicated Patient Age Range
Not Found
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
Performance testing was conducted to verify the design output met the design input requirements and to validate the device conformed to the defined user needs and intended uses. Nonclinical testing was conducted under simulated use conditions. Clinical testing was conducted to evaluate the acceptability of the companion images for assisting diagnosis. Predefined acceptance criteria were met and demonstrated that the device is as safe, as effective, and performs as well as the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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MAR 1 1 2014
K133442
Page 1 of 3
Traditional 510(k) for Bone Suppression Softwar
Carestream
"510(k) Summary"
| 510(k) Owner Name: | Carestream Health, Inc. |
|---|---|
| 510(k) Owner Address: | 150 Verona Street |
| Rochester, New York 14608 | |
| 510(k) Owner Phone: | 585-627-6528 |
| 510(k) Owner Fax: | 585-323-7643 |
| Contact Person & Info: | Carolyn Wagner |
| Regulatory Affairs Manager, X-Ray Systems | |
| carolyn.wagner@carestreamhealth.com | |
| 585-627-6557 | |
| Date Summary Prepared: | October 30. 2013 |
| Device Trade Name: | Bone Suppression Software |
| Device Common Name: | DR digital imager |
| Classification Name: | Solid state x-ray imager (flat panel/digital imager) |
| Device Class: | Class II |
| Device Code: | MQB |
| Regulation Number: | 21 CFR 892.1680 |
| Predicate Devices: | Kodak Eclipse Image Processing Software |
| Manufactured by Carestream Health, Inc. | |
| 510(k) No. - K060137 (May 16. 2006) | |
| Softview. Model 2.01 | |
| Manufactured by Riverain Medical Group | |
| 510(k) No. - K092363 (March 18, 2010) |
Device Description:
The Bone Suppression Software is a software component for use on diagnostic x-ray systems utilizing digital radiography (DR) or computed radiography (CR) technology. The software option suppresses bone anatomy in order to enhance visualization of chest pathology in a companion image that is delivered in addition to the original diagnostic image.
1
Indications for Use / Intended Use:
The Indications for Use for the device, as described in its labeling, are: ··The software's intended use is to assist diagnosis of chest pathology by minimizing anatomical distractions such as the ribs and clavicle in chest x-ray images."
The intended use for this device. as determined by descriptions and the proposed labeling contained in this submission, is similar to the Indications for Use statement provided above. The Bone Suppression software component provides a bone suppressed companion image with posterior ribs and clavicle suppressed to aid diagnosis in chest radiographs. We believe that the Bone Suppression Software and the predicate devices have the same intended use.
The Indications for Use for the "Bone Suppression Software" is different than the Kodak Eclipse Image Processing Software predicate device. but these differences do not alter the intended diagnostic use of the software component. The Kodak Eclipse Image Processing Software optimizes radiographic images for diagnosis. The Bone Suppression companion view is generated using an additional image processing step that provides a bone-suppressed image to aid diagnosis in chest radiographs.
The Indications for Use for the "Bone Suppression Software" is worded differently than the Riverain "SoftView, Model 2.1" predicate device, but these differences are appropriately described as descriptive and do not alter the intended diagnostic use of the software component. Both devices provide a bone-suppressed companion view to minimize distractions in chest images. Both devices provide the original "standard of care` image along with the companion image.
Any variation in features or technical specifications have been identified and addressed through testing (described below) to support a substantial equivalence determination.
Comparison of Technological Characteristics:
The Bone Suppression Software is an extension of the predicate device, the Kodak Eclipse Image Processing Software. The Bone Suppression Software is an optional software component that allows a companion image to be formed with bone anatomy suppressed in order to enhance visualization of chest pathology. It is available as an integrated optional feature within the predicate device Kodak Eclipse Image Processing Software (DirectView software). The new software device (feature) raises no new issues of safety or effectiveness.
The Bone Suppression Software has the same technological characteristics as the predicate device, the SoftView, Model 2.01. Both devices provide an additional companion image with bone anatomy suppressed in order to enhance visualization of chest pathology. Both devices provide the companion view along with the original
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Fraditional 510(k) for Bone Suppression Software
K133442
Page 3 of 3
ftware
"standard of care" chest radiograph. The Carestream "Bone Suppression Software" device raises no new issues of safety or effectiveness.
Discussion of Testing
Performance testing was conducted to verify the design output met the design input requirements and to validate the device conformed to the defined user needs and intended uses. Nonclinical testing was conducted under simulated use conditions. Clinical testing was conducted to evaluate the acceptability of the companion images for assisting diagnosis. Predefined acceptance criteria were met and demonstrated that the device is as safe, as effective, and performs as well as the predicate device.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of two main elements: the department's name encircling the image and an abstract symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The symbol is a stylized representation of a human figure embracing or being supported, composed of three curved lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 11, 2014
Carestream Health, Inc. % Ms. Carolyn Wagner Regulatory Affairs Manager 150 Verona Street ROCHESTER NY 14608
Re: K133442
Trade/Device Name: Bone Suppression Software Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: February 28, 2014 Received: February 28, 2014
Dear Ms. Wagner:
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. 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.
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Page 2 - Ms. Carolyn Wagner
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/dcfault.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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael D. O'Hara
for Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
5
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K133442
Device Name Bone Suppression Software
Indications for Use (Describe)
The software's intended use is to assist diagnosis of chest pathology by minimizing anatomical distractions such as the ribs and clavicle in chest x-ray images.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpant C)
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure)
Michael D. O'Hara
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