(91 days)
Not Found
No
The summary describes standard digital X-ray imaging and image processing functionalities (acquisition, calibration, display, analysis, manipulation, archiving, transmittal) but does not mention any AI or ML techniques being used for these processes or for the primary function of rapid verification. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
Explanation: The device is an X-ray imaging system used for rapid verification of excised tissue during biopsy. Its purpose is diagnostic (imaging and verification), not therapeutic (treating a disease or condition).
Yes
The device is intended to provide rapid verification that the correct tissue has been excised during percutaneous biopsy, which involves examining anatomical regions to confirm the presence or absence of specific tissue, fulfilling a diagnostic function.
No
The device is described as a "cabinet digital X-ray imaging system" and mentions conforming to performance standards for "ionizing radiation emitting products" and "Cabinet X-ray systems," indicating it includes hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to generate X-rays for examining anatomical regions and verifying excised tissue during biopsy. This is a radiological imaging function, not a diagnostic test performed in vitro (outside the body) on biological specimens.
- Device Description: The device is described as a cabinet digital X-ray imaging system. This aligns with imaging equipment, not IVD devices which typically involve reagents, analyzers, or test kits for analyzing biological samples.
- Mechanism of Action: The device uses X-rays to create images. IVD devices analyze biological samples (like blood, urine, tissue) to detect or measure substances or characteristics.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, using reagents, or performing tests on specimens in vitro. The focus is on imaging the excised tissue.
The device is clearly intended for medical imaging to assist in a surgical procedure (biopsy verification), which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Core Vision Digital Specimen Radiography (DSR) System is a cabinet digital X-ray imaging system intended to generate and control X-rays for examination of various anatomical regions, and to provide rapid verification that the correct tissue has been excised during percutaneous biopsy.
Performing the verification directly in the same biopsy procedure room enables cases to be completed faster, thus limiting the time the patient needs to be under examination. Specimen radiography can potentially limit the number of patient recalls. This device is intended to be operated wherever the medical professionals deem appropriate, including a surgical suite or a room adjacent to a surgical suite.
Product codes (comma separated list FDA assigned to the subject device)
MWP
Device Description
The Core Vision Digital Specimen Radiography (DSR) System is a stand-alone cabinet digital X-ray imaging system to provide rapid verification that the correct tissue has been excised during percutaneous biopsy.
Performing the verification directly in the same biopsy procedure room enables cases to be completed faster, thus limiting the time the patient needs to be under examination. Specimen radiography can potentially limit the number of patient recalls.
The Core Vision Digital Specimen Radiography (DSR) System employs the use of Bioptics Vision image acquisition software. The Bioptics Vision software handles the digital X-ray image acquisition, calibration, image display, image analysis and manipulation, patient database, image archiving, and transmittal. Bioptics Vision software is the central part of this system. Bioptics Vision software is Digital Imaging and Communications in Medicine (DICOM) 3.0 compliant and comes with DICOM Print, Store and Modality Work List (MWL).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Digital X-ray
Anatomical Site
Various anatomical regions
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Medical professionals, including in the biopsy procedure room, surgical suite or a room adjacent to a surgical suite.
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)
Non-clinical performance data testing and review was performed. As a cabinet or specimen X-ray device, the submitted device is required to comply with Part 1020, FDA's performance standards for ionizing radiation emitting products and specifically to 21 CFR 1020.40 Cabinet X-ray systems. The Core Vision Digital Specimen Radiography (DSR) System conforms to 21 CFR 1020.40. Evidence of the compliance is provided throughout this submission and is referenced in the appropriate exhibits. The radiation emitted from the Core Vision Digital Specimen Radiography (DSR) System cabinet x-ray system does not exceed an exposure of 0.5 milliroentgen in one hour at any point five centimeters outside the external surface.
The submitted device's software controls were subjected to significant verification and validation testing. Verification testing was performed during software coding and results were recorded as "comments" in the software code. Alpha validation testing included testing of all functionality and confirmation that all identified hazards have been adequately addressed by software functionality, the user interface or documentation. Alpha validation activities included specified system software and operating software performance and environmental testing within the specified environment.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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NOV 21 2008 PREMARKET NOTIFICATION 510(k) SUMMARY As required by §807.92
Device Name - as required by 807.92(a)(2):
| Trade Name: | Core Vision Digital Specimen Radiography (DSR)
System |
|----------------------------------------------------|----------------------------------------------------------|
| Common/Classification Name: | Specimen X-ray System/Cabinet, X-ray System |
| Classification Regulation: | 21 CFR § 892.1680 |
| Device Class: | Class II |
| Product Code (Procode): | MWP |
| Panel: | Radiologic Devices Panel |
| Premarket Notification submitter:
Company Name: | Bioptics, Inc. |
| Company Address: | 4605 S. Palo Verde Rd, Suite 605
Tucson, AZ 85714 |
| Contact: | Thom Kerr, General Manager |
| Preparation Date: | June 30, 2008 |
A. LEGALLY MARKETED PREDICATE DEVICE - as required by 807,92(a)(3)
The Core Vision Digital Specimen Radiography (DSR) System is substantially equivalent to the piXarray 100 Digital Specimen Radiography System. manufactured by Bioptics, Inc. as a cabinet X-ray system, K052433.
B. DEVICE DESCRIPTION - as required by 807.92(a)(4)
The Core Vision Digital Specimen Radiography (DSR) System is a stand-alone cabinet digital X-ray imaging system to provide rapid verification that the correct tissue has been excised during percutaneous biopsy.
Performing the verification directly in the same biopsy procedure room enables cases to be completed faster, thus limiting the time the patient needs to be under examination. Specimen radiography can potentially limit the number of patient recalls.
The Core Vision Digital Specimen Radiography (DSR) System employs the use of Bioptics Vision image acquisition software. The Bioptics Vision software handles the digital X-ray image acquisition, calibration, image display, image analysis and manipulation, patient database, image archiving, and transmittal. Bioptics Vision software is the central part of this system. Bioptics Vision software is Digital Imaging
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and Communications in Medicine (DICOM) 3.0 compliant and comes with DICOM Print, Store and Modality Work List (MWL).
C. DEVICE CLAIMS - as required by 807.92(a)(4)
The Core Vision Digital Specimen Radiography (DSR) System is of compact and portable design plugs into any A/C outlet and requires no external X-ray shielding. The Core Vision DSR System offers one-button operation utilizing automatic exposure control for optimal X-ray exposure. This device offers high resolution digital imaging with small area formats.
The Bioptics Vision software transfers images to Radiology and Pathology within seconds though DICOM interface.
PRODUCT AND TECHNICAL SPECIFICATIONS - as required by 807.92(a)(4) D.
The Core Vision Digital Specimen Radiography (DSR) System is of compact and portable design, plugs into any A/C outlet, and requires no external X-ray shielding. The Core Vision DSR System offers one-button operation utilizing automatic exposure control for optimal X-ray exposure. This device offers high resolution digital imaging with small area formats (26 X 75 mm).
The Bioptics Vision software handles the digital X-ray image acquisition, calibration, image display, image analysis and manipulation, patient database, image archiving, and transmittal. Bioptics Vision software is the central part of this system. Bioptics Vision software is Digital Imaging and Communications in Medicine (DICOM) 3.0 compliant and comes with DICOM Print, Store and Modality Work List (MWL). The Bioptics Vision software transfers images to Radiology and Pathology within seconds though the DICOM interface.
Below is a specifications chart of the Predicate Device with the Core Vision DSR System.
Specifications
Automatic KV Option Automatic Exposure Time Option Manual Exposure Time Selection Geometric Magnification One-Button Calibration Energy Range Tube Current X-ray Coverage External X-ray shielding Imaging Area (mm) Resolution (contact mode) Focal Spot DICOM Interface (store, print, work list) Manual kV Selection Window Filtration Footprint (Overall Dimensions)*
Included Included Included Included Included 5-25 kV 0.5 mA 11.2 cm Not required 26 X 75 mm 14 lo/mm 50 um nominal Included Included 0.2 mm Beryllium 31cm w x 38cm d x 46.6cm h
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E. INTENDED USE - as required by 807,92(a)(5)
Bioptics defines intended use as the objective intent of the manufacturer or person(s) legally responsible for the labeling of devices and includes labeling claims, advertising matter, and approved oral or written statements by such firms or their representatives. As such, Bioptics intends its advertising matter, specifications, user manual and other written or authorized oral statements to identify the objective intent of Bioptics.
Bioptics intends that the submitted device's intended uses include, but are not limited to, the following:
- Uses typical of those for "cabinet x-ray" or "specimen x-ray" devices. .
- . A device intended to generate and control x-rays for examination of various anatomical regions.
- . A device intended to provide rapid verification, through x-ray examination, that the correct tissue has been excised during percutaneous biopsy.
- . A device intended to create an x-ray image of biopsy material, including in the biopsy procedure room or wherever medical professionals deem appropriate, to enable the rapid x-ray examination of the biopsy specimen and the rapid verification that the correct specimen was excised.
F. INDICATIONS FOR USE
The Core Vision Digital Specimen Radiography (DSR) System is a cabinet digital X-ray imaging system intended to generate and control X-rays for examination of various anatomical regions, and to provide rapid verification that the correct tissue has been excised during percutaneous biopsy.
Performing the verification directly in the same biopsy procedure room enables cases to be completed faster, thus limiting the time the patient needs to be under examination. Specimen radiography can potentially limit the number of patient recalls. This device is intended to be operated wherever the medical professionals deem appropriate, including a surgical suite or a room adjacent to a surgical suite.
LEVEL OF CONCERN ~ as requested by recent FDA guidance G.
Bioptics has determined that the submitted device has a "moderate" software Level of Concern and has provided that documented record as part of this submission.
H-TECHNOLOGICAL CHARACTERISTICS SUMMARY -- as required by 807.92(a){6)
The Core Vision Digital Specimen Radiography (DSR) System has the same indications for use as the piXarray 100 Digital Specimen Radiography (DSR) System, K052433. The Core Vision Digital Specimen Radiography (DSR) System has the same technological characteristics as the piXarray 100 Digital Specimen Radiography (DSR) System. Section III Substantial Equivalence of this submission provides a detailed COMPARISON MATRIX of the predicate piXarray 100 Digital Specimen Radiography (DSR) System to the Core Vision Digital Specimen Radiography (DSR) System.
The submitter claims that the Core Vision Digital Specimen Radiography (DSR) System is substantially equivalent to the predicate device, the piXarray 100 Digital Specimen Radiography (DSR) System.
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The technological characteristics of the piXarray 100 Digital Specimen Radiography (DSR) System are very similar to those of the Core Vision Digital Specimen Radiography (DSR) System. The differences include:
TABLE OF DIFFERENCES BETWEEN THE piXarray 100 DIGITAL SPECIMEN RADIOGRAPHY (DSR) SYSTEM AND THE CORE VISION CABINET X-RAY SYSTEM
| Characteristic | Core Vision | piXarray 100 DSR |
|---|---|---|
| X-ray coverage | 11.2 cm | 19.0 cm |
| Imaging area (mm) | 26 X 75 | 50 x 50, 50 x 100, |
| 100 x 100 | ||
| Film or Digital Imaging | Digital Only | Yes |
| Energy Range | 5-25 kV | 5-45 kV |
| Resolution (contact mode) | 14 lp/mm (35 microns) | 10 lp/mm (50 microns) |
| Footprint | ||
| (Overall Dimensions) | 36cm w x 34cm d x 39cm h | 38cm w x 41cm d x 66cm h |
| Used for excised and | ||
| percutaneous biopsy samples | Yes | Percutaneous Only |
The submitter concludes that the piXarray 100 Digital Specimen Radiography (DSR) System employs the same type of technological characteristics including X-ray technology, power source, digital imaging, computer interface for user functionality, computer hardware, operating system, and similar functionality to the Core Vision Digita, Specimen Radiography System. The majority of differences are either not significant or relate to evolutionary changes in technology that has occurred since the release of the piXarray 100 Digital Specimen Radiography (DSR) System.
I. NON-CLINICAL PERFORMANCE DATA TESTING AND REVIEW - as required by 807.92(b)(1)
As a cabinet or specimen X-ray device, the submitted device is required to comply with Part 1020, FDA's performance standards for ionizing radiation emitting products and specifically to 21 CFR 1020.40 Cabinet X-ray systems. The Core Vision Digital Specimen Radiography (DSR) System conforms to 21 CFR 1020.40. Evidence of the compliance is provided throughout this submission and is referenced in the appropriate exhibits.
The radiation emitted from the Core Vision Digital Specimen Radiography (DSR) System cabinet x-ray system does not exceed an exposure of 0.5 milliroentgen in one hour at any point five centimeters outside the external surface. See Radiographic Control Certificate, Document # 1240 is included in this exhibit.
Additionally, the submitted device has been designed in a device design and manufacturing environment with a robust quality system.
Extremely controlled and detailed design inputs and outputs define all of Bioptics product development activities. Some of these activities include, but are not limited to, detailed design specifications, verification and validation activities, and revision history and revision documentation. An emphasis on controlled software activities include risk assessment and management, level of concern and configuration management. These activities are thoroughly documented and reviewed and approved by appropriate authorized authorities.
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The submitter believes and claims that the submitted device was developed, designed, tested and validated to perform in a manner that accurately portrays the submitted systems intended use, functionality, safety features, user interface, operation, and documentation. The results of these activities were reviewed by appropriate management and that review resulted in the documented determination that the submitted device met its design plan, is safe and effective, and, subsequent to FDA review of this submission, is ready for commercial distribution as a medical device.
The submitted device's software controls were subjected to significant verification and validation testing. Verification testing was performed during software coding and results were recorded as "comments" in the software code. Alpha validation testing included testing of all functionality and confirmation that all identified hazards have been adequately addressed by software functionality, the user interface or documentation.
Alpha validation activities included specified system software and operating software performance and environmental testing within the specified environment. Refer to "Software Revision History", Document # 1239, included in Exhibit 9.
Additionally, a few devices, labeled "Research Use Only," are being placed to further document the submitter's performance claims and attempt to identify any unknown hazards. Any significant findings will be investigated and resolved appropriately. If a significant finding rises to an appropriate level, the submitter will take appropriate FDA notification action.
The predicate device, pixarray 100 Digital Specimen Radiography (DSR) System did not provide or reference any clinical tests submitted in compliance with 807.92(b)(2), therefore the submitter believes such clinical testing is not appropriate or required by FDA and has not made or provided any summary of such testing.
J. SUBSTANTIAL EQUIVALENCE SUMMARY
The piXarrav 100 Digital Specimen Radiography (DSR) System has the same indications for use as the Core Vision Digital Specimen Radiography (DSR) System. The Core Vision Digital Specimen Radiography (DSR) System has the same technological characteristics as the piXarray 100 Digital Specimen Radiography (DSR) System. However, while the submitter believes the characteristics are sufficiently precise to assure equivalence, the submitter has carried out validation and performance testing to further document equivalence. The results of this testing substantiates that the Core Vision Digital Specimen Radiography (DSR) System performs as well as the predicate, the piXarray 100 Digital Specimen Radiography (DSR) System.
K. CONCLUSIONS
The performance testing and validation studies document that the Core Vision Digital Specimen Radiography (DSR) System is substantially equivalent to the piXarray 100 Digital Specimen Radiography (DSR) System.
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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle, with three lines representing the eagle's body and wings.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 21 2008
Bioptics, Inc. % Ms. Patricia Wade Consultant 15546 W Gelding Dr. SURPRISE AZ 85379
Re: K082432
Trade/Device Name: Core Vision Digital Specimen Radiography (DSR) System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MWP Dated: July 26, 2008 Received: August 22, 2008
Dear Ms. Wade:
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.
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 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.
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Page 2
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate 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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Arque Mr. Whang
Joyce M. Whang, Ph.D. Acting Director. Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):___ K082432
Device Name: __ Core Vision Digital Specimen Radiography (DSR) System
Indications For Use:
The Core Vision Digital Specimen Radiography (DSR) System is a cabinet digital X-ray imaging system intended to generate and control X-rays for examination of various anatomical regions, and to provide rapid verification that the correct tissue has been excised during percutaneous biopsy.
Performing the verification directly in the same biopsy procedure room enables cases to be completed faster, thus limiting the time the patient noom chanisation. Specimen radiography can potentially limit the patient recalls. This device is intended to be operated wherever the medical professionals deem appropriate, including a surgical suite or a room adjacent to a surgical suite
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence/of(CDRH, Office of Device Evaluation (ODE)
Helu Keun
(Division Stan-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number LGG2432
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