(14 days)
Vantage ExSPECT II (K992078)
No
The description details iterative reconstruction algorithms (MLEM, OSEM, Bayesian) and image processing techniques, but does not mention AI or ML.
No.
The device is an attenuation correction device for gamma camera systems, intended to enhance emission images by correcting for attenuation effects and producing images depicting anatomical density. It is used for diagnostic imaging, not for treating a condition or disease.
Yes
The device aids in producing images that depict the anatomical density of a patient with corrected attenuation effects, and its Post Acquisition QA tool provides feedback (banding, truncation, count level) to the user, allowing them to use this information, along with raw data and clinical experience, to make a diagnostic decision. This indicates its role in providing information for diagnosis.
No
The device description explicitly states that Vantage Pro is an "optional addition to ADAC Laboratories Gamma Camera products or cameras marketed by ADAC" and "utilizes two 250 mCi, easily managed, shielded radioactive scanning line sources containing 153GD, which arc attached to an ADAC gamma camera". This indicates the device includes significant hardware components (radioactive sources, shielding, attachment mechanisms) and is not solely software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide an enhancement to the emission images acquired using the gamma camera system by correcting for attenuation effects in the patient." This describes a function that improves the quality of medical images obtained from a patient, not a test performed on a sample taken from the patient.
- Device Description: The description details a system that uses radioactive sources and detectors to create images of the patient's internal anatomy and functional information. It processes this image data to improve its quality. This is consistent with an imaging device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
The device is clearly described as an "attenuation correction device" for gamma camera systems, which are medical imaging devices.
N/A
Intended Use / Indications for Use
The Vantage Pro Attenuation Correction Device option to gamma camera systems marketed by ADAC, a Philips Medical Systems Company, produces images that depict the anatomical density of a patient. The system is intended to provide an enhancement to the emission images acquired using the gamma camera system by correcting for attenuation effects in the patient. Vantage Pro includes additional quality assurance tools to evaluate the resulting density image.
Product codes
90 KPS
Device Description
Vantage™ Pro (with ExSPECT™ III a truncation compensation algorithm) is an attenuation correction device, which will be marketed as an optional addition to ADAC Laboratories Gamma Camera products or cameras markcted by ADAC.
Vantage Pro is an option that provides a patient's functional information, which is further improved by using the anatomical information, obtained using the external radioactive scanning line sources with special collimation to minimize patient exposure.
In operation, the Vantage system utilizes two 250 mCi, easily managed, shielded radioactive scanning line sources containing 153GD, which arc attached to an ADAC gamma camera or a gamma camera marketed by ADAC. They are positioned opposite each of the two dctectors with parallel hole collimation while in 90-degree orientation. When a shutter on the shicided source is opened, a collimated beam of gamma ray photons is focused at cach opposing detector to form a transmission image of a patient placed in the field of view. Simultaneously, emission data is collected from the patient. Both sets of data are acquired and processed to produce an attenuation corrected emission image via MLEM iterative processor to production than a conventional Single Photon Emission Computed Tomography (SPECT) image.
The MLEM reconstruction with attenuation correction includes image quality enhancements by correcting for the photopeak scatter via single energy window subtraction, downscatter via single energy window subtraction, and resolution recovery (RR). Also provided is a Post Acquisition QA tool that provides the uscr with feedback regarding the quality of the acquired images in that it alerts the user as to the level of any banding or truncation in the data as well as the level of counts, acquired in each data set.
The attenuation correction method includes a user-selectable Bayesian itcrative reconstruction method, or an ordered subsct expectation maximization (OSEM) method, for reconstructing the transmission map. The Bayesian method is an iterative method that reduces image noise. The key components in this method are using a gamma prior to constrain the results, and a gradient algorithm approach for determining updates. In addition, this method includes a prior for reducing noise in woor count regions and reducing biases in the soft tissue region in the transmission data set. Vantage Pro improves the Bayesian method by incorporating a new algorithm to compensate for truncation of the transmission map.
Vantage Pro (with ExSPECT III) is a modification of Vantage ExSPECT II. The algorithm modification updates the Bayesian attenuation correction algorithm to compensate for the truncated attenuation map (ExSPECT III) that may result from having a patient larger than the camera field of view.
The Post Acquisition QA tool consists of three components: banding detection, truncation detection, and count level determination. Banding refers to the presence of bright sections or strips in the acquired image data set caused by a highly irregular heartbeat. Truncation occurs when a portion of the patient's body is not fully captured within the dimensions of the acquired image. Reconstruction of an image data set which exhibits truncation or banding would yield inappropriate clinical data containing major artifacts. The Post Acquisition QA tool detects banding or truncation which allows the user to reassess the image. In addition, this tool informs the user whether the image contains sufficient count density that would cosure proper data reconstruction. These features are of informative nature only, so that the raw data is not altered. The user may then use the warning information, raw data, and their own clinical experience to procced with a diagnostic decision.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Single Photon Emission Computed Tomography (SPECT)
Anatomical Site
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Vantage ExSPECT II (K992078)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1200 Emission computed tomography system.
(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.
0
DEC 12 2003
510(k) SUMMARY SAFETY AND EFFECTIVENESS
| A. | Submitted By:
ADAC Laboratories
540 Alder Dr.
Milpitas, CA 95035 | Contact: Charlene Brumbaugh
Tel: (408) 468-3619
Fax: (408) 468-3050 |
|----|---------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| B. | Device Trade Name: | Vantage™ Pro |
| | Common Name:
Classification Name:
Device Class:
Product Code: | Attenuation Correction Device
System, Emission Computed Tomography
21 CFR 892.1200, Class II
90 KPS |
| C. | Date prepared: | November 12, 2003 |
| D. | Predicate Device: | Vantage ExSPECT II (K992078) |
-
Intended Use: E.
The Vantage Pro Attenuation Correction Device option to gamma camera systems marketed by ADAC, a Philips Medical Systems Company, produces images that depict the anatomical density of a patient. The system is intended to provide an enhancement to the emission images acquired using the gamma camera system by correcting for attenuation effects in the patient. Vantage Pro includes additional quality assurance tools to evaluate the resulting density image. -
F. Device Description:
Vantage™ Pro (with ExSPECT™ III a truncation compensation algorithm) is an attenuation correction device, which will be marketed as an optional addition to ADAC Laboratories Gamma Camera products or cameras markcted by ADAC.
Vantage Pro is an option that provides a patient's functional information, which is further improved by using the anatomical information, obtained using the external radioactive scanning line sources with special collimation to minimize patient exposure.
In operation, the Vantage system utilizes two 250 mCi, easily managed, shielded radioactive scanning line sources containing 153GD, which arc attached to an ADAC gamma camera or a gamma camera marketed by ADAC. They are positioned opposite each of the two dctectors with parallel hole collimation while in 90-degree orientation. When a shutter on the shicided source is opened, a collimated beam of gamma ray photons is focused at cach opposing detector to form a transmission image of a patient placed in the field of view. Simultaneously,
CONFIDENTIAL
1
emission data is collected from the patient. Both sets of data are acquired and processed to produce an attenuation corrected emission image via MLEM iterative processor to production than a conventional Single Photon Emission Computed Tomography (SPECT) image.
The MLEM reconstruction with attenuation correction includes image quality enhancements by correcting for the photopeak scatter via single energy window subtraction, downscatter via single energy window subtraction, and resolution recovery (RR). Also provided is a Post Acquisition QA tool that provides the uscr with feedback regarding the quality of the acquired images in that it alerts the user as to the level of any banding or truncation in the data as well as the level of counts, acquired in each data set.
The attenuation correction method includes a user-selectable Bayesian itcrative reconstruction method, or an ordered subsct expectation maximization (OSEM) method, for reconstructing the transmission map. The Bayesian method is an iterative method that reduces image noise. The key components in this method are using a gamma prior to constrain the results, and a gradient algorithm approach for determining updates. In addition, this method includes a prior for reducing noise in woor count regions and reducing biases in the soft tissue region in the transmission data set. Vantage Pro improves the Bayesian method by incorporating a new algorithm to compensate for truncation of the transmission map.
Vantage Pro (with ExSPECT III) is a modification of Vantage ExSPECT II. The algorithm modification updates the Bayesian attenuation correction algorithm to compensate for the truncated attenuation map (ExSPECT III) that may result from having a patient larger than the camera field of view.
The Post Acquisition QA tool consists of three components: banding detection, truncation detection, and count level determination. Banding refers to the presence of bright sections or strips in the acquired image data set caused by a highly irregular heartbeat. Truncation occurs when a portion of the patient's body is not fully captured within the dimensions of the acquired image. Reconstruction of an image data set which exhibits truncation or banding would yield inappropriate clinical data containing major artifacts. The Post Acquisition QA tool detects banding or truncation which allows the user to reassess the image. In addition, this tool informs the user whether the image contains sufficient count density that would cosure proper data reconstruction. These features are of informative nature only, so that the raw data is not altered. The user may then use the warning information, raw data, and their own clinical experience to procced with a diagnostic decision.
- Technological Comparison (1.
The modified device, Vantage Pro, offers all of the features of the existing device, Vantage ExSPECT II (K992078), while modifying the transmission reconstruction algorithm to compensate for truncated transmission images. The basic underlying
CONFIDENTIAL
2
algorithm of the transmission map reconstruction remains a Bayesian Iterative method. A modification has been introduced to the definition of and use of the initial estimate (prior) to allow activity outside of the ficld of view of some mittar othinated based on the projections in which data is present. As with the existing Vantage, the reconstructed transmission map is then used to correct the patient's emission data for non-uniform photon attenuation.
The modified device and the existing device have the same indications for use, same source type and geometry, same system hardware and same operating principles.
Both the modified Vantage Pro with ExSPECT III and the predicate Vantage ExSPECT II software programs provide a patient's functional information, which is further improved by using anatomical information, obtained using external radioactive scanning line sources, with special collimation to minimize patient exposure.
Both the modified Vantage Pro with ExSPECT III and the predicate Vantage ExSPECT II use the same imaging technique of SPECT with attenuation correction and image quality enhancements by correcting for the Photopeak scatter, Downscatter, and Resolution Recovery (RR).
- Conclusion H.
The modified device, Vantage Pro, is substantially equivalent to the predicate device, Vantage ExSPECT II, based upon identical indications for use, technological comparison and overall system performance.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged in a circular fashion around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 2 2003
ADAC Laboratories % Mr. Morten Christensen Office Coordinator, 510(k) Review Program Underwriters Laboratories, Inc. 1655 Scott Boulevard SANTA CLARA CA 95050-4169
Re: K033735
Trade/Device Name: Vantage™ Pro (with ExSPECTTM III a truncation compensation algorithm) Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: 90 KPS Dated: November 26, 2003 Received: November 28, 2003
Dear Mr. Christensen:
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.
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.
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Page 2
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 the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brydon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE STATEMENT
510 (k) NUMBER (IF KNOWN):
: K033735
DEVICE NAME:
Vantage™ Pro Attenuation Correction Device
SPONSOR NAME:
ADAC Laboratories
INDICATIONS FOR USE:
The Vantage Pro Attenuation Correction Device option to gamma camera systems marketed by ADAC, a Philips Medical Systems Company, produces images that depict the anatomical density of a patient. The system is intended to provide an enhancement to the emission images acquired using the gamma camera system by correcting for attenuation effects in the patient. Vantage Pro includes additional quality assurance tools to evaluate the resulting density image.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter-Use_ (Optional Format 1-2-96)
David A. Legum
(Division Sign-Off) Division of Reproductive. and Radiological Device 510(k) Number