(45 days)
Not Found
No
The summary describes automated processing but does not mention AI, ML, or related terms, nor does it provide details about training or test sets typically associated with AI/ML development.
No
The device is described as software that displays and quantifies cardiac function parameters from SPECT studies, which is an imaging and analysis tool, not a device that directly treats or prevents disease.
Yes
The device clearly states its purpose is for "quantification of left and right ventricular function parameters" and mentions key metrics like "ejection fraction, end-diastolic volume, end-systolic volume," which are used by physicians for clinical assessment and diagnosis.
Yes
The device description explicitly states it is a "software program" that runs within an operating system environment on existing computer systems. It processes data from a medical imaging modality but does not include any hardware components itself.
Based on the provided information, this device 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 BP-SPECT™ software program processes and analyzes imaging data (gated Tc99m blood pool SPECT studies) to quantify parameters of the heart's function. It does not analyze biological samples taken from the patient.
Therefore, while it is a medical device used in the diagnosis and assessment of a patient's condition, it falls under the category of medical imaging software rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The BP-SPECT™ software program should be used for the display of wall motion and quantification of left and right ventricular function parameters from gated Tc99m blood pool SPECT studies.
The intended use of this program was to provide the physician with a program which would allow him to display wall motion and determine measurements of ejection and ventricular volumes from his patient's gated blood pool SPECT study. This program serves merely as a display and processing program to aid in the diagnostic interpretation of a patient's study. It was not meant to replace or eliminate the standard visual analysis of the gated blood pool SPECT study.
Product codes (comma separated list FDA assigned to the subject device)
90 KPS
Device Description
The BP-SPECT™ is used to display gated wall motion and for quantifying parameters of left and right ventricular from gated blood pool SPECT studies. These parameters are: ejection fraction, end-diastolic volume, end-systolic volume, stroke volume, maximum and average emptying and filling rates, ejection and filling periods and times, and regional ejection fraction. This program was developed to run in the IDL operating system environment which can be executed on any nuclear medicine computer systems which supports the IDL software development. The program processes the studies automatically, however, user verification of output is required and manual processing capability is provided.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
gated Tc99m blood pool SPECT
Anatomical Site
left and right ventricular
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
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)
The effectiveness of the program has been established in in-house testing and clinical validation studies. Specific details and results concerning the validation of the . BP-SPECT™ program are listed in Item H, Testing & Validation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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
§ 892.1200 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
ITEM I
510(k) SUMMARY
Safety and Effectiveness
1. Medical Device Establishment:
Syntermed, Inc. Registration No. 1066019 Owner Operator I.D. 9041128 Voice &FAX: (714) 281-1256 Contact person: Kenneth Van Train Email: vantrain@syntermed.com Date Summary Prepared: August 3, 2004
2. Medical Device:
The BP-SPECT™ software program should be used for the display of wall motion and quantification of left and right ventricular function parameters from gated Tc99m blood pool SPECT studies.
3. Medical Device Equivalence:
Northwestern Gated Blood Pool SPECT (NUMUGAS™) Ref. 510(k) #: K020300
4. Device Description:
The BP-SPECT™ is used to display gated wall motion and for quantifying parameters of left and right ventricular from gated blood pool SPECT studies. These parameters are: ejection fraction, end-diastolic volume, end-systolic volume, stroke volume, maximum and average emptying and filling rates, ejection and filling periods and times, and regional ejection fraction. This program was developed to run in the IDL operating system environment which can be executed on any nuclear medicine computer systems which supports the IDL software development. The program processes the studies automatically, however, user verification of output is required and manual processing capability is provided.
5. Intended Use and Potential Adverse Effect on Health:
The intended use of this program was to provide the physician with a program which would allow him to display wall motion and determine measurements of ejection and ventricular volumes from his patient's gated blood pool SPECT study. This program serves merely as a display and processing program to aid in the diagnostic interpretation of a
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patient's study. It was not meant to replace or eliminate the standard visual analysis of the gated blood pool SPECT study. The physician should integrate all of the patients' clinical and diagnostic information, i.e. patients' history, stress and/or rest EKG, quality control images, visual interpretation of the gated tomographic images, and quantitative results, prior to making his final interpretation. This comprehensive processing technique (as with all diagnostic imaging) is not perfect, and will be associated with some false positive and false negative results. The expected accuracy of the program can be found in Item H. Testing & Validation and the physician should be aware of the accuracy when integrating the quantitative results for his final interpretation. Therefore, this program has no direct adverse effect on health since the results represent only a part of the information, which the physician will utilize for his final interpretation. - The final responsibility for interpretation of the study lies with the physician.
6. Marketing History:
There have been several medical device programs marketed in the past which perform similar functions to those performed by the BP-SPECT™ program. Every Nuclear Medicine manufacturer has programs that can calculate planar gated blood pool and several of them have programs for determining similar quantitative parameters of ejection fraction, end-diastolic volume, end-systolic volume, maximum and average emptying and filling rates, ejection and filling periods and times, and regional ejection fraction. BP-SPECT™ provides a program which executes in the IDL operating system environment and we believe is substantially equivalent to the Northwestern Gated Blood Pool SPECT (NUMUGAS™) program. To our knowledge there have been no safety problems with the calculation of functional parameters from SPECT myocardial perfusion studies for the Northwestern Gated Blood Pool SPECT (NUMUGAS™) program which has been used in clinical settings for over three years.
7. Conclusions:
The safety of this program has been determined through the various stages of software development which included the initial design, coding, debugging, testing, and validation. The effectiveness of the program has been established in in-house testing and clinical validation studies. Specific details and results concerning the validation of the . BP-SPECT™ program are listed in Item H, Testing & Validation. We contend that the method employed for the development and the final in-house validation results of this medical display software program, . BP-SPECT™ program, have proven its safety and effectiveness. In our opinion the . BP-SPECT™ program is substantially equivalent to the Northwestern Gated Blood Pool SPECT™ program which has been cleared for marketing. The . BP-SPECT™ program is intended for the same purpose and raises no new issues of safety or effectiveness.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 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 an abstract symbol that resembles an eagle or bird with three stylized wing-like shapes.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Kenneth F. Van Train President Syntermed, Inc. 245 Owens Drive ANAHEIM CA 92808
Re: K042258
OCT 4 - 2004
Trade/Device Name: BP-Spect™ Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system
Regulatory Class: II Product Code: 90 KPS Dated: August 4, 2004 Received: August 20, 2004
Dear Mr. Van Train:
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 (Premarket , Approval), 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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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.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrb/dsmaddsmamain.httml
Sincerely yours,
Nancy C. brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) NUMBER (IF KNOWN):
DEVICE NAME: BP-SPECT™
INDICATION FOR USE:
The BP-SPECT™ software program should be used for the display of wall The DI -ST LOT - Software program of the ventricular function parameters from gated Tc99m blood pool SPECT studies.
(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)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Dau
and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________