(145 days)
No
The description focuses on digitization, semi-automatic contour detection, and quantitative analysis, with no mention of AI, ML, or related concepts. The software is described as being developed for older Windows operating systems, which is less common for modern AI/ML applications.
No
The device is described as software for digitization and quantitative analysis of medical images and does not directly provide therapy.
Yes
The device converts IVUS/ICUS recordings into DICOM format and performs quantitative analysis of artery and stent dimensions for diagnostic purposes.
Yes
The device description explicitly states it is "software" and details its functions related to processing and analyzing existing image data (VCR recordings of IVUS/ICUS). There is no mention of accompanying hardware components being part of the device itself.
Based on the provided information, this device is likely not an IVD (In Vitro Diagnostic). Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- Device Function: The described device focuses on:
- Digitization of existing image data: It takes VCR recordings of IVUS/ICUS and converts them to a digital format (DICOM). This is a data conversion process, not an examination of a biological specimen.
- Quantitative analysis of image data: It analyzes the dimensions of structures within the digitized images. This is image analysis, not the examination of a biological specimen.
- Lack of Specimen Examination: The device does not directly interact with or analyze a biological specimen (like blood, tissue, etc.) to provide diagnostic information. It operates on pre-existing image data.
While the device provides information about a patient's physiological state (artery and stent dimensions), it does so by analyzing images, not by directly examining a biological specimen in vitro.
Therefore, based on the standard definition of an IVD, this device falls outside that category. It is more accurately described as a medical image processing and analysis software.
N/A
Intended Use / Indications for Use
- Digitization of VCR recordings of ICUS (Intra Coronary Ultra Sound ) or IVUS (Intra Vascular Ultra Sound) examinations of patients to the (IVUS) DICOM 3 format
- Quantitative analysis of artery and stent dimensions.
Product codes
DQK
Device Description
The Quantitative Intra Vascular Analysis software offers digitization of VCR recordings of IVUS pullback examinations, semi-automatic contour detection of the lumen, vessel and stent structures in different user definable regions and quantitative analysis of the dimensions of all structures. Contours can be saved and the results of the analysis can be presented in printed reports or saved to a spreadsheet file. QIVA has been developed for Windows 2000 and NT.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Intra Coronary Ultra Sound (ICUS) or Intra Vascular Ultra Sound (IVUS)
Anatomical Site
Artery and stent dimensions (likely related to coronary or intravascular sites)
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).
0
OCT 01 2002
510(k) Summary
OIVA
This summary statement complies with 21CFR, section 807.92(c). Date summary prepared: 1 May 2002
This premarket notification has been submitted by Pie Medical Imaging BV and covers the OIVA software package. Pie Medical Imaging is located at:
Pie Medical Imaging BV Becanusstraat 13 D 6216 BX Maastricht The Netherlands tel +31.43.3281328 fax +31.42.3281329 e-mail: pmi@pie.nl
The contact person is: Ms. Carla de Vries, Quality Assurance Officer
The trade name is: OIVA The common name for this type of device is: Quantitative Intra Vascular Ultrasound Analysis Software and the classification name is: Image Processing System (LLZ).
The above as stated in 21 CFR, part 892.1570, has been classified as regulatory Class II.
The OIVA software package is substantially equivalent to the OCU-CMS software package known under FDA number K011582.
The Quantitative Intra Vascular Analysis software offers digitization of VCR recordings of IVUS pullback examinations, semi-automatic contour detection of the lumen, vessel and stent structures in different user definable regions and quantitative analysis of the dimensions of all structures. Contours can be saved and the results of the analysis can be presented in printed reports or saved to a spreadsheet file. QIVA has been developed for Windows 2000 and NT.
The intended use of the QIVA is:
-
Digitization of VCR recordings of ICUS (Intra Coronary Ultra Sound ) or IVUS (Intra Vascular Ultra Sound) examinations of patients to the (IVUS) DICOM 3 format
-
Quantitative analysis of artery and stent dimensions.
The QIVA is substantially equivalent to the predicate device mentioned in this summary by using the same technological characteristics and intended use.
The OIVA is produced under the same Quality Assurance system applicable to the development and production of products currently marketed by Pie Medical Imaging.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized image of an eagle's head in profile, facing to the right. The eagle's head is composed of three curved lines, giving it a modern and abstract appearance.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT. 01 2002
Pie Medical Imaging B.V. c/o Ms. Colleen Densmore The Anson Group, LLC, an Aventor Company 7992 Castleway Drive Indianapolis, Indiana 46250
Re: K021495
Trade Name: QIVA Intra Vascular Ultrasound Analysis software Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable diagnostic computer Regulatory Class: Class II (two) Product Code: DQK Dated: August 28, 2002 Received: September 3, 2002
Dear Ms. Densmore:
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.
2
Page 2 - Ms. Colleen Densmore
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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). 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,
K Della Tiller
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Notification - QIVA
INDICATION FOR USE STATEMENT page 1 of 1
| 510(k) number (if known): | K021495 |
|---|---|
| Device Name: | QIVA |
| Indications For Use: |
-
Digitization of VCR recordings of ICUS (Intra Coronary Ultra Sound ) or IVUS (Intra Vascular Ultra Sound) examinations of patients to the (IVUS) DICOM 3 format
-
Quantitative analysis of artery and stent dimensions.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
concurrence of CDRH, Office of Device Evaluation (ODE)
ಂಡ
Division of Cardiovascular & Respiratory Devices
510(k) Number K021495
Prescription Use
(Per 21 CFR 801.109)
Over-The-Counter Use_
(Optional Format 1-2-96)