(145 days)
- 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 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 provided text is a 510(k) summary and FDA clearance letter for the QIVA device, which is quantitative intravascular ultrasound analysis software. It does not contain a detailed study report with specific acceptance criteria and performance metrics in the format requested. The document primarily focuses on demonstrating substantial equivalence to a predicate device.
Therefore, many of the requested details about acceptance criteria, study design, and performance are not available in the provided text.
However, I can extract the information that is present:
1. A table of acceptance criteria and the reported device performance:
This information is not present in the provided 510(k) summary. The document focuses on "substantial equivalence" rather than reporting specific performance metrics against pre-defined acceptance criteria for a new clinical study.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not present in the provided 510(k) summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not present in the provided 510(k) summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not present in the provided 510(k) summary.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not present in the provided 510(k) summary.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
The device description indicates it is "semi-automatic contour detection" and "quantitative analysis," implying a standalone algorithm. However, no specific standalone performance study details are provided. The clearance is based on substantial equivalence to a predicate device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not present in the provided 510(k) summary. For devices of this type (quantitative analysis), ground truth is often established by manual measurements by experts or comparison to a gold standard imaging modality, but this is not specified here.
8. The sample size for the training set:
This information is not present in the provided 510(k) summary.
9. How the ground truth for the training set was established:
This information is not present in the provided 510(k) summary.
Summary of what is available in the provided text:
- Device Name: QIVA
- Intended 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.
- Technological Characteristics: Offers digitization, semi-automatic contour detection of lumen, vessel, and stent structures, and quantitative analysis of dimensions.
- Predicate Device: OCU-CMS software package (FDA number K011582).
- Basis for Clearance: Substantial equivalence to the predicate device, using the same technological characteristics and intended use.
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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.
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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.
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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
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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)
§ 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).