QIVA

K021495 · Pie Medical Imaging BV · DQK · Oct 1, 2002 · Cardiovascular

Device Facts

• Record ID: K021495
• Device Name: QIVA
• Applicant: Pie Medical Imaging BV
• Product Code: DQK · Cardiovascular
• Decision Date: Oct 1, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1425
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

1. 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 2. Quantitative analysis of artery and stent dimensions.

Device Story

QIVA software performs quantitative analysis of intravascular ultrasound (IVUS) and intracoronary ultrasound (ICUS) examinations. Input consists of VCR recordings of IVUS/ICUS pullback examinations. Software digitizes these recordings into DICOM 3 format. It features semi-automatic contour detection for lumen, vessel, and stent structures within user-defined regions. Output includes quantitative dimensional analysis of these structures, which can be exported to spreadsheets or printed reports. Used in clinical settings by healthcare professionals to assist in assessing artery and stent dimensions. Benefits include standardized digital storage and objective measurement of vascular structures to support clinical decision-making.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based image processing system for IVUS/ICUS analysis. Features semi-automatic contour detection algorithms. Operates on Windows 2000 and NT platforms. Supports DICOM 3 connectivity for data output.

Indications for Use

Indicated for patients undergoing ICUS or IVUS examinations requiring digitization of VCR recordings to DICOM 3 format and quantitative analysis of artery and stent dimensions.

Regulatory Classification

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.

Predicate Devices

• OCU-CMS software package (K011582)

Submission Summary (Full Text)

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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 [phone] fax [phone] e-mail: [e-mail]

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:

1. 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

2. 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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: | |

1. 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

2. Quantitative analysis of artery and stent dimensions.

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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)