← Product Code [IYO](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYO) · K052348

# IN VISION GOLD WITH SPIN VISION, MODEL 891 SV (K052348)

_Volcano Corporation · IYO · Dec 2, 2005 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYO/K052348

## Device Facts

- **Applicant:** Volcano Corporation
- **Product Code:** [IYO](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYO.md)
- **Decision Date:** Dec 2, 2005
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.1560
- **Device Class:** Class 2
- **Review Panel:** Radiology

## Indications for Use

Qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature. As an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures. The pullback feature of the PIMr withdraws the imaging core within the protective sheath for a maximum of 15cm.

## Device Story

SpinVision is an accessory to the In-Vision Gold Imaging System, enabling the Revolution 45MHz Rotational Imaging Catheter to generate intravascular ultrasound (IVUS) images. The system comprises a Patient Interface Module (PIMr), an upgraded Analog/Digital/Sigma board, and host software. An RFID transmitter in the rotational catheter communicates with the PIMr to identify the catheter model and serial number. The PIMr integrates manual or automatic pullback functionality, withdrawing the imaging core within a protective sheath for up to 15cm. Used in clinical settings by physicians, the device provides real-time visualization of vessel lumen and wall structures to assist in vascular assessment and clinical decision-making during interventional procedures.

## Clinical Evidence

Bench testing only. Performance testing was conducted to evaluate the SpinVision accessory to the In-Vision Imaging System. Results were found to be acceptable according to established test plans and protocols.

## Technological Characteristics

Intravascular ultrasound imaging system; 45MHz rotational imaging catheter; RFID-based catheter identification; PIMr (Patient Interface Module) with integrated automatic/manual pullback mechanism; Analog/Digital/Sigma processing board; host software; 21 CFR 892.1560.

## Regulatory Identification

An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

## Special Controls

*Classification.* Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

## Predicate Devices

- In-Vision™ Imaging System ([K031148](/device/K031148.md))
- Automatic Pullback Device ([K962293](/device/K962293.md))
- Galaxy Intravascular Ultrasound System, Model 150 ([K980851](/device/K980851.md))

## Submission Summary (Full Text)

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| Volcano Corp.                                                                      | Traditional 510(k) Premarket Notification                                   |     |
|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|-----|
| 510(k) SUMMARY<br>The 510(k) Summary is submitted as required by Section 807.92(a) |                                                                             |     |
|                                                                                    | K052348                                                                     | 1/2 |
| Submitter Name:                                                                    | Volcano Corp.                                                               |     |
| Contact Person:                                                                    | Jennifer M. Motto<br>Associate, Regulatory Affairs                          |     |
| Address:                                                                           | 2870 Kilgore Road<br>Rancho Cordova, CA 95670                               |     |
| Phone Number:                                                                      | 916-638-9430                                                                |     |
| Fax Number:                                                                        | 916-638-8112                                                                |     |
| Date Prepared:                                                                     | August 26, 2005                                                             |     |
| Device Trade Name:                                                                 | In Vision Gold with SpinVision                                              |     |
| Device Common Name:                                                                | Intravascular Ultrasound Imaging System                                     |     |
| Classification Name,<br>Number, Product Code:                                      | Ultrasonic pulsed echo imaging system<br>21 CFR 892.1560, Product Code: IYO |     |

2005

DEC 2

In Vision Gold with SpinVision

## Predicate Device:

Submitter:

In-Vision™ Imaging System cleared under K031148 on May 28, 2003; with specific aspects compared to Automatic Pullback Device cleared under K962293 on September 16, 1996; Galaxy Intravascular Ultrasound System, Model 150 cleared under K980851 on April 22, 1998.

## Device Description:

SpinVision is an accessory to the In-Vision Gold Imaging System that enables the Revolution 45MHz Rotational Imaging Catheter to generate intravascular ultrasonic images. The primary components of the SpinVision accessory consist of the Patient Interface Module (PIMr), upgraded Analog/Digital/Sigma board, and the host software. The ability to perform an automatic or manual pullback is integrated into the PIMr. An RFID transmitter within the rotational catheter sends a low frequency signal to the PIMr allowing it to recognize the name and serial number of the catheter.

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| Submitter:    | In Vision Gold with SpinVision            |
|---------------|-------------------------------------------|
| Volcano Corp. | Traditional 510(k) Premarket Notification |

# 2

# Intended Use:

Qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature. As an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures. The pullback feature of the PIMr withdraws the imaging core within the protective sheath for a maximum of 15cm.

## Performance Data:

Applicable testing was performed to evaluate the SpinVision accessory to the In-Vision Imaging System. The test results were found to be acceptable as required by the test plans and protocols.

## Conclusion:

The testing reported in this 510(k) establishes the device is safe and effective for its intended use and substantially equivalent to the predicate devices.

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Image /page/2/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an abstract representation of a human profile, with three overlapping faces suggesting community and collaboration. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES · USA" are arranged in a circular pattern around the central emblem.

DEC 2 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Volcano Corporation c/o Ms. Jennifer M. Motto Regulatory Affairs Associate 2870 Kilgore Rd. Rancho Cordova, CA 95670

Re: K052348

Trade Name: In Vision Gold with Spin Vision, Model 891 SV Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: Class II Product Code: IYO Dated: August 26, 2005 Received: August 29, 2005

Dear Ms. Motto:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaren a seen the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use sured in the encreases - 776, the enactment date of the Medical Device Amendments, or to conninered processified in accordance with the provisions of the Federal Food, Drug, de necs that have been require approval of a premarket approval application (PMA). and Cosmetie Prov (10) 110. 110. 11. 10. 11. 11. 11. general controls provisions of the Act. The I ou may, diereleve, mains of the Act include requirements for annual registration, listing of general controls pro resering 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 rr your device is exactive (in the major regulations affecting your device can may 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. Jennifer M. Motto

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be advised that i Dr mination that your device complies with other requirements of the Act that I Dri has made a acternment administered by other Federal agencies. You must or any I caelar stutures and registments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It Fat 6017, accems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quant) by systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control pro neeting your device as described in your Section 510(k) This letter will anow you to begin mailing of substantial equivalence of your device to a legally promatics notification: "The 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 If you desire specific darioliance at (240) 276-0120. Also, please note the regulation entitled, Connact the Orition of Comparket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general miormation of your response Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Bhimmar for

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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## Indications for Use

510(k) Number (if known): _ K052348

Device Name:

In Vision Gold with SpinVision

Indications for Use:

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Qualitative and quantitative evaluation of vascular morphology in the coronary arteries Qualifative and qualifianve evaluation of vasculation of the prographic and vessels of the peripheral vasculature. The unsen and wall structures. The pullback
procedures to provide an image of the vessel lumen and wall structures and procedures to provide an mage of the vosser lainville the protective sheath for a maximum of 15cm.

Over-The-Counter Use _ × Prescription Use AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (Part 21 CFR 801 SubpartD)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANÓTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Posted November 13, 2003) Blammenge

Division Slan-Off Division of Cardlovascular Devices 510(k) Number K

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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYO/K052348](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYO/K052348)

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