K Number
K052348
Device Name
IN VISION GOLD WITH SPIN VISION, MODEL 891 SV
Date Cleared
2005-12-02

(95 days)

Product Code
Regulation Number
892.1560
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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.
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.
More Information

Not Found

No
The summary describes a system for generating and displaying intravascular ultrasound images with a pullback feature, but there is no mention of AI or ML in the intended use, device description, or any other section.

No.
The device is used for evaluation and imaging, acting as an adjunct to conventional angiographic procedures, and does not directly treat a condition.

Yes

The device performs "qualitative and quantitative evaluation of vascular morphology" and provides "an image of the vessel lumen and wall structures," which points to a diagnostic function.

No

The device description explicitly lists hardware components (Patient Interface Module (PIMr), upgraded Analog/Digital/Sigma board) as primary components of the SpinVision accessory, in addition to the host software.

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 description clearly states that this device is an accessory to an imaging system that generates intravascular ultrasonic images of the coronary arteries and peripheral vasculature. This is an in vivo imaging technique, meaning it is performed within the living body.
  • Intended Use: The intended use is to evaluate vascular morphology and provide images of the vessel lumen and wall structures. This is a diagnostic imaging procedure, not a test performed on a sample outside the body.

Therefore, the SpinVision accessory and the In-Vision Gold Imaging System it works with are considered medical imaging devices, not IVDs.

N/A

Intended Use / 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.

Product codes

IYO

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

coronary arteries and vessels of the peripheral vasculature

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)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K031148, K962293, K980851

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
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.(b)
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.

0

Volcano Corp.Traditional 510(k) Premarket Notification
510(k) SUMMARY
The 510(k) Summary is submitted as required by Section 807.92(a)
K0523481/2
Submitter Name:Volcano Corp.
Contact Person:Jennifer M. Motto
Associate, Regulatory Affairs
Address:2870 Kilgore Road
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,
Number, Product Code:Ultrasonic pulsed echo imaging system
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.

1

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.

2

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.

3

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

4

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