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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the In Vision Gold with SpinVision device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided 510(k) summary only states that "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." It does not provide specific quantitative acceptance criteria or detailed reported device performance metrics. Therefore, this section cannot be fully completed from the given text.

Acceptance Criteria (Quantitative)	Reported Device Performance (Quantitative)
Not specified	Not specified

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It simply states that "Applicable testing was performed."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

The document does not provide information on the number of experts used to establish the ground truth or their qualifications.

4. Adjudication Method for the Test Set:

The document does not mention an adjudication method for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

The document does not indicate that an MRMC comparative effectiveness study was performed, nor does it provide any effect size for human reader improvement with AI assistance.

6. Standalone (Algorithm Only) Performance:

The document does not explicitly state whether a standalone performance study (algorithm only without human-in-the-loop) was done. The description of SpinVision as an "accessory" suggests it integrates with an existing imaging system (In-Vision Gold), implying it's not a standalone diagnostic algorithm in the sense of AI-driven image interpretation.

7. Type of Ground Truth Used:

The document does not specify the type of ground truth used for testing.

8. Sample Size for the Training Set:

The document does not provide any information regarding a training set or its sample size. This is typical for 510(k) submissions of this era for devices that are not primarily AI/ML algorithms requiring extensive training data.

9. How Ground Truth for the Training Set Was Established:

As no training set is mentioned (see point 8), there is no information on how its ground truth was established.

Summary of the Study Information Provided Regarding Device Performance:

The provided 510(k) summary describes the In Vision Gold with SpinVision as an accessory to an existing Intravascular Ultrasound (IVUS) Imaging System. The primary purpose of this submission is to demonstrate its substantial equivalence to predicate devices, not primarily to showcase performance through detailed clinical trials against specific acceptance criteria.

The key statement regarding performance is: "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."

This type of statement is common in 510(k) submissions where the device builds upon established technology and the focus is on safety and effectiveness through equivalency. The document mentions the intended use of the device: "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" is also highlighted.

However, the 510(k) summary does not provide any specific quantitative (numerical) acceptance criteria or detailed results of the testing beyond the general statement of acceptability. It does not specify sample sizes, ground truth methodologies, expert qualifications, or details about the types of studies typically associated with AI/ML algorithm evaluation (like MRMC or standalone performance).

Summary

{0}------------------------------------------------

Volcano Corp.	Traditional 510(k) Premarket Notification
510(k) SUMMARYThe 510(k) Summary is submitted as required by Section 807.92(a)
	K052348	1/2
Submitter Name:	Volcano Corp.
Contact Person:	Jennifer M. MottoAssociate, Regulatory Affairs
Address:	2870 Kilgore RoadRancho 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 system21 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:

{1}------------------------------------------------

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

2 Intended Use:

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

Regulation Number and Section

§ 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.