The V8 Transluminal BAV Catheter System features an hour-glass shaped dilatation balloon on the distal end of a catheter. The catheter is inserted through a percutaneous entry site into the common femoral artery via an introducer sheath and advanced retrograde to the aortic valve. The catheter is always delivered over a guidewire. The balloon is then inflated to dilate the stenotic aortic valve leaflets in an effort to increase valve opening dimensions and systemic blood flow by improving leaflet mobility. The hour-glass shaped balloon with the undersized waist segment is intended to minimize over-dilatation of the valve annulus while allowing the full dilation of the valve leaflet. The bulbous proximal balloon segment is appropriately sized for the patient's aortic root dimensions to maximize valve leaflet opening.

AI/ML Overview

The provided text describes a 510(k) submission for the InterValve V8 Transluminal BAV Catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical trials to establish efficacy and safety from scratch. Therefore, the information typically found in acceptance criteria tables and detailed study descriptions for novel devices is not fully present.

Based on the provided text, here's what can be extracted and inferred regarding acceptance criteria and the supporting study:

1. A table of acceptance criteria and the reported device performance

The submission demonstrates substantial equivalence based on technological characteristics and performance data from predicate devices, with relevant design verification testing repeated for minor modifications.

Acceptance Criterion	Reported Device Performance
Material Composition (V8 balloon)	Made of clear non-compliant polymeric material. (Identical to predicate K123111)
Balloon Sizes (Available diameters)	22mm, 24mm, 28mm. (New dimensions for 24mm and 26mm are within bounds of original K123111 and do not change technological characteristics).
Balloon Waist Design	Hour-glass shaped with undersized waist segment, smaller than bulb diameter up to rated burst pressure. (Identical to predicate K123111)
Catheter Working Lengths	Standard working lengths (107cm - 113cm). (Identical to predicate K123111)
Introducer Sheath Compatibility	Compatible with a 12F or 14F introducer sheath. (Identical to predicate K123111)
Guidewire Compatibility	Tracked over a 0.035" wire. (Identical to predicate K123111)
Radiopaque Markers	Platinum iridium marker bands on inner shaft beneath the balloon (center of waist, outside edges of proximal and distal balloon shoulders). (Identical to predicate K123111)
Packaging & Sterilization	Packaged in heat-sealed Tyvek pouch, provided sterilized. (Identical to predicate K123111)
Intended Use	Balloon Aortic Valvuloplasty. (No change from predicate K123111 and K082776)
Safety & Effectiveness Profile	The clinical experience used to support the change to the device labeling indicates that the change does not affect the safety and effectiveness profile of the device. The minor differences do not raise new questions of safety or efficacy.
Physician Discretion for Rapid Ventricular Pacing	Revised wording on labeling to allow physician discretion (consistent with how devices are used, similar to predicate devices, and accepted industry practice).
Bonds and Balloon Characteristics (following redesign)	"Relevant design verification testing was repeated. These tests included all bonds and balloon characteristics of the redesigned balloon." "The results demonstrated that the device functions as intended."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The submission does not detail a specific "test set" in the context of a new clinical study. Instead, it relies on:

Design Verification Testing: For the minor modifications to the 24mm and 26mm balloons, all bonds and balloon characteristics were tested. The sample size for this specific testing is not provided. This would typically involve engineering tests on a batch of manufactured devices, not patient data.
Clinical Experience of Predicate Device: The submission refers to "clinical experience used to support the change to the device labeling" and "Predicate device clinical experience showed that physicians may or may not employ the use of concomitant rapid ventricular pacing." The sample size, country of origin, or retrospective/prospective nature of this predicate clinical experience are not detailed in the provided text, as this information would have been associated with the original clearance of the predicate device (K123111).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided as a formal clinical study with expert adjudication for a ground truth establishing accuracy was not conducted for this 510(k) submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/none as a formal clinical study with expert adjudication was not conducted. The assessment relies on engineering testing and the established safety/efficacy profile of the predicate devices.

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 is not applicable. This submission is for a medical catheter, not an AI-assisted diagnostic or therapeutic device that would involve human "readers" or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the design verification testing of the modified balloon characteristics, the "ground truth" would be engineering specifications and performance standards for medical balloons (e.g., burst pressure, diameter at specified pressure, material integrity). For the labeling change regarding physician discretion, the ground truth appears to be current clinical practice and accepted industry standard ("The revised wording on the device labeling was changed to be consistent with how the devices are used by physicians, giving the physician the discretion... This is similar to the predicate devices and is accepted practice in the industry.").

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of this 510(k) submission, as it does not involve machine learning or AI.

9. How the ground truth for the training set was established

This is not applicable.

Summary

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K132728

O) LIBRAMEDICAL

1. 510(K) SUMMARY

ADMINISTRATIVE INFORMATION 1.1

Date of Summary Preparation:

23-October-2013

Submitter/Manufacturer:

Mark Ungs InterValve, Inc. 16200 State Highway 7. Unit B Minnetonka, MN 55345 Phone: 952-303-3539 Fax: 952-303-6310 Email: mark@intervalveinc.com

Submission Contact:

Sew-Wah Tay, Ph.D. CEO/President Libra Medical Inc. 8401 73rd Ave North, Suite 63 Minneapolis, MN 55428 Phone: 612-801-6782 Fax: 763-477-6357 Email: swtay@libramed.com

DEVICE NAME 1.2

Device Name: Common Name: Classification Name: Product Code: Regulation Number: Device Class:

InterValve V8 Transluminal BAV Catheter Balloon Aortic Valvuloplasty Catheter Catheter, Balloon Aortic Valvuloplasty OZT 21CFR870.1250 l I

1.3 PREDICATE DEVICES

The device is substantially equivalent to the InterValve V8 Transluminal BAV Catheter (K123111) and the NuMed NuCLEUS-X BAV Catheter (K082776).

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1.4 DEVICE DESCRIPTION

INDICATIONS FOR USE / INTENDED USE ાં 'રે

The V8 Transluminal BAV Catheter is indicated for Balloon Aortic Valvuloplasty.

There is no change in intended use. The indication for use and intended use are identical to the predicate devices.

1.6 TECHNOLOGICAL CHARACTERISTICS

The V8 balloon is made of clear non-compliant polymeric material. The balloon is available in four diameter sizes (22mm, 24mm and 28mm). The waist of the hour-glass balloon is sized such that it is smaller than the bulb diameter up to the rated burst pressure.

The catheter is available in standard working lengths (107cm - 113cm) and is compatible with a 12F or 14F introducer sheath. It is introduced through the femoral artery via the introducer sheath and tracked over a 0.035" wire. The catheter's inner shaft beneath the balloon is marked with radiopaque platinum iridium marker bands, one at the center of the waist, and one each at the outside edges of the proximal and distal balloon shoulders. The catheter is packaged in a heat sealed Tyvek pouch and provided sterilized. It is intended for single use only. These characteristics are identical to the predicate V8 device (K123111).

1.7 PERFORMANCE DATA

The relevant design verification testing was repeated. These tests included all bonds and balloon characteristics of the redesigned balloon. There is no change in materials or the overall design of the device. Therefore, the biocompatibility data and catheter performance data from the predicate device cleared under K123111 is applicable. The results demonstrated that the device functions as intended.

The clinical experience used to support the change to the device labeling indicates that the change does not affect the safety and effectiveness profile of the device. Predicate device clinical experience showed that physicians may or may not employ the use of concomitant rapid ventricular pacing. The revised wording on the device labeling was changed to be consistent with how the devices are used by physicians, giving the physician the discretion with respect to the use of rapid

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ventricular pacing during balloon placement. Therefore, the data support the modification to the device instructions for use.

1.8 SUBSTANTIAL EQUIVALENCE

The V8 device covered by this submission is substantially equivalent to the predicate devices. There is no change in the indication for use or intended use.

The slight modifications to the 24mm and 26mm nylon balloons do not change the balloon technological characteristics. The new dimensions are within the bounds of the original dimensions and characteristics of the balloons initially cleared (K123111). The new dimensions do not change the technological characteristics of the new V8 devices compared with the predicate V8 devices.

The revised wording on the device labeling was changed to be consistent with how the devices are used by physicians, giving the physician the discretion with respect to the use of rapid ventricular pacing during balloon placement. This is similar to the predicate devices and is accepted practice in the industry.

The V8 device in this submission has the same intended use, and the same technological characteristics as the previously cleared predicate devices. The minor differences between this device and its predicates do not raise new questions of safety or efficacy

1.9 CONCLUSION

The modified V8 Transluminal BAV Catheter System (K132728) is substantially equivalent to the predicate devices (K123111 and K082776) in materials, function and intended use.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized eagle emblem. The eagle is depicted with its wings spread, symbolizing protection and service. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 22, 2013

InterValve, Inc. c/o Dr. Sew-Wah Tay, Ph.D. CEO/President & Regulatory Consultant Libra Medical Inc. 84801 73rd Avenue North, Suite 63 Minneapolis, MN 55428

Re: K132728

Trade/Device Name: V8 Transluminal BAV Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Balloon Aortic Valvuloplasty Catheter Regulatory Class: Class II Product Code: OZT Dated: October 23, 2013 Received: October 24, 2013

Dear Dr. Tay.

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. Please note: CDRH does not evaluate information related to contract liability warranties. ' We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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); medical device reporting (reporting of medical

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Page 2 - Dr. Sew-Wah Tay

device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

M. L. Alleman

for

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Center for Devices and Radiological Health

Enclosure

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7. INDICATIONS FOR USE STATEMENT

Indications for Use

K132728 510(k) Number (if known):

Device Name: V8 Transluminal BAV Catheter

Indications for Use:

The V8 Transluminal BAV Catheter is indicated for Balloon Aortic Valvuloplasty.

Prescription Use Over-The-Counter Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

. L. D. A. Semmen

Regulation Number and Section

§ 870.1255 Balloon aortic valvuloplasty catheter.

(a)
Identification. A balloon aortic valvuloplasty catheter is a catheter with a balloon at the distal end of the shaft, which is intended to treat stenosis in the aortic valve when the balloon is expanded.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The device must be demonstrated to be biocompatible.
(2) Sterility and shelf life testing must demonstrate the sterility of patient-contacting components and the shelf life of these components.
(3) Non-clinical performance evaluation must demonstrate that the device performs as intended under anticipated conditions of use, including device delivery, inflation, deflation, and removal.
(4) In vivo evaluation of the device must demonstrate device performance, including the ability of the device to treat aortic stenosis.
(5) Labeling must include a detailed summary of the device-related and procedure-related complications pertinent to the use of the device.