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

This document describes a 510(k) premarket notification for the "V8 Transluminal BAV Catheter" (K150343). The purpose of this submission is not to introduce a new device, but rather to update the labeling of an existing device (V8 Transluminal BAV Catheter, K133607) and establish its substantial equivalence to another predicate (Z-Med/Z-Med II, K122012).

The key finding is that no new performance data or studies were conducted for this specific submission (K150343) because the device design, materials, and function remain identical to the predicate V8 device (K133607). Therefore, the acceptance criteria and the studies proving the device meets them refer to previous submissions (K133607 and K123111).

Given this information, I will synthesize the available information regarding the acceptance criteria and prior studies:

1. Table of Acceptance Criteria and Reported Device Performance

Since this submission explicitly states "no design changes have been made to the predicate K133607 V8 device" and "performance testing performed during design verification and shelf life testing were not repeated because the design and materials of the device remain the same as the V8 predicate," the acceptance criteria and performance are referred to the previous submissions. The document lists the types of tests performed in the predicate design verification. Specific quantitative acceptance criteria are not explicitly stated in this document but are implied by the successful completion of these tests in the predicate device.

Acceptance Criteria (Implied by Predicate Verification)	Reported Device Performance (from Predicate)
Meet specified balloon rated burst pressure	Performance met for predicate V8 (K133607)
Meet specified balloon compliance	Performance met for predicate V8 (K133607)
Conform to critical dimensions	Performance met for predicate V8 (K133607)
Compatible with guidewire and introducer	Performance met for predicate V8 (K133607)
Achieve specified deflation times	Performance met for predicate V8 (K133607)
Maintain integrity over repeat inflations	Performance met for predicate V8 (K133607)
Exhibit no leaks	Performance met for predicate V8 (K133607)
Withstand specified tensile forces	Performance met for predicate V8 (K133607)
Resist kinking	Performance met for predicate V8 (K133607)
Exhibit adequate torque performance	Performance met for predicate V8 (K133607)
Biocompatible for patient contact	Achieved (test data provided in K123111)
Sterile for patient-contacting components	Achieved (sterilization validation in K123111)
Maintain shelf-life	Achieved (shelf life testing data in K133607)
Demonstrate safety and effectiveness for device delivery, inflation, deflation, and removal	Achieved (design verification in K133607, additional bench testing summarized in Section 11.5 of this submission)
Demonstrate performance, including ability to treat aortic stenosis (in vivo)	Achieved (based on predicate device in K132728, and identical shape/principle of operation)

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

This document does not provide details on sample sizes for test sets for the initial predicate device studies. It only states that the performance testing was not repeated because the design and materials are the same. Therefore, the sample sizes and data provenance would refer to the original K133607 and K123111 submissions. The nature of these tests (design verification, shelf life, biocompatibility) implies bench and potentially in-vitro/animal studies, rather than human clinical trials for this type of device. There is no mention of country of origin or retrospective/prospective for the previous studies within this document.

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

This request is primarily applicable to studies involving interpretation of data (e.g., medical images). The listed tests are primarily engineering and material performance tests (e.g., burst pressure, tensile strength, biocompatibility, sterility). For such tests, "ground truth" is typically established by objective physical measurements and adherence to recognized standards, rather than expert consensus on interpretive data. Therefore, this question is not directly applicable in the context of the provided document.

4. Adjudication Method for the Test Set

As explained above, the tests are primarily objective physical and material performance evaluations. Adjudication methods like 2+1 or 3+1 are used for subjective assessments (e.g., radiographic interpretations). This is not relevant to the types of tests described in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence of a medical device (a catheter) through bench testing, material characterization, and reference to prior regulatory submissions. MRMC studies are typically performed for diagnostic devices, especially those involving human interpretation of complex data (like imaging algorithms), to assess the impact of a device on reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the loop performance) Was Done

No, this question refers to the performance of an algorithm without human intervention, which is relevant for AI/ML devices. The V8 Transluminal BAV Catheter is a medical instrument (hardware), not an algorithm or AI system. Therefore, a "standalone algorithm performance" study is not applicable.

7. The Type of Ground Truth Used

For the performance data referred to from the predicate submissions (K133607 and K123111), the ground truth for tests like burst pressure, compliance, critical dimensions, tensile strength, kink resistance, and torque would be established through:

Objective physical measurements: Using calibrated equipment and standardized test methods.
Chemical/Biological analysis: For biocompatibility and sterility, adhering to ISO standards and laboratory protocols.
Engineering specifications: The device is designed to meet specific engineering tolerances and performance parameters.

Ground truths like expert consensus, pathology, or outcomes data would typically be used for diagnostic or treatment effectiveness studies involving patient data, which are not detailed here as the primary evidence for this 510(k) submission.

8. The Sample Size for the Training Set

This question is only relevant for artificial intelligence or machine learning models. The V8 Transluminal BAV Catheter is a physical medical device. Therefore, the concept of a "training set" is not applicable.

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

As explained above, there is no training set for this type of physical device.

Summary

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Image /page/0/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 symbol. The symbol consists of a stylized caduceus, which is a traditional symbol of medicine, with three human profiles incorporated into the design.

Public Health Service

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

April 3, 2015

Intervalve, Inc. % Ming Chew Regulatory Consultant Libra Medical Inc. 8401 73rd Avenue North, Suite 63 Brooklyn Park, Minnesota 55428

Re: K150343

Trade/Device Name: V8 Transluminal BAV Catheter Regulation Number: 21 CFR 870.1255 Regulation Name: Balloon Aortic Valvuloplasty Catheter Regulatory Class: Class II Product Code: OZT Dated: March 3, 2015 Received: March 4, 2015

Dear Ming Chew:

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

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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 of medical devicerelated 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 Industry and Consumer Education at its toll-free 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

M. A. Hilleman

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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DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration	Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement below.
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510(k) Number ( if known )	K150343
Device Name	V8 Transluminal BAV Catheter
Indications for Use ( describe )	The V8 Transluminal BAV Catheter is indicated for Balloon Aortic Valvuloplasty.

Type of Use ( select one or both, as applicable )
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (Part 21 CFR 801 Subpart C

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Image /page/3/Picture/0 description: The image shows the logo for Libra Medical. The logo consists of a stylized symbol resembling interconnected circles on the left, followed by the text "LIBRAMEDICAL" in a combination of gray and blue. The "LIBRA" portion of the text is in gray, while "MEDICAL" is in blue.

7. 510(K) SUMMARY

ADMINISTRATIVE INFORMATION 7.1

Date of Summary Preparation:

7.1.1 Contact Information

Submitter/Manufacturer	Mark UngsInterValve, Inc.2445 Xenium LanePlymouth, MN 55441Phone: (612) 599-1795Fax: 763-657-7055Email: mark@intervalveinc.com
Primary Submission Contact	Ming Cheng ChewRegulatory Consultant,Libra Medical Inc.8401 73rd Ave North, Suite 63Brooklyn Park, MN 55428Phone: 763-232-3701Fax: 763-477-6357Email: mcchew@libramed.com
Secondary Submission Contact	Sew-Wah Tay, PhDRegulatory Consultant,Libra Medical Inc.8401 73rd Ave North, Suite 63Brooklyn Park, MN 55428Phone: 612-801-6782Fax: 763-477-6357Email: swtay@libramed.com

7.1.2 Device Information

Trade Name	V8 Transluminal BAV Catheter
Common Name	Balloon Aortic Valvuloplasty Catheter
Classification Name	Catheter, Balloon Aortic Valvuloplasty
Classification Regulation	870.1255
Class	II
Panel	Cardiovascular
Product Code	OZT
FDA Documents Related toModified Device	None

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7.2 PREDICATE DEVICE

The modified device is substantially equivalent to the InterValve V8 Transluminal BAV Catheter (K133607) and the Z-Med/Z-Med II (K122012).

7.3 DEVICE DESCRIPTION

7.4 INTENDED USE

The V8 Transluminal BAV Catheter is intended to dilate aortic valve tissue.

There is no change in intended use from the V8 predicate device.

7.5 INDICATIONS FOR USE

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

There is no change in the indications for use from the predicate devices.

7.6 TECHNOLOGICAL CHARACTERISTICS

The V8 balloon is made of clear semi-compliant polymeric material. The balloon is available in four sizes (waist/bulb diameters of 17/22 mm, 21/26 mm, 21/26 mm and 23/28 mm). 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 V8 balloon is intended to provide a means for dilation of stenotic aortic valve tissue while minimizing dilation of the aortic annulus by virtue of its hour glass shape.

The catheter is currently available in a 110 cm length and is compatible with a 12F 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, two 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.

7.7 PERFORMANCE DATA

The performance testing performed during design verification and shelf life testing were not repeated because the design and materials of the device remain the same as the V8 predicate. Therefore there are no changes to the performance or safety of the predicate V8 device. The testing performed during the predicate design verification included:

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Balloon rated burst pressure ●
Balloon compliance
Critical dimension verifications ●
Guidewire and introducer compatibility
o Deflation times
Repeat inflation o
Leak o
Tensile ●
Kink ●
Torque

Additional bench testing for the use of the V8 as a post-dilatation balloon in a self-expanding TAVR included:

The durability of the V8 when used in conjunction with a self-expanding TAVR ●
The radial force exerted on a simulated annulus by a V8 and cylindrical balloon ● within a self-expanding TAVR

The proposed change to the V8 device labeling does not affect the requirements of the special controls because no design changes have been made to the predicate K133607 V8 device.

Special Control Requirement	Evidence of Conformity
The device should be demonstratedto be biocompatible.	The proposed change does not affect thebiocompatibility of the device. Thebiocompatibility test data were provided in theK123111 submission. There were no new materialsadded.
Sterility and shelf life testing shoulddemonstrate the sterility of patient-contacting components and theshelf-life of these components.	The sterile packaging and shelf carton are identicalto the predicate V8 device. The worst case device isidentical to the predicate device. Therefore thesterility data provided previously is applicable. Thesterilization validation test results provided in the510(k) notification K123111 is applicable to thisdevice.Shelf life testing was not repeated because therewere no design changes to the predicate V8 device.Shelf life testing data is provided in the K133607submission.
Non-clinical performanceevaluation of the device shoulddemonstrate substantial equivalencein terms of safety and effectivenessfor device delivery, inflation,deflation, and removal.	Design verification testing was not repeated becausethere were no design changes made. Test data canbe found in the K133607 submission.Additional bench testing was performed and issummarized in Section 11.5 of this submission.
In vivo evaluation of the deviceshould demonstrate device	The shape of the device has not changed and theprinciples of operation are also the same. The

Table 1: Special Controls
---------------------------	--	--	--	--	--

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performance, including the ability	device dimensions are identical to the predicate
of the device to treat aortic stenosis.	device submitted in 510(k) notification K132728.
Labeling must include a detailedsummary of the device-related andprocedure-related complicationspertinent to use of the device.	The IFU contains "Potential Complications,Outcomes, Adverse Events" section.

SUBSTANTIAL EQUIVALENCE 7.8

The V8 device covered by this submission is substantially equivalent to the V8 predicate device (K133607) and the Z-Med predicate device (K122012). The device intended use has not changed and the overall design principles are the same. There has been no change to the general design or materials of the balloon.

The V8 device covered by this submission has the same intended use and the same technological characteristics as the previously cleared V8 predicate device. The differences between this device and the V8 predicate do not raise new questions of safety or efficacy.

7.9 CONCLUSION

The modified V8 Transluminal BAV Catheter System is substantially equivalent to the predicate devices (K133607 and K122012) in design, materials, function and intended use.

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.