The V8 Balloon Aortic Valvuloplasty Catheter 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. The V8 Balloon Aortic Valvuloplasty Catheter can be used as both a pre-dilatation and postdilatation device for self-expanding transcatheter heart valves.

AI/ML Overview

While the provided document describes a medical device (V8 Balloon Aortic Valvuloplasty Catheter) and its substantial equivalence to a predicate device for FDA 510(k) clearance, it does not contain the information requested in your prompt regarding acceptance criteria and a study proving a device meets those criteria, particularly in the context of an AI/algorithm-based device.

This document is a 510(k) summary for a physical medical device, not a software or AI medical device. Therefore, the concepts of "test set," "ground truth," "experts to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," or "standalone (algorithm only) performance" are not applicable to the content provided.

The document discusses:

Device Description: A physical balloon catheter for aortic valvuloplasty.
Intended Use: Dilate aortic valve tissue.
Technological Characteristics: Materials, sizes, shape (hourglass), compatibility with guidewire/sheath, radiopaque markers.
Comparison to Predicate Device: The primary change is a reduced balloon bulb length (from 10mm to 8mm).
Performance Data (Non-clinical): This section details the types of tests performed to demonstrate substantial equivalence, such as:
- Biocompatibility (not re-tested due to no material change)
- Sterility and shelf-life (not re-tested due to no packaging or worst-case device change)
- Non-clinical performance evaluation of device delivery, inflation, deflation, and removal (summary below lists bond tensile strength, balloon rated burst pressure, balloon compliance).
- In vivo evaluation (stated shape and principles of operation are the same as predicate).
- Crucially, these are engineering/physical performance tests for the catheter itself, not clinical diagnostic accuracy or AI performance metrics.

Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria for an AI/algorithm study based on the provided text. The document focuses on demonstrating that a physical modification to an existing device does not raise new questions of safety or efficacy compared to its predicate.

Summary

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

December 18, 2015

InterValve, Inc. c/o Ming Chew Regulatory Consultant Libra Medical Inc. 8401 73rd Avenue North, Suite 63 Brooklyn Park, Minnesota 55428

Re: K152150

Trade/Device Name: V8 Balloon Aortic Valvuloplasty Catheter Regulation Number: 21 CFR 870.1255 Regulation Name: Balloon Aortic Valvuloplasty Catheter Regulatory Class: Class II Product Code: OZT Dated: November 12, 2015 Received: November 13, 2015

Dear Mr. 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 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 device

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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 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 vours.

M.A. Hilleman

for

for 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) K152150

Device Name

V8 Balloon Aortic Valvuloplasty Catheter

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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1. 510(K) SUMMARY

ADMINISTRATIVE INFORMATION 1.1. Date of Summary Preparation: December 16, 2015

1.1.1. Contact Information

Submitter/Manufacturer	Mark UngsInterValve, Inc.2445 Xenium LanePlymouth, MN 55441Phone: (612) 599-1795Fax: 763-657-7055Email: mark@intervalveinc.com
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Primary Submission Contact Ming Cheng Chew Regulatory Consultant, Libra Medical Inc. 8401 73rd Ave North, Suite 63 Brooklyn Park, MN 55428 Phone: 763-232-3701 Fax: 763-477-6357 Email: 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
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1.1.2. Device Information

Trade Name	V8
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 to Modified Device	None

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1.2. PREDICATE DEVICE

The modified device is substantially equivalent to the Valve V8 Transluminal BAV Catheter (K150343).

1.3. DEVICE DESCRIPTION

The V8 Balloon Aortic Valvuloplasty Catheter can be used as both a pre-dilatation and postdilatation device for self-expanding transcatheter heart valves.

1.4. INTENDED USE

The V8 Balloon Aortic Valvuloplasty Catheter is intended to be used to dilate aortic valve tissue. There is no change in intended use from the V8 predicate device.

INDICATIONS FOR USE 1.5.

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

1.6. 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, 19/24 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.

1.7. COMPARISON TO PREDICATE DEVICE

In comparison to the predicate device, the balloon bulb length has been reduced from 10mm to 8mm. All other technological characteristics remain the same.

1.8. PERFORMANCE DATA

Design verification was repeated because the balloon bulb length was modified.

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Special Control Requirement	Evidence of Conformity
The device should be demonstrated to bebiocompatible.	The proposed change does not affect thebiocompatibility of the device. Thebiocompatibility test data were provided in theK123111 submission. There were no newmaterials added.
Sterility and shelf life testing shoulddemonstrate the sterility of patient contactingcomponents and the shelf-life of thesecomponents.	The sterile packaging and shelf carton areidentical to the predicate V8 device. The worstcase device is identical to the predicate devicebecause it is larger with more material tosterilize. Therefore the sterility data providedpreviously is applicable. The sterilizationvalidation test results provided in the510(k) notification K123111 is applicable tothis device.
	Shelf life testing was not repeated because thedesign changes did not affect the validity of theshelf life testing done with the predicate V8device. The material and manufacture of thedevice remains the same as the predicate. Shelflife testing data is provided in the K133607submission.
Non-clinical performance evaluation of thedevice should demonstrate substantialequivalence in terms of safety andeffectiveness for device delivery, inflation,deflation, and removal.	See below for summary of non-clinicalperformance tests.
In vivo evaluation of the device shoulddemonstrate device performance, including theability of the device to treat aortic stenosis.	The shape of the device has not changed andthe principles of operation are also the same.The device dimensions are similar to thepredicate device submitted in 510(k)notification K150343.
Labeling must include a detailed summary ofthe device-related and procedure-relatedcomplications pertinent to use of the device.	The IFU contains "Potential Complications,Outcomes, Adverse Events" section.

Table 1-1: Special Controls

The following testing was performed to demonstrate substantial equivalence to the predicate device:

Bond tensile strength .
Balloon rated burst pressure ●
Balloon compliance (diameter vs. pressure) ●

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SUBSTANTIAL EQUIVALENCE 1.9.

The V8 device covered by this submission is substantially equivalent to the V8 predicate device. The device intended use has not changed and the design principles are the same. There has been no change to the materials or manufacture 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.

1.10. CONCLUSION

The modified V8 Balloon Aortic Valvuloplasty Catheter is substantially equivalent to the predicate device (K150343).

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.