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) premarket notification for the "V8 Transluminal BAV Catheter" and references a predicate device, the "NuMed NuCLEUS-X BAV Catheter (K082776)". The study provided focuses on establishing substantial equivalence to the predicate device rather than presenting a performance study with detailed acceptance criteria against clinical efficacy.

Therefore, the response will focus on the engineering and biocompatibility aspects, as these are the primary details provided regarding performance.

Acceptance Criteria for the V8 Transluminal BAV Catheter and Reported Device Performance

Acceptance Criteria	Reported Device Performance/Comparison to Predicate
Physical and Performance Specifications	The V8 Transluminal BAV Catheter System is tested and meets all its physical and performance specifications, including:
Balloon rated burst pressure	Met specifications.
Balloon compliance	Met specifications. The V8 balloon maintains its hour-glass shape at low and rated burst pressures, unlike the predicate device which loses its shape at working pressure. This difference is not deemed to raise new safety/effectiveness questions as the effectiveness is determined by the bulbous section (similar to predicate) and the waist reduces probability of annular distention, hence risk of dissection.
Critical dimension verifications	Met specifications. The V8 balloon is available in four diameter sizes (22mm - 28mm). The waist is smaller than the bulb diameter up to rated burst pressure. Catheter available in standard working lengths (107cm - 113cm).
Guidewire and introducer compatibility	Met specifications. Compatible with a 12F or 14F introducer sheath and tracked over a 0.035" wire. (Predicate also compatible with 0.035" wire).
Fluoroscopic visualization	Met specifications. Radiopaque platinum iridium marker bands are present on the inner shaft beneath the balloon (one at the center of the waist, and one each at the outside edges of the proximal and distal balloon shoulders).
Deflation times	Met specifications.
Repeat inflation	Met specifications.
Leak	Met specifications.
Tensile	Met specifications.
Kink	Met specifications.
Torque	Met specifications.
Luer lock compatibility	Met specifications.
Distribution	Met specifications.
Biocompatibility	Tested per ISO 10993-1 for short duration contact with blood (<24 hours). The device is sterilized by ethylene oxide to an SAL 10⁻⁶ level. These performances are similar to that described by the predicate device.
Aging Performance	Preclinical testing showed that the device meets specifications before and after aging.

Study Details:

The provided text describes a submission for 510(k) clearance, which primarily focuses on demonstrating substantial equivalence to a predicate device rather than conducting a full clinical trial to prove efficacy against acceptance criteria in the same way a PMA device would.

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a "test set" in the context of clinical performance. The testing described is primarily engineering verification and validation (V&V) on device prototypes/units. The number of units tested for each specification is not provided.
- Data Provenance: The data appears to be from retrospective in-house testing and engineering studies commissioned by InterValve, Inc. and conducted by Libra Medical Inc. The country of origin of the data is not specified but is implicitly the USA given the submission to the FDA.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in this context. The "ground truth" for the engineering performance tests would be the established engineering specifications and international standards (e.g., ISO 10993-1 for biocompatibility). These are not established by a panel of medical experts.
Adjudication method for the test set:
- Not applicable. The "adjudication method" usually refers to a process for resolving discrepancies in expert interpretations of clinical data. Here, the assessment is against predefined engineering specifications.
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:
- Not applicable. This is a medical device (catheter) and not an AI/software-as-a-medical-device (SaMD) that assists human readers with interpretation.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the performance tests described is based on established engineering specifications, material science principles, and international standards (e.g., ISO 10993 for biocompatibility) for medical devices. Clinical outcomes data or expert consensus for diagnosis are not relevant for the type of performance data presented here.
The sample size for the training set:
- Not applicable. There is no mention of a "training set" as this is for a physical device, not a machine learning algorithm. Device development and engineering often involve iterative design, prototyping, and testing, but not in the "training set" sense.
How the ground truth for the training set was established:
- Not applicable, as there is no "training set" for this type of device submission.

Summary

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

K123111

OLIBRAMEDICAL

JAN 3 1 2013

5. 510(K) SUMMARY

ADMINISTRATIVE INFORMATION 5.1

5.1.1 Sponsor

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

Date Prepared: September 28, 2012

5.1.2 Primary Contact Person

Julie Bodmer Regulatory Consultant, Libra Medical Inc. 8401 73td Ave North, Suite 63 Minneapolis, MN 55428 Phone: 612-910-3412 Fax: 763-477-6357 Email: jbodmer@libramed.com

5.1.3 Secondary Contact Person

Sew-Wah Tay, PhD Regulatory Consultant, Libra Medical Inc. 8401 73td Ave North, Suite 63 Minneapolis, MN 55428 Phone: 612-801-6782 Fax: 763-477-6357 Email: swtay@libramed.com

5.2 DEVICE NAME

Trade Name

Page lot 4

Page 5-1

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

K123111

Common Name Classification Name Classification Product Code

Balloon Aortic Valvuloplasty Catheter Catheter, Balloon Aortic Valvuloplasty II . OZT

PREDICATE DEVICE 5.3

The device is substantially equivalent to the NuMed NuCLEUS-X BAV Catheter (K082776).

5.4 DEVICE DESCRIPTION

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.

INDICATIONS FOR USE/INTENDED USE 5.5

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

The V8 and predicate device are indicated for balloon aortic valvuloplasty for both a palliative treatment as well as to predilate the annulus prior to transcatheter aortic valve replacement surgery. There are no differences in indications and therefore do not raise any new questions about the safety and effectiveness of the device.

TECHNOLOGICAL CHARACTERISTICS 5.6

The V8 balloon has an hour glass shape at low and at rated burst pressures. The V8 balloon is intended to provide a means for dilation of stenotic valve leaflets while minimizing dilation of the aortic annulus by virtue of its hour-glass shape. The V8 balloon is made of clear non-compliant polymeric material. The balloon will be available in four diameter sizes (22mm -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 will be 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 comparable with the predicate device.

Page 2 of 4
Page 5-2

{2}------------------------------------------------

The predicate device also has an hour-glass shape at low pressures. However, it loses its shape at the working pressure and the rated burst pressure. In contrast, the V8 balloon's hour-glass shape is retained even at rated burst pressure. However, this difference in the balloon shape does not raise new or different questions of safety and effectiveness. The effectiveness of the device is determined by the bulbous section of the balloon and this is similar in diameter to the predicate device. The waist of the V8 balloon reduces the probability of annular distention and hence the risk of dissection. Hence, no new questions of safety are raised.

The shaft of the V8 catheter is similar in construction to that of the predicate device. Both device shafts are dual lumen with each lumen terminating in a female luer at the proximal hub.

5.7 PERFORMANCE DATA

The V8 Transluminal BAV Catheter System is tested and meets all its physical and performance specifications including:

Balloon rated burst pressure ●
Balloon compliance ●
Critical dimension verifications .
Guidewire and introducer compatibility .
Fluoroscopic visualization .
Deflation times .
Repeat inflation
Leak
Tensile
Kink
Torque
Luer lock compatibility
Distribution

In addition, the device was tested for biocompatibility per ISO 10993-1 for short duration contact with blood (<24 hours). The device is sterilized by ethylene oxide to an SAL 10 * level. These performances are similar to that described by the predicate device.

The preclinical testing showed that the device meets specifications before and after aging indicating that the device is as safe and effective as the predicate device.

SUBSTANTIAL EQUIVALENCE 5.8

The V8 BAV Catheter System is substantially equivalent to the NuMed NuCLEUS-X BAV Catheter (K082776). They have similar intended use, and treat a similar target population. Both devices are over-the-wire catheters with coaxial lumen. Both devices employ an hour-glass shaped balloon with radiopaque markings. The predicate device, however, does not hold the hour-glass shape at the working pressure. In contrast, the V8 balloon's hour-glass shape is retained even at rated burst pressure. This difference in the balloon shape does not raise new or different questions of safety and effectiveness. Both devices are compatible with the 0.035' wire

Page 3 of 4
Page 5-3

{3}------------------------------------------------

and have the similar principles of operation. Both devices are biocompatible and meet ISO 10993-1, and both were sterilized with ethylene oxide with a sterility assurance of 100°.

CONCLUSION 5.9

The V8 and the predicate NuCLEUS-X catheters have similar intended use and technological characteristics. The noted differences in balloon waist diameter do not raise new or different questions of safety and effectiveness. Therefore, the V8 Transluminal BAV Catheter System and predicate are substantially equivalent.

ge 4 of 4

Page 5-4

{4}------------------------------------------------

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

JAN 3 1 2013

Intervalve, Inc.. c/o Libra Medical Inc. 8401 73rd Avenue North, Suite 63 Minneapolis, MN 55428 ATTN: Ms. Julie Bodmer

Re: K123111

Trade/Device Name: Intervalve V8 transluminal BAV Catheter Regulation Number: 21 CFR 870.1255 Regulation Name: Ballon Aortic Valvuloplasty Catheter Regulatory Class: Class II (two) Product Code: OZT

Dated: September 28, 2012 Received: October 3, 2012

Dear Ms. Bodmer:

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.

{5}------------------------------------------------

Page 2 - Ms. Julie Bodmer

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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 vours.

Matthew G. Hillebrenner

for

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

Enclosure

{6}------------------------------------------------

K12311

4. INDICATIONS FOR USE STATEMENT

Indications for Use

K123111 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

MSKllele

(Division Sign-Off) (Sardion Sign-Oir)
Division of Cardiovascular Devices

Page 1 of 1

510(k) Number K123111

Page 1 of 1

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.