The HAART 300 Aortic Annuloplasty Device is intended to correct annular dilatation and/or maintain annular geometry of the aortic valve in patients with tri-leaflet valve morphology with moderate to severe aortic insufficiency who are undergoing aortic valve repair due to symptoms or as part of a repair for an aortic root aneurysm.

Device Description

The HAART 300 Aortic Annuloplasty Device is designed to return aortic annular geometry toward normal for a given leaflet size and to assist in producing adequate leaflet competence by recovering normal coaptation geometry and area. It consists of a titanium frame covered with polyester fabric that is sewn onto the frame using braided polyester suture. The device has an elliptical base geometry and three subcommissural posts positioned 120° apart around its circumference. The device is available in four sizes: 19 mm, 23 mm, and 25mm. The device is provided attached to a disposable holder by means of a single polyester suture. Twelve (12) polyester pledgets are provided with each HAART 300 Aortic Annuloplasty Device. Both the device and pledgets are provided sterile by gamma irradiation sterilization and are intended for single-use. The HAART 301 Instrument Set provides accessory instruments to facilitate proper sizing and implantation of the device.

AI/ML Overview

The provided text describes the HAART 300 Aortic Annuloplasty Device, but it does not contain the specific information required to complete the requested table and answer all questions regarding acceptance criteria and a study proving the device meets them. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a study designed to meet those criteria for a novel device.

The document discusses performance data, but it presents it as "Nonclinical and clinical performance testing has demonstrated that the HAART 300 Aortic Annuloplasty Device is substantially equivalent to the predicate device." It does not outline explicit acceptance criteria that the device had to meet. Instead, it lists studies conducted to support the substantial equivalence claim.

Therefore, I cannot fully complete the requested table and answer several of the questions based solely on the provided text.

However, I can extract information about the studies performed and some performance metrics, which are presented as outcomes of those studies, rather than pre-defined acceptance criteria.

Here's what can be extracted and what cannot:

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

I cannot provide a table of acceptance criteria because they are not explicitly stated in the document. The document describes performance data that was collected during various studies to demonstrate substantial equivalence.

Here's a table based on the reported device performance from the studies mentioned:

Area of Performance Tested	Reported Device Performance (as outcomes of studies contributing to substantial equivalence)
Non-Clinical Studies
Biocompatibility	Successfully completed (per ISO 10993-1:2009)
Computational Structural Analysis	Successfully completed
Tensile Testing	Successfully completed
Suture Pull-out Testing	Successfully completed
Sterilization Validation	Successfully completed (per ISO 11137-1:2006, ISO 11137-2:2006)
Biological Testing	Successfully completed (per ISO 10993-1:2009)
Shelf Life Validation	Successfully completed (per ISO 11607:2006, ASTM F88-09, F1886-09, F192904, D4169-09)
Fatigue Testing	Successfully completed
Magnetic Resonance Compatibility	Successfully completed (per ASTM F2052-06e1, F2119-07, F2182-11a)
Animal Studies	Successfully completed
Clinical Performance
Survival Rate (6 months)	Kaplan-Meier survival estimate of 98.4%
Survival Rate (2 years)	Kaplan-Meier survival estimate of 94.7%
Device-Related Deaths	None during the 2-year follow-up period
Reduction of Aortic Insufficiency	Percentage of patients with >mild AI: 94.9% at baseline reduced to 23.3% at 6 months (N=56) and 25% at 2 years (N=48)

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

Sample Size for Test Set (Clinical Study): 65 patients
Data Provenance:
- Country of Origin: Not specified in the provided text.
- Retrospective or Prospective: Prospective, multi-centered, single-arm study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the text. The document mentions "transthoracic echocardiography (TTE)" for assessing aortic insufficiency, implying expert interpretation, but it does not specify the number or qualifications of experts involved in establishing ground truth (e.g., for AI severity classification).

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

This information is not provided in the text.

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 information is not provided in the text. The device is an annuloplasty ring, not an AI-assisted diagnostic tool.

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

This question is not applicable as the device is a physical medical implant, not an algorithm or AI system.

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

For the clinical study's assessment of aortic insufficiency, the "ground truth" seems to be based on transthoracic echocardiography (TTE) assessments, which are typically interpreted by medical professionals (e.g., cardiologists). Patient survival and device-related deaths are outcomes data.

8. The sample size for the training set

This information is not applicable as the device is a physical implant and not an algorithm that requires a "training set" in the context of machine learning. The clinical study of 65 patients represents a prospective evaluation, not a training set.

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

This information is not applicable for the reasons stated in point 8.

Summary

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

March 21, 2017

Biostable Science & Engineering Inc. % Ms. Janice Hogan Partner Hogan Lovells US LLP 1835 Market St, 29th Floor Philadelphia, Pennsylvania 19103

Re: K163608

Trade/Device Name: HAART 300 Aortic Annuloplasty Device (Sizes 19, 21, 23, and 25

mm) Regulation Number: 21 CFR 870.3800 Regulation Name: Annuloplasty Ring Regulatory Class: Class II Product Code: PST Dated: December 21, 2016 Received: December 21, 2016

Dear Ms. Hogan:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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.

Sincerelv.

M.G. Hillemann

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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Indications for Use

510(k) Number (if known) K163608

Device Name

HAART 300 Aortic Annuloplasty Device

Indications for Use (Describe)

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

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510(k) SUMMARY (K163608)

Submitter:	BioStable Science & Engineering, Inc.2621 Ridgepoint Dr., Suite 100Austin, TX 78754Contact Person: Julie ThomasPhone: 512-970-9112
Contact:	Janice M. HoganHogan Lovells US LLP1835 Market St, 29th FloorPhiladelphia, PA 19103Phone: 267-675-4611Facsimile: 267-675-4601
Date Prepared:	December 21, 2016
Trade Name:	HAART 300 Aortic Annuloplasty Device
Common Name:	Annuloplasty Ring
Classification:	21 CFR 870.3800Product Code: PST
Predicate Device:	Carpentier-Edwards Physio Tricuspid Annuloplasty Ring, Model 6200(K103520)

Device Description

Intended Use / Indications for Use

The HAART 300 Aortic Annuloplasty Device is intended to correct annular dilatation and/or maintain annular geometry of the aortic valve in patients with tri-leaflet valve

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morphology with moderate to severe aortic insufficiency who are undergoing aortic valve repair due to symptoms or as part of a repair for an aortic root aneurysm.

Summary of Technological Characteristics and Substantial Equivalence

The intended use, technological characteristics, and principles of operation of the HAART 300 Aortic Annuloplasty Device are substantially equivalent to legally marketed mitral and tricuspid annuloplasty devices. More specifically, the HAART 300 Aortic Annuloplasty Device is substantially equivalent to the Carpentier-Edwards Physio Tricuspid Annuloplasty Ring Model 6200 (K103520). The difference between the indications for use of the HAART 300 Device and its predicate is the anatomic position of the valve being treated. However, this has no impact on the therapeutic effect of the device, which is the same as the predicate, which is to reshape and stabilize the valve annulus during surgical reconstruction of valvular insufficiency. The technological characteristics of both devices are equivalent with the exception of the silicon sewing ring added to the Physio Annuloplasty Ring and the material of the thread used to sew the polyester cloth to the device. These differences do not raise different questions of safety and effectiveness. Both devices are provided with accessories that include instruments for sizing the device and a holder to facilitate implantation. The principles of operation including the implantation steps, are also equivalent. Differences in the characteristics do not present any new issues of safety or effectiveness. Thus, the HAART 300 Aortic Annuloplasty Device is substantially equivalent.

Performance Data

The HAART 300 Aortic Annuloplasty Device successfully completed design verification and validation testing based on the risk analysis for the device and in accordance with applicable standards and the FDA Guidance for Annuloplasty Rings 510(k) Submissions; Final Guidance for Industry and FDA Staff. The following nonclinical studies were conducted:

Biocompatibility (ISO 10993-1:2009) ●
Computational structural analysis ●
Tensile testing ●
Suture pull-out testing
Sterilization validation testing (ISO 11137-1:2006, ISO 11137-2:2006)
Biological testing (ISO 10993-1:2009)
Shelf life validation (ISO 11607:2006, ASTM F88-09, F1886-09, F192904, D4169-09)
Fatigue testing
Magnetic resonance compatibility testing (ASTM F2052-06e1, F2119-07, F2182-11a) ●
Animal studies ●

Clinical Performance Data

A prospective, multi-centered, single-arm study was conducted, which enrolled a total of 65 patients. The Kaplan-Meier survival estimate was 98.4% at 6 months and 94.7% at 2 years. None of the deaths occurred during the 2-year follow-up period was device related. The percentage of patients who had greater than mild aortic insufficiency (AI) as assessed by transthoracic

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echocardiography (TTE) was 23.3% at 6 months (N=56) and 25% at 2 years (N=48), as compared to 94.9% at baseline.

Conclusions

Nonclinical and clinical performance testing has demonstrated that the HAART 300 Aortic Annuloplasty Device is substantially equivalent to the predicate device, the Carpentier-Edwards Physio Tricuspid Annuloplasty Ring, Model 6200.

Regulation Number and Section

§ 870.3800 Annuloplasty ring.

(a)
Identification. An annuloplasty ring is a rigid or flexible ring implanted around the mitral or tricuspid heart valve for reconstructive treatment of valvular insufficiency.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Annuloplasty Rings 510(k) Submissions.”