(90 days)
Not Found
No
The device description and performance studies focus on a physical implantable device and its clinical outcomes, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended to treat aortic insufficiency and maintain annular geometry of the aortic valve, which indicates a therapeutic purpose.
No
The device is an annuloplasty device intended to correct annular dilatation and/or maintain annular geometry of the aortic valve during repair procedures, not to diagnose a condition.
No
The device description clearly outlines a physical implantable device made of titanium and polyester, along with accessory instruments. It is not software-only.
Based on the provided information, the HAART 300 Aortic Annuloplasty Device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is intended to "correct annular dilatation and/or maintain annular geometry of the aortic valve in patients... undergoing aortic valve repair". This describes a surgical implant used directly on a patient's anatomy.
- Device Description: The description details a physical implantable device made of titanium and polyester fabric, designed to be sewn onto the aortic valve. This is consistent with a surgical device, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
In summary, the HAART 300 Aortic Annuloplasty Device is a surgical implant used for aortic valve repair, which falls outside the definition of an In Vitro Diagnostic device.
N/A
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 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.
Product codes (comma separated list FDA assigned to the subject device)
PST
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
aortic valve
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 echocardiography (TTE) was 23.3% at 6 months (N=56) and 25% at 2 years (N=48), as compared to 94.9% at baseline.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Kaplan-Meier survival estimate: 98.4% at 6 months and 94.7% at 2 years.
Percentage of patients with greater than mild aortic insufficiency (AI): 23.3% at 6 months (N=56) and 25% at 2 years (N=48), as compared to 94.9% at baseline.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.”
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three heads, representing the department's commitment to health, human services, and the USA. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
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
1
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)
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.
| 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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3
510(k) SUMMARY (K163608)
| Submitter: | BioStable Science & Engineering, Inc.
2621 Ridgepoint Dr., Suite 100
Austin, TX 78754
Contact Person: Julie Thomas
Phone: 512-970-9112 |
|-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Janice M. Hogan
Hogan Lovells US LLP
1835 Market St, 29th Floor
Philadelphia, PA 19103
Phone: 267-675-4611
Facsimile: 267-675-4601 |
| Date Prepared: | December 21, 2016 |
| Trade Name: | HAART 300 Aortic Annuloplasty Device |
| Common Name: | Annuloplasty Ring |
| Classification: | 21 CFR 870.3800
Product Code: PST |
| Predicate Device: | Carpentier-Edwards Physio Tricuspid Annuloplasty Ring, Model 6200
(K103520) |
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.
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
4
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
5
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.