(268 days)
INOUE BALLOON™ A is intended for balloon aortic valvuloplasty (BAV) in patients with aortic stenosis.
INOUE BALLOON™ A is intended for the treatment of patients with aortic valvuloplasty (BAV). The device is transported over a guidewire as it is inserted through a percutaneous entry site and expanded with a predetermined amount of the diluted contrast medium by use of specified syringe with extension tube connected to the balloon inflation luer-lock hub. This results in the staged inflation of the balloon from hour-glass to barrel shape. The balloon is stretched and made thinner by pushing the inner tube in during passing thorough the introducer sheath. A radiopaque marker is provided for fluoroscopic positioning of the device across the valve.
This document is a 510(k) summary for the INOUE BALLOON™ A, a balloon aortic valvuloplasty catheter. It focuses on demonstrating substantial equivalence to a predicate device, not on clinical performance directly. Therefore, it does not contain the detailed clinical study information typically provided for AI/ML-driven devices.
Here's an analysis based on the provided text, addressing your questions where possible and noting where information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present acceptance criteria in a formal table with quantitative targets for each performance metric, as might be found for a new clinical efficacy study. Instead, it lists various physical performance tests and states that the device "meets specifications." The performance is implicitly deemed acceptable if it is "similar to that described by the predicate device" and indicates the device is "as safe and effective as the predicate device."
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Radio-detectability | Similar to predicate | Meets specifications |
| Surface | Similar to predicate | Meets specifications |
| Corrosion resistance | Similar to predicate | Meets specifications |
| Peak tensile force | Similar to predicate | Meets specifications |
| Freedom from leakage | Similar to predicate | Meets specifications |
| Hubs | Similar to predicate | Meets specifications |
| Designation of nominal size | Similar to predicate | Meets specifications |
| Diameter of largest guidewire | Similar to predicate | Meets specifications |
| Sheath compatibility | Similar to predicate | Meets specifications |
| Balloon minimum burst strength | Similar to predicate | Meets specifications |
| Balloon fatigue (leakage/damage) | Similar to predicate | Meets specifications |
| Balloon inflation/deflation times | Similar to predicate | Meets specifications |
| Torquing | Similar to predicate | Meets specifications |
| Balloon preparation | Similar to predicate | Meets specifications |
| Bending | Similar to predicate | Meets specifications |
| Balloon over inflation | Similar to predicate | Meets specifications |
| Catheter removal | Similar to predicate | Meets specifications |
| Usability evaluation | Similar to predicate | Meets specifications |
| Biocompatibility | ISO 10993-1 for short duration blood contact | Meets ISO 10993-1 |
| Sterilization | SAL 10^-6 level | Achieved via ethylene oxide |
2. Sample Size Used for the Test Set and Data Provenance
This document describes pre-clinical performance data, primarily engineering and material tests, not tests on human clinical data. Therefore, the concept of a "test set" and "data provenance" related to patient data (country, retrospective/prospective) is not applicable here. The "sample size" would refer to the number of devices tested for each performance characteristic, which is not specified in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth from medical experts is relevant for diagnostic claims, often involving image interpretation. This device is a medical instrument (balloon catheter), and its performance data focuses on physical and material properties. Usability evaluations would typically involve feedback from clinicians, but the number and qualifications are not specified in this summary.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (e.g., 2+1, 3+1) are used to establish a robust ground truth from multiple expert interpretations, typically in diagnostic or screening studies. This document does not describe such studies.
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
Not applicable. This device is an interventional medical device, not an AI/ML-driven diagnostic or assistive tool. Therefore, an MRMC study related to human readers and AI assistance would not be relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm.
7. The Type of Ground Truth Used
For the pre-clinical performance tests, the "ground truth" would be established by the defined test methodologies and expected outcomes (e.g., a burst strength test has a quantitative "ground truth" for the maximum pressure it can withstand). For biocompatibility, the ground truth is adherence to ISO 10993-1 standards.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML system that requires a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The "study" presented here is a collection of pre-clinical performance data (i.e., laboratory and bench testing) designed to demonstrate that the INOUE BALLOON™ A functions as intended and is as safe and effective as its predicate device. This includes:
- Mechanical and Material Property Tests: Radio-detectability, surface integrity, corrosion resistance, peak tensile force, freedom from leakage, hub integrity, nominal size designation, guidewire compatibility, sheath compatibility, balloon minimum burst strength, balloon fatigue, inflation/deflation times, torquing, balloon preparation, bending, balloon over-inflation, and catheter removal.
- Biocompatibility Testing: According to ISO 10993-1 for short-duration contact with blood (<24 hours).
- Sterilization Validation: Ethylene oxide sterilization to an SAL 10^-6 level.
- Usability Evaluation: Though details are not provided, this would assess the device's interaction with users (clinicians) in simulated or actual clinical settings.
The document explicitly states: "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." This indicates that the results of these tests met the internal specifications and regulatory requirements for demonstrating substantial equivalence to the legally marketed predicate device (NuMed NuCLEUS and NuCLEUS-X BAV Catheters, K082776/DEN080015).
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December 18, 2022
Toray Industries, Inc. % Yuya Shizume Manager Toray Industries (America), Inc. 461 Fifth Avenue, 9th Floor New York, New York 10017
Re: K220881
Trade/Device Name: Inoue Balloon A Regulation Number: 21 CFR 870.1255 Regulation Name: Balloon aortic valvuloplasty catheter Regulatory Class: Class II Product Code: OZT Dated: November 10, 2022 Received: November 14, 2022
Dear Mr. Shizume:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jaime Raben -S
Jaime Raben, Ph.D. Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K220881
Device Name INOUE BALLOON A
Indications for Use (Describe)
INOUE BALLOON A is intended for balloon aortic valvuloplasty (BAV) in patients with aortic stenosis.
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)
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510(k) Summary
I. SUBMITTER
Submission sponsor Toray Industries, Inc. 1-1, Nihonbashi-muromachi 2-chome, Chuo-ku, Tokyo 103-8666, JAPAN Phone: +81-3-3245-8606 Fax: +81-3-3245-8612 Email: ra-global-md.toray.ug(@mail.toray Contact: Satoshi Kakuyama, General Manager, Global Development and Regulatory Affairs Dept.
Submission correspondent Toray Industries (America), Inc. 461 Fifth Avenue, 9th Floor New York, NY 10017 Phone: 212-922-3711 Fax: 212-972-4279 Email: medical.tam.mb(@mail.toray Contact: Shunsuke Kobayashi, Director, Life Science
Date Prepared: March 11, 2022
II. DEVICE
Name of Device: INOUE BALLOON™ A Common or Usual Name: Balloon Aortic Valvuloplasty Catheter Classification Name: Catheter, Balloon Aortic Valvuloplasty (21 CFR 870.1255) Regulatory Class: II Product Code: OZT
III. PREDICATE DEVICE
NuMED NuCLEUS and NuCLEUS-X BAV Catheters, K082776/DEN080015
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IV. DEVICE DESCRIPTION
INOUE BALLOON™ A is intended for the treatment of patients with aortic valvuloplasty (BAV). The device is transported over a guidewire as it is inserted through a percutaneous entry site and expanded with a predetermined amount of the diluted contrast medium by use of specified syringe with extension tube connected to the balloon inflation luer-lock hub. This results in the staged inflation of the balloon from hour-glass to barrel shape. The balloon is stretched and made thinner by pushing the inner tube in during passing thorough the introducer sheath. A radiopaque marker is provided for fluoroscopic positioning of the device across the valve.
V. INDICATIONS FOR USE
INOUE BALLOON™ A is intended for balloon aortic valvuloplasty (BAV) in patients with aortic stenosis.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The INOUE BALLOON™ A is substantially equivalent in both function and use to the predicate devices, NuMED NuCLEUS and NuCLEUS-X BAV Catheters (K082776/DEN080015).
The subject device has the same intended use as and has equivalent technology to the predicate device. The predicate device is a Class II legally marketed device.
The subject device has the same construction as the predicate device; that has a coaxial shaft construction with a distally mounted balloon of the subject device consists of a complex of latex and the fiber mesh has semi-compliant characteristics which differs from non-compliant characteristics of the predicate device. Due to the semi-compliant balloon characteristics, the diameter of inflated balloon is controlled by the infusion volume. Since the balloon burst strength is almost the same as that of the predicate device, it can be said that the function of the subject device as a balloon catheter for aortic valve dilation is substantially equivalent to that of the predicate device.
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VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
- Radio-detectability
- Surface ●
- Corrosion resistance
- Peak tensile force
- Freedom from leakage
- Hubs
- Designation of nominal size
- Diameter of the largest guidewire
- Sheath compatibility
- Balloon minimum burst strength test
- Balloon fatigue test for freedom from leakage and damage on inflation
- Balloon inflation and deflation times test
- Torquing
- Balloon preparation test
- Bending test
- Balloon over inflation test
- Catheter removal test
- Usability evaluation
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 10tº 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.
VIII. CONCLUSIONS
The INOUE BALLOONTM A is substantially equivalent to the predicate devices (NuMed NuCLEUS and NuCLEUS-X BAV Catheters).
§ 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.