(30 days)
The basixTOUCH40 Inflation Syringe is used to inflate an angioplasty balloon or other interventional device, and to measure the pressure within the balloon.
The basixTOUCH40TM Inflation Syringe by Merit Medical is a 30mL disposable device with a threaded plunger assembly, a flexible high pressure extension tube. The basixTOUCH40TM is designed to generate positive and negative pressure, and monitor positive pressures over a range of zero to +40ATM/BAR (zero to 588 PSI).
This document is a 510(k) premarket notification for the basixTOUCH40 Inflation Syringe. It describes the device, its intended use, and its substantial equivalence to a predicate device. The information provided outlines performance testing that was conducted, but it does not contain specific acceptance criteria with reported device performance values in a table, nor does it detail a study that proves the device meets specific acceptance criteria in the format requested.
The document states that "The results of the testing demonstrated that the subject basixTOUCH40 Inflation Syringe met the predetermined acceptance criteria applicable to the safety and effectiveness of the device." However, the document does not list those acceptance criteria or the actual performance results of the device against those criteria. It also does not describe a clinical study or a comparative effectiveness study with human readers.
Therefore, for many of the requested points, the information is not present in the provided text.
Based on the provided text, here's what can be extracted:
1. A table of acceptance criteria and the reported device performance
This information is not present in the provided document. The document states that "The results of the testing demonstrated that the subject basixTOUCH40 Inflation Syringe met the predetermined acceptance criteria applicable to the safety and effectiveness of the device," but it does not provide the criteria themselves or the specific performance results in detail.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not present in the provided document. The document mentions "Performance testing" but does not specify sample sizes for these tests or the data provenance.
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 applicable/present as the device is a medical instrument (inflation syringe), not an AI diagnostic tool that requires expert-established ground truth on a test set. The performance testing would be engineering or bench testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/present as the device is a medical instrument and the performance testing described would not involve adjudication of a test set in the way an AI diagnostic tool would.
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 applicable/present as the device is a medical instrument (inflation syringe), not an AI diagnostic tool that would be part of a multi-reader multi-case study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/present as the device is a medical instrument and not an algorithm. Bench testing was performed for the device's functional attributes.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable/present as the device is a medical instrument, not a diagnostic tool requiring such ground truth. The "ground truth" for the performance tests would be defined by engineering specifications and physical measurements.
8. The sample size for the training set
This information is not applicable/present. The device is a physical medical instrument, not an AI model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable/present. The device is a physical medical instrument, not an AI model that requires a training set.
Summary of available information related to performance testing:
- Device: basixTOUCH40 Inflation Syringe
- Purpose: To inflate an angioplasty balloon or other interventional device and to measure the pressure within the balloon.
- Comparison to Predicate: The subject device generates a higher maximum pressure (40 ATM) compared to the predicate (35 ATM). The connection between the gauge and the syringe barrel was modified from a brass-fit to a snap-fit connection.
- Performance Testing Done (Types of tests mentioned):
- Fluid Functional Use
- Vertical Gauge Tensile
- Horizontal Gauge Tensile
- Vacuum Capability
- Gauge Accuracy
- Retainer Cap Bond Torque
- Tip Adapter Securement and Tip Securement
- Outcome of Testing: "The results of the testing demonstrated that the subject basixTOUCH40 Inflation Syringe met the predetermined acceptance criteria applicable to the safety and effectiveness of the device."
- Biocompatibility: Not required due to no patient contact.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 20, 2016
Merit Medical Systems, Inc. Dan Lindsay Project Manager, Regulatory Affairs 1600 West Merit Pkwy. South Jordan, Utah 84095
Re: K153672
Trade/Device Name: basixTOUCH40 Inflation Syringe Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector and Syringe Regulatory Class: Class II Product Code: MAV Dated: December 18, 2015 Received: December 21, 2015
Dear Dan Lindsay:
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. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. 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
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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 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 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 yours,
Kenneth J. Cavanaugh -S
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) K153672
Device Name basixTOUCH40 Inflation Syringe
Indications for Use (Describe)
The basixTOUCH40 Inflation Syringe is used to inflate an angioplasty balloon or other interventional device, and to measure the pressure within the balloon.
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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| GeneralProvisions | Submitter Name:Address:Telephone Number:Fax Number:Contact Person:Date Prepared:Registration Number: | Merit Medical Systems, Inc.1600 West Merit ParkwaySouth Jordan, UT 84095801-208-4408801-253-6945Dan W. LindsayDecember 18, 20151721504 |
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| Subject Device | Trade Name:Common/Usual Name:Classification Name:Regulatory Class:Product Code:21 CFR §:Review Panel: | basixTOUCH40 Inflation SyringeInflation SyringeAngiographic injector and syringeClass IIMAV870.165074 Cardiovascular |
| PredicateDevice | Trade Name:Classification Name:Premarket Notification:Manufacturer: | BasixTOUCH Inflation SyringeAngiographic injector and syringeK130566Merit Medical Systems, Inc.This predicate has not been subject to a design-related recall |
| DeviceDescription | The basixTOUCH40TM Inflation Syringe by Merit Medical is a 30mLdisposable device with a threaded plunger assembly, a flexible highpressure extension tube. The basixTOUCH40TM is designed togenerate positive and negative pressure, and monitor positivepressures over a range of zero to +40ATM/BAR (zero to 588 PSI). | |
| Indications forUse | The basixTOUCH40 Inflation Syringe is used to inflate and deflate anangioplasty balloon or other interventional device, and to measure thepressure within the balloon.There is no change in the Indications for Use Statement from thepredicate to the subject device. |
5.0 510(k) Summary
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The Technological characteristics of the subject basixTOUCH40 inflation syringe are considerably equivalent to those of the predicate, the Merit BasixTOUCH Inflation Syringe. The basixTOUCH40 generates higher pressure than the Predicate. Specifically, the predicate maximum pressure is 35 ATM while the subject maximum Comparison to pressure is 40 ATM. Predicate Device The connection between the gauge and the syringe barrel was modified from a brass-fit connection to a snap-fit connection. The predicate used brass and adhesive to attach the gauge to the syringe barrel; the subject device uses a plastic molded component and o-ring to connect the gauge to the syringe barrel. No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for these devices. Performance testing of the subject basixTOUCH40 Inflation Syringe was conducted based on the risk analysis. The following performance data were provided in support of the substantial equivalence determination. Biocompatibility testing Based on the categorization of the device with regard to patient contact and duration, biocompatibility testing is not required. Devices that do not have patient contact are not included in the scope of ISO 10993-1:2009, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process and FDA quidance Required Biocompatibility Training and Toxicology Profiles for Evaluation of Performance Medical Devices, May 1, 1995 (FDA Bluebook Memo G95-1). Data Performance Testing ● Fluid Functional Use Vertical Gauge Tensile ● Horizontal Gauge Tensile ● Vacuum Capability ● Gauge Accuracy ● Retainer Cap Bond Torque ● Tip Adapter Securement and Tip Securement ● The results of the testing demonstrated that the subject basixTOUCH40 Inflation Syringe met the predetermined acceptance criteria applicable to the safety and effectiveness of the device.
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| Summary ofSubstantialEquivalence | Based on the indications for use, design, safety and performancetesting, the subject basixTOUCH40 Inflation Syringe meets therequirements that are considered essential for its intended use and issubstantially equivalent to the predicate device, the BasixTOUCHInflation Syringe, K130566 manufactured by Merit Medical Systems,Inc. |
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§ 870.1650 Angiographic injector and syringe.
(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
Classification. Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.