(364 days)
The Sunmed The Inflation Device is a set of accessorial device. It is composed of an inflation device, and may be composed of a stopcock and a hemostatic valve. The inflation device is intended for use in PTCA or PTA procedures to create and monitor pressure (by connecting the rotating male luer of inflation device with the balloon catheter's female luer) in the balloon and to deflate the balloon. The hemostatic valve is recommended for use during PTCA or PTA procedures in conjunction and/or diagnostic device (e.g. balloon dilatation catheters).Stopcock is used to release and purge any trapped air (if used).
The Sunmed The Inflation Device is a set of accessorial device. It is composed of an inflation device, and may be composed of a stopcock and a hemostatic valve. The inflation device is 30ml disposable device capable of producing a maximum pressure of 40ATM. Pressure can be monitored via a pressure gauge. The manually operation of the device is achieved by the manipulation of a large handle to drive a piston housed within the body of the device.
Hemostatic valve is a single Y connector, and may be composed of an insertion tool, and a torquer. The hemostasis valve is designed to provide a port for interventional system. The insertion tool is used to facilitate placement of a guide wire tip through the hemostasis valve. The torque device is designed to hold the guide wire and provide a handle for manipulating.
This FDA 510(k) summary for the Sunmed™ Inflation Device (K133795) describes a device intended for use in PTCA or PTA procedures. However, it does not contain the detailed information required to fill out the user's requested template regarding acceptance criteria and a study proving those criteria are met.
Here's why and what information is available:
The document is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to legally marketed predicate devices, not necessarily to prove the device meets specific acceptance criteria through a clinical study in the way a PMA (Premarket Approval) might require.
Information NOT available in the provided text:
- A table of specific numerical acceptance criteria (e.g., specific thresholds for pressure accuracy, deflation time, etc.) and the reported device performance against those criteria. The document mentions "non-clinical testing" but does not provide results or specific criteria.
- Details about a specific study proving acceptance criteria:
- Sample size used for the test set.
- Data provenance (country of origin, retrospective/prospective).
- Number of experts, qualifications, or adjudication method for ground truth.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
- Standalone (algorithm only) performance.
- Type of ground truth used (expert consensus, pathology, outcomes data).
- Sample size for the training set (if applicable to an AI/algorithm-based device, which this is not).
- How ground truth for the training set was established.
What can be extracted and inferred from the document regarding testing:
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Nature of Testing: The document states "Summary of Non-Clinical Testing" and explicitly says "Clinical Evaluation was not applicable." This indicates that the device's performance was evaluated through bench testing and biocompatibility studies, not human clinical trials against specific performance endpoints.
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Types of Non-Clinical Tests Performed (as listed in section 7):
- Biocompatibility Testing:
- Pyrogen Test
- Endotoxin Test
- Acute Systemic Toxicity Test (two kinds of solvent)
- Intracutaneous Reactivity Test
- In Vitro Cytotoxicity Test
- Skin sensitization Test (two kinds of solvent)
- In Vitro Hemolysis Study
- Complement Activity Test (C3a, SC5b-9)
- In Vivo Thrombogenicity
- Package Penetrate Testing
- Asepsis Testing
- Aging Testing
- EtO and ECH Residue Testing
- Bench Testing
- Biocompatibility Testing:
-
Lack of Reported Performance Data: While these tests were performed, the document does not report the results of these tests or the specific acceptance criteria (e.g., "Pyrogen test result must be
§ 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.