(169 days)
Equalizer™ Occlusion Balloon Catheter is indicated for use for temporary vessel occlusion in applications including arteriography, preoperative occlusion, emergency control of hemorrhage, chemotherapeutic drug infusion and renal opacification procedures.
Any use for procedures other than those indicated in the instructions is not recommended.
The Equalizer™ Occlusion Balloon Catheter is constructed of a soft compliant latex balloon mounted near the tip of a dual-lumen nylon catheter shaft. Radiopaque markers are placed adjacent to the balloon to provide visual reference points for balloon positioning within the vessel. The catheter shaft is radiopaque, maximizing fluoroscopic visibility. Proximal to the bifurcation, the two lumens of the catheter are marked to differentiate their use. The tubing marked 'BALLOON' is the balloon inflation lumen. The tubing marked 'DISTAL' is the central lumen of the catheter, which terminates at the distal tip. This lumen is used to pass the catheter over a guidewire. The lumen can also be used for the infusion of contrast media or therapeutic drugs. Each lumen ends in a luer fitting hub for attachment to ancillary devices.
The provided K140273 510(k) Summary describes a medical device, the Equalizer™ Occlusion Balloon Catheter, and its performance evaluation. However, it does not involve an AI/ML device, and therefore several of the requested categories are not applicable. The study primarily relies on bench testing and biocompatibility testing rather than clinical performance data related to diagnostic accuracy or AI model performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility | ||
| Cytotoxicity | Not explicitly stated but implied to meet ISO 10993 standards for medical devices to not induce cell toxicity. | "Biocompatibility testing were performed to support a determination of substantial equivalence." (Implied to meet standards) |
| Sensitization | Not explicitly stated but implied to meet ISO 10993 standards for medical devices to not induce sensitization. | "Biocompatibility testing were performed to support a determination of substantial equivalence." (Implied to meet standards) |
| Intracutaneous Reactivity | Not explicitly stated but implied to meet ISO 10993 standards for medical devices to not induce intracutaneous reactivity. | "Biocompatibility testing were performed to support a determination of substantial equivalence." (Implied to meet standards) |
| Acute Systemic Toxicity | Not explicitly stated but implied to meet ISO 10993 standards for medical devices to not induce acute systemic toxicity. | "Biocompatibility testing were performed to support a determination of substantial equivalence." (Implied to meet standards) |
| Materials Mediated Pyrogenicity | Not explicitly stated but implied to meet ISO 10993 standards for medical devices to not induce pyrogenicity. | "Biocompatibility testing were performed to support a determination of substantial equivalence." (Implied to meet standards) |
| Hemocompatibility (Direct Hemolysis, PTT, Complement Activation, In Vitro Hemocompatibility) | Not explicitly stated but implied to meet ISO 10993 standards for medical devices for blood-contacting applications. | "Biocompatibility testing were performed to support a determination of substantial equivalence." (Implied to meet standards) |
| USP Physicochemical Tests for Plastics | Not explicitly stated but implied to meet USP standards for plastics used in medical devices. | "Biocompatibility testing were performed to support a determination of substantial equivalence." (Implied to meet standards) |
| Bench Performance | ||
| Deflated Balloon Profile | Not explicitly stated but implied to be comparable to or within acceptable limits of the predicate device for proper insertion and navigation. | "The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use." (Implied to meet criteria) |
| Proximal Bond Tensile | Not explicitly stated but implied to be sufficient for the intended use and comparable to the predicate device to prevent detachment. | "The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use." (Implied to meet criteria) |
| Inflated Balloon O.D. | Not explicitly stated but implied to be within specified dimensions for effective vessel occlusion and comparable to the predicate device. | "The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use." (Implied to meet criteria) |
| Balloon Deflation Time | Not explicitly stated but implied to be rapid enough for safe and effective use, comparable to the predicate device. | "The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use." (Implied to meet criteria) |
| Multiple Inflation, Challenge | Not explicitly stated but implied to withstand multiple inflations without loss of integrity or function, comparable to the predicate device. | "The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use." (Implied to meet criteria) |
| Balloon Burst, Challenge | Not explicitly stated but implied to withstand pressures beyond normal operating conditions without premature burst, comparable to the predicate device. | "The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use." (Implied to meet criteria) |
| Sheath Compatibility | Not explicitly stated but implied to be compatible with intended sheaths, allowing for smooth insertion and removal. | "The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use." (Implied to meet criteria) |
Notes on Acceptance Criteria: The document primarily states that testing was performed to "support a determination of substantial equivalence" and provide "reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use." Specific quantitative acceptance criteria are not detailed in this summary for each test, but they would typically reference established industry standards (e.g., ISO for biocompatibility) or internal specifications benchmarked against the predicate device (Equalizer™ Occlusion Balloon Catheter K021721).
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The study described is bench testing and biocompatibility testing, not a clinical study involving human data. Therefore:
- Sample Size for Test Set: Not specified in terms of human subjects or clinical cases. For bench tests, it would refer to the number of devices or components tested. For biocompatibility, it refers to the samples tested in vitro or in animal models (though details are not provided).
- Data Provenance: Not applicable as it's not clinical data. The tests were performed in a laboratory setting, likely at the manufacturer's facilities or a contract research organization.
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)
Not applicable. This device is a physical medical device (catheter), and its performance evaluation involves engineering and biocompatibility testing, not interpretation of medical images or diagnostic outputs for which ground truth would be established by medical experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are used in clinical studies or studies involving human readers/interpreters to resolve discrepancies in ground truth, which is not relevant for bench and biocompatibility testing of a physical device.
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 is not an AI/ML device and no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically applied to diagnostic AI/ML devices is not directly applicable here. Instead, the "ground truth" for this device's performance can be considered:
- Biocompatibility Standards: Established international standards (e.g., ISO 10993 series) define acceptable biological responses.
- Engineering Specifications: Predetermined design specifications and performance requirements (e.g., burst pressure, inflation time, tensile strength) established by the manufacturer and benchmarked against the predicate device.
- Predicate Device Performance: The performance characteristics of the legally marketed predicate device (Equalizer™ Occlusion Balloon Catheter K021721) served as the reference for establishing substantial equivalence.
8. The sample size for the training set
Not applicable. There is no AI/ML component; therefore, no training set is relevant.
9. How the ground truth for the training set was established
Not applicable. There is no AI/ML component; therefore, no ground truth for a training set was established.
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).