(144 days)
The Transseptal Cannula is used in conjunction with a transseptal guidewire to puncture the interatival septum during a transseptal catheterization procedure to gain left heart access. The Transseptal Cannula is intended for single use only.
The Transseptal Cannula is a stainless steel device that comes in three lengths equivalent to the body of a transseptal needle, 69.7cm for the 71cm cannula, 87.7cm for the 89cm cannula, and 96.7cm for the 98cm cannula, and two distal curves, Curve0 and Curve1. The size is 18 gauge with an inner diameter of .033" at the tip. The components of the Transseptal Cannula include the transseptal cannula, sterile packaging and labeling. There are six model numbers for the cannula: TSC071, TSC089, TSC171, TSC189, and TSC198. The Transseptal Cannula is sterilized by 100% ethylene oxide cycle and is for single use-only. The Transseptal Cannula is used in a healthcare facility/hospital.
The Transseptal Cannula is used in transseptal procedures to provide structural support to a transseptal guidewire to gain access to the left atrium through the right side of the heart. The device is used by a physician by inserting the device through a transseptal dilator and sheath assembly. The devices are inserted in the femoral vein. The transseptal quidewire is then advanced to the fossa ovalis with the support of the Transseptal Cannula and dilator. This allows physicians to use a transseptal guidewire in difficult cases where there is a particularly tough septum as the Transseptal Cannula provides the extra support needed. The cannula's duration in the body is less than 24 hours.
This FDA 510(k) summary is for a medical device called the "Needle Free Transseptal Cannula." It details the device's characteristics and compares it to a legally marketed predicate device to establish substantial equivalence.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative manner for specific performance metrics like a cut-off value for a pull test. Instead, it lists the types of performance tests conducted, implying that the device was deemed acceptable if it passed these tests, meaning it met internal specifications or comparative standards.
Since quantitative acceptance criteria and specific reported numerical performance values are not given, the table below will list the tests performed and indicate that the device "met requirements" or "passed" as implied by the "Conclusion" section stating the device is substantially equivalent based on performance testing.
| Acceptance Criteria Category | Reported Device Performance (as implied) |
|---|---|
| Visual and dimensional inspection | Met requirements (Passed) |
| Particulate testing (USP, Light Obscuration Method) | Met requirements (Passed) |
| Mating Joint Pull test (Handle to Hub) | Met requirements (Passed) |
| Guidewire Restriction Inspection | Met requirements (Passed) |
| Strength of Union Cannula Hub and Cannula | Met requirements (Passed) |
| Needle Point Inspection | Met requirements (Passed) |
| Hub Female Luer Taper | Met requirements (Passed) |
| Water Leak Testing | Met requirements (Passed) |
| Air Leak Testing | Met requirements (Passed) |
| Packaging Testing | Met requirements (Passed) |
| Biocompatibility (ISO 10993-5 Cytotoxicity) | Met requirements (Passed) |
| Biocompatibility (ISO 10993-10 Sensitization) | Met requirements (Passed) |
| Biocompatibility (ISO 10993-10 Irritation/Intracutaneous Reactivity) | Met requirements (Passed) |
| Biocompatibility (ISO 10993-11 Acute Systemic Toxicity) | Met requirements (Passed) |
| Biocompatibility (ISO 10993-11 Pyrogenicity) | Met requirements (Passed) |
| Biocompatibility (ISO 10993-3 Genotoxicity) | Met requirements (Passed) |
| Biocompatibility (ISO 10993-4 Hemocompatibility – ASTM Hemolysis) | Met requirements (Passed) |
| Biocompatibility (ISO 10993-4 Hemocompatibility Complement Activation) | Met requirements (Passed) |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not provide details on the sample size used for specific performance tests (e.g., number of units tested for pull strength, a specific number of animals or human subjects for biocompatibility). The provenance of the data is not explicitly stated in terms of country of origin, but all tests were conducted according to recognized international standards (e.g., USP , ISO 10993 series). The nature of the tests indicates that these are laboratory/bench tests rather than clinical studies with human patient data; therefore, the terms "retrospective or prospective" do not directly apply in the usual sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This section is not applicable (N/A) as the device is a mechanical instrument and the tests described are primarily material, mechanical, and biocompatibility evaluations, not diagnostic image or data interpretation that typically requires expert "ground truth" establishment.
4. Adjudication Method for the Test Set
This section is not applicable (N/A) for the same reasons as point 3. Adjudication methods (like 2+1 or 3+1) are typically used for disagreements in human expert assessments of data, which is not relevant here.
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 section is not applicable (N/A). The device is a physical medical instrument (a cannula), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study or AI-related effectiveness is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable (N/A) as the device is a physical medical instrument, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for the performance tests would be defined by the specifications and standards that the device had to meet (e.g., a certain pull strength, absence of particulates beyond a threshold, non-toxicity). For biocompatibility, the ground truth is established by the normative criteria outlined in the ISO 10993 standards. It is based on objective measurements and established scientific/engineering criteria rather than expert consensus on complex data or patient outcomes.
8. The Sample Size for the Training Set
This section is not applicable (N/A). As a physical medical device, there is no "training set" in the context of machine learning. The device design and manufacturing processes are validated through design verification and validation testing, not through data training.
9. How the Ground Truth for the Training Set was Established
This section is not applicable (N/A) for the same reasons as point 8.
§ 870.1390 Trocar.
(a)
Identification. A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or chamber to facilitate insertion of the cannula.(b)
Classification. Class II (special controls). Except for trocars that are reprocessed for multiple use, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.