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510(k) Data Aggregation
(90 days)
The SafeSept® is indicated for use in procedures where access to the left atrium via the transseptal technique is desired. The SafeSept® Transseptal Guidewire is intended for single use only.
The SafeSept® Needle Free Transseptal Guidewire (SafeSept NF) is 0.031" in diameter and 180cm long and consists of a flexible memory wire material called nitinol. The components of the SafeSept NF include the 0.031" transseptal guidewire, dispenser and straightener, and sterile packaging and labeling. There is one model number for the SafeSept NF, SSNF. The SafeSept NF is sterilized by 100% ethylene oxide cvcle and is for single-use only. The SafeSept is used in a healthcare facility/hospital.
The SafeSept NF is used in transseptal procedures to gain access to the left atrium through the right side of the heart. The device is used by inserting the device through a transseptal dilator and sheath located in the femoral vein. The SafeSept NF is then advanced to the fossa ovalis with the support of the dilator and sheath. The SafeSept NF's sharp distal tip is able to perforate through the fossa ovalis, a thin wall between the right and left atrium, when it is supported by a transseptal dilator and sheath. When the wire is no longer supported, it is atraumatic and operates as a typical 0.031" diameter guidewire. A radiopaque coil located along the shaft allows for fluoroscopic visualization of the wire within the left atrium and proximal marker bands help determine the location of the quidewire tip in relation to the needle. The guidewire duration in the body is less than 24 hours.
This document is an FDA 510(k) clearance letter and summary for a medical device, the SafeSept Needle Free Transseptal Guidewire. It does not describe a study involving an algorithm or AI, nor does it present acceptance criteria and performance data for such a device. Instead, it focuses on demonstrating substantial equivalence to a legally marketed predicate device through physical and biological performance testing.
Therefore, many of the requested categories are not applicable to the provided text.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document lists performance tests but does not explicitly state quantitative acceptance criteria or raw performance data (e.g., specific tensile strength values, fracture thresholds, etc.). It only states that the device "performed equivalently to the predicate device" and "met the requirements set forth in ISO-10993."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Performance Testing: | |
| Visual and dimensional inspection | Performed equivalently to the predicate device |
| Particulate testing (USP <788>, Light Obscuration Method) | Performed equivalently to the predicate device |
| Surface finish assessment | Performed equivalently to the predicate device |
| Corrosion resistance | Performed equivalently to the predicate device |
| Guidewire tensile strength | Performed equivalently to the predicate device |
| Fracture and Flex testing | Performed equivalently to the predicate device |
| Curve Integrity testing | Performed equivalently to the predicate device |
| Torque Testing | Performed equivalently to the predicate device |
| Packaging testing | Performed equivalently to the predicate device |
| Radiopacity assessment | Performed equivalently to the predicate device |
| Sterilization (ANSI/AAMI/ISO 11135-1 to SAL of 10-6) | Validated to SAL of 10-6 |
| Biocompatibility Data (ISO 10993 standards): | |
| ISO 10993-5 Cytotoxicity | Met the requirements set forth in ISO-10993 |
| ISO 10993-10 Sensitization | Met the requirements set forth in ISO-10993 |
| ISO 10993-10 Irritation/Intracutaneous Reactivity | Met the requirements set forth in ISO-10993 |
| ISO 10993-11 Acute Systemic Toxicity | Met the requirements set forth in ISO-10993 |
| ISO 10993-11 Pyrogenicity | Met the requirements set forth in ISO-10993 |
| ISO 10993-3 Genotoxicity | Met the requirements set forth in ISO-10993 |
| ISO 10993-4 Hemocompatibility ASTM Hemolysis Complete | Met the requirements set forth in ISO-10993 |
| ISO 10993-4 Hemocompatibility In-vivo Dog Thromboresistance | Met the requirements set forth in ISO-10993 |
| ISO 10993-4 Hemocompatibility Complement Activation Complete with C3a & SC5b-9 | Met the requirements set forth in ISO-10993 |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The testing described is primarily laboratory/bench testing and animal testing for biocompatibility, not clinical data sets.
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 is not an AI/algorithm study involving expert review for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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 document does not describe an AI device or an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/algorithm device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the performance testing, the "ground truth" would be the established engineering and ISO standards/requirements for the mechanical and biological properties of the device, and the performance of the predicate device.
8. The sample size for the training set
Not applicable. This is not an AI/algorithm device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
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