(228 days)
The SafeSept is indicated for use in procedures where access to the transseptal technique is desired. The SafeSept Transseptal Guidewire is intended for single use only.
The SafeSept® Transseptal Guidewire is 0.014″ in diameter and 135cm long and consists of a flexible memory wire material called nitinol. The components of the SafeSept include the 0.014″ transseptal guidewire, dispenser and straightener, and sterile packaging and labeling. There is one model number for the SafeSept, SS-135. The SafeSept is sterilized by 100% ethylene oxide cycle and is for single-use only. The SafeSept is used in a healthcare facility/hospital.
The SafeSept 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 the femoral vein. The SafeSept is then advanced to the fossa ovalis with the support of the needle and dilator. The SafeSept'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 needle and dilator. When the wire is no longer supported, it is atraumatic and operates as a typical 0.014″ 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 guidewire tip in relation to the tip of the needle. The guidewire's duration in the body is less than 24 hours.
This document is a 510(k) Pre-market Notification for a medical device called the SafeSept Transseptal Guidewire. It does not describe an AI/ML powered device, therefore, the requested information about acceptance criteria and studies does not apply in the context of an algorithmic device.
The document discusses the substantial equivalence of the SafeSept Transseptal Guidewire to a legally marketed predicate device (Oscor, SafeSept® Transseptal Trocar Guidewire, K081986). The primary difference noted is the length of the guidewire.
Here's an overview of the performance and biocompatibility testing conducted to support substantial equivalence:
Performance Testing:
- Visual and dimensional inspection
- Particulate testing (USP , Light Obscuration Method)
- Surface finish assessment
- Corrosion resistance
- Guidewire tensile strength
- Fracture and Flex testing
- Curve Integrity testing
- Torque Testing
- Packaging testing
- Radiopacity assessment
- Sterilization validation (in accordance with ANSI/AAMI/ISO 11135-1)
These tests demonstrated that the subject device performed equivalently to the predicate device.
Biocompatibility Testing (in accordance with FDA 510(k) Memorandum #G95-1 and ISO 10993):
- ISO 10993-5 Cytotoxicity
- ISO 10993-10 Sensitization
- ISO 10993-10 Irritation/Intracutaneous Reactivity
- ISO 10993-11 Acute Systemic Toxicity
- ISO 10993-11 Pyrogenicity
- ISO 10993-3 Genotoxicity
- ISO 10993-4 Hemocompatibility - ASTM Hemolysis Complete
- ISO 10993-4 Hemocompatibility - In-vivo Dog Thromboresistance
- ISO 10993-4 Hemocompatibility Complement Activation Complete with C3a & SC5b-9
The SafeSept transseptal guidewire is categorized as an external communicating device with circulating blood contact and limited exposure (less than 24 hours), and it met the requirements of ISO-10993.
Regarding your specific questions related to AI/ML powered devices:
- Acceptance Criteria & Device Performance Table: Not applicable as this is not an AI/ML device. The document primarily focuses on demonstrating substantial equivalence to a predicate device through physical and biological performance testing, rather than an algorithmic performance.
- Sample size for test set and data provenance: No "test set" in the context of an algorithm. Performance tests were conducted on the device itself.
- Number of experts for ground truth: Not applicable. Ground truth for an AI/ML algorithm is not relevant here.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: Not applicable.
- Standalone (algorithm only) performance: Not applicable.
- Type of ground truth used: Not applicable.
- Sample size for training set: Not applicable.
- How ground truth for training set was established: Not applicable.
§ 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.