(56 days)
The BNX FNA System is used to sample targeted sub-mucosal and extramural gastrointestinal lesions through the accessory channel of an ultrasound endoscope. The needle is designed with a passive (i.e., automatic) safety shielding feature to aid in the prevention of needle stick injury.
The BNX Fine Needle Aspiration (FNA) System is a sterile, single patient use endoscopic ultrasound aspiration needle. The device consists of the BNX Aspiration Delivery System and BNX Aspiration Needle which are assembled before insertion through the accessory channel of an ultrasound endoscope. The needle is used to acquire aspiration samples from lesions targeted using an ultrasound endoscope. An aspiration sample is obtained by penetrating the lesions with the needle while applying suction. The device is offered with needle sizes of 19, 22 and 25 gauge. The BNX FNA System has an integrated needle protection shield that automatically engages over the distal end of the needle during removal to cover the needle sharp. In this manner, the needle tip is covered to help protect against inadvertent needle sticks.
The referenced BNX FNA device incorporates a long stiff metallic needle with stylet housed in a sheath with handle assembly. The handle is screwed onto the luer-lock connection of the endoscope. The needle is manipulated by a handle piston which is locked and unlocked by means of a screw to avoid advancement of the needle during introduction and withdrawal of the biopsy assembly. The tips of the Aspiration Needles are etched for enhanced ultrasonic needle visualization. Tissue samples are acquired into the lumen of the needle via applied suction using a standard hypodermic syringe. The BNX FNA System is modular in design, i.e., the sheath and handle assembly are incorporated in a Delivery System as a separate component from the Aspiration Needle/stylet assembly. The modular design facilitates exchange of any size aspiration needle as the needle can be removed from the scope without requiring that the handle be disconnected. Additionally, the BNX FNA System has an integrated needle protection shield as a sharps injury protection feature that automatically engages over the distal end of the needle during removal to cover the needle sharp. In this manner, the needle tip is covered to help protect against inadvertent needle sticks. If a second sample acquisition cycle is required, the needle protector shield is captured within the handle housing to be actuated during the next needle removal cycle.
{
"1": {
"table": [
{
"Acceptance Criteria": "> 97.5% confidence that the true failure rate was no higher than 0.7%",
"Reported Device Performance": "Zero failures for the sharps injury prevention feature among >500 cycles of product use"
},
{
"Acceptance Criteria": "The sharps safety prevention mechanism did not impede or adversely affect the intended clinical performance of the device",
"Reported Device Performance": "Documented that the BNX FNA System's passive sharps safety prevention mechanism did not impede or adversely affect the intended clinical performance of the device"
},
{
"Acceptance Criteria": "The sharps safety prevention mechanism provided protection against unintended sharps injury through disposal",
"Reported Device Performance": "Documented that the BNX FNA System's passive sharps safety prevention mechanism provided protection against unintended sharps injury through disposal"
}
]
},
"2": "More than 500 cycles of product use were tested. The data provenance is not specified as retrospective or prospective, nor is the country of origin indicated, though it is based on \"Bench and simulated use testing.\"",
"3": "The document does not specify the number of experts used or their qualifications.",
"4": "The document does not specify an adjudication method.",
"5": "No multi-reader multi-case (MRMC) comparative effectiveness study was mentioned.",
"6": "No standalone (algorithm only) performance study was mentioned. The study focused on simulated use of the physical device.",
"7": "The ground truth for the device's performance was established through bench and simulated use testing, demonstrating zero failures of the sharps injury prevention feature over >500 cycles, and confirming it did not impede clinical performance nor fail to provide protection.",
"8": "The document does not mention a training set or its sample size, as this is a physical medical device, not an AI/ML model.",
"9": "Ground truth for the 'training set' is not applicable as this concerns a physical device, not an AI/ML model. The performance was assessed against predefined safety and functionality criteria through simulated use."
}
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.