(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."
}
{0}------------------------------------------------
5.0 510(k) SUMMARY Page 1 of 3
This 510(k) Summary for the BNX Fine Needle Aspiration System is being submitted in accordance with 21 CFR 807.92.
| Submitter's Name and Address: | Beacon Endoscopic Corp.2000 Commonwealth Ave. Suite 110Auburndale, MA 02466-2008 |
|---|---|
| Contact Person: | Annette Fagnant, Regulatory Affairs Consultant,MedDRA Assistance Inc.53 Kennedy RoadFoster, RI 02825Phone: 401-392-0287Fax: 401-397-6531 |
| Date: | September 23, 2013 |
| NOV 20 2013 | |
| Name of Medical Device: | Device Regulation: 21 CFR 876.1075, Class IIProduct Code: FCGCommon/Usual Name: Kit, Needle, Biopsy (FCG)Proprietary Name: BNX Fine Needle Aspiration SystemClassification Panel: Gastroenterology-Urology Devices Panel |
| Predicate Devices: | The subject device is substantially equivalent to the:- BNX Fine Needle Aspiration System (reference K103668, cleared December 30, 2010).The sharps safety protection mechanism is similar in design and use as that ofthe Personna Plus Safety Scalpel System (OMI Manufacturing Pty. Ltd,K032242, cleared September 23, 2003) |
| Device Description: | The BNX Fine Needle Aspiration (FNA) System is a sterile, single patient useendoscopic ultrasound aspiration needle. The device consists of the BNXAspiration Delivery System and BNX Aspiration Needle which are assembledbefore insertion through the accessory channel of an ultrasound endoscope.The needle is used to acquire aspiration samples from lesions targeted using anultrasound endoscope. An aspiration sample is obtained by penetrating thelesions with the needle while applying suction. The device is offered with needlesizes of 19, 22 and 25 gauge. The BNX FNA System has an integrated needleprotection shield that automatically engages over the distal end of the needleduring removal to cover the needle sharp. In this manner, the needle tip iscovered to help protect against inadvertent needle sticks. |
Traditional 510(k) – BNX™ Fine Needle Aspiration System-Sharps Injury Prevention Feature
24
{1}------------------------------------------------
:
510(k) SUMMARY Page 2 of 3
| Indication ForUse: | The BNX FNA System is used to sample targeted sub-mucosal and extramuralgastrointestinal lesions through the accessory channel of an ultrasoundendoscope. The needle is designed with a passive (i.e., automatic) safetyshielding feature to aid in the prevention of needle stick injury. |
|---|---|
| TechnologicalCharacteristics: | The proposed BNX FNA System has similar intended use and identicaltechnological characteristics compared with the predicate BNX FNA Systemcleared in K103668. There have been no changes made to the design of theBNX FNA System to allow for the expanded labeling claim. |
| The referenced BNX FNA device incorporates a long stiff metallic needle withstylet housed in a sheath with handle assembly. The handle is screwed ontothe luer-lock connection of the endoscope. The needle is manipulated by ahandle piston which is locked and unlocked by means of a screw to avoidadvancement of the needle during introduction and withdrawal of the biopsyassembly. The tips of the Aspiration Needles are etched for enhancedultrasonic needle visualization. Tissue samples are acquired into the lumen ofthe needle via applied suction using a standard hypodermic syringe. The BNXFNA System is modular in design, i.e., the sheath and handle assembly areincorporated in a Delivery System as a separate component from theAspiration Needle/stylet assembly. The modular design facilitates exchange ofany size aspiration needle as the needle can be removed from the scopewithout requiring that the handle be disconnected. Additionally, the BNX FNASystem has an integrated needle protection shield as a sharps injuryprotection feature that automatically engages over the distal end of the needleduring removal to cover the needle sharp. In this manner, the needle tip iscovered to help protect against inadvertent needle sticks. If a second sampleacquisition cycle is required, the needle protector shield is captured within thehandle housing to be actuated during the next needle removal cycle. | |
| PerformanceData: | Bench and simulated use testing were performed demonstrating that thesubject device is substantially equivalent to the predicate devices for theproposed intended use. As per CDRH's Guidance for Industry and FDA:Medical Devices with Sharps Injury Prevention Features, simulated usestudies were conducted on the subject device evaluating greater than 500cycles of product use with zero failures for the sharps injury prevention feature.Results of this evaluation met FDA's minimum standard for a "97.5%confidence that the true failure rate was no higher than 0.7% and 99.5%confidence that it is no higher than 1.1% " as per the FDA Guidance anddocumented that the BNX FNA System's passive sharps safety preventionmechanism did not impede or adversely affect the intended clinicalperformance of the device and provided protection against unintended sharpsinjury through disposal. |
Traditional 510(k) - BNX™ Fine Needle Aspiration System-Sharps Injury Prevention Feature
25
{2}------------------------------------------------
510(k) SUMMARY
Page 3 of 3
Beacon Endoscopic Corp. has demonstrated that the proposed BNX FNA Conclusion: System is substantially equivalent to the predicate BNX FNA System and has demonstrated that the passive needle protection sheath provides sharps safety protection supporting expansion of the device's indication to include that the needle is designed with a passive (i.e., automatic) safety shielding feature to aid in the prevention of needle stick injury.
{3}------------------------------------------------
Food and Drue Administration 10903 New Hampshire Avenue Document Control Center - WO66-Ghos Silver Spring, MD 20993-0002
November 20, 2013
Beacon Endoscopic Corporation. % Annette M. Fagnant Regulatory Affairs Consultant MedDRA Assistance, Inc. 53 Kennedy Road Foster, RI 02825
Re: K133008
Trade/Device Name: BNX Fine Needle Aspiration System Regulation Number: 21 CFR§ 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: FCG Dated: September 23, 2013 Received: September 25, 2013
Dear Annette M. Fagnant,
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, merclore, mains of the Act include requirements for annual registration, listing of general controls providering practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be four of the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean i least be advised that I Dris lesantes over device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
{4}------------------------------------------------
Page 2 - Annette M. Fagnant
You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/About/DA/CentersOffices/CDRH/CDRHOffices/ncm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Herbert P. Lerner -S
for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive. Gastro-Renal. and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4.0 Indication for Use Statement
510(k) Number (if known):
Device Name: BNX Fine Needle Aspiration System
Indications for Use:
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.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Herbert P. Lerner -S 2013.11.20 16:46:03
§ 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.