(58 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 19Ga. and 22Ga. BNX Aspiration Needles are also intended to implant fiducial markers under endoscopic ultrasound to radiographically mark soft tissue for future therapeutic procedures.
The BNX Fine Needle Aspiration (FNA) System is a sterile, single patient use endoscopic ultrasound aspiration needle. The device consists of the BeaconTM Endoscopic Ultrasound Delivery System and BNXTM Fine Needle Aspiration Needle which are assembled before insertion through the accessory channel of an ultrasound endoscope. The device is offered with needle sizes of 19, 22 and 25 ga (however only the 19 and 22 gauge needles will be indicated for fiducial delivery). 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. 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. For delivery of fiducial markers the needle is loaded with the fiducial marker and fixated in place using bone wax. The fiducial marker is deployed into the target tissue by advancing the stylet.
This document describes the BNX Fine Needle Aspiration (FNA) System and its clearance through the FDA 510(k) process. It primarily establishes substantial equivalence to predicate devices and describes the device's indications for use and technological characteristics.
However, the provided text does not contain the specific details required to complete your request regarding acceptance criteria and a study proving those criteria are met.
Here’s a breakdown of what is present and what is missing based on your request:
What is available in the document:
- Device Name: BNX Fine Needle Aspiration System
- Intended Use: To sample targeted sub-mucosal and extramural gastrointestinal lesions through the accessory channel of an ultrasound endoscope. The 19Ga. and 22Ga. BNX Aspiration Needles are also intended to implant fiducial markers under endoscopic ultrasound to radiographically mark soft tissue for future therapeutic procedures.
- Method of Performance Testing: "Bench and simulated use testing" was performed.
- Conclusion: The device is substantially equivalent to predicate devices for its proposed intended use.
Information NOT available in the document (and therefore cannot be provided in the requested table/description):
- A table of acceptance criteria and the reported device performance: The document states that "bench and simulated use testing" was performed to demonstrate substantial equivalence, but it does not provide any specific quantitative acceptance criteria or the numerical performance results from these tests (e.g., success rates, precision, accuracy, force measurements, tissue sampling yield, etc.).
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as specific performance measures and ground truth establishment are not detailed.
- Adjudication method for the test set: Not applicable.
- 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 device is a mechanical medical instrument, not an AI/imaging diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device, not an algorithm.
- The type of ground truth used: Not explicitly stated for performance testing. For substantial equivalence, the ground truth is often the performance of the predicate device.
- The sample size for the training set: Not applicable as this is a physical medical device, not a machine learning algorithm requiring a "training set."
- How the ground truth for the training set was established: Not applicable.
Summary of Device Performance and Acceptance Criteria (Based on Available Information):
Acceptance Criteria for Substantial Equivalence:
The primary "acceptance criterion" for this 510(k) submission is demonstrating substantial equivalence to existing legally marketed predicate devices. This means that the device must be as safe and effective as the predicate device(s). For this specific device, the predicate devices are:
- For Fine Needle Aspiration: BNX Fine Needle Aspiration System (K133008)
- For Fiducial Marker Delivery: Wilson-Cook Medical EchoTip Ultra Fiducial Needle (K111895)
Study Description:
The document states: "This premarket notification is supported with bench and simulated use testing. performed demonstrates that the subject device is substantially equivalent to the predicate devices for the proposed intended use."
This indicates that internal testing was conducted to show the device performed comparably to the predicate devices in a laboratory or simulated environment for its indicated uses (tissue sampling and fiducial marker implantation). No specific details on the methodology, results, or quantitative metrics of these tests are provided in this regulatory document. The specific "acceptance criteria" for these internal tests would have been developed by Covidien to ensure the device met its design specifications and performed as intended, demonstrating equivalence to the referenced predicates.
In essence, the document confirms that testing was done to support the claim of substantial equivalence, but it does not disclose the detailed results or specific acceptance metrics of that testing.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 8, 2014
Covidien, LLC Saket Bhatt Regulatory Affairs Manager 2000 Commonwealth Ave., Suite 110 Auburndale, MA 02466
Re: K142198 Trade/Device Name: BNX Fine Needle Aspiration System Regulation Number: 21 CFR§ 878.4300 Regulation Name: Implantable Clip Regulatory Class: II Product Code: NEU, FCG Dated: August 8, 2014 Received: August 11, 2014
Dear Saket Bhatt,
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 general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing 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 found in 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportaProblem/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 Industry and Consumer Education 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,
Benjamin R. Fisher -A
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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Food and Drug Administration Indications for Use
Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name
BNX Fine Needle Aspiration System
Indications for Use (Describe)
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 19Ga. and 22Ga. BNX Aspiration Needles are also intended to implant fiducial markers under endoscopic ultrasound to radiographically mark soft tissue for future therapeutic procedures.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
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FORM FDA 3881 (1/14)
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510(k) SUMMARY 5.0 Page 1 of 2
This 510(k) Summary for the BNX Fine Needle Aspiration System is being submitted in accordance with 21 CFR 807.92.
| Submitter'sName andAddress: | Covidien IIc2000 Commonwealth Ave. Suite 110Auburndale, MA 02466-2008 |
|---|---|
| ContactPerson: | Saket Bhatt, Regulatory Affairs Manager540 Oakmead ParkwaySunnyvale, CA 94085Phone & Fax: 408-328-7357Email: Saket.Bhatt@covidien.com |
| Date: | August 8, 2014 |
| Name ofMedical Device: | Device Regulation: 21 CFR 878.4300 and 21 CFR 876.1075, Class IICommon/Usual Name: Implantable clip and Gastroenterology-urology biopsy instrumentProduct Code: NEU (Marker, Radiographic, Implantable) and FCG (Kit, Needle, Biopsy)Proprietary Name: BNX Fine Needle Aspiration SystemClassification Panel: Gastroenterology-Urology Devices Panel |
| PredicateDevices: | The subject device is substantially equivalent to the BNX Fine Needle AspirationSystem (K133008, cleared November 20, 2013).The expanded indication for delivery of fiducial markers is substantially equivalent to theWilson-Cook Medical EchoTip Ultra Fiducial Needle cleared under K111895 (clearedApril 27, 2012). |
| DeviceDescription: | The BNX Fine Needle Aspiration (FNA) System is a sterile, single patient use endoscopicultrasound aspiration needle. The device consists of the BeaconTM EndoscopicUltrasound Delivery System and BNXTM Fine Needle Aspiration Needle which areassembled before insertion through the accessory channel of an ultrasound endoscope.The device is offered with needle sizes of 19, 22 and 25 ga (however only the 19 and 22gauge needles will be indicated for fiducial delivery). The BNX FNA System has anintegrated needle protection shield that automatically engages over the distal end of theneedle during removal to cover the needle sharp. In this manner, the needle tip iscovered to help protect against inadvertent needle sticks. |
| Indication ForUse: | The BNX FNA System is used to sample targeted sub-mucosal and extramuralgastrointestinal lesions through the accessory channel of an ultrasound endoscope. Theneedle is designed with a passive (i.e., automatic) safety |
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510(k) SUMMARY Page 2 of 2
shielding feature to aid in the prevention of needle stick injury. The 19Ga. and 22Ga. BNX Fine Needle Aspiration Needles are also intended to implant fiducial markers under endoscopic ultrasound to radiographically mark soft tissue for future therapeutic procedures.
Technological The proposed BNX FNA System's indications for use and technological characteristics are identical when compared with the predicate BNX FNA System cleared in K133008. Characteristics: With respect to fiducial delivery, the BNX FNA System indication for use statement proposed is identical to the predicate Wilson-Cook Medical EchoTip Ultra Fiducial Needle cleared under K111895. There have been no changes made to the design of the BNX FNA System to allow for expanded indication.
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. 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. For delivery of fiducial markers the needle is loaded with the fiducial marker and fixated in place using bone wax. The fiducial marker is deployed into the target tissue by advancing the stylet.
Performance This premarket notification is supported with bench and simulated use testing. Testing Data: performed demonstrates that the subject device is substantially equivalent to the predicate devices for the proposed intended use.
Conclusion: Covidien has demonstrated that the proposed BNX FNA System is substantially equivalent to the predicate BNX FNA System and Wilson-Cook Medical EchoTip Ultra Fiducial Needle when used to implant fiducial markers under endoscopic ultrasound to radiographically mark soft tissue for future therapeutic procedures.
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.