(58 days)
No
The description focuses on mechanical features, needle design, and safety mechanisms. There is no mention of AI, ML, image processing for analysis, or any software-driven decision-making based on data.
No
Explanation: The device is described as a system for sampling lesions (diagnostic) and implanting fiducial markers for future therapeutic procedures (pre-therapeutic/diagnostic aid), not for delivering therapy itself.
Yes
The device is used to sample targeted gastrointestinal lesions, which is a diagnostic procedure, and also to implant fiducial markers for future therapeutic procedures, which aids in future diagnostic imaging and treatment planning.
No
The device description clearly details physical components such as needles, sheaths, handles, and a safety shield, indicating it is a hardware device.
Based on the provided information, the BNX FNA System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The primary intended use is to sample targeted lesions and implant fiducial markers. This is a procedure performed in vivo (within the body) to obtain tissue or place markers.
- Device Description: The device is a needle system designed for aspiration and delivery within the body. It is used to physically interact with tissue.
- Lack of In Vitro Testing: The description of performance studies mentions bench and simulated use testing, but there is no mention of testing involving the analysis of samples outside the body, which is characteristic of IVD devices.
- No Mention of Sample Analysis: The device is used to obtain a sample, but there is no indication that the device itself is involved in the analysis of that sample. The analysis of the aspirated tissue would likely be performed using separate laboratory methods, which might involve IVD devices, but the BNX FNA System is not that device.
In summary, the BNX FNA System is a surgical/interventional device used for tissue acquisition and marker placement in vivo, not a device used for the examination of specimens derived from the human body in vitro.
N/A
Intended Use / 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. 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.
Product codes
NEU, FCG
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound
Anatomical Site
sub-mucosal and extramural gastrointestinal lesions, soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
This premarket notification is supported with bench and simulated use testing. Testing performed demonstrates that the subject device is substantially equivalent to the predicate devices for the proposed intended use.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is simple and recognizable, and it is used to represent the U.S. Department of Health & Human Services.
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
1
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
2
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.
| FOR FDA USE ONLY |
|---|
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) |
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FORM FDA 3881 (1/14)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
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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's
Name and
Address: | Covidien IIc
2000 Commonwealth Ave. Suite 110
Auburndale, MA 02466-2008 |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact
Person: | Saket Bhatt, Regulatory Affairs Manager
540 Oakmead Parkway
Sunnyvale, CA 94085
Phone & Fax: 408-328-7357
Email: Saket.Bhatt@covidien.com |
| Date: | August 8, 2014 |
| Name of
Medical Device: | Device Regulation: 21 CFR 878.4300 and 21 CFR 876.1075, Class II
Common/Usual Name: Implantable clip and Gastroenterology-urology biopsy instrument
Product Code: NEU (Marker, Radiographic, Implantable) and FCG (Kit, Needle, Biopsy)
Proprietary Name: BNX Fine Needle Aspiration System
Classification Panel: Gastroenterology-Urology Devices Panel |
| Predicate
Devices: | The subject device is substantially equivalent to the BNX Fine Needle Aspiration
System (K133008, cleared November 20, 2013).
The expanded indication for delivery of fiducial markers is substantially equivalent to the
Wilson-Cook Medical EchoTip Ultra Fiducial Needle cleared under K111895 (cleared
April 27, 2012). |
| Device
Description: | 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. |
| Indication 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 |
4
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.