(29 days)
Not Found
No
The document describes a mechanical device for tissue sampling and fiducial marker placement, with a passive safety feature. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
The devices are used for aspiration and biopsy of lesions, which are diagnostic procedures, not therapeutic ones. The BNX system also mentions implanting fiducial markers for "future therapeutic procedures," but the device itself is not performing the therapy.
Yes
The device is used to sample and biopsy lesions and masses, which are processes of collecting tissue for diagnostic examination. While the device itself is not performing the diagnosis, it is an essential tool in the diagnostic pathway by enabling the collection of samples needed for diagnosis.
No
The device description explicitly states it consists of physical components: the Beacon Endoscopic Ultrasound Delivery System and either the BNX Fine Needle Aspiration Needle or the SharkCore Fine Needle Biopsy Needle. It is a physical medical device used for aspiration and biopsy.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- This device is used in vivo (inside the body) to obtain samples (fine needle aspiration or biopsy) from lesions and masses within or adjacent to the gastrointestinal tract. The purpose is to collect the sample, not to perform a diagnostic test on the sample itself using the device.
The device is a tool for sample collection, which is a step that might precede an in vitro diagnostic test performed on the collected sample in a laboratory. However, the device itself is not performing the diagnostic test.
N/A
Intended Use / Indications for Use
BNX Fine Needle Aspiration System: The device is used to sample targeted sub-mucosal and extramural gastrontestinal 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 sticks. 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.
Shark Core Fine Needle Biopsy System: The device is used with an ultrasound endoscope for fine needle biopsy (FNB) of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses within or adiacent to the gastrointestinal tract. The needle is designed with a passive (i.e., automatic) safety shelding feature to aid in the prevention of needle sticks.
Product codes
FCG, NEU
Device Description
The BNX FNA / SharkCore FNB Systems are sterile, single patient use endoscopic ultrasound aspiration needles. The devices consists of the Beacon Endoscopic Ultrasound Delivery System and either the BNX Fine Needle Aspiration Needle or the SharkCore Fine Needle Biopsy Needle which are assembled before insertion through the accessory channel of an ultrasound endoscope. The devices are offered with needle sizes of 19, 22 and 25 gauge. The BNX FNA / SharkCore FNB Systems have 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
ultrasound
Anatomical Site
sub-mucosal and extramural gastrontestinal lesions; submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses within or adjacent to the gastrointestinal tract; soft tissue
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Bench testing has been performed for those attributes that may be impacted by the modifications made to the subject devices which demonstrates that the proposed modified BNX FNA / SharkCore FNB Systems met the required specifications for completed design verifications tests which included evaluation of unlocking forces, retention forces, sheath extension over the needle, dimensional specifications, bond strengths and durability.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, overlapping each other to create a sense of depth and connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 1, 2015
Covidien, LLC Saket Bhatt Regulatory Affairs Manager 540 Oakmead Parkway Sunnyvale, CA 94085
Re: K150891
Trade/Device Name: BNX™ Fine Needle Aspiration System Product Code: FCG, NEU Trade/Device Name: SharkCore™ Fine Needle Biopsy System Product Code: FCG
Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Dated: April 1, 2015 Received: April 2, 2015
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
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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 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 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 -S
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name
BNX Fine Needle Aspiration System and the SharkCore Fine Needle Biopsy System
Indications for Use (Describe)
BNX Fine Needle Aspiration System: The device is used to sample targeted sub-mucosal and extramural gastrontestinal 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 sticks. 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.
Shark Core Fine Needle Biopsy System: The device is used with an ultrasound endoscope for fine needle biopsy (FNB) of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses within or adiacent to the gastrointestinal tract. The needle is designed with a passive (i.e., automatic) safety shelding feature to aid in the prevention of needle sticks.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
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FORM FDA 3881 (8/14)
Page 1 of 1
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510(k) Summary Page 1 of 2
This 510(k) Summary for BNX™ Fine Needle Aspiration System and SharkCore™ Fine Needle Biopsy System is being submitted in accordance with 21 CFR 807.92.
| Submitter's Name and Address: | Covidien Ilc
15 Hampshire Street
Mansfield, MA 02048 |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Saket Bhatt,
Regulatory Affairs Manager
Covidien IIc
540 Oakmead Parkway
Sunnyvale, CA, 94085
Phone : 408-328-7357
Fax : 408-328-7357 (same as phone #) |
| Date: | April 1, 2015 |
| Name of Medical Device: | Device Regulation: 21 CFR 876.1075, Class II
Product Code: FCG for SharkCore Fine Needle Biopsy System
FCG and NEU for BNX Fine Needle Aspiration System
Common/Usual Name: Kit, Needle, Biopsy
Proprietary Name: BNX Fine Needle Aspiration System / SharkCore Fine Needle Biopsy System
Classification Panel: Gastroenterology-Urology Devices Panel |
| Predicate Devices: | The modified BNX EUS FNA is substantially equivalent to the BNX Fine Needle Aspiration System cleared in K142198 (October 8, 2014).
The modified SharkCore EUS FNB is substantially equivalent to the SharkCore TM EUS FNB cleared in K141894 (October 6, 2014). |
| Device Description: | The BNX FNA / SharkCore FNB Systems are sterile, single patient use endoscopic ultrasound aspiration needles. The devices consists of the Beacon TM Endoscopic Ultrasound Delivery System and either the BNX Fine Needle Aspiration Needle or the SharkCore Fine Needle Biopsy Needle which are assembled before insertion through the accessory channel of an ultrasound endoscope. The devices are offered with needle sizes of 19, 22 and |
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510(k) SUMMARY Page 2 of 2
25 gauge. The BNX FNA / SharkCore FNB Systems have 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.
BNX Fine Needle Aspiration System: The device is used to sample targeted sub-Indications For mucosal and extramural gastrointestinal lesions through the accessory channel Use: of an ultrasound endoscope. The needle is designed with a passive (i.e., automatic) safety shielding feature to aid in the prevention of needle sticks. The 19Ga. And 22 GA. BNX™ Aspiration Needles are also intended to implant fiducial markers under endoscopic ultrasound to radiographically mark soft tissue for future therapeutic procedures.
SharkCore Fine Needle Biopsy System: The device is used with an ultrasound endoscope for fine needle biopsy (FNB) of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses within or adjacent to the gastrointestinal tract. The needle is designed with a passive (i.e., automatic) safety shielding feature to aid in the prevention of needle sticks.
Technological The modified BNX FNA / SharkCore FNB Systems are similar to the legally marketed devices described in K142198 and K141894 respectively in terms of Characteristics: principle of operation, technological and performance characteristics (control mechanism, environmental specifications, dimensional specifications, ergonomics of patient-user interface, packaging, sterilization and shelf life), materials, anatomical site, operating instructions, and single-use disposition.
Performance Bench testing has been performed for those attributes that may be impacted by Data: the modifications made to the subject devices which demonstrates that the proposed modified BNX FNA / SharkCore FNB Systems met the required specifications for completed design verifications tests which included evaluation of unlocking forces, retention forces, sheath extension over the needle, dimensional specifications, bond strengths and durability.
- The results of the non-clinical testing and a comparison of similarities and Conclusion: differences between the modified devices and the respective predicate devices demonstrate that the proposed and predicate devices are substantially equivalent.