(56 days)
No
The description focuses on mechanical features, needle sizes, and a passive safety shield. There is no mention of AI, ML, or any computational analysis of data.
No
The device is used to acquire aspiration samples for diagnosis, not to treat a condition.
No
This device is used to acquire aspiration samples from lesions, which are then analyzed to make a diagnosis. The device itself is used for acquiring samples rather than performing the diagnostic analysis.
No
The device description clearly details a physical medical device consisting of a needle, sheath, handle assembly, and a safety shielding feature. It is a hardware device used for aspiration.
Based on the provided information, the BNX FNA System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to sample targeted lesions. It is a tool for collecting a sample.
- Device Description: The description focuses on the mechanical aspects of the device for obtaining a sample (needle, sheath, handle, suction, safety features).
- Lack of Diagnostic Function: The device itself does not perform any analysis or testing on the collected sample to provide diagnostic information. The sample is collected for subsequent analysis, which would be performed using separate IVD devices or laboratory procedures.
- No Mention of Reagents or Assays: IVD devices typically involve reagents, assays, or other components used to analyze a biological sample. This device does not mention any such components.
The BNX FNA System is a medical device used for sample collection, which is a step that precedes in vitro diagnostic testing.
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.
Product codes (comma separated list FDA assigned to the subject device)
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound
Anatomical Site
sub-mucosal and extramural gastrointestinal lesions
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench and simulated use testing were performed demonstrating that the subject device is substantially equivalent to the predicate devices for the proposed intended use. As per CDRH's Guidance for Industry and FDA: Medical Devices with Sharps Injury Prevention Features, simulated use studies were conducted on the subject device evaluating greater than 500 cycles 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 and 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 and provided protection against unintended sharps injury through disposal.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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 110
Auburndale, MA 02466-2008 |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Annette Fagnant, Regulatory Affairs Consultant,
MedDRA Assistance Inc.
53 Kennedy Road
Foster, RI 02825
Phone: 401-392-0287
Fax: 401-397-6531 |
| Date: | September 23, 2013 |
| | NOV 20 2013 |
| Name of Medical Device: | Device Regulation: 21 CFR 876.1075, Class II
Product Code: FCG
Common/Usual Name: Kit, Needle, Biopsy (FCG)
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 (reference K103668, cleared December 30, 2010).
The sharps safety protection mechanism is similar in design and use as that of
the 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 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. |
Traditional 510(k) – BNX™ Fine Needle Aspiration System-Sharps Injury Prevention Feature
24
1
:
510(k) SUMMARY Page 2 of 3
| 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
shielding feature to aid in the prevention of needle stick injury. |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological
Characteristics: | The proposed BNX FNA System has similar intended use and identical
technological characteristics compared with the predicate BNX FNA System
cleared in K103668. There have been no changes made to the design of the
BNX FNA System to allow for the expanded labeling claim. |
| | 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. |
| Performance
Data: | Bench and simulated use testing were performed demonstrating that the
subject device is substantially equivalent to the predicate devices for the
proposed intended use. As per CDRH's Guidance for Industry and FDA:
Medical Devices with Sharps Injury Prevention Features, simulated use
studies were conducted on the subject device evaluating greater than 500
cycles 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 and
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 and provided protection against unintended sharps
injury 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
5
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)