(14 days)
The BNX™ Fine Needle Aspiration System is used to sample targeted sub-mucosal and extramural lesions of the gastrointestinal tract through the accessory channel of an ultrasound endoscope.
The BNXTM Fine Needle Aspiration System is a sterile, single patient use endoscopic ultrasound aspiration needle. The device consists of the BNXTM Aspiration Delivery System and BNXTM Fine Needle 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 will be offered with needle sizes of 19, 22 and 25 gauge.
The provided text describes the 510(k) summary for the BNX™ Fine Needle Aspiration System, but it is a premarket notification for a medical device that does not involve AI. Therefore, most of the requested information regarding acceptance criteria, study details for AI performance, sample sizes for training and test sets, expert ground truth establishment, adjudication methods, and MRMC studies are not applicable.
The submission focuses on demonstrating substantial equivalence to predicate devices through bench testing and biocompatibility evaluations, not through clinical efficacy studies involving diagnostic accuracy or AI performance.
Here's a breakdown based on the provided text, indicating where information is not applicable (N/A) for an AI device:
1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table of acceptance criteria with numerical performance targets typical for AI models. Instead, it describes various verification tests and their outcomes.
| Acceptance Criteria (General Description from text) | Reported Device Performance (Summary from text) |
|---|---|
| Mechanical/Integrity Evaluations: | Adequately designed for use, conformance with pre-specified intended acceptance criteria. |
| - Handle Tensile Strength | Verified |
| - Handle Resistance to Torque | Verified |
| - Bond Strengths | Verified |
| - Needle Fracture | Verified |
| Performance Evaluations: | Functionally equivalent to predicate Cook and/or Olympus device. |
| - Device Function/Durability | Verified |
| - Aspiration Needle/Handle Locking Force | Verified |
| - Needle and Catheter Sheath Extension Locking Forces | Verified |
| - Stylette Withdrawal Force | Verified |
| - Perforation Testing | Verified |
| - Needle Echogenicity (Acoustic Reflection) | Equivalent to predicate devices |
| - Aspiration Capability | Verified |
| Biocompatibility | Demonstrated substantial equivalence |
| Packaging Integrity | Demonstrated for labeled shelf-life |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable for an AI device. The document describes bench testing performance, which involves a series of physical and mechanical tests on the device itself, not a test set of data. The number of units tested for each verification test is not specified.
- Data Provenance: Not applicable for an AI device. The testing was conducted in a laboratory/bench setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The "ground truth" for this device's performance is based on engineering specifications, material properties, and functional requirements, established by design and verified through laboratory testing (e.g., measuring forces, observing physical integrity). It does not involve expert clinical assessment of diagnostic output.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This concept applies to human-reviewed data for AI model evaluation. Bench testing involves direct measurement and observation against predefined engineering standards.
5. 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. No AI component is described, and therefore no human reader assistance or MRMC study was performed. The device is a physical instrument for sample acquisition.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical medical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's safety and effectiveness is established through adherence to engineering design specifications, biocompatibility standards, and functional performance benchmarks (e.g., a certain tensile strength, effective aspiration, visualizable echogenicity). These are verified through objective physical measurements and tests, rather than clinical outcomes or expert labels on medical data.
8. The sample size for the training set
Not applicable. This device does not use machine learning or AI, so there is no training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
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DEC 3 0 2010
510(k) SUMMARY
Page 1 of 3
ィ
This 510(k) Summary for the BNX™ Fine Needle Aspiration System is being submitted in accordance with 21 CFR 807.92.
| Submitter's Nameand Address: | Boston Endoscopic Engineering (BEE) Corp.18 Park StreetDanvers, MA USA 01923 |
|---|---|
| Contact Person: | Annette Fagnant, Regulatory Affairs Consultant,MedDRA Assistance Inc.53 Kennedy RoadFoster, RI 02825Phone: 401-392-0287Fax: 401-397-6531 |
| Date: | November 19, 2010 |
| Name of MedicalDevice: | Device Regulation: 21 CFR 876.1075, Class IIProduct Code: FCGCommon/Usual Name: Kit, Needle, Biopsy (FCG)Proprietary Name: BNXTM Fine Needle Aspiration SystemClassification Panel: Gastroenterology-Urology Devices Panel |
| Predicate Devices: | The subject device is substantially equivalent to the:Cook Medical EchoTip Ultrasound Needle (K083330, cleared 2/6/2009) andOlympus Single-Use Aspiration Needle (K023272, cleared 12/23/2002). |
| DeviceDescription: | The BNXTM Fine Needle Aspiration System is a sterile, single patient useendoscopic ultrasound aspiration needle. The device consists of the BNXTMAspiration Delivery System and BNXTM Fine Needle Aspiration Needle whichare assembled before insertion through the accessory channel of anultrasound endoscope. The needle is used to acquire aspiration samplesfrom lesions targeted using an ultrasound endoscope. An aspiration sample isobtained by penetrating the lesions with the needle while applying suction.The device will be offered with needle sizes of 19, 22 and 25 gauge. |
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510(k) SUMMARY Page 2 of 3
Indication For Use:
The BNX™ Fine Needle Aspiration System is used to sample targeted submucosal and extramural gastrointestinal lesions through the accessory channel of an ultrasound endoscope.
Technological Characteristics:
The proposed BNX™ Fine Needle Aspiration System has similar intended use and similar technological characteristics compared with the predicate Cook Echo-Tip Ultrasound Needle and the Olympus Single-Use Aspiration Needle. All three devices are endoscopic ultrasound fine needle aspiration (EUS-FNA) biopsy needles designed to be compatible with the accessory channel of standard ultrasonographic endoscopes. A comparison of the intended use of the proposed BNX™ Fine Needle Aspiration System and the predicate devices is provided in the table below. Although the predicate Cook device was cleared for delivery of injectable materials into tissue during endoscopic procedures, similar to the predicate Olympus Single Use Aspiration Needle, the indication for use statement for the BNX™ Fine Needle Aspiration System is limited to use for sampling targeted submucosal and extramural lesions within the gastrointestinal tract. The application of an EUS-FNA device for delivery of injectable materials is a separate and distinct use from the procedure required to sample targeted sub-mucosal and extramural gastrointestinal lesions (i.e., no delivery of injectable materials is required for sample acquisition) and therefore exclusion of delivery of injectable materials as a component of the indication statement for the proposed BNX FNA device is not relevant to the safety and effectiveness of the device when used as labeled.
| Comparison of Indication for Use Statements | ||
|---|---|---|
| Proposed DeviceBNX FNA System(This Submission) | EchoTip UltraUltraSound Needle(Cook Medical)K083330 | Single Use AspirationNeedle (OlympusMedical)K023272 |
| The BNX™ FineNeedle AspirationSystem is used tosample targeted sub-mucosal andextramuralgastrointestinallesions through theaccessory channel ofan ultrasoundendoscope. | This device is intendedto be used with anultrasound endoscopefor delivery of injectablematerials into tissuesduring endoscopicprocedures and fineneedle aspirations (FNA)of submucosal lesions,mediastinal masses,lymph nodes andintraperitoneal masseswithin or adjacent to theGI tract. | This instrument has beendesigned to be used withthe ultrasound endoscopefor ultrasonically guidedfine needle aspiration(FNA) of submucosal andextramural lesions withinthe gastrointestinal tract(i.e. pancreatic masses,mediastinal masses,perirectal masses andlymph nodes). |
The referenced EUS-FNA devices incorporate a long stiff metallic needle with stylette 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
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510(k) SUMMARY Page 3 of 3
a screw to avoid advancement of the needle during introduction and withdrawal of the biopsy assembly. The tips of these EUS-FNA 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. Whereas, the handle/ sheath/needle subassemblies of the predicate Cook and Olympus EUS-FNA are integrated in a single device, 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/stylette 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.
Performance Data:
Biocompatibility and bench testing was performed demonstrating that the subject device is substantially equivalent to the predicate devices for the proposed intended use. Specifically, verification tests were performed on the proposed BNX™ FNA System; including where applicable, a direct comparison with the predicate devices. Verification tests performed included: mechanical/integrity evaluations (i.e., handle tensile strength, handle resistance to torque, bond strengths and needle fracture) and performance evaluations (i.e., device function/durability, aspiration needle/handle locking force, needle and catheter sheath extension locking forces, stylette withdrawal force, perforation testing, needle echogenicity and aspiration capability) both before and following exposure to aging conditions. Additionally, testing has been performed that demonstrates packaging integrity for the labeled shelf-life. Results of performance testing have established that the BNX FNA System is adequately designed for its use having established conformance with pre-specified intended acceptance criteria. Furthermore, the BNX FNA System was determined to be functionally equivalent to the predicate Cook and/or Olympus device with respect to key performance criteria such as needle puncture force and echogenicity (i.e., acoustic reflection). Thus, the performance data verify that the proposed BNX FNA System is substantially equivalent to the currently marketed predicate Cook Medical EUS-FNA device. Based upon testing performed it can be established that BNX FNA System raises no new issues of safety or effectiveness compared with the predicate devices.
Clinical data are not necessary to demonstrate substantial equivalence.
Conclusion:
Boston Endoscopic Engineering Corp. has demonstrated that the proposed BNX™ Fine Needle Aspiration System is substantially equivalent to the predicate Cook Echo-Tip Ultrasound Needle and the Olympus Single Use Aspiration Needle.
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with healthcare, with three lines forming a stylized bird-like shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Boston Endoscopic Engineering Corp. c/o Paula Wilkerson, RAC Responsible Third Party Official Intertek Testing Services NA, Inc. 2307 E. Aurora Road, Unit B7 TWINSBURG OH 44087
DEC 3 0 2010
Re: K103668
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: December 15, 2010 Received: December 16, 2010
Dear Ms. Wilkerson:
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 of medical device-related
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Page 2
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/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.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/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 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Hubert Lemmer MD
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indication for Use Statement 4.0
510(k) Number (if known):
DEC 3 0 2010
Device Name:
BNX™ Fine Needle Aspiration System
Indications for Use:
The BNX™ Fine Needle Aspiration System is used to sample targeted sub-mucosal and extramural lesions of the gastrointestinal tract through the accessory channel of an ultrasound endoscope.
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)
ductive.
Traditional 510(k) - BNX™ Fine Needle Aspiration System
§ 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.