(111 days)
Not Found
No
The 510(k) summary describes a mechanical device for accessing anatomical sites and does not mention any AI/ML terms, image processing, or performance metrics typically associated with AI/ML algorithms.
No
The device is used for accessing areas of the gastrointestinal tract and facilitating guidewire placement, rather than directly treating a disease or condition.
No
The device is an access system designed to facilitate guidewire placement and deliver injectable materials into tissues, not to diagnose a condition.
No
The device description explicitly states it is a "sterile, single-use, endoscopic ultrasound device which consists of the Beacon Endoscopic Ultrasound (EUS) Delivery System and a Beacon EUS Access Needle." This clearly indicates the device is a physical, hardware-based medical device, not software only.
Based on the provided information, the Beacon EUS Access System is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use describes a device used to access anatomical locations within the gastrointestinal tract and deliver materials into tissues. This is an in vivo procedure (performed within a living organism), not an in vitro procedure (performed outside of a living organism, typically on biological samples).
- Device Description: The device is described as an endoscopic ultrasound device used to pierce tissue and facilitate guidewire placement. This aligns with an interventional medical device used directly on a patient.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (like blood, urine, tissue biopsies) to provide diagnostic information about a patient's health status.
Therefore, the Beacon EUS Access System is an interventional medical device used for accessing and facilitating procedures within the gastrointestinal tract, not an IVD.
N/A
Intended Use / Indications for Use
The Beacon EUS Access System is used to access the following areas of the gastrointestinal tract: the intra- or extrahepatic bile ducts, pancreatic duct, gallbladder or for delivery of injectable materials into tissues through the accessory channel of an ultrasound endoscope.
Product codes (comma separated list FDA assigned to the subject device)
FCG
Device Description
The Beacon™ EUS Access System is a sterile, single-use, endoscopic ultrasound device which consists of the Beacon Endoscopic Ultrasound (EUS) Delivery System and a Beacon EUS Access Needle. The Beacon EUS Delivery System with Beacon EUS Access Needle is inserted through the accessory channel of an ultrasound endoscope. The Beacon EUS Access Needle is intended to pierce tissue and then act as an access channel to facilitate guidewire placement to locations of the gastrointestinal tract.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intra- or extrahepatic bile ducts, pancreatic duct, gallbladder, tissues through the accessory channel of an ultrasound endoscope.
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)
Performance testing for the Beacon™ EUS Access System consisted of in-vitro functional testing, biocompatibility testing, sterilization validation, packaging validation, and shelf life testing. Testing performed demonstrates that the subject device is substantially equivalent to the predicate devices for the proposed intended use.
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.
K142198 BNX FNA System by Covidien Ilc, K092359 EchoTip Ultra HD Ultrasound Access Needle by Cook Ireland Ltd
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.
Not Found
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 26, 2018
Covidien LLC Rachel Silva Principal Regulatory Affairs Specialist 15 Hampshire Street Mansfield, MA 02048
Re: K180037
Trade/Device Name: Beacon EUS Access System Regulation Number: 21 CFR§ 876.1075 Regulation Name: Gastroenterology-Urology-Biopsy Instrument Regulatory Class: II Product Code: FCG Dated: March 14, 2018 Received: March 15, 2018
Dear Rachel Silva:
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.
1
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 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.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/6 description: The image shows the name "Benjamin R. Fisher -S" in a clear, sans-serif font. The text is horizontally oriented and appears to be the primary focus of the image. The background is plain and does not distract from the text.
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
Indications for Use
510(k) Number (if known) K180037
Device Name Beacon EUS Access System
Indications for Use (Describe)
The Beacon EUS Access System is used to access the following areas of the gastrointestinal tract: the intra- or extrahepatic bile ducts, pancreatic duct, gallbladder or for delivery of injectable materials into tissues through the accessory channel of an ultrasound endoscope.
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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3
510(k) Summary
Submitter's Name and Address: Covidien Ilc
15 Hampshire Street Mansfield, MA 02048
Contact Person:
Rachel Silva Principle Regulatory Affairs Specialist Phone: (408) 328-7359 Fax: (408) 328-7359
Date Prepared: January 3, 2018
Name of Device:
Proprietary Name: Beacon™ EUS Access System Common/Usual Name: Gastroenterology-urology biopsy instrument Classification Panel: Gastroenterology/Urology Device Regulation: 21 CFR 876.1075, Class II Product Code: FCG
Establishment Registration Number. Owner/Operator Number:
Establishment Registration Number: 3004904811 Owner/Operator Number: 1282497
Predicate Devices:
K142198 BNX FNA System by Covidien Ilc K092359 EchoTip Ultra HD Ultrasound Access Needle by Cook Ireland Ltd
Device Description:
The Beacon™ EUS Access System is a sterile, single-use, endoscopic ultrasound device which consists of the Beacon Endoscopic Ultrasound (EUS) Delivery System and a Beacon EUS Access Needle. The Beacon EUS Delivery System with Beacon EUS Access Needle is inserted through the accessory channel of an ultrasound endoscope. The Beacon EUS Access Needle is intended to pierce tissue and then act as an access channel to facilitate guidewire placement to locations of the gastrointestinal tract.
Indications for Use:
The Beacon EUS Access System is used to access the following areas of the gastrointestinal tract: the intra- or extra-hepatic bile ducts, pancreatic ducts, cystic duct, gallbladder or for delivery of injectable materials into tissues through the accessory channel of an ultrasound endoscope.
4
Technological Characteristics of the Device Compared to Predicate Devices
The subject device has many of the same technological characteristics as the predicate devices. All devices are sterile, single-use, manual devices used in the gastrointestinal tract. The devices are designed to be used through the accessory channel of an ultrasound endoscope and mount to the endoscope via a metal luer adapter located on the handle. All devices have delivery system handles with a series of slidable sub-sections and a catheter sheath. All device systems have metallic removable sharp needles or stylets that pierce tissue.
The primary difference in technological characteristics of the subject device from the predicate devices is the pre-curved design of the removable Beacon EUS Access Needle. The Beacon EUS Access Needle consists of a pre-curved cannula and sharp stylet. Once the stylet is removed from the cannula it takes on a curved shape.
Performance Data
Performance testing for the Beacon™ EUS Access System consisted of in-vitro functional testing, biocompatibility testing, sterilization validation, packaging validation, and shelf life testing. Testing performed demonstrates that the subject device is substantially equivalent to the predicate devices for the proposed intended use.
Conclusion
Covidien IIc considers the Beacon™ EUS Access System to be substantially equivalent to the legally marketed predicate devices BNX FNA System (K142198) and EchoTip Ultra HD Access Needle (K092359). Test results and compliance to applicable standards provided in this premarket notification establishes that similarly designed legally marketed devices have been used for the same clinical application.