(84 days)
Not Found
No
The summary describes a mechanical biopsy system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
Explanation: The device is described as a "Fine Needle Biopsy System" used for diagnostic sampling of lesions and masses, not for treating them.
No
The device is a biopsy system used to obtain tissue samples for diagnostic purposes, but it does not perform the diagnosis itself.
No
The device description clearly states it is a "Fine Needle Biopsy System" consisting of a delivery system and a needle sub-assembly, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as a system for performing fine needle biopsies (FNB) to obtain tissue samples from various anatomical sites. This is a procedure to collect a sample from the body.
- Device Description: The description details a biopsy needle and delivery system used through an endoscope to acquire tissue.
- Lack of IVD Characteristics: An IVD is a device intended for use in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic purposes. This device is used in vivo (within the body) to collect the specimen.
The SharkCore™ Fine Needle Biopsy System is a device used to collect a sample, which would then likely be sent to a laboratory for in vitro diagnostic testing (e.g., pathology or cytology). The device itself is a tool for sample acquisition, not for performing the diagnostic test on the sample.
N/A
Intended Use / Indications for Use
The SharkCore™ Fine Needle Biopsy System is used with an ultrasound endoscope for fine needle biopsy (FNB), of submucosal lesions, mediastinal masses, lymph nodes and intaperitoneal masses within or adjacent to 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 SharkCore™ Fine Needle Biopsy (FNB) System is an echogenic biopsy needle used through the instrument channel of an ultrasound imaging endoscope. The system is used to sample targeted submucosal and extramural gastrointestinal lesions through the accessory channel of an ultrasound endoscope. The SharkCore™ Fine Needle Biopsy (FNB) System is modular in design consisting of two major components; i.e., a delivery system (Beacon™ EUS Delivery System) and a separate exchangeable needle sub-assembly (SharkCore™ FNB Needle).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
submucosal lesions, mediastinal masses, lymph nodes and intaperitoneal masses within or adjacent to the gastrointestinal tract.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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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 testing demonstrates performance equivalence for the SharkCore FNB system when evaluated against its predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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.
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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 words "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, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 6, 2014
Covidien, Ilc. Saket Bhatt Regulatory Affairs Manager 2000 Commonwealth Avenue, Suite 110 Auburndale, MA 02466-2008
Re: K141894
Trade/Device Name: SharkCore™ Fine Needle Biopsy System Regulation Number: 21 CFR§ 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: FCG Dated: September 11, 2014 Received: September 12, 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.
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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/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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) To be determined K141894
Device Name
SharkCore™ Fine Needle Biopsy System
Indications for Use (Describe)
The SharkCore™ Fine Needle Biopsy System is used with an ultrasound endoscope for fine needle biopsy (FNB), of submucosal lesions, mediastinal masses, lymph nodes and intaperitoneal masses within or adjacent to the needle is designed with a passive (i.e., automatic) safety shielding feature to aid in the prevention of needle stick injury.
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)
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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510(k) SUMMARY 5.0
This 510(k) Summary for the SharkCore™ Fine Needle Biopsy System is being submitted in accordance with 21 CFR 807.92.
Submitter's Name, Address, Telephone Number and Contact Person
Covidien IIc (formerly Beacon Endoscopic Corp.) 2000 Commonwealth Ave. Suite 110 Auburndale, MA 02466-2008
Contact: Saket Bhatt, Regulatory Affairs Manager, Covidien IIc 540 Oakmead Parkway, Sunnyvale, CA, 94085
Phone: (408) 328-7357 (408) 328-7357 (same as phone#) Fax:
Date Prepared: July 10, 2014
Name of Medical Device:
SharkCore™ Fine Needle Biopsy System (includes Beacon™ EUS Delivery System and SharkCore™ FNB Needle) Device Regulation: 21 CFR 876.1075, Class II Product Code: FCG Common/Usual Name: Kit, Needle, Biopsy (FCG) Classification Panel: Gastroenterology-Urology Devices Panel
Establishment Registration Number, Owner/Operator Number:
Establishment Registration Number: 3009144059 Owner/Operator Number: 10037745
Predicate Devices
BNX Fine Needle Aspiration System (reference K133008, November 20, 2013) EchoTip Ultra Ultrasound Needle (reference K083330; Feb 06, 2009)
Device Description
The SharkCore™ Fine Needle Biopsy (FNB) System is an echogenic biopsy needle used through the instrument channel of an ultrasound imaging endoscope. The system is used to sample targeted submucosal and extramural gastrointestinal lesions through the accessory channel of an ultrasound endoscope. The SharkCore™ Fine Needle Biopsy (FNB) System is modular in design consisting of two major components; i.e., a delivery system (Beacon™ EUS Delivery System) and a separate exchangeable needle sub-assembly (SharkCore™ FNB Needle).
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Indications for Use
The SharkCore™ Fine Needle Biopsy System is used with an ultrasound endoscope for fine needle biopsy, (FNB), of submucosal lesions, mediastinal masses, lymph nodes and intaperitoneal 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 stick injury.
Technological Characteristics Compared to Predicate Devices
The SharkCore™ Fine Needle Biopsy System is identical to the legally marketed BNX™ Fine Needle Aspiration System (reference K133008) in terms of 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. The SharkCore Fine Needle Biopsy System is substantially equivalent to the legally marketed EchoTip Ultra Ultrasound Needle (reference K083330; Feb 06, 2009) in terms of indications for use, anatomical location of use and labeling.
Performance Data
Bench testing demonstrates performance equivalence for the SharkCore FNB system when evaluated against its predicate devices.
Conclusion
Covidien IIc considers the SharkCore™ Fine Needle Biopsy System to be substantially equivalent to legally marketed predicate devices BNX Fine Needle Aspiration System (reference K133008, November 20, 2013), and EchoTip Ultra Ultrasound Needle (reference K08330; Feb 06, 2009). The test results and compliance with applicable standards provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its indications for use.