(211 days)
No
The device description and performance studies focus on the mechanical aspects of the biopsy system and its biocompatibility, with no mention of AI/ML components or data analysis.
No.
The device is used for retrieving tissue specimens for diagnostic purposes, not for treating a disease or condition.
No
The device is described as a "core biopsy system" used for "retrieving specimens" and "tissue specimens." This indicates it is a tool for collecting samples, not for analyzing or interpreting them to make a diagnosis.
No
The device description explicitly lists physical components (core biopsy tool, extension tube, locking syringe, tissue removal brush) and describes their materials and function, indicating it is a hardware device.
Based on the provided information, the GenCut core biopsy system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: An IVD device is used to examine specimens derived from the human body (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- GenCut's Function: The GenCut system is a tool used during a medical procedure (endobronchial lung biopsy) to retrieve tissue specimens from the patient's body. It is a surgical/biopsy instrument, not a device that performs analysis on the collected specimen.
- Lack of In Vitro Analysis: The description focuses on the mechanism of tissue collection and the components used for that purpose. There is no mention of any analysis or testing performed on the collected tissue by the GenCut device itself. The tissue retrieved by the GenCut system would then be sent to a laboratory for in vitro diagnostic testing (e.g., pathology, histology), but the GenCut device is not performing that testing.
Therefore, the GenCut core biopsy system is a device used for specimen collection in vivo (within the body), which is a different category of medical device than an IVD.
N/A
Intended Use / Indications for Use
The GenCut core biopsy system is utilized through a flexible endoscope or with the superDimension™ navigation system by physicians who are trained in endoscopic techniques for retrieving specimens from patients with endobronchial lesions, peripheral lung nodules, or lung masses.
Product codes (comma separated list FDA assigned to the subject device)
EOQ
Device Description
The GenCut™ core biopsy system (GenCut system) is an endobronchial biopsy system that consists of a core biopsy tool, extension tube, locking syringe, and a tissue removal brush. The GenCut system is intended to retrieve tissue specimens from lungs during an endobronchial lung biopsy procedure. The product is used either through a flexible endoscope or in conjunction with the superDimension™ navigation system (cleared under 510(k) K092365).
The core biopsy tool is comprised of a polymeric shaft with steel braid reinforcement and a stainless steel side-cutting tip. The extension tube connects to the proximal end of the core biopsy tool shaft via a connection hub. The extension tube fittings allow the user to provide suction to the shaft via the supplied syringe. Upon completion of sampling, the tissue removal brush can be inserted through the length of the shaft to collect any remaining tissue not expelled through aspiration.
The product is packaged in a Tyvek pouch and sterilized with ethylene oxide. The product package contains the core biopsy tool and the following associated accessories:
- Extension tube .
- Locking syringe .
- Tissue removal brush ●
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Lung
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians who are trained in endoscopic techniques
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)
Biocompatibility Data:
Biocompatibility testing was successfully completed in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO 10993 "Biological Evaluation fo Medical Devices Part 1: Evaluation and Testing" May 1, 1995 and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process" as recognized by FDA. The following tests were conducted:
- Cytotoxicity ●
- Sensitization
- Intracutaneous Study .
Design Verification and Validation Testing Data:
- Tensile Testing ●
- Shelf Life Testing
- Simulated Use Testing ●
- . Packaging and Distribution Testing
- . Dimensional Testing
Animal Study Data:
A preclinical study was conducted in a porcine model undergoing an endobronchial lung biopsy procedure. Three physicians including two pulmonologists and one thoracic surgeon conducted the study. All acceptance criteria were met. Therefore, the design of the GenCut system meets the 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.
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
Not Found
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.
0
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 29, 2015
Covidien llc Jenny Jiang Regulatory Affairs Manager 161 Cheshire Lane, Suite 100 Plymouth, MN 55441
Re: K142839
Trade/Device Name: GenCut™ Core Biopsy System Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (flexible or rigid) and accessories Regulatory Class: II Product Code: EOQ Dated: April 2, 2015 Received: April 3, 2015
Dear Ms. Jiang:
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.
1
Page 2 - Ms. Jiang
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 (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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
| Food and Drug Administration | |
|---|---|
| 510(k) Number (if known) | K142839 |
| Device Name | GenCut™ Core Biopsy System |
| Indications for Use | |
| Form Approved: OMB No. 0910-0120 | |
| Expiration Date: January 31, 2017 | |
| See PRA Statement below. | |
| Indications for Use (Describe) | The GenCut core biopsy system is utilized through a flexible endoscope or with the superDimension™ navigation system by physicians who are trained in endoscopic techniques for retrieving specimens from patients with endobronchial lesions, peripheral lung nodules, or lung masses. |
| 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) | |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. | |
| DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: | |
| Department of Health and Human Services | |
| Food and Drug Administration | |
| Office of Chief Information Officer | |
| Paperwork Reduction Act (PRA) Staff | |
| PRAStaff@fda.hhs.gov | |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | |
| FORM FDA 3881 (8/14) | Page 1 of 1 |
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Image /page/3/Picture/0 description: The image contains the logo for Covidien. The logo consists of a blue square with a white cross in the center, and the word "COVIDIEN" in blue, sans-serif font to the right of the square. The square is a darker blue on the edges and a lighter blue in the center.
510(k) Summary
Covidien llc Traditional 510(k) GenCut™ Core Biopsy System
1. Submitter
510(k) Submitter:
Covidien llc 161 Cheshire Lane, Suite 100 Plymouth, MN 55441 U.S.A.
Contact Person:
Jenny Jiang Regulatory Affairs Manager Phone: 763-647-5531 Fax: 763-210-4098 Email: jenny.jiang@covidien.com
Date Prepared: 4/28/2015
2. Device
| Trade Name : | GenCut™ Core Biopsy System |
|---|---|
| Common Name: | Core Biopsy System |
| Model Number: | SDCT01 |
| Classification Name: | Bronchoscope (flexible or rigid) and accessories |
| 21 CFR Part 874.4680 | |
| Product code: | EOQ |
3. Predicate Device
Primary Predicate Device
| Device Name : | Wang Transbronchial Aspriation Needle |
|---|---|
| 510(k): | K914181 |
| Classification Name: | Bronchoscope (flexible or rigid) and accessories |
| 21 CFR Part 874.4680 | |
| Product code: | EOQ |
| Manufacturer: | ConMed Corporation |
Secondary Predicate Device
| Device Name : | eXcelon™ Transbronchial Aspiration Needle |
|---|---|
| 510(k): | K040018 |
| Classification Name: | Bronchoscope (flexible or rigid) and accessories |
| 21 CFR Part 874.4680 | |
| Product code: | EOQ |
4
Manufacturer: Boston Scientific
4. Device Description
The GenCut™ core biopsy system (GenCut system) is an endobronchial biopsy system that consists of a core biopsy tool, extension tube, locking syringe, and a tissue removal brush. The GenCut system is intended to retrieve tissue specimens from lungs during an endobronchial lung biopsy procedure. The product is used either through a flexible endoscope or in conjunction with the superDimension™ navigation system (cleared under 510(k) K092365).
The core biopsy tool is comprised of a polymeric shaft with steel braid reinforcement and a stainless steel side-cutting tip. The extension tube connects to the proximal end of the core biopsy tool shaft via a connection hub. The extension tube fittings allow the user to provide suction to the shaft via the supplied syringe. Upon completion of sampling, the tissue removal brush can be inserted through the length of the shaft to collect any remaining tissue not expelled through aspiration.
The product is packaged in a Tyvek pouch and sterilized with ethylene oxide. The product package contains the core biopsy tool and the following associated accessories:
- Extension tube .
- Locking syringe .
- Tissue removal brush ●
5. Indications for Use
The GenCut core biopsy system is utilized through a flexible endoscope or with the superDimension™ navigation system by physicians who are trained in endoscopic techniques for retrieving specimens from patients with endobronchial lesions, peripheral lung nodules, or lung masses.
6. Summary of Characteristics Compared to Predicate Devices
Both the subject device and predicate devices have technological principle. All of these tools are advanced into the body through a flexible endoscope or other working channel. Once they reach the target biopsy site, suction is applied through a syringe and a sample is taken from the desired site. Once the sample is obtained, the devices are withdrawn from the body and a sample can be expelled from the tool.
Overall, the subject and predicate devices are all based on the following same technological elements:
- Device introduced endoscopically and used to reach the target site
5
- Device inserted through a flexible endoscope or other working channel .
- Use of a distal tip to collect tissues and a syringe to aspirate samples out of the . shaft
- . Device intended for short-term introduction and transient use through a naturally occurring orifice
See table below for a detailed summary of the characteristics compared to the predicate device.
| Characteristic | GenCut system
(Subject Device)
K142839 | Wang Transbronchial
Aspiration Needle
(Predicate Device)
K914181 |
|----------------------------------|-------------------------------------------------------------------------------|---------------------------------------------------------------------------|
| Device Classification | Class II | Same |
| FDA Product Code | EOQ | Same |
| Technological Characteristics | | |
| Anatomical Site | Lung | Same |
| Introduction to Target
Tissue | Endobronchial
Delivered to target
tissue through a
working channel | Same |
| Specimen Sampling
Mechanism | Repeated axial motion
with applied suction
through a working
channel | Same |
| Cell Collection | Aspiration with a
syringe | Same |
| Working Outer
Diameter | 1.8 mm | 1.9 mm |
| Working Length | 106 cm - 115 cm | 130 cm |
| Shaft Marks | Present | No |
| Tip | Blunted | Sharpened |
| Retractable Distal
End | No | Yes |
| Radiopaque Distal
End | Yes | Same |
| Material | | |
| Working Outer
Material | Polymer - Copolyester
Elastomer
Braid - 304 Stainless
Steel | PTFE |
| Tip Material | Stainless Steel | Same |
6
The following technological differences exist between the subject and predicate devices:
- . The GenCut core biopsy tool contains a blunt distal tip with a side-cutting mechanism to facilitate tissue sampling while the primary predicate device features sharp distal tip with an end-cutting mechanism.
- The GenCut core biopsy tool has a polymeric shaft with steel braid reinforcement. ● The primary predicate device features a PTFE sheath.
In conclusion, the GenCut™ Core Biopsy System is technologically equivalent to the predicate device.
7. Performance Data
Non-clinical performance testing has been performed on GenCut system and demonstrates compliance with the following International and FDA-recognized consensus standards and FDA guidance document:
- ISO 10993-1:2009(Corr: 2010) Biological evaluation of medical devices Part 1: . Evaluation and testing
- . ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
- ISO 10993-7:2008(Corr:2009) Biological evaluation of medical devices -- Part 7: ● Ethylene oxide sterilization residuals
- ISO 10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and delayed-type hypersensitivity
- FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO 10993 ● "Biological Evaluation fo Medical Devices Part 1: Evaluation and Testing" May 1, 1995
The following performance data was provided in support of the substantial equivalence determination.
Biocompatibility Data:
Biocompatibility testing was successfully completed in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO 10993 "Biological Evaluation fo Medical Devices Part 1: Evaluation and Testing" May 1, 1995 and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process" as recognized by FDA. The following tests were conducted:
- Cytotoxicity ●
- Sensitization
- Intracutaneous Study .
Design Verification and Validation Testing Data:
- Tensile Testing ●
- Shelf Life Testing
- Simulated Use Testing ●
7
- . Packaging and Distribution Testing
- . Dimensional Testing
Animal Study Data:
A preclinical study was conducted in a porcine model undergoing an endobronchial lung biopsy procedure. Three physicians including two pulmonologists and one thoracic surgeon conducted the study. All acceptance criteria were met. Therefore, the design of the GenCut system meets the intended use.
8. Substantial Equivalence Discussion
Based on the indications for use, technological characteristics, performance testing, and comparison to the predicate devices, the proposed GenCut system has been shown to be substantially equivalent to the predicate devices identified in this submission, and does not present any new issues of safety or effectiveness.