(109 days)
Not Found
No
The device description and performance studies focus on mechanical and electrical functionality, with no mention of AI or ML.
No
The device is used to obtain biopsies and remove polyps, which are diagnostic and procedural functions, not directly treating a disease or condition. While the removal of polyps can be considered a therapeutic intervention in some contexts, the primary descriptions highlight tissue acquisition and removal, which are often steps in diagnosis or prevention rather than direct therapy for an existing disease state.
No
The device is used to obtain tissue biopsies and remove polyps, which are therapeutic and not diagnostic functions. The "Hot Biopsy" aspect refers to cauterization during tissue removal. While the obtained tissue may be used for diagnosis, the device itself is a surgical tool, not a diagnostic one.
No
The device description clearly describes a physical medical device (forceps) with a handle, jaws, and a plug for connection to an electrosurgical unit. It is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The EndoChoice Hot Biopsy Forceps is a surgical instrument used within the body (in vivo) to obtain tissue samples and remove polyps. It is a tool for a medical procedure, not a test performed on a sample outside the body.
- Intended Use: The intended use clearly states it's for "endoscopic use in conjunction with monopolar electrosurgical current to obtain gastrointestinal mucosal tissue biopsies and for removal of sessile polyps." This describes a surgical intervention, not a diagnostic test on a sample.
- Device Description: The description details a physical instrument with jaws and a connection for an electrosurgical unit, designed for use within the gastrointestinal tract.
The tissue obtained by this device could be used for subsequent in vitro diagnostic testing (e.g., pathology analysis), but the device itself is the tool for obtaining the sample, not the diagnostic test itself.
N/A
Intended Use / Indications for Use
EndoChoice Hot Biopsy Forceps are intended for use by trained medical professionals. The device is to be used endoscopically in conjunction with monopolar electrosurgical current to obtain gastrointestinal mucosal tissue biopsies and for removal of sessile polyps.
Product codes
KGE
Device Description
EndoChoice Hot Biopsy Forceps is a sterile single use device designed for use in the gastrointestinal tract. A plug is located on the handle for connection to an electrosurgical unit, giving the capability to apply high frequency monopolar electrocautery during resection.
The device is compatible with endoscopic access channels of at least 2.8 mm and is provided with a working length of 230.0 cm.
Using the EndoChoice Hot Biopsy Forceps, the user can cauterize and remove tissue from the mucosal wall by using the handle to open the jaws, pressing the jaws against the site, closing, applying electrical current via a compatible electrosurgical unit (not included), and gently pulling the away from the site.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal mucosal tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical professionals
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 of the functional performance, biocompatibility testing, a sterility assurance validation, shelf life testing, electrical safety testing for high frequency surgical accessories. Results demonstrate that the device is safe and effective in meeting user requirements in accordance with its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).
0
EndoChoice Hot Biopsy Forceps
EndoChoice, Inc.
510(k) Summary EndoChoice Hot Biopsy Forceps
1. Company Identification
EndoChoice, Inc. 11800 Wills Road, Suite 100 Alpharetta, GA 30009 Telephone Fax (678) 567 8218 Establishment Registration: 300759133
OCT 15 2013
2. Contact Person
Daniel Hoefer Regulatory Affairs Manager
3. Device Name
Commercial name: EndoChoice Hot Biopsy Forceps Classification name: Forceps, Biopsy, Electric
4. Device Classification
Product Code: KGE Regulation Number: 876.4300 Class: II
5. Intended Use
EndoChoice Hot Biopsy Forceps are intended for use by trained medical professionals. The device is to be used endoscopically in conjunction with monopolar electrosurgical current to obtain gastrointestinal mucosal tissue biopsies and for removal of sessile polyps.
6. Device Description
EndoChoice Hot Biopsy Forceps is a sterile single use device designed for use in the gastrointestinal tract. A plug is located on the handle for connection to an electrosurgical unit, giving the capability to apply high frequency monopolar electrocautery during resection.
The device is compatible with endoscopic access channels of at least 2.8 mm and is provided with a working length of 230.0 cm.
Using the EndoChoice Hot Biopsy Forceps, the user can cauterize and remove tissue from the mucosal wall by using the handle to open the jaws, pressing the jaws against the site, closing, applying electrical current via a compatible electrosurgical unit (not included), and gently pulling the away from the site.
page I of 2
1
EndoChoice, Inc.
7. Substantial Equivalence
The EndoChoice Hot Biopsy Forceps is substantially equivalent to the Radial Jaw 4TM Hot Biopsy Forceps (K101657) manufactured by Boston Scientific Corporation.
The devices are equivalent in terms of intended use, operating principle, technology, energy used, packaging, and materials.
8. Non-Clinical testing
Testing includes:
- Bench testing of the functional performance, .
- biocompatibility testing, .
- a sterility assurance validation,
- . shelf life testing,
- . electrical safety testing for high frequency surgical accessories.
Results demonstrate that the device is safe and effective in meeting user requirements in accordance with its intended use.
9. Conclusion
The EndoChoice Hot Biopsy Forceps is substantially equivalent to the predicate device listed above.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 15, 2013
EndoChoice, Inc. % Daniel Hoefer Regulatory Affairs Manager 11810 Wills Road Alpharetta, GA 30009
Re: K131991
Trade/Device Name: EndoChoice Hot Biopsy Forceps Regulation Number: 21 CFR§ 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: KGE Dated: August 19, 2013 Received: August 20, 2013
Dear Daniel Hoefer,
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 (reporting of
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Page 2 - Daniel Hoefer
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/ucm 1 15809.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.
Benjamin R. Fisher -S
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
4
Indications for Use
510(k) Number (if known): K131991
Device Name: EndoChoice Hot Biopsy Forceps
Indications for Use:
EndoChoice Hot Biopsy forceps are indicated for endoscopic use in in conjunction with monopolar electrosurgical current to obtain gastrointestinal mucosal tissue biopsies and for removal of sessile polyps.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Benjamin R. Fisher -S 2013.10.15 10:41:30 -04'00' Page 1 of 1