(109 days)
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.
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.
The provided text is a 510(k) summary for the EndoChoice Hot Biopsy Forceps. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving device performance through clinical trials with specific acceptance criteria as might be seen for novel or high-risk devices.
Therefore, the information requested in your prompt for "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of typical AI/software device evaluation (e.g., performance metrics, ground truth, expert review) is largely not applicable to this document. The provided text describes a physical medical device (forceps) and its regulatory clearance process, not a software or AI-based diagnostic device.
However, I can extract the relevant information from the document in the spirit of your request, interpreting "acceptance criteria" as the regulatory requirements met for 510(k) clearance, and "study" as the non-clinical testing performed.
Here's a breakdown based on the provided 510(k) summary:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Met for 510(k) equivalence) | Reported Device Performance (Summary of Non-Clinical Testing) |
|---|---|
| Functional Performance: Device operates as intended (e.g., jaw opening/closing, grasping, electrosurgical current application). | Bench testing of functional performance was conducted. Results demonstrate the device is "safe and effective in meeting user requirements in accordance with its intended use." |
| Biocompatibility: Materials are safe for contact with human tissue. | Biocompatibility testing was conducted. Results demonstrate the device is "safe and effective in meeting user requirements in accordance with its intended use." |
| Sterility Assurance: Device can be sterilized and maintained as sterile. | A sterility assurance validation was conducted. Results demonstrate the device is "safe and effective in meeting user requirements in accordance with its intended use." |
| Shelf Life: Device maintains its properties over its intended storage period. | Shelf life testing was conducted. Results demonstrate the device is "safe and effective in meeting user requirements in accordance with its intended use." |
| Electrical Safety: Device meets safety standards for electrosurgical accessories. | Electrical safety testing for high frequency surgical accessories was conducted. Results demonstrate the device is "safe and effective in meeting user requirements in accordance with its intended use." |
| Substantial Equivalence: The device is as safe and effective as a legally marketed predicate device. | The EndoChoice Hot Biopsy Forceps was determined to be "substantially equivalent to the Radial Jaw 4™ Hot Biopsy Forceps (K101657) manufactured by Boston Scientific Corporation" by both the manufacturer and the FDA. The basis for equivalence was stated as "intended use, operating principle, technology, energy used, packaging, and materials." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. For physical device testing like this, "sample size" would refer to the number of devices tested in bench studies. The summary only states that "Testing includes..." and "Results demonstrate..." without specifying quantities or detailed methodologies. Data provenance is also not mentioned, as these are primarily engineering and materials tests, not human data studies.
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)
This information is not applicable and not provided. The "ground truth" for a physical device like biopsy forceps in a 510(k) submission is established by engineering standards, material science, and functional requirements, not by expert medical review of output.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable and not provided. Adjudication methods are typically used in clinical studies or expert reviews of data or images to establish ground truth, which is not what this 510(k) summary describes.
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
This information is not applicable. MRMC studies are specifically for evaluating diagnostic performance, often for AI or software-assisted interpretation, where human readers interpret cases. This document is about a physical medical instrument and does not involve "human readers" or "AI assistance."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This device is a physical instrument, not an algorithm, and intrinsically involves a "human-in-the-loop" (the trained medical professional using the forceps).
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance, as implied by the non-clinical testing, is based on:
- Engineering specifications and validated functional performance standards.
- Biocompatibility standards.
- Sterilization standards.
- Electrical safety standards.
8. The sample size for the training set
This information is not applicable and not provided. "Training set" refers to data used to train an algorithm or AI model, which is not relevant to this physical device.
9. How the ground truth for the training set was established
This information is not applicable and not provided, for the same reason as #8.
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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
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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.
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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
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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
§ 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).