(264 days)
Not Found
No
The summary describes a mechanical device for tissue biopsy and polyp removal, with no mention of AI or ML capabilities, image processing, or data analysis.
No
The device is used to obtain tissue biopsies and remove polyps, which are diagnostic and procedural functions, not therapeutic treatments for a disease or condition.
No
Explanation: The device is described as a biopsy forceps used to obtain tissue, not to analyze or diagnose the tissue. The performance studies focus on mechanical and electrical safety, not diagnostic accuracy.
No
The device description clearly outlines physical components such as stainless steel forceps cups, a spool handle, a Pebax-coated stainless steel coilspring catheter, a stainless steel drive cable, and a brass electrosurgical pin. This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to obtain tissue biopsies and remove polyps endoscopically using electrosurgical current. This is a procedure performed on the patient, not a test performed on a sample taken from the patient to diagnose a condition.
- Device Description: The device is a tool for performing a surgical procedure (biopsy and polyp removal), not a reagent, instrument, or system intended for use in the examination of specimens derived from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information based on laboratory testing.
IVDs are devices used to perform tests on samples (like blood, urine, tissue) outside of the body to diagnose diseases or conditions. This device is used within the body to collect a sample and remove tissue.
N/A
Intended Use / Indications for Use
The Captura® Disposable Hot Biopsy Forceps is used endoscopically in conjunction with monopolar electrosurgical current to obtain gastrointestinal mucosal tissue biopsies and for removal of sessile polyps. This device is indicated for adult use only.
Product codes
KGE
Device Description
The Captura® Disposable Hot Biopsy Forceps is a sterile, single use device compatible with the accessory channel of endoscopes. The device consists of stainless steel forceps cups joined to a spool handle by a Pebax-coated stainless steel coilspring catheter and stainless steel drive cable. The handle's spool actuates the opening and closing of the forceps cups and its brass electrosurgical pin is intended for connection to an electrosurgical generator.
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
adult use only
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 consisting of sterilization, shelf life, biocompatibility, electrical safety, and non-clinical bench testing demonstrate that the Captura® Disposable Hot Biopsy Forceps meets the performance criteria required to fulfill the intended use of the device. The non-clinical bench testing conducted included:
- Endoscope and Active Cord Compatibility
- Biopsy Obtainment and Removal Testing
- Tensile Testing
- Flexibility Testing
- Post-Aging Functional Testing
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).
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March 21, 2018
Wilson-Cook Medical, Inc. Ashley Howard Specialist I - Regulatory Affairs 4900 Bethania Station Road Winston-Salem, North Carolina 27105
Re: K171973
Trade/Device Name: Captura® Disposable Hot Biopsy Forceps Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: Class II Product Code: KGE Dated: February 15, 2018 Received: February 16, 2018
Dear Ashley Howard:
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 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);
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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,
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)
K171973
Device Name Captura® Disposable Hot Biopsy Forceps
Indications for Use (Describe)
The Captura® Disposable Hot Biopsy Forceps is used endoscopically in conjunction with monopolar electrosurgical current to obtain gastrointestinal mucosal tissue biopsies and for removal of sessile polyps. This device is indicated for adult use only.
| 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) |
Over-The-Counter Use (21 CFR 801 Subpart C)
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Captura® Disposable Hot Biopsy Forceps
510(k) Premarket Notification June 30, 2017
Applicant Information
| Applicant: | Wilson-Cook Medical, Inc. / Cook Endoscopy
4900 Bethania Station Road
Winston-Salem, North Carolina 27105 |
|------------|-----------------------------------------------------------------------------------------------------------------|
| Contact: | Ashley Howard, Specialist I – Regulatory Affairs |
| Phone: | (336) 744-0157 ext. 6174 |
| Fax: | (336) 201-5994 |
Device Information
| Trade Name: | Captura® Disposable Hot Biopsy Forceps |
|---|---|
| Common Name: | Forceps, Biopsy, Electric |
| Classification Name: | Endoscopic Electrosurgical Unit and Accessories |
| Regulation Number: | 21 CFR 876.4300 |
| Product Code: | KGE |
| Device Class: | Class II |
| Review Panel: | Gastroenterology-Urology |
Predicate Device
| Name: | Disposable Hot Biopsy Forceps |
|---|---|
| 510(k) Number: | K923470 |
| Date: | Cleared April 21, 1993 |
Device Description
The Captura® Disposable Hot Biopsy Forceps is a sterile, single use device compatible with the accessory channel of endoscopes. The device consists of stainless steel forceps cups joined to a spool handle by a Pebax-coated stainless steel coilspring catheter and stainless steel drive cable. The handle's spool actuates the opening and closing of the forceps cups and its brass electrosurgical pin is intended for connection to an electrosurgical generator.
Intended Use
The Captura® Disposable Hot Biopsy Forceps is used endoscopically in conjunction with monopolar electrosurgical current to obtain gastrointestinal mucosal tissue biopsies and for the removal of sessile polyps. This device is indicated for adult use only.
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Image /page/4/Picture/0 description: The image shows the Cook Medical logo. The logo is set against a red background. The word "COOK" is written in white, block letters, with the trademark symbol to the right of the word. Below "COOK" is the word "MEDICAL" in smaller, white letters.
Comparison to Predicate Device
The Captura® Disposable Hot Biopsy Forceps has the same intended use, principles of operation, and fundamental technologies as the predicate device. Changes to the subject device include dimensions, materials, and added contraindications. These changes do not raise new questions of safety or effectiveness.
Performance Data
Performance testing consisting of sterilization, shelf life, biocompatibility, electrical safety, and non-clinical bench testing demonstrate that the Captura® Disposable Hot Biopsy Forceps meets the performance criteria required to fulfill the intended use of the device.
Summary of Non-Clinical Testing and Electrical Testing
Performance testing consisting of sterilization, shelf life, biocompatibility, electrical safety, and non-clinical bench testing demonstrate that the Captura® Disposable Hot Biopsy Forceps meets the performance criteria required to fulfill the intended use of the device. The following summarizes the non-clinical bench testing conducted:
- Endoscope and Active Cord Compatibility
- Biopsy Obtainment and Removal Testing ●
- Tensile Testing ●
- Flexibility Testing ●
- Post-Aging Functional Testing
Conclusion
We consider the risks associated with the modifications to the subject device to have been adequately addressed through our Design Control Processes, and do not affect safety or effectiveness of the device. The information and data contained in this notification supports a determination of substantial equivalence.