Captura® Disposable Hot Biopsy Forceps
Device Facts
| Record ID | K171973 |
|---|---|
| Device Name | Captura® Disposable Hot Biopsy Forceps |
| Applicant | Wilson-Cook Medical, Inc. |
| Product Code | KGE · Gastroenterology, Urology |
| Decision Date | Mar 21, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.4300 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
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 the removal of sessile polyps. This device is indicated for adult use only.
Device Story
Sterile, single-use endoscopic device; used by physicians in clinical settings. Consists of stainless steel forceps cups, Pebax-coated stainless steel coilspring catheter, and stainless steel drive cable. Operated via spool handle to open/close cups; brass electrosurgical pin connects to external electrosurgical generator. Device delivers monopolar electrosurgical current to tissue during biopsy or polyp removal. Enables tissue sampling and polyp excision; benefits patient by facilitating diagnostic and therapeutic endoscopic procedures.
Clinical Evidence
No clinical data. Performance supported by non-clinical bench testing including endoscope/active cord compatibility, biopsy obtainment/removal, tensile testing, flexibility testing, and post-aging functional testing. Biocompatibility, sterilization, shelf life, and electrical safety testing also performed.
Technological Characteristics
Materials: stainless steel (cups, drive cable, coilspring), Pebax (catheter coating), brass (electrosurgical pin). Energy: monopolar electrosurgical current. Form factor: endoscopic accessory catheter. Connectivity: connects to external electrosurgical generator. Sterilization: sterile, single-use.
Indications for Use
Indicated for adult patients requiring endoscopic gastrointestinal mucosal tissue biopsies or removal of sessile polyps using monopolar electrosurgical current.
Regulatory Classification
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.
Predicate Devices
- Disposable Hot Biopsy Forceps (K923470)
Submission Summary (Full Text)
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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) | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
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Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for Cook Medical. The logo is set against a red background. The word "COOK" is written in white, block letters in the upper portion of the logo. Below the word "COOK" is the word "MEDICAL" in white letters, set against a red banner.
# Captura® Disposable Hot Biopsy Forceps
510(k) Premarket Notification June 30, 2017
# Applicant Information
| Applicant: | Wilson-Cook Medical, Inc. / Cook Endoscopy<br>4900 Bethania Station Road<br>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.
