(22 days)
Not Found
No
The device description and performance studies focus on mechanical function and usability, with no mention of AI/ML terms or data processing that would indicate AI/ML technology.
No.
The device is an accessory that facilitates the use of other therapeutic devices by providing access and anchoring, rather than directly performing a therapeutic action itself.
No
The C2 CryoBalloon™ EndoGrip is an accessory product that aids in anchoring therapeutic catheters during endoscopic procedures. Its stated intended use is to "provide access for endoscopic device passage and exchange" and it is described as being used to "anchor catheters in place relative to the scope." There is no mention of it being used to diagnose a medical condition or ailment.
No
The device description explicitly states it consists of physical components (Clip Base, Rubber Grip, and Compression Spring) and is supplied non-sterile, indicating it is a hardware device.
Based on the provided information, the C2 CryoBalloon™ EndoGrip is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide access for endoscopic device passage and exchange throughout the endoscopic procedure" and to "anchor catheters in place relative to the scope." This describes a device used during a medical procedure on a patient, not a device used to test samples outside of the body to diagnose a condition.
- Device Description: The description details a mechanical accessory used with endoscopes and catheters within the body. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing diagnostic information about a patient's health status
The C2 CryoBalloon™ EndoGrip is a medical device used to facilitate an endoscopic procedure, specifically for managing the position of a catheter within the body. This falls under the category of a surgical or procedural accessory, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The C2 CryoBalloon™ EndoGrip is intended to provide access for endoscopic device passage and exchange throughout the endoscopic procedure.
Product codes
OCX
Device Description
The C2 CryoBalloon™ EndoGrip is an accessory product that is used in conjunction with therapeutic endoscopes and therapeutic catheters (the C2 CryoBalloon™ Catheter of the C2 CryoBalloon™ Ablation System). The C2 CryoBalloon™ EndoGrip consists of a Clip Base, Rubber Grip, and Compression Spring. This is supplied non-sterile. The EndoGrip is used to anchor catheters in place relative to the scope. In a clinical application, once the endoscope is delivered into the gastric anatomy and positioned at its desired location the physician may insert the catheter through the endoscope. When the catheter is located properly in its axial position, the EndoGrip is positioned against the biopsy valve by depressing the clip mechanism and sitting the catheter on the rubber grips. The revised design allows for placing the EndoGrip after the CryoBalloon catheter is in place in the scope and for repositioning without having to completely withdraw and reinsert the catheter. The C2 CryoBalloon™ EndoGrip is designed for one-time, continuous application use (single patient) in conjunction with a therapeutic endoscope (3.7mm accessory channel ID) or a C2 Sidecar (FG -1011), which serves as an external channel for therapeutic devices when a therapeutic endoscope is unavailable for use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Used in hospitals, sub-acute care institutions, surgery centers, or doctor's office where endoscopic procedures may be performed.
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
The performance testing for the C2 CryoBalloon™ EndoGrip included:
-
- Physical characteristic evaluations for dimensional verification
-
- Simulated use, performance, and reliability testing were performed to verify the device can be attached to and detached from endoscope, withstand 10 endoscopic delivery cycles, compatible with endoscopic devices, resist dislodgement forces, and resist kinking.
-
- Usability testing for validation of user needs
All the tests passed and met the predetermined acceptance criteria.
- Usability testing for validation of user needs
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
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November 22, 2019
PENTAX Medical, A Division of PENTAX of America, Inc. Gurvinder Nanda Senior Director of Regulatory Affairs 303 Convention Way, Suite 1 Redwood City, California 94063
Re: K193036
Trade/Device Name: C2 CryoBalloon EndoGrip Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: OCX Dated: October 30, 2019 Received: October 31, 2019
Dear Gurvinder Nanda:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K193036
Device Name C2 CryoBalloon™ EndoGrip
Indications for Use (Describe)
The C2 CryoBalloon™ EndoGrip is intended to provide access for endoscopic device passage and exchange throughout the endoscopic procedure.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
PENTAX Medical C2 CryoBalloon™ EndoGrip (K193036)
Image /page/3/Picture/1 description: The image shows the logo for Pentax Medical. The word "PENTAX" is in red, bold letters, and it is positioned above the word "MEDICAL", which is in gray, bold letters. There is a gray line separating the two words.
510(k) Summary
This 510(k) Summary is being submitted in accordance with the requirements of 21 CFR 807.92.
I. SUBMITTER
PENTAX Medical 303 Convention Way, Suite 1 Redwood City, CA 94063
Phone: 650-316-8601 Fax: 650-316-8601
Gurvinder Singh Nanda, Ph.D. Contact Person: Senior Director of Regulatory Affairs
Date Prepared: October 30, 2019
II. DEVICE
Name of Device: C2 CryoBalloon™ EndoGrip Common Name: EndoGrip Classification Name: Endoscopic and Accessories Classification Code: 21 CFR §876.1500 Regulatory Class: Class II Product Code: OCX
III. PREDICATE DEVICE
BOA Endoscopic Valve (K152140)
This predicate device has not been subject to a design-related recall.
IV. DEVICE DESCRIPTION
The C2 CryoBalloon™ EndoGrip is an accessory product that is used in conjunction with therapeutic endoscopes and therapeutic catheters (the C2 CryoBalloon™ Catheter of the C2 CryoBalloon™ Ablation System). The C2 CryoBalloon™ EndoGrip consists of a Clip Base, Rubber Grip, and Compression Spring. This is supplied non-sterile. The EndoGrip is used to anchor catheters in place relative to the scope. In a clinical application, once the endoscope is delivered into the gastric anatomy and positioned at its
4
Image /page/4/Picture/1 description: The image shows the logo for Pentax Medical. The word "PENTAX" is in red, bold, sans-serif font. Below it is a gray line, and below that is the word "MEDICAL" in gray, bold, sans-serif font.
desired location the physician may insert the catheter through the endoscope. When the catheter is located properly in its axial position, the EndoGrip is positioned against the biopsy valve by depressing the clip mechanism and sitting the catheter on the rubber grips. The revised design allows for placing the EndoGrip after the CryoBalloon catheter is in place in the scope and for repositioning without having to completely withdraw and reinsert the catheter. The C2 CryoBalloon™ EndoGrip is designed for one-time, continuous application use (single patient) in conjunction with a therapeutic endoscope (3.7mm accessory channel ID) or a C2 Sidecar (FG -1011), which serves as an external channel for therapeutic devices when a therapeutic endoscope is unavailable for use.
V. INDICATIONS FOR USE
The C2 CryoBalloon™ EndoGrip is intended to provide access for endoscopic device passage and exchange throughout the endoscopic procedure.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The subject C2 CrvoBalloon™ EndoGrip has similar technological characteristics to the legally marketed predicate C2 BOA Endoscopic Valve (K152140). The subject and predicate devices are based on the following same technological elements:
- Attached against the proximal biopsy channel port of an endoscopic device to ● provide endoscopic device passage and exchange
- . Used in hospitals, sub-acute care institutions, surgery centers, or doctor's office where endoscopic procedures may be performed
- . Used in single patient (disposable) undergoing endoscopic procedures
The following technological differences exist between the modified device and the predicate device:
The modified device is secured through the use of a spring-clip mechanism, and the predicate device is secured through the use of a twist-Tuohy tightening mechanism.
PERFORMANCE DATA VII.
The performance testing for the C2 CryoBalloon™ EndoGrip included:
-
- Physical characteristic evaluations for dimensional verification
-
- Simulated use, performance, and reliability testing were performed to verify the device can be attached to and detached from endoscope, withstand 10
5
PENTAX Medical C2 CryoBalloon™ EndoGrip (K193036)
Image /page/5/Picture/1 description: The image contains the logo for Pentax Medical. The word "PENTAX" is in red, bold, sans-serif font. A gray line is underneath the word "PENTAX". Below the gray line, the word "MEDICAL" is in gray, bold, sans-serif font.
endoscopic delivery cycles, compatible with endoscopic devices, resist dislodgement forces, and resist kinking.
-
- Usability testing for validation of user needs
All the tests passed and met the predetermined acceptance criteria.
- Usability testing for validation of user needs
VIII. CONCLUSION
The subject C2 CryoBalloon™ EndoGrip has the same clinical attributes, technological characteristics and expected performance as the legally marketed predicate, C2 BOA Endoscopic valve (K152140). The performance data demonstrate that the subject C2 CryoBalloon™ EndoGrip performs as intended in the specified use conditions and performs comparably to the legally marketed predicate device that is currently marketed for the same intended use.