(116 days)
The C2 CryoBalloon Ablation System is intended for use as a cryosurgical tool in the field of general surgery, specifically for endoscopic applications, to include ablation of Barrett's Esophagus with dysplasia.
The subject and marketed predicate device is a cryosurgical unit with a nitrous oxide cooled balloon that is compatible with commercially available endoscopes with a minimum working channel inner diameter of 3.7 mm and maximum length of 105 cm. The subject device is a cryosurgical system comprised of four components including a Catheter (sterile, single use), Controller (non-sterile, reusable), Foot Pedal (non-sterile, reusable), and Cartridge (non-sterile, single use).
The subject and marketed predicate device is used to ablate unwanted tissue by application of extreme cold. The balloon at the distal end of the Catheter comes in contact with tissue and is inflated with nitrous oxide. Tissue is visualized through the pre-inflated balloon, and the treatment site is selected is by adjusting the endoscope and Catheter The nitrous oxide spray cools the balloon to ablate the unwanted tissue, and the nitrous oxide exhausts through the Controller.
The PENTAX Medical C2 CryoBalloon Ablation System is intended for use as a cryosurgical tool in the field of general surgery, specifically for endoscopic applications, to include ablation of Barrett's Esophagus with dysplasia.
Here's an analysis of the provided information regarding acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document is a 510(k) summary for a medical device seeking substantial equivalence to a predicate device. It doesn't present a specific table of quantitative acceptance criteria for clinical performance that would typically be found in a clinical trial report. Instead, the "acceptance criteria" are implied to be the successful completion of various design verification and validation tests, ensuring the device performs as intended and is as safe and effective as its predicate.
| Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Design Verification & Validation | All physical, reliability, and safety specifications met. | "The acceptance criteria have been satisfied for all tests." |
| Sterilization | Sterilization validated in accordance with ISO 11135. | "both sterilized utilizing an Ethylene Oxide sterilization cycle validated in accordance with ISO 11135." |
| Biocompatibility | Evaluation conducted per ISO 10993-1 with passing results for patient-contacting materials. | "evaluation... conducted in accordance with 'Guidance...ISO 10993-1'... with passing results." (Note: No new testing was required due to no changes in patient-contacting materials from predicate). |
| EMC and Electrical Safety | Compliance with relevant Electromagnetic Compatibility (EMC) and electrical safety standards (IEC 60601-1-2:2014 and ES60601-1:2005/(R)2012 And A1:2012). | "acceptable level of electromagnetic compatibility (EMC) and electrical safety (ES)... confirmed by the testing to the following standards." |
| Technological Characteristics | Similar technological characteristics to the legally marketed predicate device (K163684). | "Cryoablation is the fundamental technological principle for both... same endoscopic instrumentation... similar technological characteristics... based on the following same technological elements." (Details listed in the device description). |
| Safety and Effectiveness | As safe and effective as the legally marketed predicate for the same intended use. | "The performance data results demonstrate that the subject C2 CryoBalloon™ Ablation System is as safe and effective as the legally marketed predicate that is currently marketed for the same intended use." |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes preclinical (bench) performance testing, not a clinical study with a "test set" of patients. Therefore, information regarding human sample size and data provenance (country of origin, retrospective/prospective) is not applicable or provided in this 510(k) summary. The testing performed was related to design verification and validation of the device's physical, reliability, and safety specifications.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable, as this document refers to preclinical engineering and safety testing, not a clinical study requiring expert ground truth for patient data.
4. Adjudication Method for the Test Set:
Not applicable for the reasons stated above.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence to a predicate device through preclinical performance testing, not a comparative clinical trial with human readers.
6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance):
This device is not an AI algorithm. It is a cryosurgical tool. Therefore, the concept of "standalone performance" for an algorithm is not applicable. The performance discussed relates to the device's physical and functional operation.
7. Type of Ground Truth Used:
For the performance data discussed (sterilization, biocompatibility, EMC, electrical safety, and design verification/validation), the "ground truth" is established through:
- Standardized testing procedures: Adherence to recognized national and international standards (e.g., ISO 11135, ISO 10993-1, IEC 60601-1-2, ES60601-1).
- Engineering specifications and design requirements: The device's performance is measured against predefined engineering and design specifications.
- Comparison to the predicate device: The performance is also judged in the context of being similar to the legally marketed predicate device.
8. Sample Size for the Training Set:
Not applicable, as this is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as this is not an AI/machine learning device.
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May 31, 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: K190194
Trade/Device Name: C2 CryoBalloon Ablation System Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical Unit and Accessories Regulatory Class: Class II Product Code: GEH Dated: May 2, 2019 Received: May 3, 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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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 (QS) 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,
for
Jennifer R. Stevenson Acting Division 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
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Indications for Use
510(k) Number (if known) K190194
Device Name C2 CryoBalloon™ Ablation System
Indications for Use (Describe)
The C2 CryoBalloon Ablation System is intended for use as a cryosurgical tool in the field of general surgery, specifically for endoscopic applications, to include ablation of Barrett's Esophagus with dysplasia.
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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Image /page/3/Picture/0 description: The image contains the logo for PENTAX Medical. The word "PENTAX" is in red, bold, sans-serif font. Below "PENTAX" is a gray line. Below the line is the word "MEDICAL" in gray, bold, sans-serif font.
510(k) Summary (K190194)
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
| Contact Person: | Gurvinder Singh NandaSenior Director of Regulatory Affairs |
|---|---|
| Date Prepared: | May 30, 2019 |
II. DEVICE
Name of Device: C2 CryoBalloon™ Ablation System (subject and predicate device) Common Name: Cryosurgical Unit, Cryogenic Surgical Device Classification Name: Cryosurgical Unit, Cryogenic Surgical Device 21 CFR§878.4350(a)(2) Regulatory Class: Class II Product Code: GEH
III. PREDICATE DEVICE
Predicate: C2 CryoBalloon™ Ablation System, C2 Therapeutics Inc., (now PENTAX Medical) K163684
IV. DEVICE DESCRIPTION
The subject and marketed predicate device is a cryosurgical unit with a nitrous oxide cooled balloon that is compatible with commercially available endoscopes with a minimum working channel inner diameter of 3.7 mm and maximum length of 105 cm. The subject device is a cryosurgical system comprised of four components including a Catheter (sterile, single use), Controller (non-sterile, reusable), Foot Pedal (non-sterile, reusable), and Cartridge (non-sterile, single use).
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Image /page/4/Picture/0 description: The image contains the logo for Pentax Medical. The word "PENTAX" is in red, bold letters, and above the word "MEDICAL" which is in gray, bold letters. There is a gray line separating the two words.
The subject and marketed predicate device is used to ablate unwanted tissue by application of extreme cold. The balloon at the distal end of the Catheter comes in contact with tissue and is inflated with nitrous oxide. Tissue is visualized through the pre-inflated balloon, and the treatment site is selected is by adjusting the endoscope and Catheter The nitrous oxide spray cools the balloon to ablate the unwanted tissue, and the nitrous oxide exhausts through the Controller.
V. INDICATIONS FOR USE
The C2 CryoBalloon Ablation System is intended for use as a cryosurgical tool in the field of general surgery, specifically for endoscopic applications, to include ablation of Barrett's Esophagus with dysplasia.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Cryoablation is the fundamental technological principle for both the subject C2 CryoBalloon™ Ablation System and the predicate C2 CryoBalloon™ Ablation System. Both the subject device and predicate device are based on the same endoscopic instrumentation for removing unwanted tissue using extreme cold.
The subject C2 CryoBalloon™ Ablation System has similar technological characteristics to the legally marketed predicate K163684. The subject devices and predicate are based on the following same technological elements:
- Inserted through an endoscope to access the treatment site
- Application of cryogen to ablate (freeze) the unwanted tissue ●
- Use of a compliant balloon to position the treatment diffuser and to contain and exhaust the cryogen
- User-controlled (trigger/foot pedal) to release cryogen ●
- Software activated Controller ●
The software changes that are being implemented in the subject device include:
Over-pressure monitoring post test puff, Balloon pressure transducer check during system start up, and Detection of a severely kinked Catheter.
The subject C2 CrvoBalloon™ Ablation System has the same reuse characteristics as the legally marketed reference predicate K163684. The subject device and reference predicate are based on the same reuse elements of using a disinfectant wipe-down to clean and disinfect between uses.
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Image /page/5/Picture/0 description: The image contains the logo for Pentax Medical. The word "PENTAX" is in red, bold, sans-serif font, and it is positioned above a gray line. Below the gray line, the word "MEDICAL" is in gray, bold, sans-serif font.
PERFORMANCE DATA VII.
Performance data were provided in support of the substantial equivalence determination. Design verification and validation testing was performed on the subject PENTAX Medical C2 CryoBalloon™ Ablation System to evaluate physical, reliability, and safety specifications. The acceptance criteria have been satisfied for all tests.
Sterilization
The subject PENTAX Medical C2 CryoBalloon™ Ablation System and predicate devices are both sterilized utilizing an Ethylene Oxide sterilization cycle validated in accordance with ISO 11135 - Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization
Biocompatibility
The biocompatibility evaluation of the patient contacting materials of the PENTAX Medical C2 CryoBalloon™ Ablation System was conducted in accordance with "Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process'" with passing results. Biocompatibility testing was not required for this change as there were no changes in patient contacting materials.
EMC and Electrical Safety
The acceptable level of electromagnetic compatibility (EMC) and electrical safety (ES) for the PENTAX Medical C2 CryoBalloon™ Ablation System were confirmed by the testing to the following standards: IEC 60601-1-2:2014 4th Edition and ES60601-1:2005/(R)2012 And A1:2012.
CONCLUSION
The subject C2 CryoBalloon™ Ablation System has the same clinical attributes, technological characteristics, and expected performance as the legally marketed predicate, C2 CryoBalloon™ Ablation System (K163684). The performance data results demonstrate that the subject C2 CryoBalloon™ Ablation System is as safe and effective as the legally marketed predicate that is currently marketed for the same intended use.
§ 878.4350 Cryosurgical unit and accessories.
(a)
Identification —(1)Cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories. A cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold.(2)
Cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories. A cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures, including urological applications, by applying extreme cold.(3)
Cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories. A cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold. The device is intended to treat disease conditions such as tumors, skin cancers, acne scars, or hemangiomas (benign tumors consisting of newly formed blood vessels) and various benign or malignant gynecological conditions affecting vulvar, vaginal, or cervical tissue. The device is not intended for urological applications.(b)
Classification. Class II.