(41 days)
Not Found
No
The description focuses on the mechanical and cryosurgical aspects of the device, with no mention of AI or ML in the intended use, device description, or performance studies.
Yes.
The device is intended for "destruction of unwanted tissue" and "to ablate unwanted tissue", which are therapeutic actions.
No
Explanation: The device is described as a "cryosurgical tool for the destruction of unwanted tissue" and "used to ablate unwanted tissue by application of extreme cold." Its function is therapeutic (ablation), not diagnostic (identifying or characterizing disease).
No
The device description clearly outlines hardware components including a catheter, controller, and cartridge, and the performance studies involve testing physical characteristics of these components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications." This describes a surgical procedure performed directly on the patient's tissue, not a test performed on a sample taken from the patient.
- Device Description: The device description details a system for ablating tissue using cold. It involves a catheter, controller, and cartridge used to apply cold to tissue in situ. This is a therapeutic/surgical device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to physically destroy tissue, which is a therapeutic action.
N/A
Intended Use / Indications for Use
The C2 CryoBalloon™ Focal Ablation System is intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications.
Product codes
GEH
Device Description
The subject device is the Catheter used as part of a cryosurgical unit with a nitrous oxide cooled balloon that is compatible with commercially available endoscopes with a minimum working channel inner diameter (ID) of 3.7 mm and maximum length of 100 cm. The subject Catheter is part of a cryosurgical system comprised of three components including a Catheter (sterile, single use), Controller (non-sterile, reusable), and Cartridge (non-sterile, single use).
The subject device is used to ablate unwanted tissue by application of extreme cold. The balloon at the distal end of the Catheter is 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 Controller. The nitrous oxide spray cools the balloon to ablate the unwanted tissue, and the nitrous oxide exhausts through the Controller.
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
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)
Design verification testing, based on results of risk analysis, was performed on the C2 CryoBalloon™ Focal Ablation System to evaluate the physical, reliability, and safety specifications. The testing performed includes dimensional verification, balloon integrity, balloon fatigue, and bond and connector tensile strength and integrity.
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
§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, with flowing lines extending from the heads.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 19, 2016
C2 Therapeutics, Inc. Ms. Theresa Brandner-Allen VP of Regulatory Affairs and Quality Assurance 303 Convention Way, Suite 1 Redwood City, California 94063
Re: K160994
Trade/Device Name: C2 Cryoballoon Focal Pear Catheter Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical Unit and Accessories Regulatory Class: Class II Product Code: GEH Dated: May 10, 2016 Received: May 11, 2016
Dear Ms. Brandner-Allen:
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 devicerelated 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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
Sincerely yours,
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Jennifer R. Stevenson -A For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K160994
Device Name
C2 CryoBalloon™ Focal Ablation System
Indications for Use (Describe)
The C2 CryoBalloon™ Focal Ablation System is intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications.
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) |
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5. 510(k) Summary
K160994
Special 510(k)
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.
I. SUBMITTER
C2 Therapeutics, Inc. 303 Convention Way, Suite 1 Redwood City, CA 94063
Phone: 650-521-5921 Fax: 650-556-1145
| Contact Person: | Theresa Brandner-Allen
VP of Regulatory Affairs and Quality Assurance |
|-----------------|--------------------------------------------------------------------------|
| Date Prepared: | May 9, 2016 |
II. DEVICE
Name of Device: C2 CryoBalloon™ Focal Pear Catheter 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
CryoBalloon Focal Ablation System, K131523
This predicate device has not been subject to a design-related recall.
IV. DEVICE DESCRIPTION
The subject device is the Catheter used as part of a cryosurgical unit with a nitrous oxide cooled balloon that is compatible with commercially available endoscopes with a minimum working channel inner diameter (ID) of 3.7 mm and maximum length of 100 cm. The subject Catheter is part of a cryosurgical system comprised of three components including a Catheter (sterile, single use), Controller (non-sterile, reusable), and Cartridge (non-sterile, single use).
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The subject device is used to ablate unwanted tissue by application of extreme cold. The balloon at the distal end of the Catheter is 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 Controller. 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™ Focal Ablation System is intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery. specifically for endoscopic applications.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Cryoablation is the fundamental technological principle for both the subject C2 CryoBalloon™ Focal Ablation System and the predicate CryoBalloon Focal 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™ Focal Ablation System has similar technological characteristics to the legally marketed predicate. The subject device and predicate device are based on the following same technological elements:
- Inserted through an endoscope to access the treatment site
- Apply a 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) activates release of the cryogen
- Battery-operated Controller and software
The only modifications that were made include:
- The Catheter was modified to a different shaped balloon.
- The distal Catheter tip was modified to reduce the length. ●
- . The proximal Catheter connector cryogen inflow tubing was modified to change the tubing material.
- . The product name was changed slightly.
PERFORMANCE DATA VII.
Performance data were provided in support of the substantial equivalence determination. Design verification testing, based on results of risk analysis, was performed on the C2 CryoBalloon™ Focal Ablation System to evaluate the physical, reliability, and safety specifications. The testing performed includes dimensional verification, balloon integrity, balloon fatigue, and bond and connector tensile strength and integrity.
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CONCLUSION VIII.
The subject C2 CryoBalloon™ Focal Ablation System has the same clinical attributes, technological characteristics, and expected performance as the legally marketed predicate, CryoBalloon Focal Ablation System (K131523). The performance data results demonstrate that the subject C2 CryoBalloon™ Focal Ablation System should perform as intended in the specified use conditions and should perform comparably to the legally marketed predicate that is currently marketed for the same intended use.