(78 days)
Not Found
No
The description focuses on the mechanical and thermal aspects of the cryosurgical system, with no mention of AI or ML for image analysis, treatment planning, or any other function.
Yes
The device is intended to be used as a cryosurgical tool for the destruction of unwanted tissue, which is a therapeutic function.
No
The device is described as a cryosurgical tool for the destruction of unwanted tissue, indicating its purpose is therapeutic (ablation), not diagnostic.
No
The device description clearly outlines hardware components (Catheter, Handle, Cartridge) and their physical interaction with tissue and gas, indicating it is a hardware-based medical device with associated software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications." This describes a surgical procedure performed on the patient's body, not a test performed on a sample taken from the patient's body.
- Device Description: The description details a system that applies extreme cold directly to tissue within the body using a balloon probe. This is a therapeutic intervention, not a diagnostic test.
- Lack of IVD Characteristics: The description does not mention analyzing biological samples (blood, urine, tissue samples, etc.) or providing information about a patient's health status based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device performs a therapeutic action (tissue destruction) directly on the patient.
N/A
Intended Use / Indications for Use
The Coldplay CryoBalloon 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 (comma separated list FDA assigned to the subject device)
GEH
Device Description
The modified device is a cryosurgical unit with a nitrous oxide cooled balloon probe that is intended for use with commercially available endoscopes with a minimum working channel inner diameter (ID) of 3.7 mm. It is comprised of three components including a Catheter (sterile), Handle (non-sterile), and Cartridge (non-sterile).
The modified device is used to destroy unwanted tissue by application of extreme cold to either a 360° circumference or a 90° circumference. The balloon probe at the end of the catheter is inflated with nitrous oxide gas and comes in contact with tissue. Tissue is visualized through the pre-inflated balloon, and the treatment site is selected is by manipulation of the endoscope and Handle. The liquid nitrous oxide spray ablates the unwanted tissue. Nitrous oxide is fully contained within the balloon probe and does not directly contact the tissue. The nitrous oxide gas exits the patient through the Catheter lumen and exhausts out the Handle.
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)
Performance data were provided in support of the substantial equivalence determination including. Design verification and validation testing were performed on the Coldplay CryoBalloon Ablation System to evaluate physical, simulated use, reliability, safety, biocompatibility, sterilization, and shelf life specifications. Software verification and validation were performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name encircling a stylized emblem. The emblem features three human profiles facing right, layered to create a sense of depth and unity. The profiles are rendered in a simple, elegant style.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 7, 2015
C2 Therapeutics Incorporated Ms. Theresa Brandner-Allen Vice President of Regulatory Affairs and Quality Assurance 303 Convention Way, Suite 1 Redwood City, California 94063
Re: K151054
Trade/Device Name: Coldplay Full CryoBalloon Ablation System, Coldplay Swipe CryoBalloon Ablation System Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: Class II Product Code: GEH Dated: June 10, 2015 Received: June 11, 2015
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 (reporting of medical
1
device-related 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.
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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Jennifer R. Stevenson -S
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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| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|---|
| Food and Drug Administration |
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name
Coldplay Full CryoBalloon Ablation System, Coldplay Swipe CryoBalloon Ablation System
Indications for Use (Describe)
The Coldplay CryoBalloon 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
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FORM FDA 3881 (8/14)
3
510(k) Summary
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.
I. SUBMITTER
| Submitter Name: C2 Therapeutics, Inc. | |
|---|---|
| Address: | 303 Convention Way, Suite 1 |
| Redwood City, CA 94063 | |
| Phone Number: | 650-521-5921 |
| Fax Number: | 650-556-1145 |
| Contact Person: | Theresa Brandner-Allen |
| VP of Regulatory Affairs and Quality Assurance | |
| Date Prepared: | July 06, 2015 |
II. DEVICE
Name of Device: Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon Ablation System
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
K131523, Cryoballoon Focal Ablation System
This predicate has not been subject to a design-related recall.
IV. DEVICE DESCRIPTION
The modified device is a cryosurgical unit with a nitrous oxide cooled balloon probe that is intended for use with commercially available endoscopes with a minimum working
4
channel inner diameter (ID) of 3.7 mm. It is comprised of three components including a Catheter (sterile), Handle (non-sterile), and Cartridge (non-sterile).
The modified device is used to destroy unwanted tissue by application of extreme cold to either a 360° circumference or a 90° circumference. The balloon probe at the end of the catheter is inflated with nitrous oxide gas and comes in contact with tissue. Tissue is visualized through the pre-inflated balloon, and the treatment site is selected is by manipulation of the endoscope and Handle. The liquid nitrous oxide spray ablates the unwanted tissue. Nitrous oxide is fully contained within the balloon probe and does not directly contact the tissue. The nitrous oxide gas exits the patient through the Catheter lumen and exhausts out the Handle.
A detailed comparison of the modified and predicate devices is presented in detail in Section 11 and Section 12.
V. INDICATIONS FOR USE
The Coldplay CryoBalloon 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 modified Coldplay CryoBalloon Ablation System and the predicate CryoBalloon Focal Ablation System. Both the modified device and predicate device are based on the same endoscopic instrumentation for removing unwanted tissue using extreme cold.
The modified Coldplay CryoBalloon Ablation System has similar technological characteristics to the legally marketed predicate. The modified 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 Handle controller and software
The only modifications that were made include:
- . The cryogen diffuser was changed from a focal spray a circumferential spray that traverses during treatment
- . The Handle software and catheter interface were modified to accommodate the circumferential spray
- The cryogen cylinder was changed to a larger cylinder to accommodate the ●
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circumferential spray
PERFORMANCE DATA VII.
Performance data were provided in support of the substantial equivalence determination including. Design verification and validation testing were performed on the Coldplay CryoBalloon Ablation System to evaluate physical, simulated use, reliability, safety, biocompatibility, sterilization, and shelf life specifications. Software verification and validation were performed.
VIII. CONCLUSION
The modified Coldplay CryoBalloon 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 Coldplay CryoBalloon 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.