(28 days)
Not Found
No
The description focuses on the mechanical and thermal aspects of cryoablation and does not mention any AI/ML components or functionalities.
Yes.
The device is clearly described as intended for "destruction of unwanted tissue" and "to ablate unwanted tissue by application of extreme cold," which are therapeutic actions.
No
The device is described as a cryosurgical tool used for the destruction/ablation of unwanted tissue, which is a therapeutic function, not diagnostic.
No
The device description clearly outlines physical components like a Catheter, Handle, and Cartridge, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is described as a "cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications." This describes a therapeutic procedure performed directly on the patient's body.
- Device Description: The device description details a system used to ablate tissue using cold. This is a physical intervention, not a test performed on a sample taken from the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Measuring biomarkers or other biological indicators
IVDs are devices 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 ablation) directly on the patient.
N/A
Intended Use / Indications for Use
The Coldplay CryoBalloon® Ablation System is intended for use 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 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 modified Catheter is part of a system comprised of three components including a Catheter (sterile, single use), Handle (non-sterile, reusable), and Cartridge (non-sterile, single use).
The modified 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 Handle. The nitrous oxide spray cools the balloon to ablate the unwanted tissue, and the nitrous oxide exhausts through 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. Design verification testing was performed on the Coldplay CryoBalloon® Ablation System to evaluate physical, reliability, and safety specifications. The performance data results demonstrate that the modified 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.
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 a stylized caduceus symbol, which features three human profiles facing right, overlaid on top of each other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
January 7, 2016
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
C2 Therapeutics, Inc. Theresa Brandner-Allen VP Of Regulatory Affairs And Quality Assurance 303 Convention Way, Suite 1 Redwood City, California 94063
Re: K153541
Trade/Device Name: Coldplay CryoBalloon® Ablation System Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical Unit And Accessories Regulatory Class: Class II Product Code: GEH Dated: December 9, 2015 Received: December 10, 2015
Dear Theresa 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
1
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/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
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerelv vours.
Joshua
Binita S. Ashar, M.D., M.B.A., F.A.C.S. For 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) K153541
Device Name
Coldplay CryoBalloon® Ablation System
Indications for Use (Describe)
The Coldplay CryoBalloon® Ablation System is intended for use 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
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: | December 09, 2015 |
II. DEVICE
Name of Device: Coldplay 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
Coldplay CrvoBalloon® Full Ablation System, K151054
This predicate has not been subject to a design-related recall.
IV. DEVICE DESCRIPTION
The modified 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 modified Catheter is part of a system comprised of three components including a Catheter (sterile, single use), Handle (non-sterile, reusable), and Cartridge (non-sterile, single use).
The modified 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
4
inflated with nitrous oxide. Tissue is visualized through the pre-inflated balloon, and the treatment site is selected is by adjusting the endoscope and Handle. The nitrous oxide spray cools the balloon to ablate the unwanted tissue, and the nitrous oxide exhausts through the Handle. A detailed comparison of the modified device to the predicate device 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 Coldplay CryoBalloon® Full 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 Catheter was modified to have a smaller (8mm diameter) distal balloon. .
VII. PERFORMANCE DATA
Performance data were provided in support of the substantial equivalence determination. Design verification testing was performed on the Coldplay CryoBalloon® Ablation System to evaluate physical, reliability, and safety specifications.
VII. CONCLUSION
The modified Coldplay CryoBalloon® Ablation System has the same clinical attributes, technological characteristics, and expected performance as the legally marketed Coldplay CryoBalloon® Full Ablation System (K151054) predicate. The
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performance data results demonstrate that the modified 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.