(90 days)
Not Found
No
The description focuses on the mechanical and thermal aspects of the device, with no mention of AI or ML for control, analysis, or decision-making.
Yes
The device is described as a "CryoBalloon Ablation System" intended to destroy "unwanted tissue" through cryosurgery, which is a therapeutic intervention.
No
The device is described as a cryosurgical tool for the destruction of unwanted tissue, which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines multiple hardware components including a catheter, handle with internal battery, and a cartridge containing nitrous oxide. It is a physical medical device that uses cryotherapy for tissue ablation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is 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 tissue.
- Device Description: The device description details a system that physically ablates tissue using extreme cold (cryosurgery). It involves a catheter, balloon probe, and a handle containing a refrigerant. This is a surgical tool used for treatment.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) or to provide diagnostic information about a patient's condition. IVDs are used to diagnose diseases or other conditions, including a state of health, in order to cure, mitigate, treat, or prevent disease.
The CryoBalloon Ablation System is a therapeutic device used for surgical intervention, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The C2 Therapeutics 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
GEH
Device Description
The CryoBalloon Ablation System ("System") is used to destroy unwanted tissue by application of extreme cold. Upon activation by a physician, the balloon probe at the end of the catheter is simultaneously inflated and cooled with nitrous oxide. The balloon probe comes in contact with the wall of the esophagus and ablates unwanted tissue. Nitrous oxide is fully contained within the balloon probe and does not contact the esophagus. The nitrous oxide gas exits the patient through the proximal end of the catheter. The CryoBalloon Ablation System is designed for one time, continuous application use (single patient) in conjunction with a therapeutic endoscope (3.7mm accessory channel ID). The System is comprised of the following main components:
- CryoBalloon Ablation Catheter (REF FG-1000) consists of a connector, catheter . shaft, balloon probe, and protective sheath. This is supplied sterile.
- CryoBalloon Ablation Handle (REF FG-1001) contains the cartridge heater and . refrigerant delivery valve which is controlled via the trigger. The unit is internally powered (9VDC non-replaceable lithium battery pack) and supplied non-sterile.
- CryoBalloon Ablation Cartridge (REF FG-1002) contains liquid nitrous oxide. The . Cartridge is supplied non-sterile and contains enough refrigerant for one to two ablation sites.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Esophagus (implied, per product description)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician / general surgery, endoscopic applications
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)
Comparative performance test data demonstrated adequate device performance and safety.
Biocompatibility, performance and animal test results demonstrated the safety and effectiveness of the CryoBalloon Ablation System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K060555, K070893, K021387, K051168
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.
0
101825
CONFIDENTIAL
Section 5-510(k) Summary or 510(k) Statement
t
I. General Information
Submitter: C2 Therapeutics, Inc. SEP 2 9 2010 303 Convention Way, Suite 1 Redwood City, CA 94063 Contact Person: Anne Worden Regulatory Consultant 925-895-1200 Summary Preparation Date: 6/30/2010
II. Names
Device Names: CryoBalloon Ablation System
Primary Classification Names: Cryosurgical unit with a nitrous oxide cooled balloon probe and accessories
III. Predicate Devices
- CryMed Technologies SprayGenix™ Ablation System K060555 .
- CSA Medical CryoSpray Ablation System K070893 .
- GI Supply Polar Wand Cryotherapy System K021387 .
- Barrx Medical HALO360 Coagulation System - K051168 .
IV. Product Description
The CryoBalloon Ablation System ("System") is used to destroy unwanted tissue by application of extreme cold. Upon activation by a physician, the balloon probe at the end of the catheter is simultaneously inflated and cooled with nitrous oxide. The balloon probe comes in contact with the wall of the esophagus and ablates unwanted tissue. Nitrous oxide is fully contained within the balloon probe and does not contact the esophagus. The nitrous oxide gas exits the patient through the proximal end of the catheter. The CryoBalloon Ablation System is designed for one time, continuous application use (single patient) in conjunction with a therapeutic endoscope (3.7mm accessory channel ID). The System is comprised of the following main components:
- CryoBalloon Ablation Catheter (REF FG-1000) consists of a connector, catheter . shaft, balloon probe, and protective sheath. This is supplied sterile.
- CryoBalloon Ablation Handle (REF FG-1001) contains the cartridge heater and . refrigerant delivery valve which is controlled via the trigger. The unit is internally powered (9VDC non-replaceable lithium battery pack) and supplied non-sterile.
- CryoBalloon Ablation Cartridge (REF FG-1002) contains liquid nitrous oxide. The . Cartridge is supplied non-sterile and contains enough refrigerant for one to two ablation sites.
1
V. Indications for Use
The C2 Therapeutics 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. Rationale for Substantial Equivalence
The CryoBalloon Ablation System shares the same or similar indications for use, device operation, overall technical and functional capabilities, and therefore is substantially equivalent for use to the predicate devices as a cryosurgical unit with a nitrous oxide cooled balloon probe and accessories.
In addition, comparative performance test data demonstrated adequate device performance and safety.
| Comparison
| Characteristic | K10 | K070893 & K060555 | K021387 | K051168 |
|---|---|---|---|---|
| Brand Name | CryoBalloon | |||
| Ablation System | CryoSpray Ablation™ | |||
| & SprayGenix™ Cryo | Polar Wand | |||
| Cryotherapy System | HALO 360 | |||
| Coagulation System | ||||
| Intended Use | ||||
| Intended Use | Destruction of | |||
| unwanted tissue with | ||||
| extreme cold | Destruction of | |||
| unwanted tissue with | ||||
| extreme cold | Ablation of unwanted | |||
| tissue with extreme cold | RF for tissue | |||
| coagulation | ||||
| Indications for | ||||
| Use | Intended to be used as | |||
| a cryosurgical tool for | ||||
| destruction of | ||||
| unwanted tissue in | ||||
| the field of general | ||||
| surgery, specifically | ||||
| for endoscopic | ||||
| applications. | Intended to be used as a | |||
| cryosurgical tool for | ||||
| destruction of unwanted | ||||
| tissue in the field of | ||||
| general surgery, | ||||
| specifically for | ||||
| endoscopic applications. | Used for ablation of | |||
| unwanted tissue in the | ||||
| fields of dermatology, | ||||
| gynecology, general | ||||
| surgery, urology, and | ||||
| gastroenterology. The | ||||
| system may be used | ||||
| with a variety of | ||||
| cryogens, e.g. carbon | ||||
| dioxide, nitrous oxide, | ||||
| argon, krypton | Indicated for use in the | |||
| coagulation of bleeding | ||||
| and non-bleeding sites | ||||
| in the gastrointestinal | ||||
| tract including but not | ||||
| limited to the | ||||
| esophagus. Indications | ||||
| include Esophageal | ||||
| Ulcers, Mallory-Weiss | ||||
| tears, Arteriovenous | ||||
| Malformations, | ||||
| Angiomata, Barrett's | ||||
| esophagus, Dieulafoy | ||||
| Lesions, and | ||||
| Angiodysplasia. | ||||
| Key Technical Characteristics | ||||
| Control | User | User | User | User |
| Method of | ||||
| Action | Thermal | Thermal | Thermal | Thermal |
| Endoscopic | ||||
| procedure | Yes | Yes | Yes | Yes |
See Table 9 - Substantial Equivalence Comparison of Intended Use and Technical Characteristics for comprehensive analysis of Technical Characteristics.
Safety and Effectiveness Information VII.
The review of the indications for use and technical characteristics provided demonstrates that the CryoBalloon Ablation System is substantially equivalent to the predicate devices.
2
Biocompatibility, performance and animal test results demonstrated the safety and effectiveness of the CryoBalloon Ablation System.
VIII. Conclusion
The CryoBalloon Ablation System was found to be substantially equivalent to the predicate devices.
The CryoBalloon Ablation System shares identical indications for use, similar design features, and functional features with, and thus is substantially equivalent to, the predicate devices.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP 2 9 2010
C2 Therapeutics, Inc. % Mr. Peter Garcia-Meza President and CEO 303 Convention Way, Suite 1 Redwood City, California 94063
Re: K101825
Trade/Device Name: CyroBalloon Ablation System Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: Class II Product Code: GEH Dated: June 30, 2010 Received: July 01, 2010
Dear Mr. Garcia-Meza:
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
:
4
Page 2 - Mr. Peter Garcia-Meza
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 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 go to http://www.fda.gov/AboutFDA/CentersQffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely vours.
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
CONFIDENTIAL
Indications for Use Statement
510(k) Number (if known): K10 | 82 ・
Device Name: CryoBalloon Ablation System
Indications for Use:
The C2 Therapeutics 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.
| Prescription Use | ✓ |
|---|---|
| (Part 21 CFR 801 Subpart D) |
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Surgical, Orthopedic, and Restorative Devices | |
| 510(k) Number | K10/825 |
Page 1 of 1C2 Therapeutics Premarket Notification 510(k) Submission for: CryoBalloon Ablation System
Section 4: Indications for Use - Page 4-2