(28 days)
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.
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.
The provided document focuses on the K153541 C2 Therapeutics, Inc. Coldplay CryoBalloon® Ablation System and its substantial equivalence to a predicate device, rather than presenting a study proving a device meets specific acceptance criteria for diagnostic performance or AI model evaluation.
Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, ground truth for training set, etc.) are not applicable to this document's content.
However, I can extract information related to the device's performance data and a comparison to its predicate.
Here's a summary based on the provided text, while noting the limitations:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria for clinical efficacy or diagnostic accuracy, as it's a 510(k) submission for a non-diagnostic device. Instead, it focuses on demonstrating substantial equivalence to a predicate device.
The reported "performance" is primarily related to physical, reliability, and safety specifications, which were evaluated through "Design verification testing." The document asserts that the modified device performs "as intended" and "comparably" to the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Physical specifications met | "Design verification testing was performed on the Coldplay CryoBalloon® Ablation System to evaluate physical... specifications." The conclusion states it "should perform as intended." |
| Reliability specifications met | "Design verification testing was performed... to evaluate ... reliability... specifications." The conclusion states it "should perform as intended." |
| Safety specifications met | "Design verification testing was performed... to evaluate ... safety specifications." The conclusion states it "should perform as intended." |
| Comparable performance to predicate device (K151054) | "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." "should perform comparably to the legally marketed predicate." |
| Effective for destruction of unwanted tissue by cryoablation | The fundamental technological principle is cryoablation for both devices. The device is "intended for use as a cryosurgical tool for the destruction of unwanted tissue." |
| Compatible with specific endoscopes (3.7mm ID, 100cm length) | The catheter "is compatible with commercially available endoscopes with a minimum working channel inner diameter (ID) of 3.7 mm and maximum length of 100 cm." |
| Nitrous oxide cools balloon effectively for ablation | "The nitrous oxide spray cools the balloon to ablate the unwanted tissue." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The "Design verification testing" refers to engineering and bench testing, not a clinical study on a patient test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable/not provided. The document describes a cryoablation device, not a diagnostic tool requiring expert ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not provided.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable/not provided. This is not an AI-assisted diagnostic device, nor is an MRMC study mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable/not provided. This is not an algorithm, but a medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable/not provided in the context of diagnostic performance. For a medical device, the "ground truth" for its performance would typically come from engineering specifications, bench testing results, and potentially animal or human clinical data demonstrating its ability to achieve its intended therapeutic effect (e.g., tissue destruction), but such specific data for establishing "ground truth" in a structured way is not detailed here for a 510(k) summary. The document relies on "Design verification testing" to demonstrate functionality and safety against pre-defined specifications.
8. The sample size for the training set
This information is not applicable/not provided. This device does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
This information is not applicable/not provided.
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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 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
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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
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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.
§ 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.