(239 days)
The Coldplay CryoBalloon™ Focal Ablation System, Coldplay CryoBalloon™ Full Ablation System, and Coldplay CryoBalloon™ Swipe Ablation System are intended for use as a cryosurgical tool in the field of general surgery, specifically for endoscopic applications, to include ablation of Barrett's Esophagus with high grade dysplasia.
The subject device is a cryosurgical system 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 length of 100 cm. The subject device is a system comprised of three components including a Catheter (sterile), Handle (nonsterile), and Cartridge (non-sterile). The subject device is used to ablate unwanted tissue by application of extreme cold to a 360° circumference, 90° circumference, or 45° circumference and is identical to the respective Coldplay CryoBalloon™ Ablation System predicates. The balloon at the distal end of the Catheter 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 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 text describes a 510(k) summary for the Coldplay CryoBalloon™ Ablation System, focusing on a modification to its indications for use to include ablation of Barrett's Esophagus with high-grade dysplasia. The information primarily covers the clinical study conducted to support this new indication.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state quantitative acceptance criteria in terms of specific performance metrics with predefined thresholds (e.g., "90% complete response rate"). Instead, the clinical study aimed to demonstrate the device's effectiveness in achieving "complete response" (full conversion of Barrett's epithelium to neosquamous epithelium) and its safety (absence of serious adverse events, manageable pain).
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Effectiveness: Complete response of high grade dysplasia. | - Full conversion to neosquamous epithelium observed significantly more frequently: |
- 60% for 6-second ablations
- 82% for 8-second ablations
- 100% for 10-second ablations (P=0.04)
- Confirmed through biopsy.
- "Effective at demonstrating complete response of high grade dysplasia at follow-up." |
| Safety: No serious adverse events, manageable adverse events. | - No serious adverse events reported. - Pain:
- Immediate post-procedure: 10 patients (27%) reported pain (median score 2.5).
- 2 days post-procedure: 5 patients (14%) reported pain (median score 4) and pain swallowing (median score 4).
- 3 patients (8%) used additional pain medication post-procedure.
- No adverse events during follow-up. |
2. Sample size used for the test set and the data provenance
- Sample Size: 37 patients
- Test Set Description: These 37 patients underwent a total of 56 focal ablations. The ablations had different durations: 10 ablations for 6 seconds, 28 for 8 seconds, and 18 for 10 seconds.
- Data Provenance: The study was a prospective, multicenter clinical study. The country of origin is not specified in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document states, "Conversion was confirmed through biopsy." This implies a pathological assessment was used for ground truth. However, it does not specify the number of experts (e.g., pathologists) involved or their qualifications.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
The document does not describe any specific adjudication method for establishing ground truth, beyond confirming conversion via biopsy. It doesn't mention multiple readers or a consensus process for the biopsy results.
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
No, an MRMC comparative effectiveness study was not done. The device is a cryoablation system, not an AI-assisted diagnostic tool. Therefore, the concept of human readers improving with AI assistance is not applicable here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone (algorithm only) performance study was not done. This device is a surgical tool, and its effectiveness is inherently tied to its use by medical professionals in a clinical setting.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The primary ground truth used for effectiveness was pathology (biopsy confirmation of full conversion of Barrett's epithelium to neosquamous epithelium). Safety was assessed based on reported adverse events and pain levels, which can be considered a form of clinical outcomes data.
8. The sample size for the training set
The document does not describe any "training set." This study is a clinical efficacy and safety study for a medical device, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
As there was no training set mentioned or implied, this question is not applicable.
§ 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.