(110 days)
The CMS Cryo-lite® System has the same indications for use as its predicate devices, the Frigitronics Model 5900, Frigitronics Cryocare I and the Cryomedics Model MT700 . The Cryo-lite® System is intended to be used as a cryosurgical tool for destruction of unwanted tissue in the fields of dermatology, gynecology general surgery, etc. and veterinary medicine.
The CMS Cryo-lite® System is a completely disposable hand-held cryosurgical device. Both Crvo-lite® System Models 2001 and 2002 consist of hand-helo body, a physician-selected cryogen packet and single cryoprope of varying materials, sizes and shapes. Cryogens available with this system are liquid nitrogen, nitrous oxide, carbon dioxide and argon.
The Crvo-lite® System is used to destroy unwanted tissue by application of extreme cold to the selected site. The cryogen is forced through the cryoprobes under pressure. The cryoprobe, having been placed in the appropriate position through the use of ultrasound, another imaging device or visual observation then becomes cold and freezes the unwanted tissue. Cryosurgical procedures are used when surgical resection is not indicated, and may also provide an alternative to typical resection in certain cases.
The provided text describes a 510(k) premarket notification for the CMS Cryo-lite® System, a cryosurgical device. Crucially, this document does not contain details of an acceptance criteria study or performance data against specific criteria.
Instead, the submission focuses on demonstrating substantial equivalence to predicate devices already on the market by comparing features and intended use. This is a common regulatory pathway for medical devices that are similar in technology and purpose to existing cleared devices.
Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, ground truth, or expert involvement because this type of study was not performed or detailed in the provided document.
Here's an explanation based on the available information:
- Acceptance Criteria and Reported Device Performance: Not applicable/not provided. The document focuses on demonstrating substantial equivalence to predicate devices, not on meeting specific, quantifiable performance metrics from a new study.
- Study Details (Sample Size, Data Provenance): Not applicable/not provided. No new clinical or performance study data is presented.
- Ground Truth Establishment (Number of Experts, Qualifications, Adjudication Method, Type of Ground Truth): Not applicable/not provided. Ground truth is not a concept typically applied to substantial equivalence demonstrations based on feature comparison.
- Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: Not applicable/not provided. This type of study involves human readers interpreting data, usually images, with and without AI assistance, and is not relevant to a cryosurgical device's feature comparison.
- Standalone Performance (Algorithm Only): Not applicable/not provided. This device is a cryosurgical unit, not an AI algorithm.
- Training Set Details (Sample Size, Ground Truth Establishment): Not applicable/not provided. The document does not describe the development or training of an algorithm.
Summary of available information related to equivalence:
1. Comparison Tables (Features Demonstrating Substantial Equivalence):
| Feature/Criteria | Cryolite System Performance (as reported for equivalence) |
|---|---|
| Cryoprobes | Spray and closed-tip, various, interchangeable |
| Power source | Non-electric |
| Cryogen | Choice of liquid nitrogen, carbon dioxide, nitrous oxide, and argon |
| Flow control | Dial with flow rate markings/control |
| Size | Portable, hand-held |
| Capacity | 9 oz. cryogen packet and different capacities depending on commercial cryogen containers used with transfer line |
| Intended Use | Destruction of unwanted tissue in dermatology, gynecology, general surgery, etc., and veterinary medicine. |
Study Information (Based on Substantial Equivalence Argument):
- Sample size used for the test set and the data provenance: Not applicable. No test set as defined for a performance study was used. The demonstration relies on a comparison of features and intended use to predicate devices already cleared by the FDA.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a performance study was not established. The FDA reviewer (Celia M. Witten, Ph.D., M.D., Director, Division of General and Restorative Devices) made the determination of substantial equivalence based on the submitted documentation and comparison to predicate devices.
- Adjudication method for the test set: Not applicable. No test set requiring adjudication was used.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This type of study is not relevant for this device.
- Standalone (i.e. algorithm only without human-in-the loop performance) was done: No. This is a physical cryosurgical device, not an algorithm.
- The type of ground truth used: Not applicable in the context of a new performance study. The "ground truth" for this submission is the established safety and effectiveness of the predicate devices.
- The sample size for the training set: Not applicable. No algorithm training set was involved.
- How the ground truth for the training set was established: Not applicable. No training set was involved.
In essence, the provided document is a regulatory submission focused on equivalence rather than a new performance study with explicit acceptance criteria. The "proof" that the device meets "acceptance criteria" is the FDA's determination of substantial equivalence to already approved predicate devices.
§ 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.