(300 days)
Indications for Use statement for the ERBECRYO 2 cryosurgical unit:
"The ERBECRYO 2 cryosurgical unit and accessories are intended for cryoadhesion and devitalization of tissue by the application of extreme cold."
Indications for Use statement for the Erbe Flexible Cryoprobes:
"The Erbe Flexible Cryoprobes are intended for palliative devitalization) of tissue during interventional procedures by the application of extreme cold and cryoadhesion for applications such as the removal of foreign bodies, mucus plugs, blood clots, necrotic tissue, tissue tumors (palliative recanalization) and tissue biopsies."
The ERBECRYO® 2 Unit and Accessories are manufactured with various metals, plastics, silicone, adhesive, etc. The system consists of connecting hoses, an adapter, a switching valve (optional for using two gas cylinders), the Unit, electrical cables, the footswitch, and the flexible cryoprobes. The ERBECRYO® 2 unit is a standalone unit that can be placed on a table top or secured on a cart. The Cryosurgical Unit has a monochromatic display that provides operational information. The display is surrounded by buttons allowing for user interface (e.g., set the effect, select a program, etc.). Default settings are also displayed per the cryoprobe that is attached. The Cryorugical Unit is connected to an electrical power source, a carbon dioxide (CO2) source, the footswitch and a flexible cryoprobe. The Cryosurgical Unit displays errors and/or emits audio alarms to alert users of malfunctions or user errors. Typically, a cryoprobe is placed down the working channel of an endoscope (e.g., bronchoscope, etc.) that can accommodate the dimensional attributes (i.e., outer diameter and length) of the probe. Upon activation via the pedal of the footswitch, the Unit delivers the regulated flow of the CO2 to the tip of the flexible cryoprobe. Through the Joule-Thomson Effect and in the presence of moisture, an ice is formed and surrounding tissue is cooled. The extreme cold is used for cryoadhesion and/or devitalization (i.e., the destruction) of target tissue (Note: The smaller 1.1mm single use cryoprobes have an oversheath so that tissue frozen to the tip can be removed through the endoscope without having to remove the scope from the patient.). The Unit and all of the Accessories, except for the single use flexible cryprobes, are supplied non-sterile and are reusable. The single use cryoprobes are provided sterile and are single patient use.
The provided text describes a 510(k) premarket notification for the ERBECRYO 2 Cryosurgical Unit and Accessories (K190651), comparing it to a legally marketed predicate device (K151041). The document primarily focuses on demonstrating substantial equivalence rather than a clinical study establishing acceptance criteria for a new AI/software device. There is no mention of an AI/software component in this submission.
Therefore, many of the requested categories are not applicable to the information provided. The document describes a medical device (cryosurgical unit and cryoprobes) and its physical and performance characteristics, along with various standard tests to ensure its safety and effectiveness relative to a predicate device.
However, I can extract the relevant information where applicable and indicate "Not applicable" for items that are not present or relevant to this type of medical device submission.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is not an AI/software device and the submission focuses on substantial equivalence to a predicate, the "acceptance criteria" are generally compliance with recognized standards and demonstration that new features (like different cryoprobe dimensions or sterile single-use probes) do not raise new safety or effectiveness concerns. The performance reported relates to the cryosurgical function and material properties.
| Acceptance Criteria Category | Specific Acceptance Criteria (if quantifiable) | Reported Device Performance (if quantifiable) |
|---|---|---|
| Biocompatibility | No sensitizing, irritating, or cytotoxic properties. No acute systemic toxic characteristics. | Probes showed no sensitizing or irritating properties. No release of substances in cytotoxic concentration observed. No acute systemic toxic characteristics demonstrated. |
| Sterilization | Sterility Assurance Level (SAL) of 10^-6 for EO sterilization (per ISO 11135:2014). Residual EO and ECH gas levels within limits (per ISO 10993-7:2009). | SAL of 10^-6 achieved. Residual EO and ECH gas levels were within limits. |
| Shelf Life | Ability to maintain sterility and integrity for 3 years after accelerated aging and transport simulation (per ISO 11607). | Samples passed visual inspection, dye penetration, burst test, peel test, bubble emission test, microbial barrier test, and function test for 3 years. |
| Electrical Safety & EMC | Compliance with ANSI AAMI ES60601-1, IEC 60601-1-2. | Compliance with these standards is implied by their mention and the submission's purpose. (Specific performance values not detailed). |
| Risk Management | Implementation of risk management process per ANSI AAMI ISO 14971. | Implied compliance through mention of standard. |
| Software Life Cycle | Compliance with IEC 62304. | Implied compliance through mention of standard. |
| Usability | Compliance with IEC 62366-1 and IEC 60601-1-6. | Implied compliance through mention of standards. |
| Freezing Performance & Stability | Comparable to predicate device. | Comparative testing conducted to determine freezing performance and stability. (Specific quantitative results not detailed, but described as comparable). |
| Biopsy Weight (Ex-vivo) | Comparable to predicate device. | Comparative ex vivo tissue testing on bovine liver, porcine kidney, and porcine lung demonstrated comparability. (Specific quantitative results not detailed, but described as comparable). |
| In-vivo Performance | Comparable to predicate device. | Animal testing in an in vivo porcine lung model demonstrated comparability. (Specific quantitative results not detailed, but described as comparable). |
| Removal of Blood Clots | Device is safe and effective for this application. | Supported by peer-reviewed real-world evidence (literature and published case reports). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in terms of clinical trial patient numbers or image counts, as this is primarily a device safety and performance submission based on bench testing, ex-vivo, and in-vivo (animal) studies, and literature review.
- Biocompatibility: "Erbe Flexible cryoprobes" tested. Specific number of probes or samples not given.
- Sterilization Validation: "Mixed load sterilization cycle" validated. Specific number of samples not given.
- Shelf Life Validation: "Sterilized samples" tested. Specific number of samples not given.
- Performance Testing (Freezing, Biopsy Weight, In-vivo): "Comparative ex vivo tissue testing on three different tissues (bovine liver, porcine kidney and porcine lung)" and "animal testing in an in vivo porcine lung model" were conducted. Specific numbers of tissue samples or animals not given.
- Data Provenance:
- Biocompatibility, Sterilization, Shelf Life, and Performance Testing were conducted by Erbe Elektromedizin GmbH, based in Germany. The specific testing facilities are not mentioned.
- For the "removal of blood clots" indication, "peer-reviewed real world evidence (literature and published case reports)" were provided. This implies a retrospective review of existing published data globally.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable as there is no "ground truth" established by experts in the context of an AI/software device. The data is physical measurements, biological evaluations, and performance characteristics compared to a predicate device and existing literature.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable, as there is no expert review or adjudication method described for establishing ground truth for an AI/software output. The testing methodologies are based on laboratory measurements and comparisons.
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
- Not applicable. This is a submission for a physical cryosurgical unit and cryoprobes, not an AI or software device. No human reader studies with or without AI assistance were performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device does not involve an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" in this context refers to the established scientific and engineering principles for device performance, safety standards, and comparative data against a legally marketed predicate device.
- Benchmarking/Comparative Data: Performance as measured against the predicate device (e.g., freezing performance, biopsy weight).
- Standard Compliance: Adherence to international standards (e.g., ISO 10993 for biocompatibility, ISO 11135 for sterilization, ISO 11607 for shelf life, IEC 60601 series for electrical safety).
- Animal Model Data: In-vivo performance (porcine lung model).
- Literature Review: Real-world evidence from peer-reviewed literature and published case reports for specific indications (e.g., removal of blood clots).
- Laboratory Procedures: Sterility, shelf-life, and biocompatibility testing results.
8. The sample size for the training set
- Not applicable. This is not an AI/software device, so there is no training set.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set for an AI/software device.
§ 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.