(88 days)
Each proposed intended use description will have the letter (A ) which represents any of the family of AccuProbe® devices, the AccuProbe® 450, AccuProbe® 550/530 and the AccuProbe® 600 Series inclusive.
Urology
- system may be used to ablate prostatic tissue. The (A) .
- (A) system may be used for the ablation of prostate . The tissue in cases of prostate cancer and benign prostatic hyperplasia. 1
Oncology
- system may be used for ablation of cancerous or ● The (A) malignant tissue.
- system may be used for ablation of benign tumors. . The (A)
- The (A) system may be used for palliative intervention.
Dermatology
- . The (A) system may be used for the ablation or freezing of skin cancers and other cutaneous disorders.
Gynecology - The ● (A) system may be used for the ablation of malignant neoplasia or benign dysplasia of the female genitalia.
General Surgery
- system may be used for the ablation of ● The (A) leukoplakia of mouth, angiomas, sebaceous hyperpalsia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas, small hemangiomas, mucocele cysts, multiple warts, plantar warts, hemorthoids, anal fissures, perianal condylomata, pilonidal cysts, actinic and sebortheic keratoses , cavernous hemangiomas, recurrent cancerous lesions.
- system may be used for the destruction of warts The (A) . or lesions.
- system may be used for the palliation of tumors ● (A) The of the oral cavity, rectum, breast, and skin.
Thoracic Surgery
- system may be used for the ablation of . The (A) arthythmic cardiac tissue.
- system may be used for the ablation of . The (A) cancerous lesions.
Proctology
- system may be used for the ablation of benign or . The (A) malignant growths of the anus and rectum
- systems may be used for the ablation of . (A) The hemorrhoids.
Cryosurgical Units, Cryogenic Surgical Device. Console with multiple ports and spray/closed probes.
This is a 510(k) premarket notification for a Class II medical device, the Cryomedical Sciences (CMS) AccuProbe cryosurgical unit. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than on providing extensive clinical performance data showing a device meets specific numeric acceptance criteria.
The 510(k) summary provided does not contain the kind of detailed acceptance criteria and performance study data typically found in clinical trials for novel devices with specific performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it focuses on comparing the proposed device's intended use and characteristics to existing, legally marketed predicate devices. Therefore, many of the requested elements for acceptance criteria and study design are not applicable in this context.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission asserting substantial equivalence, there isn't a table of discrete, pre-defined quantitative acceptance criteria and corresponding reported performance metrics (e.g., sensitivity > 90%). The "acceptance criteria" for a 510(k) is primarily the demonstration of substantial equivalence in terms of intended use, technological characteristics, and safety/effectiveness as compared to predicate devices.
The document states: "The company believes that its CMS AccuProbe® device's original predicate devices and other legally marketed cryosurgical devices... are substantially equivalent for intended use and advertisement."
The "performance" is implicitly demonstrated through the device's technological characteristics (Console with multiple ports and spray/closed probes, Liquid nitrogen cryogen) being comparable to the listed predicate devices in Section {1}. The "intended use" is also compared through specific predicate device citations for each proposed use (e.g., Urology, Oncology, Dermatology, etc.) in Sections {2}, {3}, {4}, {7}, and {8}.
The FDA's decision in Section {5} confirms this: "We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..."
Key "Acceptance Criterion" Implicit in a 510(k): The device must be deemed "substantially equivalent" to one or more predicate devices as defined by the Federal Food, Drug, and Cosmetic Act.
Reported Device Performance: Not applicable in the sense of quantitative metrics from a performance study. The performance is implied to be equivalent to that of the predicate devices for their respective indications.
2. Sample size used for the test set and the data provenance
Not Applicable. This 510(k) submission does not include a performance study on a test set in the traditional sense of evaluating diagnostic accuracy or clinical outcomes with a specific sample size. The submission focuses on comparing the device's design and intended uses to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not Applicable. No ground truth was established by experts for a test set in this submission. The "ground truth" for the substantial equivalence claim relies on the legal marketing and established safety/effectiveness of the predicate devices.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not Applicable. There was no test set requiring adjudication in this submission.
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 device is a cryosurgical unit, not an AI-assisted diagnostic or imaging device, and therefore, an MRMC study is irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not Applicable. This is a hardware cryosurgical device, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Implicit Ground Truth: The "ground truth" for this 510(k) submission is the established safety and effectiveness of the legally marketed predicate devices for their respective indications. The applicant is asserting that their device is sufficiently similar to these predicates that it can be considered equally safe and effective for the same indications.
8. The sample size for the training set
Not Applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not Applicable. As there is no training set for this type of device, this question is not relevant.
Summary of the 510(k) Process Reflected in the Document:
The provided document describes a 510(k) submission for a cryosurgical device. The primary "study" involved here is a comparison study where the applicant details the technological characteristics and proposed indications for use of their AccuProbe device family against those of legally marketed predicate cryosurgical devices.
The acceptance (clearance) decision by the FDA is based on the determination that the AccuProbe devices are substantially equivalent to the identified predicate devices, particularly regarding their intended uses in Urology, Oncology, Dermatology, Gynecology, General Surgery, Thoracic Surgery, and Proctology.
A notable point in the "Dear Dr. Reinhart" letter (Section {5} and {6}) is that the FDA did not accept an indication for "cryoablation of the endometrium," stating it "raises new types of safety and effectiveness questions" and would require a Premarket Approval Application (PMA). This highlights that even in a 510(k), if an indication is deemed to significantly differ from predicates or raise new questions, substantial equivalence may not be found.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.