ACCUPROBE 800 SERIES MODEL NUMBERS : 810, 820, 830, 840, 850, 860, 870 AND 880

• K Number: K982055
• Device Name: ACCUPROBE 800 SERIES MODEL NUMBERS : 810, 820, 830, 840, 850, 860, 870 AND 880
• Manufacturer: CRYOMEDICAL SCIENCES, INC.
• Date Cleared: 1998-09-08 ( 89 days)
• Product Code: GEH , OCL
• Regulation Number: 878.4350
• Type: Traditional
• Panel: SU
• Reference & Predicate Devices: K973190 , K964336

Intended Use

The CMS AccuProbe® 800 Series (all models depicted as A) has the same indications for use as its predicate device, the AccuProbe® 600 Series [510(k) number K973190 cleared November 21, 1997].

Urology

• The (A) system may be used to ablate prostatic tissue.
• . The (A) system may be used for the ablation of prostate tissue in cases of prostate cancer and benign prostatic hyperplasia.

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

• system may be used for the ablation or freezing of The (A) . skin cancers and other cutaneous disorders.

Gynecology

• system may be used for the ablation of malignant . The (A) neoplasia or benign dysplasia of the female genitalia.

General Surgery

• (A) system may be used for the ablation of The . leukoplakia of mouth, anaiomas, sebaceous hyperpalsia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas, small hemangiomas, mucocele cysts, multiple warts, plantar warts, hemorrhoids, anal fissures, perianal condylomata, pilonidal cysts, actinic and seborrheic keratoses , cavernous hemanaiomas recurrent cancerous lesions.
• . The (A) system may be used for the destruction of warts or lesions.
• . The (A) system may be used for the palliation of tumors of the oral cavity, rectum, and skin.

Thoracic Surgery

• The . (A) system may be used for the ablation of arrhythmic cardiac tissue.
• . The system may be used for the ablation of cancerous (A) lesions.

Proctology

• The (A) system may be used for the ablation of benign or malignant growths of the anus and rectum
• . systems may be used for the ablation of The (A) hemorrhoids.

Device Description

The CMS AccuProbe® 800 Series consists of eight models, each of which has two components: i) a console with a pumping mechanism to compress and pressurize the cryogen and ii) one to eight (models 810 through 880) cryoprobes with tips extending from the console. The may include an optional on-board computer which is as redundant display system and archival system to store information about the procedure. The computer does not control or affect the operation of the cryoprobes in any fashion. The cryoprobes consist of interchangeable tips of various materials, sizes and shapes which are used a necessary.

The AccuProbe® 800 Series is used to destroy unwanted tissue by the application of extreme cold to the selected site. Liquid nitrogen is forced through the cryoprobes under pressure. The cryoprobe, having been placed in the appropriate position through the used of utlrasound or other imaging device, then becomes cold and freezes the unwanted tissue. The procedure may be monitored in real-time through the use of imaging modes such as ultrasound, Once the freezing is completed (approximately 20 minutes), the cryoprobe will be heated using warming gas in order to facilitate thawing and removal of the cryoprobe from the frozen tissue.

AI/ML Overview

This 510(k) submission describes a cryosurgical unit, the CMS AccuProbe® 800 Series, and states its substantial equivalence to a previously cleared device, the AccuProbe® 600 Series. The provided document focuses on comparing the features of the new device to the predicate device and listing its indications for use.

No information regarding acceptance criteria, device performance metrics, or study design (including sample size, ground truth establishment, expert qualifications, or adjudication methods) is present in the provided text. The 510(k) process for this type of device typically relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new clinical performance studies with predefined acceptance criteria.

Therefore, I cannot provide the requested information from the given text.

Here's what can be extracted based on the document's content:

1. A table of acceptance criteria and the reported device performance

• Not provided. The document does not define acceptance criteria or report specific performance metrics for the CMS AccuProbe® 800 Series against such criteria. It instead focuses on comparing features to a predicate device.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not provided. No test set or corresponding data provenance is mentioned as part of this 510(k) submission.

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)

• Not provided. No ground truth establishment experts are mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not provided. No adjudication method is mentioned.

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-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study with AI assistance is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This device is a cryosurgical unit, not a standalone algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• Not provided. No specific ground truth related to performance evaluation is mentioned. The submission relies on substantial equivalence to a predicate device for its safety and effectiveness claims.

8. The sample size for the training set

• Not applicable / Not provided. As this is a physical medical device (cryosurgical unit) and not an AI/software algorithm requiring a training set, the concept of a "training set sample size" does not apply in this context.

9. How the ground truth for the training set was established

• Not applicable / Not provided. As there is no training set mentioned, there is no discussion of how ground truth was established for it.

Regulation Number and Section

§ 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.