Search Results

Date Cleared

1998-07-17

(147 days)

Product Code

GEH,OCL

Regulation Number

Type

Panel

CMS BLIZZARD 700 SERIES MODELS 710, 711, 712, 720, 721 AND 722

Reference & Predicate Devices

N/A

Intended Use

Depending on the cryogen used, the following are indications for use:

Liquid Nitrogen:
For use as a cryosurgical tool for destruction of unwanted tissue in the fields of dermatology, general surgery, neurosurgery, thoracic surgery, urology, proctology, oncology, gynecology and ENT.

May be used to ablate prostatic tissue.
May be used for the ablation of prostatic tissue in cases of prostate cancer and benign prostatic hyperplasia.
May be used for ablation of cancerous or malignant tissue.
May be used for ablation of benign tumors.
May be used for palliative intervention.
May be used for ablation or freezing of skin cancers and other cutaneous disorders.
May be used for the ablation of malignant neoplasia or benign dysplasia of the female genitalia.
May be used for ablation of leukoplakia of mouth, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid and canthus area, ulcerated basal cell tumors, dermatofibromas, small hemangiomas, mucocele cysts, multiple warts, plantar warts, hemorrhoids, and fissures, peri-anal condylomata, pilonidal cysts. actinic and seborrheic keratoses, cavernous hemangiomas, recurrent cancerous lesions.
May be used for the destruction of warts or lesions.
May be used for the palliation of tumors of the oral cavity, rectum, and skin.
May be used for ablation of arrhythmic cardiac tissue.
May be used for the ablation of benign or malignant growths of the anus and rectum.
May be used for the ablation of hemorrhoids.

Nitrous Oxide:
For use as a tool in the destruction of unwanted tissue in the fields of dermatology, gynecology, general surgery, urology, and veterinary medicine.

Carbon Dioxide:
For used as a tool in the destruction of unwanted tissue in the fields of dermatology, gynecology, and general surgery.

Argon and Krypton:
For use as a cryosurgical tool in general surgery, dermatology, neurology, thoracic surgery, ENT, gynecology, oncology, proctology, and urology for the ablation of tissue including liver metastass, skin lesions, warts and prostate tissue.

Device Description

The CMS Blizzard 700 Series Models 730, 740, 750, 760, 770, 780 & 790 are made up of two components: 1) a console which holds up to two cryogen packets of varving sizes and 2) depending on the model, can employ from three to nine individually controlled cryoprobes. The consoles includes a power switch, individually controlled cryogen flow switches, thermocouple temperature displays and, depending on the model between three and nine cryoprobe ports. The devices are used to destroy unwanted tissue by the application of cold to the selected site. The cryogen is forced through the cryoprobe under pressure. The cryoprobe, having been placed in the appropriate position, then becomes cold and freezes the tissue.

AI/ML Overview

The provided text is a 510(k) summary for the CMS Blizzard 700 Series cryosurgical units. It describes the device, its intended use, and compares it to predicate devices. However, this document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

The 510(k) summary is a regulatory document used to demonstrate substantial equivalence to a legally marketed predicate device, primarily focusing on similarities in intended use, technology, and safety/effectiveness. It is not a clinical study report or a detailed performance validation report.

Therefore, for your request, I must report that the requested information is not present in the provided text.

Specifically:

A table of acceptance criteria and the reported device performance: Not present. The document focuses on comparing features with predicate devices, not on quantitative performance metrics or acceptance criteria for those metrics.
Sample size used for the test set and the data provenance: Not present. No test set or study data is mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. There is no mention of ground truth establishment.
Adjudication method for the test set: Not present.
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 present. This document describes a cryosurgical unit, not an AI-assisted diagnostic or therapeutic device.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not present. This is a physical medical device, not an algorithm.
The type of ground truth used: Not present.
The sample size for the training set: Not present.
How the ground truth for the training set was established: Not present.

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K Number

K980670

Device Name

Manufacturer

Date Cleared

1998-07-17

(147 days)

Product Code

GEH,OCL

Regulation Number

Type

Panel

ACCUPROBE 450, ACCUPROBE 550/530 AND THE ACCUPROBE 600 SERIES

Reference & Predicate Devices

N/A

Intended Use

The CMS Blizzard 700 Series Models 710, 711, 712, 720, 721and 722, depending on the cryogen selected, are intended to be used:

Liquid Nitrogen:

as a cryosuraical tool for destruction of unwanted tissue in the fields . of dermatology, general surgery, neurosurgery, thoracic surgery, urology, proctology, oncology, gynecology and ENT;
to ablate prostatic tissue; .
for the ablation of prostatic tissue in cases of prostate cancer and . benian prostatic hyperplasia;
for ablation of cancerous or malignant tissue; .
for ablation of benign tumors; .
for palliative intervention; .
for ablation or freezing of skin cancers and other cutaneous . disorders;
for the ablation of malignant neoplasia or benign dysplasia of the . female genitalia;
for ablation of leukoplakia of mouth, angiomas, sebaceous . hyperplasia, basal cell tumors of the eyelid and canthus area, ulcerated basal cell tumors, dermatofibromas, small hemangiomas, mucocele cysts, multiple warts, plantar warts, hemorrhoids, and fissures, peri-anal condylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemanaiomas, recurrent cancerous lesions;
for the destruction of warts or lesions: ●
for the palliation of tumors of the oral cavity, rectum, and skin;. .
for ablation of arrhythmic cardiac tissue; ●
. for the ablation of benign or malignant growths of the anus and rectum;
for the ablation of hemorrhoids; ●

Nitrous Oxide:

as a tool in the destruction of unwanted tissue in the fields of . dermatology, gynecology, general surgery, and urology;

Carbon Dioxide:

as a tool in the destruction of unwanted tissue in the fields of . dermatology, gynecology, and general surgery;

Argon and Krypton:

as a cryosurgical tool in general surgery, dermatology, neurology, . thoracic surgery, ENT, gynecology, oncology, proctology, and urology for the ablation of tissue including liver metastases, skin lesions, warts and prostate tissue;

Device Description

The CMS Blizzard 700 Series Models 710, 711, 712, 720, 721 and 722 are simple, portable cryosurgical devices. All models feature physician-selected cryogen choices as well as a selection of cryoprobes of various sizes and shapes. Models 710, 711 and 712 are single cryoport devices while models 720, 721 and 722 have a two cryoport capacity. Although all models operate in the exact same way, their casings differ to allow desired positioning. The 710 and 720 are wheeled pole type configuration; the 711 and the 721 are tabletop configuration; while the 712 and the 722 are suitcase or attaché type configuration.

The devices are used to destroy unwanted tissue by the application of cold to the selected site. The cryogen is forced through the cryoprobe under pressure. The cryoprobe having been placed in the appropriate position, then becomes cold and freezes the tissue.

AI/ML Overview

The provided 510(k) summary for the K980670 device (CMS Blizzard 700 Series) does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of performance metrics like accuracy, sensitivity, or specificity.

This document is a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than conducting new clinical trials for performance claims against pre-defined acceptance criteria, especially in the way an AI/ML device submission would.

The document primarily provides:

Device Description: What the device is and how it works (a cryosurgical unit designed to destroy unwanted tissue by applying cold).
Comparison to Predicate Devices: Detailed tables comparing features (cryogens, number of cryoprobes, cryogen containers, size, cryoprobe types, control) of the CMS Blizzard 700 Series to its own previous models (Cryo-lite™ System, AccuProbe® 600 Series) and competitor devices (Cabot Medical Cryomedics MT700, Erbe Erbokryo CA). This is the core of demonstrating substantial equivalence.
Indications for Use: A comprehensive list of medical applications for which the device is intended, varying by the cryogen selected.
FDA Correspondence: An FDA letter confirming substantial equivalence.

Therefore, I cannot extract the requested information as it is not present in the provided text.

Here's a breakdown of why and what kind of information is missing, based on your request:

Table of Acceptance Criteria and Reported Device Performance: This document does not establish specific performance metrics (like accuracy, sensitivity, specificity) for the device. The "performance" being demonstrated is similarity in function and safety features to legally marketed predicate devices, not a quantitative performance score against a benchmark.
Sample Size used for the test set and data provenance: No test set is described. The approval is based on "substantial equivalence" to existing devices, inferring that if the predicate devices are safe and effective, and the new device is sufficiently similar, it also meets those standards.
Number of experts used to establish the ground truth for the test set and qualifications of those experts: Not applicable. Ground truth for a test set is not mentioned as no performance study of this nature was conducted or reported.
Adjudication method: Not applicable.
Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not applicable. This type of study is specifically relevant for AI/ML devices assessing impact on human reader performance. The device here is a physical cryosurgical unit, not an AI diagnostic tool.
Standalone (algorithm-only) performance: Not applicable. The device is not an algorithm.
Type of ground truth used: Not applicable.
Sample size for the training set: Not applicable. This device is not an AI/ML model that requires a training set.
How the ground truth for the training set was established: Not applicable.

In summary, the provided text describes a traditional medical device (cryosurgical unit) submission for 510(k) clearance, which relies on demonstrating substantial equivalence to predicate devices. It does not involve the types of acceptance criteria, performance studies, or AI/ML specific data (training/test sets, ground truth, expert review) that your prompt is looking for.

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K Number

K973190

Device Name

Manufacturer

Date Cleared

1997-11-21

(88 days)

Product Code

GEI

Regulation Number

878.4400

Type

Panel

Reference & Predicate Devices

N/A

Intended Use

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.

Device Description

Cryosurgical Units, Cryogenic Surgical Device. Console with multiple ports and spray/closed probes.

AI/ML Overview

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.

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K Number

K970995

Device Name

CMS CRYOLITE

Manufacturer

Date Cleared

1997-07-07

(110 days)

Product Code

GEH

Regulation Number

Type

Panel

CMS ACCUPROBE 610, 620, 630, 640, 650, 660, 670, 680

Reference & Predicate Devices

K840536

Intended Use

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.

Device Description

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.

AI/ML Overview

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.

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K Number

K964336

Device Name

Manufacturer

Date Cleared

1997-03-20

(140 days)

Product Code

GEH

Regulation Number

Type

Panel