The CryoSpray Ablation™ System is intended to be used as a cryosurgical tool for destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications.

Device Description

The CryoSpray Ablation™ System is used to destroy unwanted tissue by application of extreme cold to a selected site. Liquid Nitrogen is stored in a tank and then propelled through a cryocatheter to perform the cryo-ablation procedure. The catheter, an accessory component of the CSA System, is placed in the appropriate position through the use of visual observation. The cryo-catheter applies the cryogen to a selected area and freezes the unwanted tissue. The catheter detailed in the K060555 submission is of a single lumen, straight tip design.

AI/ML Overview

This document is a Special 510(k) submission for a modification to the CryoSpray Ablation™ System, specifically a directional spray catheter. The submission focuses on demonstrating substantial equivalence to a previously cleared device (K060555) rather than providing detailed performance studies with acceptance criteria.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them, including sample sizes, ground truth establishment, expert qualifications, and MRMC studies, is not present in the provided text. The document is a regulatory submission for a device modification, and as such, relies on comparisons to the predicate device and established technical characteristics rather than new performance studies with specific statistical acceptance criteria.

Here's a breakdown of why each specific point cannot be answered from the provided text:

A table of acceptance criteria and the reported device performance: Not provided. The submission states the modification "does not change the operating principals or mechanism of action" and that the "surface area of the radial hole... is similar to the hole in the lumen opening of the straight spraying catheter." This implies equivalence in performance rather than new, independently measured performance against specific criteria.
Sample sized used for the test set and the data provenance: No test set is described. The submission focuses on the design change of the catheter tip.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no test set requiring ground truth establishment is described.
Adjudication method for the test set: Not applicable.
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 tool, not an AI-assisted diagnostic or interpretive system.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable. This is not an AI/ML device.
How the ground truth for the training set was established: Not applicable.

Summary of available relevant information from the document:

Device Modification: The only modification is a tip configuration change in the cryocatheter. The end of the cryo-catheter is closed, and a side hole is located in the distal side, allowing a radial spray of the cryogen.
Materials: Identical materials are used as compared to the predicate catheter (K060555).
Dimensions: All other dimensional specifications are identical to the predicate catheter.
Surface Area: The surface area of the radial hole of the new catheter is similar to the hole in the lumen opening of the straight spraying catheter.
Operating Principles: The modification "does not change the operating principals or mechanism of action" for the CryoSpray Ablation System.
Intended Use: The intended use has not changed.
Basis for Equivalence: Based on principles of operation, design, materials, and intended use, the modified catheter is considered substantially equivalent to devices currently marketed.

The document demonstrates substantial equivalence by focusing on the lack of significant change in the device's fundamental characteristics and intended use, rather than presenting a performance study with defined acceptance criteria.

Summary

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Special 510(k) Submission CSA TM System Directional Spray Catheter CU8407020500

Image /page/0/Picture/1 description: The image contains a sequence of characters that appear to be handwritten. The characters are K, O, 7, O, 8, 9, and 7. The characters are written in a bold, cursive style. There is a line underneath the first four characters.

MAY - 1 2007

510(k) Safety Summary

March 2007 Submitted by:

CSA Medical, Inc. Emerging Technology Center 1101 E. 33rd, Third Floor - #A305 Baltimore, MD 21218 0: 443.921.8053 Contact Person: Jennifer Cartledge, VP Development CSA Medical, Inc. (Direct Contact Number 864.506.0097)

Name of Device

Trade Name: . CryoSpray Ablation System CU8407020500 Directional Spray Catheter
Common Name: Cryosurgical Unit, Cryogenic Surgical Device ●
Classification: Cryosurgical unit with Liquid Nitrogen, Class II . [21 CFR & 878.4350(a)].
Establishment Registration Number: . 9062377

Predicate Devices

Device

Premarket Notification

SprayGenix™ Cryo Ablation System KOROSSS

Company History:

CSA Medical, formerly CryMed Technologies received market clearance for the SprayGenix™ Cryo Ablation System (K060555). The name for the SprayGenix™ Cryo Ablation System was changed to the CryoSpray Ablation™ System as documented in the letter to file dated March 12, 2007.

Device Description:

CSAM 05-00002-00

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Description of Modification:

The only device modification presented in this Special 510k submission involves a tip configuration modification for the cryocatheter. It was desirable to allow the end user's the ability to direct the cryogen radially. While the identical materials are used as compared to the catheter listed in submission K060555, the end of cryo-catheter is closed and a side hole is located in the distal side the catheter, allowing a radial spray of the cryogen. All other dimensional specifications are identical to the catheter detailed in submission K060555. The surface area of the radial hole of the catheter is similar to the hole in the lumen opening of the straight spraying catheter. Refer to Attachments 5 and 6.

Indications for Use:

The CryoSpray Ablation™ System is intended to be used as a cryosurgical too! for destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications.

The intended use of the modified catheter, as described in its labeling, has not changed as a result of the tip configuration modification. Refer to Attachment 3.

Technical Characteristics:

The modification to the catheter does not change the operating principals or mechanism of action for the CryoSpray Ablation System and it is substantially equivalent to the above listed predicate devices.

Summary:

Based on the principles of operation, design, materials and intended use, the modification to the Straight Catheter to produce a Directional Catheter results in a CryoSpray Ablation™ System that is substantially equivalent to devices currently marketed in the United States.

Declaration of Conformity: Refer to Attachment 2.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name in a circular arrangement around a stylized graphic. The graphic consists of three abstract human profiles facing to the right, stacked on top of each other, with flowing lines suggesting movement or connection.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

CSA Medical, Inc. % Ms. Jennifer Cartledge Vice President, Development 1101 East 33td Street, Third Floor - #A305 Baltimore, Maryland 21218

MAY - 1 2007

Re: K070893

Trade/Device Name: CryoSpray Ablation™ System Regulation Number: 21 CFR 878.4350(a) Regulation Name: Cryosurgical unit and accessories Regulatory Class: II Product Code: GEH Dated: March 26, 2007 Received: April 3, 2007

Dear Ms. Cartledge:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -- Ms. Jennifer Cartledge

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely fours,

Mark N. Melkerson

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Special 510(k) Submission CSA TM System Directional Spray Catheter CU8407020500

Indications for Use

510(k) Number (if known): _(x_07 6893

DEVICE NAME: CryoSpray Ablation™ System

CSA Medical, Inc.

INDICATIONS FOR USE:

The CryoSpray Ablation™ System is intended to be used as a cryosurgical tool for destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X	or Over-The-Counter Use _____
(per 21 CFR 801.109

(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number	1090893
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CSAM 05-00002-00

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.