(79 days)
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.
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 Nasal/Oral Gastric Tube detailed in the K060555 and K070893 submission is of a single lumen design, with suction ports spanning the distal 15 inches of the tube, allowing ports to be positioned in the esophagus and stomach simultaneously. The only device modification presented in this Abbreviated 510(k) submission involves a tubing configuration modification for the Nasal/Oral Gastric Tube. The modified Nasal/Oral Gastric Tube is a dual lumen product with the addition of a vent lumen for the gastric section of the tube. While identical materials are used as compared to the Nasal/Oral Gastric Tube listed in submission K060555 and K070893, the dual lumen tubing allows one lumen to provide active suction while the second lumen provides passive venting in the gastric section.
The provided text is a 510(k) premarket notification for a medical device modification, specifically the CryoSpray Ablation™ System. This type of submission focuses on demonstrating "substantial equivalence" to a predicate device rather than presenting new clinical study data with acceptance criteria for device performance. Therefore, most of the requested information regarding acceptance criteria, study design, sample size, ground truth, and expert evaluation is not available in this document.
Here's an analysis of what can be extracted and what is missing:
1. Table of acceptance criteria and the reported device performance
- Not Available. This document describes a modification to an existing device (Nasal/Oral Gastric Tube) and relies on the substantial equivalence principle. It does not present performance data against specific acceptance criteria for the device itself, as would be expected for a new device requiring detailed clinical testing for efficacy or diagnostic performance. Instead, it states that the modified device "does not change the operating principals or mechanism of action" and is "substantially equivalent" to predicate devices.
2. Sample size used for the test set and the data provenance
- Not Available. No specific test set or associated sample size is mentioned. The submission is about a component modification and its substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Available. As no test set data is presented, there's no mention of experts establishing ground truth.
4. Adjudication method for the test set
- Not Available. No test set data or adjudication is described.
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 ablation system, not an imaging or diagnostic AI device. Therefore, MRMC studies and AI assistance metrics are 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 physical medical device, not an algorithm, so standalone algorithm performance is not relevant.
7. The type of ground truth used
- Not Available. No specific ground truth related to performance evaluation is mentioned in this document. The "ground truth" for substantial equivalence in this context is the performance and safety of the legally marketed predicate devices.
8. The sample size for the training set
- Not Applicable/Not Available. The concept of a "training set" for an algorithm does not apply to this physical device modification.
9. How the ground truth for the training set was established
- Not Applicable/Not Available. As above, this concept is not relevant to this submission.
Summary of Device Modification and Substantial Equivalence Claim:
The document describes a modification to the Nasal/Oral Gastric Tube component of the CryoSpray Ablation™ System.
- Original Tube: Single lumen design with suction ports.
- Modified Tube: Dual lumen design, adding a vent lumen for passive venting in the gastric section while one lumen provides active suction.
- Claim for Substantial Equivalence: The manufacturer asserts that the modification does not change the operating principles or mechanism of action of the system and that "identical materials are used". Therefore, the modified device is considered substantially equivalent to the previously cleared CryoSpray Ablation™ System (K070893 and K060555) and the CryMed Cryo-Ablator (K040809).
The FDA's decision to clear the device (K072651) indicates agreement with the manufacturer's claim of substantial equivalence based on the provided technical information, rather than new clinical performance data against specific acceptance criteria.
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CryoSpray "Ablation System Abbreviated 510(k) Submission
DEC - 7 2007
510(k) Safety Summary
September 2007 Submitted by:
CSA Medical, Inc. Emerging Technology Center 1101 E. 33rd, Third Floor - #E305 Baltimore, MD 21218 O: 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
- Common Name: Cryosurgical Unit, Cryogenic Surgical Device .
- Cryosurgical unit with Liquid Nitrogen, Class II Classification: . [21 CFR § 878.4350(a)].
- Establishment Registration Number: � 9062377
Predicate Devices Device
Premarket Notification
| SprayGenix™ Cryo Ablation System | K060555 |
|---|---|
| CryoSpray Ablation System | K070893 |
| CryMed Cryo-Ablator | K040809 |
Company History:
CSA Medical, Inc., formerly CryMed Technologies, Inc., 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 Modification 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
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CryoSpray TM Ablation System Abbreviated 510(k) Submission
appropriate position through the use of visual observation. The cryo-catheter applies the cryogen to a selected area and freezes the unwanted tissue. The Nasal/Oral Gastric Tube detailed in the K060555 and K070893 submission is of a single lumen design, with suction ports spanning the distal 15 inches of the tube, allowing ports to be positioned in the esophagus and stomach simultaneously.
The only device modification presented in this Abbreviated 510(k) submission involves a tubing configuration modification for the Nasal/Oral Gastric Tube. The modified Nasal/Oral Gastric Tube is a dual lumen product with the addition of a vent lumen for the gastric section of the tube. While identical materials are used as compared to the Nasal/Oral Gastric Tube listed in submission K060555 and K070893, the dual lumen tubing allows one lumen to provide active suction while the second lumen provides passive venting in the gastric section. Refer to Attachments A.
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 qeneral surgery, specifically for endoscopic applications.
The intended use of the Nasal/Oral Gastric Tube, as described in its labeling, has not changed as a result of the configuration modification. Refer to Attachment C.
Technical Characteristics:
The modification to the Nasal/Oral Gastric Tube 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 Nasal/Oral Gastric Tube results in a CryoSpray Ablation™ System that is substantially equivalent to devices currently marketed in the United States.
Certification of Conformance Standard: Refer to Attachment 2.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a representation of human figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
CSA Medical, Inc. % Mr. Tim Askew President & CEO 1101 E. 33rd Street, #E305 Baltimore, Maryland 21218
DEC - 7 2007
Re: K072651
Trade/Device Name: CryoSpray Ablation™ System Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: II Product Code: GEH Dated: November 8, 2007 Received: November 20, 2007
Dear Mr. Askew:
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 - Mr. Tim Askew
This letter will allow you to begin marketing your device as described in your Section 510(k) rms loter will and my your e FDA finding of substantial equivalence of your device to a legally promated 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 yours,
Mark M Millican
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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CryoSpray TM Ablation System Abbreviated 510(k) Submission
Indications for Use
510(k) Number (if known): __
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 (per 21 CFR 801.109
Over-The-Counter Use__
Sign-Ol Division of General, Restorative, and Neurological De
510(k) Number 1672657
4
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§ 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.