(79 days)
No
The description focuses on the mechanical and cryo-ablation aspects of the device, with no mention of AI or ML. The modification described is a physical change to a tube configuration.
Yes
The device is intended to destroy unwanted tissue by applying extreme cold, which is a therapeutic action.
No
The device is described as a cryosurgical tool for destruction of unwanted tissue, not for diagnosis.
No
The device description clearly outlines hardware components such as a liquid nitrogen tank, cryocatheter, and a Nasal/Oral Gastric Tube, indicating it is a hardware-based system, not software-only.
Based on the provided information, the CryoSpray Ablation™ System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "as a cryosurgical tool for destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications." This describes a surgical procedure performed directly on a patient's tissue in vivo (within the living body).
- Device Description: The description details a system that applies extreme cold to tissue to destroy it. This is a therapeutic intervention, not a diagnostic test performed on samples in vitro (outside the living body).
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue samples, etc.) or the use of reagents or assays to detect specific substances or conditions.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The CryoSpray Ablation™ System's function is to treat tissue by destroying it, not to diagnose a condition by analyzing a sample.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GEH
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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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
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