(220 days)
Not Found
No
The document describes a cryosurgical system that uses liquid nitrogen spray for tissue ablation. There is no mention of AI or ML in the intended use, device description, or performance studies. The system appears to be a purely mechanical and cryogen-based device.
Yes.
The device is intended for the "cryogenic destruction of tissue" to "ablate benign" conditions in the upper gastrointestinal tract, which falls under the definition of therapeutic use.
No
The device is intended for cryogenic destruction and ablation of tissue, which are therapeutic actions, not diagnostic ones.
No
The device description clearly outlines hardware components including a console, catheter, suction canister connector, and patient tube, which are integral to the device's function. While software verification is mentioned in the performance studies, the device is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "cryogenic destruction of tissue" and "to ablate benign (e.g., Barrett's Esophagus with high grade and/or low grade dysplasia) in the upper gastrointestinal tract". This is a therapeutic procedure performed directly on the patient's tissue in vivo.
- Device Description: The device is a system for delivering liquid nitrogen spray to ablate tissue. It includes a console, catheter, and components for suctioning gas. These are all tools used for a surgical procedure.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) in vitro to provide diagnostic information about a patient's health.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device performs a therapeutic action (tissue ablation) directly on the patient.
N/A
Intended Use / Indications for Use
Intended Use:
The truFreeze® System is intended for cryogenic destruction of tissue using Liquid Nitrogen spray that has a boiling point of -196°C, requiring either active or passive venting during surgical procedures.
Indications for Use. VortexTM Radial Spray catheter:
The Vortex™ Radial Spray catheter is indicated for use as a cryosurgical tool to ablate benign (e.g., Barrett's Esophagus with high grade and/or low grade dysplasia) in the upper gastrointestinal tract using active venting.
Product codes (comma separated list FDA assigned to the subject device)
GEH
Device Description
The CSA Medical (CSA) truFreeze® System consists of a truFreeze Console and a truFreeze Spray Catheter Kit. The truFreeze Console is to be used only with a truFreeze Spray Kit. This document specifically applies to the Vortex Radial Spray Kit (20-00360) for use with the truFreeze® System. Vortex Radial delivers liquid nitrogen in a 3-cm long, 360° spray pattern to ablate circumferential, epithelium such as Barrett's Esophagus.
The Vortex Radial Spray Kit (20-00360) consists of one (1) truFreeze Vortex Radial Spray Catheter (20-00187), one (1) 4-inch Suction Canister Connector, and one (1) Patient Tube.
The catheter is connected to the console and transports cryogen from the console to the targeted ablation area. The Suction Cannector and Patient Tube provide the connection from the suction source in the console to the Cryo-Decompression Tube (CDT) at the end of the catheter, to provide active evacuation (suction) of nitrogen gas at the ablation site. The spray head is surrounded by the Mesh that expands to dilate the lumen to a diameter of 20 mm and center the device during the delivery of cryogen spray.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper gastrointestinal tract
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)
A number of bench tests were conducted to verify the product design met the predetermined product performance specifications. Testing was inclusive of the following: Product Design and Software verification, Shelf-life in accordance with ISO 11607, Sterilization in accordance with ISO 11135:2014, EMC/Safety per IEC 60601-12:2014, Distribution Testing per ISTA 2A:2011 and Usability. The Vortex™ Radial Spray catheter is classified as surfacting, mucosal membrane device having limited contact duration (
§ 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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December 7, 2020
CSA Medical, Inc. Heather Nigro SVP, Regulatory/Quality/Clinical Affairs 91 Hartwell Ave Lexington, Massachusetts 02421
Re: K201183
Trade/Device Name: Vortex Radial Spray Catheter Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical Unit And Accessories Regulatory Class: Class II Product Code: GEH Dated: November 4, 2020 Received: November 5, 2020
Dear Heather Nigro:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
1
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); medical device reporting of medical device-related adverse events) (21 CFR 803) for
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201183
Device Name truFreeze® System, Vortex™ Radial Spray Catheter
Indications for Use (Describe)
Intended Use:
The truFreeze® System is intended for cryogenic destruction of tissue using Liquid Nitrogen spray that has a boiling point of -196°C, requiring either active or passive venting during surgical procedures.
Indications for Use. VortexTM Radial Spray catheter:
The Vortex™ Radial Spray catheter is indicated for use as a cryosurgical tool to ablate benign (e.g., Barrett's Esophagus with high grade and/or low grade dysplasia) in the upper gastrointestinal tract using active venting.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
CSA Medical, Inc. truFreeze® System Vortex™ Radial Spray Catheter Traditional 510(k) Premarket Notification
K201183
510(k) Summary
This 510(k) Summary is being submitted in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The content contained in this 510(k) summary has been provided in conformance with 21 CFR §807.92
Date Prepared:
December 7, 2020
Submitter's Information:
| Name: | CSA Medical, Inc. |
|---|---|
| Address: | 91 Hartwell Avenue |
| Lexington, MA 02421 | |
| FDA Establishment | |
| Owner/Operator Number: | 3010140265 |
| Contact Person: | Heather V. Nigro, MS, RAC |
| SVP, Regulatory/Quality/Clinical Affairs | |
| Phone: | 781-538-4793 (office) or 781-640-8426 (mobile) |
| Fax: | 866-300-5183 |
| e-mail: | hnigro@csamedical.com |
| Legal Manufacturer: | CSA Medical, Inc. |
| 91 Hartwell Avenue | |
| Lexington, MA 02421 | |
| Facility Establishment | |
| Identification (FEI) Number: | 3004534508 |
| Trade/Proprietary Name: | truFreeze® System, Vortex™ Radial Spray Catheter |
| Common/Usual Name: | Cryosurgical Catheter |
| Classification Name: | Cryosurgical Unit, Cryogenic Surgical Device |
| Regulation Number: | 21 CFR 878.4350 |
| Product Code: | GEH |
| Device Classification: | Class II |
| Predicate Device | truFreeze System, K171626 |
4
CSA Medical, Inc. truFreeze® System Vortex™ Radial Sprav Catheter Traditional 510(k) Premarket Notification
Device Description:
The CSA Medical (CSA) truFreeze® System consists of a truFreeze Console and a truFreeze Spray Catheter Kit. The truFreeze Console is to be used only with a truFreeze Spray Kit. This document specifically applies to the Vortex Radial Spray Kit (20-00360) for use with the truFreeze® System. Vortex Radial delivers liquid nitrogen in a 3-cm long, 360° spray pattern to ablate circumferential, epithelium such as Barrett's Esophagus.
The Vortex Radial Spray Kit (20-00360) consists of one (1) truFreeze Vortex Radial Spray Catheter (20-00187), one (1) 4-inch Suction Canister Connector, and one (1) Patient Tube.
The catheter is connected to the console and transports cryogen from the console to the targeted ablation area. The Suction Cannector and Patient Tube provide the connection from the suction source in the console to the Cryo-Decompression Tube (CDT) at the end of the catheter, to provide active evacuation (suction) of nitrogen gas at the ablation site. The spray head is surrounded by the Mesh that expands to dilate the lumen to a diameter of 20 mm and center the device during the delivery of cryogen spray.
Indications for use:
The Indications for Use statement for the truFreeze® System is:
The truFreeze System is intended for cryogenic destruction of tissue using Liquid Nitrogen spray that has a boiling point of -196°C requiring either active or passive venting during surgical procedures. The Vortex™ Radial Spray catheter is indicated for use as a cryosurgical tool to ablate benign lesions (e.g., Barrett's Esophagus with high grade and/or low grade dysplasia) in the upper gastrointestinal tract using active venting.
Technological Characteristics:
The proposed device and predicate device are based on the same technological characteristics including principle of operation via pressure-propelled cryogen, application of liquid nitrogen to ablate unwanted tissue, and delivery of equivalent cooling power density per unit area. The differentiator for the Vortex™ catheter is that the cryogen is sprayed radially as compared to the previously cleared catheters which spray linearly.
| Characteristic | Predicate truFreeze® System, (171626) | Proposed truFreeze® System, Vortex™ Radial Spray Kit |
|---|---|---|
| Intended Use | Intended for cryogenic destruction of tissue using liquid nitrogen spray that has a boiling point of -196°C requiring either active or passive venting during surgical procedures. | Intended for cryogenic destruction of tissue using liquid nitrogen spray that has a boiling point of - 196°C requiring either active or passive venting during surgical procedures. |
| Indication for Use | The truFreeze® System is | |
| indicated for use as a | ||
| cryosurgical tool in the fields of | ||
| dermatology, gynecology, and | ||
| general surgery, to ablate | ||
| benign (eg. Barrett's | ||
| Esophagus with high grade | ||
| and/or low grade dysplasia) | ||
| and malignant lesions. | The truFreeze System is intended | |
| for cryogenic destruction of tissue | ||
| using Liquid Nitrogen spray that | ||
| has a boiling point of -196°C | ||
| requiring either active or passive | ||
| venting during surgical | ||
| procedures. The Vortex™ Radial | ||
| Spray catheter is indicated for use | ||
| as a cryosurgical tool to ablate | ||
| benign lesions (e.g., Barrett's | ||
| Esophagus with high grade | ||
| and/or low grade dysplasia) in the | ||
| upper gastrointestinal tract | ||
| Cryogen | Liquid nitrogen | Liquid nitrogen |
| Principle of Operation | Pressure Propelled Cryogen | Pressure Propelled Cryogen |
| Mode of Ablation | ≥1 freeze-thaw cycles, | |
| Quantity determined by | ||
| physician | ≥1 freeze-thaw cycles, | |
| Quantity determined by physician | ||
| Delivery/Cryoprobe | Spray Tip (Linear) | Spray Tip (Circumferential) |
| Output Temperature | -196°C | -196°C |
| Cooling Power Density, | ||
| Low Flow (12.5 W, N/A | ||
| W) | 2.7 to 4.0 W/cm² | N/A |
| Cooling Power Density, | ||
| Normal Flow (25 W, | ||
| 100 W) | 5.3 to 8.0 W/cm² | 5.3 W/cm² |
| 1Depth of Freeze in | ||
| Hydrogel when used | ||
| per IFU at nominal | ||
| settings (mean ± SD) | 1.0 mm ± 0.4 mm | 1.0 mm ± 0.2 mm |
| Delivery of Cryogen | ||
| (spray dosimetry) | Physician-controlled duration | |
| (GUI activated timer with | ||
| audible cues) | Physician-controlled duration | |
| (pedal activated timer with audible | ||
| cues) | ||
| 0 s to 60 s, 5-s increment | 10 s to 20 s, 1-s increment | |
| Procedure | ||
| Visualization | Direct visualization via | |
| endoscope | Direct visualization via endoscope | |
| Early spray termination | User control via foot pedal | |
| release or emergency stop | ||
| button | User control via foot pedal | |
| release or emergency stop button | ||
| Prevent use/reuse of | ||
| expired or invalid | ||
| catheter | Confirms use of valid catheter | |
| using RFID | Confirms use of valid catheter | |
| using RFID | ||
| Notifies physician to | ||
| stop spraying | Audible beeper to coincide with | |
| visual display of timer | Audible beeper to coincide with | |
| visual display of timer. Console | ||
| terminates spray at physician- | ||
| selected duration | ||
| Computerized test of | ||
| system prior to use | Software test confirms system | |
| is properly operating before | ||
| exposure of cryotherapy | Software test confirms system is | |
| properly operating before | ||
| exposure of cryotherapy | ||
| Computerized | ||
| continuous monitoring | ||
| of system during | ||
| procedures | Uses computer program to | |
| abort freezing if a system failure | ||
| is detected | Uses computer program to abort | |
| freezing if a system failure is | ||
| detected | ||
| Ensure patient is not | ||
| exposed to high | ||
| pressure gases | Uses active suction pump and | |
| CDT (active), or a natural orifice | ||
| (passive), as per instructions for | ||
| use. IFU provides venting | ||
| guidance for proper gas egress. | Uses active suction pump and | |
| integral CDT (active) and passive | ||
| egress channels as per | ||
| instructions for use. Console | ||
| pump activation during spray | ||
| delivery. IFU provides venting | ||
| guidance for proper gas egress. | ||
| Protect healthy tissue | ||
| from excessive | ||
| temperatures | Provides sufficient insulation to | |
| maintain safe temperature on | ||
| patient and user exposure | ||
| surfaces | Provides sufficient insulation to | |
| maintain safe temperature on | ||
| patient and user exposure | ||
| surfaces | ||
| Pressure Controls | Valves and pressure transducer | |
| to control pressure of liquid | ||
| nitrogen; redundant pressure | ||
| switch; mechanical relief valve; | ||
| redundant burst disc. | Valves and pressure transducer | |
| to control pressure of liquid | ||
| nitrogen; redundant pressure | ||
| switch; mechanical relief valve; | ||
| redundant burst disc. | ||
| Thermal/Defrost | Active defrost capability to thaw | |
| catheter using warm nitrogen | ||
| gas | Active defrost capability to thaw | |
| catheter using warm nitrogen gas | ||
| Safe Storage of | ||
| Cryogen | Internal Pressure-rated vacuum | |
| insulated Dewar | Internal Pressure-rated vacuum | |
| insulated Dewar | ||
| Product Label | Uniquely identifies catheter as | |
| linear spray for active or | ||
| passive venting procedures. | Uniquely identifies catheter as | |
| radial spray for active venting | ||
| procedures. | ||
| Sterility | Sterile catheter provided using | |
| Ethylene Oxide with SAL 10-6 | Sterile catheter provided using | |
| Ethylene Oxide with SAL 10-6 | ||
| Biocompatibility | Patient (direct and indirect) | |
| contacting materials comply | ||
| with ISO 10993 | Patient (direct and indirect) | |
| contacting materials comply with | ||
| ISO 10993 |
5
CSA Medical, Inc. truFreeze® System
Vortex™ Radial Spray Catheter Traditional 510(k) Premarket Notification
6
CSA Medical, Inc. truFreeze® System Vortex™ Radial Spray Catheter Traditional 510(k) Premarket Notification
Summary of Performance Testing - Bench, Non-clinical, Clinical:
A number of bench tests were conducted to verify the product design met the predetermined product performance specifications. Testing was inclusive of the following: Product Design and Software verification, Shelf-life in accordance with ISO 11607, Sterilization in accordance with ISO 11135:2014, EMC/Safety per IEC 60601-12:2014, Distribution Testing per ISTA 2A:2011 and Usability. The Vortex™ Radial Spray catheter is classified as surfacting, mucosal membrane device having limited contact duration (