(220 days)
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.
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.
The provided text is a 510(k) Premarket Notification for the CSA Medical, Inc. truFreeze® System, specifically the Vortex™ Radial Spray Catheter. This document primarily focuses on establishing substantial equivalence to a predicate device (K171626) by comparing technological characteristics and presenting performance testing results.
Crucially, this document does not contain a typical "acceptance criteria and study that proves the device meets the acceptance criteria" in the format of a clinical trial designed with defined endpoints (like sensitivity, specificity, accuracy) for a diagnostic AI device.
Instead, this submission is for a cryosurgical treatment device, not an AI/ML diagnostic tool. Therefore, the "acceptance criteria" and "study" are geared towards demonstrating the device's safety and effectiveness compared to a predicate device that performs a similar function.
Based on the provided text, here's an attempt to extract relevant information, adapting to the nature of the device:
1. Table of "Acceptance Criteria" (interpreted as performance specifications/comparisons to predicate) and Reported Device Performance:
| Characteristic / Acceptance Metric | Predicate Device (K171626) Performance | Proposed Device (Vortex™ Radial) Performance / Comparison |
|---|---|---|
| Intended Use | Cryogenic destruction of tissue using Liquid Nitrogen spray (-196°C), active/passive venting. | Same. |
| Indication for Use | Cryosurgical tool in dermatology, gynecology, general surgery to ablate benign (e.g., Barrett's Esophagus with HGD/LGD) and malignant lesions. | Cryosurgical tool to ablate benign lesions (e.g., Barrett's Esophagus with HGD/LGD) in the upper gastrointestinal tract using active venting. |
| Cryogen | Liquid nitrogen | Liquid nitrogen (Same) |
| Principle of Operation | Pressure Propelled Cryogen | Pressure Propelled Cryogen (Same) |
| Mode of Ablation | ≥1 freeze-thaw cycles, quantity determined by physician | ≥1 freeze-thaw cycles, quantity determined by physician (Same) |
| Delivery/Cryoprobe | Spray Tip (Linear) | Spray Tip (Circumferential) - This is a key differentiator and the focus of the submission's evidence. |
| Output Temperature | -196°C | -196°C (Same) |
| Cooling Power Density (Normal Flow) | 5.3 to 8.0 W/cm² | 5.3 W/cm² (Comparable) |
| Depth of Freeze in Hydrogel (mean ± SD) | 1.0 mm ± 0.4 mm | 1.0 mm ± 0.2 mm (Comparable) |
| Delivery of Cryogen (spray dosimetry) - Duration | 0s to 60s, 5s increment | 10s to 20s, 1s increment (Different, specific to radial spray) |
| Procedure Visualization | Direct visualization via endoscope | Direct visualization via endoscope (Same) |
| Early spray termination | User control via foot pedal release or emergency stop button | User control via foot pedal release or emergency stop button (Same) |
| Prevent use/reuse of expired/invalid catheter | Confirms use of valid catheter using RFID | Confirms use of valid catheter using RFID (Same) |
| Notifies physician to stop spraying | Audible beeper/visual display of timer | Audible beeper/visual display of timer. Console terminates spray (Same/Enhanced) |
| Computerized test of system prior to use | Software test confirms system is properly operating | Software test confirms system is properly operating (Same) |
| Computerized continuous monitoring of system during procedures | Uses computer program to abort freezing if system failure detected | Uses computer program to abort freezing if system failure detected (Same) |
| Ensure patient not exposed to high pressure gases | Active suction pump and CDT (active) or natural orifice (passive) per IFU. | Active suction pump and integral CDT (active) and passive egress channels per IFU. Console pump activation during spray delivery. (Same/Enhanced) |
| Protect healthy tissue from excessive temperatures | Sufficient insulation on patient/user exposure surfaces | Sufficient insulation on patient/user exposure surfaces (Same) |
| Pressure Controls | Valves, pressure transducer, redundant pressure switch, mechanical relief valve, redundant burst disc. | Valves, pressure transducer, redundant pressure switch, mechanical relief valve, redundant burst disc. (Same) |
| Thermal/Defrost | Active defrost capability to thaw catheter using warm nitrogen gas | Active defrost capability to thaw catheter using warm nitrogen gas (Same) |
| Safe Storage of Cryogen | Internal Pressure-rated vacuum insulated Dewar | Internal Pressure-rated vacuum insulated Dewar (Same) |
| Product Label | Uniquely identifies catheter as linear spray for active or passive venting. | Uniquely identifies catheter as radial spray for active venting. (Specific to device) |
| Sterility | Sterile catheter using Ethylene Oxide with SAL 10-6 | Sterile catheter using Ethylene Oxide with SAL 10-6 (Same) |
| Biocompatibility | Patient contacting materials comply with ISO 10993 | Patient contacting materials comply with ISO 10993 (Same) |
| Safety and Effectiveness (Clinical Equivalence to Predicate) | Established via prior clearance (K171626) with literature/RWD on linear spray | Bench, pre-clinical (swine), and clinical (literature/RWD for linear spray) to support safety and similar effect for radial spray |
| Procedural Safety (via pre-clinical swine studies) | N/A (implied by previous clearance) | All animals survived, no serious adverse events. Controlled depth of injury without reaching serosa. |
| Treatment Zone (via pre-clinical swine studies) | N/A (different spray pattern) | 3-cm-long circumferential treatment zone confirmed. |
2. Sample Size Used for the Test Set and Data Provenance:
- Bench Tests: "A number of bench tests were conducted to verify the product design met the predetermined product performance specifications." No specific sample sizes for these tests are mentioned.
- Pre-clinical (GLP Studies): "Three preclinical GLP studies were completed utilizing the Vortex™ Radial Spray catheter in swine." The exact number of swine used is not specified, only the number of studies.
- Clinical Data (Literature/RWD for Predicate Device):
- Literature: "Three scientific, peer-reviewed literature articles have been published demonstrating the ability of the predicate device (i.e. linear spray) to achieve circumferential freezing of diseased tissue in the esophagus."
- Patient Count from Literature: "73 patients have been treated with spray LN2 circumferentially since 2012 to ablate BE lesions."
- Real-World Data (RWD) from Registry: "Real-World Data (RWD) has been extracted from an ongoing prospective, multi-center patient registry."
- Patient Count from RWD: "Of the 112 patients identified in the registry as having Barrett's Esophagus, 49 of those patients received circumferential ablation."
- Provenance: No specific country of origin is mentioned for the literature or RWD, but it can be inferred to be from regions where such studies are conducted (likely US/Europe). The RWD is "prospective, multi-center."
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable in the context of this submission. This is not an AI diagnostic device requiring expert reading for ground truth establishment. The "ground truth" for this device's performance would be direct measurements (e.g., cooling power, depth of freeze in hydrogel) and histological assessment in animal models. Clinical outcomes cited from literature/RWD would be physician-documented.
4. Adjudication Method for the Test Set:
Not applicable. This is not a study requiring adjudication of expert readings from a test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No. This type of study (MRMC) is typically performed for diagnostic imaging devices to assess human reader performance with and without AI assistance. This submission is for a medical device that performs a physical ablation.
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. Bench and preclinical data are provided for the device's standalone physical performance.
7. The Type of Ground Truth Used:
- Bench Testing: Engineering specifications and direct physical measurements (e.g., temperature, power density, dimensional measurements).
- Pre-clinical (Swine Studies): Histopathology data (e.g., assessment of lesion size, depth of injury) and survival/adverse event data.
- Clinical Data (from Literature/RWD for predicate): Clinical outcomes (ablation endpoint, adverse events like stricture), and physician observations.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/ML device with a distinct training set. The "training" in this context refers to the development and iterative testing of the device throughout its design process.
9. How the Ground Truth for the Training Set Was Established:
Not applicable for the reasons stated above.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font.
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
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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
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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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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 AvenueLexington, MA 02421 |
| FDA EstablishmentOwner/Operator Number: | 3010140265 |
| Contact Person: | Heather V. Nigro, MS, RACSVP, 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 AvenueLexington, MA 02421 |
| Facility EstablishmentIdentification (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 |
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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 isindicated for use as acryosurgical tool in the fields ofdermatology, gynecology, andgeneral surgery, to ablatebenign (eg. Barrett'sEsophagus with high gradeand/or low grade dysplasia)and malignant lesions. | The truFreeze System is intendedfor cryogenic destruction of tissueusing Liquid Nitrogen spray thathas a boiling point of -196°Crequiring either active or passiveventing during surgicalprocedures. The Vortex™ RadialSpray catheter is indicated for useas a cryosurgical tool to ablatebenign lesions (e.g., Barrett'sEsophagus with high gradeand/or low grade dysplasia) in theupper 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 byphysician | ≥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/AW) | 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 inHydrogel when usedper IFU at nominalsettings (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 withaudible cues) | Physician-controlled duration(pedal activated timer with audiblecues) |
| 0 s to 60 s, 5-s increment | 10 s to 20 s, 1-s increment | |
| ProcedureVisualization | Direct visualization viaendoscope | Direct visualization via endoscope |
| Early spray termination | User control via foot pedalrelease or emergency stopbutton | User control via foot pedalrelease or emergency stop button |
| Prevent use/reuse ofexpired or invalidcatheter | Confirms use of valid catheterusing RFID | Confirms use of valid catheterusing RFID |
| Notifies physician tostop spraying | Audible beeper to coincide withvisual display of timer | Audible beeper to coincide withvisual display of timer. Consoleterminates spray at physician-selected duration |
| Computerized test ofsystem prior to use | Software test confirms systemis properly operating beforeexposure of cryotherapy | Software test confirms system isproperly operating beforeexposure of cryotherapy |
| Computerizedcontinuous monitoringof system duringprocedures | Uses computer program toabort freezing if a system failureis detected | Uses computer program to abortfreezing if a system failure isdetected |
| Ensure patient is notexposed to highpressure gases | Uses active suction pump andCDT (active), or a natural orifice(passive), as per instructions foruse. IFU provides ventingguidance for proper gas egress. | Uses active suction pump andintegral CDT (active) and passiveegress channels as perinstructions for use. Consolepump activation during spraydelivery. IFU provides ventingguidance for proper gas egress. |
| Protect healthy tissuefrom excessivetemperatures | Provides sufficient insulation tomaintain safe temperature onpatient and user exposuresurfaces | Provides sufficient insulation tomaintain safe temperature onpatient and user exposuresurfaces |
| Pressure Controls | Valves and pressure transducerto control pressure of liquidnitrogen; redundant pressureswitch; mechanical relief valve;redundant burst disc. | Valves and pressure transducerto control pressure of liquidnitrogen; redundant pressureswitch; mechanical relief valve;redundant burst disc. |
| Thermal/Defrost | Active defrost capability to thawcatheter using warm nitrogengas | Active defrost capability to thawcatheter using warm nitrogen gas |
| Safe Storage ofCryogen | Internal Pressure-rated vacuuminsulated Dewar | Internal Pressure-rated vacuuminsulated Dewar |
| Product Label | Uniquely identifies catheter aslinear spray for active orpassive venting procedures. | Uniquely identifies catheter asradial spray for active ventingprocedures. |
| Sterility | Sterile catheter provided usingEthylene Oxide with SAL 10-6 | Sterile catheter provided usingEthylene Oxide with SAL 10-6 |
| Biocompatibility | Patient (direct and indirect)contacting materials complywith ISO 10993 | Patient (direct and indirect)contacting materials comply withISO 10993 |
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CSA Medical, Inc. truFreeze® System
Vortex™ Radial Spray Catheter Traditional 510(k) Premarket Notification
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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 (<24 hours) therefore requiring cytotoxicity,
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CSA Medical, Inc. truFreeze® System Vortex™ Radial Sprav Catheter Traditional 510(k) Premarket Notification
sensitization and irritation testing. This testing was conducted in accordance with ISO 10993-1:2018, including 10993:5 and 10993:10. All testing confirmed that the product specifications had been met, demonstrated that the device is adequately designed for the labeled indications for use and the risk management report concluded that the benefits of the device outweigh the associated risks.
Three preclinical GLP studies were completed utilizing the Vortex™ Radial Spray catheter in swine for the purposes of dose ranging and gathering evidence of procedural safety consistent with other cleared truFreeze® accessories. Histopathology data confirmed a 3-cm-long circumferential treatment zone and showed controlled depth of injury without reaching the serosa. All animals survived and no serious adverse events were reported.
Three scientific, peer-reviewed literature articles have been published demonstrating the ability of the predicate device (i.e. linear spray) to achieve circumferential freezing of diseased tissue in the esophagus. The scientific, peer-reviewed literature provided evidence that 73 patients have been treated with spray LN2 circumferentially since 2012 to ablate BE lesions with a safety and efficacy profile. Additionally, Real-World Data (RWD) has been extracted from an ongoing prospective, multi-center patient registry which further documents evidence of circumferential spray of LN2 with a safety profile. Of the 112 patients identified in the registry as having Barrett's Esophagus, 49 of those patients received circumferential ablation. The mean BE segment length from the first procedure was 4.8 cm (range 1.0 - 13.0 cm) and the mean number of circumferentially ablated segments per procedure was 2.64 (range 2.0 - 7.0). The dosimetry used was consistent with the IFU for the linear spray catheter as most patients were treated with two sprays for 20 seconds. Procedures associated with an adverse event, stricture or serious adverse event are all below 4%.
Comparison to Predicate:
The truFreeze® Vortex™ catheter has the same intended use and utilizes the same fundamental technology as the predicate truFreeze® System and catheters (K171626). The truFreeze® Vortex™ catheter has been compared to the legally marketed predicate device as cleared through K171626 (August 30, 2017) and there are no new safety or effectiveness questions raised with this proposed modification. Therefore, it is believed that the proposed Vortex™ Radial Spray catheter is substantially equivalent to the truFreeze® System described in K171626.
§ 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.