(28 days)
The truFreeze System is indicated for use as a cryosurgical tool in the fields of dermatology, gynecology, and general surgery, to ablate benign (e.g. Barrett's Esophagus with high grade dysplasia and/or low grade dysplasia) and malignant lesions.
The truFreeze system is a cryosurgical tool that applies medical-grade liquid nitrogen to the ablation area via a small, low pressure, open tipped catheter. The truFreeze System consists of a console and a disposable spray kit. The console is the central interface of the system and is comprised of a touch panel computer (TPC) and cryogen, suction, and electronics modules packaged in a mobile cart. Users interact with the console through a dual foot pedal and a touch panel. An off-the-shelf controller and associated software manage the cryogen level sensing, filling, pressure, cooling, defrost, suction, timing and data management functions. A fill kit, stored on the rear of the console, allows for liquid nitrogen transfer from the source tank to the console. Safety features include indicators, tank pressure relief valves, an isolated low voltage power system, and an emergency button to be used in the event of user or technical malfunction. There are 2 types of spray kits available. One kit is available for active venting procedures and one is available for passive venting procedures. Both active and passive venting kits are provided in a carton of five (5) individually packaged sterile, single-use catheters with introducers (an introducer is a spring that is introduced into the accessory channel port of the endoscope to provide additional strain relief to the catheter during insertion and retraction from the endoscope) in individual pouches. These catheters are used to introduce the liquid nitrogen to the desired site. Additionally, the active venting kit is provided with a carton of five (5) individually packaged sterile, single-use cryo decompression tubes (CDTs) with associated tubing in individual pouches. The CDTs are used for the removal of the gaseous nitrogen from the patient. Each carton within a spray kit contains the instructions for use.
The truFreeze System is a cryosurgical tool validated through a series of non-clinical performance tests. The acceptance criteria and the study results are as follows:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria (Implicit from "Pass") | Reported Device Performance |
|---|---|---|
| Suction flow rate | Meets specified flow rate requirements | Pass |
| Kink Resistance | Maintains patency under specified kinking conditions | Pass |
| Dimensional measurements | Adheres to design specifications | Pass |
| Tensile strength of bonded joints | Meets specified tensile strength requirements | Pass |
| Biocompatibility testing | Complies with ISO-10993 requirements | Pass |
| Product sterility adoption | Achieves a Sterility Assurance Level (SAL) of 10^-6 | Pass |
| Simulated use testing | Performs as intended during simulated use scenarios | Pass |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample sizes for each specific test in the "Summary of Non-Clinical Performance Testing." The tests are labeled as "verification testing," which typically involves conducting tests on a representative number of units to ensure consistency and compliance.
The data provenance is from non-clinical testing conducted by STERIS Corporation for a modification to their existing truFreeze System (K222272). This is presumably prospective testing, as it was specifically done to validate the redesigned 16 French (Fr) cryo-decompression tube. The country of origin of the data is not explicitly stated, but given STERIS Corporation's address in Mentor, Ohio, USA, it can be inferred that the testing was conducted in the USA or by labs commissioned by them.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the described study is a series of non-clinical performance tests, not a clinical study involving human or image-based ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable for the same reason as point 3. The testing involves objective physical and functional measurements against predefined specifications.
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:
This information is not applicable. The truFreeze System is a cryosurgical tool, not an AI-assisted diagnostic or imaging device used with human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. The truFreeze System is a physical medical device, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the non-clinical performance testing, the "ground truth" is defined by engineering specifications, established standards (e.g., ISO-10993 for biocompatibility), and functional requirements derived from the intended use of the device. For example, for "Suction flow rate," the ground truth would be a predetermined flow rate range that the device must achieve.
8. The sample size for the training set:
This information is not applicable. The device is a hardware system, and the reported testing is traditional engineering verification, not machine learning model training.
9. How the ground truth for the training set was established:
This information is not applicable for the same reason as point 8.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services-USA. To the right, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
December 2, 2022
STERIS Corporation Mr. Carroll Martin Regulatory Affairs Director 5960 Heislev Road Mentor, Ohio 44060
Re: K223369
Trade/Device Name: truFreeze System Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: Class II Product Code: GEH Dated: November 1, 2022 Received: November 4, 2022
Dear Mr. Martin:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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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 (OS) 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 mediation-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,
Colin K. Chen -S
for
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) K223369
Device Name truFreeze System
Indications for Use (Describe)
The truFreeze System is indicated for use as a cryosurgical tool in the fields of dermatology, and general surgery, to ablate benign (e.g. Barrett's Esophagus with high grade dysplasia and/or low grade dysplasa) and malignant lesions.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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STERIS®
510(k) Summary for the truFreeze System
STERIS Corporation Manufacturer 5960 Heisley Road Mentor, OH 44060
Contact:
Mr. Carroll Martin Regulatory Affairs Director 5976 Heisley Road Mentor, Ohio 44060 Tel: 440-358-6259 Email: Carroll_Martin@steris.com
Submission Date: November 1, 2022
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
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Device Name 1.
| Trade Name: | truFreeze System |
|---|---|
| Device Class: | Class II |
| Regulation Name: | Cryosurgical Unit and Accessories |
| Common/usual Name: | Cryosurgical Unit |
| Regulation Number: | 21 CFR 878.4350 |
| Product Code: | GEH |
2. Predicate Device
truFreeze System, K222272
This submission is for a modification to the device that was the subject of K222272, the predicate device
3. Device Description
The truFreeze system is a cryosurgical tool that applies medical-grade liquid nitrogen to the ablation area via a small, low pressure, open tipped catheter. The truFreeze System consists of a console and a disposable spray kit.
The console is the central interface of the system and is comprised of a touch panel computer (TPC) and cryogen, suction, and electronics modules packaged in a mobile cart. Users interact with the console through a dual foot pedal and a touch panel. An off-the-shelf controller and associated software manage the cryogen level sensing, filling, pressure, cooling, defrost, suction, timing and data management functions. A fill kit, stored on the rear of the console, allows for liquid nitrogen transfer from the source tank to the console. Safety features include indicators, tank pressure relief valves, an isolated low voltage power system, and an emergency button to be used in the event of user or technical malfunction.
There are 2 types of spray kits available. One kit is available for active venting procedures and one is available for passive venting procedures. Both active and passive venting kits are provided in a carton of five (5) individually packaged sterile, single-use catheters with introducers (an introducer is a spring that is introduced into the accessory channel port of the endoscope to provide additional strain relief to the catheter during insertion and retraction from the endoscope) in individual pouches. These catheters are used to introduce the liquid nitrogen to the desired site.
Additionally, the active venting kit is provided with a carton of five (5) individually packaged sterile, single-use cryo decompression tubes (CDTs) with associated tubing in individual pouches. The CDTs are used for the removal of the gaseous nitrogen from the patient. Each carton within a spray kit contains the instructions for use.
4. Indications 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 (e.g. Barrett's Esophagus with high grade dysplasia and/or low grade dysplasia) and malignant lesions.
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Technological Characteristics Comparison Table 5.
A comparison of technical characteristics between the proposed and predicate devices is summarized in Table 1.
| Features | truFreeze SystemPredicate Device K222272 | Modified Device | Comparison |
|---|---|---|---|
| Intended Use | The truFreeze System isindicated for use as acryosurgical tool in the fields ofdermatology, gynecology, andgeneral surgery, to ablate benign(e.g. Barrett's Esophagus withhigh grade dysplasia and/or lowgrade dysplasia) and malignantlesions. | The truFreeze System isindicated for use as acryosurgical tool in the fields ofdermatology, gynecology, andgeneral surgery, to ablate benign(e.g. Barrett's Esophagus withhigh grade dysplasia and/or lowgrade dysplasia) and malignantlesions. | Identical |
| Construction | The truFreeze System consists ofa console that is used to controlthe application of the cryogen,spray catheters, active and passiveventing sets and cryo-decompression tubing sets andconnectors | The truFreeze System consists ofa console that is used to controlthe application of the cryogen,spray catheters, active and passiveventing sets and cryo-decompression tubing sets andconnectors | Identical |
| Sterile/Non-sterile | Non-sterile (console)Sterile (spray catheters and cryo-decompression tube) | Non-sterile (console)Sterile (spray catheters and cryo-decompression tube) | Identical |
| SterilizationMethod | Ethylene Oxide | Ethylene Oxide | Identical |
| SterilizationAssurance Level | 10-6Single Use:Spray catheters and cryo-decompression tubing | 10-6Single Use:Spray catheters and cryo-decompression tubing | Identical |
| Usage | Reusable:Console | Reusable:Console | Identical |
| Principle ofOperation toAchieve Cooling | Via pressurized liquid nitrogen(LN2) | Via pressurized liquid nitrogen(LN2) | Identical |
| Method toDestroy Tissue | Uses freeze/thaw/freeze cycle | Uses freeze/thaw/freeze cycle | Identical |
| Ability to ReachEquivalent Dose | Achieve a 4 cm ice ball within 12min (total elapsed time) | Achieve a 4 cm ice ball within 12min (total elapsed time) | Identical |
| Point Source forDestruction ofTissue | Catheter head | Catheter head | Identical |
| Liquid NitrogenCapability toFreeze Tissue | -196°C | -196°C | Identical |
| Features | truFreeze SystemPredicate Device K222272 | Modified Device | Comparison |
| OutputTemperature atCatheter Tip | -196°C | -196°C | Identical |
| Equivalent IceFormation | Able to produce an average 23.4mm (radius measurement) ice ballwithin 5 minutes | Able to produce an average 23.4 mm(radius measurement) ice ball within5 minutes | Identical |
| EquivalentTemperatureDistribution | (a) freeze depth of 21.87mm at 0°C-20°C isotherm at 15.5mm depth-40°C isotherm at 11.8mm depth | (a) freeze depth of 21.87mm at 0°C-20°C isotherm at 15.5mm depth-40°C isotherm at 11.8mm depth | Identical |
| Delivery ofCryogen | A spray delivered through a 2.2mm(7 F) sterile conduit; straightcatheterControlled by user | A spray delivered through a 2.2mm(7 F) sterile conduit; straight catheterControlled by user | Identical |
| Consistentdelivery ofcryogencontrolled fortarget site | Computer driven | Computer driven | Identical |
| Guidancerequired forprocedure | Direct visualization via anendoscope or bronchoscope | Direct visualization via an endoscopeor bronchoscope | Identical |
| Safety Features/Mitigations | Users can stop dose at any time viafoot pedal activation or emergencystop button | Users can stop dose at any time viafoot pedal activation or emergencystop button | Identical |
| Features/Mitigations(catheter/probe) | Confirms use of a compatiblecatheter using RFID | Confirms use of a compatiblecatheter using RFID | Identical |
| Notifies physicianto stop spraying | Audible beeper to coincide withvisual display of timer. | Audible beeper to coincide withvisual display of timer. | Identical |
| Computerized testof system prior touse | Uses computer program to test thatsystem is properly operating beforeexposure of cryotherapy | Uses computer program to test thatsystem is properly operating beforeexposure of cryotherapy | Identical |
| Computerizedcontinuousmonitoring ofsystem duringprocedure | Uses computer program to abortfreezing if a system failure isdetected | Uses computer program to abortfreezing if a system failure isdetected | Identical |
| Ensure patient isnot exposed tohigh pressuregases | Uses active suction pump and CDT,or a natural orifice, as perinstructions for use.Instructions for Use provide ventingguidance for proper gas egress | Uses active suction pump and CDT,or a natural orifice, as perinstructions for use.Instructions for Use provide ventingguidance for proper gas egress | Identical |
| Protect healthytissue fromexcessivetemperatures | Uses endoscope or bronchoscope tohelp insulate when using internally.Contains insulation outside of scopeto protect user. | Uses endoscope or bronchoscope tohelp insulate when using internally.Contains insulation outside of scopeto protect user. | Identical |
| Pressure Controls | Valves and pressure transducer tocontrol pressure of liquid nitrogen(LN2); Redundant pressure switch;Mechanical Relief | Valves and pressure transducer tocontrol pressure of liquid nitrogen(LN2); Redundant pressure switch;Mechanical Relief | Identical |
| Features | truFreeze SystemPredicate Device K222272 | Modified Device | Comparison |
| Thermal/Defrost | Active defrost capability to thawcatheter using warm Nitrogen gas | Active defrost capability to thawcatheter using warm Nitrogen gas | Identical |
| Safe storage ofcryogenic agent | Single Dewar tank | Single Dewar tank | Identical |
| Biocompatibility | Patient contact materials complywith ISO -10993 | Patient contact materials complywith ISO -10993 | Identical |
Table 1. Technological Characteristics Comparison Table
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6. Summary of Changes
The changes that are the subject of this submission are as follows:
-
The 16 French (Fr) cryo-decompression tube has been redesigned to make it more robust. Stainless steel support wires have been added to make the tube substantially more robust, even during challenging procedures. This modification has also resulted in a change to the specification of the bend radius of the cryo-decompression tube specification from 3 inches to 1.5 inches to reflect an improvement in stability.
The changes were initiated for the following reasons: -
Redesign to the 16Fr cyro-decompression tube is being conducted due to ● customer feedback that the device required careful handling.
Summary of Non-Clinical Performance Testing 7.
For the redesign of the 16 Fr cryo-decompression tube, the following verification testing was conducted:
| Test | Result |
|---|---|
| Suction flow rate | Pass |
| Kink Resistance | Pass |
| Dimensional measurements | Pass |
| Tensile strength of bonded joints | Pass |
| Biocompatibility testing | Pass |
| Product sterility adoption | Pass |
| Simulated use testing | Pass |
8. Conclusion
Based on the intended use and technological characteristics, the subject device is as safe and effective as the legally marketed predicate device (K222272).
§ 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.