(20 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 provided text is a 510(k) Summary for the truFreeze System, which is a cryosurgical tool. This document primarily focuses on demonstrating substantial equivalence to a predicate device and addresses labeling changes, rather than presenting a performance study with acceptance criteria for a new or modified device.
Therefore, most of the requested information regarding acceptance criteria and performance study details is not available in this document. The document explicitly states:
- "No performance testing was conducted as the subject of this submission is changes to the labeling only."
This means there is no study described that "proves the device meets the acceptance criteria" in the traditional sense of a clinical or performance study for a new device. The submission is for administrative and labeling changes.
However, I can extract information related to the device's characteristics and the basis for its substantial equivalence, which implicitly indicates its expected performance based on the predicate device.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as "acceptance criteria" for a new performance study. However, the "Technological Characteristics Comparison Table" (Table 1 on page 5) lists performance specifications that the device is expected to meet because it's identical to the predicate device. These characteristics essentially serve as the "performance" assumed to be met.
- Reported Device Performance: The document states the device's characteristics are "Identical" to the predicate, K171626. Therefore, the performance values are the same as those established for the predicate device.
| Characteristic | Acceptance Criteria (from predicate) | Reported Device Performance |
|---|---|---|
| Intended Use | Same as predicate | Identical |
| Construction | Same as predicate | Identical |
| Sterile/Non-sterile | Non-sterile (console), Sterile (catheters & CDTs) | Identical |
| Sterilization Method | Ethylene Oxide | Identical |
| Sterilization Assurance Level | 10-6 | Identical |
| Usage | Single Use (catheters & CDTs), Reusable (console) | Identical |
| Principle of Operation to Achieve Cooling | Via pressurized liquid nitrogen (LN2) | Identical |
| Method to Destroy Tissue | Uses freeze/thaw/freeze cycle | Identical |
| Ability to Reach Equivalent Dose | Achieve a 4 cm ice ball within 12 min (total elapsed time) | Identical |
| Point Source for Destruction of Tissue | Catheter head | Identical |
| Liquid Nitrogen Capability to Freeze Tissue | -196°C | Identical |
| Output Temperature at Catheter Tip | -196°C | Identical |
| Equivalent Ice Formation | Able to produce an average 23.4 mm (radius) ice ball within 5 minutes | Identical |
| Equivalent Temperature Distribution | @ freeze depth of 21.87mm at 0°C; -20°C isotherm at 15.5mm depth; -40°C isotherm at 11.8mm depth | Identical |
| Delivery of Cryogen | A spray through a 2.2mm (7 F) sterile conduit; straight catheter, Controlled by user | Identical |
| Consistent delivery of cryogen controlled for target site | Computer driven | Identical |
| Guidance required for procedure | Direct visualization via an endoscope or bronchoscope | Identical |
| Safety Features/Mitigations | Stop dose via foot pedal/emergency button; compatible catheter check (RFID); audible beeper/visual timer; computerized system test/monitoring/abort | Identical |
| Ensure patient is not exposed to high pressure gases | Uses active suction pump and CDT, or natural orifice, as per IFU; venting guidance | Identical |
| Protect healthy tissue from excessive temperatures | Uses endoscope/bronchoscope for insulation; insulation outside of scope | Identical |
| Pressure Controls | Valves and pressure transducer for LN2 pressure control; redundant pressure switch; mechanical relief | Identical |
| Thermal/Defrost | Active defrost using warm Nitrogen gas | Identical |
| Safe storage of cryogenic agent | Single Dewar tank | Identical |
| Biocompatibility | Patient contact materials comply with ISO -10993 | Identical |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. The document states "No performance testing was conducted." Therefore, there is no test set, sample size, or data provenance from a new study to report.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable / Not provided. No new performance study was conducted that would require expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. No new performance study was conducted.
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 / Not provided. This device is a cryosurgical tool, not an AI/imaging diagnostic device. No MRMC study was mentioned or performed for this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable / Not provided. This is a hardware device, not an algorithm. No standalone algorithm performance was assessed for this submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Not provided. No new performance study requiring ground truth establishment was conducted for this submission. The basis for safety and effectiveness is substantial equivalence to the predicate device, which would have had its performance and safety established through prior testing and clinical use.
8. The sample size for the training set
- Not applicable / Not provided. No machine learning or AI model development is described, so there is no training set mentioned.
9. How the ground truth for the training set was established
- Not applicable / Not provided. No machine learning or AI model development is described, so there is no training set or ground truth establishment for it.
In summary, this 510(k) submission is for administrative and labeling changes for a cryosurgical system and explicitly states that no new performance testing was conducted. Therefore, the detailed information about acceptance criteria, study design, and ground truth establishment requested for a performance study is not available within the provided document. The device's performance is assumed to be identical to its predicate, K171626, based on the lack of changes affecting performance.
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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 is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 18, 2022
STERIS Corporation Mr. Carroll Martin Regulatory Affairs Director 5960 Heisley Road Mentor, Ohio 44060
Re: K222272
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: July 29, 2022 Received: July 29, 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 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
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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,
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) K222272
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 dysplasia) and malignant lesions.
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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Image /page/3/Picture/1 description: The image shows the logo for STERIS. The logo consists of the word "STERIS" in a bold, sans-serif font, with the registered trademark symbol (®) to the right of the word. Below the word "STERIS" is a graphic of several horizontal, wavy lines in a light blue color.
510(k) Summary for the truFreeze System
STERIS Corporation 5960 Heisley Road Mentor, OH 44060
| Contact: | Mr. Carroll Martin |
|---|---|
| Regulatory Affairs Director | |
| Tel: 440-358-6259 | |
| Email: Carroll_Martin@steris.com |
Submission Date: July 29, 2022
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
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1. Device Name
| 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, K171626
Device Description 3.
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.
Indications for Use 4.
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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5. Technological Characteristics Comparison Table
A comparison of technical characteristics between the proposed and predicate devices is summarized in Table 1.
| Features | truFreeze SystemPredicate Device K171626 | 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 andcryodecompression tubing setsand connectors | The truFreeze System consists ofa console that is used to controlthe application of the cryogen,spray catheters, active and passiveventing sets andcryodecompression tubing setsand connectors | Identical |
| Sterile/Non-sterile | Non-sterile (console)Sterile (spray catheters andcryodecompression tube) | Non-sterile (console)Sterile (spray catheters andcryodecompression tube) | Identical |
| SterilizationMethod | Ethylene Oxide | Ethylene Oxide | Identical |
| SterilizationAssurance Level | 10-6 | 10-6 | Identical |
| Usage | Single Use:Spray catheters andcryodecompression tubing | Single Use:Spray catheters andcryodecompression tubing | Identical |
| Reusable:Console | Reusable:Console | ||
| 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 K171626 | 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 | @ freeze depth of 21.87mm at 0°C-20°C isotherm at 15.5mm depth-40°C isotherm at 11.8mm depth | @ 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 K171626 | 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 following is a summary of the changes in this submission:
- To take the previous instructions for use that contained instructions for both passive and active venting and separate it into two instructions for use: one for active venting and one for passive venting.
- Update the previous owner's manual
These changes were initiated for the following reasons:
- Transfer of the truFreeze device from CSA to STERIS ●
- Clarification of some information in the original instructions for use
- Addition of information for user convenience ●
- . Standardization of information in accordance with STERIS instructions for use
- Formatting
None of the modified information is related to issues of device performance.
7. Summary of Non-Clinical Performance Testing
No performance testing was conducted as the subject of this submission is changes to the labeling only.
Conclusion 8.
Based on the intended use and technological characteristics, the subject device is as safe and effective as the legally marketed predicate device (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.