(28 days)
Not Found
No
The description focuses on the mechanical and electronic components of a cryosurgical system, with no mention of AI or ML capabilities for image analysis, decision support, or other functions.
Yes.
Explanation: The device is indicated for use as a cryosurgical tool to ablate benign and malignant lesions, which directly aligns with the definition of a therapeutic device that treats or alleviates a disease or condition.
No.
The device is described as a "cryosurgical tool" used to "ablate" (destroy) benign and malignant lesions, indicating a therapeutic rather than diagnostic function.
No
The device description clearly outlines hardware components including a console, touch panel computer, cryogen/suction/electronics modules, foot pedal, fill kit, safety features, and disposable spray kits (catheters and decompression tubes). While software is mentioned as managing functions, it is integral to and controls the operation of the physical hardware system.
Based on the provided information, the truFreeze System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is described as a "cryosurgical tool" to "ablate benign and malignant lesions." This is a therapeutic procedure performed directly on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details a system that delivers liquid nitrogen to a target area within the body. This is consistent with a surgical or therapeutic device, not a device used for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (like blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The truFreeze System's function is to physically destroy tissue through freezing, which is a therapeutic action.
N/A
Intended Use / 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.
Product codes
GEH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
For the redesign of the 16 Fr cryo-decompression tube, the following verification testing was conducted:
- 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
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4350 Cryosurgical unit and accessories.
(a)
Identification —(1)Cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories. A cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold.(2)
Cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories. A cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures, including urological applications, by applying extreme cold.(3)
Cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories. A cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold. The device is intended to treat disease conditions such as tumors, skin cancers, acne scars, or hemangiomas (benign tumors consisting of newly formed blood vessels) and various benign or malignant gynecological conditions affecting vulvar, vaginal, or cervical tissue. The device is not intended for urological applications.(b)
Classification. Class II.
0
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
1
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
2
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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3
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
4
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.
5
Technological Characteristics Comparison Table 5.
A comparison of technical characteristics between the proposed and predicate devices is summarized in Table 1.
| Features | truFreeze System
Predicate Device K222272 | Modified Device | Comparison |
|---------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Intended 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. | 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. | Identical |
| Construction | The truFreeze System consists of
a console that is used to control
the application of the cryogen,
spray catheters, active and passive
venting sets and cryo-
decompression tubing sets and
connectors | The truFreeze System consists of
a console that is used to control
the application of the cryogen,
spray catheters, active and passive
venting sets and cryo-
decompression tubing sets and
connectors | 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 |
| Sterilization
Method | Ethylene Oxide | Ethylene Oxide | Identical |
| Sterilization
Assurance Level | 10-6
Single Use:
Spray catheters and cryo-
decompression tubing | 10-6
Single Use:
Spray catheters and cryo-
decompression tubing | Identical |
| Usage | Reusable:
Console | Reusable:
Console | Identical |
| Principle of
Operation to
Achieve Cooling | Via pressurized liquid nitrogen
(LN2) | Via pressurized liquid nitrogen
(LN2) | Identical |
| Method to
Destroy Tissue | Uses freeze/thaw/freeze cycle | Uses freeze/thaw/freeze cycle | Identical |
| Ability to Reach
Equivalent Dose | Achieve a 4 cm ice ball within 12
min (total elapsed time) | Achieve a 4 cm ice ball within 12
min (total elapsed time) | Identical |
| Point Source for
Destruction of
Tissue | Catheter head | Catheter head | Identical |
| Liquid Nitrogen
Capability to
Freeze Tissue | -196°C | -196°C | Identical |
| Features | truFreeze System
Predicate Device K222272 | Modified Device | Comparison |
| Output
Temperature at
Catheter Tip | -196°C | -196°C | Identical |
| Equivalent Ice
Formation | Able to produce an average 23.4
mm (radius measurement) ice ball
within 5 minutes | Able to produce an average 23.4 mm
(radius measurement) ice ball within
5 minutes | Identical |
| Equivalent
Temperature
Distribution | (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 of
Cryogen | A spray delivered through a 2.2mm
(7 F) sterile conduit; straight
catheter
Controlled by user | A spray delivered through a 2.2mm
(7 F) sterile conduit; straight catheter
Controlled by user | Identical |
| Consistent
delivery of
cryogen
controlled for
target site | Computer driven | Computer driven | Identical |
| Guidance
required for
procedure | Direct visualization via an
endoscope or bronchoscope | Direct visualization via an endoscope
or bronchoscope | Identical |
| Safety Features
/Mitigations | Users can stop dose at any time via
foot pedal activation or emergency
stop button | Users can stop dose at any time via
foot pedal activation or emergency
stop button | Identical |
| Features
/Mitigations
(catheter/probe) | Confirms use of a compatible
catheter using RFID | Confirms use of a compatible
catheter using RFID | Identical |
| Notifies physician
to stop spraying | Audible beeper to coincide with
visual display of timer. | Audible beeper to coincide with
visual display of timer. | Identical |
| Computerized test
of system prior to
use | Uses computer program to test that
system is properly operating before
exposure of cryotherapy | Uses computer program to test that
system is properly operating before
exposure of cryotherapy | Identical |
| Computerized
continuous
monitoring of
system during
procedure | Uses computer program to abort
freezing if a system failure is
detected | Uses computer program to abort
freezing if a system failure is
detected | Identical |
| Ensure patient is
not exposed to
high pressure
gases | Uses active suction pump and CDT,
or a natural orifice, as per
instructions for use.
Instructions for Use provide venting
guidance for proper gas egress | Uses active suction pump and CDT,
or a natural orifice, as per
instructions for use.
Instructions for Use provide venting
guidance for proper gas egress | Identical |
| Protect healthy
tissue from
excessive
temperatures | Uses endoscope or bronchoscope to
help insulate when using internally.
Contains insulation outside of scope
to protect user. | Uses endoscope or bronchoscope to
help insulate when using internally.
Contains insulation outside of scope
to protect user. | Identical |
| Pressure Controls | Valves and pressure transducer to
control pressure of liquid nitrogen
(LN2); Redundant pressure switch;
Mechanical Relief | Valves and pressure transducer to
control pressure of liquid nitrogen
(LN2); Redundant pressure switch;
Mechanical Relief | Identical |
| Features | truFreeze System
Predicate Device K222272 | Modified Device | Comparison |
| Thermal/Defrost | Active defrost capability to thaw
catheter using warm Nitrogen gas | Active defrost capability to thaw
catheter using warm Nitrogen gas | Identical |
| Safe storage of
cryogenic agent | Single Dewar tank | Single Dewar tank | Identical |
| Biocompatibility | Patient contact materials comply
with ISO -10993 | Patient contact materials comply
with ISO -10993 | Identical |
Table 1. Technological Characteristics Comparison Table
6
7
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).