(187 days)
Not Found
No
The device description and performance studies focus on the mechanical and thermal aspects of cryosurgery, with no mention of AI or ML technologies. The "Mentions AI, DNN, or ML" and "Description of the training set..." sections are explicitly marked as "Not Found".
Yes
The device is described as a "cryosurgical device" intended for "cryoadhesion applications" and "palliative devitalization (destruction) of tissue by the application of extreme cold," which directly indicates a therapeutic purpose.
No
The device is described as a cryosurgical device used for therapeutic applications such as tissue removal and devitalization by applying extreme cold, not for diagnosing conditions.
No
The device description clearly outlines hardware components including a flexible cryocatheter, a CO2 refrigerant cartridge, and a refrigerant dispenser. It also describes a physical mechanism of action (Joule-Thomson effect) involving these hardware components.
Based on the provided information, the Celsio Flexible Cryocatheter System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly describes a device used during interventional procedures to physically interact with and manipulate tissue (removal, destruction, biopsy). This is an in vivo application, meaning it's used within a living organism.
- Device Description: The description details a cryosurgical device that applies extreme cold to tissue in contact with the catheter tip. This is a direct physical interaction with tissue within the body.
- Anatomical Site: The anatomical sites listed are within the body (respiratory tree, GI tract, urethral tract).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens outside of the body (in vitro), such as blood, urine, or tissue samples. There is no indication of it being used for diagnostic purposes based on analyzing these samples.
IVD devices are specifically designed to examine specimens obtained from the human body to provide information for diagnostic, monitoring, or screening purposes. The Celsio Flexible Cryocatheter System's function is therapeutic and interventional, not diagnostic based on in vitro analysis.
N/A
Intended Use / Indications for Use
The Celsio Flexible Cryocatheter System is intended for cryoadhesion applications during interventional procedures such as the removal of tissue, foreign bodies, mucous plugs, blood clots, necrotic tissue, tumors and tissue biopsies, and for palliative devitalization (destruction) of tissue by the application of extreme cold.
Product codes
GEH
Device Description
The Celsio Flexible Cryocatheter System is a cryosurgical device with a disposable carbon dioxide (CO2) cartridge that is used with commercially available endoscopes with a minimum working channel diameter of 2mm and maximum working length of 1052 mm, in interventional endoscopic procedures.
The Celsio Flexible Cryocatheter System is comprised of a Flexible Cryocatheter (sterile, single use), a CO2 Refrigerant Cartridge (non-sterile, single use) and a Refrigerant Dispenser (nonsterile, single use).
The flexible cryocatheter is typically delivered using a compatible endoscope to the target location. Once the refrigerant dispenser is activated, pressurized refrigerant fluid is delivered to the catheter tip where it undergoes expansion to its lower temperature (the Joule-Thomson effect), causing surrounding tissue in contact with the catheter tip to freeze and adhere.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Endoscopic uses through natural orifice (respiratory tree, GI tract, urethral tract etc.)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospital Setting
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
To support the substantial equivalence, performance testing of the subject device was conducted in accordance with the applicable standards and guidance documents to ensure that the subject device performs as intended. Design Verification and Validation testing was performed to evaluate the physical, performance and the safety specifications of the device. Device sterility, shelf life, and biological safety of device materials to the point of use were validated according to FDA recognized consensus standards and guidance documents. Thermal characteristics were tested and measured to evaluate substantial equivalence by assessing the ice ball dimensions, temperature, cooling and thawing rates. Pre-clinical testing (ex-vivo, in-vivo and post mortem) was conducted to evaluate the performance and safety of the subject device. The tests demonstrated that the technological characteristics of the subject device do not raise any new questions of safety or effectiveness. The acceptance criteria have been satisfied for all the tests.
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 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.
September 24, 2024
Endocision Technologies Inc. Anthony Sirgi Director, Regulatory Affairs and Quality 338 Rue Saint-Antoine Est, Suite 407 Montreal, QC H2Y1A3 Canada
Re: K240776
Trade/Device Name: Celsio Flexible Cryocatheter System Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical Unit And Accessories Regulatory Class: Class II Product Code: GEH Dated: March 14, 2024 Received: August 30, 2024
Dear Anthony Sirgi:
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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrb/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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
2
Sincerely,
Digitally signed by Long H. Chen Long H. Chen-S Date: 2024.09.24 11:44:11 -04'00'
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
3
Indications for Use
Submission Number (if known)
Device Name
Celsio Flexible Cryocatheter System
Indications for Use (Describe)
The Celsio Flexible Cryocatheter System is intended for cryoadhesion applications during interventional procedures such as the removal of tissue, foreign bodies, mucous plugs, blood clots, necrotic tissue, tumors and tissue biopsies, and for palliative devitalization (destruction) of tissue by the application of extreme cold.
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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K240776
ഫ് EndoCision 510(k) Summary: Celsio Flexible Cryocatheter System
In accordance with the requirements of 21 CFR 807.92 of the Federal Code of Regulations, the following information is a summary of safety and effectiveness for the Celsio Flexible Cryocatheter System.
| SUBMITTERS INFORMATION | |
|---|---|
| Submitted by: | Endocision Technologies Inc. |
| 338 Rue Saint - Antoine Est, Suite 407 | |
| Montreal, Quebec | |
| H2Y1A3, Canada | |
| Contact Person: | Anthony Sirgi |
| Director, Regulatory Affairs and Quality | |
| Tel: 857-529-5014 ext 202 | |
| Date Prepared: | September 24th, 2024 |
| DEVICE INFORMATION | |
| Registration Number: | K240776 |
| Device Trade Name: | Celsio Flexible Cryocatheter System |
| Regulation Name: | Cryosurgical Unit and Accessories |
| Device Class: | Class II |
| Product Code: | GEH |
| Classification Panel: | General & Plastic Surgery |
21 CFR 878.4350
PREDICATE DEVICE
Regulation Number:
K190651 - ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe
DEVICE DESCRIPTION
The Celsio Flexible Cryocatheter System is a cryosurgical device with a disposable carbon dioxide (CO2) cartridge that is used with commercially available endoscopes with a minimum working channel diameter of 2mm and maximum working length of 1052 mm, in interventional endoscopic procedures.
5
് Endocision 510(k) Summary: Celsio Flexible Cryocatheter System
The Celsio Flexible Cryocatheter System is comprised of a Flexible Cryocatheter (sterile, single use), a CO2 Refrigerant Cartridge (non-sterile, single use) and a Refrigerant Dispenser (nonsterile, single use).
The flexible cryocatheter is typically delivered using a compatible endoscope to the target location. Once the refrigerant dispenser is activated, pressurized refrigerant fluid is delivered to the catheter tip where it undergoes expansion to its lower temperature (the Joule-Thomson effect), causing surrounding tissue in contact with the catheter tip to freeze and adhere.
INTENDED USE/INDICATIONS FOR USE
The Celsio Flexible Cryocatheter System is intended for cryoadhesion applications during interventional procedures such as the removal of tissue, foreign bodies, mucous plugs, blood clots, necrotic tissue, tumors and tissue biopsies, and for palliative devitalization (destruction) of tissue by the application of extreme cold.
SUBSTANTIAL EQUIVALENCE COMPARISON
| Table 1: Comparison of Celsio Flexible Cryocatheter System (Subject Device) and
| Erbecryo 2 (Predicate Device) | ||
|---|---|---|
| Characteristics | Subject Device (K240776) | Predicate Device (K190651) |
| Trade Name | Celsio Flexible Cryocatheter | |
| system | ERBECRYO 2 Cryosurgical | |
| Unit and Accessories: | ||
| ERBECRYO 2 cryosurgical | ||
| unit; Erbe Flexible Cryoprobe | ||
| Manufacturer | Endocision Technologies Inc. | Erbe Elektromedizin GmbH |
| Product Code | GEH | GEH |
| Regulation | 21 CFR 878.4350 | 21 CFR 878.4350 |
| Device Class | Class II | Class II |
| Indication for use/Intended | ||
| Use | The Celsio Flexible | |
| Cryocatheter System is | ||
| intended for cryoadhesion | ||
| applications during | ||
| interventional procedures | ||
| such as the removal of tissue, | ||
| foreign bodies, mucous | ||
| plugs, blood clots, necrotic | ||
| tissue, tumors and tissue | The Erbe Flexible | |
| Cryoprobes are intended for | ||
| palliative devitalization | ||
| (destruction) of tissue during | ||
| interventional procedures by | ||
| the application of extreme | ||
| cold and cryoadhesion for | ||
| applications such as the | ||
| removal of foreign bodies, | ||
| biopsies, and for palliative | ||
| devitalization (destruction) of | ||
| tissue by the application of | ||
| extreme cold. | mucus plugs, blood clots, | |
| necrotic tissue, tissue tumors | ||
| (palliative recanalization) and | ||
| tissue biopsies. | ||
| Target Population | Patients which required | |
| removal of foreign body, | ||
| tissue and palliative | ||
| destruction of tissue through | ||
| endoscopic techniques | Patients which required | |
| removal of foreign body, | ||
| tissue and palliative | ||
| destruction of tissue through | ||
| endoscopic techniques | ||
| Intended Anatomical Site | Endoscopic uses through | |
| natural orifice (respiratory | ||
| tree, GI tract, urethral tract | ||
| etc.) | Endoscopic uses through | |
| natural orifice (respiratory | ||
| tree, GI tract, urethral tract | ||
| etc.) | ||
| Prescription Use | Yes | Yes |
| Environment of Use/Usage | Hospital Setting / single- | |
| patient use device | Hospital Setting / single- | |
| patient use catheter | ||
| Cryogenic Gas used | Carbon Dioxide (CO2) | Carbon Dioxide (CO2) |
| Cryogen Source | Disposable CO2 Cartridge | Refillable CO2 Cylinder |
| Provided Sterile | Yes, ethylene oxide (Flexible | |
| Cryocatheter and tissue | ||
| removal tool) | Yes, ethylene oxide (Flexible | |
| Cryocatheter and tissue | ||
| removal tool) | ||
| Application of Cryogenic Gas | ||
| (Cooling activation method) | Handheld Refrigerant | |
| Dispenser with a lever | Foot Pedal and | |
| Electromechanical console | ||
| Dimensions | Outer Diameter: 1.7mm (5 Fr) | |
| Working Length: 1200mm | Outer Diameter: 1.7mm (5 Fr) | |
| Working Length: 1150mm | ||
| Umbilical Cord: 2.5m | ||
| Connection of Catheter to | ||
| User Interface | Proprietary Quick-Connect | |
| Connector | Proprietary Three-Pronged | |
| Connector | ||
| Thermodynamic Effect | Joule-Thomson | Joule-Thomson |
| Safety and Performance | ||
| Standards | Conformity to current | |
| recognized Standards | Conformity to current | |
| recognized Standards |
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EndoCision 510(k) Summary: Celsio Flexible Cryocatheter System
The differences are not significant and do not raise additional questions of safety and effectiveness as can be demonstrated by a review of predicate device characteristics, design and development standards, and non-clinical performance testing.
7
ڪ Endocision 510(k) Summary: Celsio Flexible Cryocatheter System
PERFORMANCE DATA
To support the substantial equivalence, performance testing of the subject device was conducted in accordance with the applicable standards and guidance documents to ensure that the subject device performs as intended. Design Verification and Validation testing was performed to evaluate the physical, performance and the safety specifications of the device. Device sterility, shelf life, and biological safety of device materials to the point of use were validated according to FDA recognized consensus standards and guidance documents. Thermal characteristics were tested and measured to evaluate substantial equivalence by assessing the ice ball dimensions, temperature, cooling and thawing rates. Pre-clinical testing (ex-vivo, in-vivo and post mortem) was conducted to evaluate the performance and safety of the subject device. The tests demonstrated that the technological characteristics of the subject device do not raise any new questions of safety or effectiveness. The acceptance criteria have been satisfied for all the tests.
CONCLUSION
The subject device (Celsio Flexible Cryocatheter System K240776) and the predicate device (ERBEcryo2 Cryosurgical unit and accessories, K190651) are both cryosurgical devices intended for cryoadhesion and cryodevitalization. There are only minor technological differences between the two devices. However, the similarities in function, purpose and the performance testing for the subject device assure that it is at least as safe and effective as the legally marketed predicate device.