(60 days)
Not Found
No
The document describes a cryotherapy system that uses gas to freeze tissue. There is no mention of AI or ML in the intended use, device description, or performance studies. The software manages the therapy delivery but is not described as using AI/ML algorithms.
Yes
The device is explicitly intended to "freeze/ablate tissue" for a variety of medical conditions, including cancerous tissue, tumors, and lesions, which are therapeutic interventions.
No
This device is a cryotherapy delivery system designed to freeze/ablate tissue, which is a therapeutic rather than a diagnostic function.
No
The device description clearly outlines a physical system including a console, monitor, power supply, gas ports, and interfaces for cryoprobes and temp probes, in addition to the software.
Based on the provided information, the CRYOCARE TOUCH™ System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the system is for use in surgical procedures to freeze/ablate tissue within the body. IVD devices are used to examine specimens from the body (like blood, urine, or tissue samples) to provide information about a person's health.
- Device Description: The description details a surgical system that delivers extreme cold temperatures directly to tissue. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing samples, providing diagnostic information based on sample analysis, or any of the typical characteristics of an IVD device.
The CRYOCARE TOUCH™ System is a therapeutic device used for surgical intervention, not for in vitro diagnosis.
N/A
Intended Use / Indications for Use
The CRYOCARE TOUCH™ System is intended for use in open, minimally invasive or endoscopic surgical procedures in the areas in general surgery, urology, oncology, oncology, dermatology, ENT, proctology, pulmonary surgery and thoracic surgery. The system is designed to freeze/ablate tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts. In addition, the system is intended for use in the following indications:
General Surgery
- · Destruction of warts or lesions
- · Palliation of tumors of the oral cavity, rectum and skin
- · Ablation of breast fibroadenomas
• Ablation of leukoplakia of the mouth, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas, small hemangiomas, mucocele cysts, multiple warts, hemorrhoids, anal fissures, perianal condylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemangiomas, recurrent cancerous lesions
Urology
· Ablation of prostate tissue in cases of prostate cancer and benign prostatic hyperplasia
Gynecology
· Ablation of malignant neoplasia or benign dysplasia of the female genitalia
Oncology
- · Ablation of cancerous or malignant tissue
- Ablation of benign tumors
- · Palliative intervention
Neurology
- · Freezing of nerve tissue in pain management/cryoanalgesia
Dermatology
· Ablation or freezing of skin cancers and other cutaneous disorders
Proctology
- Ablation of benign or malignant growths of the anus or rectum
- · Ablation of hemorrhoids
Thoracic Surgery
· Ablation of cancerous lesions
Product codes
GEH
Device Description
The CRYOCARE TOUCH™ System and accessories are a cryotherapy delivery system that is used to freeze/ablate tissue by the application of extreme cold temperatures.
The CRYOCARE TOUCH System is a standalone surgical system consists of a compact, easyto-operate console and associated accessories that include Endocare™ Cryoprobe devices to deliver cold temperatures to the therapeutic tissue and Endocare TempProbe™ Devices to monitor temperatures in the surrounding tissue. The system utilizes the Joule-Thomson effect and inert argon and helium gases to provide cryotherapy and is comprised of the following:
- . CRYOCARE TOUCH Control Console
- 15-inch LCD Touchscreen Monitor with folding Monitor Arm
- Side Handles to facilitate mobility ●
- Wheels with wheel locks
- . Power Supply
- . Argon Port, Regulator, and Supply Line
- . Helium Port, Regulator, and Supply Line
- . Cryoprobe Interface with eight (8) cryoprobe connections
- . TempProbe Interface with eight (8) TempProbe connections
- Alarm Audio Output on Back Panel
- . Remote Keypad
The CRYOCARE TOUCH system software manages the therapy delivered to the patient by the Endocare cryoprobes. The cryoprobes are designed to deliver cold temperatures for cryotherapy using highpressure argon gas circulated through the cryoprobe. Active tissue thawing is achieved by circulating helium gas through the cryoprobe. The refrigerative and warming capacity is limited to the distal end of the probe shaft.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
prostate and kidney tissue, liver metastases, tumors, skin, oral cavity, rectum, breast, eyelid or canthus area, anus
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Design Verification and Design Validation testing were completed to demonstrate that the CRYOCARE TOUCH System and Accessories performs as intended and meets its essential performance specifications:
- Each individual port displays the type of the probe connected adjacent to the port controls.
- . Monitor/ Screen must display temperature values of each probe (Cryoprobe and TempProbe) used for the cryoablation treatment. Temperature values shall be within +/- 3 °C of the displayed value from -150°C to 40°C.
- Monitor/ Screen must display the freeze, stick and thaw duration time; the time shall have an accuracy of +/- 1 second.
- System must display a warning and alarm if unexpected behavior is observed.
The biocompatibility testing of the Endocare cryoprobes was intended to demonstrate the biological safety of the subject cryoprobe model number PCS-17RS.
The sterilization validation testing of the Endocare cryoprobes was intended to demonstrate that the gamma radiation sterilization method achieves cryoprobe sterility.
Bench testing included testing of the system, software, and cryoprobes, including:
- Electrical Safety Testing in accordance with IEC 60601-1. ●
- . Electromagnetic Compatibility Testing in accordance with IEC 60601-1-2.
- . Human Factors and Usability Testing in accordance with IEC 60601-1-6 and IEC 62366.
- . Alarm system testing in accordance with IEC 60601-1-8.
- . Software development in accordance with IEC 62304 and the FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
- PCS-17RS Cryoprobe Biocompatibility Testing in accordance with ISO 10993 series of standards, including ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-12.
- . PCS-17RS Cryoprobe Sterilization Validation in accordance with ISO 11137-1, ISO 11137-2, 11137-3, ISO 11737-1, and ISO 11737-2.
Test results showed conformance to applicable requirements specifications and assured hazard safeguards functioned properly.
No animal studies or clinical tests have been included in this pre-market submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
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August 11, 2020
Varian Medical Systems, Inc. Mr. Peter Coronado Senior Director Regulatory Affairs 3100 Hansen Way, m/s E110 Palo Alto, California 94304
Re: K201588
Trade/Device Name: CRYOCARE TOUCH System and Accessories
Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical Unit and Accessories Regulatory Class: Class II Product Code: GEH Dated: June 11, 2020 Received: June 12, 2020
Dear Mr. Coronado:
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.
1
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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-
542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201588
Device Name CRYOCARE TOUCHTM System and Accessories
Indications for Use (Describe)
The CRYOCARE TOUCH™ System is intended for use in open, minimally invasive or endoscopic surgical procedures in the areas in general surgery, urology, oncology, oncology, dermatology, ENT, proctology, pulmonary surgery and thoracic surgery. The system is designed to freeze/ablate tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts. In addition, the system is intended for use in the following indications:
General Surgery
- · Destruction of warts or lesions
- · Palliation of tumors of the oral cavity, rectum and skin
- · Ablation of breast fibroadenomas
• Ablation of leukoplakia of the mouth, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas, small hemangiomas, mucocele cysts, multiple warts, hemorrhoids, anal fissures, perianal condylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemangiomas, recurrent cancerous lesions
Urology
· Ablation of prostate tissue in cases of prostate cancer and benign prostatic hyperplasia
Gynecology
· Ablation of malignant neoplasia or benign dysplasia of the female genitalia
Oncology
- · Ablation of cancerous or malignant tissue
- Ablation of benign tumors
- · Palliative intervention
Neurology
- · Freezing of nerve tissue in pain management/cryoanalgesia
Dermatology
· Ablation or freezing of skin cancers and other cutaneous disorders
Proctology
- Ablation of benign or malignant growths of the anus or rectum
- · Ablation of hemorrhoids
Thoracic Surgery
· Ablation of cancerous 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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Image /page/4/Picture/0 description: The image shows the word "varian" in a bold, sans-serif font. The letters are all lowercase and evenly spaced. The word is centered and takes up most of the frame. The color of the text is black, and the background is white.
Endocare, Inc. 9825 Spectrum Drive Building 2. Suite 250 Austin, TX 78717 www.varian.com
PREMARKET NOTIFICATION
K201588 510(k) Summary
CRYOCARE TOUCH™ System and Accessories
The following information is provided as required by 21 CFR 807.92
l. Submitter's Name:
Varian Medical Systems 3100 Hansen Way, m/s E110 Palo Alto, CA 94304
Contact Name: Mr. Peter J. Coronado, Senior Director Regulatory Affairs Phone: 650-424-6320 | Fax: 650-646-9200 E-mail: submissions.support@varian.com Date Prepared: 11 June 2020
ll. Device Information:
| Proprietary Name: | CRYOCARE TOUCH™ System and Accessories |
|---|---|
| Common/ Usual Name: | Cryosurgical Unit and accessories |
| Classification Name: | Cryosurgical unit and accessories |
| Regulation Number: | 21 CFR 878.4350 |
| Product Code: | GEH |
lll. Predicate Device:
Cryocare CS™ Surgical System (K153489)
IV. Device Description:
The CRYOCARE TOUCH™ System and accessories are a cryotherapy delivery system that is used to freeze/ablate tissue by the application of extreme cold temperatures.
The CRYOCARE TOUCH System is a standalone surgical system consists of a compact, easyto-operate console and associated accessories that include Endocare™ Cryoprobe devices to deliver cold temperatures to the therapeutic tissue and Endocare TempProbe™ Devices to monitor temperatures in the surrounding tissue. The system utilizes the Joule-Thomson effect and inert argon and helium gases to provide cryotherapy and is comprised of the following:
- . CRYOCARE TOUCH Control Console
- 15-inch LCD Touchscreen Monitor with folding Monitor Arm
- Side Handles to facilitate mobility ●
- Wheels with wheel locks
- . Power Supply
- . Argon Port, Regulator, and Supply Line
- . Helium Port, Regulator, and Supply Line
- . Cryoprobe Interface with eight (8) cryoprobe connections
- . TempProbe Interface with eight (8) TempProbe connections
- Alarm Audio Output on Back Panel
- . Remote Keypad
The CRYOCARE TOUCH system software manages the therapy delivered to the patient by the Endocare cryoprobes. The cryoprobes are designed to deliver cold temperatures for cryotherapy using highpressure argon gas circulated through the cryoprobe. Active tissue thawing is achieved by circulating helium gas through the cryoprobe. The refrigerative and warming capacity is limited to the distal end of the probe shaft.
5
Endocare. Inc. 9825 Spectrum Drive Building 2. Suite 250 www.varian.com
Endocare Cryoprobes consists of the following cryoprobe families:
- Variable Ice ("V-Probe™") Cryoprobes in straight and right-angle configurations with model ● numbers CVA2400, CVA2400RA.
- . Endocare™ Right Angle Cryoprobes with model numbers R3.8 and R3.8L.
- Endocare™ Cryoprobes in straight configuration with model number CRYO-48-F.
- Slimline™ Cryoprobes in right-angle configuration with model numbers PCS-17. PCS-17R, PCS-. 17RS, RS-17, RS-17L, PCS-24, PCS-24L, RS-24, RS-24L.
The TempProbe™ device is designed for use with the Endocare Cryocare Systems to monitor tissue temperatures in or around the targeted freeze zone. The TempProbe devices has model number CRYO-54-F and CRYO-55-F.
The Endocare Cryoprobes and TempProbe devices are previously cleared within K153489, except for the PCS-17RS cryoprobe model number which is included as a line extension within K201588. Additionally, K201588 proposes a standalone indicate for use the Endocare Cryoprobes (excluding the TempProbe devices). The proposed indication is included in the following section.
V. Indications for Use:
The CRYOCARE TOUCH™ System is intended for use in open, minimally invasive or endoscopic surgical procedures in the areas in general surgery, urology, gynecology, neurology, dermatology, ENT, proctology, pulmonary surgery and thoracic surgery. The system is designed to freeze/ablate tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts.
In addition, the system is intended for use in the following indications:
General Surgery
- Destruction of warts or lesions ●
- Palliation of tumors of the oral cavity, rectum and skin
- . Ablation of breast fibroadenomas
- Ablation of leukoplakia of the mouth, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas, small hemangiomas, mucocele cysts, multiple warts, plantar warts, hemorrhoids, anal fissures, perianal condylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemangiomas, recurrent cancerous lesions
Urology
. Ablation of prostate tissue in cases of prostate cancer and benign prostatic hyperplasia Gynecology
. Ablation of malignant neoplasia or benign dysplasia of the female genitalia Oncology
- . Ablation of cancerous or malignant tissue
- . Ablation of benign tumors
- . Palliative intervention
Neurology
. Freezing of nerve tissue in pain management/cryoanalgesia Dermatology
Ablation or freezing of skin cancers and other cutaneous disorders ● Proctology
- Ablation of benign or malignant growths of the anus or rectum
- Ablation of hemorrhoids
- Thoracic Surgery
- . Ablation of cancerous lesions
6
Endocare, Inc. 9825 Spectrum Drive Building 2, Suite 250 Austin, TX 78717 www.varian.com
VI. Comparison of Technological Characteristics with the Predicate Device:
At a high level, the subject device differs from the predicate as a result of the following characteristics:
- Removal of indication for ablation of arrhythmic cardiac tissue ●
- Touchscreen user interface
- Addition of pressure transducers
- . Corresponding software updates to incorporate the touchscreen and pressure transducers
- . Line extension to include model number PCS-17RS as a compatible accessory
The tables below include a high-level comparison of the predicate and subject devices.
| Feature and/or
Specification | Subject Device
CRYOCARE TOUCH System and
Accessories | Predicate Device
Cryocare CS Surgical System and
Accessories | Comparison
between Subject
and Predicate |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| 510(k) | K201588 | K153489 | N/A |
| Indications for
use | The Cryocare CS Surgical System is
intended for use in open, minimally
invasive or endoscopic surgical
procedures in the areas in general
surgery, urology, gynecology, oncology,
neurology, dermatology, ENT, proctology,
pulmonary surgery and thoracic surgery.
The system is designed to freeze/ablate
tissue by the application of extreme cold
temperatures including prostate and
kidney tissue, liver metastases, tumors,
skin lesions, and warts.
In addition, the system is intended for use
in the following indications:
General Surgery
• Destruction of warts or lesions
• Palliation of tumors of the oral cavity,
rectum and skin
• Ablation of breast fibroadenomas
• Ablation of leukoplakia of the mouth,
angiomas, sebaceous hyperplasia,
basal cell tumors of the eyelid or
canthus area, ulcerated basal cell
tumors, dermatofibromas, small
hemangiomas, mucocele cysts,
multiple warts, plantar warts,
hemorrhoids, anal fissures, perianal
condylomata, pilonidal cysts, actinic
and seborrheic keratoses, cavernous
hemangiomas, recurrent cancerous
lesions
Urology
• Ablation of prostate tissue in cases of
prostate cancer and benign prostatic
hyperplasia
Gynecology
• Ablation of malignant neoplasia or
benign dysplasia of the female
genitalia | The CRYOCARE TOUCH™ System is
intended for use in open, minimally
invasive or endoscopic surgical
procedures in the areas in general
surgery, urology, gynecology, oncology,
neurology, dermatology, ENT, proctology,
pulmonary surgery and thoracic surgery.
The system is designed to freeze/ablate
tissue by the application of extreme cold
temperatures including prostate and
kidney tissue, liver metastases, tumors,
skin lesions, and warts.
In addition, the system is intended for use
in the following indications:
General Surgery
• Destruction of warts or lesions
• Palliation of tumors of the oral cavity,
rectum and skin
• Ablation of breast fibroadenomas
• Ablation of leukoplakia of the mouth,
angiomas, sebaceous hyperplasia,
basal cell tumors of the eyelid or
canthus area, ulcerated basal cell
tumors, dermatofibromas, small
hemangiomas, mucocele cysts,
multiple warts, plantar warts,
hemorrhoids, anal fissures, perianal
condylomata, pilonidal cysts, actinic
and seborrheic keratoses, cavernous
hemangiomas, recurrent cancerous
lesions
Urology
• Ablation of prostate tissue in cases of
prostate cancer and benign prostatic
hyperplasia
Gynecology
• Ablation of malignant neoplasia or
benign dysplasia of the female
genitalia | Subject Device
removes the
indication for
"Ablation of
arrhythmic cardiac
tissue" |
| Feature and/or
Specification | Subject Device
CRYOCARE TOUCH System and
Accessories | Predicate Device
Cryocare CS Surgical System and
Accessories | Comparison
between Subject
and Predicate |
| | Ablation of cancerous or malignant tissue Ablation of benign tumors Palliative intervention Neurology Freezing of nerve tissue in pain management/cryoanalgesia Dermatology Ablation or freezing of skin cancers and other cutaneous disorders Proctology Ablation of benign or malignant growths of the anus or rectum Ablation of hemorrhoids Thoracic Surgery Ablation of arrhythmic cardiac tissue Ablation of cancerous lesions | Ablation of cancerous or malignant tissue Ablation of benign tumors Palliative intervention Neurology Freezing of nerve tissue in pain management/cryoanalgesia Dermatology Ablation or freezing of skin cancers and other cutaneous disorders Proctology Ablation of benign or malignant growths of the anus or rectum Ablation of hemorrhoids Thoracic Surgery Ablation of cancerous lesions | |
| Mechanism of
Action | Joule-Thomson Effect | Joule-Thomson Effect | Same |
| Freeze Gas | Argon | Argon | Same |
| Thaw Gas | Helium | Helium | Same |
| Human Interface
Device/
Connections | 1x Touchscreen
1 X Remote Keypad | 1x Integrated Main Keyboard
1 X Remote Keypad | Subject devices
incorporate
touchscreen
capability |
Table 1. – Predicate and Subject Device Comparison – CRYOCARE TOUCH System and Accessories
7
Endocare, Inc. 9825 Spectrum Drive Building 2. Suite 250 Austin, TX 78717 www.varian.com
Table 1. – Predicate and Subject Device Comparison – CRYOCARE TOUCH System and Accessories
Table 2. Predicate and Subject Device Comparison - PCS-17RS Cryoprobe
| Feature and/ or
Specification | Subject Device: PCS-17RS Endocare™
1.7mm Round Ice PerCryo™
Cryoprobe, Short | Predicate Device: PCS-17R Endocare™
1.7mm Round Ice PerCryo™ Cryoprobe | Comparison
between Subject
and Predicate |
|----------------------------------|------------------------------------------------------------------------------------|---------------------------------------------------------------------------|------------------------------------------------|
| 510(k) | K201588 | K153489 | N/A |
| Model | PCS-17RS | PCS-17R | New Model Number |
| Indications for use | Shares the CRYOCARE TOUCH System
indications for use. | Shares the CRYOCARE CS Surgical System
indications for use. | Same |
| Shaft Diameter | 1.7 mm | 1.7 mm | Same |
| Shaft Length | 7 cm | 15 cm | Subject device has
shorter shaft length |
| Shape of Probe Tip | Trocar | Trocar | Same |
| Usage | Sterile, Single-Use | Sterile, Single-Use | Same |
VII. Performance Data (Non-Clinical Testing)
Design Verification and Design Validation testing were completed to demonstrate that the CRYOCARE TOUCH System and Accessories performs as intended and meets its essential performance specifications:
- Each individual port displays the type of the probe connected adjacent to the port controls.
- . Monitor/ Screen must display temperature values of each probe (Cryoprobe and TempProbe) used for the cryoablation treatment. Temperature values shall be within +/- 3 °C of the displayed value from -150°C to 40°C.
- Monitor/ Screen must display the freeze, stick and thaw duration time; the time shall have an accuracy of +/- 1 second.
- System must display a warning and alarm if unexpected behavior is observed.
8
Fndocare, Inc. 9825 Spectrum Drive Building 2. Suite 250 www.varian.com
The system software for the subject device is considered to have a "major" level of concern, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator.
The biocompatibility testing of the Endocare cryoprobes was intended to demonstrate the biological safety of the subject cryoprobe model number PCS-17RS.
The sterilization validation testing of the Endocare cryoprobes was intended to demonstrate that the gamma radiation sterilization method achieves cryoprobe sterility.
Bench testing included testing of the system, software, and cryoprobes, including:
- Electrical Safety Testing in accordance with IEC 60601-1. ●
- . Electromagnetic Compatibility Testing in accordance with IEC 60601-1-2.
- . Human Factors and Usability Testing in accordance with IEC 60601-1-6 and IEC 62366.
- . Alarm system testing in accordance with IEC 60601-1-8.
- . Software development in accordance with IEC 62304 and the FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
- PCS-17RS Cryoprobe Biocompatibility Testing in accordance with ISO 10993 series of standards, including ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-12.
- . PCS-17RS Cryoprobe Sterilization Validation in accordance with ISO 11137-1, ISO 11137-2, 11137-3, ISO 11737-1, and ISO 11737-2.
Test results showed conformance to applicable requirements specifications and assured hazard safeguards functioned properly.
No animal studies or clinical tests have been included in this pre-market submission.
VIII. Determination of Substantial Equivalence to the Predicate Device
A subset of technological characteristics and features of the subject device differs from the predicate device. These differences are all considered to be enhancements of the predicate, intended to modernize the user interface.
The Intended Use and indications for use are substantially the same as the predicate device. Further, there are no changes in the principle of operation of the devices. The Verification and Validation demonstrates that the device is as safe and effective as the predicate. Varian therefore believes the data demonstrates that the CRYOCARE TOUCH System and Accessories is substantially equivalent to the predicate device, CRYOCARE CS Surgical System and Accessories.
IX. Conclusion
The assessment following the outcomes observed in the performance testing and software design verification and design validation determines that the CRYOCARE TOUCH System and Accessories conforms to the defined user needs and intended uses. Varian therefore considers the CRYOCARE TOUCH System and Accessories to be safe and effective and to perform at least as well as the predicate device.