(161 days)
Not Found
No
The summary describes a cryoablation system that uses gas circulation and a heating element for tissue freezing and thawing. There is no mention of AI, ML, image processing, or any data-driven decision-making components in the device description or performance studies.
Yes
The device is intended for cryoablative destruction of tissue during surgical procedures for various medical conditions, including cancer, benign tumors, and pain palliation, which clearly falls under therapeutic use.
No
The device is a therapeutic system intended for the destruction of tissue using extreme cold temperatures (cryoablation) during surgical procedures, not for diagnostic purposes.
No
The device description explicitly states it is a "mobile console system" and uses "high-pressure argon gas" and "helium gas" circulating through "closed-tip cryoablation needles" and potentially a "heating element inside the cryoablation needle." This indicates significant hardware components beyond just software.
Based on the provided information, the Visual-ICE™ Cryoablation System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the system is for "cryoablative destruction of tissue during surgical procedures." This involves directly treating tissue within the body.
- Device Description: The description details a system that uses gases and heating elements to freeze and thaw tissue in situ.
- Lack of IVD Characteristics: IVD devices are designed to examine specimens (like blood, urine, or tissue samples) outside the body to provide information for diagnosis, monitoring, or screening. The Visual-ICE™ system does not perform this function. It is a therapeutic device used for tissue destruction.
Therefore, the Visual-ICE™ Cryoablation System is a therapeutic device, not an IVD.
N/A
Intended Use / Indications for Use
The Visual-ICE™ Cryoablation System is intended for cryoablative destruction of tissue during surgical procedures. The Visual-ICE™ Cryoablation System is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery (with the exception of cardiac tissue), ENT, gynecology, oncology, proctology, and urology. The system is designed to destroy tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, and skin lesions.
The Visual-ICE Cryoablation System has the following specific indications:
· Urology Ablation of prostate tissue in cases of prostate cancer and Benign Prostate Hyperplasia (BPH)
· Oncology Ablation of cancerous or malignant tissue and beingn tumors, and palliative intervention. Palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard radiation therapy.
· Dermatology Ablation or freezing of skin cancers and other cutaneous disorders; destruction of warts or lesions, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas, small hemangiomas, mucocele cysts, multiple warts, actinic and sebortheic keratosis, cavernous hemangiomas, peri-anal condylomata, and palliation of tumors of the skin
· Gynecology Ablation of malignant neoplasia or benign dysplasia of the female genitalia
· General surgery Palliation of tumors of the rectum, anal fissures, and recurrent cancerous lessions, ablation of breast fibroadenomas
• ENT Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth
· Thoracic surgery (with the exception of cardiac tissue)
• Proctology Ablation of benign or malignant growths of the anus or rectum
Product codes
GEH
Device Description
The Visual-ICE Cryoablation System is a mobile console system intended for cryoablative tissue destruction using a minimally invasive procedure. The Visual-ICE™ System uses high-pressure argon gas that circulates through closed-tip cryoablation needles to induce tissue freezing. Active tissue thawing is achieved by circulating helium gas through the needles or, alternatively, using Boston Scientific's i-Thaw technology in which a heating element inside the cryoablation needle can be energized to cause thawing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
prostate, kidney, liver, skin, bone, female genitalia, rectum, anal, breast, oral cavity, 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)
The safety and effectiveness of use of the Visual-ICE™ Cryoablation System for pain palliation of metastatic lesions in bone was evaluated in 'Multicenter Study of Cryoablation for Palliation of Painful Bone Metastases (MOTION)'. This was a multi-center (11 sites: 7 in US and 4 in Europe), single-arm, prospective, nonrandomized clinical trial assessing the efficacy of cryoablation for palliation of painful metastases in patients (n=66).
Key Results: A 2-point reduction from baseline in BPI score for worst pain in the last 24 hours was achieved with respect to mean change and median change at week 1 and every subsequent timepoint through week 24. When evaluated using measures of worst pain reduction and decrease in analgesic usage as outlined by the International Bone Metastases Consensus Working Party, 57.8% of patients achieved complete or partial response by week 1, with scores improving until the maximum percentage of patients (70%) achieved complete or partial response at week 12. Treatment with the Visual-ICE Cryoablation System led to consistent improvements from baseline in subjects' quality of life, as assessed using the BPI-SF Pain Interference tool. The study demonstrated an equivalent risk profile to the predicate device, with no new or increased risks. Three (3) subjects experienced a total of 3 SAEs (abdominal pain, hematoma, and skin burn/frostbite), which are anticipated events.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Worst pain reduction and decrease in analgesic usage, complete/partial response rate based on International Bone Metastases Consensus Working Party criteria, quality of life (BPI-SF Pain Interference tool).
Predicate Device(s)
Visual-ICETM Cryoablation System (K113860, K143564, K152133)
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 shows 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 8, 2023
Boston Scientific Corporation Amy Mckinney Regulatory Affairs Fellow One Scimed Place Maple Grove, Minnesota 55311-1566
Re: K230551
Trade/Device Name: Visual-ICE Cryoablation System Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical Unit And Accessories Regulatory Class: Class II Product Code: GEH Dated: February 28, 2023 Received: February 28, 2023
Dear Amy Mckinney:
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
1
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,
Jesse Muir-S
Jesse Muir, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K230551
Device Name Visual-ICE Cryoablation System
Indications for Use (Describe)
The Visual-ICE™ Cryoablation System is intended for cryoablative destruction of tissue during surgical procedures. The Visual-ICE™ Cryoablation System is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery (with the exception of cardiac tissue), ENT, gynecology, oncology, proctology, and urology. The system is destroy tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, and skin lesions.
The Visual-ICE Cryoablation System has the following specific indications:
· Urology Ablation of prostate tissue in cases of prostate cancer and Benign Prostate Hyperplasia (BPH)
· Oncology Ablation of cancerous or malignant tissue and beingn tumors, and palliative intervention. Palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard radiation therapy.
· Dermatology Ablation or freezing of skin cancers and other cutaneous disorders; destruction of warts or lesions, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas, small hemangiomas, mucocele cysts, multiple warts, actinic and sebortheic keratosis, cavernous hemangiomas, peri-anal condylomata, and palliation of tumors of the skin
· Gynecology Ablation of malignant neoplasia or benign dysplasia of the female genitalia
· General surgery Palliation of tumors of the rectum, anal fissures, and recurrent cancerous lessions, ablation of breast fibroadenomas
• ENT Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth
· Thoracic surgery (with the exception of cardiac tissue)
• Proctology Ablation of benign or malignant growths of the anus or rectum
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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510(k) Summary - K230551
| Device Trade Name: | Visual-ICE Cryoablation System |
|---|---|
| Manufacturer: | Boston Scientific Corporation |
| 300 Boston Scientific Way | |
| Marlborough, MA 01752 | |
| Manufacturing Site: | Boston Scientific Corporation |
| 4100 Hamline Ave North | |
| St. Paul, MN 55112 | |
| Primary Contact: | Amy McKinney, MS, RAC |
| Fellow, Regulatory Affairs | |
| Boston Scientific Corporation | |
| Office: 651-287-5096 | |
| Cell: 979-236-1622 | |
| Email: amy.mckinney@bsci.com | |
| Alternate Contact: | Rebeka Stoltman, MBA, RAC |
| Director, Regulatory Affairs | |
| Boston Scientific Corporation | |
| Cell: 952-457-9228 | |
| Email: Rebeka.stoltman@bsci.com | |
| Date Prepared: | July 7, 2023 |
| Classifications: | 21 CFR 878.4350 Cryosurgical unit and accessories |
| Class: | II |
| Product Codes: | GEH |
| Primary Predicate: | Visual-ICETM Cryoablation System (K113860, K143564, K152133) |
| Additional Predicate: | N/A |
Indications For Use:
The Visual-ICE™ Cryoablation System is intended for cryoablative destruction of tissue during surgical procedures. The Visual-ICE™ Cryoablation System is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery (with the exception of cardiac tissue), ENT, gynecology, oncology, proctology, and urology. The system is designed to destroy tissue by the application of extreme coldtemperatures
5
including prostate and kidney tissue, liver metastases, tumors, and skin lesions.
The Visual-ICE Cryoablation System has the following specific indications:
| • Urology | Ablation of prostate tissue in cases of prostate cancer and Benign
Prostate Hyperplasia (BPH) |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| • Oncology | Ablation of cancerous or malignant tissue and benign tumors, and
palliative intervention. Palliation of pain associated with
metastatic lesions involving bone in patients who have failed or
are not candidates for standard radiation therapy. |
| • Dermatology | Ablation or freezing of skin cancers and other cutaneous disorders |
| | Destruction of warts or lesions, 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, actinic and seborrheic keratosis,
cavernous hemangiomas, peri-anal condylomata, and palliation of
tumors of the skin |
| • Gynecology | Ablation of malignant neoplasia or benign dysplasia of the female
genitalia |
| • General surgery | Palliation of tumors of the rectum, anal fissures, pilonidal cysts,
and recurrent cancerous lesions, ablation of breast fibroadenomas |
| • ENT | Palliation of tumors of the oral cavity and ablation of leukoplakia
of the mouth |
| • Thoracic surgery | (with the exception of cardiac tissue) |
| • Proctology | Ablation of benign or malignant growths of the anus or rectum |
Device Description:
The Visual-ICE Cryoablation System is a mobile console system intended for cryoablative tissue destruction using a minimally invasive procedure. The Visual-ICE™ System uses high-pressure argon gas that circulates through closed-tip cryoablation needles to induce tissue freezing. Active tissue thawing is achieved by circulating helium gas through the needles or, alternatively, using Boston Scientific's i-Thaw technology in which a heating element inside the cryoablation needle can be energized to cause thawing.
Predicate Device:
Boston Scientific Corporation submits the following information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, Visual-ICE
6
Cryoablation System is substantially equivalent in indications, design principles, and performance to the predicate Visual-ICE Cryoablation System.
Non-Clinical Performance Testing Summary:
A full battery of verification and validation testing was conducted on the Visual-ICE Cryoablation System to ensure that the design, functionality, and performance met the specified requirements. Testing was conducted according to protocols based on international standards and in-house requirements.
Verification testing included the following:
- System Verification Testing verified functional requirements associated with the । complete system
- Mechanical Verification Testing verified mechanical requirements associated with the gas components, chassis, and shipping of the packaged system
- Electrical Verification Testing verified electrical performance requirements, including -IEC 60601-1 and IEC 60601-1-2 requirements for safety and emissions
- Software Verification Testing verified all software requirements ।
- Labeling and Packaging Testing verified requirements associated with labels, the user manual, and shipping carton.
Validation testing included the following:
- Design and Usability Testing validated the Visual-ICE™ Cryoablation System in a simulated use environment to assess usability of the system, as well as to demonstrate that the system offered the required functionality for a cryoablation procedure
- Animal Cadaver Study validated the system in a representative operating room to assess usability of the system, the ability to complete a cryoablation procedure in a realistic setting with an animal cadaver, and to assess interference between the cryoablation system and operating room monitoring equipment.
System testing assessed whether the functional requirements of the system as a whole were satisfied by the design. Mechanical testing evaluated the mechanical robustness of the system and sub-systems, functional testing of the gas system, and tests of mechanical safety requirements. Electrical testing assessed the functional aspects of the circuit assemblies, tests of electromagnetic compatibility and immunity (EMC/EMI), and tests of electrical safety requirements. Software testing exercised individual units of software as well as tests of the functionality of the entire software package. Validation testing included design and usability testing and animal testing. Test results demonstrated that the Visual-ICE Cryoablation System meets defined specifications, is substantially equivalent to the predicate device, and does not raise any new issues of safety and effectiveness for its intended use.
Acceptance criteria for all verification and validation testing were based on the pre-defined system and software requirements. The Visual-ICE Cryoablation System passed all verification and validation testing determining that the design outputs met the design inputs, and the Visual-ICE Cryoablation System is validated for use.
Clinical Testing Summary:
The safety and effectiveness of use of the Visual-ICE™ Cryoablation System for pain palliation of metastatic lesions in bone was evaluated in 'Multicenter Study of Cryoablation for Palliation of
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Painful Bone Metastases (MOTION)' to assess the efficacy of cryoablation for palliation of painful metastases in patients with metastatic lesions involving bone who had failed, were not candidates for, or were not experiencing adequate pain relief from current pain therapies (e.g., radiation, analgesics). The MOTION clinical trial was a multi-center (11 sites: 7 in US and 4 in Europe), single-arm, prospective, nonrandomized clinical trial assessing the efficacy of cryoablation for palliation of painful metastases in patients (n=66).
The median age of study subjects was 60.5 years (interquartile range: 51 to 70 years), 53% of subjects were male, and the median body mass index (BMI) was 23.6 kg/m². Information on race and ethnicity is not available for approximately half of the study subjects; these subjects were enrolled at sites in France where collection of information on the race and ethnicity of clinical trial subjects is not permitted. Of the 53% of subjects with data on race and ethnicity, most were Caucasian (77.2%) and non-Hispanic (97.1%). Eight (8) patients were African American (22.8%).
The Visual-ICE™ Cryoablation System, when used in accordance with cleared indications, has been demonstrated to have an acceptable risk profile that is equivalent to predicate devices. A 2point reduction from baseline in BPI score for worst pain in the last 24 hours was achieved with respect to mean change and median change at week 1 and every subsequent timepoint through week 24. When evaluated using measures of worst pain reduction and decrease in analgesic usage as outlined by the International Bone Metastases Consensus Working Party, 57.8% of patients achieved complete or partial response by week 1, with scores improving until the maximum percentage of patients (70%) achieved complete or partial response at week 12. Furthermore, treatment with the Visual-ICE Cryoablation System led to consistent improvements from baseline in subjects' quality of life, as assessed using the BPI-SF Pain Interference tool.
The results of the MOTION Study demonstrate an equivalent risk profile to the predicate device, with no new or increased risks. Three (3) subjects experienced a total of 3 SAEs (abdominal pain, hematoma, and skin burn/frostbite). All event types are anticipated and captured in the cleared system labelling.
Results of this clinical study demonstrated that the specific use did not introduce new risks not normally associated with the general use of the device and demonstrated the safety and effectiveness of the system when used for the specific indication of pain palliation of metastatic lesions in bone.
Substantial Equivalence:
The subject device is identical in technology and functionality to the primary predicate Visual-ICE™ Cryoablation System. The subject Traditional 510(k) proposes a specific indication which represents a subset of the general indications cleared for the Visual-ICE™ Cryoablation System. The proposed specific indication is supported by clinical data demonstrating safety and effectiveness when used for the specific indication. Results of clinical testing demonstrated no new risks associated with the specific indication when used as indicated.
Conclusion:
The subject device and the predicate device are identical in intended use, technological characteristics, materials of manufacture, packaging, and sterilization. The clinical data provided in this submission support expansion of the general system indications to include specific indications for pain palliation of metastatic lesions in bone. The data included in this submission demonstrate substantial equivalence to the predicate device listed above.