(28 days)
Not Found
No
The document describes a cryoablation needle and its intended use for tissue destruction. There is no mention of AI or ML in the device description, intended use, or performance studies. The change described is an internal component change, not a change in technological characteristics related to AI/ML.
Yes
The device is intended for "cryoablative destruction of tissue during surgical procedures" to treat various conditions, which aligns with the definition of a therapeutic device.
No
This device is a cryoablation needle intended for the destruction of tissue during surgical procedures, not for diagnostic purposes.
No
The device description explicitly states that the device is a sterile, single-use, disposable component (a needle) used in conjunction with cryoablation systems to perform cryoablative destruction of tissue. This clearly indicates a hardware component, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "cryoablative destruction of tissue during surgical procedures." This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is a "Cryoablation Needle" used to "perform cryoablative destruction of tissue." It converts gas to cold or warm temperatures for tissue destruction.
- Lack of In Vitro Activity: IVD devices are intended for use in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of specimens.
The device is a surgical tool used for a therapeutic intervention, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
Galil Medical's IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needle families are intended for cryoablative destruction of tissue during surgical procedures. The IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needle families are 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, and urology. The systems are designed to destroy tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts.
The Galil Medical IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needle families have 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)
- 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 hemanglomas, mucocele cysts, multiple warts, actinic and seborrheic keratoses, cavernous hemanglomas, perianal 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, hemorrhoids, anal fissures, pilonidal cysts, and recurrent cancerous lesions, ablation of breast fibroadenoma)
- 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 (comma separated list FDA assigned to the subject device)
GEH
Device Description
Galil Medical's IcePearl 2.1 CX, IceFORCE 2.1 CX, IcePearl 2.1 CX L, and IceFORCE 2.1 CX L Cryoablation Needles (collectively referred to as the 2.1 CX Cryoablation Needles) are sterile, single use, disposable components, when used in conjunction with Galil Medical's commercially available cryoablation systems, to perform cryoablative destruction of tissue. The needles are intended to convert high-pressure gas to either a very cold freezing application or to a warm thawing application.
The 2.1 CX Cryoablation Needles are disposable 2.1 mm needles that have a sharp cutting tip, a color-coded handle, a gas tube, and a connector. Both the IcePearl and IceFORCE needle families offer handles configured as straight and in a 90-degree angled configuration (to aid positioning of the needle within the CT imaging system gantry). Additionally, both needle families offer a long version of the needle that contains a longer needle shaft and a 90-degree angled handle configuration (IcePearl 2.1 CX L and IceFORCE 2.1 CX L).
The change presented in this Special 510(k) is an internal component change. There are no changes to the intended use, indications for use, or technological characteristics.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT imaging system gantry
Anatomical Site
Prostate, kidney tissue, liver, skin, warts, female genitalia, rectum, hemorrhoids, anal fissures, pilonidal cysts, breast, oral cavity, cardiac tissue (exception), anus.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgical procedures
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)
Verification and performance testing was conducted on needles built with the modified component to verify safety and performance characteristics and to establish substantial equivalence to the predicate devices.
This testing included:
- Thermal testing to ensure needle temperatures met specifications for freezing and thawing
- Electrical testing to verify electrical insulation of the needles
- Durability testing to verify durability of the modified component
- Freezing performance testing to verify that the needles meet freezing performance specifications.
Testing was done to established test methods documented in the original 510(k)s of the predicate devices. Test results demonstrated that the modified 2.1 CX Needles meet defined specifications, demonstrate improved reliability over the predicate devices, and do not raise any new safety or effectiveness issues.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
November 2, 2020
Galil Medical Inc. Ms. Amy McKinney, MS, RAC Sr. Regulatory Affairs Manager 4634 Round Lake Rd. W Arden Hills, Minnesota 55112
Re: K203032
Trade/Device Name: IcePearl 2.1 CX 90 Needle, IcePearl 2.1 CX L 90 Needle, IcePearl 2.1 CX Needle, IceFORCE 2.1 CX 90 Needle, IceFORCE 2.1 CX L 90 Needle, and IceFORCE 2.1 CX Needle
Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical Unit and Accessories Regulatory Class: Class II Product Code: GEH Dated: October 2, 2020 Received: October 5, 2020
Dear Ms. 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.
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 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.
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) K203032
Device Name
IcePearl 2.1 CX 90° Needle (FPRPR3601);IcePearl 2.1 CX L 90° Needle (FPRPR3617); IcePearl 2.1 CX Needle (FPRPR3603);IceFORCE 2.1 CX 90° Needle (FPRPR3602); IceFORCE 2.1 CX L 90° Needle (FPRPR3618);IceFORCE 2.1 CX Needle (FPRPR3604)
Indications for Use (Describe)
Galil Medical's IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needle families are intended for cryoablative destruction of tissue during surgical procedures. The IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needle families are 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, and urology. The systems are designed to destroy tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts.
The Galil Medical IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needle families have 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)
- · 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 hemanglomas, mucocele cysts, multiple warts, actinic and seborrheic keratoses, cavernous hemanglomas, perianal 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, hemorrhoids, anal fissures, pilonidal cysts, and recurrent cancerous lesions, ablation of breast fibroadenoma) -
· 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) |
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3
K203032 510(k) SUMMARY
A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.
| Submitter: | Galil Medical Ltd.
Tavor Building 1
Industrial Park, PO Box 224
Yokneam Industrial Park 2069203
Israel |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact Person: | Ms. Amy E McKinney, MS, RAC
Sr. Manager, Regulatory Affairs
Boston Scientific Corp
Phone: 651-402-0008
Email: Amy.mckinney@bsci.com |
| Alternate Contact Person: | Ms. Rebeka Stoltman
Director, Regulatory Affairs
Boston Scientific Corp.
Phone: 651-287-5020
Email: Rebeka.stoltman@bsci.com |
| Device Name: | IcePearl 2.1 CX Cryoablation Needle
IceFORCE 2.1 CX Cryoablation Needle
IcePearl 2.1 CX L Cryoablation Needle
IceFORCE 2.1 CX L Cryoablation Needle |
| Device Classification Name: | Cryosurgical unit and accessories (GEH)
21 CFR 878.4350 |
| Predicate Devices / Reference
510(k): | IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation
Needles (K152133)
IcePearl 2.1 CX L and IceFORCE 2.1 CX L
Cryoablation Needles (K162599) |
| Date of Preparation: | October 23, 2020 |
Device Description:
Galil Medical's IcePearl 2.1 CX, IceFORCE 2.1 CX, IcePearl 2.1 CX L, and IceFORCE 2.1 CX L Cryoablation Needles (collectively referred to as the 2.1 CX Cryoablation Needles) are sterile, single use, disposable components, when used in conjunction with Galil Medical's commercially available cryoablation systems, to perform cryoablative destruction of tissue. The needles are intended to convert high-pressure gas to either a very cold freezing application or to a warm thawing application.
The 2.1 CX Cryoablation Needles are disposable 2.1 mm needles that have a sharp cutting tip, a color-coded handle, a gas tube, and a connector. Both the IcePearl and IceFORCE needle families offer handles configured as straight and in a 90-degree angled configuration (to aid positioning of the needle within the CT imaging system gantry). Additionally, both needle families offer a long version of the needle that contains a longer needle shaft and a 90-degree angled handle configuration (IcePearl 2.1 CX L and IceFORCE 2.1 CX L).
The change presented in this Special 510(k) is an internal component change. There are no changes to the intended use, indications for use, or technological characteristics.
4
Intended Use:
There are no changes to the indications for use of the 2.1 CX Cryoablation Needles as a result of the component change in this 510(k).
Galil Medical's IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needle families are intended for cryoablative destruction of tissue during surgical procedures. The IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needle families are 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, and urology. The systems are designed to destroy tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts.
The Galil Medical IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needle families have the following specific indications:
• Uroloqy (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)
• 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 hemanglomas, multiple warts, plantar warts, actinic and seborrheic keratoses, cavernous hemanglomas, perianal condylomata, and palliation of tumors of the skin.)
-
· Gynecology (ablation of malignant neoplasia or benign dysplasia of the female genitalia)
· General surgery (palliation of the rectum, hemorrhoids, anal fissures, pilonidal cysts, and recurrent cancerous lesions, ablation of breast fibroadenoma) -
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)
Technological Comparison:
The table below provides a summary comparison of the submitted devices compared to the predicate devices.
| Description of Submitted Device: | Comments related to Predicates: |
|---|---|
| Design and Construction | |
| Needle Tip | Same as predicate |
| Needle Shaft | Shaft length is 55 mm longer than predicate |
| Gas Pathway Tubing | Same as predicate |
| Handle | Same as predicate |
| Needle Connector | Same as predicate |
| Internal heater assembly design | Same design as predicate; modified dimensions and modified |
| material | |
| Performance and Function | |
| Freezing/Thawing Technology | Same as predicate |
| Function | Same as predicate |
| Freezing Parameters | Same as predicate |
| Thaw Parameters | Same as predicate |
| Track Ablation | Same as predicate |
| Indications for Use | Same as predicate |
The component change submitted in this Special 510(k) does not alter the technological characteristics of the lceFORCE and IcePearl 2.1 CX needle families. In summary, the modified IcePearl and IceFORCE needles submitted in this 510(k) have the same technology, same principle of operation, and same indications for use as the predicate devices.
5
Summary of Performance Data and Substantial Equivalence:
Verification and performance testing was conducted on needles built with the modified component to verify safety and performance characteristics and to establish substantial equivalence to the predicate devices.
This testing included:
- . Thermal testing to ensure needle temperatures met specifications for freezing and thawing
- . Electrical testing to verify electrical insulation of the needles
- Durability testing to verify durability of the modified component .
- . Freezing performance testing to verify that the needles meet freezing performance specifications.
Testing was done to established test methods documented in the original 510(k)s of the predicate devices. Test results demonstrated that the modified 2.1 CX Needles meet defined specifications, demonstrate improved reliability over the predicate devices, and do not raise any new safety or effectiveness issues.
Conclusion:
The information and data provided in this Special 510(k) Notification establish that the modified 2.1 CX Cryoablation Needles are substantially equivalent to the legally marketed predicate devices.