The Boston Scientific disposable IceRod Cryoablation Needle, IceSphere Cryoablation Needle, IceSeed Cryoablation Needle, IcePearl Cryoablation Needle, and IceForce Cryoablation Needle (CX Needles) are meant to be connected to a Boston Scientific ICEfx Cryoablation System or Visual-ICE Cryoablation System when performing cryoablative tissue destruction through application of extremely cold temperatures. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.

The Boston Scientific CX Needles, when used with ICEfx Cryoablation System or Visual-ICE Cryoablation System, 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, proctology, and urology. The CX Needles are designed to destroy tissue (including prostate and kidney tissue, liver metastases, tumors, and skin lesions) by the application of extremely cold temperatures.

The CX Needles 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. 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 seborrheic keratosis, cavernous hemangiomas, peri-anal condylomata, and palliation 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

Boston Scientific Corporation's (BSC) IceSeed 1.5 CX Straight Cryoablation Needle, IceSphere 1.5 CX Straight Cryoablation Needle, and IceRod 1.5 CX Straight Cryoablation Needle (hereafter referred collectively as the Straight Needles) are sterile, single use, disposable devices used in conjunction with a Boston Scientific cryoablation system for cryoablative destruction of tissue during surgical procedures under CT guidance. The Straight CX Needles are disposable 1.5 mm needles that have a sharp cutting tip, a color-coded handle, a gas tube, and a connector. The needles convert high-pressure gas to either a very cold freezing application or to a warm thawing application. Active tissue thawing may also be achieved by activating the heating element inside the Straight CX Needles.

AI/ML Overview

The provided document is a 510(k) summary for Boston Scientific's IceSeed 1.5 CX Straight Needle, IceSphere 1.5 CX Straight Needle, and IceRod 1.5 CX Straight Needle. It focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a clinical study with acceptance criteria for a new device's performance.

Therefore, the specific information requested, such as acceptance criteria, reported device performance for these criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment from a clinical effectiveness study, is not available in this document.

The document primarily describes engineering and functional verification testing to show that the new straight needles perform similarly to existing predicate bent-tip needles.

Here's a breakdown of what is available related to your request, and what is not:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria (Implied by equivalence to predicate devices and functional requirements): The document states that "Verification testing was conducted on the Straight CX Cryoablation Needles to ensure that the design, functionality, and performance met all the specified requirements and that the features of the needle satisfy its intended use." It also notes that "Test results demonstrated that the Straight CX Cryoablation Needles meets defined specifications."
- Specific performance parameters are mentioned as matching the predicate devices, such as:
  - Shaft working length: 175mm
  - Shaft Diameter: 1.5mm
  - Markings: Thin and Thick marks at specific distances
  - Length of low friction coating on shaft: Specific starts and ends from the tip
  - Active zone Indicator: Specific starts from the tip and band length
  - Freezing cryogen: Argon 99.995%
  - Thawing gas: Helium 99.998%
  - Isotherm diameter: (IceSeed: -40°C: 15 ± 3 mm, -20°C: 24 ± 3 mm, 0°C: 37.5 ± 3 mm; IceSphere: -40°C: 16 ± 3 mm, -20°C: 26 ± 3 mm, 0°C: 39 ± 3 mm; IceRod: -40°C: 17 ± 3 mm, -20°C: 28 ± 3 mm, 0°C: 43 ± 3 mm)
  - Isotherm height: (IceSeed: -40°C: 21 ± 4 mm, -20°C: 28 ± 4 mm, 0°C: 41 ± 4 mm; IceSphere: -40°C: 24 ± 4 mm, -20°C: 32 ± 4 mm, 0°C: 45 ± 4 mm; IceRod: -40°C: 41 ± 4 mm, -20°C: 47 ± 4 mm, 0°C: 60 ± 4 mm)
Reported Device Performance: The document generally states that "Test results demonstrated that the Straight CX Cryoablation Needles meets defined specifications, is substantially equivalent to the predicate devices, and does not raise any new issues of safety and effectiveness for its intended use." It implicitly means the new devices performed within the acceptable ranges for the parameters listed above, matching the predicate devices. No specific raw data or numerical results of the functional tests are provided.

2. Sample size used for the test set and the data provenance:

Not Available. The document refers to "verification testing" and "functional testing" but does not specify sample sizes for these tests. There is no mention of a "test set" in the context of clinical data or patient studies. The provenance of any data is not mentioned, as it's primarily bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable / Not Available. This information relates to clinical studies and expert review for ground truth, which is not described in this 510(k) summary.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not Applicable / Not Available. Adjudication methods are typically used in clinical studies for establishing ground truth, which is not detailed here.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not Applicable / Not Available. This device is a cryoablation needle, a surgical tool. It is not an AI-assisted diagnostic or decision-support system, so an MRMC study with AI assistance is irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not Applicable / Not Available. As above, this is a physical medical device, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not Applicable / Not Available (for clinical ground truth). The "ground truth" for the device's performance is established by industrial standards and in-house functional requirements, and comparison to the parameters of the predicate device. It's engineering and performance specifications, not clinical outcomes or expert consensus on diagnoses.

8. The sample size for the training set:

Not Applicable / Not Available. There is no mention of a training set as this is about a physical medical device, not a machine learning model.

9. How the ground truth for the training set was established:

Not Applicable / Not Available. As there is no training set, this question is not applicable.

Summary

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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.

October 18, 2024

Boston Scientific Corp. Dana Borris Regulatory Affairs Specialist II 1 Scimed Place Maple Grove, Minnesota 55311

Re: K243245

Trade/Device Name: IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (H7493968435730); IceRod 1.5 CX Straight Needle (H7493968535330) Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical Unit And Accessories Regulatory Class: Class II Product Code: GEH Dated: October 11, 2024 Received: October 11, 2024

Dear Dana Borris:

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 (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/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.

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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" (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 QS regulation requires device manufacturers to review and approve changes to device design and production (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 (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 bear a unique 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-advice-comprehensiveregulatory-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-reporting-mdr-howreport-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device (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-devices/device-advice-comprehensive-regulatory

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assistance/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,

James H. Digitally signed by
James H. Jang -S
Date: 2024.10.18
Jang -S
14:35:27-04'00'

For Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K243245

Device Name

IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (H7493968435730); IceRod 1.5 CX Straight Needle (H7493968535330)

Indications for Use (Describe)

The Boston Scientific disposable IceRod Cryoablation Needle, IceSphere Cryoablation Needle, IceSeed Cryablation Needle, IcePearl Cryoablation Needle, and IceForce Cryoablation Needles) are meant to be connected to a Boston Scientific ICEfx Cryoablation System or Visual-ICE Cryoablation System when performing cryoablative tissue destruction through application of extremely cold temperatures. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.

The Boston Scientific CX Needles, when used with ICEfx Cryoablation System or Visual-ICE Cryoablation System, 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, proctology, and urology. The CX Needles are designed to destroy tissue (including prostate and kidney tissue, liver metastases, tumors, and skin lesions) by the application of extremely cold temperatures.

The CX Needles 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 tumors, and palliative intervention. Palliation of pain associated with metastatic lesions 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 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

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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K243245 510(k) SUMMARY

A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.

Submitter:	Boston Scientific1 Scimed PlMaple Grove MN55311United States
Company Contact Person:	Dana BorrisRegulatory Affairs SpecialistBoston ScientificPhone: 763-494-1850Email: Dana.Borris@bsci.com
Alternate Contact Person:	Rachel OwensSr. Manager, Regulatory AffairsBoston ScientificPhone: 763-273-6865Email: rachel.owens@bsci.com
Device Name:	IceSeed 1.5 CX Straight Needle (H7493968333170)IceSphere 1.5 CX Straight Needle (H7493968435730)IceRod 1.5 CX Straight Needle (H7493968535330)
Device Classification Name:	Cryosurgical unit and accessoriesRegulation Number: 21 CFR 878.4350Product Code: GEH
Predicate Device 510(k):	IceSeed 1.5 CX 90° Cryoablation Needle (K232635)IceSphere 1.5 CX 90° Cryoablation Needle (K181741)IceRod 1.5 CX 90° Cryoablation Needle (K140584)
Date of Preparation:	October 15, 2024

Device Description:

The table below provides a summary comparison of the submitted devices compared to the predicate devices.

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Description	Submitted Devices:IceSeed 1.5 CX Straight Cryoablation Needle,IceSphere 1.5 CX Straight Cryoablation Needle, andIceRod 1.5 CX Straight Cryoablation Needle	Predicate Devices:IceSeed 1.5 CX 90° Cryoablation Needle (K232635),IceSphere 1.5 CX 90° Cryoablation Needle (K181741),and IceRod 1.5 CX 90° Cryoablation Needle (K140584)
IntendedUse /Indicationsfor Use	The Boston Scientific disposable IceRod Cryoablation Needle, IceSphere Cryoablation Needle, IcePearl Cryoablation Needle, and IceForce Cryoablation Needle (CX Needles) are meant to be connected to a Boston Scientific ICEfx Cryoablation System or Visual-ICE Cryoablation System when performing cryoablative tissue destruction through application of extremely cold temperatures. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.
	The Boston Scientific CX Needles, when used with ICEfx Cryoablation System or Visual-ICE Cryoablation System, 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, proctology, and urology. The CX Needles are designed to destroy tissue (including prostate and kidney tissue, liver metastases, tumors, and skin lesions) by the application of extremely cold temperatures.
	The CX Needles 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. 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
Tiptechnology	Closed trocar tip	Closed trocar tip
Shaftworkinglength	175mm	175 mm
ShaftDiameter	1.5 mm	1.5 mm
Markings:Thin Marks	IceSeed and IceSphere:45 mm from tip in 5 mm intervalsIceRod:Starts 55 mm from tip in 5 mm intervals	IceSeed and IceSphere:45 mm from tip in 5 mm intervalsIceRod:Starts 55 mm from tip in 5 mm intervals
Markings:ThickMarks	IceSeed and IceSphere:40 mm from tip in 10 mm intervalsIceRod:Starts 60 mm from tip in 10 mm intervals	IceSeed and IceSphere:40 mm from tip in 10 mm intervalsIceRod:Starts 60 mm from tip in 10 mm intervals
Description	Submitted Devices:IceSeed 1.5 CX Straight Cryoablation Needle,IceSphere 1.5 CX Straight Cryoablation Needle, andIceRod 1.5 CX Straight Cryoablation Needle	Predicate Devices:IceSeed 1.5 CX 90° Cryoablation Needle (K232635),IceSphere 1.5 CX 90° Cryoablation Needle (K181741),and IceRod 1.5 CX 90° Cryoablation Needle (K140584)
Length oflow frictioncoating onshaft	IceSeed and IceSphere:Begins 4.5mm from tip; ends 35mm from tip	IceSeed and IceSphere:Begins 4.5mm from tip; ends 35mm from tip
	IceRod:Begins 4.5mm from tip; ends 50mm from tip	IceRod:Begins 4.5mm from tip; ends 50mm from tip
Active zoneIndicator	IceSeed and IceSphere:Starts 55 mm from tip; 10mm band	IceSeed and IceSphere:Starts 55 mm from tip; 10mm band
	IceRod:Starts 70 mm from tip; 10mm band	IceRod:Starts 70 mm from tip; 10mm band
Freezingcryogen	Argon 99.995%	Argon 99.995%
Thawinggas	Helium 99.998%	Helium 99.998%
Isothermdiameter	IceSeed:-40°C: 15 ± 3 mm-20°C: 24 ± 3 mm0°C: 37.5 ± 3 mm	IceSeed:-40°C: 15 ± 3 mm-20°C: 24 ± 3 mm0°C: 37.5 ± 3 mm
	IceSphere:-40°C: 16 ± 3 mm-20°C: 26 ± 3 mm0°C: 39 ± 3 mm	IceSphere:-40°C: 16 ± 3 mm-20°C: 26 ± 3 mm0°C: 39 ± 3 mm
	IceRod:-40°C: 17 ± 3 mm-20°C: 28 ± 3 mm0°C: 43 ± 3 mm	IceRod:-40°C: 17 ± 3 mm-20°C: 28 ± 3 mm0°C: 43 ± 3 mm
Isothermheight	IceSeed:-40°C: 21 ± 4 mm-20°C: 28 ± 4 mm0°C: 41 ± 4 mm	IceSeed:-40°C: 21 ± 4 mm-20°C: 28 ± 4 mm0°C: 41 ± 4 mm
	IceSphere:-40°C: 24 ± 4 mm-20°C: 32 ± 4 mm0°C: 45 ± 4 mm	IceSphere:-40°C: 24 ± 4 mm-20°C: 32 ± 4 mm0°C: 45 ± 4 mm
	IceRod:-40°C: 41 ± 4 mm-20°C: 47 ± 4 mm0°C: 60 ± 4 mm	IceRod:-40°C: 41 ± 4 mm-20°C: 47 ± 4 mm0°C: 60 ± 4 mm

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In summary, the submitted Straight CX Cryoablation Needles have the same technology and principle of operation as the predicate devices.

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Indications for Use / Intended Use:

The CX Needles have the following specific indications:

· Urology - Ablation of prostate tissue in cases of prostate cancer and Benign Prostate Hyperplasia (BPH)

• 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

Summary of Performance Data and Substantial Equivalence:

Verification testing was conducted on the Straight CX Cryoablation Needles to ensure that the design, functionality, and performance met all the specified requirements and that the features of the needle satisfy its intended use. Testing was conducted according to protocols based on international standards and inhouse requirements. Verification testing included functional testing, system compatibility testing, and labeling review. Functional testing assessed whether the electrical heater requirements and functional requirements were met. System compatibility testing ensured the needle would operate with a Boston Scientific Cryoablation System. Labeling verification evaluated instructions for use and labeling accuracy with respect to design requrements and risk mitigations. Test results demonstrated that the Straight CX Cryoablation Needles meets defined specifications, is substantially equivalent to the predicate devices, and does not raise any new issues of safety and effectiveness for its intended use.

Conclusion (Statement of Equivalence):

As the indications for use and fundamental scientific technology have not changed, verification testing provided in this Special 510(k) Premarket Notification supports a determination that the Straight CX Cryoablation Needles are substantially equivalent to the legally marketed predicate devices, with regard to performance, safety, and effectiveness for its intended use.

Regulation Number and Section

§ 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.