The Boston Scientific disposable IceRod Cryoablation Needle, IceSphere Cryoablation Needle, IceSeed Cryoablation Needle, IcePearl Cryoablation Needle, and IceForce Cryoablation Needle (CX Needles), when used with a Boston Scientific ICEfx Cryoablation System or Visual-ICE Cryoablation System, are designed to destroy tissue by the application of extremely cold temperatures.

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.
· 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 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, 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
Additionally, when used with the Visual-ICE Cryoablation System, the CX Needles are indicated for use in the field of Oncology for palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard radiation therapy.

Device Description

Boston Scientific Corporation's (BSC) IceSeed 1.5 CX 90° Needle and IceSeed 1.5 CX S 90° Needle (IceSeed CX 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 IceSeed CX Needles are disposable 1.5 mm needles that have a sharp cutting tip, a colorcoded handle, a gas tube, and a connector. The IceSeed CX Needles offer a handle configured in a 90° angled configuration to aid positioning of the needle within the CT imaging system gantry. The needles convert high-pressure gas to either a very cold freezing application or to a warm thawing application. Active tissue thawing is may also be achieved by activating the heating element inside IceSeed CX Needles.

AI/ML Overview

The provided text is a 510(k) Premarket Notification from the FDA for medical devices (cryoablation needles). It details the device's description, intended use, and a comparison to predicate devices, ultimately concluding substantial equivalence.

However, the document does not contain any information about an AI/ML powered medical device, acceptance criteria related to AI/ML performance, or any studies involving AI/ML models, human readers, or ground truth establishment based on expert consensus, pathology, or outcomes data.

The "Performance Data and Substantial Equivalence" section only mentions:

Functional testing (electrical heater requirements, functional requirements)
System compatibility testing
Labeling review

These are standard engineering and regulatory tests for physical medical devices and are not related to the performance evaluation of an AI/ML algorithm.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves an AI/ML device meets the acceptance criteria, as the input document does not pertain to an AI/ML device.

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 seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.

November 22, 2023

Boston Scientific Jake Burke Sr. Regulatory Affairs Specialist 1 Scimed Pl Maple Grove, Minnesota 55311

Re: K232635

Trade/Device Name: IceSeed 1.5 CX 90° Needle (H7493967433170); IceSeed 1.5 CX S 90° Needle (H7493967233100) Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical Unit And Accessories Regulatory Class: Class II Product Code: GEH Dated: October 20, 2023 Received: October 23, 2023

Dear Jake Burke:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/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 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Digitally signed by Mark Mark Trumbore -S Trumbore -S Date: 2023.11.22 07:40:33 -05'00'

Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical

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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) K232635

Device Name

IceSeed 1.5 CX 90° Needle (H7493967433170) IceSeed 1.5 CX S 90° Needle (H7493967233100)

Indications for Use (Describe)

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 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, dermatoffbromas, small hemangiomas, multiple warts, plantar 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

Additionally, when used with the Visual-ICE Cryoablation System, the CX Needles are indicated for use in the field of Oncology for palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard radiation therapy.

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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K232635 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:	Jake BurkeRegulatory Affairs SpecialistBoston ScientificPhone: 651-210-2813Email: jake.burke@bsci.com
Alternate Contact Person:	Rachel OwensSr. Manager, Regulatory AffairsBoston ScientificPhone: 763-273-6865Email: rachel.owens@bsci.com
Device Name:	IceSeed 1.5 CX 90° Needle (H7493967433170)IceSeed 1.5 CX S 90° Needle (H7493967233100)
Device Classification Name:	Cryosurgical unit and accessories
Regulation Number:	21 CFR 878.4350
Product Code:	GEH
Predicate Device 510(k):	IceSphere CX Cryoablation Needle (K181741)IceSeed 90° Cryoablation Needle (K060144)Visual-ICE Cryoablation System (K230551)
Date of Preparation:	November 21, 2023

Device Description:

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

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Description	Submitted Device: IceSeed 1.5 CX 90° Cryoablation Needle andIceSeed 1.5 CX S 90° Cryoablation Needle	Predicate Device: IceSphere 1.5 CX (K1817414)	Reference Device: IceSeed 1.5 90° (K060144)
Intended Use / Indications for Use	The Boston Scientific disposable IceRod Cryoablation Needle, IceSphere Cryoablation Needle, IceSeedCryoablation Needle, IcePearl Cryoablation Needle, and IceForce Cryoablation Needle (CX Needles), whenused with a Boston Scientific ICEfx Cryoablation System or Visual-ICE Cryoablation System, are designed todestroy tissue by the application of extremely cold temperatures.The Boston Scientific CX Needles, when used with ICEfx Cryoablation System or Visual-ICE CryoablationSystem, 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.• 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 canthusarea, ulcerated basal cell tumors, dermatofibromas, small hemangiomas, mucocele cysts, multiple warts, plantarwarts, actinic and seborrheic keratosis, cavernous hemangiomas, peri-anal condylomata, and palliation of tumorsof 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 cancerouslesions, 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 rectumAdditionally, when used with the Visual-ICE Cryoablation System, the CX Needles are indicated for use in thefield of Oncology for palliation of pain associated with metastatic lesions involving bone in patients who havefailed or are not candidates for standard radiation therapy.	The Boston Scientific disposable IceRod Cryoablation Needle, IceSphere Cryoablation Needle, IceSeedCryoablation Needle, IcePearl Cryoablation Needle, and IceForce Cryoablation Needle (CX Needles), whenused with a Boston Scientific ICEfx Cryoablation System or Visual-ICE Cryoablation System, are designed todestroy tissue by the application of extremely cold temperatures.The Boston Scientific CX Needles, when used with ICEfx Cryoablation System or Visual-ICE CryoablationSystem, 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.• 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 canthusarea, ulcerated basal cell tumors, dermatofibromas, small hemangiomas, mucocele cysts, multiple warts, plantarwarts, actinic and seborrheic keratosis, cavernous hemangiomas, peri-anal condylomata, and palliation of tumorsof 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 cancerouslesions, 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 rectumAdditionally, when used with the Visual-ICE Cryoablation System, the CX Needles are indicated for use in thefield of Oncology for palliation of pain associated with metastatic lesions involving bone in patients who havefailed or are not candidates for standard radiation therapy.	The Boston Scientific disposable IceRod Cryoablation Needle, IceSphere Cryoablation Needle, IceSeedCryoablation Needle, IcePearl Cryoablation Needle, and IceForce Cryoablation Needle (CX Needles), whenused with a Boston Scientific ICEfx Cryoablation System or Visual-ICE Cryoablation System, are designed todestroy tissue by the application of extremely cold temperatures.The Boston Scientific CX Needles, when used with ICEfx Cryoablation System or Visual-ICE CryoablationSystem, 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.• 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 canthusarea, ulcerated basal cell tumors, dermatofibromas, small hemangiomas, mucocele cysts, multiple warts, plantarwarts, actinic and seborrheic keratosis, cavernous hemangiomas, peri-anal condylomata, and palliation of tumorsof 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 cancerouslesions, 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 rectumAdditionally, when used with the Visual-ICE Cryoablation System, the CX Needles are indicated for use in thefield of Oncology for palliation of pain associated with metastatic lesions involving bone in patients who havefailed or are not candidates for standard radiation therapy.
Tiptechnology	Closed trocar tip	Closed trocar tip	Closed trocar tip
Shaftworkinglength	1.5 CX: 175mm1.5 CX S: 100mm	175 mm	175 mm
ShaftDiameter	1.5 mm	1.5 mm	1.5 mm
Markings	Thin Marks: 45 mm from tip in 10mm intervalsThick Marks:40 mm from tip in 10 mmintervals	Thin Marks: 45 mm from tip in 10mm intervalsThick Marks:40 mm from tip in 10 mmintervals	Thin Marks: 25 mm from tip in 5mm intervalsThick Marks:20 mm from tip in 10 mmintervals
Length oflow frictioncoating onshaft	Coated shaft [4.5, 35] mm from tip	Coated shaft [4.5, 35] mm from tip	N/A
Active zoneIndicator	Starts 55 mm from tip; 10mmband	Starts 55 mm from tip; 10mmband	N/A
Freezingcryogen	Argon 99.995%	Argon 99.995%	Argon 99.995%
Description	Submitted Device: IceSeed 1.5CX 90° Cryoablation Needle andIceSeed 1.5 CX S 90°Cryoablation Needle	Predicate Device: IceSphere 1.5CX (K1817414)	Reference Device: IceSeed 1.590° (K060144)
Thawinggas	Helium 99.998%	Helium 99.998%	Helium 99.998%
Isothermdiameter	1.5 CX:-40°C: 15 mm-20°C: 24 mm0°C: 37.5 mm1.5 CX S:-40°C: 12 mm-20°C: 21 mm0°C: 34 mm	-40°C: 16 mm-20°C: 26 mm0°C: 39 mm	-40°C: 11 mm-20°C: 20 mm0°C: 33 mm
Isothermheight	1.5 CX:-40°C: 21 mm-20°C: 28 mm0°C: 41 mm1.5 CX S:-40°C: 20 mm-20°C: 26 mm0°C: 39 mm	-40°C: 24 mm-20°C: 32 mm0°C: 45 mm	-40°C: 20 mm-20°C: 27 mm0°C: 38 mm

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

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)
· 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, mucocele cysts, multiple warts, plantar 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, 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)

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Proctology Ablation of benign or malignant growths of the anus or rectum
Additionally, when used with the Visual-ICE Cryoablation System, the CX Needles are indicated for use in the field of Oncology for palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard radiation therapy.

Summary of Performance Data and Substantial Equivalence:

Verification testing was conducted on the IceSeed 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 in-house 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 requirements and risk mitigations. Test results demonstrated that the IceSeed 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 IceSeed 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.