(7 days)
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
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.
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:
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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)
- Specific performance parameters are mentioned as matching the predicate devices, such as:
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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.
§ 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.