(157 days)
The Portable Scalp Cooling System (PSCS) is indicated to reduce the likelihood of chemotherapy-induced alopecia in cancer patients with solid tumors. The PSCS is indicated for adult patients only.
The Portable Scalp Cooling System (PSCS) is a wearable device for people undergoing chemotherapy treatment for solid tumor cancer who want to avoid chemotherapy-induced hair loss, or alopecia. Treatment with the PSCS is administered by a user or caregiver in a treatment center, during travel time to the patient's home and in the home setting. It is designed for continual use during the transition from the infusion center to the patient's home. The portable device provides the cooling therapy by circulating a water/isopropyl alcohol (IPA) mixture through a cooling cap worn securely on the patient's head.
The provided text describes a 510(k) summary for the Portable Scalp Cooling System (PSCS). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed clinical study with specific acceptance criteria for performance metrics like sensitivity, specificity, or reader improvement.
Therefore, the requested information regarding acceptance criteria and a study proving the device meets them, particularly in the context of diagnostic accuracy/performance metrics, is largely not applicable or not available in this document. The document focuses on demonstrating safety and effectiveness through non-clinical testing and comparison to a predicate device.
Here's a breakdown based on the information provided and what is not available:
1. Table of Acceptance Criteria and Reported Device Performance:
No specific "acceptance criteria" for clinical performance metrics (like sensitivity, specificity, or a certain reduction in alopecia percentage) are outlined in this document. The document describes non-clinical testing to ensure the device is as safe and effective as the predicate.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Electrical Safety (IEC 60601-1, IEC 60601-1-6, IEC 60601-1-11) | PSCS meets the requirements. |
| Electromagnetic Compatibility (IEC 60601-1-2) | PSCS meets the requirements. |
| Software V&V (IEC 62304) | PSCS meets the requirements. |
| Performance Bench Testing (scalp cooling, cooling stability) | PSCS meets the requirements, indicating similar performance to the predicate. |
| Human Factor Testing (IEC 62366-1) | PSCS meets the requirements, ensuring safety and effectiveness for home use. |
| Biocompatibility (ISO 10993-1) | PSCS meets the requirements for a surface device with prolonged contact. |
| Overall Safety & Effectiveness | Concluded to be substantially equivalent to the predicate device, raising no new issues of safety or effectiveness. |
2. Sample Size for the Test Set and Data Provenance:
- Sample Size for Test Set: Not applicable/not provided for clinical performance as no such study is described. The "test set" in this context refers to the non-clinical tests performed.
- Data Provenance: Not applicable for device performance; the non-clinical testing was performed by the manufacturer, Cooler Heads Care, Inc.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Number of Experts: Not applicable/not provided. This is relevant for diagnostic devices requiring expert interpretation.
- Qualifications of Experts: Not applicable/not provided.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable/not provided. This is relevant for diagnostic devices where multiple expert opinions are reconciled.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- MRMC Study: No, an MRMC comparative effectiveness study was not described or referenced. The device is a "Scalp Cooling System," not an AI diagnostic tool that assists human readers.
- Effect Size of Human Readers: Not applicable as no MRMC study was performed.
6. Standalone (Algorithm Only) Performance Study:
- Standalone Study: No, a standalone algorithm performance study was not described or referenced. The PSCS is a physical device, not an algorithm.
7. Type of Ground Truth Used:
- Type of Ground Truth: Not applicable for clinical ground truth. For the non-clinical tests, the "ground truth" was established by adherence to recognized international standards (e.g., IEC, ISO) and comparison to the predicate device's characteristics and performance.
8. Sample Size for the Training Set:
- Sample Size for Training Set: Not applicable. The PSCS is a physical medical device, not an AI/ML algorithm that requires a training set of data.
9. How the Ground Truth for the Training Set was Established:
- Ground Truth for Training Set: Not applicable as there is no training set for an AI/ML algorithm.
In summary: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It does not contain information about clinical trials with traditional acceptance criteria for performance metrics, human reader studies, or AI/ML algorithm performance.
§ 878.4360 Scalp cooling system to reduce the likelihood of chemotherapy-induced alopecia.
(a)
Identification. A scalp cooling system to reduce the likelihood of chemotherapy-induced alopecia is a prescription device intended to reduce the frequency and severity of alopecia during chemotherapy in which alopecia-inducing chemotherapeutic agents are used.(b)
Classification —Class II (special controls). The special controls for this device are:(1) Non-clinical performance testing must demonstrate that the device meets all design specifications and performance requirements, and that the device performs as intended under anticipated conditions of use. This information must include testing to demonstrate accuracy of the temperature control mechanism.
(2) Performance testing must demonstrate the electromagnetic compatibility and electrical safety of the device.
(3) Software verification, validation, and hazard analysis must be performed.
(4) The patient contacting components of the device must be demonstrated to be biocompatible. Material names must be provided.
(5) Labeling must include the following:
(i) A statement describing the potential risk of developing scalp metastasis.
(ii) Information on the patient population and chemotherapeutic agents/regimen for which the device has been demonstrated to be effective.
(iii) A summary of the non-clinical and/or clinical testing pertinent to use of the device.
(iv) A summary of the device technical parameters, including temperature cooling range and duration of cooling.
(v) A summary of the device- and procedure-related adverse events pertinent to use of the device.
(vi) Information on how the device operates and the typical course of treatment.
(6) Patient labeling must be provided and must include:
(i) Relevant contraindications, warnings, precautions, and adverse effects/complications.
(ii) Information on how the device operates and the typical course of treatment.
(iii) Information on the patient population for which there is clinical evidence of effectiveness.
(iv) The potential risks and benefits associated with use of the device.
(v) Postoperative care instructions.
(vi) A statement describing the potential risk of developing scalp metastasis.