PMC · Scalp Cooling System
General, Plastic Surgery · 21 CFR 878.4360 · Class 2
Overview
| Product Code | PMC |
|---|---|
| Device Name | Scalp Cooling System |
| Regulation | 21 CFR 878.4360 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
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.
Classification Rationale
Class II (special controls). The special controls for this device are:
Special Controls
*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.
Recent Cleared Devices (7 of 7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252289 | Eva Scalp Cooling System | Stemtech Medical Devices Private Limited | Nov 25, 2025 | SESE |
| K211526 | Portable Scalp Cooling System | Cooler Heads Care, Inc. | Oct 21, 2021 | SESE |
| K191166 | DigniCap Delta | Dignitana, Inc. | Jun 26, 2019 | SESE |
| K173032 | Paxman Scalp Cooler | Paxman Coolers Limited | Jun 7, 2018 | SESE |
| K170871 | DigniCap Scalp Cooling System | Dignitana AB | Jul 3, 2017 | SESE |
| K163484 | Paxman Scalp Cooler | Paxman Coolers Limited | Apr 17, 2017 | SESE |
| DEN150010 | Dignitana AB DigniCap System | Dignitana AB | Dec 8, 2015 | DENG |
Top Applicants
- Dignitana AB — 2 clearances
- Paxman Coolers Limited — 2 clearances
- Cooler Heads Care, Inc. — 1 clearance
- Dignitana, Inc. — 1 clearance
- Stemtech Medical Devices Private Limited — 1 clearance
