← Product Code [PMC](/submissions/SU/subpart-e%E2%80%94surgical-devices/PMC) · K211526 # Portable Scalp Cooling System (K211526) _Cooler Heads Care, Inc. · PMC · Oct 21, 2021 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PMC/K211526 ## Device Facts - **Applicant:** Cooler Heads Care, Inc. - **Product Code:** [PMC](/submissions/SU/subpart-e%E2%80%94surgical-devices/PMC.md) - **Decision Date:** Oct 21, 2021 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4360 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Intended Use 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. ## Device Story Portable Scalp Cooling System (PSCS) is a wearable device for adult cancer patients undergoing chemotherapy for solid tumors. Device aims to reduce chemotherapy-induced alopecia. System circulates a water/isopropyl alcohol (IPA) mixture through a cooling cap worn on the patient's head. Operated by user or caregiver in treatment centers, during travel, and in home settings. Provides continuous cooling therapy during transition from infusion center to home. Powered by wall outlet, internal rechargeable lithium battery, or car charger. Differences from predicate include portability, power options, and use of water/IPA/ice coolant mixture versus proprietary coolant. Healthcare providers/caregivers monitor therapy; device usage intended to mitigate hair loss, potentially improving patient quality of life. ## Clinical Evidence Bench testing only. No clinical data provided. Testing included electrical safety (IEC 60601-1, 1-6, 1-11), electromagnetic compatibility (IEC 60601-1-2), software V&V (IEC 62304), performance bench testing (scalp cooling performance, cooling stability), human factor testing (IEC 62366-1), and biocompatibility (ISO 10993-1). ## Technological Characteristics Wearable scalp cooling system. Materials meet ISO 10993-1 for prolonged skin contact. Cooling via circulating water/70% isopropyl alcohol/ice mixture. Power: 100-240 VAC, internal rechargeable lithium battery, or 11-15 VDC car charger. Connectivity: Portable/mobile. Software V&V per IEC 62304. ## Regulatory 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. ## 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. ## Predicate Devices - Paxman Scalp Cooler ([K173032](/device/K173032.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the full name of the agency on the right. The symbol on the left is a stylized representation of a human figure. To the right of the symbol is a blue square containing the acronym "FDA" in white letters. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue. Cooler Heads Care, Inc. % Pierre Bounaud Principal Consultant Acknowledge Regulatory Strategies 2251 San Diego Avenue, Suite B-257 San Diego, California 92110 October 21, 2021 ## Re: K211526 Trade/Device Name: Portable Scalp Cooling System Regulation Number: 21 CFR 878.4360 Regulation Name: Scalp Cooling System to reduce the likelihood of Chemotherapy-Induced Alopecia Regulatory Class: Class II Product Code: PMC Dated: October 1, 2021 Received: October 4, 2021 ## Dear Pierre Bounaud: 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 (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 located at https://www.accessdata.fda.gov/scripts/cdrh/ofdocs/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. 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 {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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, Neil R.P. Ogden Assistant Director, THT4A4 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K211526 Device Name Portable Scalp Cooling System Indications for Use (Describe) 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. Type of Use (Select one or both, as applicable) | ☑ Beneficial Use (Part 31 CFR 901.2, subpart D) | |----------------------------------------------------------------------------------------------------------------------------------------| | ☐ Own-The-Counter Use (31 CFR 901.2, subpart C) | > Prescription Use (Part 21 CFR 801 Subpart D) __ Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW * The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary DATE PREPARED May 13, 2021 #### MANUFACTURER AND 510(k) OWNER Cooler Heads Care, Inc. 2801 B Street, #209, San Diego, CA 92102, USA Telephone: Official Contact: Kate Dilligan, CEO #### REPRESENTATIVE/CONSULTANT Pierre Bounaud, Ph.D. Allison C. Komiyama, Ph.D., R.A.C. AcKnowledge Regulatory Strategies, LLC Telephone: +1 (619) 458-9547 Email: pbounaud@acknowledge-rs.com #### DEVICE INFORMATION | Proprietary Name/Trade Name: | Portable Scalp Cooling System (PSCS) | |------------------------------|-------------------------------------------| | Common Name: | Scalp Cooling System | | Regulation Number: | 21 CFR 878.4360 | | Class: | II | | Product Code: | PMC | | Premarket Review: | OPEQ/OHT4/General Surgery Devices (DHT4A) | | Review Panel: | General & Plastic Surgery | #### PREDICATE DEVICE IDENTIFICATION The PSCS is substantially equivalent to the following predicate: | 510(k) Number | Predicate Device Name / Manufacturer | Primary Predicate | |---------------|------------------------------------------|-------------------| | K173032 | Paxman Scalp Cooler / Paxman Coolers Ltd | ✓ | The predicate device has not been subject to a design related recall. #### DEVICE DESCRIPTION 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. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the words "Cooler Heads" stacked on top of each other. The words are written in a sans-serif font and are a light blue color. The background is white. The text is slightly blurred, giving it a soft appearance. #### 510(k) Summary ## INDICATIONS FOR USE 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. ## COMPARISON OF TECHNOLOGICAL CHARACTERISTICS Cooler Heads Care, Inc. believes that the PSCS is substantially equivalent to the predicate device based on the information summarized here: The subject device has the same intended use as the device cleared in K173032. Both devices are scalp cooling systems intended to reduce the likelihood of chemotherapy-induced alopecia. The subject device is indicated for home use, while the predicate device is indicated for healthcare facilities. This difference has undergone human factor testing to ensure the device is as safe and effective as the predicate. The subject device has similar, albeit more compact design, similar materials, and similar technological characteristics as the device cleared in K173032. The main technological differences of the subject device, as compared to the predicate device cleared in K173032, are: - The type of coolant. The subject device uses a mixture of readily available 70% isopropyl o alcohol, water, and ice. The predicate device uses a proprietary cooling mixture (OrbisC). - . The power source. The subject device was designed to be a mobile device and includes three different power sources: wall outlet (100-240 VAC – 50/60 Hz), internal rechargeable lithium battery, and a car charger (11-15 VDC 10A). The predicate device is intended to be plugged into a wall outlet only (100-120 VAC). These technological differences have undergone testing to ensure the subject device is as safe and effective as the predicate device. #### SUMMARY OF NON-CLINICAL TESTING No FDA performance standards have been established for the PSCS. The following tests were performed to demonstrate safety based on current industry standards: - o Electrical safety per IEC 60601-1, IEC 60601-1-6, and IEC 60601-1-11 - Electromagnetic compatibility per IEC 60601-1-2 o - . Software V&V per IEC 62304 - . Performance bench testing (scalp cooling performance, cooling stability between power sources) - . Human factor testing per IEC 62366-1 The results of these tests indicate that the PSCS is substantially equivalent to the predicate device. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the words "Cooler Heads" stacked on top of each other. The words are written in a sans-serif font and are a light blue color. The background is white, which makes the text stand out. The text is slightly blurred. ## 510(k) Summary PSCS meets the requirements of ISO 10993-1 and FDA's Guidance for Industry and Food and Druq Administration Staff - Use of International ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", for a surface device with cumulative prolonged contact duration with intact skin. #### CONCLUSION Based on the testing performed, including electrical safety, electromagnetic compatibility, software V&V, performance bench testing, and human factor testing, it can be concluded that the subject device does not raise new issues of safety or effectiveness compared to the predicate device. The similar indications for use, technological characteristics, and performance characteristics for the proposed PSCS are assessed to be substantially equivalent to the predicate device. --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PMC/K211526](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PMC/K211526) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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