(157 days)
Not Found
No
The summary describes a physical cooling system with no mention of AI/ML terms, image processing, or data-driven performance metrics.
Yes
The device is indicated to "reduce the likelihood of chemotherapy-induced alopecia," which is a medical condition, making it a therapeutic device.
No
The device is indicated to reduce the likelihood of chemotherapy-induced alopecia, which is a therapeutic purpose, not a diagnostic one.
No
The device description explicitly states it is a "wearable device" that provides cooling therapy by circulating a liquid mixture through a "cooling cap," indicating it includes significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Portable Scalp Cooling System (PSCS) is a physical therapy device that applies cooling to the scalp. It does not analyze biological samples or provide diagnostic information.
- Intended Use: The intended use is to reduce the likelihood of chemotherapy-induced hair loss, which is a preventative/mitigative physical treatment, not a diagnostic test.
- Device Description: The description focuses on the physical mechanism of cooling the scalp.
- Performance Studies: The performance studies listed are related to electrical safety, electromagnetic compatibility, software validation, performance bench testing (cooling), and human factors – all typical for a physical medical device, not an IVD.
Therefore, the PSCS falls under the category of a therapeutic or physical medical device, not an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
PMC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Scalp
Indicated Patient Age Range
adult patients only
Intended User / Care Setting
user or caregiver in a treatment center, during travel time to the patient's home and in the home setting.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
No FDA performance standards have been established for the PSCS. The following tests were performed to demonstrate safety based on current industry standards:
- Electrical safety per IEC 60601-1, IEC 60601-1-6, and IEC 60601-1-11
- Electromagnetic compatibility per IEC 60601-1-2
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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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)
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)
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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.
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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.
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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.