Paxman Scalp Cooler

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of three human profiles facing right, stacked on top of each other. Above the profiles is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 April 17, 2017 Paxman Coolers Limited % Richard Vincins Vice President, QA/RA Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, Texas 78746 Re: K163484 Trade/Device Name: Paxman Scalp Cooler Regulation Number: 21 CFR 878.4360 Regulation Name: Scalp Cooling System Regulatory Class: Class II Product Code: PMC Dated: March 17, 2017 Received: March 21, 2017 Dear Richard Vincins: 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. 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 801); medical device reporting (reporting of medical device {1}------------------------------------------------ related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely. Jennifer R. Stevenson -S For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K163484 Device Name Paxman Scalp Cooler Indications for Use (Describe) The Paxman Scalp Cooler is indicated to reduce the likelihood of chemotherapy-induced alopecia (CIA) in women with breast cancer. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| X 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 # Paxman Scalp Cooler # K163484 # 1. Submission Sponsor Paxman Coolers Limited International House Penistone Road Fenay Bridge Huddersfield HD8 OLE United Kingdom Contact: Richard PAXMAN Title: Managing Director # 2. Submission Correspondent Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746 Office Phone: (512) 327.9997 Contact: Carrie Hetrick, Senior Consultant, RA Email: project.management@emergogroup.com #### 3. Date Prepared 17th March, 2017 {4}------------------------------------------------ ### 4. Device Identification | Trade/Proprietary Name: | Paxman Scalp Cooler | |-------------------------|-----------------------------------------------------------------------------------| | Common/Usual Name: | Scalp Cooling System | | Classification Name: | Scalp Cooling System to Reduce the Likelihood of Chemotherapy-Induced<br>Alopecia | | Regulation Number: | 878.4360 | | Product Code: | PMC, Scalp Cooling System | | Device Class: | Class II | | Classification Panel: | General and Plastic Surgery | #### 5. Legally Marketed Predicate Device DEN150010, DigniCap™ Scalp Cooling System, Dignitana AB #### 6. Device Description The Paxman Scalp Cooler is a self-contained, mobile, electrically-powered refrigeration unit that circulates a refrigerated liquid coolant, at a pre-set temperature and flow rate, through a cooling cap, which is fitted to the top of the patient's head and connected to the refrigeration unit by a pair of coolant lines. A touch screen controller with a menu-driven, graphical user interface, integrated into the refrigeration unit, allows the healthcare professional to initiate, monitor, and complete the scalp cooling process. Two (2) models of the Paxman Scalp Cooler are available: - . ORBIS I – featuring one pair of coolant lines for attaching a single cooling cap; designed for scalp cooling of one patient at a time; and, - . ORBIS II – featuring two pairs of coolant lines for attaching two cooling caps; designed for scalp cooling of up to two (2) patients at a time. The touch screen displays a menu-driven Graphical User Interface (GUI) that provides information to the user concerning the operational status of the scalp cooling unit; it also prompts the user to initiate certain actions relating to the scalp cooling procedure and provides a timer count-down function for scalp cooling sessions. The GUI does not, however, directly control the scalp cooling process as there are pre-established programs for the scalp cooling administration. The touch screen controller provides feedback to the user concerning the status of the Paxman Scalp Cooler as it relates to achievement of the pre-set temperature of the coolant, operation of the recirculation pump and connection of a cooling cap to the software also provides a timer count-down function for the initiated pre- and post-infusion cooling procedure. At the pre {5}------------------------------------------------ set time, a message is displayed on the touch screen and a buzzer sounds to alert the fact that the scalp cooling time is complete. #### 7. Indication for Use Statement The Paxman Scalp Cooler is indicated to reduce the likelihood of chemotherapy-induced alopecia (CIA) in women with breast cancer. #### 8. Substantial Equivalence Discussion The following table compares the Paxman Scalp Cooler to the predicate device with respect to indications for use, principles of operation, technological characteristics, materials, and performance testing. The comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence. The subject device does not raise any new issues of safety or effectiveness based on the similarities to the predicate device. | Manufacturer | Paxman Coolers Limited | Dignitana AB | Significant Differences | |-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade Name | Paxman Scalp Cooler | DigniCap™ Scalp Cooling System | | | 510(k) Number | Not assigned | DEN150010 | Not applicable | | Product Code | PMC | PMC | Same | | Regulation Number | 878.4360 | 878.4360 | Same | | Regulation Name | Scalp Cooling System | Scalp Cooling System | Same | | Indications for Use | The Paxman Scalp Cooler is indicated to reduce the likelihood of chemotherapy-induced alopecia (CIA) in women with breast cancer. | The DigniCap™ Scalp Cooling System is indicated to reduce the likelihood of chemotherapy - induced alopecia in women with breast cancer. | Same | | Mechanism of Action | The unit is a compact, mobile refrigeration unit which circulates liquid coolant at low pressure through a special cooling cap on the patient's head. The circulation of the refrigerated coolant | The Dignitana DigniCap™ Scalp Cooling System consists of a computer controlled system that includes a refrigerated tank containing the cooling agent. The liquid coolant circulates from the cooling unit to and | Same | | Manufacturer | Paxman Coolers Limited | Dignitana AB | Significant<br>Differences | | Trade Name | Paxman Scalp Cooler | DigniCap™ Scalp Cooling<br>System | | | | through the cap extracts<br>heat from the patient's<br>scalp maintaining<br>temperature. | through the channels of<br>the cap and back to the<br>cooling unit. The<br>circulation of the<br>refrigerant extracts heat<br>from the patient's scalp<br>maintaining a<br>temperature. | | | Technology<br>Overview | The unit is composed of<br>a main unit that<br>contains the<br>refrigeration<br>components, touch<br>screen controller, and<br>coolant tank. There are<br>detachable coolant lines<br>with covers, detachable<br>cooling cap with covers,<br>and proprietary coolant. | The DigniCap Cooling<br>System consists of a<br>refrigerator unit with<br>integral control system<br>operated via a touch<br>screen monitor and<br>capable of controlling<br>two separate cooling<br>caps. The scalp cooling is<br>performed in conjunction<br>with a silicone inner cap,<br>outer neoprene cap, and<br>the liquid coolant which<br>are proprietary. | Same | | Patient Population | Women with Stage I - II<br>breast cancer<br>undergoing neoadjuvant<br>or adjavent<br>chemotherapy. | Women with Stage I - II<br>breast cancer undergoing<br>neoadjuvant or adjavent<br>chemotherapy. | Same | | Set Cooling Time | Yes | Yes | Same | | Pre/Post Cooling<br>Time | Yes | Yes | Same | | Material of Cooling<br>Cap | Silicone | Silicone | Same | | Size of Cooling Cap | Small, Medium, Large | Extra Small, Small,<br>Medium, and Large | Similar; there is an<br>additional Extra Small<br>cooling cap provided<br>for predicate does not | | Manufacturer | Paxman Coolers Limited | Dignitana AB | Significant<br>Differences | | Trade Name | Paxman Scalp Cooler | DigniCap™ Scalp Cooling<br>System | | | Number of Cooling<br>Caps/Lines | 2 | 2 | Same | | Quick Disconnect | Yes | Yes | Same | | Coolant<br>Temperature Range | -15°C to 5°C | -15°C to 5°C | Same | | Refrigerant Type | Proprietary coolant | Proprietary coolant | Similar; both are<br>refrigerants that are<br>used for cooling<br>purposes.<br>Performance testing<br>of the system does<br>not raise any<br>additional questions<br>for safety and efficacy. | | Coolant Refilling | Yes | Yes | Same | | Sterile | No | No | Same | | Single-Use | No | No | Same | | Touch Screen<br>Interface | Yes | Yes | Same | | Software Controlled | Yes | Yes | Same | | Complies with ISO<br>10993-1 | Yes | Yes | Same | | Electrical Safety<br>Testing Passed | Yes | Yes | Same | #### Table 5A - Comparison of Characteristics {6}------------------------------------------------ {7}------------------------------------------------ # 9. Non-Clinical Performance Data As part of demonstrating safety and effectiveness of Paxman Scalp Cooler and in showing substantial equivalence to the predicate devices that are subject to this 510(k) submission, Paxman Coolers Limited completed a number of non-clinical performance tests. The Paxman Scalp Cooler meets all the {8}------------------------------------------------ requirements for overall design, labeling, biocompatibility, software testing, and electrical safety results confirming that the design output meets the design inputs and specifications for the device. The Paxman Scalp Cooler passed all the testing in accordance with internal requirements, national standards, and international standards shown below to support substantial equivalence of the subject device: - . Biocompatibility testing of Cooling Cap per ISO 10993-1: Passed - Electrical safety testing per ANSI/AAMI ES60601-1: Passed - Electromagnetic Disturbance (EMD) testing per IEC 60601-1-2: Passed - Software verification and validation testing per IEC 62304/FDA Guidance - . Useable life of the device of five (5) years and Cooling Cap shelf life of three (3) years - Storage and Transport Testing conformance to ISTA requirements: Passed - . Heat extraction validation testing - Scalp temperature validation testing - Performance testing of coolant management: Passed - . Leak testing of Cooling Cap: Passed # 10. Clinical Performance Data A clinical study was conducted to evaluate safety and efficacy of the Paxman Scalp Cooler to physically cool the scalp of patients who are undergoing chemotherapy for the treatment of breast cancer, in order to reduce chemotherapy-induced alopecia. The study was a prospective, randomized, two-arm study of women with Type I-II breast cancer undergoing chemotherapy treatment with Paxman Scalp Cooler used as the cooling arm and no cooling serving as the control group. The overall summary of the clinical study is shown: - . Study Design: The study was a prospective, randomized, two-arm study of women with breast cancer undergoing chemotherapy to evaluate effect of scalp cooling to reduce chemotherapyinduced alopecia. - . Study Objectives: To demonstrate that the Paxman Scalp Cooler is safe and effective in reducing chemotherapy-induced alopecia in women with breast cancer undergoing neoadjuvant or adjuvant chemotherapy - Comparing success in hair preservation, between the Paxman Scalp Cooler (cooling arm) O and control group (no cooling arm) after four (4) cycles of chemotherapy - To estimate the rate of significant cold-related anticipated adverse device effects O (AADEs) self-reported by subjects during treatment with the Paxman Scalp Cooler {9}------------------------------------------------ - . Study Endpoints: All eligible study subjects who receive at least one (1) cycle of chemotherapy will be evaluable for hair-preservation response: success in hair preservation by a Healthcare Professional, success in hair preservation by subject self and Oncologist, use of wigs and/or hair wrap, and Quality of Life using three questionnaires. - . Study Procedure: All subjects are randomized to cooling arm will undergo scalp cooling using the Paxman Scalp Cooler, during and after administration of each chemotherapy session, for four (4) complete cycles of full-dose anthracycline or taxane based chemotherapy that are specified in inclusion criteria for the chemotherapy treatment regimen. Scalp cooling will begin a minimum of 30 minutes pre-infusion administration of chemotherapy. Cooling commences for the duration of chemotherapy treatment administered by the Paxman Scalp Cooler. Temperature will be maintained through scalp cooling with the device a minimum of 90 minutes post-infusion. At baseline and after each cycle, subjects will have an alopecia assessment by a delegated physician or nurse practitioner and a second independent healthcare provider who is blinded to study treatment. Each subject will be followed up 2-3 weeks after completion of each chemotherapy cycle, and 2-4 weeks after completion of the final chemotherapy cycle. - Number of Patients/Sites: Number of evaluable subject is 142 (one hundred forty two) that were analyzed based on the intent to treat (ITT) population across six (6) clinical sites in the United States. - Study Treatment: Duration of device use depends on the type of chemotherapy the subject is receiving; subject is assessed after each cycle of chemotherapy (maximum of 8 cycles). - Results Effectiveness: Of the 142 evaluable patients, 95 were in the cooling group and 47 were in the control group (no cooling). Results show 48 (50.5%) out of 95 in the cooling group and 0 (0%) out of 47 in the control group had hair preservation. The success rate difference between the two groups was 50.5%, 95% Cl: 40.5% - 60.6%, one-tailed p-value from the Fisher's exact test was <0.0001. - Results Safety: Total of 28 patients (27.7%) had 54 adverse events in combination through all treatment sessions. All adverse events were grade 1 or 2. There was no serious adverse device event. Results of the clinical investigation support the safety, efficacy, and indications for use of the Paxman Scalp Cooler in reducing chemotherapy-induced alopecia by achieving less than 50% hair loss compared with no scalp cooling after chemotherapy treatment. Clinical study conclusion confirms that the device is safe and effective as used according to the instructions for use. # 11. Statement of Substantial Equivalence By definition, a device is substantially equivalent to a predicate device has the same intended use and the same technological characteristics as the previously cleared predicate device. Based on the comparison and analysis above, the Paxman Scalp Cooler is determined to be substantially {10}------------------------------------------------ equivalent to the referenced predicate device.