(126 days)
Not Found
No
The device description focuses on a refrigeration unit, coolant circulation, and a basic GUI for monitoring and control based on pre-established programs. There is no mention of AI, ML, or any learning or adaptive capabilities.
Yes
The device is indicated to reduce the likelihood of chemotherapy-induced alopecia (CIA), which addresses a medical condition, making it a therapeutic device.
No
The device is indicated to reduce the likelihood of chemotherapy-induced alopecia, and its description focuses on cooling the scalp rather than diagnosing any condition.
No
The device description clearly states it is a "self-contained, mobile, electrically-powered refrigeration unit" that circulates a liquid coolant through a cooling cap. This involves significant hardware components beyond just software.
Based on the provided information, the Paxman Scalp Cooler is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Paxman Scalp Cooler Function: The Paxman Scalp Cooler is a physical device that applies cooling to the patient's scalp. It does not analyze any biological specimens. Its function is to physically reduce the temperature of the scalp to mitigate a side effect of chemotherapy.
- Intended Use: The intended use is to "reduce the likelihood of chemotherapy-induced alopecia (CIA) in women with breast cancer." This is a therapeutic or preventative measure applied directly to the patient, not a diagnostic test performed on a sample.
Therefore, the Paxman Scalp Cooler falls under the category of a therapeutic or physical medicine device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Paxman Scalp Cooler is indicated to reduce the likelihood of chemotherapy-induced alopecia (CIA) in women with breast cancer.
Product codes (comma separated list FDA assigned to the subject device)
PMC
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-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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Scalp
Indicated Patient Age Range
Not Found. Indicated for "women with breast cancer".
Intended User / Care Setting
Healthcare professional / Not specified, likely clinical 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)
Study type: Prospective, randomized, two-arm study.
Sample size: 142 evaluable subjects (95 in cooling group, 47 in control group) across six (6) clinical sites in the United States.
Key results:
- Effectiveness: 48 (50.5%) out of 95 in the cooling group had hair preservation, compared to 0 (0%) out of 47 in the control group. The success rate difference was 50.5%, 95% Cl: 40.5% - 60.6%, one-tailed p-value from the Fisher's exact test was
§ 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.
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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)
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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
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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 |
| 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 |
| Differences | |||
| Trade Name | Paxman Scalp Cooler | DigniCap™ Scalp Cooling | |
| System | |||
| through the cap extracts | |||
| heat from the patient's | |||
| scalp maintaining | |||
| temperature. | through the channels of | ||
| the cap and back to the | |||
| cooling unit. The | |||
| circulation of the | |||
| refrigerant extracts heat | |||
| from the patient's scalp | |||
| maintaining a | |||
| temperature. | |||
| Technology | |||
| Overview | The unit is composed of | ||
| a main unit that | |||
| contains the | |||
| refrigeration | |||
| components, touch | |||
| screen controller, and | |||
| coolant tank. There are | |||
| detachable coolant lines | |||
| with covers, detachable | |||
| cooling cap with covers, | |||
| and proprietary coolant. | The DigniCap Cooling | ||
| System consists of a | |||
| refrigerator unit with | |||
| integral control system | |||
| operated via a touch | |||
| screen monitor and | |||
| capable of controlling | |||
| two separate cooling | |||
| caps. The scalp cooling is | |||
| performed in conjunction | |||
| with a silicone inner cap, | |||
| outer neoprene cap, and | |||
| the liquid coolant which | |||
| are proprietary. | Same | ||
| Patient Population | Women with Stage I - II | ||
| breast cancer | |||
| undergoing neoadjuvant | |||
| or adjavent | |||
| chemotherapy. | Women with Stage I - II | ||
| breast cancer undergoing | |||
| neoadjuvant or adjavent | |||
| chemotherapy. | Same | ||
| Set Cooling Time | Yes | Yes | Same |
| Pre/Post Cooling | |||
| Time | Yes | Yes | Same |
| Material of Cooling | |||
| Cap | Silicone | Silicone | Same |
| Size of Cooling Cap | Small, Medium, Large | Extra Small, Small, | |
| Medium, and Large | Similar; there is an | ||
| additional Extra Small | |||
| cooling cap provided | |||
| for predicate does not | |||
| Manufacturer | Paxman Coolers Limited | Dignitana AB | Significant |
| Differences | |||
| Trade Name | Paxman Scalp Cooler | DigniCap™ Scalp Cooling | |
| System | |||
| Number of Cooling | |||
| Caps/Lines | 2 | 2 | Same |
| Quick Disconnect | Yes | Yes | Same |
| Coolant | |||
| Temperature Range | -15°C to 5°C | -15°C to 5°C | Same |
| Refrigerant Type | Proprietary coolant | Proprietary coolant | Similar; both are |
| refrigerants that are | |||
| used for cooling | |||
| purposes. | |||
| Performance testing | |||
| of the system does | |||
| not raise any | |||
| additional questions | |||
| for safety and efficacy. | |||
| Coolant Refilling | Yes | Yes | Same |
| Sterile | No | No | Same |
| Single-Use | No | No | Same |
| Touch Screen | |||
| Interface | Yes | Yes | Same |
| Software Controlled | Yes | Yes | Same |
| Complies with ISO | |||
| 10993-1 | Yes | Yes | Same |
| Electrical Safety | |||
| Testing Passed | Yes | Yes | Same |
Table 5A - Comparison of Characteristics
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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