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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study proving device performance, based on the provided text:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Success Metric)	Reported Device Performance (Cooling Group)	Reported Device Performance (Control Group)
Hair preservation (less than 50% hair loss)	50.5% (48 out of 95 patients)	0% (0 out of 47 patients)
Safety Profile	All adverse events (54 total in 28 patients) were Grade 1 or 2; no serious adverse device events.	Not applicable (no device used)

Study Details

Sample Size used for the test set and the data provenance:
- Sample Size: 142 evaluable patients (95 in cooling group, 47 in control group).
- Data Provenance: Prospective, randomized, two-arm study conducted across six (6) clinical sites in the United States.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Two (a delegated physician or nurse practitioner, and a second independent healthcare provider).
- Qualifications: "delegated physician or nurse practitioner" and "second independent healthcare provider who is blinded to study treatment." Specific experience levels are not detailed.
Adjudication method for the test set:
- An alopecia assessment was performed "by a delegated physician or nurse practitioner and a second independent healthcare provider who is blinded to study treatment." This implies a form of independent assessment, potentially with reconciliation if there were discrepancies, though the specific adjudication method (e.g., 2+1, 3+1) is not explicitly stated. The "blinded" aspect for the second provider is noted.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- This was not an MRMC comparative effectiveness study involving AI assistance. It was a clinical trial comparing a medical device (scalp cooler) with a control group (no cooling) for reducing chemotherapy-induced alopecia.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This was not a standalone algorithm-only performance study. It was a device study involving human patients and a physical medical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The primary effectiveness ground truth was expert assessment/consensus (alopecia assessment by a delegated physician or nurse practitioner and a second independent healthcare provider) and patient self-report (success in hair preservation by subject self, use of wigs and/or hair wrap, and Quality of Life questionnaires).
The sample size for the training set:
- The document describes a clinical study to evaluate the safety and efficacy of the Paxman Scalp Cooler. It does not mention a "training set" as would be used in an AI/machine learning context. This device is a physical cooling unit, not an AI algorithm, so the concept of a training set is not applicable here.
How the ground truth for the training set was established:
- As this is a physical medical device and not an AI algorithm, there is no "training set" or corresponding ground truth establishment process described in the context of machine learning. The clinical study described in the document served as the performance evaluation for the device itself.

Summary

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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

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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

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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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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-InducedAlopecia
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

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.

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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	SignificantDifferences
Trade Name	Paxman Scalp Cooler	DigniCap™ Scalp CoolingSystem
	through the cap extractsheat from the patient'sscalp maintainingtemperature.	through the channels ofthe cap and back to thecooling unit. Thecirculation of therefrigerant extracts heatfrom the patient's scalpmaintaining atemperature.
TechnologyOverview	The unit is composed ofa main unit thatcontains therefrigerationcomponents, touchscreen controller, andcoolant tank. There aredetachable coolant lineswith covers, detachablecooling cap with covers,and proprietary coolant.	The DigniCap CoolingSystem consists of arefrigerator unit withintegral control systemoperated via a touchscreen monitor andcapable of controllingtwo separate coolingcaps. The scalp cooling isperformed in conjunctionwith a silicone inner cap,outer neoprene cap, andthe liquid coolant whichare proprietary.	Same
Patient Population	Women with Stage I - IIbreast cancerundergoing neoadjuvantor adjaventchemotherapy.	Women with Stage I - IIbreast cancer undergoingneoadjuvant or adjaventchemotherapy.	Same
Set Cooling Time	Yes	Yes	Same
Pre/Post CoolingTime	Yes	Yes	Same
Material of CoolingCap	Silicone	Silicone	Same
Size of Cooling Cap	Small, Medium, Large	Extra Small, Small,Medium, and Large	Similar; there is anadditional Extra Smallcooling cap providedfor predicate does not
Manufacturer	Paxman Coolers Limited	Dignitana AB	SignificantDifferences
Trade Name	Paxman Scalp Cooler	DigniCap™ Scalp CoolingSystem
Number of CoolingCaps/Lines	2	2	Same
Quick Disconnect	Yes	Yes	Same
CoolantTemperature Range	-15°C to 5°C	-15°C to 5°C	Same
Refrigerant Type	Proprietary coolant	Proprietary coolant	Similar; both arerefrigerants that areused for coolingpurposes.Performance testingof the system doesnot raise anyadditional questionsfor safety and efficacy.
Coolant Refilling	Yes	Yes	Same
Sterile	No	No	Same
Single-Use	No	No	Same
Touch ScreenInterface	Yes	Yes	Same
Software Controlled	Yes	Yes	Same
Complies with ISO10993-1	Yes	Yes	Same
Electrical SafetyTesting 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

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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

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. 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

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equivalent to the referenced predicate device.

Regulation Number and Section

§ 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.