← Product Code [PMC](/submissions/SU/subpart-e%E2%80%94surgical-devices/PMC) · K173032
# Paxman Scalp Cooler (K173032)
_Paxman Coolers Limited · PMC · Jun 7, 2018 · General, Plastic Surgery · SESE_
**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PMC/K173032
## Device Facts
- **Applicant:** Paxman Coolers Limited
- **Product Code:** [PMC](/submissions/SU/subpart-e%E2%80%94surgical-devices/PMC.md)
- **Decision Date:** Jun 7, 2018
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.4360
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery
- **Attributes:** Therapeutic
## Intended Use
The Paxman Scalp Cooler is indicated to reduce the likelihood of chemotherapy-induced alopecia (CIA) in cancer patients with solid tumors.
## Device Story
The Paxman Scalp Cooler is a mobile, electrically-powered refrigeration unit that circulates refrigerated liquid coolant through a cooling cap fitted to the patient's head. The system extracts heat from the scalp to maintain a low temperature, which reduces the likelihood of chemotherapy-induced alopecia. It is used in clinical settings by trained healthcare professionals. The device features a touchscreen controller with a graphical user interface (GUI) that allows the user to initiate, monitor, and complete the cooling process. The GUI provides status updates, timer countdowns, and alerts. The system uses pre-established programs for cooling administration. By maintaining scalp hypothermia during chemotherapy infusion, the device aims to reduce hair loss, potentially improving patient quality of life. The device is not intended for use with Taxanes plus anthracyclines in combination or sequence.
## Clinical Evidence
Evidence includes registry data (Dutch Scalp Cooling Registry, n>6000), a randomized multi-center trial (NCT01986140, n=182), and various observational/retrospective studies. The SCALP trial demonstrated 50.5% successful hair preservation in the cooling group vs 0% in control (p=0.0061). Registry data and literature across various solid tumors (breast, lung, prostate, etc.) support efficacy, with variable success rates depending on chemotherapy regimen (e.g., higher success with taxanes, lower with anthracyclines). Adverse events were generally mild (grades 1-2), primarily cold sensation and headache.
## Technological Characteristics
Mobile refrigeration unit; circulates liquid coolant (OrbisC organic salt-based) through silicone cooling caps (Primasil Sil 100, 20-80 Shore Durometer). Dimensions: 640mm x 320mm x 420mm; Weight: 29.5kg. Power: 100-120V, 50/60Hz. Coolant temperature range: -15°C to 5°C. Features touchscreen controller, recirculation pump, and quick-disconnect lines. Non-sterile, reusable system. Software-controlled with pre-established programs.
## 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 ([K163484](/device/K163484.md))
## Reference Devices
- DigniCap Scalp Cooling System ([K170871](/device/K170871.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 contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
June 7, 2018
Paxman Coolers Limited % Heather Crawford Senior Consultant, Quality and Regulatory Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, Texas 78746
Re: K173032
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: May 2, 2018 Received: May 7, 2018
Dear Heather Crawford:
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, 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
> Sincerely, Jennifer R. Stevenson -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) K173032
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 cancer patients with solid tumors.
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
# K173032
### 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: Heather Crawford, Senior Consultant, Quality and Regulatory
Email: project.management@emergogroup.com
#### 3. Date Prepared
June 03, 2018
{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 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/Reference Devices
Predicate Device: K163484, Paxman Scalp Cooler, Paxman Coolers Limited Reference Device: K170871, DigniCap Scalp Cooling System, Dignitana AB
#### 6. Device Description
The Paxman Scalp Cooler is a scalp cooling system used to reduce the likelihood of chemotherapyinduced alopecia previously cleared by FDA in women with breast cancer (K163484). The only change from the previously cleared device is the indication for use from "women with breast cancer" to use in "cancer patients with solid tumors." There are no changes to the hardware or software in the subject device when compared to the device cleared under K163484.
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 touchscreen 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.
The touchscreen 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 some actions regarding 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 touchscreen controller provides feedback to the user concerning the status of the Paxman Scalp Cooler as it relates to the achievement of the pre-set temperature of the coolant, operation of the recirculation pump and connection of a cooling cap to the system. The software also
{5}------------------------------------------------
provides a timer count-down function for the initiated pre- and post-infusion cooling procedure. At the end of the pre-set time, a message is displayed on the touchscreen, and a buzzer sounds to alert the user to 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 cancer patients with solid tumors.
### 8. Limitations
The sale, distribution, and use of Paxman Scalp Cooler are restricted to prescription use in accordance with 21 CFR §801.109.
Limitations on device use are also achieved through the following contraindications, warnings and precautions included in the instructions for use.
### 9. Contraindications
Scalp cooling is contraindicated in pediatric patients.
Scalp cooling is contraindicated in patients with:
- . An existing history of scalp metastases or the presence of scalp metastasis is suspected.
- Cancers of the head and neck.
- CNS malignancies (either primary or metastatic).
- Cold sensitivity, cold agglutinin disease, cryoglobulinemia, cryofibrinogenemia, cold migraine, cold urticaria, and post-traumatic cold dystrophy.
- . Hematological malignancies (leukemia, non-Hodgkin and other generalized lymphomas) or hematological malignancies that are being treated for cure.
- Imminent bone marrow ablation chemotherapy.
- . Imminent skull irradiation.
- . Previously received, or scheduled to undergo skull irradiation.
- . Scalp metastases have rarely been reported in the literature, but caution regarding their development has been a limitation for the broad-scale application of scalp cooling during chemotherapy. Theoretically, tumor cells that have seeded in the scalp might not receive adequate chemotherapy during hypothermia, thus allowing them to grow at a later date.
- . Severe liver or renal disease from any etiology who may not be able to metabolize or clear the metabolites of the chemotherapeutic agent.
- . Skin cancers including melanoma, squamous cell carcinoma, and Merkel cell carcinoma.
{6}------------------------------------------------
- Small cell carcinoma of the lung.
- . Solid tumors that have a high likelihood for metastasis in transit.
- Squamous cell carcinoma of the lung.
#### 10. Warnings and Precautions
Scalp and/or cutaneous metastases have been reported in patients with non-small cell lung cancer, colon cancer, renal cell carcinoma, ovarian cancer, and bladder cancer. Patients with advanced forms of these tumors may be more likely to experience scalp metastases with the scalp cooling system.
It cannot be guaranteed that scalp cooling will prevent all patients undergoing chemotherapy from losing any or all of their hair. The success rate of scalp cooling in reducing chemotherapyinduced hair loss varies from patient and according to the chemotherapy regimen administered.
Long-term effects of scalp-cooling and scalp metastasis have not been thoroughly studied.
Use of scalp cooling in the palliative setting in patients with metastatic cancer may also increase the risk for scalp metastases.
Use of scalp cooling with Taxanes plus anthracyclines when used together or in sequence has not been shown to be successful in preventing chemotherapeutic drug induced alopecia. The Paxman Scalp Cooler should not be used in these patients.
The effectiveness of this device in patients who have received previous chemotherapy has not been evaluated.
Clinical studies have demonstrated variable success rates in patient reduction of chemotherapyinduced alopecia with scalp cooling since the outcome is dependent on multiple factors including chemotherapy regimen, dose, duration of drug infusion, chemotherapy drug metabolism, and concomitant comorbidities. Data have shown that women who experience hair loss despite using scalp cooling might have worse quality of life than women who did not have scalp cooling.
The Paxman Scalp Cooler should only be used by appropriately qualified healthcare professionals who have been trained in the operation of the device.
Do not allow any liquids to be placed on the scalp cooler or near the touch screen controller, including drips from the cooling caps.
Avoid use at ambient temperatures of over 30°C/86°F.
Do not touch the side ventilation grills whilst the device is in use.
{7}------------------------------------------------
#### 11. Substantial Equivalence Discussion
Aside from the change in the Indications for Use, the Paxman Scalp Cooler is identical in technological characteristics, design, and performance to the predicate.
The following table compares the Paxman Scalp Cooler to the predicate device with respect to indications for use, principles of operation, technological characteristics, 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.
| | Subject Device | Predicate Device | |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Paxman Coolers Limited | Paxman Coolers Limited | Significant Differences |
| Trade Name | Paxman Scalp Cooler | Paxman Scalp Cooler | |
| 510(k) Number | K173032 | K163484 | 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 cancer patients with solid tumors. | The Paxman Scalp Cooler is indicated to reduce the likelihood of chemotherapy-induced alopecia (CIA) in women with breast cancer. | The subject device is identical in technological characteristics to the predicate device K163484 apart from the indications for use, which are being broadened from “in women with breast cancer” to “in cancer patients with solid tumors.” The subject device indications for use are identical to DigniCap, |
#### Table 5A – Comparison of Characteristics
{8}------------------------------------------------
| | Subject Device | Predicate Device | Significant Differences |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Paxman Coolers Limited | Paxman Coolers Limited | |
| Trade Name | Paxman Scalp Cooler | Paxman Scalp Cooler | K170871. |
| 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 through the cap extracts heat from the patient's scalp maintaining temperature. | 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 through the cap extracts heat from the patient's scalp maintaining temperature. | Same |
| Technology Overview | The unit is composed of the 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 unit is composed of the 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. | Same |
| Patient Population | Cancer patients with solid tumors | Women with Stage I - II breast cancer undergoing neoadjuvant or adjuvant chemotherapy. | Differs - The expanded patient population includes all cancer patients with solid tumors, which includes women with breast cancer. |
| Set Cooling Time | Yes | Yes | Same |
| Pre/Post Cooling Time | Yes | Yes | Same |
{9}------------------------------------------------
| | Subject Device | Predicate Device | Significant Differences |
|------------------------------|------------------------------------------------------------------|------------------------------------------------------------------|-------------------------|
| Manufacturer | Paxman Coolers Limited | Paxman Coolers Limited | |
| Trade Name | Paxman Scalp Cooler | Paxman Scalp Cooler | |
| Material of Cooling Cap | Silicone; Primasil Sil 100 silicone from 20 – 80 Shore Duromater | Silicone; Primasil Sil 100 silicone from 20 - 80 Shore Duromater | Same |
| Size of Cooling Cap | Small, Medium, Large | Small, Medium, Large | Same |
| 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 | OrbisC (organic salt based) | OrbisC (organic salt based) | Same |
| Coolant Refilling | Yes | Yes | Same |
| Sterile | No | No | Same |
| Single-Use | No | No | Same |
| Main Unit Dimensions | Height: 640 mm
Width: 320 mm
Depth: 420 mm | Height: 640 mm
Width: 320 mm
Depth: 420 mm | Same |
| Weight | 29.5 kg | 29.5 kg | Same |
| AC Powered | 100 – 120 V, 50/60 Hz | 100 – 120 V, 50/60 Hz | Same |
| Touch Screen Interface | Yes | Yes | Same |
| Software Controlled | Yes | Yes | Same |
| Complies with | Yes | Yes | Same |
{10}------------------------------------------------
| | Subject Device | Predicate Device | Significant Differences |
|----------------------------------------|------------------------|------------------------|-------------------------|
| Manufacturer | Paxman Coolers Limited | Paxman Coolers Limited | |
| Trade Name | Paxman Scalp Cooler | Paxman Scalp Cooler | |
| ISO 10993-1 | | | |
| Electrical
Safety Testing
Passed | Yes | Yes | Same |
#### 12. Non-Clinical Performance Data
No additional testing was conducted for this 510(k) to support substantial equivalence. The device in this submission is identical to the previously cleared device, as the purpose of this application was for the expansion of the treatment population only. Testing of the predicate device included biocompatibility, shelf-life, shipping and packaging, electromagnetic compatibility and electrical safety, software, and bench testing. All tests met the pre-determined specifications and acceptance criteria and demonstrated the Paxman Scalp Cooler to be safe and effective as labeled.
#### 13. Clinical Performance Data
Published and non-published clinical data support use of the Paxman Scalp Cooling System in cancer patients with solid tumors. Clinical data in this application comprises registry data, a manufacturer-sponsored clinical study, clinical literature and non-published studies as described below.
#### Dutch Scalp Cooling Registry
The Dutch Scalp Cooling Registry has enrolled over 6000 cancer patients, including multiple cancer types and varies chemotherapy regimens. Seventy-one percent of all solid tumor patients wore no head cover at their last cooling session (p < 0.05) compared to 50% of all breast cancer patients at their last cooling session. Registry data demonstrate some subgroups, e.g. patients treated with certain chemotherapeutic agents, including AC, DAC and Irino mono, as well as patients with Asian or chemically-colored hair may be least likely to benefit from scalp cooling.
#### Paxman Coolers Limited SCALP study
The Paxman Coolers Limited SCALP (Scalp Cooling to Prevent Chemo-induced Hair Loss) clinical study (ClinicalTrials.gov identifier: NCT01986140) was initiated to evaluate the safety and efficacy of the Paxman Scalp Cooler, in support of its initial indication to reduce the likelihood of CIA in women with breast cancer (K163484).
Successful hair preservation was demonstrated in 69 of 130 women with cooling (53.1%; 95%CJ, 44.5%-61.4%) compared with 0 of 54 women in the no cooling (control) group (0%; 95%C), 0%-
{11}------------------------------------------------
6.6%) (success rate difference, 53.1%; 95%Cl, 44.5%-61.7%). Seventy-one device-related adverse events were reported in the cooling group, all grades 1 and 2. No serious device-related adverse events occurred.
Primary and secondary study endpoints are complete. Enrolled subjects are currently in long-term follow-up for disease status and survival.
#### Clinical literature and non-published studies
The performance and/or safety of scalp cooling with the Paxman Scalp Cooler is reported in the clinical literature and non-published studies. These documents report the effects of scalp cooling on a range of cancer types, chemotherapeutic agents and regimens, and patient characteristics. Scalp cooling treatments appear well-tolerated and were infrequently discontinued by patients. The sensation of cold was sometimes reported, no serious adverse events occurred, and patient ratings of cooling therapy were generally favorable.
Findings from the clinical literature include:
- . No unfavorable development of disease due to scalp cooling has been documented in patients with solid tumors, scalp cooling can safely be offered to patients treated with alopeciainducing chemotherapy;
- . Among women with stage I to II breast cancer receiving chemotherapy with a taxane, anthracycline, or both, those who underwent scalp cooling were significantly more likely to have < 50% hair loss after the 4th chemotherapy cycle compared with those who received no scalp cooling; and
- Solid tumor cancer patients undergoing docetaxel chemotherapy with Paxman scalp cooling had a lower occurrence of alopecia compared to patients without cooling. Alopecia occurrence among Paxman Scalp Cooler patients in the 3-weekly docetaxel regimen group was 23% compared with 74% in no cooling (control) patients. Similarly, alopecia occurrence was 7% among Paxman Scalp Cooler patients undergoing weekly docetaxel treatments compared with 17% in the no cooling patient group.
Findings from non-published studies include:
- . An observational multi-center study of patients with several types of cancers reported a head cover was used by 51% of scalp-cooled patients; 38% of scalp-cooled patients were thought to have needlessly purchased a wig;
- A multi-center trial of breast, prostate and lung cancer patients demonstrated no head cover or wig was required in 88% of patients following 45 minutes of post-infusion cooling after 3weekly docetaxel, compared with 74% of patients after 90 minutes post-infusion cooling; and
- A multi-center observational study of Lebanese patients reported a 91% success rate including 6 of 6 (100%) patients undergoing treatment with TAC who showed no signs of hair loss.
Table 5B and Table 5C, respectively, summarize published and non-published studies using the Paxman Scalp Cooling System on patients receiving chemotherapy.
{12}------------------------------------------------
#### 14. Statement of Substantial Equivalence
The Paxman Scalp Cooler described in this application is unchanged from the device previously cleared in K163484. This application is limited to a revision of the indications for use. The clinical data from the Dutch Scalp Cooling Registry, Paxman Coolers Limited SCALP study, clinical literature and non-published studies provided in this application demonstrate the Paxman Scalp Cooler can be used to reduce the likelihood of chemotherapy-induced alopecia in cancer patients with solid tumors.
{13}------------------------------------------------
| Author | Type of Study/
Method | Patients | Chemotherapy Agents | Objective | Results
(Performance and Safety) | Conclusion | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| van den Hurk, CJ,
et al. (2012)
Note: Study data
is included 2006-
2010 Dutch
registry data and
Paxman
Netherlands
Clinical Study of
Efficacy/3 | Registry,
multi-center
(28)
Nurses and
patients
completed
questionnaires
on patients,
chemotherapy
and scalp
cooling;
logistic
regression
analysis was
used to
examine
associated
characteristics
of the scalp
cooling result | n=1411
Male n=50 (4%),
female n=1357
(96%), missing n=4
Types of cancer:
breast n=1216
(86%), female
genital n=65 (5%),
gastrointestinal/
colorectal n=63
(4%), lung n=19
(1%), prostate n=27
(2%), other n=16
(1%), missing n=5 | A60C600 (AC) (n=74),
A60C600/D100 (ACD)
(n=16), ACT overall
(n=50), D75A50C500
(TAC) (n=66), D overall
(n=120), F500A50C500
(FAC) (n=39), FEC
overall (n=752),
F500E100C500/D100
(FE100CD) (n=46),
TCarbo overall (n=68),
T70-90 (42), Irino 250
(n=42), other (n=64) | To estimate the results of
scalp cooling for currently
used chemotherapies to
provide patient information
and identify characteristics
associated with the results. | Overall, 50% of the 1411
scalp-cooled patients did not
wear a head cover during
their last chemotherapy
session.
Patients were satisfied with
the results in 8% of cases after
TAC chemotherapy and up to
95% after paclitaxel
treatment.
Besides the type of
chemotherapy, higher dose
and shorter infusion time,
older age, female gender and
non-West-European type of
hair significantly increased the
proportion head cover use.
Hair length, quantity,
chemical manipulation
(dyeing, waving, coloring),
wetting hair before scalp
cooling, and treatment with
chemotherapy ever before did
not influence the degree of
head covering among | Scalp cooling results as
recorded in this open
patient registry were
positive for most
regimens, justifying its use
by all eligible patients,
except for those needing
TAC.
Lengthening infusion time
may improve the results. | |
| Author | Type of Study/
Method | Patients | Chemotherapy Agents | Objective | Results
(Performance and Safety) | Conclusion | |
| | | | | | patients. | | |
| van den Hurk, CJ,
et al. (2013) | Review of
observational
studies,
autopsy
studies and
Munich cancer
registry | Studies of skin and
scalp skin
metastases in
patients with breast
cancer without
scalp cooling:
studies of scalp skin
metastases in scalp-
cooled patients with
(mainly) breast
cancer | Diverse | Using frequency data on
metastases in breast cancer to
discuss the risk of whether
scalp cooling might facilitate
hiding and disseminating scalp
skin metastases and thus
decrease survival. | The incidence of scalp skin
metastases in breast cancer
patients seems to be
comparable for scalp-cooled
(0.04-1%) and for non-scalp-
cooled (0.03-3%) patients. | In patients with solid
tumors, an unfavorable
development of the
disease due to scalp
cooling has never been
documented.
Scalp cooling can safely be
offered to patients treated
with alopecia-inducing
chemotherapy. | |
| Lemieux J, et al.
(2015) | Retrospective
cohort | n=1370 women
with non-metastatic
breast carcinoma
who received
chemotherapy in
neoadjuvant
(n=140) or adjuvant
setting (n=1230)
n=553 used scalp
cooling; n=817 were
treated in facilities
where scalp cooling
was not routinely
available | Not reported | To compare overall survival
according to whether or not
scalp cooling was used during
neoadjuvant or adjuvant
chemotherapy for non-
metastatic breast cancer. | Median follow-up was 6.3
years for scalp-cooled group
and 8.0 years for non-scalp-
cooled group.
No difference in overall
mortality was observed
between scalp-cooled
patients and non-scalp-cooled
patients (adjusted hazard
ratio 0.89, 95% confidence
interval 0.68-1.17, p=0.40). | Among women undergoing
neoadjuvant or adjuvant
chemotherapy for non-
metastatic breast cancer,
scalp cooling used to
prevent CIA had no
negative effect on survival. | |
| Author | Type of Study/
Method | Patients | Chemotherapy Agents | Objective | Results
(Performance and Safety) | Conclusion | |
| Nangia J, et al.
(2017)
Clinicaltrials.gov
identifier
NCT01986140 | Randomized,
multi-center
(7)
A comfort
scale was
administered
after each
treatment in
scalp-cooling
group.
Alopecia
assessments
using Common
Terminology
Criteria for
Adverse
Events
(CTCAE) v4.0
at baseline
and after
chemotherapy
cycle by a
blinded
clinician,
patient's
clinician and
patient;
participants | n=182 women with
stage 1 or II breast
cancer undergoing
chemotherapy from
December 2013 to
September 2016
Randomized to
receive scalp
cooling (n=119) or
no cooling (n=63)
Each patient
underwent scalp
cooling for 30
minutes pre-
infusion, during
infusion and 90
minutes post-
infusion | Planning to receive at
least 4 cycles of taxane-
(n=91, 64%) and/or
anthracycline-based
chemotherapy for
curative intent (n=51,
36%) | To assess whether use of the
Orbis Paxman Hair Loss
Prevention System is safe and
effective in reducing CIA in
woman with breast cancer
undergoing neoadjuvant or
adjuvant chemotherapy. | Publication reports on interim
analysis (n=142 patients);
patients will be followed for 5
years for safety (time and site
of first recurrence) and overall
survival.
48 of 95 (50.5%) in cooling
group had successful hair
preservation (95% confidence
interval 40.7%-60.4%)
compared to 0 of 47 (0%) in
the control group (95%
confidence interval, 0%-7.6%).
Success rate difference was
50.5% (95% confidence
interval, 40.5%-60.6%).
The trial was stopped early for
superiority (p=0.0061).
No statistically significant
differences in changes in any
of the quality-of-life (QOL)
scales from baseline to
chemotherapy cycle 4 were
observed between the scalp
cooling and control groups.
54 adverse events (all grades
1 and 2) were reported in the | Among women with stage
I to II breast cancer
receiving chemotherapy
with a taxane,
anthracycline, or both,
those who underwent
scalp cooling were
significantly more likely to
have < 50% hair loss after
the 4th chemotherapy
cycle compared with those
who received no scalp
cooling. | |
| Author | Type of Study/
Method | Patients | Chemotherapy Agents | Objective | Results
(Performance and Safety) | Conclusion | |
| | were asked if
they needed
to use a wig
and/or a head
wrap | | | | | | |
| Massey C (2004)
Note: Data is
included in
Paxman UK
Clinical Study of
Efficacy | Open, non-
randomized,
observational,
multi-center
(8)
Alopecia was
assessed using
the World
Health
Organization
(WHO) grading
system;
patient
acceptability
assessed by
questionnaire;
results
compiled by
Scalp Cooling
Assessment
Groups | n=94 breast cancer
patients who
underwent
treatment 1997-
2000 | 5-fluorouracil,
epirubicin and
cyclophosphamide
(FEC) regimen | To assess the efficacy of scalp
cooling to reduce alopecia for
women undergoing treatment
for breast cancer using the
Paxman Scalp Cooler.
To assess patient views on the
comfort and acceptability of
scalp cooling using the
Paxman Scalp Cooler. | Use of the Paxman Scalp
Cooler was judged a success
for 89% of all patients using
the WHO grading system for
alopecia and for 87% of
patients being specifically
administered the commonly
used 5-fluorouracil, epirubicin
and cyclophosphamide (FEC)
regimen.
When asked about degrees of
comfort during the scalp-
cooling process, 85% of
patients described it as very
comfortable, reasonably
comfortable or comfortable,
with only 15% of patients
reporting a description of
uncomfortable or very
uncomfortable. | Scalp cooling using the
Paxman Scalp Cooler was
found to be an effective
technique with minimal
side-effects for patients
treated with commonly
prescribed alopecia-
inducing chemotherapy
drugs. | |
| Bini M, et al. | Observational | N=47 breast cancer | 70% of patients | To verify effectiveness of | Median number of the | The Paxman scalp cooler | |
| Author | Type of Study/
Method | Patients | Chemotherapy Agents…
---
**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PMC/K173032](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PMC/K173032)
**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. If you're preparing [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/), [get in touch](https://innolitics.com/contact).
**Cite:** Innolitics at https://innolitics.com