(252 days)
No
The description focuses on the mechanical and refrigeration aspects of the device, and explicitly states "Not Found" for mentions of AI, DNN, or ML, and descriptions of training/test sets.
Yes
The device is intended to reduce the likelihood of chemotherapy-induced alopecia, directly addressing a medical condition (alopecia) and acting on the patient's body to achieve a therapeutic outcome (hair preservation).
No
The Paxman Scalp Cooler is indicated to reduce the likelihood of chemotherapy-induced alopecia, which is a therapeutic rather than a diagnostic function. It does not identify or characterize a disease or condition.
No
The device description clearly states it is a "self-contained, mobile, electrically-powered refrigeration unit" with a "cooling cap" and "coolant lines," indicating it is a hardware device with integrated software for control.
Based on the provided information, the Paxman Scalp Cooler is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Paxman Scalp Cooler Function: The Paxman Scalp Cooler is a physical device that applies cold to the patient's scalp. It does not analyze any biological samples from the patient. Its function is to reduce the likelihood of hair loss, a physical effect of chemotherapy.
- Intended Use: The intended use clearly states it is "indicated to reduce the likelihood of chemotherapy-induced alopecia (CIA) in cancer patients with solid tumors." This is a therapeutic or preventative physical intervention, not a diagnostic test.
- Device Description: The description details a refrigeration unit, cooling cap, and coolant circulation. This aligns with a physical cooling system, not an analytical device.
Therefore, the Paxman Scalp Cooler falls under the category of a therapeutic or preventative medical 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 cancer patients with solid tumors.
Product codes
PMC
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
scalp
Indicated Patient Age Range
Scalp cooling is contraindicated in pediatric patients.
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
The Paxman Scalp Cooler should only be used by appropriately qualified healthcare professionals who have been trained in the operation of the device.
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)
- Dutch Scalp Cooling Registry
- Study Type: Registry
- Sample Size: over 6000 cancer patients (2006-2010: n=1411; 2010-2015: n=4864; 2015-2017: n=827)
- Key Results: 71% of all solid tumor patients wore no head cover at their last cooling session (p
§ 878.4360 Scalp cooling system to reduce the likelihood of chemotherapy-induced alopecia.
(a)
Identification. A scalp cooling system to reduce the likelihood of chemotherapy-induced alopecia is a prescription device intended to reduce the frequency and severity of alopecia during chemotherapy in which alopecia-inducing chemotherapeutic agents are used.(b)
Classification —Class II (special controls). The special controls for this device are:(1) Non-clinical performance testing must demonstrate that the device meets all design specifications and performance requirements, and that the device performs as intended under anticipated conditions of use. This information must include testing to demonstrate accuracy of the temperature control mechanism.
(2) Performance testing must demonstrate the electromagnetic compatibility and electrical safety of the device.
(3) Software verification, validation, and hazard analysis must be performed.
(4) The patient contacting components of the device must be demonstrated to be biocompatible. Material names must be provided.
(5) Labeling must include the following:
(i) A statement describing the potential risk of developing scalp metastasis.
(ii) Information on the patient population and chemotherapeutic agents/regimen for which the device has been demonstrated to be effective.
(iii) A summary of the non-clinical and/or clinical testing pertinent to use of the device.
(iv) A summary of the device technical parameters, including temperature cooling range and duration of cooling.
(v) A summary of the device- and procedure-related adverse events pertinent to use of the device.
(vi) Information on how the device operates and the typical course of treatment.
(6) Patient labeling must be provided and must include:
(i) Relevant contraindications, warnings, precautions, and adverse effects/complications.
(ii) Information on how the device operates and the typical course of treatment.
(iii) Information on the patient population for which there is clinical evidence of effectiveness.
(iv) The potential risks and benefits associated with use of the device.
(v) Postoperative care instructions.
(vi) A statement describing the potential risk of developing scalp metastasis.
0
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)
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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
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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/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