Who is the manufacturer of DigniCap Scalp Cooling System?

Dignitana AB filed the 510(k) submission for DigniCap Scalp Cooling System (K170871).

What is the FDA product code for DigniCap Scalp Cooling System?

PMC. It is classified under 21 CFR 878.4360 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for DigniCap Scalp Cooling System?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like DigniCap Scalp Cooling System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

DigniCap Scalp Cooling System

Q: What are the predicate devices for DigniCap Scalp Cooling System?

DigniCap® Scalp Cooling System (DEN150010).

K170871 · Dignitana AB · PMC · Jul 3, 2017 · General, Plastic Surgery

Device Facts

Record ID	K170871
Device Name	DigniCap Scalp Cooling System
Applicant	Dignitana AB
Product Code	PMC · General, Plastic Surgery
Decision Date	Jul 3, 2017
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4360
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The DigniCap® Scalp Cooling System is indicated to reduce the likelihood of chemotherapy-induced alopecia in cancer patients with solid tumors.

Device Story

DigniCap Scalp Cooling System reduces chemotherapy-induced alopecia in solid tumor patients. System comprises a refrigerated unit (Digni C3) circulating liquid coolant (monopropylene glycol) through a silicone inner cap (DigniCap) and an outer neoprene insulating cap (DigniTherm). Three integrated sensors monitor scalp temperature; system automatically adjusts coolant flow to maintain scalp temperature at -7 ± 2°C. Operated by clinical staff in oncology settings. Treatment requires a DigniCard key to initiate. Data logging and software updates performed via DigniStick. By inducing scalp hypothermia, the device reduces blood flow to hair follicles, potentially mitigating chemotherapy-induced hair loss. Effectiveness varies based on chemotherapy regimen, dose, and patient factors.

Clinical Evidence

Evidence includes 18 non-U.S. clinical evaluations and literature reviews. Studies were primarily single-arm, non-randomized, prospective, or retrospective, involving various solid tumor types and chemotherapy regimens. Success rates (defined as <50% hair loss) varied significantly across studies (range ~50% to 100%). Safety data noted potential risks of scalp metastases, particularly in patients with advanced non-small cell lung cancer, colon, renal, ovarian, and bladder cancers. Adverse events included cold sensation, headache, and scalp pain. No long-term follow-up data regarding recurrence or metastasis risk is available.

Technological Characteristics

System includes a refrigerated unit (Digni C3) with touch screen control, silicone inner cap with two cooling circuits, neoprene outer cap (DigniTherm), and monopropylene glycol coolant (DigniCool). Features three temperature sensors for feedback control (accuracy ± 2.0°C). Connectivity via DigniStick for data export and software updates. Requires DigniCard for operation. Software-controlled cooling loop.

Indications for Use

Indicated for cancer patients with solid tumors to reduce chemotherapy-induced alopecia. Contraindicated in pediatric patients and adults with cold sensitivity, cold agglutinin disease, cryoglobulinemia, cryofibrinogenemia, cold urticaria, CNS malignancies (primary or metastatic), head/neck cancers, skin cancers (melanoma, squamous cell, Merkel cell), hematological malignancies treated with curative intent, solid tumors with high likelihood of metastases in transit, or patients scheduled for bone marrow ablation or skull irradiation.

Regulatory Classification

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

DigniCap® Scalp Cooling System (DEN150010)

Related Devices

DEN150010 — Dignitana AB DigniCap System · Dignitana AB · Dec 8, 2015
K191166 — DigniCap Delta · Dignitana, Inc. · Jun 26, 2019
K252289 — Eva Scalp Cooling System · Stemtech Medical Devices Private Limited · Nov 25, 2025
K173032 — Paxman Scalp Cooler · Paxman Coolers Limited · Jun 7, 2018

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, with flowing lines beneath them. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 3, 2017 Dignitana AB % Mr. Michael Billig Experien Group, LLC 224 Airport Parkway. Suite 250 San Jose, California 95110 Re: K170871 Trade/Device Name: DigniCap Scalp Cooling System Regulation Number: 21 CFR 878.4360 Regulation Name: Scalp Cooling System to Reduce the Likelihood of Chemotherapy Induced Alopecia Regulatory Class: Class II Product Code: PMC Dated: March 21, 2017 Received: March 23, 2017 Dear Mr. Billig: 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 Actinclude 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 {1}------------------------------------------------ Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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. 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 -S3 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) K170871 Device Name DigniCap® Scalp Cooling System Indications for Use (Describe) The DigniCap® Scalp Cooling System is indicated to reduce the likelihood of chemotherapy-induced alopecia 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}------------------------------------------------ K170871 510(k) Notification DigniCap® Scalp Cooling System Page 1 of 15 #### 510(k) Summary (K170871) ## Applicant Dignitana AB Traktorgränden 3 Lund, Sweden SE-226 60 Phone: +46 46 16 30 92 Fax: +46 46 16 30 99 Johan Ericsson, CEO johan.ericsson@dignitana.se ## Contact Person: Michael J. Billig, CEO Experien Group LLC Regulatory Consultant to Dignitana AB 224 Airport Parkway, Suite 250 San Jose, CA 95110 Tel: (408) 400-0856 Fax: (408) 400-0865 mjb@experiengroup.com ### Date of Summary: June 20, 2017 | Device Proprietary Name | DigniCap® Scalp Cooling System | | | |--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|--------------| | Common/Usual Name | Scalp Cooling System | | | | Classification Names / Numbers and Code | 21 CFR | Classification Name | Product Code | | | 878.4360 | Scalp Cooling System | PMC | | Regulatory Class | II | | | | Prescription Status | Prescription Device | | | | Device / Classification Panel | General & Plastic Surgery | | | | Predicate Device | DigniCap® Scalp Cooling System DEN150010 | | | | Description of Device | The DigniCap® Scalp Cooling System consists of a computer controlled system that includes a refrigerated tank containing the liquid coolant that is maintained at -7 $\pm$ 2°C. The coolant circulates from the cooling unit to and through the channels of the cap and back to the cooling unit. The scalp temperature is monitored by three separate sensors. Deviations from the treatment temperature are automatically adjusted by the system (scalp temperature can be controlled with an accuracy of $\pm$ 2.0°C). The DigniCap® Scalp Cooling System components include the following: | | | {4}------------------------------------------------ | Description of Device (cont.) | Digni C3 – Is a refrigerator unit with an integral control system operated via a touch screen and is capable of controlling two separate DigniCap® Cooling caps independently of each other. Scalp cooling is performed in conjunction with a silicone inner cap (DigniCap®), an outer neoprene cap (DigniTherm), and the liquid coolant (DigniCool). | |-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | DigniCap® – A soft, tight-fitting silicone cap which has two separate cooling circuits, one for the front and one for the back of the head. Each cooling circuit is equipped with a temperature sensor, and the cap is also equipped with a third sensor for safety control. The cap is available in different sizes. | | | DigniCool - The liquid coolant monopropylene glycol. | | | DigniTherm - The outer neoprene cap that insulates and keeps the inner cap in place. This neoprene cover cap, called the DigniTherm, comes in different sizes and is colored coded to match the corresponding DigniCap® Cooling cap. | | | DigniStick- A component used to save data from a treatment or for troubleshooting. It can also be used to update software. | | | DigniCard - A key card which has to be inserted in order to start a treatment. | | Indications for Use | The DigniCap® Scalp Cooling System is indicated to reduce the likelihood of chemotherapy-induced alopecia in cancer patients with solid tumors. | ### Limitations The sale, distribution, and use of DigniCap™ Scalp Cooling System are restricted to prescription use in accordance with 21 CFR 801.109. Limitations on device use are also achieved through the following statements included in the instructions for use: ## Contraindications The use of Dignicap is contraindicated in pediatric patients. The use of Dignicap is contraindicated in adult patients with: - cold sensitivity, - cold agglutinin disease, ● - cryoglobulinemia ● - cryofibrinogenemia. ● - Cold urticaria - CNS malignancies (either primary or metastatic), - squamous cell carcinoma of the lung, - small cell carcinoma of the lung, - cancers of the head and neck, ● - skin cancers including melanoma, squamous cell carcinoma, and Merkel cell ● carcinoma. - hematological malignancies treated with curative intent by chemotherapy ● {5}------------------------------------------------ K170871 510(k) Notification DigniCap® Scalp Cooling System Page 3 of 15 - solid tumor malignancies with a high likelihood of metastases in transit. - patients who are scheduled for bone marrow ablation chemotherapy - patients who are scheduled to undergo skull irradiation ● - patients who have previously received skull irradiation #### Warnings 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 cancers may be more likely to experience scalp metastases with the scalp cooling svstem. 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 in combination has not been shown to be successful in preventing chemotherapeutic drug induced alopecia. Dignicap® Scalp Cooling System should not be used in these patients. Scalp radiation can cause stenosis of small cutaneous vessels decreasing device effectiveness. The effectiveness of this device in patients who have received previous chemotherapy has not been evaluated. The risk of scalp-cooling may outweigh the benefits in patients receiving chemotherapeutic agents with low incidence of inducing alopecia. Long-term effects of scalp-cooling and risk of scalp metastasis have not been fully studied. Clinical studies have demonstrated variable success rates in patient reduction of chemotherapy induced 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 in spite of using scalp cooling might have worse quality of life than women who did not have scalp cooling. #### Comparison to Predicate Devices Aside from the change in the Indications for Use, the DigniCap® Scalp Cooling System is identical in technological characteristics, design and performance to the predicate. #### Summary of Testing #### Pre-clinical Testing 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, bench testing, and two clinical studies. All tests met the pre-determined specifications and acceptance criteria and demonstrated the DigniCap® Scalp Cooling System to be safe and effective as labeled. {6}------------------------------------------------ K170871 510(k) Notification DigniCap® Scalp Cooling System Page 4 of 15 #### Clinical Data The efficacy of scalp cooling with the DigniCap System has been reported in 18 clinical evaluations outside of the U.S. These studies investigated the effects of scalp cooling on the incidence of alopecia in patients with various malignancies using a variety of chemotherapy regimens in both the adjuvant and palliative settings. Efficacy has best been demonstrated in chemotherapy regimens containing docetaxel, paclitaxel, cyclophosphamide, and/or carboplatin. These studies did not have long term follow up, and were single armed non-randomized prospective studies. Long-term effects of scalp-cooling and scalp metastasis have not been fully studied in the adjuvant setting outside of stage I and II breast cancer. It is not clear whether there is increased risk of recurrence, particularly scalp or skull metastases, based on the data available. Some of the studies did not list the names of the solid tumor malignancies or their frequencies. A literature review was conducted to address the safety and effectiveness of the DigniCap device. A search in PubMed, EMBASE, Clinical Trial register and Manufacturer and User Facility Device Experience Database - (MAUDE) was performed using the following search terms: DigniCap, Digni and scalp, Digni and alopecia, Digni and hypothermia, and Dignitana. Abstracts and peer reviewed articles (Table 1) of clinical trials covering the majority of the relevance and methodology questions in the appraisal plan of the pivotal clinical evaluation report were selected. Due to the literature review method and the design of these studies, safety and effectiveness results presented in these studies may not be accurate. Based on the above published data there is insufficient evidence to assess long term effect. Use of DigniCap Scalp Cooling System in these patients may increase the risk of scalp metastasis, metastasis elsewhere in the body or impact the natural course of the disease #### Conclusion The DigniCap Cooling System described in this application is unchanged from the device approved in DEN150010. This application is limited to a revision of the indication for use. The clinical data described in the literature documents provided in this application do demonstrate that the DigniCap Cooling System can be used to reduce the likelihood of chemotherapy-induced alopecia in cancer patients with solid tumors. {7}------------------------------------------------ # Table 1 # Clinical Data with the DigniCap® Scalp Cooling System Outside of U.S. | Publication (author, year, institution) | Type of study (RCT, retrospective, single arm prospective nonrandomized studies.) | Treatment group | Control group | Sample size | Length of Follow- up | Follow-up schedule | Completed Cooling % | % Success with <50% hair loss | List of Adverse Events | Reason for discontinuation of cooling | |-----------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Hernández et al., 2016 American British Cowdray, ABC Medical Center, Mexico City | Retrospective Consecutive series of patients; December 2010 - January 2015. | Weekly TX for 12 cycles (n=4). Weekly TX for 12 cycles and AC every 3 weeks for 4-6 cycles (n=66). AC every 3 weeks for 6-8 cycles (n=28). | N/A | 204 patients with Stage I-V breast (n=120), ovary, lung, uterus, esophagus, prostate, chest, urethra, rectum, larynx, bladder, colon, liver cancer and non-Hodgkin´s lymphoma. | Not stated | Hair loss - Photos Dean scale | 72% (98/120) | 84% (82/98) | At follow-up: no side effects or scalp metastasis present. | Hair loss. | | Fehr et al., 2016 1. Clinic of Kempten- Oberallgäu, Germany 2. Cantonal Hospital Frauenfeld, Switzerland | Non randomized prospective | PT 175 mg/m2 and carboplatin 6 AUC (area under the curve) for 6 three- week cycles [n = 12 (22%)] D 60 mg/m2 and C 600 mg/m2 for 4 three-week cycles, followed by DT 100 mg/m2 for 4 three-week cycles [n = 11 (20%)] E 90 mg/m2 and C 600 mg/m2 for 4 three-week cycles, followed by PT 80 mg/m2 weekly for 12 weeks [n = 10 (18%)] PT 80 mg/m2 weekly for 16 weeks [n = 8 (15%)] DT 75 mg/m2 and C 500 mg/m2 for 4 three-week cycles [n = 6 (11%)] F 500 mg/m2, E 100 mg/m2, and C 500 mg/m2 for 3 three- week cycles, followed by DT 100 mg/m2 for 3 three-week cycles [n = 64 (7%)] DT 75 mg/m2, D 50 mg/m2, and C 500 mg/m2 for 6 three-week cycles [n = 4 (7%) | N/A | Women with breast, endometrial, or ovarian cancer (n=55) Breast cancer 35adjuvant, 5 palliative, 2 neo- adjuvant Ovarian cancer 12 (22%) Endometrial cancer 1 patient (1.8%) | Not stated | Photographs of the patient's head from 5 different views. WHO scale. Grade 0: no hair loss Grade 1: minimal hair loss (>0% to 25%). Corresponds to Dean score 0 and 1. | 78% (43/55) | 56% (28/50) (up to 25% hair loss) | 1.8% (1/55) could not tolerate scalp cooling. | Hair loss (n=7), death (n=3), change of treatment centre (n=1), and doubts about study participation resulting in withdrawal of consent within 30 minutes of initiation of the 1st cycle (n=1). | | Publication (author, year, institution) | Type of study (RCT, retrospective, single arm prospective nonrandomized studies. | Treatment group | Control group | Sample size | Length of Follow- up | Follow-up schedule | Completed Cooling % | % Success with <50% hair loss | List of Adverse Events | Reason for discontinuation of cooling | | Drinkut et al., 2016 Medizinische Hochschule Hannover, Klinik für Frauenheilkunde und Geburtshilfe, Hannover, Germany | Non randomized prospective June 2014 - February 2016 | 4 x E/C 90/600 mg/m2 + 12 x PT 80 mg/m2 | N/A | Women with breast cancer (n=34) | Not stated | Quantification of hair loss by patients and nursing staff. Photos. | 56% (19/34) | 100% (Patient assessm.: all <50% hair loss, Nurses assessm.: all <25% hair loss) | Not stated (>50% of patients did not report any side effects.) | Cold sensation (n=6) Other (n=9) | | Schaffrin-Nabe et al., 2016 Gemeinschaftspraxis Bochum, Germany | Non randomized prospective | Neo-adjuvant EC-PT | Neo-adjuvant EC-PT | Breast cancer patients (n=40) Scalp cooled (n=32), controls (n=8) | Not stated | Hair-mass- index (trichometer) No visible hair loss was considered treatment success. | 100% (32/32) | 63% (20/32) (no visible hair loss) Complete hair loss in controls. | Not stated. | N/A | | Traub et al., 2016 Agaplesion Markus Krankenhaus Frankfurt am Main, Germany | Non randomized prospective October 2015 - | 4 × EC → 12 × PT (n = 7) 4 × PT → 4 × EC (n = 1) 4 × EC (n = 1) 18 × PT Mono (n = 1) 4 × Nab-PT Mono (n = 1) 18 × PT plus Myocet (n = 1) | N/A | Women with breast cancer (n=12) | Not stated | Objective assessment of photographs. | 75% (9/12) | 75% (9/12) (<20% hair loss) | Cooling- induced side effects | Hair loss (n=1), or cooling-induced side effects (n=2) | | Campennì et al., 2016 European Institute Oncology, Milan | Non randomized prospective | EC EC-TX +/- Trastuzumab TC | N/A | Patients with stage I- III breast cancer receiving adjuvant chemotherapy (n=109). | Not stated | Hair loss Patient self- assessment & assessment by treating physician Dean scale | 79% (86/109) | 77% (84/109) | Headaches and coldness. No serious adverse events. | Hair loss (n=12), Discomfort during the cooling period (n=4), other reasons (n=7). | {8}------------------------------------------------ {9}------------------------------------------------ K170871 510(k) Notification DigniCap® Scalp Cooling System Page 7 of 15 | Publication (author, year, institution) | Type of study (RCT, retrospective, single arm prospective nonrandomized studies.) | Treatment group | Control group | Sample size | Length of Follow- up | Follow-up schedule | Completed Cooling % | % Success with <50% hair loss | List of Adverse Events | Reason for discontinuation of cooling | |---------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------|------------------------|------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------| | Schaffrin-Nabe et al., 2015 Gemeinschafts praxis für Hämatologie und Onkologie Bochum, Germany | Non randomized prospective | E 90 mg/m² + C 3w→PT w E 90 mg/m² + C 2w→ PT w E 90 mg/m2 + C 3w ->DT 100 mg/m² F + E 100 mg/m² + C F + E 90 mg/m² + C DT 75 mg/m² Carboplatin AUC6 F + E 100 mg/m² + C → DT 100 mg/m² E 150 mg/m² + PT 225 mg/m² + C 2000 mg/m² DT 75 mg/m² + A50 C 500 mg/m² PT 100 mg/m² + Carboplatin AUC2 Gemcitabine 1000 mg/m² + Carboplatin AUC2 DT 75 mg/m2 + C 600 mg/m2 | N/A | In total 226 cancer patients with solid tumors. Breast cancer receiving (neo) adjuvant and palliative chemotherapy (n=136). | Not stated | Hair loss, common toxicity criteria (CTC German version 1.0) scale for alopecia. No or not visible hair loss, CTC 0-1. | 3.1% (7/226) | 65% (no or not visible hair loss, CTC 0-1.) | Slight and well tolerable sensation of cold and mild cranial pressure. No skin irritations recorded. | Cold intolerance and aversion. | | Andrews et al., 2014 Patricia Ritchie Centre, the Mater Hospital Sydney, Australia | Prospective feasibility | AC or combination FEC or FEC-D TC Other | N/A | Early stage breast cancer (n=122) | Not stated | Completion rate Hair loss: Dean score | 80.5% (98/122) | 50% (61/122) | Not stated | Adverse events not listed specifically for patients using the DigniCap. | {10}------------------------------------------------ K170871 510(k) Notification DigniCap® Scalp Cooling System Page 8 of 15 | Publication (author, year, institution) | Type of study (RCT, retrospective, single arm prospective nonrandomized studies.) | Treatment group | Control group | Sample size | Length of Follow- up | Follow-up schedule | Completed Cooling % | % Success with <50% hair loss | List of Adverse Events | Reason for discontinuation of cooling | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Friedrich and Carstensen, 2014 Mammazentrum, Jerusalem Hospital, Hamburg, Germany | Non randomized prospective June 2011-December 2012 | Multiple combinations (Neo-) adjuvant chemotherapy E 90 mg/m² + C 600 mg/m² (q3w*4) → DT 100/175 mg/m² (q3w*4) F 500 mg/m2 + E 100 mg/m² + C 500 mg/m² (q3w*6) F 500 mg/m2 + E 100 mg/m² + C 500 mg/m² (q3w*6) → DT 100 mg/m2 (q3w*3) E 90 mg/m² + C 600 mg/m² (q3w*4) CarboplaPt/DT (q3w*6) Palliative chemotherapy Taxol 135/Herceptin 8mg/kg Halaven 1.23 Taxol 90 Avastin 10mg/kg Carboplatin Gemcitabine/Cisplatin | N/A | Breast cancer (n=83) Adjuvant (n=58) Palliative (n=6) Drop outs (n=19) | Not stated | Hair loss: Photo documentation Numerical VAS (1- 10) | 77% (64/83 finished chemotherapy and scalp cooling.) | 52.6% | Feeling of cold Headaches Heaviness of head Scalp pain Frequency differed between patients with (neo-) adjuvant and palliative CT | Out of 19 patients; hair loss (n=5), Cancer related emergency cases or disease progression (n=3), Feeling of cold/headaches (n=2), Unspecified intolerance (n=9). | | Publication (author, year, institution) | Type of study (RCT, retrospective, single arm prospective nonrandomized studies.) | Treatment group | Control group | Sample size | Length of Follow- up | Follow-up schedule | Completed Cooling % | % Success with <50% hair loss | List of Adverse Events | Reason for discontinuation of cooling | | Udrea et al., 2014 Medisprof Oncology day hospital, Cluj, Romania | Non randomized prospective March 2012 - November 2013 | E 100mg/m2 + C 600 mg/m2 (n=53) DT 100 mg/m² (n=10) PT 175 mg/m² + carboplatin AUC5-6 (n=21) Irinotecan 80 mg/m2 (n=4), Etoposide 100 mg/m² day 1- 3 + Carboplatin AUC5 (n=3) TXT 75 mg/m² (n=2) DT 75 mg/m² + Cisplatine 75 mg/m² + Capecitabine 1000 mg/m² (n=2) Other combinations (n=13) | N/A | 108 cancer patients (Treatment ongoing for 8 patients). | Not stated | Hair loss: US NCI (CTCAE) v4.0. No alopecia / crown like alopecia | 96% (104/108) | 57% (62/108) (No alopecia / crown like alopecia) | Not stated | Discomfort (n=4) | | Meunier et al., 2013 1) Service de chimiothérapie, Clinique Charcot, Lyon, France 2) Centre Alexis Vautrin, Nancy, France 3) Jerusalem Krankenhaus Mammazentrum Hamburg, Germany | Non randomized prospective multicenter | (Neo-) adjuvant chemotherapy 4 E90 C600 + 4 Taxotere (n=26) 3 FEC100 + 3 Taxotere (n=10) 6 FEC 100 (n=15) 4 T75C600 +/- Trastuzumab (n=7) Taxane +/-anthracyclines (n=11) Palliative chemotherapy Paclitaxel, Eribuline, Carbo + cisplatin, gemcitabine (n=6) | N/A (Comparison 3 versus 8 degrees C) | Cancer patients (total n=133). Breast cancer (n=75) (Neo) adjuvant (n=69) Palliative (n=6). | Not stated | Hair loss: Patient self- assessment VAS 0-100, with 100 being total hair preservation. (success: keeping 60-100% of hair) | 44.6% | (neo) adjuvant: 65% Palliative: 83% | Headaches (22%) Cold sensation or pain to the scalp (4%) | Intolerance (9%) Headaches (9%) Unknown (9%) Hair loss (22%) Stopped chemo/disease progression (9%) | | Publication (author, year, institution) | Type of study (RCT, retrospective, single arm prospective nonrandomized studies.) | Treatment group | Control group | Sample size | Length of Follow- up | Follow-up schedule | Completed Cooling % | % Success with <50% hair loss | List of Adverse Events | Reason for discontinuation of cooling | | Ekwall et al., 2013 Örebro University Hospital, Örebro, Sweden | Randomized prospective | PT (175 mg/m2) + carboplatin (AUC 5-6) | N/A | Gynecological cancer (total n=43); Ovarian cancer (n=22) Endometrial cancer (n=17) Cervical cancer (n=2) Tubal cancer (n=1) Peritoneal cancer (n=1) | Not stated | Hair loss: Photo documentation as assessed by two Investigators VAS (0-10) as assessed by the patients | 91% (43/47) | 51% | Scalp cooling was generally very well tolerated. Headaches VAS ≤ 1 Coldness VAS ≤ 3.4 | Anaphylactic reactions, peripheral neuropathy and regimen modification. | | Abramov et al., 2011 N.N. Blokhin Russian Center Research, Chemo- therapy and combined treatment Moscow. Russian federation | Non randomized prospective | ANR (n=5) TX (n=8) ANR+TX (n=7) | N/A | Breast cancer (n=20) | Not stated | Hair loss: CTCAE v3.0 Grade 1: (thinning or patchy) | Not stated. | 100% ANR: 100% no hair loss TX: 50% no hair loss, 50% grade 1 ANR+TX: 29% no hair loss, 71% Grade 1 | Not stated | N/A | | Kato et al., 2011 Kato Breast Clinic, Shiga, Japan | Non randomized prospective August 2007- October 2010 | PT 60 mg/m2 weekly + C 400 mg/m2 (n=252) PT+ H (n=29) E 40 mg/m2 biweekly+ C 400 mg/m2 (n=54) Other combinations (n=24) (Combination by 5FU, CPT- 11, Gemcitabine and CBDCA.) | N/A | Breast cancer (n=359) | Not stated | Modified WHO scale (Grade 1-5) Success defined as <30% hair loss. Photos | Not stated | 96% | No abnormal scalp sensation or headaches during or after treatment. No scalp metastasis. | N/A | | Byahov et al., 2006 Semashko Central Clinical Hospital, Moscow, Russia | Non randomized prospective | ANR (n=43) Non-ANR (n=34) | N/A | Breast cancer, ovarian cancer, colorectal cancer (total n=77) | Not stated | Hair loss CTCAE v 3.0 | Not stated | ANR: 79% Non-ANR: 94% | Well tolerated by all patients. | N/A | | Publication (author, year, institution) | Type of study (RCT, retrospective, single arm prospective nonrandomized studies.) | Treatment group | Control group | Sample size | Length of Follow- up | Follow-up schedule | Completed Cooling % | % Success with <50% hair loss | List of Adverse Events | Reason for discontinuation of cooling | | Ridderheim et al., 2003 Lund University Hospital, Sweden | Non randomized prospective pilot | PT 175 mg/m², Carboplatin AUC 5 PT 175 mg/m², E 75 mg/m2, Carboplatin AUC ട DT 100 mg/m² PT 175 mg/m² Gemcitabine 1,000 mg/m² day 1+8, E 75 mg/m² day 1 E 60 mg/m², C 600 mg/m², 5-FU 600 mg/m² D 50 mg/m², Cisplatin 50 mg/m² E 50 mg/m², Carboplatin AUC 5 Vinorelbine 30 mg/m² D 25 mg/m² Bleomycin 10,000 E/m² Vinblastin 6 mg/m² Darcabazin 375 mg/m² Bleomycin 30,000 day 1, 5, 16 Etoposide 100 mg/m² day 1-5 Cisplatin 20 mg/m² day 1—5 Topotecan 1.0 mg/m² day 1-5 Etoposide 50 mg/day 6- 12 Topotecan 1.0 mg/m² | | In total 74 cancer patients Ovarian cancer (n=60) Hodgkin´s Lymphoma (n=8) Breast cancer (n=3) Endometrial cancer (n=2) Sarcoma (n=1) | 15 months (range 3-44). | Hair loss: Photo documentation Numerical VAS (0-10) | 97% (72/74) | Minimal to no hair loss in ANR or TX treated patients. Median hair loss was VAS 6 (range 1.5- 8) in patients treated when combining ANR and TX. | Discomfort was modest (median value 1.5; range 0.5-8). No presence of scalp metastases | Discomfort | | Publication (author, year, institution) | Type of study (RCT, retrospective, single arm prospective nonrandomized studies.) | Treatment group | Control group | Sample size | Length of Follow- up | Follow-up schedule | Completed Cooling % | % Success with <50% hair loss | List of Adverse Events | Reason for discontinuation of cooling | | Henriksen et al., 2003 Herlev Hospital, University of Copenhagen Denmark | Non randomized prospective interim | Seven cycles of FEC (Adjuvant). Dose not stated. | N/A | Breast cancer (n=26) | Not stated | Hair loss: Patients self- assessment Clinical photos Numerical VAS, wig use Side effects: Numerical VAS Post-treatment questionnaire | Not stated | 88% success rate, 23/26 patients choose not to use a wig. | Side effects and extra time accepted by the patients. | N/A | | Lundgren et al., 1999 Umeå University Hospital & Lund University Hospital, Sweden | Non randomized prospective pilot | PT 135-175 mg/m2 (n=3) DT 100 mg/ m2 (n=3) FEC (n=2) CMF (n=1) | PT | Ovarian cancer (n=3) Breast cancer (n=6) Ovarian cancer control (n=2) | Not stated | Hair loss: Numerical VAS (1- 10) assessed by independent observers. Discomfort assessed by the patients. | 100% | Scalp cooled patients: 100% Controls: 0% (Minimal to no hair loss (VAS < 2.5) in all scalp cooled patients.) | Discomfort level initially low (mean VAS 3) and decreased after 10 min (mean VAS 1.5). No presence of scalp metastases | N/A | {11}------------------------------------------------ {12}------------------------------------------------ K170871 510(k) Notification DigniCap® Scalp Cooling System Page 10 of 15 {13}------------------------------------------------ {14}------------------------------------------------ # K170871 510(k) Notification DigniCap® Scalp Cooling System Page 12 of 15 DigniCap® Scalp Cooling System {15}------------------------------------------------ K170871 510(k) Notification DigniCap® Scalp Cooling System Page 13 of 15 #### Chemotherapy and Abbreviations ANR: anthracyclines H: Herceptin TCH: docetaxel + carboplatin + trastuzumab AC: doxorubin + cyclophosphamide M: methotrexate TC: docetaxel + cyclophosphamide C: cyclophosphamide D: doxorubicin DT: docetaxel E: epirubicin F: 5-fluorouracil Mi: mitoxanthrone PT: paclitaxel TX: taxanes Vc: vincristine {16}------------------------------------------------ #### Bibliography: - 1. Lundgren-Eriksson,L,etal."Totalpreventionoftacoi-induced alopecia by a new model of cold cap(dignitana)."The European Journal of Cancer. Vol. 35, Supp. 4. September 1999. - 2. Henriksen.T.etal."Advanced.computerizedcoldcapforpreventing chemotherapy induced alopecia."The European Journal of Cancer. Vol. 1, No. 5. September 2003. S369. - 3. Ridderheim,M,etal."Scalphypothermiatopreventcherapy-induced alopecia is effective and safe: A pilot study oif a new difitized scalp-cooling system used in 74 patients. Support Care Cancer. Vol. 11. 2003. 371-377. - 4. Byahov.MandOShevlev."Alopeciapreventioninchemotherapypatients.Methodof controlledscalpcooling."Meditsinskaya Cartoteka.2006. - 5. Kato.M.etal."EvaluationofDigniCap System for the Prevention of Chemotherapy-induced Hair LossinBreastCancerPatient."St. Gallen Oncology Conference. 2011. - 6. Abramov,MandSemenova,I."CoolingoftheScalptoPreventAnticancerChemotherapy- induced Alopecia."Poster. - 7. Ekwall, E, et al."Determinationofthemosteffectivecoolingtemperaturefortheprevention of chemotherapy-inducedalopecia." Molecular and Clinical Oncology. Vol. 1. 2013. 1071. - 8. Meunier,A,etal."Evaluationdelatoléranceetdel'efficacitéd'uncasqueàrefrigeration continue (DIGNICAP)danslapréventiondel'alopéciechimio-induite."(Translationfrom French). Presented at the Society For Science-Based Medicine , 2013. - 9. Udrea.A. "Scalpcoolingsystemingchemotherapy-induced alopecia: a pilot study on 108 patients -a Romanian oncology -dayhospitalexperience."Medisprof Oncology. Psycho-Oncology 23 (Suppl. 3):169-254 (2014), P1-0062. - 10. Friedrichs,KandMCarstensen. "Successfulreductionofalopeciainducedbyanthracycline and taxane containing adjuvant chemotherapy in breast cancer -clinical evaluation of sensorcontrolledscalpcooling."SPrignerPlus. Vol. 3, No. 500 2014. 1-7. - 11. Andrews.K.etal. "CrowningGlory:Isthatthewholestory?Implementingscalpcoolingin an Australian setting." Poster presentation at Cancer Nurses Society of Australia, 17th winter congress, 2014. - 12. Schaffrin-Nabe,D.etal. "Theinfluenceofvariousparametersonthesuccessofsensor- controlled scalp cooling in preventing chemotherapy-inducedalopecia."Oncology Research and Treatment. Vol. 38. 2015. 489-495. - 13. Drinkut,K.etal."coolHAIR-scalp cooling to prevent chemotherapy-inducedalopecia." (Translation from German). Geburtshilfe Frauenheilkunde 2016:76-P171. - 14. Schaffrin-Nabe,D,etal."Hair-mass-Index (HMI) as indicator for the efficacy oif scalp cooling(SC)andtheassociatedqualityoflife." Journal of Clinical Oncology. 34. 2016. (suppl: abstr e21692) - 15. Traub,L,etal."EfficacyandsideeffectsoftheDigniCap®systemtopreventcytostaticinduced alopecia."(TranslationfromGerman).Geburtshilfe Frauenheilkunde 2016:76-P068 - 16. Campenni,GM,etal."Preventingchemotherapy-induced alopecia by scalp cooling: preliminary data from a study on the efficacy and safety of dignicap® system in breast cancer patients."Ann Oncol. Vol. 27. Supp. 4. 2016. iv63-iv64. - 17. Fehr,MK,etal. "Sensor-controlled scalp cooling to prevent chemotherapy-induced alopecia in {17}------------------------------------------------ K170871 510(k) Notification DigniCap® Scalp Cooling System Page 15 of 15 femalecancerpatients."Current Oncology. Vol. 23, No. 6. December 2016. e576-e582. - 18. Hernández R.E. et al., Experience at the ABC Medical Center of Mexico City, 2010-2015, using the scalp cooling system DigniCap® for the prevention of chemotherapy-induced alopecia. Poster 850794 at the San Antonio Breast…

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