(102 days)
Not Found
No
The device description focuses on a computer-controlled system for temperature regulation based on sensor input, which is standard automation and control technology, not AI/ML. There is no mention of AI, ML, or related concepts in the document.
Yes.
The device is indicated to reduce the likelihood of chemotherapy-induced alopecia, which is a therapeutic intervention aimed at preventing a medical condition.
No
Explanation: The device is described as a system to prevent chemotherapy-induced hair loss by cooling the scalp, not to diagnose a condition or disease. The description focuses on its therapeutic function in reducing the likelihood of alopecia.
No
The device description clearly outlines multiple hardware components including a refrigerated tank, cooling unit, caps, sensors, and a control system operated via a touch screen. While software is mentioned for control and updates, it is integral to and dependent on the physical hardware for its function.
Based on the provided information, the DigniCap® Scalp Cooling System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "reduce the likelihood of chemotherapy-induced alopecia in cancer patients with solid tumors." This is a therapeutic intervention applied directly to the patient's body (the scalp) to prevent a physical side effect.
- Device Description: The device description details a system that cools the scalp using a circulating liquid coolant and temperature sensors. This is a physical process applied externally to the patient.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The DigniCap system does not interact with or analyze any bodily specimens.
Therefore, the DigniCap® Scalp Cooling System is a therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The DigniCap® Scalp Cooling System is indicated to reduce the likelihood of chemotherapy-induced alopecia in cancer patients with solid tumors.
Product codes (comma separated list FDA assigned to the subject device)
PMC
Device Description
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 ± 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 ± 2.0°C).
The DigniCap® Scalp Cooling System components include the following:
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Scalp
Indicated Patient Age Range
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
- 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
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
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.
Summary of individual studies from Table 1:
- Hernández et al., 2016: Retrospective Consecutive series of patients; December 2010 - January 2015. Sample size: 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. Completed Cooling %: 72% (98/120). % Success with 50% of patients did not report any side effects.). Reason for discontinuation: Cold sensation (n=6), Other (n=9).
- Schaffrin-Nabe et al., 2016: Non randomized prospective. Sample size: Breast cancer patients (n=40). Scalp cooled (n=32), controls (n=8). Completed Cooling %: 100% (32/32). % Success with
§ 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/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)
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)
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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
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% 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)
(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