(56 days)
No
The description focuses on a fluid cooling and circulation system with user interface controls, and there is no mention of AI or ML in the device description, performance studies, or key metrics.
Yes
The intended use states that the device is "indicated to reduce the likelihood of chemotherapy-induced alopecia in cancer patients with solid tumors," which is a therapeutic purpose.
No
The device is described as a cooling system intended to reduce the likelihood of chemotherapy-induced alopecia by cooling the scalp, not by diagnosing a condition or disease.
No
The device description explicitly states it is a "cooling system" that cools and circulates fluid through a cooling wrap, and the performance studies include testing for electrical safety, biocompatibility, and accessory performance, all of which are indicative of a hardware-based medical device.
Based on the provided information, the DigniCap Delta 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).
- Device Description: The device cools and circulates fluid through a cooling wrap applied to the scalp. This is a physical treatment method.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health. The DigniCap Delta does not interact with or analyze any biological specimens.
Therefore, the DigniCap Delta is a therapeutic medical device, not an IVD.
N/A
Intended Use / Indications for Use
The DigniCap Delta® Scalp Cooling System is indicated to reduce the likelihood of chemotherapy-induced alopecia in cancer patients with solid tumors.
Product codes
PMC
Device Description
The DigniCap Delta Scalp Cooling System ("DigniCap Delta")is a device that is intended to function as a cooling system to reduce the likelihood of chemotherapy-induced alopecia in cancer patients with solid tumors. The proposed therapy of the new device is comparable to the therapy of the predicate device, DigniCap Scalp Cooling System (K170871).
DigniCap Delta cools fluid to a prescribed set temperature and circulates that cooled fluid through a cooling wrap and then back to the device. This mode of operation is equivalent to other scalp cooling devices. User operation of the DigniCap Delta system is carried out on the illuminated graphics display with the integrated touch control, located on the front of the unit. The navigation and selection buttons on the display are used to interface with the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Scalp
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Nonclinical Testing Summary:
DigniCap Delta was tested to confirm the device met all performance requirements and is considered safe and effective for its intended use. Testing was completed per relevant FDA guidance documents. Specifically, the device was evaluated for the following through nonclinical, bench testing:
- Biocompatibility Testing of Cooling Cap (Cap materials are biocompatible in accordance with ISO 10993-1)
- Accessory Performance Testing
- Stable Fluid Temperature Verification
- Notifications and Alarms System Testing
- Electrical Safety in accordance with IEC 60601-1:2005(R)2012 and IEC 62133-2:2017 and Electromagnetic Compatibility Testing in accordance with IEC 60601-1-2:2014
- Software verification and validation testing
The collective results of the nonclinical testing demonstrate that the materials chosen, the manufacturing processes, and design of DigniCap Delta meet the established specifications necessary for consistent performance during its intended use. The bench testing has demonstrated that the DigniCap Delta can maintain and adjust cooling fluid temperature as needed to meet the predetermined treatment specifications. The collective bench testing demonstrates that DigniCap Delta does not raise new questions of safety or effectiveness for scalp cooling when compared to the predicate devices.
Clinical Testing Summary:
Not applicable. Clinical testing was not performed to support this 510(k) submission.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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 shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Dignitana Inc. % Valerie Defiesta-Ng Vice President, Regulatory Affairs Experien Group 224 Airport Parkway, Suite 250 San Jose, California 95110
June 26, 2019
Re: K191166
Trade/Device Name: DigniCap Delta 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: April 30, 2019 Received: May 1, 2019
Dear Valerie Defiesta-Ng:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Neil R.P. Ogden, MS Assistant Director THT4A4 DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name DigniCap Delta® Scalp Cooling System
Indications for Use (Describe)
The DigniCap Delta® Scalp Cooling System is indicated toreduce the likelihood of chemotherapy-induced alopecia in cancer patients with solid tumors.
Type of Use (Select one or both, as applicable)
XX Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Notification K191166
GENERAL INFORMATION
Applicant:
Dignitana, Inc. 10925 Estate Lane, Suite W-185 Dallas, Texas 75238 Phone: 469-917-5555 info@dignitana.com
Contact Person:
Valerie Defiesta-Ng Vice President, Regulatory Affairs Experien Group, LLC 224 Airport Parkway, Suite 250 San Jose, CA 95110 USA
Date Prepared: April 30, 2019
DEVICE INFORMATION
Trade/Proprietary Name: DigniCap Delta®
Generic/Common Name:
Scalp Cooling System
Classification:
21 CFR §878.4360
Product Code: PMC
Establishment Registration: 3012146457- Dignitana, Inc. Dallas, Texas 2019, Complaint File Establishment
Manufacturing Facility: Dignitana, Inc.
10925 Estate Lane, Suite W-185 Dallas, Texas 75238
4
PREDICATE DEVICE(S)
DigniCap Delta is substantially equivalent to the predicate device, the Dignitana DigniCap Scalp Cooling System, cleared under K170871. DigniCap Delta is intended for use in the same population, with the same mechanism of action and Indications for Use. Any differences in the technological characteristics between the devices do not raise different questions of safety or effectiveness.
DEVICE DESCRIPTION
The DigniCap Delta Scalp Cooling System ("DigniCap Delta")is a device that is intended to function as a cooling system to reduce the likelihood of chemotherapy-induced alopecia in cancer patients with solid tumors. The proposed therapy of the new device is comparable to the therapy of the predicate device, DigniCap Scalp Cooling System (K170871).
DigniCap Delta cools fluid to a prescribed set temperature and circulates that cooled fluid through a cooling wrap and then back to the device. This mode of operation is equivalent to other scalp cooling devices. User operation of the DigniCap Delta system is carried out on the illuminated graphics display with the integrated touch control, located on the front of the unit. The navigation and selection buttons on the display are used to interface with the device.
INDICATIONS FOR USE
The DigniCap Delta® Scalp Cooling System is indicated to reduce the likelihood of chemotherapy-induced alopecia in cancer patients with solid tumors.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES
DigniCap Delta is substantially equivalent to the predicate device, the Dignitana DigniCap® Scalp Cooling System, cleared under K170871. Any differences in the technological characteristics between the devices do not raise different questions of safety or effectiveness. DigniCap Delta has the same Indications for Use, population and mechanism of action as the predicate device. Thus, DigniCap Delta is substantially equivalent to the predicate device.
The tables below compare the regulatory information (Table 5.1) and technical characteristics (Table 5.2) for the proposed and predicate devices.
5
510(k) SUMMARY
| | DigniCap Delta® Scalp Cooling System
(Subject Device) | DigniCap® Scalp Cooling System
(Predicate Device) | Analysis of
Differences |
|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | | | |
| 510(k)
Number | To Be Assigned | K170871 | N/A |
| Classification | II | II | Same |
| Product
Code | PMC | PMC | Same |
| Regulatory
Number | $878.4360 | $878.4360 | Same |
| Regulation
Name | Scalp Cooling System | Scalp Cooling System | Same |
| Indications
for Use | The DigniCap Delta® Scalp Cooling System is indicated to
reduce the likelihood of chemotherapy-induced alopecia in
cancer patients with solid tumors. | The DigniCap® Scalp Cooling System is indicated to
reduce the likelihood of chemotherapy-induced alopecia in
cancer patients with solid tumors. | Same |
| Mechanism
of Action | The DigniCap Delta Scalp Cooling System transports
temperature controlled cooled fluid from the device to a
cooling cap to cool the patient's scalp thus reducing
chemotherapy-induced alopecia | The DigniCap Scalp Cooling System transports
temperature controlled cooled fluid from the device to a
cooling cap to cool the patient's scalp thus reducing
chemotherapy-induced alopecia. | Same |
| Population | Chemotherapy Patients with Solid Tumors | Chemotherapy Patients with Solid Tumors | Same |
| | DigniCap Delta® Scalp Cooling System
(Subject Device) | DigniCap® Scalp Cooling System
(Predicate Device) | Analysis of Differences |
| Feature | | | |
| Technological
Features | The DigniCap Delta Scalp Cooling System
consists of a solid-state thermoelectric
cooling unit with integral control system
operated via a touchscreen monitor, capable
of precisely controlling the temperature of
one cooling cap. | The DigniCap Scalp Cooling System
consists of a refrigerator unit with integral
control system operated via a touch screen
monitor and capable of controlling two
separate cooling caps. | Any differences in the technological
characteristics between the devices do not
raise different questions of safety or
effectiveness. |
| User Interface | Touchscreen | Touchscreen | Same
Updated for user ease. |
| | Cooling Cap Features | | |
| Inner Cooling
Cap | Yes, includes adjustable tabs | Yes | The differences in the technological
characteristics between the devices are
minor and do not raise different questions
of safety or effectiveness. |
| Detachable
Coolant Lines | Yes | Yes | Same |
| Outer Cover/
Material | Yes/Neoprene | Yes/Neoprene | Same |
| Cooling Fluid
Required | Yes | Yes | Cooling fluid is similar; the DigniCap Delta
uses an isopropyl alcohol/water mixture,
while the predicate uses MPG
(monopropylene glycol). The cooling fluids
are used for the same purpose. This
difference does not raise different questions
of safety or effectiveness as demonstrated
by performance testing. |
| Fluid
Temperature | Fluid temperatures are regulated through
temperature sensors in the fluid lines. | Fluid temperatures are regulated through
temperature sensors in the cooling cap. | The sensors are located in a different region
but are used for the same purpose and have
been tested to prove that they work as
effectively as the predicate device. This
difference does not raise different questions
of safety or effectiveness as demonstrated
by performance testing. |
| Feature | DigniCap Delta® Scalp Cooling System
(Subject Device) | DigniCap® Scalp Cooling System
(Predicate Device) | Analysis of Differences |
| Pre /Post
Cooling Phase | Yes | Yes | Same |
| Coolant
Temperature
Range | -7 to 1.5°C | -15°C to 5°C | This range is within the range originally
cleared with the predicate device but is
tighter to provide more consistent cooling
to the patient's scalp. This difference does
not raise different questions of safety or
effectiveness. |
| Outer Cooling
Cap | Single Patient Use | Multiple Patient Use | This difference does not raise different
questions of safety or effectiveness. |
| Inner Cooling
Cap - Single
Use | Single Patient Use | Multiple Patient Use | This difference does not raise different
questions of safety or effectiveness. |
| Device Testing | | | |
| Biocompatibility
Testing | Yes. Cap materials are biocompatible in
accordance with ISO 10993-1. | Yes. Cap materials are biocompatible in
accordance with ISO 10993-1. | Same |
| Electrical Safety
Testing | Yes.
IEC 60601-1:2005/(R)2012
IEC 62133-2:2017 | Yes.
IEC 60601-1:2007 | Electrical Safety Testing was conducted to
the current standard. |
| Electromagnetic
Compatibility
Testing | Yes.
IEC60601-1-2:2014 | Yes.
IEC 60601-1-2:2007 | Electrical Safety Testing was conducted to
the current standard. |
Table 5.1: Substantial Equivalence Table – Regulatory Information
6
510(k) SUMMARY
Table 5.2: Substantial Equivalence Table – Technological Information
7
510(k) SUMMARY
Table 5.2: Substantial Equivalence Table – Technological Information (cont.)
8
SUBSTANTIAL EQUIVALENCE
DigniCap Delta has the same Indications for Use, patient population and mechanism of action as the predicate device (K170871). Any differences in the technological characteristics between the devices do not raise different questions of safety or effectiveness. Thus, DigniCap Delta is substantially equivalent to the predicate device.
PERFORMANCE DATA
All necessary non-clinical performance testing was conducted on DigniCap Delta to support a determination of substantial equivalence to the predicate device.
Nonclinical Testing Summary:
DigniCap Delta was tested to confirm the device met all performance requirements and is considered safe and effective for its intended use. Testing was completed per relevant FDA guidance documents. Specifically, the device was evaluated for the following through nonclinical, bench testing:
- . Biocompatibility Testing of Cooling Cap (Cap materials are biocompatible in accordance with ISO 10993-1)
- Accessory Performance Testing ●
- Stable Fluid Temperature Verification
- Notifications and Alarms System Testing
- Electrical Safety in accordance with IEC 60601-1:2005(R)2012 and IEC 62133-2:2017 ● and Electromagnetic Compatibility Testing in accordance with IEC 60601-1-2:2014
- Software verification and validation testing
The collective results of the nonclinical testing demonstrate that the materials chosen, the manufacturing processes, and design of DigniCap Delta meet the established specifications necessary for consistent performance during its intended use. The bench testing has demonstrated that the DigniCap Delta can maintain and adjust cooling fluid temperature as needed to meet the predetermined treatment specifications. The collective bench testing demonstrates that DigniCap Delta does not raise new questions of safety or effectiveness for scalp cooling when compared to the predicate devices.
Clinical Testing Summary:
Not applicable. Clinical testing was not performed to support this 510(k) submission.
CONCLUSIONS
The collective results of the performance testing demonstrate that DigniCap Delta meets the established specifications necessary for consistent performance during its intended use. In addition, the collective performance testing demonstrate that DigniCap Delta does not raise different questions of safety or effectiveness when compared to the predicate device.
Based on the non-clinical performance testing results, the differences in the technological characteristics between the subject and predicate devices do not raise any new issues of safety or
9
effectiveness. DigniCap Delta is intended for use in the same population and with the same Indications for Use as its predicate device. Thus, DigniCap Delta is substantially equivalent to the predicate device.