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.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for the DigniCap Delta Scalp Cooling System. This document focuses on demonstrating substantial equivalence to a predicate device (DigniCap Scalp Cooling System, K170871) rather than establishing new acceptance criteria and proving device performance against them through a clinical study.

Therefore, the requested information (acceptance criteria, study details, sample sizes, expert qualifications, adjudication, MRMC, standalone performance, ground truth, training set information) for a new, independent study demonstrating fundamental device performance against specific acceptance criteria is largely not present in this document.

Instead, the document details non-clinical bench testing to demonstrate that the modifications in the DigniCap Delta (subject device) do not raise new questions of safety or effectiveness compared to the already cleared predicate device.

However, I can extract the information that is present and indicate where the requested information is not applicable or not provided.

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

1. Table of acceptance criteria and the reported device performance:

Since this 510(k) relies on substantial equivalence and non-clinical bench testing for minor modifications, there isn't a table of "acceptance criteria" for a new clinical efficacy study in the traditional sense. The "acceptance criteria" are implied by the performance requirements tested during non-clinical bench testing to ensure the device performs as intended and is safe. The "reported device performance" is a summary statement that the device met these requirements.

Acceptance Criteria (Implied from Non-Clinical Testing)	Reported Device Performance
Biocompatibility of Cooling Cap Materials (ISO 10993-1 compliant)	Met: Cap materials are biocompatible in accordance with ISO 10993-1.
Accessory Performance	Met: Device met all performance requirements and is considered safe and effective for its intended use.
Stable Fluid Temperature Verification	Met: The bench testing has demonstrated that the DigniCap Delta can maintain and adjust cooling fluid temperature as needed to meet the predetermined treatment specifications. (Coolant Temperature Range: -7 to 1.5°C)
Notifications and Alarms System Functionality	Met: Tested and confirmed to function as intended.
Electrical Safety (IEC 60601-1:2005(R)2012 and IEC 62133-2:2017 compliant)	Met: Electrical Safety Testing was conducted to the current standard.
Electromagnetic Compatibility (IEC 60601-1-2:2014 compliant)	Met: Electromagnetic Compatibility Testing was conducted to the current standard.
Software Verification and Validation	Met: Software verification and validation testing performed.
Overall Safety and Effectiveness (no new questions of safety/effectiveness compared to predicate)	Met: The collective results of the performance testing demonstrate that DigniCap Delta meets the established specifications necessary for consistent performance during its intended use and does not raise different questions of safety or effectiveness when compared to the predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Sample Size for Test Set: Not applicable. No clinical test set (patient-based) was used as this submission relies on non-clinical bench testing and substantial equivalence to a predicate device.
Data Provenance: Not applicable. The data is from non-clinical bench testing, not patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. There was no clinical test set requiring expert-established ground truth for a diagnostic or treatment outcome. Non-clinical testing results are verified against established engineering and regulatory standards by qualified personnel within the testing process.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. No clinical test set was used requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a scalp cooling system, not an AI diagnostic tool involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a physical cooling system, not an algorithm. Its operation is "standalone" in that it performs its cooling function independently, but this is not the typical interpretation of "standalone" performance for an AI/algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the non-clinical testing, the "ground truth" refers to established engineering specifications, published standards (e.g., ISO 10993-1, IEC 60601 series), and the intended functional performance of the device (e.g., maintaining specific temperatures, correct alarm function).

8. The sample size for the training set:

Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established:

Not applicable. No training set was used.

Summary

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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

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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

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Indications for Use

510(k) Number (if known)

K191166

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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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

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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

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.

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510(k) SUMMARY

	DigniCap Delta® Scalp Cooling System(Subject Device)	DigniCap® Scalp Cooling System(Predicate Device)	Analysis ofDifferences
Feature
510(k)Number	To Be Assigned	K170871	N/A
Classification	II	II	Same
ProductCode	PMC	PMC	Same
RegulatoryNumber	$878.4360	$878.4360	Same
RegulationName	Scalp Cooling System	Scalp Cooling System	Same
Indicationsfor Use	The DigniCap Delta® Scalp Cooling System is indicated toreduce the likelihood of chemotherapy-induced alopecia incancer patients with solid tumors.	The DigniCap® Scalp Cooling System is indicated toreduce the likelihood of chemotherapy-induced alopecia incancer patients with solid tumors.	Same
Mechanismof Action	The DigniCap Delta Scalp Cooling System transportstemperature controlled cooled fluid from the device to acooling cap to cool the patient's scalp thus reducingchemotherapy-induced alopecia	The DigniCap Scalp Cooling System transportstemperature controlled cooled fluid from the device to acooling cap to cool the patient's scalp thus reducingchemotherapy-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
TechnologicalFeatures	The DigniCap Delta Scalp Cooling Systemconsists of a solid-state thermoelectriccooling unit with integral control systemoperated via a touchscreen monitor, capableof precisely controlling the temperature ofone cooling cap.	The DigniCap Scalp Cooling Systemconsists of a refrigerator unit with integralcontrol system operated via a touch screenmonitor and capable of controlling twoseparate cooling caps.	Any differences in the technologicalcharacteristics between the devices do notraise different questions of safety oreffectiveness.
User Interface	Touchscreen	Touchscreen	SameUpdated for user ease.
	Cooling Cap Features
Inner CoolingCap	Yes, includes adjustable tabs	Yes	The differences in the technologicalcharacteristics between the devices areminor and do not raise different questionsof safety or effectiveness.
DetachableCoolant Lines	Yes	Yes	Same
Outer Cover/Material	Yes/Neoprene	Yes/Neoprene	Same
Cooling FluidRequired	Yes	Yes	Cooling fluid is similar; the DigniCap Deltauses an isopropyl alcohol/water mixture,while the predicate uses MPG(monopropylene glycol). The cooling fluidsare used for the same purpose. Thisdifference does not raise different questionsof safety or effectiveness as demonstratedby performance testing.
FluidTemperature	Fluid temperatures are regulated throughtemperature sensors in the fluid lines.	Fluid temperatures are regulated throughtemperature sensors in the cooling cap.	The sensors are located in a different regionbut are used for the same purpose and havebeen tested to prove that they work aseffectively as the predicate device. Thisdifference does not raise different questionsof safety or effectiveness as demonstratedby performance testing.
Feature	DigniCap Delta® Scalp Cooling System(Subject Device)	DigniCap® Scalp Cooling System(Predicate Device)	Analysis of Differences
Pre /PostCooling Phase	Yes	Yes	Same
CoolantTemperatureRange	-7 to 1.5°C	-15°C to 5°C	This range is within the range originallycleared with the predicate device but istighter to provide more consistent coolingto the patient's scalp. This difference doesnot raise different questions of safety oreffectiveness.
Outer CoolingCap	Single Patient Use	Multiple Patient Use	This difference does not raise differentquestions of safety or effectiveness.
Inner CoolingCap - SingleUse	Single Patient Use	Multiple Patient Use	This difference does not raise differentquestions of safety or effectiveness.
Device Testing
BiocompatibilityTesting	Yes. Cap materials are biocompatible inaccordance with ISO 10993-1.	Yes. Cap materials are biocompatible inaccordance with ISO 10993-1.	Same
Electrical SafetyTesting	Yes.IEC 60601-1:2005/(R)2012IEC 62133-2:2017	Yes.IEC 60601-1:2007	Electrical Safety Testing was conducted tothe current standard.
ElectromagneticCompatibilityTesting	Yes.IEC60601-1-2:2014	Yes.IEC 60601-1-2:2007	Electrical Safety Testing was conducted tothe current standard.

Table 5.1: Substantial Equivalence Table – Regulatory Information

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510(k) SUMMARY

Table 5.2: Substantial Equivalence Table – Technological Information

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510(k) SUMMARY

Table 5.2: Substantial Equivalence Table – Technological Information (cont.)

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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

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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.

Regulation Number and Section

§ 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.