The Invictus Medical, Inc. GelShield is a gel-filled positioning product that helps alleviate pressure caused by prolonged immobility or other conditions where frequent repositioning is contraindicated.

Device Description

Invictus Medical, Inc. (Invictus) has developed the Invictus Medical, Inc. GELShield to reduce pressure localization on the heads of infants in Neonatal Intensive Care Units (NICU). The Invictus device is a gel-filled positioning product that helps alleviate pressure caused by prolonged immobility or other conditions where frequent repositioning is contraindicated. The product achieves this through two design characteristics: first to reduce overall friction between the outer laver of skin covering the skull and external surface; and second, to evenly redistribute external pressures over boney prominences of the skull.

The device wraps around the back of the head starting just behind the ears. It has a three dimensional curvature from foam panels that creates a curved surface of the primary outer material, Recovery5™ HF Healthcare Fabric, a low-friction material that is also used on surgical mattresses. Coupled with silicone appliques on the inner surface, the design helps the device stay in place on the head allowing the infant to move normally. This is augmented through the use of Velcro™ (as part of the device) which is used to snugly secure the device to the head. The Velcro allows the nursing staff to easily remove and re-secure the device as part of the usual care of the patient. The device also contains panels of hydrogel encased in Versaflex designed to reduce pressure localization. The Invictus Medical GELShield is not sterile when used. The device is single patient use, but can be worn by a given patient for multiple use periods during the patient's stay in NICU.

AI/ML Overview

Based on the provided text, here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Biocompatibility (ISO 10993 series)	Passed all testing requirements
Pressure Redistribution	Confirmed a redistribution of pressure, reducing the potential impact of localized pressure
Dermal rating < 2 for all ratings in usability study	Passed the pre-determined acceptance criteria
No adverse events during usability study	No adverse events occurred

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

Sample Size: Not explicitly stated for the usability safety study. The text mentions "Consented subjects wore the Invictus GELShield over a representative period of time."
Data Provenance: Not explicitly stated, though the context of the submission to the FDA for a device to be used in US NICUs suggests the data would likely be from the US. The study appears to be prospective as it involved "Consented subjects wore the Invictus GELShield" and "Safety information was collected at specified time points."

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)

The text does not specify the number of experts or their qualifications for establishing the dermal assessment ratings. It refers to "overall HCP (Healthcare Provider) assessments."

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

The text does not describe any specific adjudication method for the dermal assessments. It states that "All rating scale data was collected and analyzed using descriptive statistics to determine overall HCP assessments."

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a "skin pressure protector," not an AI-powered diagnostic or assistive tool for human readers.

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

No, a standalone algorithm-only performance study was not done. The product is a physical medical device (a gel-filled positioning product), not an algorithm.

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

For the usability safety study, the "ground truth" for safety and performance (specifically dermal integrity and absence of adverse events) was established by Healthcare Provider (HCP) assessments using a "widely recognized dermal assessment tool" and monitoring for adverse events. This resembles a form of clinical observation/assessment.
For the pressure mapping profiles, the "ground truth" seems to be derived from in-vitro testing using pressure mapping technology, which quantitatively measures pressure distribution.

8. The sample size for the training set

This question is not applicable as the device is a physical product and not an AI/ML algorithm that requires a training set.

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

This question is not applicable as the device is a physical product and not an AI/ML algorithm.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 1, 2015

Invictus Medical, Incorporated c/o Mr. Scott Thiel Navigant Consulting 9001 Wesleyan Road. Suite 200 Indianapolis, Indiana 46268

Re: K150243

Trade/Device Name: Invictus Medical, Inc. GELShield Regulation Number: 21 CFR 880.6450 Regulation Name: Skin pressure protector Regulatory Class: I Product Code: FMP Dated: January 30, 2015 Received: February 2, 2015

Dear Mr. Thiel:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing 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.

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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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 yours,

lina Kiang -S

for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K150243

Device Name Invictus Medical, Inc. GelShield

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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K150243 510(k) Summary

Submitter Information

Invictus Medical, Inc. 12500 Network Blvd. Suite 308 San Antonio, TX 78249

Contact Person: Scott Thiel 317.228.8700 Scott.thiel@navigant.com
Date: January 30, 2015
Trade Name: Invictus Medical Inc. GELShield
Common Name: Skin pressure protectors
Classification Name(s): Skin pressure protectors
Classification Number: 21 CFR 880.6450 (FMP); Class I

Predicate Device

510(k) Number	Device Name	Submitter Name
K812344	Heel or Elbow Protector	Fred Sammons

Reference Device(s)

510(k) Number	Device Name	Submitter Name
K801694	Flotation Pad	Action Products, Inc.

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Device Description

Intended Use(s)

The Invictus Medical. Inc. GELShield is a gel-filled positioning product that helps alleviate pressure caused by prolonged immobility or other conditions where frequent repositioning is contraindicated.

Property orCharacteristic	Proposed DeviceInvictus GelShield	Predicate Device(K812344)Heel/ElbowProtector(Sammons)	Reference Device(K801694)Flotation Pad forOperating Table(ActionProducts)
Use Environment	Used in neonatal intensivecare unit (NICU)	Anywhere	Used generally inoperating suites
Property orCharacteristic	Proposed DeviceInvictus GelShield	Predicate Device(K812344)Heel/ElbowProtector(Sammons)	Reference Device(K801694)Flotation Pad forOperating Table(ActionProducts)
Sterility	N/A	N/A	N/A
Conditions of Use	Disposable, single-patientuse	Reusable, multi-patientuse	Reusable, multi-patient use
Mechanism ofAction	Utilizes low-frictionmaterial surrounding sealedcontainers of hydrogel todiffuse and distributelocalized pressure.	Utilizes compressionbandage materialsurrounding containersof hydrogel to diffuseand distribute localizedpressure.	Utilizes low-frictionmaterialsurrounding sealedcontainers ofhydrogel to diffuseand distributelocalized pressure.
Outer MaterialDesign Features	Recovery5™ HF HealthcareFabricSilicone stripes	Acrylic/spandex	RecoveryHealthcare Fabric(various versions)
PressureDistributionDesign Features	FoamHydrogel encased inVersaflex	Hydrogel pad	High-density foamAkton® Polymer
Closure/AttachmentDesign Features	Velcro strips to holdsupport device in place	Compression sleeveholds gel pad in place	N/A – patient lieson
In-Vitro Diagnosticdevice?	The product is not an invitro diagnostic device	Same	Same

Technological Characteristics

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Non-Clinical Performance Data

Biocompatibility testing performed on the assembled devices per applicable standards within the ISO 10993 series of standards passed all testing requirements.

Pressure mapping profiles of the Invictus GELShield design confirmed a redistribution of pressure, reducing the potential impact of localized pressure.

Clinical Performance Data

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A usability safety study was performed to assess product design and labeling use in a Neonatal Intensive Care environment. Consented subjects wore the Invictus GELShield over a representative period of time to assess the function of the device and associated labeling. Safety information was collected at specified time points utilizing a widely recognized dermal assessment tool, health assessments (temperature, pulse, respiration rate), and note of any excessive scalp sweating/moisture accumulation. There were no adverse events during the study.

A pre-determined dermal rating of < 2 for all ratings was required for the study to pass. All rating scale data was collected and analyzed using descriptive statistics to determine overall HCP assessments of the products form, fit and performance. Dermal assessment scores and occurrence of adverse events were collected and analyzed using descriptive statistics. Any open-ended comments were captured and reviewed by the sponsor to guide future potential design changes, etc., should they be needed.

Rating data collected during the study passed the pre-determined acceptance criteria.

Non-Clinical and Clinical Performance Data Conclusions

The testing results indicate the Invictus GELShield is as safe and effective as the predicate device and appropriate for use with the patient population for the purpose intended.

Regulation Number and Section

§ 880.6450 Skin pressure protectors.

Link to an amendment published at 90 FR 55988, Dec. 4, 2025. (a)
Identification. A skin pressure protector is a device intended for medical purposes that is used to reduce pressure on the skin over a bony prominence to reduce the likelihood of the patient's developing decubitus ulcers (bedsores).(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.