← Product Code [FMP](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMP) · K150243

# Invictus Medical GelShield (K150243)

_Invictus Medical, Inc. · FMP · May 1, 2015 · General Hospital · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMP/K150243

## Device Facts

- **Applicant:** Invictus Medical, Inc.
- **Product Code:** [FMP](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMP.md)
- **Decision Date:** May 1, 2015
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.6450
- **Device Class:** Class 1
- **Review Panel:** General Hospital
- **Attributes:** Therapeutic, Pediatric

## Indications for Use

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 Story

GELShield is a gel-filled positioning device for infants in NICU; designed to reduce pressure localization on the skull. Device wraps around the back of the head; secured with Velcro. Features include Recovery5™ HF Healthcare Fabric (low-friction) and silicone appliques to maintain position; hydrogel panels encased in Versaflex redistribute pressure over bony prominences. Operated by nursing staff; easily removed/re-secured during routine care. Device is single-patient use; non-sterile. By reducing friction and redistributing pressure, the device helps prevent pressure-related injuries in immobile infants.

## Clinical Evidence

Usability safety study conducted in a NICU environment. Subjects wore the device to assess function, labeling, and safety. Metrics included dermal assessment scores (using a standardized tool), vital signs (temperature, pulse, respiration), and monitoring for scalp moisture. No adverse events reported; all dermal ratings were < 2, meeting pre-determined acceptance criteria.

## Technological Characteristics

Materials: Recovery5™ HF Healthcare Fabric, silicone appliques, hydrogel, Versaflex, foam, Velcro. Biocompatibility: ISO 10993 compliant. Form factor: 3D curved wrap for infant skull. Energy source: None (passive). Sterilization: Non-sterile. Connectivity: None.

## Regulatory 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).

## Predicate Devices

- Heel or Elbow Protector ([K812344](/device/K812344.md))

## Reference Devices

- Flotation Pad ([K801694](/device/K801694.md))

## Submission Summary (Full Text)

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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)

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.

| 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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# 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

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.

#### 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 or<br>Characteristic               | Proposed Device<br>Invictus GelShield                                                                                              | Predicate Device<br>(K812344)<br>Heel/Elbow<br>Protector<br>(Sammons)                                                                 | Reference Device<br>(K801694)<br>Flotation Pad for<br>Operating Table<br>(Action<br>Products)                                            |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Use Environment                             | Used in neonatal intensive<br>care unit (NICU)                                                                                     | Anywhere                                                                                                                              | Used generally in<br>operating suites                                                                                                    |
| Property or<br>Characteristic               | Proposed Device<br>Invictus <i>GelShield</i>                                                                                       | Predicate Device<br>(K812344)<br>Heel/Elbow<br>Protector<br>(Sammons)                                                                 | Reference Device<br>(K801694)<br>Flotation Pad for<br>Operating Table<br>(Action<br>Products)                                            |
| Sterility                                   | N/A                                                                                                                                | N/A                                                                                                                                   | N/A                                                                                                                                      |
| Conditions of Use                           | Disposable, single-patient<br>use                                                                                                  | Reusable, multi-patient<br>use                                                                                                        | Reusable, multi-<br>patient use                                                                                                          |
| Mechanism of<br>Action                      | Utilizes low-friction<br>material surrounding sealed<br>containers of hydrogel to<br>diffuse and distribute<br>localized pressure. | Utilizes compression<br>bandage material<br>surrounding containers<br>of hydrogel to diffuse<br>and distribute localized<br>pressure. | Utilizes low-friction<br>material<br>surrounding sealed<br>containers of<br>hydrogel to diffuse<br>and distribute<br>localized pressure. |
| Outer Material<br>Design Features           | Recovery5™ HF Healthcare<br>Fabric<br>Silicone stripes                                                                             | Acrylic/spandex                                                                                                                       | Recovery<br>Healthcare Fabric<br>(various versions)                                                                                      |
| Pressure<br>Distribution<br>Design Features | Foam<br>Hydrogel encased in<br>Versaflex                                                                                           | Hydrogel pad                                                                                                                          | High-density foam<br>Akton® Polymer                                                                                                      |
| Closure/Attachment<br>Design Features       | Velcro strips to hold<br>support device in place                                                                                   | Compression sleeve<br>holds gel pad in place                                                                                          | N/A – patient lies<br>on                                                                                                                 |
| In-Vitro Diagnostic<br>device?              | The product is not an <i>in<br/>vitro</i> 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.

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMP/K150243](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMP/K150243)

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