(88 days)
No
The description focuses on the physical design and materials of the device for pressure redistribution and friction reduction. There is no mention of AI, ML, or any computational analysis of data.
Yes.
The device is designed to alleviate pressure caused by prolonged immobility, which is a therapeutic effect aimed at preventing pressure injuries.
No
The device is described as a gel-filled positioning product intended to alleviate pressure and reduce friction, not to diagnose a condition. Performance studies focus on usability and dermal assessment, not diagnostic accuracy.
No
The device description clearly states it is a "gel-filled positioning product" made of physical materials like foam panels, fabric, silicone appliques, Velcro, and hydrogel. It is a physical medical device, not software.
Based on the provided information, the Invictus Medical, Inc. GelShield is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to alleviate pressure on the heads of infants caused by prolonged immobility. This is a physical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a physical positioning product designed to redistribute pressure and reduce friction. It does not involve the analysis of biological samples.
- Lack of Diagnostic Function: The device does not provide information about a patient's health status or condition based on in vitro examination of specimens.
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 GelShield does not perform any such function.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FMP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
heads of infants
Indicated Patient Age Range
infants
Intended User / Care Setting
Used in neonatal intensive care unit (NICU)
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)
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
§ 880.6450 Skin pressure protectors.
(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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, representing the department's focus on people and health.
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.
1
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
2
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. |
4
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
Characteristic | Proposed Device
Invictus GelShield | Predicate Device
(K812344)
Heel/Elbow
Protector
(Sammons) | Reference Device
(K801694)
Flotation Pad for
Operating Table
(Action
Products) |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Use Environment | Used in neonatal intensive
care unit (NICU) | Anywhere | Used generally in
operating suites |
| Property or
Characteristic | Proposed Device
Invictus GelShield | Predicate Device
(K812344)
Heel/Elbow
Protector
(Sammons) | Reference Device
(K801694)
Flotation Pad for
Operating Table
(Action
Products) |
| Sterility | N/A | N/A | N/A |
| Conditions of Use | Disposable, single-patient
use | Reusable, multi-patient
use | Reusable, multi-
patient use |
| Mechanism of
Action | Utilizes low-friction
material surrounding sealed
containers of hydrogel to
diffuse and distribute
localized pressure. | Utilizes compression
bandage material
surrounding containers
of hydrogel to diffuse
and distribute localized
pressure. | Utilizes low-friction
material
surrounding sealed
containers of
hydrogel to diffuse
and distribute
localized pressure. |
| Outer Material
Design Features | Recovery5™ HF Healthcare
Fabric
Silicone stripes | Acrylic/spandex | Recovery
Healthcare Fabric
(various versions) |
| Pressure
Distribution
Design Features | Foam
Hydrogel encased in
Versaflex | Hydrogel pad | High-density foam
Akton® Polymer |
| Closure/Attachment
Design Features | Velcro strips to hold
support device in place | Compression sleeve
holds gel pad in place | N/A – patient lies
on |
| In-Vitro Diagnostic
device? | The product is not an in
vitro diagnostic device | Same | Same |
Technological Characteristics
5
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
6
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