(83 days)
None
Not Found
No
The summary describes a physical restraint device with no mention of software, algorithms, or any technology that would suggest AI/ML.
No.
Explanation: The device is a restraint used to prevent patients from interacting with medical equipment or causing self-harm, not to treat a medical condition or restore health.
No
The mitts are restraints to prevent patients from interacting with medical devices or self-harm; they do not diagnose any condition.
No
The device description clearly outlines physical components (cotton, polyester, mesh, Velcro, D-Ring) and does not mention any software functionality.
Based on the provided information, the Great Hands Mitts hand restraints are not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens from the human body. This includes things like blood, urine, tissue, etc., to provide information about a person's health.
- The Great Hands Mitts are a physical restraint. Their intended use is to prevent patients from physically interacting with medical lines or causing self-harm. They do not involve the analysis of any biological specimens.
The description clearly indicates a physical device worn on the hands for restraint purposes, which falls outside the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Great Hands Mitts hand restraints are worn like gloves. The mitts are intended to prevent patients from grasping or pulling out catheters, I.V. tubes and other vital lines. The mitts also prevent patients from scratching themselves or inflicting other injuries to themselves or others.
Product codes
Not Found
Device Description
Great Hands Mitts are hand restraints that are worn like gloves. The cotton covered mitt is filled with polyester and is covered with a mesh material on one side. The glove-like finger lanes are sewn into the mesh material and a Velcro wrist strap with a D-Ring loop fastener helps secure the glove in place.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands
Indicated Patient Age Range
adults, infants, toddlers, and youths
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Great Hands Mitts
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.6760 Protective restraint.
(a)
Identification. A protective restraint is a device, including but not limited to a wristlet, anklet, vest, mitt, straight jacket, body/limb holder, or other type of strap, that is intended for medical purposes and that limits the patient's movements to the extent necessary for treatment, examination, or protection of the patient or others.(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.
0
Image /page/0/Picture/0 description: The image shows the text "Heelbo, Inc." in a bold, black font. The text is arranged horizontally, with "Heelbo" appearing first, followed by a comma, and then "Inc." The font is sans-serif and the text is clear and legible.
312/489-7711
Telex RCA 297-248 800/323-5444 Fax 312/489-7744
OCT - 9 1996
Heelbo, Inc. Great Hands Mitts
Safety and Effectiveness Summary
1. Submitter's name, Address and Contact Person
- Submitter Heelbo, Inc. 1134 N. Homan Ave. Chicago, IL
Contact Person Joseph S. Tokarz, Manager, Regulatory Affairs Hollister Incorporated 2000 Hollister Drive Libertyville, IL 60048 Ph: (847)680-2849, Fax: (847)918-3860
Date Summary Prepared - July 15, 1996
2. Name of Device:
Great Hands Mitts
3. Name of Predicate Device(s)
Great Hands Mitts
4. Description of Device
Great Hands Mitts are hand restraints that are worn like gloves. The cotton covered mitt is filled with polyester and is covered with a mesh material on one side. The glove-like finger lanes are sewn into the mesh material and a Velcro wrist strap with a D-Ring loop fastener helps secure the glove in place.
The mitts are intended to prevent patients from grasping or pulling out catheters. I.V. tubes and other vital lines. The mitts also prevent patients from scratching themselves or inflicting other injuries to themselves or others.
The Great Hands Mitts are available in one size, and three colors to accommodate adult hands and three sizes, three colors to accommodate infants, toddlers and youths. Below is the listing of stock numbers and availability.
| Stock Number | Description | Color |
|---|---|---|
| 1000, 1000HP, 1000N | adult | white, hot pink, navy |
| 1110, 1110HP, 1110N | infant | white, hot pink, navy |
| 1120, 1120HP, 1120N | toddler | white, hot pink, navy |
| 1130, 1130HP, 1130N | youth | white, hot pink, navy |
1
Image /page/1/Picture/0 description: The image shows the text "Heelbo, Inc." in a bold, sans-serif font. The text is arranged horizontally, with "Heelbo" appearing first, followed by a comma, and then "Inc.". The text is black against a white background.
1134 N. Homan Ave. Chicago, IL 60651 312/489-7711
Telex RCA 297-248 800/323-5444 Fax 312/489-7744
Heelbo, Inc. Great Hands Mitts
5. Statement of Intended Use
Great Hands Mitts hand restraints are worn like gloves. The mitts are intended to prevent patients from grasping or pulling out catheters, I.V. tubes and other vital lines. The mitts also prevent patients from scratching themselves or inflicting other injuries to themselves or others.
6. Statement of Technological Characteristics of the Device
Great Hands Mitts are hand restraints that are worn like gloves. The cotton covered mitt is filled with polyester and is covered with a mesh material on one side. The glove-like finger lanes are sewn into the mesh material and a Velcro wrist strap with a D-Ring loop fastener secures the glove in place.
The subject devices are identical in intended use, design, materials, manufacturing process. physical and mechanical specifications and issues of safety and effectiveness to the devices prior to the submission of this notification. The only difference is that the product labeling has been revised to comply with the Agency's labeling requirements set forth in the draft "Guidance on the Content of Premarket Notification [501(k)] Submissions for Protective Restraints" dated December 1995.
7. Biocompatibility Assessment
The subject devices are identical in component materials to the predicate devices. The suppliers of the materials use in the fabrication of these devices have stated that there is a history of safe use of their materials in the clothing and garment industry. In addition, Heelbo, Inc., is not aware of any reports or complaints of skin irritation associated with these materials.
9. Conclusion
Based upon the information presented above it is concluded that the Heelbo Great Hands Mitts are safe and effective for their intended use and are substantially equivalent to the predicate device.