(83 days)
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.
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.
This document does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. Instead, it describes a medical device called "Great Hands Mitts" and provides a "Safety and Effectiveness Summary" for a 510(k) submission.
The document focuses on:
- Device Description: What the Great Hands Mitts are, their components, and how they function.
- Intended Use: To prevent patients from grasping or pulling out medical lines and to prevent self-inflicted injuries.
- Technological Characteristics: Emphasizing that 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 change mentioned is revised labeling to comply with agency requirements.
- Biocompatibility Assessment: Stating that the materials have a history of safe use in the clothing and garment industry and that there are no known skin irritation reports.
- Conclusion: That the device is safe, effective, and substantially equivalent to a predicate device.
There is no mention of:
- Specific performance metrics or quantitative acceptance criteria.
- Any study, trial, or testing methodology used to assess performance against such criteria.
- Information regarding sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment.
Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria and study details based on the provided text.
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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 |
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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.
§ 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.