(72 days)
The Heelbo ER Wrist Restraint is intended to be a protective limb restraint that limits the patient's movement to the extent necessary for treatment, examination, or protection of the patient or others. The device can be used in the supine or elevated positions.
The Heelbo ER Wrist Restraint combines a neoprene and nylon cuff limb holder with a Velcro® fastener, Quick-Release closure, Double D-Rings, and two straps. The patient's wrist is secured into the neoprene and nylon cuff by Velcro® hook and loop straps and a Quick release closure. The attached webbed straps are then wrapped around the bed or gurney frame and are woven through a Double D-ring closure. This d-ring closure allows the caregiver to quickly and easily disconnect the restraint from the bed or gurney frame by eliminating time consuming untying of knots. The Heelbo ER Wrist Restraint are machine washable.
The provided text describes a medical device, the "Heelbo ER Wrist Restraint," but it does not contain information about acceptance criteria, a study proving device performance, sample sizes, expert involvement, adjudication methods, or complex statistical analyses like MRMC studies or standalone algorithm performance.
The document is a "Safety and Effectiveness Summary" which focuses on establishing substantial equivalence to a predicate device, rather than presenting a performance study with detailed acceptance criteria and evidence of meeting them.
Essentially, the document states:
- The device's description and intended use.
- Its technological characteristics.
- That it's identical in design, materials, manufacturing, physical/mechanical specifications, and safety/effectiveness to its predicate device.
- The only difference is updated product labeling to comply with regulatory guidance.
- A biocompatibility assessment indicating low potential for adverse reactions, based on existing materials and lack of prior complaints.
- A conclusion of safety, effectiveness, and substantial equivalence to the predicate device.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance: This information is not present. The document asserts equivalence rather than demonstrating performance against specific criteria.
- Sample sized used for the test set and the data provenance: Not applicable, as no performance study is detailed.
- Number of experts used to establish the ground truth... and the qualifications: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done...: Not applicable.
- If a standalone (i.e. algorithm only...) was done: Not applicable.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
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Image /page/0/Picture/1 description: The image shows the text "Heelbo, Inc." in a bold, sans-serif font. The text is black and appears to be the name of a company. The word "Heelbo" is followed by a comma, and then "Inc." indicating that it is an incorporated entity.
1134 N. Homan Ave. Chicago, IL 60651
312/489-7711
Telex RCA 297-248 800/323-5444 Fax 312/489-7744
NOV -7 1996
Heelbo, Inc. Heelbo ER Wrist Restraint
Safety and Effectiveness Summary
1. Submitter's name, Address and Contact Person
Submitter Heelbo, Inc. 1134 N. Homan Ave. Chicago, IL 60651
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 - August 23, 1996
- Name of Device:
Heelbo ER Wrist Restraint
3. Name of Predicate Device
Heelbo ER Wrist Restraint
4. Description of Device
The Heelbo ER Wrist Restraint is intended to be a protective limb restraint that limits the patient's movement to the extent necessary for treatment, examination, or protection of the patient or others. The ER Wrist restraint can be used in the supine and elevated positions.
The Heelbo ER Wrist Restraint combines a neoprene and nylon cuff limb holder with a Velcro® fastener, Quick-Release closure, Double D-Rings, and two straps. The patient's wrist is secured into the neoprene and nylon cuff by Velcro® hook and loop straps and a Quick release closure. The attached webbed straps are then wrapped around the bed or gurney frame and are woven through a Double D-ring closure. This d-ring closure allows the caregiver to quickly and easily disconnect the restraint from the bed or gurney frame by eliminating time consuming untving of knots. The Heelbo ER Wrist Restraint are machine washable.
5. Statement of Intended Use
The Heelbo ER Wrist Restraint is intended to be a protective limb restraint that limits the patient's movement to the extent necessary for treatment, examination, or protection of the patient or others. The device can be used in the supine or elevated positions.
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Heelbo, Inc.
1134 N. Homan Ave. Chicago, IL 60651 312/489-7711
Telex RCA 297-248 800/323-5444 Fax 312/489-7744
Heelbo. Inc. Heelbo ER Wrist Restraint
6. Statement of Technological Characteristics of the Device
The Heelbo ER Wrist Restraint combines a neoprene and nylon cuff limb holder with a Velcro® fastener, Quick-Release closure, Double D-Rings, and two straps. The patient's wrist is secured into the neoprene and nylon cuff by Velcro® hook and loop straps and a Quick release closure. The attached webbed straps are then wrapped around the bed or gurney frame and are woven through a Double D-ring closure. This d-ring closure allows the caregiver to quickly and easily disconnect the restraint from the bed or gurney frame by eliminating time consuming untying of knots.
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 [510(k)] Submissions for Protective Restraints" dated December 1995.
7. Biocompatibility Assessment
The subject devices are identical in component materials to the predicate devices. Heelbo. Inc., is not aware of any reports or complaints of skin irritation associated with the materials used in these devices. A biocompatibility review of these materials indicated little potential to evoke an adverse reaction.
8. Conclusion
Based upon the information presented above it is concluded that the proposed Heelbo ER Wrist Restraint is safe and effective for its intended use and is substantially equivalent to the predicate device.
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§ 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.