(87 days)
The Heelbo Life Jacket with Crotch Support is intended to help prevent a patient from slumping or sliding forward while seated in a wheelchair or geriatric chair.
The Heelbo Life Jacket with Crotch Support is a poncho-style safety vest with padded crotch support. The vest has three sets of two straps that are secured to various components of a wheelchair or geriatric chair to support the upper torso. When all the straps are connected per the instructions the Heelbo Life Jacket with Crotch Support is intended to help prevent a patient from slumping or sliding forward while seated in a wheelchair or geriatric chair.
The Life Jacket with Crotch Support is available in a polyester and cotton blend (9400) or a polyester mesh material (9400B).
The provided text is a 510(k) summary for the Heelbo Life Jacket with Crotch Support. It is a regulatory document intended to demonstrate substantial equivalence to a predicate device, not a study describing the de novo establishment of acceptance criteria and device performance. As such, the document does not contain the information requested regarding acceptance criteria from a study for a new device.
Specifically, the document focuses on demonstrating that the "new" Heelbo Life Jacket with Crotch Support is identical to its predicate device, with the only change being a revision to product labeling to comply with regulatory guidance. It explicitly states:
- "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 subject devices are identical in components materials to the predicate devices."
Therefore, it does not describe:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for a test set or data provenance.
- Number or qualifications of experts used to establish ground truth.
- Adjudication methods.
- Multi-reader multi-case comparative effectiveness studies.
- Standalone algorithm performance (as this is a physical device, not an algorithm).
- Type of ground truth used.
- Sample size for a training set.
- How ground truth for a training set was established.
This document serves as evidence of substantial equivalence based on a change in labeling for an existing device, rather than a clinical study evaluating the performance of a newly designed device against specific acceptance criteria.
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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 printed on a white background. A horizontal line is present underneath the text.
1134 N. Homan Ave. Chicago, IL 60651
Telex RCA 297-248 800/323-5444
16 31 130
312/489-7711
Fax 312/489-7744
Heelbo, Inc. Life Jacket with Crotch Support
510(k) Summary
1. 1. Submitter's name, Address and Contact Person
Submitter Heelbo, Inc. 1134 N. Homan 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 - October 30, 1996
2. Name of Device:
Heelbo Life Jacket with Crotch Support
3. Name of Predicate Device(s)
Heelbo Life Jacket with Crotch Support
4. Description of Device
The Heelbo Life Jacket with Crotch Support is a poncho-style safety vest with padded crotch support. The vest has three sets of two straps that are secured to various components of a wheelchair or geriatric chair to support the upper torso. When all the straps are connected per the instructions the Heelbo Life Jacket with Crotch Support is intended to help prevent a patient from slumping or sliding forward while seated in a wheelchair or geriatric chair.
The Life Jacket with Crotch Support is available in a polyester and cotton blend (9400) or a polyester mesh material (9400B). The following chart shows product availability:
| Stock Number | Size of Vest | Color |
|---|---|---|
| 9400 | x-small | White |
| 9400 | small | Yellow |
| 9400 | medium | Blue |
| 9400 | large | Green |
| 9400 | x-large | Beige |
| 9400B | x-small | White bias on white breezewear |
| 9400B | small | Yellow bias on white breezewear |
| 9400B | medium | Blue bias on white breezewear |
| 9400B | large | Green bias on white breezewear |
| 9400B | x-large | Beige bias on white breezewear |
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Image /page/1/Picture/2 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. There is a horizontal line underneath the text, which may be part of a logo or design element.
1134 N. Homan Ave. Telex RCA 297-248 Chicago, IL 60651 800/323-5444 312/489-7711 Fax 312/489-7744
Heelbo. Inc. Life Jacket with Crotch Support
5. Statement of Intended Use
The Heelbo Life Jacket with Crotch Support is intended to help prevent a patient from slumping or sliding forward while seated in a wheelchair or geriatric chair.
6. Statement of Technological Characteristics of the Device
The Heelbo Life Jacket with Crotch Support is a poncho-style safety vest with padded crotch support. The vest has three sets of two straps that are secured to various components of a wheelchair or geriatric chair to support the upper torso. When all the straps are connected per the instructions the Heelbo Life Jacket with Crotch Support is intended to help prevent a patient from slumping or sliding forward while seated in a wheelchair or geriatric chair.
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 components materials to the predicate devices. The suppliers of the materials used 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.
8. Conclusion
Based upon the information presented above it is concluded that the proposed Heelbo Life Jacket with Crotch Support is safe and effective for it's intended use and is 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.