(89 days)
The Heelbo Security Belt is intended to help secure the patient while seated in a wheelchair or geriatric chair.
The Heelbo Security Belt is a padded belt 4% inches wide by 22 inches long with cotton webbed straps sewn onto both ends. The webbed straps tie to the frame of the wheelchair or geriatric chair to help secure the patient while seated.
This document is a 510(k) summary for a medical device (Heelbo Security Belt). It describes the device, its intended use, and argues for its substantial equivalence to a predicate device.
Crucially, this document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of diagnostic or AI-driven performance.
The information provided relates to the physical characteristics, materials, and intended use of a restraint belt, and its equivalence to an older version of the same product, primarily focusing on labeling changes.
Therefore, I cannot provide the requested information. The document does not describe:
- Acceptance criteria for a performance study (e.g., sensitivity, specificity, accuracy thresholds).
- Reported device performance statistics against such criteria.
- Sample sizes for test sets in a "study" of performance as typically understood for AI or diagnostic devices.
- Data provenance for such studies.
- Number/qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study.
- Standalone algorithm performance study.
- Type of ground truth (e.g., pathology, outcomes).
- Sample size for the training set.
- How ground truth for the training set was established.
The "study" referenced in Section 8 is a conclusion based on substantial equivalence to a predicate device, primarily due to identical physical characteristics and materials, with the only change being a revision to product labeling to comply with FDA guidance. This is a regulatory pathway, not a performance study as would be conducted for a new diagnostic or AI-based device.
{0}------------------------------------------------
63060
Image /page/0/Picture/2 description: The image shows the word "Heelbo, Inc." in bold black font. The words are on a white background. There is a thin black line underneath the words.
1134 N. Homan Ave. Chicago, IL 60651 312/489-7711
Telex RCA 297-248 800/323-5444
Fax 312/489-7744
NOW 4 1888
Heelbo. Inc. Security Belt
510(k) Summary
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 (847)680-2849, Fax (847)918-3860 Ph
Date Summary Prepared - November 1, 1996
2. Name of Device:
Heelbo Security Belt
3. Name of Predicate Device(s)
Heelbo Security Belt
4. Description of Device
The Heelbo Security Belt is a padded belt 4% inches wide by 22 inches long with cotton webbed straps sewn onto both ends. The webbed straps tie to the frame of the wheelchair or geriatric chair to help secure the patient while seated.
5. Statement of Intended Use
The Heelbo Security Belt is intended to help secure the patient while seated in a wheelchair or geriatric chair.
6. Statement of Technological Characteristics of the Device
The Heelbo Security Belt is a padded belt 4% inches wide by 22 inches long with cotton webbed straps sewn onto both ends. The webbed straps tie to the frame of the wheelchair or geriatric chair to help secure the patient while seated.
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.
{1}------------------------------------------------
Image /page/1/Picture/2 description: The image shows the text "Heelbo, Inc." in a bold, sans-serif font. The text is black and is set against a white background. A horizontal line is present under the text, emphasizing the name.
1134 N. Homan Ave. Chicago, IL 60651 312/489-7711
Telex RCA 297-248 800/323-5444 Fax 312/489-7744
Heelbo, Inc. Security Belt
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 Security Belt is safe and effective for its 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.