(58 days)
The Heelbo Quilted Torso Restraint is intended to help secure a patient at the torso or legs while lying on a bed or gurney.
The Heelbo Quilted Torso Restraint is a reinforced, padded belt 4½ inches wide by 33½ inches long. The Quilted Torso Restraint is designed with polyester webbed strapping that is wrapped around the frame of a bed or gurney and threaded through a drop-jaw buckle to secure the patient at the torso or legs.
This document describes a 510(k) premarket notification for the Heelbo Quilted Torso Restraint. It asserts substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics. Therefore, it does not contain the detailed information requested in your prompt regarding acceptance criteria, study design, sample sizes, expert ground truthing, or AI-related metrics.
Here's an analysis based on the provided text, highlighting what is and is not found:
1. Table of acceptance criteria and the reported device performance:
- Not Available. The document does not provide a table of acceptance criteria or quantitative performance metrics. It relies on a claim of substantial equivalence to a predicate device.
2. Sample sized used for the test set and the data provenance:
- Not Available. There is no mention of a test set, sample size, or data provenance from a study evaluating the device's performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable / Not Available. Ground truth establishment by experts is relevant for studies involving qualitative or diagnostic assessments, which are not described here.
4. Adjudication method for the test set:
- Not Applicable / Not Available. No test set or adjudication method is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This device is a physical restraint, not an AI diagnostic or assistive tool. Therefore, an MRMC study and AI-related metrics are irrelevant and not present.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This device is a physical restraint, not an algorithm. Standalone performance is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable / Not Available. The document does not describe a study that required establishing 'ground truth' in a clinical or diagnostic sense. The safety and effectiveness are established through documented material safety and previous market experience of the predicate device.
8. The sample size for the training set:
- Not Applicable / Not Available. There is no mention of a training set as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
- Not Applicable / Not Available. Not relevant for this device.
Summary of what the document does state regarding safety and effectiveness:
The document states that the Heelbo Quilted Torso Restraint is considered "safe and effective for its intended use and is substantially equivalent to the predicate device."
This conclusion is based on:
- Identical characteristics: The device is stated to be "identical in intended use, design, materials, manufacturing process, physical and mechanical specifications and issues of safety and effectiveness" to its predicate device.
- Material Biocompatibility: The component materials are identical to the predicate devices. Suppliers report a "history of safe use of their materials in the clothing and garment industry." Heelbo, Inc. is "not aware of any reports or complaints of skin irritation associated with these materials."
- Labeling Compliance: The only difference from the predicate device is revised product labeling to comply with FDA guidance.
Essentially, the study proving safety and effectiveness is implicitly the historical data and regulatory acceptance of the predicate device, combined with the fact that the new device is materially and functionally identical and its materials have a history of safe use. No new performance studies were conducted or described beyond this assertion of equivalence.
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Image /page/0/Picture/0 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." is written after the comma.
1134 N. Homan Ave. Chicago, IL 60651 312/489-7711
Telex RCA 297-248 800/323-5444 Fax 312/489-7744
OCT - 9 1996
Heelbo, Inc. Quilted Torso Restraint
Safety and Effectiveness Summary
1. Submitter's name, Address and Contact Person
| Submitter | Contact Person |
|---|---|
| Heelbo, Inc.1134 N. Homan Ave.Chicago, IL 60651 | Joseph S. Tokarz; Manager, Regulatory AffairsHollister Incorporated2000 Hollister DriveLibertyville, IL 60048Ph: (847)680-2849, Fax: (847)918-3860 |
| Date Summary Prepared - August 8, 1996 |
- Name of Device:
Heelbo Quilted Torso Restraint
3. Name of Predicate Device(s)
Heelbo Quilted Torso Restraint
4. Description of Device
The Heelbo Quilted Torso Restraint is a reinforced, padded belt 4½ inches wide by 33½ inches long. The Quilted Torso Restraint is designed with polyester webbed strapping that is wrapped around the frame of a bed or gurney and threaded through a drop-jaw buckle to secure the patient at the torso or legs.
5. Statement of Intended Use
The Heelbo Quilted Torso Restraint is intended to help secure a patient at the torso or legs while lying on a bed or gurney.
6. Statement of Technological Characteristics of the Device
The Heelbo Quilted Torso Restraint is a reinforced, padded belt 4½ inches wide by 33½ inches long. The Quilted Torso Restraint is designed with polyester webbed strapping that is wrapped around the frame of a bed or gurney and threaded through a drop-iaw buckle to secure the patient at the torso or legs.
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
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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 black and appears to be the name of a company. The comma after "Heelbo" and the period after "Inc." are clearly visible.
1134 N. Homan Ave. Chicago, IL 60651 312/489-7711
Telex RCA 297-248 800/323-5444 Fax 312/489-7744
and the country of the submit and the subsequence a
Heelbo, Inc. Quilted Torso Restraint
forth in the draft "Guidance on the Content of Premarket Notification [501(k)] Submissions for Protective Restraints" dated December 1995.
7. Biocompatibility
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.
8. Conclusion
Based upon the information presented above it is concluded that the proposed Heelbo Quilted Torso Restraint 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.