(88 days)
Heelbo Quilted Limb Holder with Buckle and Strap 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 sitting positions.
The Heelbo Quilted Limb Holder with Buckle and Strap is a quilted limb holder with a Velcro® fastener, buckle and straps that secure to a bed, gurney, chair or wheelchair. The Heelbo Quilted Limb Holder with Buckle and Strap 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 adjustable buckle allows for supine and sitting positions. The Heelbo Quilted Limb Holder is machine washable.
This document is a 510(k) premarket notification for a medical device called the "Heelbo Quilted Limb Holder with Buckle and Strap." It makes claims of substantial equivalence to a predicate device, rather than providing new clinical study data or performance metrics that would typically be associated with software or AI device acceptance criteria.
Therefore, many of the requested sections (e.g., sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types) are not applicable to the information provided in this submission.
Here's an analysis based on the available text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety and Effectiveness (for intended use) | "The proposed Heelbo Quilted Limb Holder with Buckle and Strap are safe and effective for their intended use and are substantially equivalent to the predicate device." |
| Technological Characteristics (comparable to predicate) | "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." |
| Biocompatibility (no skin irritation) | "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." |
| Labeling Compliance | "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." |
Study that proves the device meets the acceptance criteria:
The submission itself serves as the "study" or justification. It makes a claim of substantial equivalence to a previously cleared predicate device, the "Heelbo Quilted Limb Holder with Buckle and Strap." The "proof" is the assertion that the new device is identical in all critical aspects (intended use, design, materials, manufacturing process, physical and mechanical specifications, safety, and effectiveness) to the predicate, with the only change being updated labeling for regulatory compliance.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a 510(k) submission based on substantial equivalence to a predicate device, not on new clinical trials or performance data generated from a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No new ground truth was established for a test set for this submission. The safety and effectiveness are predicated on the established history of the legally marketed predicate device and its materials.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set requiring expert adjudication was used.
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
Not applicable. This device is a physical limb holder, not an AI or software-based device intended for diagnostic interpretation or human reader assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" implicitly relies on the historical safety and effectiveness established for the predicate device through its prior clearance and market experience. For biocompatibility, the ground truth is the "history of safe use of their materials in the clothing and garment industry" and the absence of reported skin irritation complaints.
8. The sample size for the training set
Not applicable. No training set for an algorithm was used.
9. How the ground truth for the training set was established
Not applicable. No training set for an algorithm was used.
§ 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.