HEELBO PELVIC RESTRAINT

• K Number: K963199
• Device Name: HEELBO PELVIC RESTRAINT
• Manufacturer: HOLLISTER, INC.
• Date Cleared: 1996-11-01 ( 78 days)
• Product Code: FMQ
• Regulation Number: 880.6760
• Type: Traditional
• Panel: General Hospital
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The Heelbo Pelvic Restraint is intended to help secure a patient while seated in a wheelchair or geriatric chair.

Device Description

The Heelbo Pelvic Restraint is constructed of polyester mesh. Straps sewn onto both sides of the front panel and back panel are used to secure the patient to the wheelchair or geriatric chair. A catheter access slot has been incorporated into the restraint design for those patients that utilize an indwelling catheter. The Pelvic Restraints are available in three sizes, small, medium and large to accommodate a wide range of patients. The Pelvic Restraints are machine washable for continued use.

AI/ML Overview

This appears to be a 510(k) premarket notification document for a medical device, specifically a "Heelbo Pelvic Restraint." This type of document is submitted to the FDA to demonstrate that a medical device is at least as safe and effective as an already legally marketed device (predicate device).

However, the provided text does not contain any information regarding clinical studies, acceptance criteria, or performance data in the way you've outlined in your request. It primarily focuses on:

• Device identification and contact information.
• Description of the device and its intended use.
• Comparison to a predicate device, stating that the only difference is revised labeling to comply with FDA guidance.
• Biocompatibility, again relying on the predicate device's materials and lack of reported issues.
• Conclusion of substantial equivalence based on the above.

Therefore, I cannot fulfill your request for the following reasons:

1. No Acceptance Criteria or Reported Device Performance: The document does not define any specific performance metrics (e.g., accuracy, sensitivity, specificity) or acceptance criteria for those metrics. It assumes the device is safe and effective by being substantially equivalent to a predicate.
2. No Study Conducted: The text explicitly states that 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." This indicates that no new clinical study was conducted for this specific submission to prove performance against acceptance criteria. The basis for safety and effectiveness is simply that it's the same as an already marketed device.
3. No mention of experts, ground truth, sample sizes, or adjudication methods. These details are associated with clinical trials or performance studies, which are not described in this document.

In essence, this document is a regulatory submission arguing for substantial equivalence, not a report of a new clinical investigation of device performance.

Regulation Number and Section

§ 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.