(51 days)
The Heelbo ICU 911 Blazer Sleeved Jacket is intended to help support and help prevent a patient from slumping or sliding forward while seated in a wheelchair. The Heelbo ICU 911 Blazer Sleeved Jacket is also intended to limit the patient's movement while lying in bed to prevent the patient from falling out of bed or climbing over the side rails.
The Heelbo ICU 911 Blazer Sleeved Jacket is a jacket-style safety vest. The jacket has short sleeves and straps on each side of the vest that can be tied together to ensure a comfortable fit. The jacket is constructed with Velcro® fasteners and a zipper in the back to ensure a secure fit as well as allowing for quick and easy release. Additional zippers are located on the back of the vest along each shoulder blade area of the device. These zippers are provided to allow the caregiver quick and easy access to vital monitoring support leads and IV lines. The jacket also has been designed with an extra deep neckline to accommodate tracheal tubes and arterial catheters. The jacket is secured to the bed or wheelchair with two straps that are attached to the bottom of the vest. Optional loops sewn to the shoulder area of the vest are provided in the event extra support is needed. The ICU 911 Blazer Sleeved Jacket is available with a knotless system (quick disconnect option). The ICU 911 Blazer Sleeved Jacket is available in a poly/cotton blend or a polyester mesh material. Five sizes accommodate a wide range of patients. The ICU 911 Blazer Sleeved Jacket is made of durable machine washable materials and is color coded for easy size identification.
The provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria based on performance metrics. The document is a 510(k) premarket notification for a medical device (Heelbo ICU 911 Blazer Sleeved Jacket), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria.
The key points of the submission are:
- Device Description: Details the physical characteristics, materials, and intended use of the ICU 911 Blazer Sleeved Jacket.
- Intended Use: Explains that the jacket is designed to support patients in wheelchairs to prevent slumping/sliding and to limit movement in bed to prevent falls.
- Technological Characteristics: Reaffirms the design features.
- Substantial Equivalence Claim: States that the subject devices are identical in intended use, design, materials, manufacturing process, physical and mechanical specifications, and safety/effectiveness to the predicate devices. The only change mentioned is revised labeling to comply with agency guidance.
- Biocompatibility: Asserts that component materials have a history of safe use in the clothing industry and no reported skin irritation.
- Conclusion: Concludes that the proposed device is safe, effective, and substantially equivalent to the predicate device.
To answer your request, here's what can be extracted based on the document's content, and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety: Device materials are safe for patient contact. | "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." Concluded as "safe" based on substantial equivalence to predicate. |
| Effectiveness: Device effectively supports patients and limits movement as intended. | The device is intended "to help support and help prevent a patient from slumping or sliding forward while seated in a wheelchair or geri-chair" and "to limit the patient's movement while lying on a bed or gurney to prevent the patient from falling out of bed or climbing over the side rails." The conclusion states it is "effective for its intended use" based on substantial equivalence. No specific performance metrics (e.g., a percentage reduction in falls, a measure of support effectiveness) are provided. |
| Technological Characteristics: Device maintains specified design and function. | "The subject devices are identical in intended use, design, materials, manufacturing process, physical and mechanical specifications... to the devices prior to the submission of this notification." Features such as Velcro® fasteners, zippers for quick release and access, deep neckline, and securing straps are described as part of its design. The knotless system is an optional feature for quick disconnect. |
| Substantial Equivalence: Device is equivalent to predicate device. | "Based upon the information presented above it is concluded that the proposed Heelbo ICU 911 Blazer Sleeved Jacket is safe and effective for its intended use and is substantially equivalent to the predicate device." The only stated difference is updated labeling. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
No test set or performance data from a study is reported. The submission relies on substantial equivalence to a predicate device.
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, as no test set or ground truth determination by experts is described for performance evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as no test set or adjudication process 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:
Not applicable. This device is a physical restraint, not an AI-assisted diagnostic or interpretive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable, as no specific performance study requiring ground truth is described. The "ground truth" for the submission is the historical safety and effectiveness of the predicate device and the materials used.
8. The sample size for the training set:
Not applicable, as no machine learning or AI component exists for which a training set would be required.
9. How the ground truth for the training set was established:
Not applicable.
§ 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.