(70 days)
The Economy Restraint, Jacket Restraint, Two Piece Vest Restraint, Safety Vest and Hand Control Mitt are incended for use to assist cooperative patients who require minimum support in wheelchair. The devices are labeled for prescription use and are not intended for lay use.
These devices are vest, jacket and mitt style restraints used to restrain patients in a wheelchair or bed. These devices are made of polyester, cotton, nylon and polyethelen configured into either a mesh or weave substrate. Each device utilizes straps for securing (tie) the patient in place.
This 510(k) summary (K96-3492) describes patient restraints (Economy Restraint, Jacket Restraint, Two Piece Vest Restraint, Safety Vest, and Hand Control Mitt) manufactured by Smith & Nephew DonJoy Inc.
Based on the provided text, the submission focuses on demonstrating substantial equivalence to legally marketed predicate devices rather than proving performance against specific acceptance criteria through a study with detailed statistical analysis. Therefore, most of the requested information regarding acceptance criteria and study design is not present in this document.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated as quantifiable metrics. The implicit acceptance criterion appears to be "no association with an MDR type complaint" over four years of commercial distribution.
- Reported Device Performance:
- "intended for use to assist cooperative patients who require minimum support in wheelchair."
- "labeled for prescription use and are not intended for lay use."
- "vest, jacket and mitt style restraints used to restrain patients in a wheelchair or bed."
- "made of polyester, cotton, nylon and polyethelen configured into either a mesh or weave substrate."
- "Each device utilizes straps for securing (tie) the patient in place."
- "have been commercially distributed for over four years and have not been associated with an MDR type complaint."
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Safe and effective for intended use | No association with MDR type complaints over four years. |
| Suitable for restraining cooperative patients in wheelchairs | Intended for use to assist cooperative patients... in wheelchair. |
| Suitable for restraining patients in wheelchairs or beds | Used to restrain patients in a wheelchair or bed. |
| Durable and appropriate materials | Made of polyester, cotton, nylon and polyethelen. |
| Provides secure restraint | Utilizes straps for securing (tie) the patient in place. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The performance claim of "commercially distributed for over four years" implies a real-world usage base, but no specific number of devices or patient uses is provided.
- Data Provenance: The data is retrospective, based on a four-year period of commercial distribution. The country of origin is not explicitly stated for the "data," but the manufacturer is based in the USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This submission relies on a lack of adverse events from commercial distribution rather than expert-adjudicated test data.
4. Adjudication method for the test set:
- Not applicable. There's no test set in the traditional sense with adjudicated ground truth. The "adjudication" is essentially the absence of adverse event reports (MDRs) during commercial use.
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 or diagnostic imaging device.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
- Not applicable. This device is a physical restraint.
7. The type of ground truth used:
- The "ground truth" for the safety aspect is the absence of adverse event reports (MDRs) during commercial distribution. For effectiveness, the "ground truth" is the presumed successful use of the devices for their intended purpose in the market, supported by the lack of complaints.
8. The sample size for the training set:
- Not applicable. There is no "training set" for this type of device submission. The device design is based on established engineering principles for restraints and materials, not machine learning.
9. How the ground truth for the training set was established:
- Not applicable.
In summary:
This 510(k) summary leverages the established market history and safety record of the devices as evidence for substantial equivalence, rather than providing a detailed study against specific numerical acceptance criteria. The focus is on demonstrating that the devices are similar to existing legally marketed devices and have a safe history of use.
§ 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.