(55 days)
Reduction of patient movement, or restrain of patient, during medical procedure, during transportation of the patient, or in other situation s deemed appropriate by the health car facility.
The devices are fabricated various lengths and widths as described in advertising. The closure is "hook and loop".
This document is a 510(k) summary for "Various Procedural Restraints" manufactured by AliMed®, inc. It does not present information about a novel device requiring performance acceptance criteria or a study to prove it meets them in the way medical software or AI devices do.
Instead, this document is focused on establishing substantial equivalence for existing devices (various types of straps and restraints) by comparing them to pre-amendment devices and describing their current use and safety history.
Therefore, I cannot directly extract the requested information (acceptance criteria table, sample size for test/training sets, ground truth details, MRMC study results, etc.) because these concepts are not applicable to the content provided.
Here's what can be inferred or stated based on the document's purpose:
- Acceptance Criteria & Device Performance: Not applicable in the context of this 510(k). The "acceptance criteria" here would be meeting the definition of a patient restraint and demonstrating safe use, which is addressed through comparative information and user experience data.
- Study That Proves the Device Meets Acceptance Criteria: No formal study is presented to meet quantifiable performance metrics as would be required for a novel device. The "proof" is based on historical use and the lack of adverse events.
- Sample Size for Test Set and Data Provenance: Not applicable. There's no "test set" in the sense of a new system being evaluated.
- Number of Experts Used to Establish Ground Truth and Qualifications: Not applicable.
- Adjudication Method: Not applicable.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable.
- Standalone Performance Study: Not applicable.
- Type of Ground Truth Used: Not applicable. The closest concept is "user experience" and "lack of adverse events."
- Sample Size for Training Set: Not applicable.
- How Ground Truth for Training Set Was Established: Not applicable.
Summary of relevant information from the document as it pertains to safety/effectiveness:
- Comparative Information: The devices are compared to "Various Preamendments straps and restraints." The document states that similar devices were in use prior to the Medical Device Amendment (1976) and others were introduced afterward. Pre-1976 catalogs showing these exact devices were not found, but "it is understood that these types of devices were in use prior to the Medical Device Amendment."
- Biocompatibility: "Based on the materials, and the method of use (topological), it is unlikely that any concern of this nature would develop."
- User Experience: "The firm has received no information related to a death, serious injury or allergenic reaction to the materials used during the time these devices have been marketed." This serves as the primary "evidence" for the safety and effectiveness of the existing devices.
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Image /page/0/Picture/0 description: The image shows the logo for AliMed Inc. The logo consists of a black square with a white diamond inside, followed by the text "AliMed" in a bold, sans-serif font. To the right of "AliMed" is a registered trademark symbol, and then the word "inc." in a smaller, bold, sans-serif font.
297 High Street Dedham, MA 02026
OCT 29 1996
K 963528
510(k) SUMMARY
Various Procedural Restraints
Applicant:
AliMed®, inc. 297 High Street Dedham, MA 02026
Contact: Jonathan C. Bretz
Telephone: 617-329-2900 617-329-8392 FAX:
Submitted by:
د الاستقاري الأ
/
놀이터 노래 대전 대표 등록 [대표 대통령 관찰 [
Curtin & Associates International 1200 East Street Dedham, MA 02026
Contact: Donald A. Lincoln
Telephone: 617-329-1955 FAX: 617-329-2529
Date this Summary was prepared: 27 August 1996
AliMed® Positioning & Safety Straps, Semi-Disposable Arm Straps, Trade Names: Stretcher Straps Common Name: Strap or Restraint Classification Name: Patient Restraint
Legally Marketed Devices to Which Substantial Equivalence is claimed:
Various Preamendments straps and restraints.
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510(k) SUMMARY-continued
Description of Device: The devices are fabricated various lengths and widths as described in advertising. The closure is "hook and loop".
Intended Use of the Device: Reduction of patient movement, or restrain of patient, during medical procedure, during transportation of the patient, or in other situation s deemed appropriate by the health car facility.
| CODE | NAME | SIZE | FIRSTMANUFACTURED | USE |
|---|---|---|---|---|
| 9-931 | Universal Body Strap | 5" x 65" | 1990 | Positioning & safety strap |
| 9-930 | Wrist/Ankle Straps | 1 @ 5" x 45"2 @ 2" x 12" | 1991* | Positioning patient on table |
| 9-950 | Wrist Straps | 2 @ 2" x 12" | 1991 | Restraint wrists/arms |
| 95-022 | Semi-Disposable ArmStraps | 2" x 18" | 1986 | Bulk arm strap |
| 7686 | Wheel Stretcher Strap | 2" x 62" | 1978** | Stretcher strap |
| 7687 | Wheel Stretcher Strap | 2" x 66" | 1978** | Stretcher strap |
| 7688 | Wheel Stretcher Strap | 2" x 72" | 1978** | Stretcher strap |
-
- = Converted from Distributed by to Manufactured by in the year shown. First year of sale by original company not know at this time.
- ** = Converted from Distributed by to Manufactured for, by the actual manufacturer. Date shown is that firm's drawing date.
Comparative Information: Pre-1976 catalogs were not found which showed devices such as those contained in this notification. However, it is understood that these types of devices were in use prior to the Medical Device Amendment and others were introduced after the Act.
Biocompatibility: Based on the materials, and the method of use (topological), it is unlikely that any concern of this nature would develop.
User Experience: The firm has received no information related to a death, serious injury or allergenic reaction to the materials used during the time these devices have been marketed.
§ 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.