(45 days)
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No
The device description and intended use focus on physical restraints and materials, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device description and intended use indicate that these padded mitts are designed as restraints to prevent patients from accessing wounds or medical tubes, or to control hand contracture, rather than directly treating a medical condition.
No.
The devices are described as physical restraints (mitts) designed to prevent patients from interacting with their bodies or medical devices, not for diagnosing conditions.
No
The device description clearly details physical components like woven polyester, foam, mesh, straps, buckles, and a PVC insert, indicating it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The described padded mitts are physical restraints designed to prevent patients from interfering with medical devices or wounds. They are applied externally to the patient's hand and arm.
- Intended Use: The intended use clearly states the purpose is to prevent patients from removing bandages, picking at wounds, or pulling out tubes. This is a physical intervention, not a diagnostic test performed on a specimen.
The description of the device, its intended use, and the lack of any mention of analyzing biological samples all indicate that this is a physical medical device, not an IVD.
N/A
Intended Use / Indications for Use
Padded Mitts, Padded-Plus Mitts, Rigid Palm Padded Mitts, and Finger Separator Padded Mitts are intended for patients who remove bandages and dressings, pick and scratch at wounds, grasp and pull out feeding and naso-gastric tubes.
Rigid Palm Padded Mitts have a rigid insert and are intended for patients who require an additional barrier to prevent grasping.
Finger-Separator Padded Mitts have finger channels that help to control hand contracture.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
Padded Mitts are constructed from woven polyester that encloses a 3/4-inch-thick foam palm pad. A top piece of polyester mesh is sewn on the mitts to prevent heat build-up. The mitts have a 1 1/4-inch-wide polyester wrist strap that secures by means of a metal buckle. The underside of the mitt cuff has a loop through which a 44-inch-long looped strap passes. This strap is used to secure the patient's hand/arm range of motion. The outer edges are finished with a bias cut binding. All straps are made of polyester webbing.
Padded-Plus Mitts are identical to the above except that the foam used for the palm pad is two-inches-thick.
Finger Separator Padded Mitts are identical to Padded-Plus Mitts except that the polyester mesh top piece is stitched to the polyester woven fabric in a such a way as to form finger channels.
Rigid-Palm Padded Mitts are identical to the Padded Mitts except that they have a pocket on the bottom side which contains a 6mm pvc insert. This rigid insert, which removes for laundering, is used for patients who require an additional barrier to prevent against grasping at feeding and naso-gastric tubes.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Padded Mitts, Padded-Plus Mitts, Finger Separator Padded Mitts, and Rigid Palm Padded Mitts marketed by Skil-Care Corporation.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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Image /page/0/Picture/0 description: The image shows the logo for "Ski-Care Corporation". The words "Ski" and "Care" are connected by a line. The word "Corporation" is written in a smaller font size below the first line.
OCT TAB F: 510(k) Summary of Safety and Effectiveness Name, address, phone and fax numbers for person submitting the 510(k) notifica
Arnold Silverman, President Skil-Care Corporation 167 Saw Mill River Road Yonkers, NY 10701 Phone: 1-914-963-2040 1-914-963-2567 Fax:
Contact person: Arnold Silverman
Date summary was prepared: August 27, 1996
Device name:
| Trade name: | Padded Mitts, Finger Separator Padded Mitts, Rigid Palm Padded Mitts |
|---|---|
| Common name: | Same |
| Classification name: | Protective Restraint |
Predicate device:
Padded Mitts, Padded-Plus Mitts, Finger Separator Padded Mitts, and Rigid Palm Padded Mitts marketed by Skil-Care Corporation.
Device Description:
Padded Mitts are constructed from woven polyester that encloses a 3/4-inch-thick foam palm pad. A top piece of polyester mesh is sewn on the mitts to prevent heat build-up. The mitts have a 1 1/4-inch-wide polyester wrist strap that secures by means of a metal buckle. The underside of the mitt cuff has a loop through which a 44-inch-long looped strap passes. This strap is used to secure the patient's hand/arm range of motion. The outer edges are finished with a bias cut binding. All straps are made of polyester webbing.
Padded-Plus Mitts are identical to the above except that the foam used for the palm pad is two-inches-thick.
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Finger Separator Padded Mitts are identical to Padded-Plus Mitts except that the polyester mesh top piece is stitched to the polyester woven fabric in a such a way as to form finger channels.
Finger seportator
Rigid-Palm Padded Mitts are identical to the Padded Mitts except that they have a pocket on the bottom side which contains a 6mm pvc insert. This rigid insert, which removes for laundering, is used for patients who require an additional barrier to prevent against grasping at feeding and naso-gastric tubes.
Indications for use:
Padded Mitts, Padded-Plus Mitts, Rigid Palm Padded Mitts, and Finger Separator Padded Mitts are intended for patients who remove bandages and dressings, pick and scratch at wounds, grasp and pull out feeding and naso-gastric tubes.
Rigid Palm Padded Mitts have a rigid insert and are intended for patients who require an additional barrier to prevent grasping.
Finger-Separator Padded Mitts have finger channels that help to control hand contracture.
Comparative information:
The device (devices) used for comparative purposes is (are) currently marketed as described in this submission. Device (devices) is (are): Padded Mitts, Padded-Plus Mitts, Rigid-Palm Padded Mitts, and Finger Separator Padded Mitts.
These devices are currently exempt from 510(k) Premarket Notification Procedures and Good Manufacturing Practice Regulations and are legally marketed by Skil-Care Corporation as of the date of this submission. Skil-Care Corporation has been marketing and commercially distributing these devices for approximately 18 years.
The difference from our currently marketed devices are that the labeling will be changed to incorporate many of the suggestions in FDA's draft document, "Guidance on the Content of Premarket Notification [510(k)] Submissions for Protective Restraints.
The use of all patient restraints in nursing homes are subject to Health Care Financing Administration's Regulations which prohibit the use of any restraint, physical or chemical, imposed for the purpose of discipline or convenience. Further, most health care facilities are accredited. HCFA rules governing appropriate use and accreditation standards for device use and personnel training provide the control necessary to ensure that the devices are used correctly. The application of these standards along with public awareness and health care provider training have contributed significantly to
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ensuring that the least restrictive restraint is used, that restraints are used only when needed for proper medical treatment, and that their use is under appropriate supervision.
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