(86 days)
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No
The device description details a physical restraint system with no mention of software, data processing, or AI/ML terms.
No
The device is described as a restraint system for patient control, not for treating any medical condition or improving health.
No
The device, a Checkmate Ankle Restraint System, is described as a restraint system intended for patient control by securing ankles. Its purpose is to physically restrict movement, not to diagnose any medical condition or gather diagnostic information.
No
The device description explicitly details physical components like quilted ankle restraints, security straps, and Velcro closures, indicating it is a hardware-based medical device.
Based on the provided information, the Checkmate Ankle Restraint System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. This includes things like blood, urine, tissue, etc., to provide information about a patient's health.
- The Checkmate Ankle Restraint System is a physical restraint device. Its purpose is to secure a patient's ankles for control, not to analyze biological samples.
The description clearly outlines a physical device used for patient restraint, not for diagnostic testing using in vitro methods.
N/A
Intended Use / Indications for Use
The Checkmate Ankle Restraint System is intended to be used in situations requiring patient control while the patient is lying on a bed or gurney. The Checkmate Ankle Restraint System is intended to secure the patient's ankles by keeping them in a fixed position.
Product codes
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Device Description
The Checkmate Ankle Restraint System is designed for situations requiring patient control. The Checkmate System is a restraint system that secures the patient's ankles in a fixed position. It consists of two individual quilted ankle restraints that are permanently attached at a specific distance apart from each other to a long security strap. The security strap is constructed from a woven polypropylene fabric that is 4 inches wide and 33 inches long. The webbed straps attached to both ends of the security strap secure the ankle restraint system to a bed or gurney. The individual ankle restraints are made of a soft polyester and polyurethane foam laminate that forms a cuff that closes around the patient's ankle. The ankle restraint is held securely closed with Velcro® (hook and loop) and a Double D-Ring closure with strap.
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
ankles
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)
Checkmate Ankle Restraint System
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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.
0
K96296-3
Image /page/0/Picture/1 description: The image shows the text "Heelbo, Inc.". The text is in bold and black. The text is likely the name of a company.
1134 N. Homan Ave. Chicago, IL 60651 312/489-7711
Telex RCA 297-248 800/323-5444 Fax 312/489-7744
OCT 2 4 1996
Heelbo, Inc. Checkmate Ankle Restraint System
Safety and Effectiveness Summary
1. Submitter's name, Address and Contact Person
Submitter Heelbo, Inc. 1134 N. Homan Ave. Chicago, IL
Contact Person Joseph S. Tokarz, Manager, Regulatory Affairs Hollister Incorporated 2000 Hollister Drive Libertyville, IL 60048 Ph: (847)680-2849, Fax: (847)918-3860
Date Summary Prepared - July 25, 1996
2. Name of Device:
Checkmate Ankle Restraint System
3. Name of Predicate Device(s)
Checkmate Ankle Restraint System
4. Description of Device
The Checkmate Ankle Restraint System is designed for situations requiring patient control. The Checkmate System is a restraint system that secures the patient's ankles in a fixed position. It consists of two individual quilted ankle restraints that are permanently attached at a specific distance apart from each other to a long security strap. The security strap is constructed from a woven polypropylene fabric that is 4 inches wide and 33 inches long. The webbed straps attached to both ends of the security strap secure the ankle restraint system to a bed or gurney. The individual ankle restraints are made of a soft polyester and polyurethane foam laminate that forms a cuff that closes around the patient's ankle. The ankle restraint is held securely closed with Velcro® (hook and loop) and a Double D-Ring closure with strap.
5. Statement of Intended Use
The Checkmate Ankle Restraint System is intended to be used in situations requiring patient control while the patient is lying on a bed or gurney. The Checkmate Ankle Restraint System is intended to secure the patient's ankles by keeping them in a fixed position.
1
Image /page/1/Picture/0 description: The image shows the text "Heelbo, Inc." in a bold, sans-serif font. The text is arranged on a single line, with "Heelbo" followed by a comma and then "Inc." The text is black against a white background, creating a high contrast and making it easily readable.
1134 N. Homan Ave. Chicago, IL 60651 312/489-7711
Telex RCA 297-248 800/323-5444 Fax 312/489-7744
Heelbo, Inc. Checkmate Ankle Restraint System
6. Statement of Technological Characteristics of the Device
The Checkmate Ankle Restraint System is designed for situations requiring patient control. The Checkmate System is a restraint system that secures the patient's ankles in a fixed position. It consists of two individual quilted ankle restraints that are permanently attached at a specific distance apart from each other to a long security strap. The security strap is constructed from a woven polypropylene fabric that is 4 inches wide and 33 inches long. The webbed straps attached to both ends of the security strap secure the ankle restraint system to a bed or gurney. The individual ankle restraints are made of a soft polyester and polyurethane foam laminate that forms a cuff that closes around the patient's ankle. The ankle restraint is held securely closed with Velcro® (hook and loop) and a Double D-Ring closure with strap.
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. The only difference is that the product labeling has been revised to comply with the Agency's labeling requirements set forth in the draft "Guidance on the Content of Premarket Notification [501(k)] Submissions for Protective Restraints" dated December 1995.
7. Biocompatibility Assessment
The subject devices are identical in component materials to the predicate devices. 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.
8. Conclusion
Based upon the information presented above it is concluded that the proposed Checkmate Ankle Restraint System is safe and effective for its intended use and is substantially equivalent to the predicate device.