(86 days)
The Johnny Grait Belt Security Belt is intended to be used as a safety belt to secure a patient who is seated in a wheelchair or geri-chair. It is also used to secure a patient sitting on a chair commode or lying on a bed or gurney.
The Heelbo Johnny Grait Belt Security Belt is a security belt made of cotton with a polypropylene, quick release snap buckle closure and two D-Ring Velcro loop fasteners. The belt is 2 inches wide and 60 inches long to accommodate a wide range of patients. The Velcro fasteners quickly attach and detach to chair commodes, wheelchairs, beds and gurneys.
This document is a 510(k) summary for the Heelbo Johnny Grait Belt Security Belt. It does not contain information about acceptance criteria and a study proving the device meets those criteria.
This document is a premarket notification for a medical device that appears to be a physical restraint. The core of this submission is a claim of substantial equivalence to a predicate device, meaning the new device is as safe and effective as a legally marketed device.
Here's why the requested information about acceptance criteria and a study to prove performance is not present in this type of document:
- Substantial Equivalence: For devices cleared through the 510(k) pathway, the primary demonstration of safety and effectiveness is by showing substantial equivalence to a predicate device. This typically involves comparing design, materials, intended use, and performance characteristics to the predicate device, rather than conducting new clinical studies or detailed performance studies with acceptance criteria as would be expected for a novel device or a PMA submission.
- Device Type: This is a physical restraint, which is a relatively low-risk device. Clinical studies with robust statistical acceptance criteria, MRMC studies, or extensive standalone performance evaluations are generally not required for this class and type of device under the 510(k) pathway.
- Date: The document is dated October 1996. Regulatory requirements and expectations for device evaluations were different than today.
Instead, the document highlights:
- Identicality: "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." This is a key statement in a substantial equivalence claim.
- Labeling Compliance: The only noted difference with the predicate device is revised labeling to comply with agency guidance.
- Biocompatibility Assessment: This is based on the history of safe use of materials in clothing and garment industry and absence of prior complaints for the company's devices, not specific biocompatibility testing reported with acceptance criteria.
Therefore, I cannot extract the requested information (table of acceptance criteria, study details, sample sizes, expert qualifications, etc.) because it is not provided in the provided 510(k) summary. This document focuses on demonstrating equivalence rather than presenting data from a new performance study against defined acceptance criteria.
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Image /page/0/Picture/1 description: The image shows the text "Heelbo, Inc.". The text is in a bold, sans-serif font. The text is black and the background is white.
1134 N. Homan Ave. Chicago. IL 60651
Telex RCA 297-248 800/323-5444
312/489-7711
Fax 312/489-7744
OCT 2 4 1996
Heelbo, Inc. Johnny Grait Belt Security Belt
510(k) Summary
1. 1. Submitter's name, Address and Contact Person
Submitter Heelbo, Inc. 1134 N. Homan Chicago, IL
Contact Person Joseph S. Tokarz, Manager, Regulatory Affairs Hollister Incorporated 2000 Hollister Drive Libertyville, IL 60048 (847)680-2849, Fax (847)918-3860 Ph
Date Summary Prepared - October 22, 1996
2. Name of Device:
Heelbo Johnny Grait Belt Security Belt
3. Name of Predicate Device(s)
Heelbo Johnny Grait Belt Security Belt
4. Description of Device
The Heelbo Johnny Grait Belt Security Belt is a security belt made of cotton with a polypropylene, quick release snap buckle closure and two D-Ring Velcro loop fasteners. The belt is 2 inches wide and 60 inches long to accommodate a wide range of patients. The Velcro fasteners quickly attach and detach to chair commodes, wheelchairs, beds and gurneys.
The Johnny Grait Belt Security Belt is intended to be used as a safety belt to secure a patient who is seated in a wheelchair or geri-chair. It is also used to secure a patient sitting on a chair commode or lying on a bed or gurney.
5. Statement of Intended Use
The Johnny Grait Belt Security Belt is intended to be used as a safety belt to secure a patient who is seated in a wheelchair or geri-chair. It is also used to secure a patient sitting on a chair commode or lying on a bed or gurney.
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Image /page/1/Picture/0 description: The image shows the text "Heelbo, Inc." in a bold, sans-serif font. The text is black and appears to be the name of a company or organization. The word "Heelbo" is followed by a comma, and then "Inc." is written after the comma.
1134 N. Homan Ave. Chicago, IL 60651
Telex RCA 297-248 800/323-5444
312/489-7711
Fax 312/489-7744
Heelbo, Inc. Johnny Grait Belt Security Belt
6. Statement of Technological Characteristics of the Device
The Heelbo Johnny Grait Belt Security Belt is a security belt made of cotton with a polypropylene, quick release snap buckle closure and two D-Ring Velcro loop fasteners. The belt is 2 inches wide and 60 inches long to accommodate a wide range of patients. The Velcro fasteners quickly attach and detach to chair commodes, wheelchairs, beds and gurneys.
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 [510(k)] Submissions for Protective Restraints dated December 1995.
7. Biocompatibility Assessment
The subject devices are identical in components materials to the predicate devices. The suppliers of the materials used 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 Heelbo Johnny Grait Belt Security Belt is safe and effective for it's intended use and is substantially equivalent to the predicate device.
§ 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.