(78 days)
The Heelbo Pelvic Restraint is intended to help secure a patient while seated in a wheelchair or geriatric chair.
The Heelbo Pelvic Restraint is constructed of polyester mesh. Straps sewn onto both sides of the front panel and back panel are used to secure the patient to the wheelchair or geriatric chair. A catheter access slot has been incorporated into the restraint design for those patients that utilize an indwelling catheter. The Pelvic Restraints are available in three sizes, small, medium and large to accommodate a wide range of patients. The Pelvic Restraints are machine washable for continued use.
This appears to be a 510(k) premarket notification document for a medical device, specifically a "Heelbo Pelvic Restraint." This type of document is submitted to the FDA to demonstrate that a medical device is at least as safe and effective as an already legally marketed device (predicate device).
However, the provided text does not contain any information regarding clinical studies, acceptance criteria, or performance data in the way you've outlined in your request. It primarily focuses on:
- Device identification and contact information.
- Description of the device and its intended use.
- Comparison to a predicate device, stating that the only difference is revised labeling to comply with FDA guidance.
- Biocompatibility, again relying on the predicate device's materials and lack of reported issues.
- Conclusion of substantial equivalence based on the above.
Therefore, I cannot fulfill your request for the following reasons:
- No Acceptance Criteria or Reported Device Performance: The document does not define any specific performance metrics (e.g., accuracy, sensitivity, specificity) or acceptance criteria for those metrics. It assumes the device is safe and effective by being substantially equivalent to a predicate.
- No Study Conducted: The text explicitly states that 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 indicates that no new clinical study was conducted for this specific submission to prove performance against acceptance criteria. The basis for safety and effectiveness is simply that it's the same as an already marketed device.
- No mention of experts, ground truth, sample sizes, or adjudication methods. These details are associated with clinical trials or performance studies, which are not described in this document.
In essence, this document is a regulatory submission arguing for substantial equivalence, not a report of a new clinical investigation of device performance.
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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 and is black. The background is white. 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
1 1996
Heelbo, Inc. Pelvic Restraint
Safety and Effectiveness Summary
1. Submitter's name, Address and Contact Person
Submitter Heelbo, Inc. 1134 N. Homan Ave. Chicago, IL 60651
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 - August 13, 1996
2. Name of Device:
Heelbo Pelvic Restraint
3. Name of Predicate Device(s)
Heelbo Pelvic Restraint
4. Description of Device
The Heelbo Pelvic Restraint is constructed of polyester mesh. Straps sewn onto both sides of the front panel and back panel are used to secure the patient to the wheelchair or geriatric chair. A catheter access slot has been incorporated into the restraint design for those patients that utilize an indwelling catheter.
The Pelvic Restraints are available in three sizes, small, medium and large to accommodate a wide range of patients. The Pelvic Restraints are machine washable for continued use.
5. Statement of Intended Use
The Heelbo Pelvic Restraint is intended to help secure a patient while seated in a wheelchair or geriatric chair.
6. Statement of Technological Characteristics of the Device
The Heelbo Pelvic Restraint is constructed of polyester mesh. Straps sewn onto both sides of the front panel and back panel are used to secure the patient to the wheelchair or geriatric chair. A catheter access slot has been incorporated into the restraint design for those patients that utilize an indwelling catheter.
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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 arranged horizontally, with "Heelbo" appearing first, followed by a comma, and then "Inc." with a period at the end. A horizontal line is placed underneath the text.
1134 N. Homan Ave. Chicago. IL 60651 312/489-7711
Telex RCA 297-248 800/323-5444 Fax 312/489-7744
Heelbo, Inc. Pelvic Restraint
The Pelvic Restraints are available in three sizes, small, medium and large to accommodate a wide range of patients. The Pelvic Restraints are machine washable for continued use.
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
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 Heelbo Pelvic Restraint is safe and effective for its 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.