(51 days)
Though the prompt implies I need to extract K/DEN numbers, the provided text does not contain any such numbers. Therefore, I will respond with "None".
None
No
The device description and intended use focus solely on the physical design and function of a safety vest, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is a jacket-style safety vest intended for patient restraint to prevent falls and maintain positioning, not to provide therapeutic treatment or improve a health condition.
No
The device's intended use and description explain that it is a safety vest designed to support patients and limit their movement, not to diagnose any medical condition.
No
The device description clearly describes a physical garment (jacket-style safety vest) made of materials like poly/cotton blend or polyester mesh, with features like sleeves, straps, Velcro fasteners, zippers, and loops. There is no mention of any software component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The Heelbo ICU 911 Blazer Sleeved Jacket is a physical restraint device. Its purpose is to support and limit a patient's movement for safety reasons (preventing slumping, sliding, or falling).
- Lack of Specimen Analysis: The device does not interact with or analyze any specimens from the human body. It is a physical garment used externally.
Therefore, based on the provided information, the Heelbo ICU 911 Blazer Sleeved Jacket clearly falls outside the definition and function of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Heelbo ICU 911 Blazer Sleeved Jacket is intended to help support and help prevent a patient from slumping or sliding forward while seated in a wheelchair. The Heelbo ICU 911 Blazer Sleeved Jacket is also intended to limit the patient's movement while lying in bed to prevent the patient from falling out of bed or climbing over the side rails.
Product codes
Not Found
Device Description
The Heelbo ICU 911 Blazer Sleeved Jacket is a jacket-style safety vest. The Heelbo ICU 911 Blazer Sleeved Jacket is intended for use in the ICU (Intensive Care Unit), critical care situations as well as other area of the health care facility. The jacket is intended to help support and help prevent a patient from slumping or sliding forward while seated in a wheelchair or geri-chair. The Heelbo ICU 911 Blazer Sleeved Jacket is also intended to limit the patient's movement while lying on a bed or gurney to prevent the patient from falling out of bed or climbing over the side rails.
The jacket has short sleeves and straps on each side of the vest that can be tied together to ensure a comfortable fit. The jacket is constructed with Velcro® fasteners and a zipper in the back to ensure a secure fit as well as allowing for quick and easy release. Additional zippers are located in the back of the vest along each shoulder blade area of the device. These zippers are provided to allow the caregiver quick and easy access to vital monitoring support leads and IV lines. The jacket also has been designed with an extra deep neckline to accommodate tracheal tubes and arterial catheters.
The jacket is secured to the bed or wheelchair with two straps that are attached to the bottom of the vest. Optional loops sewn to the shoulder area of the vest are provided in the event extra support is needed.
The ICU 911 Blazer Sleeved Jacket is available with a knotless system (quick disconnect option). This option allows the caregiver to quickly and easily disconnect the restraint from the chair or bed frame by eliminating time consuming untying of knots (a picture of the loop accessory is attached to this section).
The ICU 911 Blazer Sleeved Jacket is available in a poly/cotton blend or a polyester mesh material. Five sizes accommodate a wide range of patients. The ICU 911 Blazer Sleeved Jacket is made of durable machine washable materials and is color coded for easy size identification.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Heelbo ICU 911 Blazer Sleeved Jacket
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
Heelbo.
1134 N. Homan Ave. Chicago, IL 60651
312/489-7711
Telex RCA 297-248 800/323-5444 Fax 312/489-7744
OCT - 9 1996
Heelbo, Inc. ICU 911 Blazer Sleeved Jacket
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 Ph: (847)680-2849, Fax: (847)918-3860
Date Summary Prepared - August 14, 1996
2. Name of Device:
Heelbo ICU 911 Blazer Sleeved Jacket
3. Name of Predicate Device(s)
Heelbo ICU 911 Blazer Sleeved Jacket
4. Description of Device
The Heelbo ICU 911 Blazer Sleeved Jacket is a jacket-style safety vest. The Heelbo ICU 911 Blazer Sleeved Jacket is intended for use in the ICU (Intensive Care Unit), critical care situations as well as other area of the health care facility. The jacket is intended to help support and help prevent a patient from slumping or sliding forward while seated in a wheelchair or geri-chair. The Heelbo ICU 911 Blazer Sleeved Jacket is also intended to limit the patient's movement while lying on a bed or gurney to prevent the patient from falling out of bed or climbing over the side rails.
The jacket has short sleeves and straps on each side of the vest that can be tied together to ensure a comfortable fit. The jacket is constructed with Velcro® fasteners and a zipper in the back to ensure a secure fit as well as allowing for quick and easy release. Additional zippers are located on the back of the vest along each shoulder blade area of the device. These zippers are provided to allow the caregiver quick and easy access to vital monitoring support leads and IV lines. The jacket also has been designed with an extra deep neckline to accommodate tracheal tubes and arterial catheters.
1
1134 N. Homan Ave. Chicago, IL 60651 312/489-7711
Telex RCA 297-248 800/323-5444 Fax 312/489-7744
Heelbo, Inc. ICU 911 Blazer Sleeved Jacket
The jacket is secured to the bed or wheelchair with two straps that are attached to the bottom of the vest. Optional loops sewn to the shoulder area of the vest are provided in the event extra support is needed.
The ICU 911 Blazer Sleeved Jacket is available with a knotless system (quick disconnect option). This option allows the caregiver to quickly and easily disconnect the restraint from the chair or bed frame by eliminating time consuming untying of knots (a picture of the loop accessory is attached to this section).
The ICU 911 Blazer Sleeved Jacket is available in a poly/cotton blend or a polyester mesh material. Five sizes accommodate a wide range of patients. The ICU 911 Blazer Sleeved Jacket is made of durable machine washable materials and is color coded for easy size identification.
The following chart shows product availability:
| Series | Material | Size of Vest | Color |
|---|---|---|---|
| 9417 | Poly/Cotton blend | x-small | White |
| 9417K | small | Yellow | |
| medium | Blue | ||
| large | Green | ||
| x-large | Beige | ||
| 9417B | Polyester Mesh material | ||
| 9417BK | small | Yellow bias on white breezewear | |
| medium | Blue bias on white breezewear | ||
| large | Green bias on white breezewear | ||
| x-large | Beige bias on white breezewear |
ICU 911 Blazer Sleeved Jacket is Available in the following Sizes and Configurations
5. Statement of Intended Use
The Heelbo ICU 911 Blazer Sleeved Jacket is intended to help support and help prevent a patient from slumping or sliding forward while seated in a wheelchair. The Heelbo ICU 911 Blazer Sleeved Jacket is also intended to limit the patient's movement while lying in bed to prevent the patient from falling out of bed or climbing over the side rails.
2
Image /page/2/Picture/0 description: The image shows the text "Heelbo, Inc.". The text is in bold, black font. The text is on a white background.
1134 N. Homan Ave. Chicago, IL 60651 312/489-7711
Telex RCA 297-248 800/323-5444 Fax 312/489-7744
Heelbo, Inc. ICU 911 Blazer Sleeved Jacket
6. Statement of Technological Characteristics of the Device
The jacket has short sleeves and straps on each side of the vest that can be tied together to ensure a comfortable fit. The jacket is constructed with Velcro® fasteners and a zipper in the back to ensure a secure fit as well as allowing for quick and easy release. Additional zippers are located on the back of the vest along each shoulder blade area of the device. These zippers are provided to allow the caregiver quick and easy access to vital monitoring support leads and IV lines. The jacket also has been designed with an extra deep neckline to accommodate tracheal tubes and arterial catheters.
The jacket is secured to the bed or wheelchair with two straps that are attached to the bottom of the vest. Optional loops sewn to the shoulder area of the vest are provided in the event extra support is needed.
The ICU 911 Blazer Sleeved Jacket is available with a knotless system (quick disconnect option). This option allows the caregiver to quickly and easily disconnect the restraint from the chair or bed frame by eliminating time consuming untying of knots (a picture of the loop accessory is attached to this section).
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 ICU 911 Blazer Sleeved Jacket is safe and effective for its intended use and is substantially equivalent to the predicate device.