The Heelbo Waist and Chest Vest is intended to 1) help support and help prevent a patient from slumping or sliding forward while seated in a wheelchair or geriatric chair and 2) help prevent a patient from falling out of bed or climbing over slide rails.

Device Description

The Heelbo Waist and Chest Vest is a poncho style safety vest that has two sets of two straps that are secured to a wheelchair to support the upper torso. When all the straps are connected per the instructions the Heelbo Waist and Chest Vest is intended to help prevent the patient from slumping or sliding forward while seated in a wheelchair and helps to prevent a patient from falling out of bed. The Waist and Chest Vest is available in a polyester/cotton blend (9340) or a polyester mesh material (9340B).

AI/ML Overview

The provided text is a 510(k) summary for the Heelbo Waist and Chest Vest. It describes the device, its intended use, and compares it to predicate devices. However, the document does not contain information about a study that proves the device meets specific acceptance criteria in the manner requested.

Instead, the submission focuses on demonstrating substantial equivalence to existing legally marketed devices (predicates) based on intended use and technological characteristics, which is the primary requirement for a 510(k) premarket notification. This type of submission typically does not include extensive clinical trial data with specific performance metrics and acceptance criteria in the way a new, non-substantially equivalent device might.

Therefore, most of the requested information regarding acceptance criteria and a study to prove they are met cannot be extracted from the provided text.

Here's what can be gathered:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria: Not explicitly stated as quantifiable performance metrics. The underlying "acceptance criteria" for a 510(k) submission are generally that the device is safe and effective for its intended use and is substantially equivalent to predicate devices.
Reported Device Performance: The document claims the device is "safe and effective for its intended use and is substantially equivalent to the predicate device." However, no specific performance data (e.g., how effectively it prevents falls, or slumping) is provided.

Table (based on substantial equivalence comparison, not performance metrics):

Characteristic	Acceptance Criteria (Implied by Predicate)	Reported Device Performance (Heelbo Waist and Chest Vest)
Intended Use	Same as predicate	1) help support and help prevent a patient from slumping or sliding forward while seated in a wheelchair or geriatric chair2) help prevent a patient from falling out of bed or climbing over slide rails.
Materials	Generally safe materials for patient contact (as evidenced by predicate)	Polyester Cotton Blend, Polyester Mesh (materials identical to previously cleared Heelbo devices K963099 and K963041)
Number of straps	Same as predicate (2 straps)	2
Where used	Same as predicate (wheelchair, geriatric chair, bed)	wheelchair, geriatric chair, bed

2. Sample size used for the test set and the data provenance: Not applicable. No "test set" in the context of a performance study is described. The submission relies on a comparison to predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for a test set is discussed.

4. Adjudication method for the test set: Not applicable. No test set requiring adjudication is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This document describes a medical device for physical support, not an AI-assisted diagnostic or imaging device for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm or software device.

7. The type of ground truth used: Not applicable in the context of a performance study. The "ground truth" for this 510(k) submission is the regulatory acceptance of the predicate devices as safe and effective.

8. The sample size for the training set: Not applicable. No training set is mentioned as this is not an algorithm development.

9. How the ground truth for the training set was established: Not applicable. No training set is mentioned.

Summary of available information regarding the "study":

The "study" in this context is the 510(k) submission itself, which primarily demonstrates substantial equivalence to predicate devices. The arguments presented are:

Comparison Chart: A direct comparison of the proposed device's characteristics (intended use, materials, number of straps, where used) to a predicate device (Posey® Waist and Chest Vest) and other cleared Heelbo devices.
Biocompatibility: The materials used are identical to those cleared in previous Heelbo devices (K963099, K963041). The suppliers have a history of safe use in clothing/garment, and Heelbo Inc. reports no adverse biological incidents over 15 years with these materials.

In essence, the document implies that because the device is technologically similar and has the same intended use as already legally marketed devices, it can be considered safe and effective without requiring new clinical performance studies.

Summary

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980640

Heelbo.

1134 N. Homan Ave. Chicago, IL 60651

Telex RCA 297-248 800/323-5444

312/489-7711

Fax 312/489-7744

MAY 1 1998

Heelbo. Inc. Waist and Chest Vest

510(k) Summary

1. Submitter's name, Address and Contact Person

Submitter Heelbo, Inc. 1134 N. Homan Ave. Chicago, IL 60048

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 - February 17, 1998

Name of Device:

Heelbo Waist and Chest Vest

3. Name of Predicate Device(s)

Heelbo Pullover Poncho, K963099 Heelbo Life Jacket Poncho with Crotch Support, K963041 Posey®Waist and Chest Vest

4. Description of Device

5. Statement of Intended Use

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Heelbo

1134 N. Homan Ave. Chicago. IL 60651

Telex RCA 297-248 800/323-5444

312/489-7711

Fax 312/489-7744

Heelbo. Inc. Waist and Chest Vest

6. Statement of Technological Characteristics of the Device

The proposed device is substantially equivalent to the predicate devices. The following is a chart comparing the devices.

Characteristics	Heelbo Waist and Chest Vest(proposed device)	Posey®Waist and Chest Vest(predicate device)
Intended Use	1) help support and help prevent apatient from slumping or slidingforward while seated in a wheelchairor geriatric chair2) help prevent a patient from fallingout of bed or climbing over slide rails.	Same
Materials	Polyester Cotton BlendPolyester Mesh	CottonBreezeline Mesh
Number of straps	2	2
Where used	wheelchair, geriatric chair, bed	wheelchair, geriatric chair, bed

7. Biocompatibility

Materials used in the construction of the proposed device are identical to materials reviewed and cleared under K963099 "Heelbo Pullover Poncho" and K963041 "Heelbo Life Jacket Poncho w/crotch Support." 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, over a fifteen year period using these materials, Heelbo Inc., is not aware of any adverse biological incidence.

8. Conclusion

Based upon the information presented above it is concluded that the proposed Heelbo Waist and Chest Vest is safe and effective for its intended use and is substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a symbol. The symbol is a stylized representation of a human figure, composed of three overlapping profiles facing right. The profiles are rendered in black, creating a sense of depth and unity.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 1998

Heelbo, Incorporated C/O Mr. Joseph S. Tokarz Manager, Regulatory Affairs Hollister Incorporated 2000 Hollister Drive Libertyville, Illionis 60048

K980640 Re : Heelbo Waist and Chest Vest Trade Name: Regulatory Class: I Product Code: FMO Dated: February 17, 1998 February 19, 1998 Received:

Dear Mr. Tokarz:

We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act): You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A ... substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 - Mr. Tokarz

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda/gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Heelbo, Inc. Waist and Chest Vest

Statement of Intended Use

510(k) Number (if Known): Device Name:

K980640 Waist and Chest Vest

Intended Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V (Per 21 CFR 801.109)

Over-the-Counter-Use _________________________________________________________________________________________________________________________________________________________

Brenda Burke

(Optional Format 1-2-96)

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number

Page 5

Regulation Number and Section

§ 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.