NURSE'S AID PATIENT ROTATION SYSTEM by AIR MED ASSIST PRODUCTS

This device is used to provide cushioning, torso support and totation (by manually-controlled alternating pressure) with pressure-relieving capabilities, as well as provide an aid to a nurse or other care-giver, in the home, we read foinical setting, to assist a patient in shifting their body position, to minimize possibility of bed sores, or other problems that can result from lying or sitting in one position for excessive periods of time.

Device Description

An air-flotation, alternating pressure mattress, with detachable electric pump/compressor, reuseable, with available washable/disposable mattress cover.

AI/ML Overview

The provided text describes a flotation mattress called "Nurse's Aid Patient Rotation System." This is a Class II medical device (Product Code: IOQ) intended to cushion patients, provide torso support and rotation with pressure-relieving capabilities, and assist caregivers in shifting a patient's body position to minimize issues like bed sores.

The submission is a 510(k) premarket notification, which aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. Therefore, the "acceptance criteria" here are actually the criteria for demonstrating substantial equivalence, and the "study" is the comparison made against the predicate devices.

Here's an analysis of the provided text based on your requested information points:

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

Since this is a 510(k) submission demonstrating substantial equivalence, the "acceptance criteria" are implied to be the characteristics and performance of the predicate devices. The "reported device performance" is the claim that the new device meets or is equivalent to these.

Acceptance Criterion (Implied from Predicate Devices)	Reported Device Performance
01. Device Name: Similar to predicate devices (K931594 and K933091)	Flotation mattress / Nurse's Aid Patient Rotation System
03. Description: Air-flotation, alternating pressure mattress, detachable electric pump/compressor, reusable, with available washable/disposable mattress cover. Similar to or better than predicate devices.	5.1, 5.2, 5.4, 06: "No substantive change in materials, basic components, or method of manufacture between this device and the predicate." "No change in basic construction." "The function and use of this product will be no different than that of the predicate devices." "There are no substantive differences between the products..."
04. Intended Use: To cushion patient; provide torso support/rotation with pressure-relieving capabilities; assist nurse/caregiver in shifting patient's body position; minimize bed sores, embolisms.	Indications For Use (Revised 01/05/98): "This device is used to provide cushioning, torso support and rotation (by manually-controlled alternating pressure) with pressure-relieving capabilities, as well as provide an aid to a nurse or other care-giver... to assist a patient in shifting their body position, to minimize possibility of bed sores..."
Safety: Materials/components used without patient problems in medical industry; compliant with EMC and safety standards.	5.1: "The raw materials/components used have been used in the medical (and water-boyancy) industry on similar/identical products and for similar/identical uses since pre-amendment, with no record of any patient problems, adverse reactions."5.3: "The device and its components have been tested by an independent lab for EMC and safety..."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This submission does not describe a formal clinical "test set" in the way one might for a novel diagnostic or therapeutic device. It is a substantial equivalence claim based on comparison to predicate devices, material safety, and independent lab testing for EMC and safety. Therefore, concepts like "sample size for the test set" or "data provenance" related to patient outcomes are not applicable in this type of submission. The "test set" is the device itself and its components, evaluated against known standards and predicate device characteristics.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The "ground truth" here is established by the characteristics and safety of the predicate devices and general medical practice regarding flotation mattresses. There is no mention of external experts used to establish a "ground truth" for a specific test set of this device. The FDA's review process itself involves expert evaluation by the Division of General and Restorative Devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There is no human-involved "test set" requiring adjudication or consensus for this type of substantial equivalence claim.

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 device is a physical medical mattress, not an AI-powered diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical medical mattress, not an algorithm. However, the device itself does function "standalone" in its ability to alternate pressure, cushion, and provide support, performing its intended function without continuous human intervention once set up. The "aid to a nurse or other care-giver" is about facilitating their tasks, not replacing judgment.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's substantial equivalence claim relies on:

Predicate Device Characteristics: The established design, function, and safety profile of the legally marketed predicate devices (K931594 and K933091).
Material Safety Data: Historical use of materials/components in the medical industry without adverse events.
Engineering and Safety Standards: Compliance with independent laboratory testing for EMC and safety (implied to be against recognized standards, though specific standards aren't listed).

8. The sample size for the training set

Not applicable. This is a physical device, not an AI or machine learning algorithm requiring a "training set."

9. How the ground truth for the training set was established

Not applicable, as there is no "training set" for this physical device.

Summary

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SUMMARY OF SAFETY AND EFFECTIVENE

JAN 2 1 1998

1. DEVICE NAME (Trade, common, and classification): Flotation mattress.
1. PREDICATE DEVICE(s): K931594 and K933091 submissions, attached, which were determined to be SE, and several others.
1. DESCRIPTION: An air-flotation, alternating pressure mattress, with detachable electric pump/compressor, reuseable, with available washable/disposable mattress cover.
1. INTENDED USE: To cushion patient, and provide torso support and rotation with _ pressure-relieving capabilities: to assist a nurse/other care giver in shifting a patient's body position, to minimize possibility of bed sores, embolisims, or other problems which can develop from lying in one position for prolonged periods.
1. We believe this submission should be found substantially equivalent by virtue of the following points, expanded upon elsewhere in this submission:
- 5.1. No substantitive change in materials, basic components, or method of manufacture between this device and the predicate; the raw materials/components used have been used in the medical (and water-boyancy) industry on similiar/identical products and for similiar/identical uses since pre-amendment, with no record of any patient problems, adverse reactions;
- 5.2. No change in basic construction;

ﺔ ﻣﻌﻬﺪ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪ

5.3. The device and its components have been tested by an independent lab for EMC and safety, and will be subjected to inspection/testing at IQA, and during/after manufacture and prior to release to the field: "Suitshasserverokening clease to CHO emergency procedures with large colored/labeled pullatag.
5.4. The function and use of this product will be no different than that of the predicate devices, and countless other similiar devices in the marketplace since pre-amendment.
1. There are no substantive differences between the products defined in this 510(k) submission and the predicate devices.

Signed: Dopong B.C. Hara Dated: 9-19-99

Tommy B. Haas, CEO/General Manager AIR MED ASSIST PRODUCTS LLC 1488 South State Street, Suite 100 Salt Lake City UT 84115 Phone: 801-463-6600

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Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines forming its body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The text is in all caps and is evenly spaced around the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

IAN 21 1998

Mr. Tommy B. Haas · CEO/General Manager Air Med Assist Products LLC 1488 South State Street, Suite 100 Salt Lake City, Utah 84115

Re: K973624 Nurse's Aid Patient Rotation System Regulatory Class: II Product Code: IOQ Dated: January 5, 1998 Received: January 6, 1998

Dear Mr. Haas:

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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with ---the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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 the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Tommy B. Haas

This letter will allow you to beqin 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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,

a M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1 ---

510(k) Number (if known): K973624

Device Name:_ Nurse's Aid Patient Rotation System

Indications For Use:

(Revised 01/05/98) ¨¨¨¨¨¨ ¨¨ ¨ ¨ ¨ ¨ ¨ ¨ ¨ ¨ ¨ ¨ ¨ ¨ ¨ ¨ ¨ ¨ ¨ ¨ ¨ ¨ ¨ ¨ ´

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	K973624

Prescription Use_XX (Per 21 CFR 801.109)

OR AND/

Over-The-Counter Use XX

(Optional Format 1-2-96)

Regulation Number and Section

§ 890.5170 Powered flotation therapy bed.

(a)
Identification. A powered flotation therapy bed is a device that is equipped with a mattress that contains a large volume of constantly moving water, air, mud, or sand. It is intended for medical purposes to treat or prevent a patient's bedsores, to treat severe or extensive burns, or to aid circulation. The mattress may be electrically heated.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.