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K Number
K962871
Device Name
ODS1 - HOOD DRIVER
Manufacturer
REIMERS SYSTEMS, INC.
Date Cleared
1996-10-23

(92 days)

Product Code
CBF
Regulation Number
868.5470
Type
Traditional
Panel
Anesthesiology
Reference & Predicate Devices
K951125
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Hyperbaric chambers are used for treating the indications as currently listed by the Undersea Hyperbaric & Medical Association for hyperbaric oxygen therapy.

Device Description

The Model ODS1 - Hood Driver is intended for use with monoplace hyperbaric chambers. It is normally used to permit the patient to breath oxygen while the chamber is pressurized on air. However, it can be used to supply the patient with any physiologically appropriate gas which may or may not be the same as the gas used to pressurize the chamber. The ODSI circuit is designed to supply a steady flow of breathing gas to the breathing apparatus used in the chamber. The breathing apparatus can be either a "Sea-Long" hood or a free-flow mask arrangement.

AI/ML Overview

The provided text is a 510(k) summary for a hyperbaric chamber breathing station (ODS1 Hood Driver). It does not contain information about acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, ground truth types, or training set details that would be found in a study proving a device meets acceptance criteria.

This document describes the device's function, its intended use, and compares it to a similar, already legally marketed device (Lifeforce Hyperbaric Chamber System) to demonstrate substantial equivalence. This is a regulatory submission, not a clinical study report.

Therefore, I cannot provide the requested information from the given text as it is not present.

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OCT 23 1996

K962871

REIMERS SYSTEMS, INC. 7668 FULLERTON ROAD SPRINGFIELD, VIRGINIA 22153

S. D. REIMERS PRESIDENT

510(k) SUMMARY - ODS1 HOOD DRIVER

TELEPHONE (703) 866-5490

TELECOPIER (703) 866-9066

July 18, 1996 DATE:

SUBMITTER: Stephen D. Reimers, PE President

  • CONTACT : Carlyle H. Smith, PE Staff Engineer

DEVICE INFORMATION:

Trade name: ODS1 - Hood Driver Hyperbaric Chamber Breathing Station Common name: Classification name: Chambers, Hyperbaric 73CBF

DESCRIPTION:

The Model ODS1 - Hood Driver is intended for use with monoplace hyperbaric chambers. It is normally used to permit the patient to breath oxygen while the chamber is pressurized on air. However, it can be used to supply the patient with any physiologically appropriate gas which may or may not be the same as the gas used to pressurize the chamber.

The ODSI circuit is designed to supply a steady flow of breathing gas to the breathing apparatus used in the chamber. The breathing apparatus can be either a "Sea-Long" hood or a free-flow mask arrangement.

INDICATIONS:

Hyperbaric chambers are used for treating the indications as currently listed by the Undersea Hyperbaric & Medical Association for hyperbaric oxygen therapy.

COMPARISON TO EXISTING EQUIPMENT:

Similarities:

The ODS1 is substantially equivalent to the breathing stations found in larger hyperbaric chamber systems, such as the Lifeforce Hyperbaric Chamber System (K951125) built by Reimers Engineering. They are similar in the following ways :

    1. Supplies a steady flow of breathing gas to the breathing apparatus.
    1. Controls a steady the exhaust flow from the breathing apparatus to chamber exterior.

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  • Can be used with both hoods and constant flow masks. 3.
  • Designed around standard 22 mm respiratory fittings. 4 .
  • Patient is adequately protected from suction injury caused by 5 . excessive exhaust flow or inadequate supply flow.
    1. Requires minimal flow adjustments after initial setup.
  • Same range of supply flow control: ODS1: 20 200 scfh 7. Lifeforce: 21 - 212 scfh
    1. Works with oxygen or air.
    1. Same wetted materials (Copper, Brass, Stainless-Steel)
    1. 100% oxygen compatible softgoods

Differences

The significant differences between the ODS1 - Hood Driver and the Lifeforce breathing stations are as follows:

  1. The Lifeforce breathing stations are located inside the chamber. The ODS1 controls can be placed inside or outside of the chamber. With the controls outside of the chamber, an outside attendant sets the controls instead of an inside attendant.

  2. The Lifeforce breathing stations contain an additional supply flowmeter and throttle valve for a separate nebulizer flow. The ODSI has only one supply flowmeter and throttle valve. The ODS1 can still be used with certain types of nebulizers if desired. However the additional dedicated nebulizer circuit has been found unnecessary for most monoplace chamber applications.

DISCUSSION:

Neither of these differences affect the safety or effectiveness of the ODS1 which is inherent in the circuit design. The differences are only related to the packaging of the circuit.

CONCLUSION:

The ODS1 - Hood Driver is substantially equivalent to existing, legally marketed devices.

§ 868.5470 Hyperbaric chamber.

(a)
Identification. A hyperbaric chamber is a device that is intended to increase the environmental oxygen pressure to promote the movement of oxygen from the environment to a patient's tissue by means of pressurization that is greater than atmospheric pressure. This device does not include topical oxygen chambers for extremities (§ 878.5650).(b)
Classification. Class II (performance standards).