(92 days)
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No
The summary describes a device for delivering breathing gas in a hyperbaric chamber and makes no mention of AI or ML technology.
Yes
The device is described as a "Hood Driver" used with hyperbaric chambers for "hyperbaric oxygen therapy," which is a medical treatment. It is intended to permit the patient to breathe oxygen within the chamber, implying a direct role in patient therapy.
No
The device, a "Hood Driver," is described as supplying breathing gas to a patient within a hyperbaric chamber for treatment. It does not measure, analyze, or provide information about a patient's health status or disease. Its function is purely therapeutic assistance.
No
The device description clearly states it is a "Hood Driver" and describes a circuit designed to supply gas flow, indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for treating medical conditions using hyperbaric oxygen therapy within a hyperbaric chamber. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is a "Hood Driver" that supplies breathing gas to a patient inside a hyperbaric chamber. This is a component of a therapeutic system, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.), diagnostic testing, or providing information for diagnosis.
Therefore, the Model ODS1 - Hood Driver is a therapeutic device used in conjunction with a hyperbaric chamber, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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. Hyperbaric chambers are used for treating the indications as currently listed by the Undersea Hyperbaric & Medical Association for hyperbaric oxygen therapy.
Product codes
73CBF
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
0
OCT 23 1996
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 :
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- Supplies a steady flow of breathing gas to the breathing apparatus.
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- Controls a steady the exhaust flow from the breathing apparatus to chamber exterior.
1
- 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.
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- Requires minimal flow adjustments after initial setup.
- Same range of supply flow control: ODS1: 20 200 scfh 7. Lifeforce: 21 - 212 scfh
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- Works with oxygen or air.
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- Same wetted materials (Copper, Brass, Stainless-Steel)
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- 100% oxygen compatible softgoods
Differences
The significant differences between the ODS1 - Hood Driver and the Lifeforce breathing stations are as follows:
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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.
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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.