INOGEN SATELLITE CONSERVER

K033197 · Medical Electronic Devices, Inc. · NFB · May 13, 2004 · Anesthesiology

Device Facts

• Record ID: K033197
• Device Name: INOGEN SATELLITE CONSERVER
• Applicant: Medical Electronic Devices, Inc.
• Product Code: NFB · Anesthesiology
• Decision Date: May 13, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Inogen Satellite Conserver is intended for use to conserve oxygen for patients prescribed supplemental oxygen and use nasal cannulas and an oxygen concentrator.

Device Story

Inogen Satellite Conserver is a battery-operated, microprocessor-controlled oxygen conserver accessory for the Inogen One Oxygen Concentrator. Device connects to concentrator via oxygen supply tube; utilizes internal breath sensor and normally closed valve to detect onset of inhalation. Upon detection, device delivers oxygen bolus equivalent to 1-5 liters per minute constant flow, based on user-selected settings. Used by patients prescribed supplemental oxygen; operates via electronic control of oxygen delivery to conserve supply. Healthcare providers use device to manage oxygen therapy delivery; bolus delivery mechanism aims to improve patient oxygenation efficiency while extending concentrator utility.

Clinical Evidence

Bench testing only. Performance, mechanical, and electrical testing were conducted to verify device functionality and substantial equivalence to predicate devices.

Technological Characteristics

Battery-operated electronic device; microprocessor-controlled; includes breath sensor and normally closed valve. Connectivity via oxygen supply tube to Inogen One Oxygen Concentrator. Dosing algorithm based on 5 switch settings and supply pressure.

Indications for Use

Indicated for patients prescribed supplemental oxygen requiring use of nasal cannulas and an oxygen concentrator.

Regulatory Classification

Identification

A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.

Predicate Devices

• Medical Electronic Devices Corporation unmodified POCD (K023420)
• Airsep Lifestyle Oxygen Concentrator (K020324)

Reference Devices

• Inogen One Oxygen Concentrator (K032818)

Submission Summary (Full Text)

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KQ33197

# MED Corporation

# MAY 1 3 2004

# Special 510(K)

# 510(K) Summary

# Medical Electronic Devices Corporation

# Modified Medical Electronic Devices Corporation POCDE Pulsed Oxygen Conserving Device

October 1, 2003

#### Submitter Information:

Medical Electronic Devices Corporation 2807 Oregon Court, D6 Torrance, California 90503

| Submitter's Name: | Thomas Wenzel |
|-------------------|----------------|
| Phone: | [phone] |

#### Device Name:

| Proprietary Name: | Inogen Satellite Conserver |
|----------------------|----------------------------|
| Common Name: | Oxygen Conserver |
| Classification Name: | Noncontinuous Ventilator |

### Predicate Device Equivalence:

Substantial equivalence is claimed to the Medical Electronic Devices Corporation unmodified POCD a cleared for commercial distribution per K023420 and the Airsep Lifestyle Oxygen Concentrator K020324.

### Device Description:

Classification Name:

The Inogen Satellite Conserver intended to be used as an accessory to the Inogen One Oxygen Concentrator (K032818). The device uses the Inogen One Oxygen Concentrator as its oxygen supply and is connected by an oxygen supply tube. The Inogen Satellite Conserver is a battery operated electronic device that is microprocessor controlled and contains a breath sensor and normally closed valve. Upon detecting the beginning of inhalation, the device delivers a bolus of oxygen that is equivalent in most users to 1 to 5 liters per minute constant flow, depending on the flow setting.

#### Intended Use:

The Inogen Satellite Conserver is intended for use to conserve oxygen for patients prescribed supplemental oxygen and use nasal cannulas and an oxygen concentrator.

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#### Comparison of Technological Characteristics:

The Inogen Satellite Conserver has the same technological characteristics as the predicate device, i.e. the POCDEB. The electronic circuity of the device is identical to the POCDEs. There device, f.c. the POODE. The closeling and device enclosure needed to differentiate the two products.

The software has been modified in order to control the valve to deliver the appropriate size bolus of oxygen. This dosing algorithm is based on the 5 switch settings and the oxygen supply pressure of the Inogen One Oxygen Concentrator. This dosing algorithm is identical to the algorithm used in the predicate device, the Airsep Lifestyle Oxygen Concentrator.

#### Summary of Testing:

Appropriate performance, mechanical, and electrical testing was performed to demonstrate that the Inogen Satellite Conserver would perform as intended.

#### Conclusions:

Based on the above, we concluded that the Inogen Satellite Conserver is substantially equivalent to currently marketed devices and is safe and effective for its intended use.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 3 2004

Mr. Thomas Wenzel President Medical Eletronic Devices, Incorporated 2807 Oregon Court Unit D6 Torrance, CA 90503

Re: K033197

Trade Name: Inogen Oxygen Conserver Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: NFB Dated: March 5, 2004 Received: March 8, 2004

Dear Mr. Wenzel:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becarely be device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regard to the Medical Device Amendments, or to commerce prior to May 20, 1978, the encordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, utcretore, manol the Act include requirements for annual registration, listing of general controls provisions of the rece labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classimod (see aboro) ins. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations of P be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may be found in the Souce of Pources oncerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease oe advised that I Dris 155aanse over device complies with other requirements of the Act that IDA has made a decemmation administered by other Federal agencies. You must of ally rederal slatures and regalations and limited to: registration and listing (21

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Page 2 - Mr. Thomas Wenzel

CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as setting CFR Part 807); labeling (21 CFR Part 601); good manata 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Path 100-1050 forth in the quality systems (Sections 531-542 of the Act); 21 CFF 100-1050.
product radiation control provisions (Sections 531-542 of the Action Section 5 product radiation control provisions (Sections 95 device as described in your Section 510(k)
This letter will allow you to begin marketing your device of your device to legal This letter will allow you to begin marketing your anderice of your device to a legally
premarket notification. The FDA finding of substantial equivalence and this permits v premarket notification. The FDA iniding of substanted equile 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), please
rs the results of the most of the time of the reculetion entitled If you desire specific advice for your de 1100 01-4646. Also, please note the regulation entitled, contact the Office of Collipiance at [phone] (1217). You may obtain "Misbranding by reference to prematics notified. Virtual virus the Act from the Division of Small
other general information on your responsibilities under the Act from worker other general information on your responsion.com its toll-free number [phone] or
Manufacturers, International and Consumer Assistance at its toll-ifrememain html Manufacturers, International and Collibaner Prosis.
[phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html.

Sincerely yours,

Susa
Chiu Lin, Ph.D.

fo

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

Enclosure

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# Indications for Use

510(k) Number (if known): K033197

Device Name: Inogen Satelliite Conserver

Indications For Use: The Inogen Satellite Conserver is intended for use to conserve as parated for Indications I or Use. The mogen Octories Concert In Call cannulas and an oxygen concentrator.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ruwim

(Division Sign Off) Division of Anesthestology, General Hospital. Infection Control, Dental De

510(k) Number:

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