The Model 306 iGo Portable Oxygen Concentrator System is indicated for the administration of supplemental oxygen. The device is not intended for life support, nor does it provide any patient monitoring capabilities.

Device Description

The model 306 Series oxygen concentrator system is a device that produces an oxygen enriched gas mixture by drawing in room air and extracting nitrogen, thus allowing oxygen to be delivered at a range of prescribed flows to patients with low oxygen saturation levels in the blood. The 306 Series is light weight and can operate on an external battery pack, features which allow the 306 Series to be readily transported by the patient. It has two operating modes: continuous product flow at up to 3 LPM and pulse dosage mode at settings of 1 to 6. In pulse dosage mode, the concentrator delivers a bolus of oxygen at each inhalation in an amount equal to 14cc times the setting value.

AI/ML Overview

The provided text describes a 510(k) submission for the DeVilbiss Portable Oxygen Concentrator System (Model 306 Series). It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a clinical study with detailed acceptance criteria and performance metrics in the way one might see for a diagnostic AI device.

Therefore, many of the requested categories (2, 3, 4, 5, 6, 7, 8, 9) are not applicable or cannot be extracted from this type of regulatory document. The primary "acceptance criteria" here relate to meeting established engineering and safety standards and demonstrating equivalent performance to the predicate device.

Here's the information that can be extracted, and where information is not available, it is noted:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Oxygen Concentration	No less than 91% +/- 3% enriched gaseous oxygen concentration	Met: Device generates "no less than 91% +/-3% enriched gaseous oxygen concentration"
Flow Rates	Delivers flow rates between 0.5 and 6 liters per minute	Met: Device delivers "flow rates between .5 and 6 liters per minute of oxygen"
Operating Modes	Continuous product flow up to 3 LPM; Pulse dosage mode at settings 1-6 (14cc per setting value per inhalation)	Met: Device has "two operating modes: continuous product flow at up to 3 LPM and pulse dosage mode at settings of 1 to 6. In pulse dosage mode, the concentrator delivers a bolus of oxygen at each inhalation in an amount equal to 14cc times the setting value."
Safety Standards	Tested and approved to recognized safety standards (ISO, ASTM, IEC, FDA Guidance)	Met: "This device has been tested to appropriate ISO, ASTM, and IEC standards and other applicable requirements passing all test protocols." The device "met the required performance criteria and functioned as intended."
Equivalence	Functionally equivalent to the existing legally marketed predicate device (Sequal Eclipse Portable Oxygen Concentrator - K013931)	Met: "The DeVilbiss Portable Oxygen Concentrator is equivalent in functional characteristics to the existing legally marketed predicate device." "Analysis of comparison of design, function and features... together with the results of testing demonstrates the device to be substantially equivalent to the predicate device."
New Technologies	No new technologies introduced	Met: "No new technologies have been introduced in the DeVilbiss Portable Oxygen Concentrator."

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

Not Applicable/Not Provided: This document describes non-clinical engineering and performance testing against standards and a predicate device, not a human-data-based clinical study test set.

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/Not Provided: Ground truth in the context of expert consensus is not relevant for this type of device submission. Performance is measured against engineering specifications and regulatory standards.

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

Not Applicable/Not Provided: This type of adjudication is for human expert agreement, which is not relevant here.

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 product is a portable oxygen concentrator, not an AI-assisted diagnostic tool.

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

Not Applicable: This product is a portable oxygen concentrator, not an algorithm.

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

For oxygen concentration and flow rates: Measured engineering specifications (e.g., sensor readings, flow meters).
For safety and performance: Compliance with recognized ISO, ASTM, IEC standards, and FDA guidance documents.

8. The sample size for the training set

Not Applicable/Not Provided: This document describes a medical device, not a machine learning model, so there is no "training set" in that context.

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

Not Applicable/Not Provided: As above, no training set for a machine learning model.

Summary

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Section 5.0 510(k) Summary

881468

Administrative Information and Device Identification

	AUG 2 5 2008
Name and address of the manufacturer andsponsor of the 510(k) submission:	Sunrise Medical100 Devilbiss DriveSomerset, PA 15501
FDA registration number of the manufacturerof the new device:	2515872
Official contact person for all correspondence:	Joseph E. OlsavskyVP – Global Quality & RegulatorySunrise Medical100 DeVilbiss DriveSomerset, PA 15501Phone: 814-443-7690Fax: 814-443-7597Email:joe.olsavsky@devilbisshc.com
Date Prepared:	May 15, 2008
Device Name:	DeVilbiss Portable OxygenConcentrator System
Proprietary name of new device:	DeVilbiss Portable OxygenConcentrator System
Common or usual name of the device:	Portable Oxygen Concentrator
DeVilbiss Model Number	Model 306 Series
Classification of the predicate device:	Class II
Classification of new device:	Class II
Classification Panel:	Anesthesiology
Panel Code:	CAW
CFR Regulation Number:	21 CFR 868.5440
Predicate Device Name(s) and 510(k)number(s):	Sequal Eclipse Portable OxygenConcentrator - K013931

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Description of Device:

Comparison of Device Technological Characteristics to Predicate Device:

This device has similar technological characteristics as the predicate device. The DeVilbiss Portable Oxygen Concentrator is equivalent in functional characteristics to the existing legally marketed predicate device. The device generates no less then 91% +/-3% enriched gaseous oxygen concentration by drawing in room air and extracting nitrogen. Both devices are tested and approved to recognized safety standards. No new technologies have been introduced in the DeVilbiss Portable Oxygen Concentrator. See Section 12.0.

Statement of Intended Use:

The DeVilbiss Portable Oxygen Concentrator is intended to provide supplemental oxygen to persons requiring low flow oxygen therapy. The patient typically receives the oxygen through a nasal cannula. The device delivers flow rates between .5 and 6 liters per minute of oxygen over 90% concentration. It is used at a patient's home or for their portable needs outside the home and can also be used in institutions such as nursing homes or subacute care facilities. Oxygen concentrators are not considered either life supporting or life sustaining. The device has no contraindications

Non-Clinical Testing:

This device has been tested to appropriate ISO, ASTM, and IEC standards and other applicable requirements passing all test protocols. The DeVilbiss Portable Oxygen Concentrator was designed and tested according to guidance outlined in:

1. FDA's Draft Reviewer Guidance for Premarket Notification Submissions -Anesthesiology and Respiratory Devices Branch; Division of Cardiovascular, Respiratory, and Neurological Devices (November 1993); and
1. FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005),

As suggested by FDA's November 1993 publication entitled "Reviewer Guidance for Premarket Notification Submissions – Anesthesiology and Respiratory Devices Branch; Division of Cardiovascular, Respiratory, and Neurological Devices" the DeVilbiss

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Portable Oxygen Concentrator was tested in accordance with the applicable voluntary standards. The DeVilbiss Portable Oxygen Concentrator met the required performance criteria and functioned as intended.

See Section 16.8, Section 17.0, Section 18.0 and Attachment B.

Statement of Safety and Effectiveness:

Analysis of comparison of design, function and features of the DeVilbiss Portable Oxygen Concentrator System to the Sequal Eclipse (K013931), together with the results of testing demonstrates the device to be substantially equivalent to the predicate device in terms of meeting performance criteria and functioning as intended.

Conclusion:

The DeVilbiss Portable Oxygen Concentrator System is substantially equivalent to the predicate device listed in this Summary and the device, as changed, does not rais to any new issues of safety and effectiveness.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a caduceus, rendered in black.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 5 2008

Mr. Joseph E. Olsavsky Vice President Global Quality and Regulatory Sunrise Medical DeVilbiss Healthcare 100 DeVilbiss Drive Somerset, Pennsylvania 15501

Re: K081468

Trade/Device Name: DeVilbiss Portable Oxygen Concentrator Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II Product Code: CAW Dated: May 22, 2008 Received: May 27, 2008

Dear Mr. Olsavsky:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) 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 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Olsavsky

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Cle
Chin-Lien, Ph.D.

Chiu Lin, Ph.D. 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):

Device Name: DeVilbiss Portable Oxygen Concentrator

Indications For Use:

Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices

510(k) Number: K081468

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Section 4.0-1

510(k) Number:

Regulation Number and Section

§ 868.5440 Portable oxygen generator.

(a)
Identification. A portable oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve).(b)
Classification. Class II (performance standards).