K Number
K043615
Device Name
OXYTEC, MODEL 900
Date Cleared
2005-02-09

(41 days)

Product Code
Regulation Number
868.5440
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The OxyTec 900 is intended for prescription use by patients requiring high concentrations of oxygen on a supplemental basis. It is small, portable and is capable of continuous use in the home, institutional, and travel / mobile environments.
Device Description
The OxyTec 900 is a small, portable oxygen concentrator which operates by pressure swing adsorption, molecular sieve. It has various flow rate settings, utilizes a conserver trigger method, and delivers 89% ± 3% pure oxygen. It is capable of continuous use in the home, institutional settings and mobile environments. It may be powered by 100-250 VAC, 12-14 VDC or batteries.
More Information

Not Found

No
The summary describes a standard oxygen concentrator with no mention of AI or ML features, training data, or performance metrics typically associated with AI/ML devices.

Yes

The device delivers pure oxygen to patients requiring high concentrations of oxygen on a supplemental basis, which directly addresses a physiological need for therapeutic purposes.

No

The device description indicates it is an oxygen concentrator that delivers pure oxygen to patients. This is a therapeutic device, not a diagnostic device which would typically identify or characterize a medical condition.

No

The device description clearly states it is a "small, portable oxygen concentrator" which operates using "pressure swing adsorption, molecular sieve" and delivers oxygen. This indicates a physical hardware device, not software only.

Based on the provided information, the OxyTec 900 is not an IVD (In Vitro Diagnostic) device.

Here's why:

  • Intended Use: The intended use is to provide supplemental oxygen to patients requiring high concentrations of oxygen. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
  • Device Description: The device description details its function as an oxygen concentrator, which is a medical device used for respiratory support. It does not describe any components or processes related to analyzing biological samples.
  • Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
    • Analyzing biological samples (blood, urine, tissue, etc.)
    • Detecting or measuring substances in biological samples
    • Providing information for diagnosis, monitoring, or prognosis of a disease or condition

The OxyTec 900 is clearly described as a device for delivering oxygen directly to a patient, which falls under the category of a therapeutic medical device, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

The OxyTec 900 is intended for prescription use by patients requiring high concentrations of oxygen on a supplemental basis. It is small, portable and is capable of continuous use in the home, institutional, and travel / mobile environments.

Product codes (comma separated list FDA assigned to the subject device)

CAW

Device Description

The OxyTec 900 is a small, portable oxygen concentrator which operates by pressure swing adsorption, molecular sieve. It has various flow rate settings, utilizes a conserver trigger method, and delivers 89% ± 3% pure oxygen. It is capable of continuous use in the home, institutional settings and mobile environments. It may be powered by 100-250 VAC, 12-14 VDC or batteries.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Home, Hospital, Sub-acute Institutions, Mobile environments

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

AirSep - LifeStyle - K020324

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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).

0

OxyTec 900

Summary of Safety and Effectiveness 3.1

K 043615

Non-Confidential Summary of Safety and Effectiveness

Page 1 of 2 December 28, 2004

| 5150 E. La Palma Ave.
Suite 203

Anaheim Hills, CA 92807Tel:(714) 701-9933
Fax:(714) 701-9931
Official Contact:Charles Atlas, President
Proprietary or Trade Name:OxyTec 900
Common/Usual Name:Portable oxygen generator (concentrator)
Classification Name:Portable oxygen generator
Device:OxyTec 900
Predicate Devices:AirSep - LifeStyle - K020324

Device Description:

OxyTec Medical Corp.

The OxyTec 900 is a small, portable oxygen concentrator which operates by pressure swing adsorption, molecular sieve. It has various flow rate settings, utilizes a conserver trigger method, and delivers 89% ± 3% pure oxygen. It is capable of continuous use in the home, institutional settings and mobile environments. It may be powered by 100-250 VAC, 12-14 VDC or batteries.

Indications:

| Indications for Use -- | The OxyTec 900 is intended for prescription use by patients
requiring high concentrations of oxygen on a supplemental
basis. It is small, portable and is capable of continuous use in
the home, institutional, and travel / mobile environments. |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Patient Population -- | Patients requiring supplemental oxygen. |
| Environment of Use -- | Home, Hospital, Sub-acute Institutions, Mobile environments |

1

...

Non-Confidential Summary of Safety and Effectiveness Page 2 of 2 December 28, 2004

Comparison to Predicate Devices:

OxyTec 900Predicate
Attributes
Indications for useThe OxyTec 900 is intended for prescription
use by patients requiring high concentrations of
oxygen on a supplemental basis. It is small,
portable and may be used in the home,
institutional, and travel / mobile environments.AirSep Lifestyle – K020324
Same
Environments of useHome, Hospital, Sub-acute Institutions,
Mobile environmentsSame
Patient PopulationPatients requiring supplemental oxygenSame
ContraindicationsNoneSame
Technology
Oxygen separationPSA - pressure swing adsorptionYes
Portable, battery
operatedYesYes
Oxygen purity89% $\pm$ 3%AirSep - 90% $\pm$ 3%
AlarmsVarious user alarmsYes
Variable flow settings
with pulsed dosesYesYes
Conserver integrated
in the systemYesYes

Differences Between Other Legally Marketed Predicate Devices

There are no significant differences between the proposed device, OxyTec 900 and the identified predicates.

2

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/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" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized lines forming its body and wings.

Public Health Service

FEB - 9 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OxyTec Medical Corporation C/O Mr. Paul E. Dryden President ProMedic, Incorporated 6329 W. Waterview Court McCordsville, Indiana 46055-9501

Re: K043615

Trade/Device Name: OxyTec 900 Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II Product Code: CAW Dated: December 29, 2004 Received: January 4, 2005

Dear Mr. Dryden:

We have reviewed your Section 510(k) premarket notification of intent to market the device w C nave roviewed your betermined the device is substantially equivalent (for the indications ferenced about and sure) to legally marketed predicate devices marketed in interstate 10 and caronior 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). and Oosmetier fore, market the device, subject to the general controls provisions of the Act. The I ou may, ateres, mains 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 If your de rice is classinod (voral controls. Existing major regulations affecting your device can may or subject to back acceral Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

3

Page 2 - Mr. Dryden

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be actived that I Drivisian 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 1 ou must compt 7 mixt an 2 1 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 1000: The reast notification. The FDA finding of substantial equivalence of your device to a s ro(ts) promatice nedicate 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 11 you atent office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other gottorers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Shin-Lian, 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

4

3.3 Indications for UsePage 1 of 1
510(k) Number:K043615 (To be assigned)
Device Name:OxyTec 900
Indications for Use:The OxyTec 900 is intended for prescription use by patients requiring high concentrations of oxygen on a supplemental basis.
It is small, portable and is capable of continuous use in the home, institutional, and travel / mobile environments.
Prescription Use XX (Per CFR 801.109)or Over-the-counter use

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ouu Sution

(Division Sign-Off) (Division Sign-Chi)
Division of Anesthesiology, General Hospital, ്. സംഖ്യാപരാഹരാമത്തിന്റെ സ്വീകര 643615

.

്‍10(k) Number ______________________________________________________________________________________________________________________________________________________________