The Invacare TPOC Portable Oxygen Concentrator is intended to be used by patients with respiratory disorders who require supplemental oxygen. It supplies a high concentration of supplemental oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The Invacare TPOC Portable Oxygen Concentrator can be used in a home, institution, vehicle, and various mobile environments. The Invacare TPOC Portable Oxygen Concentrator does not nor is it intended to sustain or support life.

Device Description

The Invacare TPOC is to be used by patients with respiratory disorders who require supplemental oxygen. The device can be used in the home, an institution, vehicle and various mobile and outdoor environments. The device is not intended to sustain or support life. The device is typically used with a nasal cannula to direct oxygen from the device to the patient.

When set for Continuous Flow Mode, the TPOC can deliver up to 3 LPM continuous flow in 0.5 LPM increments. While in Pulse Delivery Mode, when the demand for oxygen is detected, the oxygen is delivered through pulsed flow with pulse flow settings of 1 through 5. The oxygen concentration level of the output gas ranges from 87% to 95.6% in all modes.

The modified TPOC contains an integrated oxygen sensor to provide added monitoring of the output gas purity, as well as additional patient warnings and alarms based on those levels. The oxygen sensor process uses a heated Zirconia element as the method of measurement. This is the exact same sensor process used in previously cleared oxygen concentrators such as the Invacare Platinum 5 Oxygen Concentrator, K020386.

With the addition of continuous flow, the TPOC is now capable of supporting two features commonly with the addition of ocultified no ne nextrators; usc with a humidification and use in conjunction with PAP, Bi-Level and other such devices as an oxygen bleed-in. The use of this equipment is only during continuous flow mode, as indicated in the User's Manual. odulphileit is only aaning othium battery pack, standard power options include switching power Anong with a rents from AC power outlet (120 VAC/ 60 Hertz nominal) and from accessory DC outlets typically found in a mobile vehicle type environment (12 VDC nominal).

The Invacare TPOC uses a molecular sieve and pressure swing adsorption methodology to produce the The in theater Tr C abber a nair enters the device, is filtered and then compressed. This compressed air is then directed toward one of two nitrogen adsorbing sieve beds. Concentrated oxygen exits the opposite end of the active sieve bed and is directed into an oxygen reservoir where it is delivered to the patient in specific volumes during the inhalation portion of a detected breath in pulse mode. In continuous flow mode, the operation is the same with the exception that the oxygen is delivered continuously, without the need for breath detection.

The basic technology of the Invacare TPOC is equivalent to its predicate device.

AI/ML Overview

This document describes the Invacare Transportable Oxygen Concentrator (TPOC, Model TPOC100) and its 510(k) summary, which essentially acts as a claim for substantial equivalence to a predicate device, the Invacare Flyer Oxygen Concentrator (K0719028).

There is no detailed study provided within the given text that explicitly describes acceptance criteria and then presents study results to prove those criteria were met for the Invacare TPOC.

The document states: "Performance Testing: The performance testing conducted as a result of the modifications to the Invacare Flyer, as required by the risk analysis, was performed and the results demonstrated that the predetermined acceptance criteria were met." However, it does not provide the specifics of these acceptance criteria or the study details.

Based only on the provided text, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Parameter	Acceptance Criteria (Inferred/Missing Details)	Reported Device Performance (Invacare TPOC100)
Intended Use	Matches predicate device.	Matches predicate device (Invacare Flyer).
Oxygen Purity	"87% minimum at all flow rates"	"87% minimum at all flow rates"
Flow Rates	Continuous: 0.5 - 3.0 LPM (0.5 LPM resolution)	Continuous: 0.5 - 3.0 LPM (0.5 LPM resolution)
	Pulse Flow: 1, 2, 3, 4, 5	Pulse Flow: 1, 2, 3, 4, 5
Method of Oxygen Release	Molecular sieve (mechanical)	Molecular sieve (mechanical)
Process of Oxygen Release	Pressure swing adsorption	Pressure swing adsorption
Sieve Bed Material	Synthetic zeolite	Synthetic zeolite
Software/Hardware	Analog and digital electronics with microprocessor	Analog and digital electronics with microprocessor
Flow Control	Microprocessor controlled valves	Microprocessor controlled valves
Oxygen Sensor	Yes (integrated for added monitoring)	Yes (integrated)
Weight	≤ 18.0 lbs. (without battery module or cart)	≤ 18.0 lbs. (without battery module or cart)
Power Options	AC (100-240 V, 50/60 Hz), DC (11-16 V)	AC (100-240 V, 50/60 Hz), DC (11-16 V)
Battery	Li-ion, 16.8 Volt, 15.6 Ah	Li-ion, 16.8 Volt, 15.6 Ah

Explanation: The "acceptance criteria" are implied by the performance characteristics listed for the device itself and against its predicate. The text explicitly states that "Performance Testing... was performed and the results demonstrated that the predetermined acceptance criteria were met," but it does not list those specific criteria or the detailed results of the tests. The table above largely compares the TPOC's specifications to the predicate and notes its own specifications as the "reported device performance."

Regarding the study proving the device meets the acceptance criteria:

The provided text only makes a general statement about performance testing, rather than describing a specific study with detailed methodology. Therefore, most of the following information is missing from the input text:

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

Missing. The document does not specify any sample size for a test set or the provenance of data. The "performance testing" mentioned is generic.

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 / Missing. This device is an oxygen concentrator, not an imaging or diagnostic device that would typically rely on expert human interpretation for ground truth establishment. Therefore, there would not be "experts" establishing ground truth in this context, but rather engineering/technical verification against specifications.

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

Not applicable / Missing. As above, this concept typically applies to studies where human reviewers are assessing data (e.g., medical images) and their agreement is critical for ground truth. It's not relevant to the performance testing of a physical medical device like an oxygen concentrator against its specifications.

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

No. This is not an AI-assisted diagnostic or interpretive device. An MRMC study would not be applicable to an oxygen concentrator.

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

Not applicable. This isn't an algorithm; it's a hardware device with embedded software. Its performance would inherently be "standalone" in terms of its mechanical and electronic functions. The "standalone" concept typically applies to pure AI/algorithm performance.

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

Inferred: The "ground truth" for oxygen concentrators meeting performance criteria is based on direct physical measurements against engineering specifications and validated test methods (e.g., oxygen concentration using a sensor, flow rate measurement, weight measurement, battery life tests, safety tests). The document mentions an integrated oxygen sensor and "predetermined acceptance criteria" from risk analysis, which implies such direct measurements.

8. The sample size for the training set

Not applicable/Missing. This device does not use a "training set" in the context of machine learning or AI. Performance testing involves demonstrating the device meets its specifications, not training an algorithm.

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

Not applicable/Missing. No training set is involved for this type of device.

Summary

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Image /page/0/Picture/0 description: The image shows the Invacare logo. The logo is in black and white and features the word "INVACARE" in bold, white letters against a black oval background. The oval has a curved line above and below the wordmark.

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510(K) SUMMARY FOR THE INVACARE TRANSPORTABLE OXYGEN CONCENTRATOR (TPOC)

This summary of 510(k) safety and effectiveness information is being supplied in accordance with the requirements of the SMDA of 1990 and 21 CFR 807.92

The assigned 510(k) number is_ 1( ひ ¥ 3 つく

Date: December 11, 2008

Submitted by: Invacare Corporation Registration No. 1525712 One Invacare Way Elyria, Ohio 44035-4190

Telephone: 440-326-6356 Fax: 440-326-3458

Contact Person: Mr. Carroll Martin

Trade Name: TPOC

Model: TPOC100

Common Name: Oxygen Concentrator

Classification Name: Generator, Oxygen, Portable per 21 CFR 868.5440

Legally Marketed Predicate Device(s): Invacare Flyer Oxygen Concentrator; K0719028, Dec 12, 2007.

Device Description: The Invacare TPOC is to be used by patients with respiratory disorders who require supplemental oxygen. The device can be used in the home, an institution, vehicle and various mobile and outdoor environments. The device is not intended to sustain or support life. The device is typically used with a nasal cannula to direct oxygen from the device to the patient.

INVACARE CORPORATION

One Invacare Way P.O. Box 4028 Elvria, OH 44036-2125 USA 440-329-6000 Fax: 440-366-1803 www.invaca

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Image /page/1/Picture/0 description: The image shows the Invacare logo. The logo is in black and white and features the word "INVACARE" in a bold, sans-serif font. The word is set inside of a black oval shape with white lines above and below the word. The logo is simple and recognizable.

The basic technology of the Invacare TPOC is equivalent to its predicate device.

Intended Use: The Invacare TPOC is intended to be used by patients with respiratory disorders who require supplemental oxygen. It supplies a high concentration of supplemental oxygen and is weed with a nasal cannula to channel oxygen from the concentrator to the patient. The Invacare TPOC can be used in a home, institution, vehicle, and various mobile environments. The Invacare TPOC does not nor is it intended to sustain or support life.

Features	Invacare TPOC100	Invacare Flyer
510(k) Number	TBD	K0719028
Date Cleared	TBD	12/12/2007
Intended Use	The Invacare TPOC is intended to beused by patients with respiratorydisorders who require supplementaloxygen. It supplies a high concentrationof supplemental oxygen and is used witha nasal cannula to channel oxygen fromthe concentrator to the patient. TheInvacare TPOC can be used in a home,institution, vehicle and various mobileenvironments. The Invacare TPOC doesnot nor is it intended to sustain orsupport life.	The Invacare Flyer is intended to beused by patients with respiratorydisorders who require supplementaloxygen. It supplies a highconcentration of supplemental oxygenand is used with a nasal cannula tochannel oxygen from the concentratorto the patient. The Invacare Flyer canbe used in a home, institution, vehicleand various mobile environments. TheInvacare Flyer does not nor is itintended to sustain or support life
Method by whichOxygen is Released	Molecular sieve (mechanical)	Molecular sieve (mechanical)

Substantial Equivalence:

VACARE CORPORATIC

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Image /page/2/Picture/0 description: The image shows the Invacare logo. The logo is in black and white and features the word "INVACARE" in a bold, sans-serif font. The word is placed inside of a black oval shape. The logo is simple and recognizable.

Process by whichOxygen is Released	Pressure swing adsorption	Pressure swing adsorption
Sieve Bed Material	Synthetic zeolite	Synthetic zeolite
Software/Hardware	Analog and digital electronics withmicroprocessor	Analog and digital electronics withmicroprocessor
Flow Control	Microprocessor controlled valves	Microprocessor controlled valves
Weight	≤ 18.0 lbs. (without battery module orcart)	≤ 7.0 lbs. (with internal battery)
Oxygen Purity	87% minimum at all flow rates	87% minimum at all flow rates
Oxygen Sensor	Yes	No
Flow Rates	Continuous flow rates of 0.5 - 3.0 LPM(0.5 LPM resolution)	No Continuous flow rate
	Pulse Flow - 1, 2, 3, 4, 5	Pulse Flow - 1, 2, 3, 4, 5
Power Options	AC power supply100-240 V, 50/60 Hz;DC power supply 11-16 V	AC power supply100-240 V, 50/60 Hz;DC power supply 11-16 V
Battery	Li-ion, 16.8 Volt, 15.6 Ah	Li-ion, 16.8 Volt, 5.2 Ah

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Performance Testing: The performance testing conducted as a result of the modifications to the Invacare Flyer, as required by the risk analysis, was performed and the results demonstrated that the predetermined acceptance criteria were met.

INVACARE CORPORATION

One Invacare Way P.O.Box 4028 Elyria, OH 44036-2125 USA 410-329-6000 Fax: 440-366-1803 www.invacare.com

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Carroll L. Martin, RAC Regulatory Manager Invacare Corporation One Invacare Way P.O. Box 4028 Elyria, Ohio 44036-2125

Re: K083751

Trade/Device Name: Invacare TPOC Portable Oxygen Concentrator Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II Product Code: CAW Dated: April 30, 2009 Received: May 4, 2009

MAY 2 1 2009

Dear Mr. Martin:

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 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.

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.

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Page 2- Mr. Martin

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 vours.

Susan Runner

Susan Runner, D.D.S., MA Acting 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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510(k) Number (if known): |کر 3 7 3 7 3 7 /

Device Name: Invacare TPOC Portable Oxygen Concentrator

Indications for Use: The Invacare TPOC Portable Oxygen Concentrator is intended to be used by patients with respiratory disorders who require supplemental oxygen. It supplies a high concentration of supplemental oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The Invacare TPOC Portable Oxygen Concentrator can be used in a home, institution, vehicle, and various mobile environments. The Invacare TPOC Portable Oxygen Concentrator does not nor is it intended to sustain or support life.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number: k 083751

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).