(155 days)
K0719028
No
The document describes standard oxygen concentration technology and mentions a breath detection mechanism for pulse mode, but there is no mention of AI or ML algorithms for this detection or any other function. The technology is stated to be equivalent to the predicate device.
Yes
The device is described as being "intended to be used by patients with respiratory disorders who require supplemental oxygen" and supplies a "high concentration of supplemental oxygen," indicating its use in treating a medical condition.
No
The device is an oxygen concentrator intended to provide supplemental oxygen to patients with respiratory disorders. Its function is therapeutic, delivering oxygen, rather than diagnostic, which would involve identifying or monitoring a medical condition.
No
The device description clearly details hardware components such as a molecular sieve, pressure swing adsorption methodology, oxygen sensor (heated Zirconia element), battery pack, and power options (AC/DC). It is a physical medical device that produces oxygen.
Based on the provided text, the Invacare TPOC Portable Oxygen Concentrator is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Invacare TPOC Function: The Invacare TPOC is a device that delivers oxygen to a patient with respiratory disorders. It does not analyze any biological specimens from the patient. Its function is to provide a therapeutic intervention (oxygen delivery), not to perform diagnostic testing on a sample.
The description clearly states its purpose is to "supply a high concentration of supplemental oxygen" and is "used with a nasal cannula to channel oxygen from the concentrator to the patient." This is a direct treatment/support function, not an in vitro diagnostic function.
N/A
Intended Use / Indications for 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 used 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.
Product codes
CAW
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.
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, institution, vehicle, and various 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)
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.
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.
K0719028
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.
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
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.
. .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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.
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.
INVACARE CORPORATION
One Invacare Way P.O. Box 4028 Elvria, OH 44036-2125 USA 440-329-6000 Fax: 440-366-1803 www.invaca
1
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.
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.
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 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 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. | The Invacare Flyer 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 Flyer can | ||
| be used in a home, institution, vehicle | ||
| and various mobile environments. The | ||
| Invacare Flyer does not nor is it | ||
| intended to sustain or support life | ||
| Method by which | ||
| Oxygen is Released | Molecular sieve (mechanical) | Molecular sieve (mechanical) |
Substantial Equivalence:
VACARE CORPORATIC
2
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 which
| Oxygen is Released | 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 |
| Weight | ≤ 18.0 lbs. (without battery module or | |
| cart) | ≤ 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 supply | |
| 100-240 V, 50/60 Hz; | ||
| DC power supply 11-16 V | AC power supply | |
| 100-240 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 |
, 花
やらなくないとい
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
3
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.
4
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
5
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