(433 days)
Not Found
No
The description focuses on the physical process of oxygen concentration and does not mention any AI/ML components or functions.
Yes
The device is intended to provide supplemental oxygen to persons requiring oxygen therapy, which is a therapeutic intervention.
No
The device is an oxygen concentrator, intended to provide supplemental oxygen. It does not perform any diagnostic function.
No
The device description explicitly states it is a "medical device that produces concentrated oxygen from room air" using a "molecular sieve and a pressure differential absorption process," which are hardware components. The performance studies also mention "Mechanical / Climatic Device Performance Life test," further indicating a physical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide supplemental oxygen to persons requiring oxygen therapy." This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device "produces concentrated oxygen from room air." This describes a process of air separation and concentration, not the analysis of 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 screening of diseases or conditions.
The device is clearly described as a medical device for oxygen therapy, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The Precision Medical Concentrator is intended to provide supplemental oxygen to persons requiring oxygen therapy. The device is not intended to be life supporting or life sustaining. The concentrator is intended for use in the home or hospital institutional environment.
Product codes
CAW
Device Description
Precision Medical, Inc. Concentrator is a medical device that produces concentrated oxygen from room air. The concentrator uses a molecular sieve and a pressure differential absorption process to concentrate oxygen from air.
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 or hospital institutional environment
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
The Precision Medical, Inc. Oxygen Concentrator will successfully pass tests in the following areas;
- Mechanical / Climatic Device Performance Life test Alarm testing
Key Metrics
Oxygen%: 93% ±3%
Liter flow: 0.5 to 5.0 liters per minute
Flow accuracy: 10%or ±200ml
Operating temperature: 55 to 90 °F
Storage temperature: -30 to 140°F
Humidity: Up to 95% noncondensing
Power requirements: 120 vac ±10%, 450w 60 HZ
Power alarm: LED and audible
O2 concentration Alarm: LED and audible
Warm up time: ≤ 10 minutes
Dimensions: 29inches x 15 inches x 10 inches
Weight: ≤36lbs.
Sound level: 53.3dBA
Out let pressure: 5.0psi
Back pressure: 1.0psi
Out let gas temp: Max above abient 0.5°F or 0.3°C
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
OCT 2 7 2008
510(k) Summary Precision Medical, Inc. Oxygen concentrator
Submitter Information
Submitter
Contact
- Tel: Fax: Preparation Date:
Precision Medical, Inc. 300 Held Drive Northampton, Pa. 18067 James Parker Quality Assurance Manager (610)-262-6090 Extensions 228 (610)-262-6080 August 17, 2007
Device Name
Proprietary Name: Common Name: Classification Name: Classification Product Code: Regulation number:
Precision Oxygen Concentrator Oxygen concentrator Concentrator, oxygen CAW 868.5440
Predicate Device Equivalence
Precision Medical, Inc. is claiming substantial equivalence to the Respironics Oxygen concentrator ,L4 Manufactured by: Respironics Inc. 1001 Murry Ridge Lane. Murrysville, Pa 15668 510 K number: K061261
Device Description
Precision Medical, Inc. Concentrator is a medical device that produces concentrated oxygen from room air. The concentrator uses a molecular sieve and a pressure differential absorption process to concentrate oxygen from air.
Intended Use
The Precision Medical Concentrator is intended to provide supplemental oxygen to persons requiring oxygen therapy. The device is not intended to be life supporting or life sustaining. The concentrator is intended for use in the home or hospital institutional environment.
1
| Specifications | Respironics | Precision Medical | Precision medical test number | ISO 8359 :1996 Clause | Meets The requirement |
|---|---|---|---|---|---|
| Oxygen % | 93% ±3% | 93% ±3% | 731-1,22,23 | 8.1,50.4,50.5 | Meets requirements |
| Liter flow | 0.5 to 5.0 liters per minute | 0.5 to 5.0 liters per minute | 731-24 | 8.1,50.6,50.5 | Meets requirements |
| Flow accuracy | 10%or ±200ml | 731-14 | 8.1,50.3 | Meets requirements | |
| Operating temperature | 55 to 90 °F | 55 to 90 °F | 731-4A | 7-42.3 | Meets requirements |
| Storage temperature | -30 to 160°F | -30 to 140°F | 731-5 | 60601-1 Section 10.1 | Meets requirements |
| Humidity | Up to 95% noncondensing | Up to 95% noncondensing | 731-5 | 60601-1 Section 10.1 | Meets requirements |
| Power requirements | 120 vac ±10% | ||||
| 360w 60 HZ | 120 vac ±10% | ||||
| 450w 60 HZ | 731-15 | Meets requirements | |||
| Power alarm | LED and audible | LED and audible | 731-10 | Meets requirements | |
| O2 concentration Alarm | LED and audible | LED and audible | 731-10 | Meets requirements | |
| Warm up time | ≤ 10 minutes | ≤ 10 minutes | 731-1 | 8.1,50.4 | Meets requirements |
| Dimensions | 29inches x 15 inches x 10 inches | 29inches x 15 inches x 10 inches | 731-2 | na | |
| Weight | ≤31lbs. | ≤36lbs. | 731-2 | na | |
| Sound level | 45 dBA | 53.3dBA | 731-9 | 4.6,26.1 | Meets requirements |
| Out let pressure | 5.5psi | 5.0psi | 731-19 | 8.1,50.8 | Meets requirements |
| Back pressure | Unknown | 1.0psi | 731-20 | 8.1, 50.7 | Meets requirements |
| Out let gas temp | unknown | Max above abient 0.5°F or 0.3°C | 731-18 | 7,42.3 | Meets requirements |
Table of Comparisons to Predicate Device
Summary of Performance Testing
The Precision Medical, Inc. Oxygen Concentrator will successfully pass tests in the following areas;
- Mechanical / Climatic Device Performance Life test Alarm testing
Conclusions
In Summary, Precision Medical, Inc. has demonstrated that the Precision Medical, Inc. oxygen Concentrator is safe and effective. The combined testing and analysis of results provides assurance that the device meets the specifications and is safe and effective for the intended use.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services, USA. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. James Parker Quality Manager Precision Medical, Incorporated 300 Held Drive Northampton, Pennsylvania 18067
OCT 2 7 2008
Re: K072348
Trade/Device Name: Precision Medical Inc. Concentrator Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II Product Code: CAW Dated: October 17, 2008 Received: October 20, 2008
Dear Mr. Parker:
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.
3
Page 2 - Mr. Parker
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) 276-0115. 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,
CHSkomell-Rukins for U
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
Indications for Use
510(k) Number: K072348
Device Name: Precision Medical Inc. Concentrator
Indications For Use:
The Precision Medical Concentrator is intended to provide supplemental oxygen to persons requiring oxygen therapy. The device is not intended to be life supporting or life sustaining. The concentrator is intended for use in the home or hospital institutional environment.
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)
A. m, D
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
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510(k) Number: K072344