(87 days)
Not Found
No
The device description details a system based on a cryogenic Dewar, regulators, and an electronic PCB that responds to breath rate thresholds with fixed increases in oxygen volume. This functionality is based on pre-programmed logic and does not involve learning or adaptive algorithms characteristic of AI/ML. The document explicitly states "Mentions AI, DNN, or ML: Not Found".
Yes
The device is intended to provide supplemental oxygen to patients, which is a therapeutic intervention for conditions like COPD.
No.
The device is described as a liquid oxygen portable unit that provides supplemental oxygen. Its functions involve storing, vaporizing, and dispensing oxygen, as well as tracking breath rate to adjust oxygen delivery. None of these functions are diagnostic in nature; they are therapeutic or supportive. The "Intended Use" explicitly states it provides "a source of supplemental oxygen."
No
The device description clearly outlines multiple hardware components including a Dewar, economizer regulator, electronic PCB, oxygen conserving system, and protective case. The performance studies also include bench testing and independent testing related to the physical device and its electrical safety and electromagnetic compatibility.
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 patients by vaporizing liquid oxygen and dispensing it. This is a therapeutic function, not a diagnostic one.
- Device Description: The description details a system for storing and delivering oxygen gas. It does not mention any components or processes related to testing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing information for diagnosis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that definition.
N/A
Intended Use / Indications for Use
The COPD Partners Model 300P Liquid Oxygen Portable will provide a source of supplemental oxygen for ambulatory home healthcare patients, by vaporizing medical grade liquid oxygen, and then dispensing it to the patient via an integral electronic conserving device. The Model 300P Liquid Oxygen Portable is neither a life-sustaining nor life-supporting device.
Product codes (comma separated list FDA assigned to the subject device)
BYJ
Device Description
The COPD Partners' Model 300P is a small, lightweight, liquid oxygen portable unit. The unit consists of a vacuum-insulated cryogenic Dewar, an economizer regulator, electronic printed circuit board (PCB), an oxygen conserving system, and a protective case.
The Dewar has a capacity and capability to store 0.33 liters of liquid oxygen. Dependant on the flow selection setting, the control system either delivers the oxygen to the conserving device or delivers a 2 LPM continuous flow directly to the oxygen outlet. The continuous flow setting is labeled CF on the flow method selector. The conserving device has an equivalent setting for 1, 2, 3, 4, and 5 LPM prescriptions. At the various conserving device settings, the outlet oxygen gas is delivered in quick pulses beginning at the start of inhalation.
The device also has a provision to track the patient's breath rate and in the event of an increase in breath rate, will deliver an increased volume of oxygen. There are two levels of increased volume, one at 4 breath per minute (BPM) over normal breath rate and another at 8 BPM over normal breath rate. The device delivers an extra 16 cc at each of these two thresholds. The COPD Partners Model 300P is transfilled from a commercially available medical grade liquid oxygen source.
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
ambulatory home healthcare patients
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)
Verification and Validation testing has been completed using the COPD Partners Model 300P Liquid Oxygen Portable to assure that the device meets the safety and performance requirements described in the specifications. This testing includes:
-
- Bench testing to verify that:
- a. Oxygen purity levels in the product specification are met.
- b. Safety mitigations as identified in the Model 300P risk assessment have been completed
- c. Oxygen delivery rate settings as defined in the product specification are met
-
- Independent testing and evaluation to verify that the Model 300P Liquid Oxygen Portable meets the requirements of:
- a. UL 60601-1-1:2005 Medical electrical equipment Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical system
- b. IEC 60601-1-2:2001 and A1-2004 Medical electrical equipment Part 1-2 : General requirements for safety - Section 2: Collateral standard: Electromagnetic compatibility - Requirements and tests.
All results of tests met the acceptance criteria. Testing demonstrates that the COPD Partners Model 300P Liquid Oxygen Portable performs at least as well and is as safe and as effective as the predicate Caire 300.
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.
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
§ 868.5655 Portable liquid oxygen unit.
(a)
Identification. A portable liquid oxygen unit is a portable, thermally insulated container of liquid oxygen that is intended to supplement gases to be inhaled by a patient, is sometimes accompanied by tubing and an oxygen mask. An empty portable liquid oxygen unit is a device, while the oxygen contained therein is a drug.(b)
Classification. Class II (performance standards).
0
Section 5 - 510(k) Summary
OCT 1 8 2007
510(k) Summary COPD Partners Model 300P Liquid Oxygen Portable
| Submitter | Richard J. Kocinski
COPD Partners, Inc.
1061 Main Street - #24
North Huntingdon, PA 15642
Phone: 724-861-5510
FAX: 724-861-5530
e-mail rkocinski@copdpartners.net |
|-------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared | 7-19-2007 |
| Device Trade Name | Model 300 P Liquid Oxygen Portable |
| Common Name | Portable Liquid Oxygen Unit |
| Classification | 868.5655 |
| Product Codes | BYJ |
| Predicate Device | Spirit 300
510(k) Number: K013251
Manufacturer:
Caire Inc.,
1800 Sandy Plains Industrial Parkway
Marietta, GA 30066 |
Intended use
The COPD Partners Model 300P Liquid Oxygen Portable will provide a source of supplemental oxygen for ambulatory home healthcare patients, by vaporizing medical grade liquid oxygen, and then dispensing it to the patient via an integral electronic conserving device. The Model 300P Liquid Oxygen Portable is neither a life-sustaining nor life-supporting device.
Device Description
The COPD Partners' Model 300P is a small, lightweight, liquid oxygen portable unit. The unit consists of a vacuum-insulated cryogenic Dewar, an economizer regulator, electronic printed circuit board (PCB), an oxygen conserving system, and a protective case.
The Dewar has a capacity and capability to store 0.33 liters of liquid oxygen. Dependant on the flow selection setting, the control system either delivers the oxygen to the conserving device or delivers a 2 LPM continuous flow directly to the oxygen outlet. The continuous flow setting is labeled CF on the flow method selector. The conserving
1
Section 5 - 510(k) Summary
device has an equivalent setting for 1, 2, 3, 4, and 5 LPM prescriptions. At the various conserving device settings, the outlet oxygen gas is delivered in quick pulses beginning at the start of inhalation.
The device also has a provision to track the patient's breath rate and in the event of an increase in breath rate, will deliver an increased volume of oxygen. There are two levels of increased volume, one at 4 breath per minute (BPM) over normal breath rate and another at 8 BPM over normal breath rate. The device delivers an extra 16 cc at each of these two thresholds. The COPD Partners Model 300P is transfilled from a commercially available medical grade liquid oxygen source.
Technological Characteristics as Compared to the Predicate
The COPD Partners 300P Liquid Oxygen portable is mechanically the same as the Caire Spirit 300 portable oxygen system. As such, the user interface and physical attributes are the same.
There are three primary differences:
- The method of delivering oxygen in the COPD Partners 300P Liquid Oxygen Portable has been optimized to deliver the required volume of 16 cc per L seting at a variable flow rate using two control valves to deliver the best flow rate based upon the patient's current breath rate and prescription setting. The Caire Spirit 300 uses a single control valve (flow) which delivers a fixed volume of 15 cc per L of prescription flow setting.
Additonally, the COPD Partners' Model 300P uses a relatively quick rise in breath rate as an indicator of need. When a rise of > 4 breaths per minute (BPM) in rate is noticed, the unit delivers an additional 16 cc of oxygen per breath, the equivalent to turning the knob up one setting. If the patient's BPM rises > 8 BPM, the conserver adds yet another 16 cc of O2 per breath. When the user drops below the 4 BPM threshold and returns to normal breathing, the volume is lowered to the normal setting volume. In this way, the device does not stay at a higher O2 delivery mode. which can happen when patients are adjusting their own settings. In effect, the COPD Partners' conserver attempts to automate an adjustment that is currently being done by the user in a manual process.
The Caire Spirit 300 does not have this capability.
- The 300P Liquid Oxygen System uses 4 AA batteries for an estimated 300 hours of battery life. The Caire Spirit 300 uses 2 C batteries for and estimated 500 hours of battery life. Since both systems have a low battery warning indicator and allow the patient to switch to a manual 2 LPM continuous flow setting if batteries are depleted, there is no change in safety of effectiveness of the COPD Partners 300P Liquid Oxygen Portable vs.
2
Section 5 - 510(k) Summary
the Caire Spirit 300 Portable.
- The COPD Partners model 300P does not have a 1.5 LPM flow rate setting. The bench testing for the revised conserver algorithm indicate the new algorithm is capable of covering this flow rate. No new patient safety issues have been identified
Summarv of Testing
Verification and Validation testing has been completed using the COPD Partners Model 300P Liquid Oxygen Portable to assure that the device meets the safety and performance requirements described in the specifications. This testing includes:
-
- Bench testing to verify that:
- a. Oxygen purity levels in the product specification are met.
- b. Safety mitigations as identified in the Model 300P risk assessment have been completed
- c. Oxygen delivery rate settings as defined in the product specification are met
-
- Independent testing and evaluation to verify that the Model 300P Liquid Oxygen Portable meets the requirements of:
- a. UL 60601-1-1:2005 Medical electrical equipment Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical system
- b. IEC 60601-1-2:2001 and A1-2004 Medical electrical equipment Part 1-2 : General requirements for safety - Section 2: Collateral standard: Electromagnetic compatibility - Requirements and tests.
All results of tests met the acceptance criteria. Testing demonstrates that the COPD Partners Model 300P Liquid Oxygen Portable performs at least as well and is as safe and as effective as the predicate Caire 300.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. In the center of the seal is an abstract image of a human figure with three arms or wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 8 2007
COPD Partners, Incorporated Mr. Paul Dryden Consultant ProMedic, Incorporated 3460 Pointe Creek Court, # 102 Bonita Springs, Florida 34134-2015
Re: K072011
Trade/Device Name: Model 300P Liquid Oxygen Portable Regulation Number: 21 CFR 868.5655 Regulation Name: Portable Liquid Oxygen Unit Regulatory Class: II Product Code: BYJ Dated: July 19, 2007 Received: July 23, 2007
Dear Mr. Dryden:
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.
4
Image /page/4/Picture/2 description: The image shows the logo for the Department of Health and Human Services, USA. The logo features a stylized image of an eagle with its wings spread, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle. The eagle is composed of three thick, curved lines that create the impression of feathers.
Page 2 - Mr. Dryden
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
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 Office of Compliance at (240) 276-0115. 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 Manufacturers, 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,
Synette Y. Michael Davis
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
5
Indications for Use
510(k) Number (if known):
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The COPD Partners Model 300P Liquid Oxygen Portable will provide a source of supplemental oxygen for ambulatory home healthcare patients, by vaporizing medical grade liquid oxygen, and then dispensing it to the patient via an integral electronic conserving device. The Model 300P Liquid Oxygen Portable is neither a life-sustaining nor life-supporting device.
Prescription Use XX (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)
Mill Holland
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K072011