(34 days)
No
The description details a mechanical process (Pressure Swing Adsorption) for oxygen concentration and does not mention any computational or algorithmic components indicative of AI/ML. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".
Yes
The device is described as providing "supplemental oxygen to patients with respiratory disorders," which indicates a therapeutic purpose.
No
The device is an oxygen concentrator designed to provide supplemental oxygen to patients with respiratory disorders, which is a therapeutic function, not a diagnostic one. It separates nitrogen from room air to concentrate oxygen, it does not analyze or interpret any biological data to infer a condition.
No
The device description clearly outlines a hardware-based system involving compressors, filters, sieve beds, and pneumatic valves for oxygen concentration. There is no mention of software being the primary or sole component.
Based on the provided information, the Drive Solstice Oxygen Concentrator is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to provide supplemental oxygen to patients with respiratory disorders by separating nitrogen from room air. This is a therapeutic function, not a diagnostic one.
- Device Description: The description details a mechanical process of air separation using a molecular sieve. It does not involve analyzing biological samples (like blood, urine, or tissue) to diagnose a condition.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing biological samples.
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.
- Using reagents or assays.
The device is clearly designed to provide a medical treatment (oxygen therapy) directly to the 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 intended function and use of the Drive Solistice Oxygen Concentrator (models 18050 and 18055) is to provide supplemental oxygen to patients with respiratory disorders, by separating nitrogen from room air, by way of a molecular sieve. It is not intended to sustain or support life.
Product codes (comma separated list FDA assigned to the subject device)
CAW
Device Description
The Drive Solstice Oxygen Concentrator is a PSA (Pressure Swing Adsorption) system Oxygen Concentrator, the output of oxygen is 1 to 5 liter per minute. Room air enters the piston type compressor via a series of filters for removing dust particles. The output compressed air is directed by a pneumatic valve into one of the two sieve beds which is full of the adsorption material -molecular sieve. Nitrogen is adsorbed by the molecular sieve as the pressure increases; oxygen flows through the molecular sieve and concentrates at the sieve bed top. The enriched oxygen is divided into two streams; one stream enters a storage tank. The pressurized oxygen is regulated down to the suitable pressure, an adjustable flow meter and out to the patient. At the same time the second bed is in exhausted status, the molecular sieve desorbs nitrogen as the pressure decreases; another oxygen stream from first bed enters the top of the second bed, promotes purging the nitrogen and is exhausted into the atmosphere. Two sieve beds exchange the role of oxygen concentration and continue to produce 90% oxygen to the patient.
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
Not Found
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.
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
510(K) SUMMARY (as required by 807.92(c))
MAR 1 8 2008
| Submitter of 510(k): | Medical Depot
99 Seaview Blvd
Port Washington, NY 11050
USA |
|-------------------------|----------------------------------------------------------------------|
| | Phone: 877-224-0946
Fax: 516-998-4601 |
| Contact Person: | Randy Rosen |
| Date of Summary: | January 23, 2008 |
| Trade/Proprietary Name: | Drive Solstice Oxygen Concentrator |
| Classification Name: | Generator, Oxygen, Portable |
| Product Code: | CAW |
Intended Use:
The intended function and use of the Drive Solistice Oxygen Concentrator (models 18050 and 18055) is to provide supplemental oxygen to patients with respiratory disorders, by separating nitrogen from room air, by way of a molecular sieve. It is not intended to sustain or support life.
Device Description:
The Drive Solstice Oxygen Concentrator is a PSA (Pressure Swing Adsorption) system Oxygen Concentrator, the output of oxygen is 1 to 5 liter per minute. Room air enters the piston type compressor via a series of filters for removing dust particles. The output compressed air is directed by a pneumatic valve into one of the two sieve beds which is full of the adsorption material -molecular sieve. Nitrogen is adsorbed by the molecular sieve as the pressure increases; oxygen flows through the molecular sieve and concentrates at the sieve bed top. The enriched oxygen is divided into two streams; one stream enters a storage tank. The pressurized oxygen is regulated down to the suitable pressure, an adjustable flow meter and out to the patient. At the same time the second bed is in exhausted status, the molecular sieve desorbs nitrogen as the pressure decreases; another oxygen stream from first bed enters the top of the second bed, promotes purging the nitrogen and is exhausted into the atmosphere. Two sieve beds exchange the role of oxygen concentration and continue to produce 90% oxygen to the patient.
1
Predicate Device:
Invacare Platinum 5 Oxygen Concentrator - K020386 - Invacare Corporation A & J-POCA01 Oxygen Concentrator - K 071608 - Zhongshan A&J Medical Equipment Co., Ltd
Substantial Equivalence:
Medical Depot claims the proposed device to be substantially equivalent to the device previously cleared by FDA in K071608. Medical Depot claims this equivalence because the proposed device has an equivalent intended use, manufacturing materials, operating principles, and physical, operational specification as compared to the predicate device. The Medical Depot Concentrator is identical to this predicate device except for the labels
The similarities and differences between the proposed and predicate devices have been identified and explained in the Comparison Matrix which has been included in Section 9 of this submission. Additionally, this matrix is included as an attachment to the 510(k) summary. These differences have no effect on safety and effectiveness.
2
| Ver. 2.6.06 | |||
|---|---|---|---|
| mfg. | Invacare | Drive | Zhongshan A&J Medical |
| product name | Invacare Platinum XL 5- | Solstice | A&J-POCA01 Oxygen |
| Liter 02 Concentrator with | Concentrator | ||
| Sens 02 | |||
| model No. | IRC5LXO2 | 18050, 18055 | POCA01 |
| concentration | 95.6% to 87% at all flow | 1-5 LPM: 90% ± 3%) | 1-5 LPM: 90% ± 3%) |
| levels | rates | ||
| delivery rate | 0.5 to 5 LPM | 1 to 5 LPM | 1 to 5 LPM |
| Outlet pressure | 5 psi +/- 0.5 psi | 8.5 psig | 8.5 psig |
| alarms | battery-free power loss; | pressure relief / thermal | pressure relief / thermal |
| sieve performance; oxygen | protection on compressor | protection on compressor | |
| monitor; low-flow; | high / low pressure | high / low pressure | |
| compressor 35 psi pressure- | power failure | power failure | |
| releif valve | low oxygen purity(optional) | low oxygen purity(optional) | |
| current overload shoutdown | current overload shoutdown | ||
| electrical rating | 115V 60Hz | 115V/60Hz | 115V/60Hz |
| power | 4.3 amps average @ 5L/min. | 300W average | 300W average |
| consumption | (400W) | ||
| battery | |||
| filters | Cabinet, outlet HEPA, | Cabinet, intake,outlet HEPA | Cabinet, intake, outlet HEPA |
| compressor inlet | filter | filter | |
| dimensions | 14-3/8 x 18-3/8 x 26-3/8 | 12x14x20 | 12x14x20 |
| (in. L x W x H) | |||
| weight (lbs) | 51 | 38 | 38 |
| specs/ | |||
| standards | |||
| approvals | Class II equip | Class II equip | |
| double insulated | double insulated | ||
| Type B Applied Part | Type B Applied Part | ||
| operating | pressure based system | Timed cycle / pressure swing | Timed cycle / pressure swing |
| system | |||
| sound level | |||
| 50dBA avg | 45~48dBA | 45~48dBA | |
| operating | 50 to 95 deg. F, Humidity: | 50 to 95 deg. F, Humidity: | |
| environment | 30% to 75% | 30% to 75% | |
| warranty | 5 yrs | ||
| valve | unique designed (? Popet | The dual solenoid, three- | The dual solenoid, three- |
| style valve | position, five-way valve | position, five-way valve | |
| increases shift efficiency, | increases shift efficiency. | ||
| valve life, and reliability and | valve life, and reliability and | ||
| comes with a lifetime | comes with a lifetime | ||
| warranty | warranty | ||
| compressor | Thomas Based Double | GSE-280A compressor | GSE-280A compressor |
| wobble, may be chineese | |||
| made today | |||
| other | self-diagnostic electronics | ||
| compatible w/HomeFill II O2 | |||
| filling system | |||
| Oxygen Sensor | Yes (Optional) | Yes (Optional) | Yes (Optional) |
| HEPA Filter | Yes | Yes | Yes |
| ASTM 1464 | Meets Standard | Meets Standard | Meets Standard |
3
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, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 8 2008
Medical Depot C/O Mr. Daniel W. Lehtonen Responsible Third Party Official Intertek Testing Services NA, Incorporated 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087
Re: K080391
Trade/Device Name: Drive Solistice Oxygen Concentrator Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II Product Code: CAW Dated: March 3, 2008 Received: March 4, 2008
Dear Mr. Lehtonen:
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
Page 2 - Mr. Lehtonen
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.
Sautte y. Michie M.D.
Chin 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: Drive Solistice Oxygen Concentrator
Indications for Use:
The intended function and use of the Drive Solistice Oxygen Concentrator (models 18050 and 18055) is to provide supplemental oxygen to patients with respiratory disorders, by separating nitrogen from room air, by way of a molecular sieve. It is not intended to sustain or support life.
Thul
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Kolozal 510(k) Number:
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Drive Solstice Oxygen Concentrator Supplemental Response 1