DRIVE SOLSTICE OXYGEN CONCENTRATOR

K080391 · Medical Depot · CAW · Mar 18, 2008 · Anesthesiology

Device Facts

• Record ID: K080391
• Device Name: DRIVE SOLSTICE OXYGEN CONCENTRATOR
• Applicant: Medical Depot
• Product Code: CAW · Anesthesiology
• Decision Date: Mar 18, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5440
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

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 Story

Drive Solstice Oxygen Concentrator (models 18050, 18055) is a portable PSA (Pressure Swing Adsorption) oxygen generator. Device draws room air through intake filters into a piston-type compressor; compressed air is directed via pneumatic valve into one of two molecular sieve beds. Nitrogen is adsorbed under pressure; oxygen concentrates at bed top. Enriched oxygen (90% ± 3%) is regulated and delivered to patient at 1-5 LPM. Second bed simultaneously exhausts nitrogen as pressure decreases. Dual solenoid, three-position, five-way valve manages cycle. Used in clinical or home settings; operated by patient or caregiver. Output monitored via optional oxygen purity sensor. Safety features include pressure relief, thermal protection, high/low pressure alarms, and power failure alerts. Benefits patients by providing supplemental oxygen for respiratory disorders.

Clinical Evidence

Bench testing only. Device performance verified against ASTM 1464 standards. Comparative data provided for concentration levels (90% ± 3%), flow rates (1-5 LPM), outlet pressure (8.5 psig), and sound levels (45-48 dBA).

Technological Characteristics

PSA oxygen concentrator; molecular sieve adsorption material. GSE-280A compressor. Dual solenoid, three-position, five-way valve. Class II equipment, double insulated, Type B Applied Part. Meets ASTM 1464. Dimensions: 12x14x20 inches; weight: 38 lbs. Electrical: 115V/60Hz, 300W average. Filters: cabinet, intake, outlet HEPA.

Indications for Use

Indicated for patients with respiratory disorders requiring supplemental oxygen. Not intended for life support.

Regulatory Classification

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).

Predicate Devices

• Invacare Platinum 5 Oxygen Concentrator (K020386)
• A & J-POCA01 Oxygen Concentrator (K071608)

Submission Summary (Full Text)

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# 510(K) SUMMARY (as required by 807.92(c))

MAR 1 8 2008

| Submitter of 510(k): | Medical Depot<br>99 Seaview Blvd<br>Port Washington, NY 11050<br>USA |
|-------------------------|----------------------------------------------------------------------|
| | Phone: [phone]<br>Fax: [phone] |
| 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.

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#### 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.

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| 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 |

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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.

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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 [phone]. 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 [phone] or [phone] 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

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## 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