(34 days)
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.
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.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the Drive Solstice Oxygen Concentrator:
The provided document is a 510(k) summary for the Drive Solstice Oxygen Concentrator. It primarily focuses on establishing substantial equivalence to a predicate device rather than presenting a standalone study of the device's performance against pre-defined acceptance criteria. Therefore, much of the requested information regarding acceptance criteria, study data, ground truth establishment, expert involvement, and sample sizes for testing and training sets is not explicitly present in this type of regulatory submission.
The document argues that the device meets acceptance criteria by demonstrating that it is substantially equivalent to a legally marketed predicate device (Zhongshan A&J Medical Equipment Co., Ltd's A&J-POCA01 Oxygen Concentrator - K071608). The underlying assumption is that if the predicate device met its acceptance criteria and the proposed device is equivalent, then the proposed device also meets those implied criteria.
Let's break down what can be inferred or is missing based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document does not explicitly state "acceptance criteria." Instead, it presents a comparison of specifications between the proposed device and two predicate devices. The acceptance criteria are implicitly the performance characteristics of the predicate device, which the proposed device must meet or be comparable to.
| Parameter | Acceptance Criteria (Implied from Predicate - Zhongshan A&J A&J-POCA01 K071608) | Reported Device Performance (Drive Solstice Oxygen Concentrator) |
|---|---|---|
| Oxygen Concentration | 1-5 LPM: 90% ± 3% | 1-5 LPM: 90% ± 3% |
| Delivery Rate | 1 to 5 LPM | 1 to 5 LPM |
| Outlet Pressure | 8.5 psig | 8.5 psig |
| Alarms | pressure relief / thermal protection on compressor, high / low pressure, power failure, low oxygen purity (optional), current overload shutdown | pressure relief / thermal protection on compressor, high / low pressure, power failure, low oxygen purity (optional), current overload shutdown |
| Electrical Rating | 115V/60Hz | 115V/60Hz |
| Power Consumption | 300W average | 300W average |
| Filters | Cabinet, intake, outlet HEPA filter | Cabinet, intake, outlet HEPA filter |
| Dimensions (in. L x W x H) | 12x14x20 | 12x14x20 |
| Weight (lbs) | 38 | 38 |
| Approvals | Class II equip, double insulated, Type B Applied Part | Class II equip, double insulated, Type B Applied Part |
| Operating System | Timed cycle / pressure swing | Timed cycle / pressure swing |
| Sound Level | 45~48dBA | 45~48dBA |
| Operating Environment | 50 to 95 deg. F, Humidity: 30% to 75% | 50 to 95 deg. F, Humidity: 30% to 75% |
| Valve | The dual solenoid, three-position, five-way valve increases shift efficiency, valve life, and reliability and comes with a lifetime warranty | The dual solenoid, three-position, five-way valve increases shift efficiency, valve life, and reliability and comes with a lifetime warranty |
| Compressor | GSE-280A compressor | GSE-280A compressor |
| Oxygen Sensor | Yes (Optional) | Yes (Optional) |
| HEPA Filter | Yes | Yes |
| ASTM 1464 | Meets Standard | Meets Standard |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable/not provided. This document does not describe a performance testing study with a "test set" in the traditional sense of a clinical or image-based AI study. The "test" here is a comparison of specifications to a predicate device.
- Data Provenance: Not applicable/not provided. The document states "Medical Depot claims the proposed device to be substantially equivalent to the device previously cleared by FDA in K071608." This implies the "data" is the set of specifications published or known for the predicate devices. There is no mention of country of origin for any new test data or whether it was retrospective or prospective, as no such new test data is presented for this device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable/not provided. There is no mention of experts establishing ground truth for a test set, as no such test set or study is described. The "ground truth," in this context, is the established performance and safety of the predicate device, which the FDA has already cleared based on its own review.
- Qualifications of Experts: Not applicable/not provided.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/not provided. No test set requiring expert adjudication is described in the 510(k) summary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or at least not described in this 510(k) summary. This type of study is typically associated with AI/medical imaging devices, assessing human reader performance with and without AI assistance. The device in question is an oxygen concentrator, a physical medical device, not a diagnostic AI tool.
- Effect Size: Not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
- Standalone Study: No, a standalone algorithm-only performance study was not done or described. This concept is most relevant for AI algorithms. For a physical device like an oxygen concentrator, performance is measured against its technical specifications (e.g., oxygen purity, flow rate, alarms). While the manufacturer would have performed internal testing to ensure the device met its specifications, this 510(k) summary does not detail those specific test results or methodology; instead, it relies on substantial equivalence.
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" implicitly used in this 510(k) submission is the established performance and safety of the legally marketed predicate device(s), specifically the Zhongshan A&J A&J-POCA01 Oxygen Concentrator (K071608). The manufacturer is asserting that their device is essentially identical in form, function, and materials, and therefore shares the same "truth" of being safe and effective.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable/not provided. This concept applies to machine learning models. The Drive Solstice Oxygen Concentrator is a physical device, not an algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment for Training Set: Not applicable/not provided. As the device is not an AI algorithm, there is no training set or ground truth associated with it in that context.
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510(K) SUMMARY (as required by 807.92(c))
MAR 1 8 2008
| Submitter of 510(k): | Medical Depot99 Seaview BlvdPort Washington, NY 11050USA |
|---|---|
| Phone: 877-224-0946Fax: 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.
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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 (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
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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
§ 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).