(725 days)
The LFY-I-5 Oxygen Concentrators are indicated fro the administration of supplemental oxygen. The LFY-I-5 Oxygen Concentrators are not intended for life support nor does it provide any patient monitoring capabilities.
The Longfei Model LFY-I-5 Oxygen concentrator is an electromechanical, prescription device designed for use in the home, by patients that require supplemental oxygen. Its intended function and use 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. Oxygen is delivered to the user by means of standard oxygen supply tubing and a standard nasal cannula, which are not supplied with the device. A standard humidifier bottle may be used, if desired. The front panel of the device contains the controls and indicators. These include a standard barb fitting for attaching the oxygen tubing, the adjustable flow meter, a power light indicator, an elapsed time meter, and a standard on/off rocker type power switch. The LFY-I-5 Oxygen concentrator is a 5-liter per minute oxygen concentrator that is of the pressure swing adsorption (PSA) type. The pneumatic system consists of 5 major components: inlet filtration, air compressor and heat exchanger, synthetic Zeolite molecular sieve beds and distribution value module, outlet filtration, and flow meter. The electrical system consists of AC power distribution to the air compressor and a motor with gear reduction used to drive the distribution valve; the unit is double insulated and uses a two-conductor power cable. Device monitoring circuit are included that monitor oxygen concentration. In the event of a malfunction, the unit will shut down and activate visual.
The provided document is a 510(k) summary for a medical device (Oxygen Concentrator), and therefore it does not contain the level of detail typically found in a clinical study report regarding acceptance criteria, performance metrics, and study design elements like sample size, ground truth establishment, or expert qualifications.
The 510(k) process is primarily focused on demonstrating substantial equivalence to a predicate device, rather than proving device performance against specific clinical acceptance criteria through a standalone study.
Here's what can be extracted and what cannot based on the provided text:
Acceptance Criteria and Device Performance:
The document indicates that the device "complies with the ASTM Standard Specifications for Oxygen concentrators for Domiciliary Use (Anesthesia) and the ISO standard 8359: 1996, Oxygen concentrators for Medical Use (Anesthesia)."
Compliance with these standards implicitly means meeting the performance criteria outlined within them. However, the document does not explicitly list the specific quantitative acceptance criteria or the reported device performance values against those criteria. It states that "Conformance or variance with these standards is described on the following pages," but those pages are not included in the provided text.
Therefore, a table of explicit acceptance criteria and reported device performance cannot be created from this document. The "device performance" in this context is the general statement of compliance with the mentioned standards.
Regarding the study proving the device meets acceptance criteria:
The document does not describe a specific clinical study designed to prove the device meets acceptance criteria in the manner usually associated with a standalone performance study. The 510(k) process for this type of device relies on demonstrating equivalence to a predicate device and compliance with recognized standards through engineering tests, rather than a prospective clinical trial with human subjects.
Given the nature of the device (an oxygen concentrator) and the regulatory pathway (510(k)), the "study" likely refers to bench testing and engineering verification to ensure the device meets the specifications outlined in the ASTM and ISO standards it claims to comply with.
Information that cannot be provided from the text:
The following information cannot be found in the provided 510(k) summary:
- Sample sized used for the test set and the data provenance: Not applicable in the context of this 510(k) submission, which relies on engineering and performance testing against standards rather than a clinical "test set" with human data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an oxygen concentrator's performance would be established through calibrated instruments and engineering measurements, not expert consensus on clinical data.
- Adjudication method: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This is completely irrelevant for an oxygen concentrator, which is not an AI-powered diagnostic imaging device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as it's not an algorithm-based device. Its performance is inherent in its electromechanical function.
- The type of ground truth used: As mentioned, ground truth would be based on precise physical measurements (e.g., oxygen concentration, flow rate) using calibrated equipment, not pathology, expert consensus, or outcomes data in the clinical sense.
- The sample size for the training set: Not applicable, as this is an electromechanical device, not a machine learning model requiring a training set.
- How the ground truth for the training set was established: Not applicable.
Summary based on the document:
The provided document, a 510(k) summary for an oxygen concentrator, indicates the device's compliance with established industry standards (ASTM and ISO). This compliance is the primary "proof" of its performance as required for 510(k) clearance. The document does not describe a clinical study or provide specific quantitative performance data or details about study design elements typically associated with clinical trials of diagnostic or AI-enabled software devices.
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Image /page/0/Picture/1 description: The image is a black and white logo. The logo features a circle with horizontal lines at the top and an abstract shape in the center that resembles a stylized bird or airplane. Below the circle, the word "LONGFE" is written in block letters. The overall design is simple and geometric.
OCT 1 8 2005
ng Longfei Industrial Co., L
338 Ningkang West Road, Yueqing, Zhejiang, P.R. China
II. 510(K) Summary
| Submitted by: | Zhejiang Longfei Industrial Co., Ltd. |
|---|---|
| No.338, Ningkang West Road, | |
| Yueqing 325600, Zhejiang, | |
| P.R.China | |
| Tel: 0086-21-52661572 | |
| Fax: 0086-21-52661040 | |
| Contact Person: | Ms. Coco Wang |
| Date Prepared: | 2003-10-08 |
| Proprietary Name: | Longfei LFY-I-5 Oxygen concentrator |
| Common Name: | Oxygen concentrator |
| Classification Name: | Portable Oxygen Generator (21 CFR 868.5440) |
| Predicate Device: | Invacare Platinum 5 Oxygen concentrator510(k) #K[020386] |
Description of the Device:
The Longfei Model LFY-I-5 Oxygen concentrator is an electromechanical, prescription device designed for use in the home, by patients that require supplemental oxygen. Its intended function and use 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.
Oxygen is delivered to the user by means of standard oxygen supply tubing and a standard nasal cannula, which are not supplied with the device. A standard humidifier bottle may be used, if desired.
The front panel of the device contains the controls and indicators. These include a standard barb fitting for attaching the oxygen tubing, the adjustable flow meter, a power light indicator, an elapsed time meter, and a standard on/off rocker type power switch.
Intended Use of the Device:
The LFY-I-5 Oxygen concentrator is a 5-liter per minute oxygen concentrator that is of the pressure swing adsorption (PSA) type. The pneumatic system consists of 5 major components: inlet filtration, air compressor and heat exchanger, synthetic Zeolite molecular sieve beds and
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Image /page/1/Picture/0 description: The image shows a logo with a circular design featuring horizontal lines and a stylized letter "Z" in the center. The logo is black and white, with the design appearing to be set against a solid background. Below the circular design, the word "LONGE" is written in a blocky, sans-serif font.
Zhejiang Longfei Industrial Co., Ltd.
No. 338 Ningkang West Road, Yueqing, Zhejiang, P.R. China
distribution value module, outlet filtration, and flow meter.
The electrical system consists of AC power distribution to the air compressor and a motor with gear reduction used to drive the distribution valve; the unit is double insulated and uses a two-conductor power cable. Device monitoring circuit are included that monitor oxygen concentration. In the event of a malfunction, the unit will shut down and activate visual.
The intended function and use 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.
Technological Characteristics:
The Longfei LFY-I-5 Oxygen concentrator complies with the ASTM Standard Specifications for Oxygen concentrators for Domiciliary Use (Anesthesia) and the ISO standard 8359: 1996, Oxygen concentrators for Medical Use (Anesthesia). Conformance or variance with these standards is described on the following pages.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three abstract shapes resembling human figures or birds in flight.
Public Health Service
OCT 1 8 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Coco Wang General Manager Zhejiang Longfei Industrial Company Limited Room 1202, No. 28 Building 2288 Caoyang Road Shanghai, CHINA 200333
Rc: K033405
Trade/Device Name: Model LFY-1-5 Oxygen Concentrators Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II Product Code: CAW Dated: August 1, 2005 Reccived: August 1, 2005
Dear Ms. Wang:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially cquivalent (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. Wang
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) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilitics 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,
Swa Runsey
Chiu Lin, Ph.D.
Director Division of Anesthesiology, Gencral 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: K033405
Device Name: Model LFY-I-5 Oxygen Concentrators
Indications For Use:
The LFY-I-5 Oxygen Concentrators are indicated fro the administration of supplemental The LT-T-F o Oxygon Contractors for life support nor does it provide any patient monitoring capabilities.
Prescription Use (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Melvin McDonald
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number K033405
§ 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).