(54 days)
The L4 Oxygen Concentrator is intended to provide supplemental oxygen to persons requiring oxygen therapy. The device is not intended to be life supporting or life sustaining. For use in the home or hospital/institutional environment.
The Respironics L4 Oxygen Concentrator is a smaller and lighter medical device that produces concentrated oxygen from room air for delivery to a patient requiring oxygen therapy. Like its predicate the Respironics L4 Oxygen Concentrator uses molecular sieve and a pressure swing adsorption process to concentrate oxygen from air. The device is capable of providing oxygen flow up to 5 LPM and is offered with an optional Oxygen Percentage Indicator. Like its predicate, the Respironics L4 Oxygen Concentrator delivers oxygen to the patient via a nasal cannula.
The provided text is for a 510(k) premarket notification for the Respironics L4 Oxygen Concentrator. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical studies to prove effectiveness against predefined acceptance criteria for diagnostic performance. Therefore, the information requested regarding a clinical study with specific performance metrics, sample sizes for test and training sets, expert qualifications, and adjudication methods is not present in this document.
However, based on the provided text, here's what can be extracted and inferred regarding acceptance criteria and device performance in the context of this 510(k) submission:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implied for safety/effectiveness) | Reported Device Performance |
|---|---|
| Intended Use: Provide supplemental oxygen to persons requiring oxygen therapy (not life supporting/sustaining). For home or hospital/institutional environment. | Intended Use: Same as predicate device (stated on page 1). |
| Operating Principle: Concentrates oxygen from room air using molecular sieve and pressure swing adsorption. | Operating Principle: Same as predicate device (stated on page 1). |
| Technology: Use of molecular sieve and pressure swing adsorption. | Technology: Same as predicate device (stated on page 1). |
| Oxygen Flow: Capable of providing oxygen flow up to 5 LPM. | Oxygen Flow: Capable of providing oxygen flow up to 5 LPM (stated on page 1). |
| Physical Characteristics: Smaller and lighter. | Physical Characteristics: "Smaller and lighter medical device" (stated on page 1). |
| Safety: No impact on safety from modifications. | Safety: "modifications have no impact on the safety and effectiveness of the device" (stated on page 1). |
| Effectiveness: No impact on effectiveness from modifications. | Effectiveness: "modifications have no impact on the safety and effectiveness of the device" (stated on page 1). |
| Design Verification Tests: All tests meet required acceptance criteria. | Design Verification Tests: "All tests were verified to meet the required acceptance criteria" (stated on page 1). |
Explanation: In a 510(k) submission for a modified device, the "acceptance criteria" are primarily related to maintaining the safety and effectiveness of the predicate device and ensuring that the modifications do not negatively impact these aspects. The "reported device performance" is essentially that the modified device continues to meet the functional and safety expectations established by the predicate. The document states that design verification tests were performed and all met the required acceptance criteria, but it does not detail these specific criteria or their quantitative results.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not applicable/Not provided. This submission is for device modification and focuses on design verification, not a clinical trial with a "test set" in the sense of patient data. The "test set" here refers to engineering and quality assurance testing of the device itself.
- Data Provenance: Not applicable/Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Number of Experts: Not applicable/Not provided. Ground truth in this context would be engineering specifications and standards against which the device's performance attributes (e.g., oxygen concentration, flow rate, safety features) are measured, not expert medical opinion on patient data.
- Qualifications of Experts: Not applicable/Not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable/Not provided. Adjudication is typically used in clinical studies involving interpretation of data by multiple experts.
5. 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:
- MRMC Study: No. This is not an AI-enabled device or an imaging device requiring reader studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. This is not an algorithm/AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Type of Ground Truth: For a device like an oxygen concentrator, the "ground truth" for design verification would be engineering specifications, performance standards (e.g., for oxygen purity, flow rate, durability, electrical safety), and risk analyses. The device's performance would be measured against these predefined technical benchmarks. The document states "Design verification tests were performed... All tests were verified to meet the required acceptance criteria," implying these technical benchmarks serve as the ground truth.
8. The sample size for the training set:
- Sample Size: Not applicable/Not provided. This is not a machine learning device and therefore does not have a "training set" in that context.
9. How the ground truth for the training set was established:
- Ground Truth Establishment: Not applicable/Not provided, as there is no training set.
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Respironics L4 Oxygen Concentrator
TAB 3 510(K) SU ETY & EFFECTIVENE 【 S
| Official Contact | Zita A. YurkoManager, Regulatory AffairsRespironics, Inc.1001 Murry Ridge LaneMurrysville, PA 15668 |
|---|---|
| 724-387-4120724-387-4206 (fax)Email: Zita.Yurko@Respironics.com | |
| Classification Reference | 21 CFR 868.5440 |
| Product Code | CAW - Generator, Oxygen, Portable |
| Common/Usual Name | Oxygen Concentrator |
| Proprietary Name | Respironics L4 Oxygen Concentrator |
| Predicate Device(s) | Respironics "Twister" Oxygen Concentrator (K972614) |
| Reason for submission | Modified design. |
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Substantial Equivalence
The modified device has the following similarities to the previously cleared predicate device:
- O Same intended use.
- Same operating principle. ם
- 0 Same technology.
- D Same manufacturing process.
Design verification tests were performed on the Respironics L4 Oxygen Concentrator as a result of the risk analysis and product requirements. All tests were verified to meet the required acceptance criteria. Respironics has determined that the modifications have no impact on the safety and effectiveness of the device. In summary, the device described in this submission is substantially equivalent to the predicate devices.
Intended Use
The Respironics L4 Oxygen Concentrator is intended to provide supplemental oxygen to persons requiring oxygen therapy. The device is not intended to be life supporting or life sustaining.
The Respironics L4 Oxygen Concentrator is intended for use in the home or hospital/institutional environment.
Device Description
The Respironics L4 Oxygen Concentrator is a smaller and lighter medical device that produces concentrated oxygen from room air for delivery to a patient requiring oxygen therapy. Like its predicate the Respironics L4 Oxygen Concentrator uses molecular sieve and a pressure swing adsorption process to concentrate oxygen from air. The device is capable of providing oxygen flow up to 5 LPM and is offered with an optional Oxygen Percentage Indicator.
Like its predicate, the Respironics L4 Oxygen Concentrator delivers oxygen to the patient via a nasal cannula.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES" written around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Respironics, Incorporated Ms. Zita A. Yurko Manager, Regulatory Affairs Sleep & Home Respiratory Group 1001 Murry Ridge Lane Murrysville, Pennsylvania 15668
UN 2 8 2006
Re: K061261
Trade/Device Name: L4 Oxygen Concentrator Regulation Number: 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II Product Code: CAW Dated: June 7, 2006 Received: June 9. 2006
Dear Ms. Yurko:
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 (five the indications for use stated in the enclosure) to legally marketed predicate devires 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 offecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 10.0898. In addition. FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Yurko
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 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,
Oive
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
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Indications for Use
510(k) Number (if known): K061261
Device Name: L4 Oxygen Concentrator
Indications For Use: The L4 Oxygen Concentrator is intended to provide supplemental oxygen to persons requiring oxygen therapy. The device is not intended to be life supporting or life sustaining
For use in the home or hospital/institutional environment.
Prescription Use × (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)
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Page 1 of
§ 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).