(85 days)
The modified devices are intended solely for medical use in oxygen therapy programs under the supervision of a physician. This device is available by prescription only and is not intended to support or sustain life.
The modified devices are substantially equivalent to the predicate devices. Modifications were made to improve reliability, ease of assembly and serviceability The compressor was changed from a vertically oriented tension spring supported configuration to a horizontally oriented compression spring supported configuration to minimize damage from shipment and handling. The cabinet back was changed from a single part to two parts to simplify assembly and serviceability. Labeling was changed to increase type size for improved readability and to correct some clerical errors. The motor run capacitor was changed to a type that includes an internal protective device. The device circuit breaker was changed from a 10 A rating to a 5 A rating. The modified devices continue to be AC powered devices that provide a high level of inspired oxygen, using the same method as that of the predicate devices, by separating oxygen from ambient air with the pressure swing adsorption (PSA) process. Air is drawn into the device with a piston-type compressor and exposed to molecular sieve adsorbent that selectively retains nitrogen and other components that are released when the pressure is vented to the atmosphere. This cycle is controlled by an electronic valve and protected from over pressurization by the compressor's pressure relief valve. The device provides a nominal oxygen enriched gas concentration of 90% +6.5%/-3% at a flow rate of 5 l/min ±10%. The modified device is a durable, reusable, semi-portable unit weighing approximately 32 pounds [14.5 kg.]. The device is available in both 115V and 230V models. The device status indicators are the same as in the predicate devices: They are controlled by a printed circuit board which is device model specific. For the OCSI model, device status indicators are mains power and oxygen concentration. For the STD model, device status indicators are mains power and system pressure. The modified device is not life supporting, life sustaining or sterile. The modified devices may be used with one of the many legally marketed humidifiers, connecting tubing and nasal cannula as prescribed. Recommended accessory devices are described in the User's Guide. One of these devices may optionally be included with the device.
The provided document is a 510(k) summary for the Mark 5 Nuvo Lite OCSI and Mark 5 Nuvo Lite STD oxygen concentrators. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical or performance study against predefined metrics.
Therefore, most of the requested information (items 1-9) regarding acceptance criteria and a study to prove meeting those criteria is not directly applicable or available in this 510(k) summary. The summary details modifications made to existing predicate devices and argues for substantial equivalence based on technological characteristics and non-clinical performance (bench testing against relevant standards).
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not present explicit "acceptance criteria" in the traditional sense of a clinical trial or performance study with numerical targets. Instead, it compares the modified devices' characteristics to those of the predicate devices to demonstrate substantial equivalence. The "performance" is implicitly deemed acceptable if it matches or is within an acceptable range of the predicate device's performance, along with meeting certain non-clinical standards.
| Characteristic | Acceptance Criteria (Predicate Device) | Reported Device Performance (Modified Devices) |
|---|---|---|
| Intended Use | Intended solely for medical use inoxygen therapy programs under thesupervision of a physician. Thisdevice is available by prescriptiononly and is not intended to supportor sustain life. | Same as Predicate |
| Operating Life | 5 years | 3 years (This is a difference, not an acceptance criterion met. The rationale for acceptance despite this difference is based on overall substantial equivalence.) |
| Oxygen Concentration | 90% (±6.5/-3%)0.125 to 5 lpm | Same as Predicate |
| Oxygen Concentration Status Indicator | OSCI - YesSTD - No | Same as Predicate |
| Compressor | Self-lubricated piston typeVertical axis | Self-lubricated piston type;Horizontal axis |
| Compressor Support | Tension Steel SpringsVertical Axis | Compression Steel SpringsHorizontal Axis |
| Capacitor | P0 Class Protection per IEC 20252 | P2 Protection per IEC20252 |
| Circuit Breaker | 10 Amp | 5 Amp |
| Other Characteristics | (Refer to the table in the document for many others listed as "Same as Predicate") | Same as Predicate |
Notes on the "Acceptance Criteria" column: For a 510(k) demonstrating substantial equivalence, the "acceptance criteria" are generally that the modified device performs comparably to the predicate device, or that any differences do not raise new questions of safety or effectiveness. The values listed in the "Predicate Devices" column serve as the benchmark for comparison.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not applicable. This summary presents engineering and design changes and bench testing results, not a study with a "test set" of patients or clinical data. The "test set" implicitly refers to the modified device prototypes and components during iterative development and verification.
- Data Provenance: Not applicable in the context of clinical data. The data provenance relates to the non-clinical testing against standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Not applicable. As this is a 510(k) for device modifications and substantial equivalence, there is no mention of experts establishing a "ground truth" for a clinical test set. The determination of substantial equivalence is made by regulatory bodies (FDA) based on the submitted technical documentation and performance data against established standards and predicate devices.
4. Adjudication Method:
- Not applicable. No clinical test set or expert adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study was not done. These are oxygen concentrators, not diagnostic imaging devices where MRMC studies are common to assess human reader performance with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. These are medical devices with mechanical and electronic components, not AI algorithms. Performance testing focuses on the physical device's specifications (e.g., oxygen concentration, flow rate, safety features) rather than algorithm standalone performance.
7. The Type of Ground Truth Used:
- Not applicable in the sense of clinical ground truth (e.g., pathology, outcomes data). The "ground truth" for this submission is adherence to engineering specifications, safety standards (ISO 8359:1996, EN 60601-1-2:2001, IEC 60601-1:1988, UL 60601-1:2003, CAN/CSA-C22.2 No 601.1-M90), and comparability to the predicate device's established performance characteristics.
8. The Sample Size for the Training Set:
- Not applicable. This device does not involve machine learning or AI algorithms requiring training sets.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set for an AI algorithm.
Summary of the Study provided:
The "study" presented in this 510(k) is a non-clinical performance evaluation and comparison report. The manufacturer conducted various tests to ensure the modified devices continued to meet relevant safety and performance standards and were substantially equivalent to their predicate devices despite the changes.
- Non-Clinical Performance: "The device was tested to applicable requirements ISO 8359:1996, EN 60601-1-2:2001, IEC 60601-1:1988 + A1:1991 + A2:1995, UL 60601-1:2003, CAN/CSA-C22.2 No 601.1-M90, and FDA Reviewer Guidance document 'Excerpts Related to EMI from November 1993' as appropriate to the area of usage."
- Conclusion: "The modified devices include all the same or similar materials, operate with the same technology and demonstrate the same performance so are substantially equivalent to the legally marketed predicate devices."
This indicates that various bench tests and measurements were performed to verify that changes to components (compressor, capacitor, circuit breaker, etc.) did not negatively impact the overall performance (e.g., oxygen concentration, flow rate, noise level, operating ranges) or safety of the device when compared to the established performance of the predicate device and relevant industry standards.
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FEB 2 8 2013
.
510(k) Summary (Rev 12/21/12) б
| 510(k) Summary | This summary of 510(k) safety and effectiveness informationis being submitted in accordance with the requirements of 21CFR 807.92. | |
|---|---|---|
| Submitter | Nidek Medical Products, Inc.3949 Valley East Industrial DriveBirmingham, AL 35217Phone (205) 856-7200Fax (205)856-0533 | |
| SubmissionCorrespondent | Van MuthRegulatory AffairsNidek Medical Productslmuth@nidekmedical.comPhone (205) 856-7200 x242Fax (205)856-0533 | |
| Date Prepared | December 19, 2012 | |
| Trade Name | Modified Device #1 | Mark 5 Nuvo Lite OCSI |
| Modified Device #2 | Mark 5 Nuvo Lite STD | |
| Common Name | Oxygen Concentrator or Generator | |
| Classification Name | Generator, Oxygen Portable | |
| Regulation Number | 21CFR 868.5440 | |
| Class | II | |
| Panel | Anesthesiology | |
| Product Code | CAW | |
| Predicate Device #1 | Mark 5 Nuvo Lite OCSI oxygen concentrator cleared underK082566 on December 3, 2008 | |
| Predicate Device #2 | Mark 5 Nuvo Lite Std oxygen concentrator cleared underK082566 on December 3, 2008 | |
| PerformanceStandards | No applicable mandatory performance standards or specialcontrols have been established for this device under section514 of the Federal Food, Drug and Cosmetic Act. | |
| Indications for Use | The modified devices are intended solely for medical use inoxygen therapy programs under the supervision of aphysician. This device is available by prescription only andis not intended to support or sustain life.There has been no change to the intended use compared tothe predicate devices. | |
| Device Description | ||
| Device Description | The modified devices are substantially equivalent to the predicate devices. Modifications were made to improve reliability, ease of assembly and serviceability The compressor was changed from a vertically oriented tension spring supported configuration to a horizontally oriented compression spring supported configuration to minimize damage from shipment and handling. The cabinet back was changed from a single part to two parts to simplify assembly and serviceability. Labeling was changed to increase type size for improved readability and to correct some clerical errors. The motor run capacitor was changed to a type that includes an internal protective device. The device circuit breaker was changed from a 10 A rating to a 5 A rating. The modified devices continue to be AC powered devices that provide a high level of inspired oxygen, using the same method as that of the predicate devices, by separating oxygen from ambient air with the pressure swing adsorption (PSA) process. Air is drawn into the device with a piston-type compressor and exposed to molecular sieve adsorbent that selectively retains nitrogen and other components that are released when the pressure is vented to the atmosphere. This cycle is controlled by an electronic valve and protected from over pressurization by the compressor's pressure relief valve. The device provides a nominal oxygen enriched gas concentration of 90% +6.5%/-3% at a flow rate of 5 l/min ±10%. The modified device is a durable, reusable, semi-portable unit weighing approximately 32 pounds [14.5 kg.]. The device is available in both 115V and 230V models. The device status indicators are the same as in the predicate devices: They are controlled by a printed circuit board which is device model specific. For the OCSI model, device status indicators are mains power and oxygen concentration. For the STD model, device status indicators are mains power and system pressure. The modified device is not life supporting, life sustaining or sterile. The modified devices may be used with one of the many legally marketed humidifiers, connecting tubing and nasal cannula as prescribed. Recommended accessory devices are described in the User's Guide. One of these devices may optionally be included with the device. |
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6 510(k) SUMMARY (REV 12/21/12) CONTINUED
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| TechnologicalCharacteristics | The modified devices are substantially equivalent to thepredicate devices as they utilize the same technology currentlyused in the predicate Nuvo Lite concentrators.The following table indicates the similarities and differencesbetween the modified devices and the predicates: | ||
|---|---|---|---|
| Characteristic | Modified Devices#1 & #2Mark 5 Nuvo Lite | Predicate Devices#1 & #2Mark 5 Nuvo Lite | |
| Intended Use | Same as Predicate | Intended solely for medical use inoxygen therapy programs under thesupervision of a physician. Thisdevice is available by prescriptiononly and is not intended to supportor sustain life. | |
| Usage Environment | Same as Predicate | Home/Clinical | |
| Operating Life | 3 years | 5 years | |
| Oxygen Concentration | Same as Predicate | 90% (±6.5/-3%)0.125 to 5 Ipm | |
| Oxygen ConcentrationStatus Indicator | Same as Predicate | OSCI - YesSTD - No | |
| OperatingRanges | Same as Predicate | 40°F - 100°F(5°C - 40°C)up to 95% RH | |
| StorageRanges | Same as Predicate | -4°F - 140°F(-20°C - 60°C)up to 95% RH | |
| Over-TemperatureProtection | Same as Predicate | UL 547 Class B145 +/- 5°C | |
| Avg. PowerConsumption | Same as Predicate | 330 WATTS | |
| Input Power | Same as Predicate | 115V ~ 60 Hz | |
| Flow RegulationAssembly | Same as Predicate | Single-stage diaphragm pressurereducer | |
| Flow Settings | Same as Predicate | 0.125 to 5 lpm | |
| Flow Control | Same as Predicate | Flow Valve(12 positionorifice) | |
| Noise Level | Same as Predicate | 45 dBA | |
| Compressor | Self-lubricated piston type;Horizontal axis | Self-lubricated piston typeVertical axis | |
| Compressor Free Flow | Same as Predicate | 2.7 scfm / 76 l/m | |
| Compressor Support | Compression Steel SpringsHorizontal Axis | Tension Steel SpringsVertical Axis | |
| Compressor ReliefValve | Same as Predicate | 45 psig/310kPa | |
| Compressor Cooling | Same as Predicate | Tube-Axial Fan | |
| Characteristic | Modified Devices#1 & #2Mark 5 Nuvo Lite | Predicate Devices#1 Mark 5 Nuvo Lite | |
| Electric Motor | Same as Predicate | Inductive type | |
| Capacitor | P2 Protection per IEC20252 | P0 Class Protection per IEC 20252 | |
| Process Timing | Same as Predicate | Timer Printed Circuit Board | |
| Air Separation Module | Same as Predicate | Two beds | |
| Sieve Material | Same as Predicate | Zeochem synthetic zeolite | |
| Outlet Pressure | Same as Predicate | 7 psig/48kPa | |
| Filtration | Same as Predicate | Polyurethane foam 10 ppi cells,nominal 5 um inlet air filter, and0.3 µm bacterial filter | |
| Protective Enclosure | Same as Predicate | ABS thermoplasticUL-94 V0 | |
| Cabinet Dimensions | Same as Predicate | 14"W x 9"D x 23"H | |
| Weight | Same as Predicate | 32 lbs./14.5kg | |
| Wiring | Same as Predicate | Power cord, power on/off switch,& inter connecting lead wires | |
| Power Cord | Same as Predicate | 16 Ga/1.3mm PVC Sheath, Integral | |
| Power Plug | Same as Predicate | Two Blade, Polarized | |
| Circuit Breaker | 5 Amp | 10 Amp | |
| TubingMaterials | Same as Predicate | PVC, Aluminum, Silicone, &Polyurethane | |
| Labeling | Same as Predicate | English Text & Symbols | |
| Optional Accessories | Same as Predicate | Legally marketed nasal cannula,connecting tubing, & humidifiers | |
| Labeling | Same as Predicate | English Text & Symbols | |
| NonclinicalPerformance | The device was tested to applicable requirements ISO8359:1996, EN 60601-1-2:2001, IEC 60601-1:1988 + A1:1991+ A2:1995, UL 60601-1:2003, CAN/CSA-C22.2 No 601.1-M90, and FDA Reviewer Guidance document "ExcerptsRelated to EMI from November 1993" as appropriate to thearea of usage. | ||
| Conclusion | The modified devices include all the same or similar materials,operate with the same technology and demonstrate the sameperformance so are substantially equivalent to the legallymarketed predicate devices. |
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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three arms, representing health, services, and people. The figure is enclosed in a circle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 28, 2013
Mr. Van Muth Regulatory Affairs Nidek Medical Products, Incorporated 3949 Valley East Industrial Drive BIRMINGHAM AL 35217
Re: K123738
Trade/Device Name: Mark 5 Nuvo Lite OCSI, Mark 5 Nuvo Lite STD Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II Product Code: CAW Dated: January 21, 2013 Received: January 31, 2013
Dear Mr. Muth:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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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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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Kwame O. Ulmer
for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
5 STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known): Device Names:
Mark 5 Nuvo Lite OCSI Mark 5 Nuvo Lite STD
Indications for Use:
The modified devices are intended solely for medical use in oxygen therapy programs under the supervision of a physician. This device is available by prescription only and is not intended to support or sustain life.
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)
Lester V 2013.02.28
(Division Sign-Off) Division of Anesthesiology, General Hospi Infection Control, Dem
510(k) Number:
Page 1 of 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).