MARK 5 NUVO LITE OCSI, MARK 5 NUVO LITE STD

• K Number: K123738
• Device Name: MARK 5 NUVO LITE OCSI, MARK 5 NUVO LITE STD
• Manufacturer: NIDEK MEDICAL PRODUCTS, INC.
• Date Cleared: 2013-02-28 ( 85 days)
• Product Code: CAW
• Regulation Number: 868.5440

Intended 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.

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.

Predicate Devices

K082566, K082566

Reference Devices

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on mechanical and electrical modifications to improve reliability and serviceability of a standard oxygen concentrator using a PSA process. There is no mention of AI or ML.

Therapeutic

Yes.
The device is intended for medical use in oxygen therapy programs, indicating its role in treating medical conditions.

Diagnostic

No

The device is an oxygen concentrator used in oxygen therapy programs to provide oxygen, not to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device description clearly details physical components like a compressor, cabinet, motor run capacitor, circuit breaker, and a printed circuit board, indicating it is a hardware device with some electronic control.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is "solely for medical use in oxygen therapy programs under the supervision of a physician." This describes a therapeutic device used directly on a patient to provide oxygen, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
• Device Description: The description details an oxygen concentrator that separates oxygen from ambient air using a physical process (pressure swing adsorption). This is a functional device for delivering a gas, not a device for analyzing biological samples.
• Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
  • Analyzing biological specimens (blood, urine, tissue, etc.)
  • Providing diagnostic information
  • Using reagents or assays
  • Measuring biomarkers

The device is clearly described as a medical device used for oxygen therapy, which falls under a different regulatory category than In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Extract the following key information from the FDA summary:

• Intended Use / Indications for Use
• Product codes (comma separated list FDA assigned to the subject device)
• Device Description
• Mentions image processing
• Mentions AI, DNN, or ML
• Input Imaging Modality
• Anatomical Site
• Indicated Patient Age Range
• Intended User / Care Setting
• Description of the training set, sample size, data source, and annotation protocol
• Description of the test set, sample size, data source, and annotation protocol
• Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
• Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
• Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
• Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
• Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Instructions:

• Quote the text exactly as it appears in the document unless you are converting to human readable text.
• If the exact text is not available, summarize and infer based on the provided content without adding external commentary.
• Do not include any additional analysis, opinions, or explanations.
• If the document does not contain the information, respond with 'Not Found'. Do not make up information.
• Output the response in markdown format. Do not include any other commentary or backticks.
• Convert math markup like mathrm to human readable text.

Example output:

Intended Use / Indications for Use

...

Device Description

...

Predetermined Change Control Plan (PCCP) - All Relevant Information

...

Input:
0

FEB 2 8 2013

.

510(k) Summary (Rev 12/21/12) б

| 510(k) Summary | This summary of 510(k) safety and effectiveness information
is being submitted in accordance with the requirements of 21
CFR 807.92. | |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|
| Submitter | Nidek Medical Products, Inc.
3949 Valley East Industrial Drive
Birmingham, AL 35217
Phone [phone]
Fax [phone] | |
| Submission
Correspondent | Van Muth
Regulatory Affairs
Nidek Medical Products
[e-mail]
Phone [phone] x242
Fax [phone] | |
| 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 RY

Intended Use / 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.
There has been no change to the intended use compared to the predicate devices.

Product codes (comma separated list FDA assigned to the subject device)

CAW

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Home/Clinical

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K082566, K082566

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

0

FEB 2 8 2013

.

510(k) Summary (Rev 12/21/12) б

| 510(k) Summary | This summary of 510(k) safety and effectiveness information
is being submitted in accordance with the requirements of 21
CFR 807.92. | |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|
| Submitter | Nidek Medical Products, Inc.
3949 Valley East Industrial Drive
Birmingham, AL 35217
Phone [phone]
Fax [phone] | |
| Submission
Correspondent | Van Muth
Regulatory Affairs
Nidek Medical Products
[e-mail]
Phone [phone] x242
Fax [phone] | |
| 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 under
K082566 on December 3, 2008 | |
| Predicate Device #2 | Mark 5 Nuvo Lite Std oxygen concentrator cleared under
K082566 on December 3, 2008 | |
| Performance
Standards | No applicable mandatory performance standards or special
controls have been established for this device under section
514 of the Federal Food, Drug and Cosmetic Act. | |
| 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.
There has been no change to the intended use compared to
the 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. | |

1

6 510(k) SUMMARY (REV 12/21/12) CONTINUED

.

2

| Technological
Characteristics | The modified devices are substantially equivalent to the
predicate devices as they utilize the same technology currently
used in the predicate Nuvo Lite concentrators.
The following table indicates the similarities and differences
between the modified devices and the predicates: | | |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Characteristic | Modified Devices
#1 & #2
Mark 5 Nuvo Lite | Predicate Devices
#1 & #2
Mark 5 Nuvo Lite | |
| Intended Use | Same as Predicate | 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. | |
| 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 Concentration
Status Indicator | Same as Predicate | OSCI - Yes
STD - No | |
| Operating
Ranges | Same as Predicate | 40°F - 100°F
(5°C - 40°C)
up to 95% RH | |
| Storage
Ranges | Same as Predicate | -4°F - 140°F
(-20°C - 60°C)
up to 95% RH | |
| Over-Temperature
Protection | Same as Predicate | UL 547 Class B
145 +/- 5°C | |
| Avg. Power
Consumption | Same as Predicate | 330 WATTS | |
| Input Power | Same as Predicate | 115V ~ 60 Hz | |
| Flow Regulation
Assembly | Same as Predicate | Single-stage diaphragm pressure
reducer | |
| 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 type
Vertical axis | |
| Compressor Free Flow | Same as Predicate | 2.7 scfm / 76 l/m | |
| Compressor Support | Compression Steel Springs
Horizontal Axis | Tension Steel Springs
Vertical Axis | |
| Compressor Relief
Valve | Same as Predicate | 45 psig/310kPa | |
| Compressor Cooling | Same as Predicate | Tube-Axial Fan | |
| Characteristic | Modified Devices
#1 & #2
Mark 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, and
0.3 µm bacterial filter | |
| Protective Enclosure | Same as Predicate | ABS thermoplastic
UL-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 | |
| Tubing
Materials | 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 | |
| Nonclinical
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. | | |

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4

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.

5

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 [phone] or [phone] 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

6

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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.

K123738

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