A9800 ANESTHESIA WORKSTATION

K131790 · Oricare, Inc. · BSZ · May 9, 2014 · Anesthesiology

Device Facts

• Record ID: K131790
• Device Name: A9800 ANESTHESIA WORKSTATION
• Applicant: Oricare, Inc.
• Product Code: BSZ · Anesthesiology
• Decision Date: May 9, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5160
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The A9800 Anesthesia Workstation provides general inhalation anesthesia and ventilatory support for adolescents to adults in an operating room environment. The device is indicated for volume or pressure control ventilation.

Device Story

A9800 Anesthesia Workstation provides pneumatically driven, electronically controlled ventilation for anesthesia delivery. Inputs include medical gases (O2, Air, N2O) and patient respiratory signals; device transforms these via electronic flow meters and APL valve control to deliver precise tidal volumes and pressures. Output includes anesthetic gas delivery, ventilation support, and real-time monitoring of FiO2, CO2, N2O, anesthetic agents, and spirometry loops on a 15-inch touchscreen. Used in hospital operating rooms by licensed clinicians. Features include electronic flow meters for low-flow applications, an O2/Air blender for auxiliary gas, and data export to hospital EMR. Enhances patient safety through electronic PEEP regulation, hypoxic guard, and AGSS for waste gas removal. Clinicians use the interface to adjust ventilation modes (Volume, Pressure Control, Pressure Support, SIMV, PCV-VG) and review waveforms to guide intraoperative therapy.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including waveform analysis, simulated use validation, hardware unit testing (control boards, sensors, flow meters), life cycle testing for switches, and biological safety assessments (cytotoxicity, systemic toxicity, sensitization).

Technological Characteristics

Pneumatically driven, electronically controlled anesthesia workstation. Features 15-inch touchscreen, electronic flow meters, and APL valve. Connectivity includes data export to hospital IT/EMR. Complies with IEC 60601-1 (electrical/mechanical safety), IEC 60601-1-2 (EMC), IEC 60601-1-8 (alarms), and ISO 80601-2-13. Includes auxiliary O2/Air blender. Sterilization via high-level disinfection/autoclave for breathing circuit components.

Indications for Use

Indicated for adolescents to adults requiring general inhalation anesthesia and ventilatory support in an operating room environment. Supports volume or pressure control ventilation.

Regulatory Classification

Identification

A gas machine for anesthesia is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The device may include a gas flowmeter, vaporizer, ventilator, breathing circuit with bag, and emergency air supply. A gas machine for analgesia is a device used to administer to a patient an analgesic agent, such as a nitrous oxide-oxygen mixture (maximum concentration of 70 percent nitrous oxide).

Predicate Devices

• GE Datex-Ohmeda Avance (K123125)
• Mindray A5 Anesthesia Delivery System (K123211)
• Draeger Apollo US (K042607)

Submission Summary (Full Text)

{0}------------------------------------------------

MAY 0 9 2014 K131790

ORICARE™

1900 AM Drive
Quakertown, Pennsylvania 18951
[phone]

# 5 510(K) Summary

| 510 (K) Summary | | | | |
|-----------------|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|-----|
| 5.1 | Submitter/Owner | Oricare, Inc.<br>FDA #3009129579<br>1900 AM Drive<br>Quakertown, Pennsylvania 18951<br>[phone] Phone | | |
| 5.2 | Key Contacts | Kurtis Montegna<br>Quality Assurance & Regulatory Affairs Manager<br>[e-mail]<br>David Jamison<br>Executive VP<br>[e-mail] | | |
| 5.3 | Date Prepared | 06/13/2013 | | |
| 5.4 | 510(K) Submission Type | This is a traditional 510(K) | | |
| 5.5 | Prior Submissions | There have been no prior submissions to FDA about this device. | | |
| 5.6 | Trade Name | A9800 Anesthesia Workstation | | |
| 5.7 | Common Name | Anesthesia Workstation | | |
| 5.8 | Classification Name | Class II<br>BSZ<br>Panel 73: Anesthesiology<br>Subpart F: Therapeutic Devices<br>CFR 868.5160 Gas machine for anesthesia or analgesia | | |
| | | K123125 | GE Datex-Ohmeda Avance | BSZ |
| 5.9 | Predicate Devices | K123211 | Mindray A5 Anesthesia<br>Delivery System | BSZ |
| | | K042607 | Draeger Apollo US | BSZ |

:

The A9800 Anesthesia Workstation is substantially equivalent to the legally marketed (predicate) GE-Datex-Ohmeda Avance K123125, the Mindray A5 K123211, and the Draeger Appollo K042607.

Oricare, Inc.

FDA Device Registration Number 3009129579 – K131790

·

5-1 [phone], [e-mail], [e-mail]

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Image /page/1/Picture/0 description: The image shows the logo for Oricare, followed by the address 1900 AM Drive, Quakertown, Pennsylvania 18951. The phone number [phone] is listed below the address. The logo is in bold, black font.

#### 5.10 A9800 - Description of the device per 21 CFR 807.92(a) (4)

The A9800 Anesthesia Workstation provides accurate, pneumatically driven and electronically controlled ventilation. The A9800 includes modes that provide patient-appropriate defaults and ranges. The A9800 was rigorously tested to harmonized standards, which included a full human factors study with physicians.

Like the predicate device (K123125) A9800 provides complete anesthesia ventilation capabilities that include traditional and "intensive care type" ventilation modes. Low-flow anesthesia delivery creates savings by lower facility gas usage. The integrated electronic flow meter provides accurate monitoring and intuitive operation. The A9800 bellows contains breathing gasses to be delivered to the patient as does the predicate device. Likewise, for patient safety both the predicate and the A9800 maintain positive pressure in the breathing system so any leakage that occurs is outward. PEEP (Positive End Expiratory Pressure) in A9800 is electronically regulated for patient safety and is substantially equivalent to the predicate device. Both the A9800 and the predicate device offer an ACGO (alternate common gas outlet) to provide fresh gas to non-rebreathing adapters.

The A9800 and the predicate device (K123125) include the following ventilation modes: Volume Mode, Pressure Control Mode, Pressure Support Mode with Apnea Backup, Synchronized Intermittent Mandatory Ventilation Mode (SIMV), and Pressure Controlled Ventilation with Volume Guarantee (PCV-VG). The predicate offers SIMV-PCV-VG, which is not offered on the A9800. The A9800 method of control, of the maximum applied breathing pressure, during manual ventilation (by using a single turn APL valve along with a manual breathing bag) is equivalent to the predicate device.

Both the predicate device (K123125) and the A9800 have an accessory gas analyzer that can monitor FiO2 and patient respiratory gas for CO2, N2O, and five types of anesthetic agents. A9800 and the predicate also have an Anesthetic Gas Scavenging System (AGSS) for the safe and effective removal of waste gas.

Both the predicate device (K123125) and the A9800 utilize a large 15 inch touch screen monitor with a navigator wheel that provides a simple intuitive interface for user control. The screen can be tilted upward and downward according to the doctor's needs and position. The parameter areas on the main screen are shown in different colors for ease of identification. The waveforms and alarm records are clearly shown for easy review by the clinician.

Like the predicate device (K123125) the A9800 displays patient data with waveforms and spirometry loops. A reference loop can be stored to best understand changes in patient response to therapy. Both the A9800 and its predicate device (K123125) contain electronic flow meters for Oz, Air, and NzO, which are designed especially for low flow applications. Electronic fresh gas flow displays are used in addition to traditional mechanical flow controllers for enhanced patient safety. Data communications export is supported to connect to the Hospital IT systems and support electronic medical records (EMR).

Oricare, Inc.

FDA Device Registration Number 3009129579 - K131790

5-2 [phone], [e-mail], [e-mail]

5

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# Quakertown, Pennsylvania 18951 [phone]

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| 5.11 Intended Use as required by 807.92(a)(5) | | | | | |
|--------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|
| Item of comparison | GE Avance Predicate | Mindray A5 Predicate | Draeger Apollo Predicate | Oricare A9800 Current Submission | Substantial Equivalence |
| Intended use | The GE-Datex Avance CS2 Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The device is intended for volume or pressure control ventilation. | The A5/A3 Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic, and to maintain a patient's ventilation. The A5/A3 is intended for use by licensed clinicians, for patients requiring anesthesia within a health care facility, and can be used for adult and pediatric populations. | The Apollo is indicated as a continuous flow anesthesia system. The Apollo may be used for manually assisted or automatic ventilation, delivery of gases and anesthetic vapor, and monitoring of oxygen and CO2 concentration, breathing pressure, respiratory volume, and anesthetic agent concentration and identification. | The A9800 Anesthesia Workstation provides general inhalation anesthesia and ventilatory support for adolescents to adults in an operating room environment. The device is indicated for volume or pressure control ventilation. | No Difference SE |
| Indications for Use | The GE-Datex Avance CS2 Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The device is intended for volume or pressure control ventilation. | The A5/A3 Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic, and to maintain a patient's ventilation. The A5/A3 is intended for use by licensed clinicians, for patients requiring anesthesia within a health care facility, and can be used for adult and pediatric populations. | The Apollo is indicated as a continuous flow anesthesia system. The Apollo may be used for manually assisted or automatic ventilation, delivery of gases and anesthetic vapor, and monitoring of oxygen and CO2 concentration, breathing pressure, respiratory volume, and anesthetic agent concentration and identification. | The A9800 Anesthesia Workstation provides general inhalation anesthesia and ventilatory support for adolescents to adults in an operating room environment. The device is indicated for volume or pressure control ventilation. | No Difference SE |
| 5.12 Primary Predicate Device Comparison Table - Physical Specifications | | | | | |
| Item of comparison | GE Avance Predicate | Mindray A5 Predicate | Draeger Apollo Predicate | Oricare A9800 Current Submission | Substantial Equivalence |
| Target Population | Neonatal, pediatric, adult | Pediatric, Adult | Neonatal, pediatric, adult | Adolescent to Adult | No Difference - SE |
| Anatomical Sites | No patient contacting parts | No patient contacting parts | No patient contacting parts | No patient contacting parts | No Difference - SE |
| Where Used | Hospital Environment | Hospital Environment | Hospital Environment | Hospital Environment | No Difference - SE |
| Power | AC Power/DC Backup | AC Power/DC Backup | AC Power/DC Backup | AC Power/DC Backup | No Difference - SE |
| Human Factors | Tested | Tested | Tested | Tested | No Difference - SE |
| Electrical Safety | ISO 60601-1 | ISO 60601-1 | ISO 60601-1 | ISO 60601-1 | No Difference - SE |
| Mechanical Safety | ISO 60601-1 | ISO 60601-1 | ISO 60601-1 | ISO 60601-1 | No Difference - SE |
| Chemical safety | NA | NA | NA | NA | No Difference - SE |
| Thermal Safety | NA | NA | NA | NA | No Difference - SE |
| Radiation Safety | NA | NA | NA | NA | No Difference - SE |
| Height | 53 inches | 55 inches | 59 inches | 56 inches | Substantially Equivalent |
| Width | 28 inches | 41 inches | 33 inches | 36 inches | Substantially Equivalent |
| Depth | 29 inches | 31 inches | 31 inches | 30 inches | Substantially Equivalent |
| 5.12 Primary Predicate Device Comparison Table - Physical Specifications (Continued) | | | | | |
| Item of comparison | GE Avance<br>Predicate | Mindray A5<br>Predicate | Draeger Apollo<br>Predicate | Oricare A9800<br>Current<br>Submission | Substantial Equivalence |
| Weight | 275 pounds | 330 pounds | 363 pounds | 287 pounds | Substantially Equivalent |
| Operating Temp | 50-100 °F | 50-104 °F | 59-104 °F | 50-104 °F | Substantially Equivalent |
| Operating Humidity | Less than 95%<br>RH | 15-90% Non-<br>condensating | 25-85% Non-<br>condensating | 15-90% Non-<br>condensating | Substantially Equivalent |
| Top Shelf Width | 26 inches | 24 inches | 24 inches | 25.5 inches | Substantially Equivalent |
| Top Shelf Depth | 15.75 inches | 14 inches | 20 inches | 15 inches | Substantially Equivalent |
| Top shelf Weight Limit | 75 pounds | 88 pounds | 100 | 55 pounds | Substantially Equivalent |
| Work Surface Height | 32 inches | 33 inches | Not Specified | 33 inches | Substantially Equivalent |
| Work Surface | 409 in² | 364 in² | 234 in² | 319 in² | Substantially Equivalent |
| Din Rail | Yes | Yes | Yes | Yes | Substantially Equivalent |
| Drawers | 2 | 2 | 3 | 3 | Substantially Equivalent |
| Drawer Height | 6.9 inches | 5.3 inches | Not Specified | 5.1 inches | Substantially Equivalent |
| Drawer Width | 13 inches | 17.3 inches | Not Specified | 19.4 inches | Substantially Equivalent |
| Drawer Depth | 10.4 inches | 15.1 inches | Not Specified | 13.8 inches | Substantially Equivalent |
| Total Storage (all drawers) | 1866 in³ | 2769 in³ | Not Specified | 4096 in³ | Substantially Equivalent |
| Casters | 4 | 4 | 4 | 4 | Substantially Equivalent |
| Brakes | Central Brake<br>for Casters | Central Brake for<br>Casters | Central Brake for<br>Casters | Locking front<br>casters | Substantially Equivalent |

Oricare, Inc.

FDA Device Registration Number 3009129579 – K131790

5-3 [phone], [e-mail], [e-mail]

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Image /page/3/Picture/0 description: The image shows the word "ORICARE" in large, bold, black letters. Below the word is the address "1900 AM Drive, Quakertown, Pennsylvania 18951" and the phone number "[phone]". The address and phone number are in a smaller font size than the word "ORICARE".

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______________________________________________________________________________________________________________________________________________________________________________

and the same of the same of the same of the same of the same of

Oricare, Inc.

FDA Device Registration Number 3009129579 – K131790

[phone], [e-mail], [e-mail] 5-4

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Image /page/4/Picture/0 description: The image shows the logo for "ORICARE" in bold, black font. Below the logo is the address "1900 AM Drive" and "Quakertown, Pennsylvania 18951". The logo is simple and modern, and the address is clear and easy to read. The image is likely from a company's website or marketing materials.

| Quakertown, Pennsylvania 18951 |
|--------------------------------|
| [phone] |

| 5.13 Primary Predicate Device Comparison Table - Ventilator Operating Specifications | | | | | |
|--------------------------------------------------------------------------------------|------------------------|-------------------------|-----------------------------|----------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Item of comparison | GE Avance<br>Predicate | Mindray A5<br>Predicate | Draeger Apollo<br>Predicate | Oricare A9800<br>Current<br>Submission | Substantial Equivalence |
| Volume Control with tidal compensation | Yes | Yes | Yes | Yes | Substantially Equivalent |
| Pressure Control | Yes | Yes | Yes | Yes | Substantially Equivalent |
| Pressure Control with Volume<br>Guaranteed<br>(PCV-VG) | Yes | Yes | NO | Yes | Substantially Equivalent |
| Synchronized Intermittent Mandatory<br>Ventilation (SIMV-VCV, SIMV-PCV) | Yes | Yes | No | Yes | Substantially Equivalent |
| Synchronized Intermittent Mandatory<br>Ventilation (SIMV-PCV-VG) | Yes | Yes | Not Offered | Not Offered | There is no patient safety<br>risk by not offering this<br>mode - SE |
| Pressure Support | Yes | Yes | Yes | Yes | Substantially Equivalent |
| Apnea Backup | Yes | No | Yes | Yes | Substantially Equivalent |
| Tidal Volume Range (VT) | 20 to 1500 mL | 0 to 1500 mL | 20 to 1400 mL | 20 to 1500 mL | Substantially Equivalent |
| Incremental Settings (20-100 mL) | 5 ml | 1 | Not Specified | 5 mL | Substantially Equivalent |
| Incremental Settings (100-300) | 10 mL | 1 | Not Specified | 10 mL | Substantially Equivalent |
| Incremental Settings (300-1000) | 25 mL | 1 | Not Specified | 10 mL | Predicate and A9800<br>offer Vt adjustment and<br>for this setting the A9800<br>has better resolution -SE |
| Incremental Settings (1000-1500) | 50 mL | 1 | Not Specified | 50 mL | Substantially Equivalent |
| Minute Volume Measurement Range | 2 - 20 L/min | 0 to 30 L/min | 0 - 99.9 L/min | 0 to 30 L/min | Substantially Equivalent |
| Pressure (Pinspired) range | 5-60 cm H2O | 5-70 cm H2O | 5-70 cm H2O | 5 - 70 cm H2O | Both predicate and<br>A9800 offer Inspired<br>settings and the A9800<br>adjustment range Is<br>slightly greater - SE |

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Oricare, Inc.

FDA Device Registration Number 3009129579 – K131790

5-5 [phone], [e-mail], [e-mail]

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the word "ORICARE" in bold, black letters. There is a horizontal line underneath the word. Below the line, the text "1900 AM Drive" is written in a smaller font.

Quakertown, Pennsylvania 18951

| 5.14 Predicate Device(s) Comparison Table - Breathing Circuit | | | | | |
|---------------------------------------------------------------------------|-------------------------------------------------------------|----------------------------------------------------------|----------------------------------------------------------|----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Item of comparison | GE Avance<br>Predicate | Mindray A5<br>Predicate | Draeger Apollo<br>Predicate | Oricare A9800<br>Current<br>Submission | Substantial Equivalence |
| N2O shut off with loss of O2 pressure? | Yes | Yes | Yes | Yes | Substantially Equivalent |
| O₂ flush range | >35 L/min | >35 L/min | >35 L/min | >35 L/min | Substantially Equivalent |
| Fresh gas flow range | 0 mL/min - 15<br>L/min | 0 mL/min - 15<br>L/min | 0 and 0.2 - 18<br>L/min | 0 mL/min - 15<br>L/min | Substantially Equivalent |
| O₂ flow accuracy | ±5% or ±20<br>mL/min | ± 10% or 120 mL<br>/min | ± 10% or 120 mL<br>/min | ± 10% or 120<br>mL /min | Substantially Equivalent |
| O₂ concentration range | 21 - 100% | 21 - 100% | 21 - 100% | 21 - 100% | Substantially Equivalent |
| Hypoxic Guard | Yes | Yes | Yes | Yes | Substantially Equivalent |
| Circle Mode | Yes | Yes | Yes | Yes | Substantially Equivalent |
| ACGO Mode | Yes | Yes | Yes | Yes | Substantially Equivalent |
| CO₂ Canister | Yes | Yes | Yes | Yes | Substantially Equivalent |
| Exhalation port | 22 mm OD ISO<br>15 mm ID taper | 22 mm OD ISO<br>15 mm ID taper | 22 mm OD ISO<br>15 mm ID taper | 22 mm OD ISO<br>15 mm ID taper | Substantially Equivalent |
| 5.14 Predicate Device(s) Comparison Table - Breathing Circuit (Continued) | | | | | |
| ltem of comparison | GE Avance<br>Predicate | Mindray A5<br>Predicate | Draeger Apollo<br>Predicate | Oricare A9800<br>Current Submission | Substantial<br>Equivalence |
| Inhalation port…