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 Description

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).

AI/ML Overview

The Oricare™ A9800 Anesthesia Workstation is indicated to provide general inhalation anesthesia and ventilatory support for adolescents to adults in an operating room environment, specifically for volume or pressure control ventilation.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document uses a "Substantial Equivalence" comparison against predicate devices rather than specific quantitative acceptance criteria with reported device performance values. The acceptance criterion is generally being substantially equivalent to the predicate devices for each specified item.

Item of Comparison	Predicate Device Performance (GE Avance, Mindray A5, Draeger Apollo)	Oricare A9800 Reported Performance	Acceptance Criteria Met? (Substantial Equivalence)	Notes
Intended Use	General inhalation anesthesia and ventilatory support for various patient ranges (neonatal, pediatric, adult)	General inhalation anesthesia and ventilatory support for adolescents to adults	Yes	Slight difference in target population (adolescents to adults vs. including neonatal/pediatric) but deemed substantially equivalent.
Target Population	Neonatal, pediatric, adult (GE, Draeger); Pediatric, Adult (Mindray)	Adolescent to Adult	Yes	Considered "No Difference - SE".
Ventilation Modes	Volume Control, Pressure Control, PCV-VG (except Draeger), SIMV-VCV/PCV (except Draeger), SIMV-PCV-VG (GE, Mindray), Pressure Support, Apnea Backup	Volume Control, Pressure Control, PCV-VG, SIMV-VCV/PCV, Pressure Support, Apnea Backup	Yes	SIMV-PCV-VG is not offered on A9800, but deemed "no patient safety risk by not offering this mode." Oricare A9800 has better resolution for incremental settings of Tidal Volume (300-1000 mL range).
Tidal Volume Range (VT)	0-1500 mL (Mindray), 20-1500 mL (GE), 20-1400 mL (Draeger)	20 to 1500 mL	Yes
O2 Flow Accuracy	±5% or ±20 mL/min (GE), ±10% or 120 mL/min (Mindray, Draeger)	±10% or 120 mL/min	Yes	Within the range of predicate devices.
Auxiliary Oxygen System	O2 only (No Blender)	Blender (O2/Air)	Yes	Highlighted as a "SAFETY FEATURE" with additional capability to lower O2 concentration below 100% to prevent surgical fires, aligning with FDA, ASA, and APSF initiatives. No patient risk.
Safety Standards Compliance (e.g., IEC 60601-1)	Tested	Passed	Yes	Device underwent rigorous testing to harmonized standards.
Human Factors	Tested	Tested	Yes	Included a full human factors study with physicians.
Electrical Safety	ISO 60601-1	ISO 60601-1	Yes
Mechanical Safety	ISO 60601-1	ISO 60601-1	Yes
Physical Specifications (Height, Width, Depth, Weight)	Varied between predicates	Varied, but deemed equivalent	Yes	Small differences in physical dimensions and weight were individually assessed and found to be "Substantially Equivalent," not introducing new safety concerns.
Operating Temperature	50-100°F (GE), 50-104°F (Mindray), 59-104°F (Draeger)	50-104°F	Yes	Within the range of predicate devices.
Operating Humidity	Less than 95% RH (GE), 15-90% Non-condensating (Mindray, Draeger)	15-90% Non-condensating	Yes	Within the range of predicate devices.
N2O shut off with loss of O2 pressure	Yes	Yes	Yes
Hypoxic Guard	Yes	Yes	Yes
AGSS Type	Adjustable Flow	Adjustable Flow	Yes

2. Sample size used for the test set and the data provenance:

The document describes extensive non-clinical testing for safety and performance (harmonized standards adherence, bench tests, and simulated use validation). However, these are not described as using a "test set" in the context of clinical or diagnostic performance with a specific sample size of patients or data points.

Test set: Not explicitly defined in terms of patient data or clinical cases. The "tests" refer to engineering and safety verifications.
Data provenance: Not applicable in the context of clinical data. The tests performed are laboratory and engineering tests conducted by 3rd party testing labs (TUV, National Testing and Inspection Center) and internally by Oricare.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of experts: Not explicitly stated for specific ground truth establishment.
Qualifications of experts: The device underwent a "full human factors study with physicians." This indicates involvement of qualified medical professionals in evaluating usability and safety from a human interaction perspective, but not for establishing "ground truth" for a diagnostic or prognostic test.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Adjudication method: Not applicable. The studies described are non-clinical engineering and safety validations, not studies requiring expert adjudication of clinical outcomes or images.

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 device is an anesthesia workstation, not a diagnostic AI device requiring MRMC studies to assess AI assistance.
Effect size of human readers improve with AI: Not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Standalone performance: Not applicable. The device is a medical apparatus (anesthesia workstation) and its performance is evaluated through engineering standards, bench testing, and usability, not as a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Type of ground truth: The "ground truth" for this device's performance is established by adherence to recognized national and international safety and performance standards (e.g., IEC 60601-1, ISO 80601-2-13), as well as internal engineering and simulated use testing against design specifications. For biological safety, specific tests like cytotoxicity, systemic toxicity, and sensitization tests define the "ground truth" of biocompatibility.

8. The sample size for the training set:

Training set sample size: Not applicable. This device is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established:

Ground truth for training set: Not applicable.

Summary of the Study Proving Acceptance Criteria:

The study proving the device meets its "acceptance criteria" (which in this context is primarily substantial equivalence to predicate devices and adherence to safety/performance standards) consists of comprehensive non-clinical testing. This includes:

Adherence to Harmonized Standards: The A9800 passed safety tests for compliance with various IEC and ISO standards related to medical electrical equipment, electromagnetic compatibility, alarm systems, and usability engineering (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 62366, ISO 80601-2-13, IEC 60601-1-6). These tests were conducted by 3rd party testing labs (TUV, National Testing and Inspection Center).
Bench Tests: A wide array of specific bench tests were performed, including:
- Waveform analysis comparing A9800 to the GE Avance predicate.
- Simulated Use Validation.
- Phasein standard requirements report.
- ISTA shipping test report.
- Gas Analyzer test report.
- Multiple hardware unit test reports (BDU/PSU, SBU, KBD, EFM).
- Integration test and prototype machine verification.
- Blender test report.
- Breathing system manual/auto switch life cycle test.
- Breathing system test to ISO 8835-2.
- ACGO Switch life cycle test.
- Hardware system Verification and Validation Report.
- Breathing system Hi temperature steaming test and heating test.
- Battery charge & discharge test.
- AGSS Test to ISO 8835-3-2007.
Biological Safety Assessment (NAMSA reports): This included cytotoxicity, systemic toxicity in mice, and intracutaneous and sensitization tests in rabbits and guinea pigs.
Sterilization and Disinfection Validation: Steam sterilization cycle validation and high-level disinfection validation reports were provided (LSO Autoclave, Nelson Lab Disinfectant).
Human Factors Study: A "full human factors study with physicians" was conducted.

The conclusion drawn from these non-clinical tests is that the A9800 Anesthesia Workstation is substantially equivalent to the listed predicate devices (K123125, K123211, and K042607) and introduces no new issues of safety or effectiveness. No clinical trials were required for this device type.

Summary

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MAY 0 9 2014 K131790

ORICARE™

1900 AM Drive
Quakertown, Pennsylvania 18951
(215) 538-2470

5 510(K) Summary

510 (K) Summary
5.1	Submitter/Owner	Oricare, Inc.FDA #30091295791900 AM DriveQuakertown, Pennsylvania 18951+1-215-538-2470 Phone
5.2	Key Contacts	Kurtis MontegnaQuality Assurance & Regulatory Affairs Managerkmontegna@Oricaremed.comDavid JamisonExecutive VPdjamison@Oricaremed.com
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 IIBSZPanel 73: AnesthesiologySubpart F: Therapeutic DevicesCFR 868.5160 Gas machine for anesthesia or analgesia
		K123125	GE Datex-Ohmeda Avance	BSZ
5.9	Predicate Devices	K123211	Mindray A5 AnesthesiaDelivery 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 +1-215-538-2470, kmontegna@Oricaremed.com, djamison@Oricaremed.com

{1}------------------------------------------------

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 (215) 538-2470 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)

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 +1-215-538-2470, kmontegna@Oricaremed.com, djamison@Oricaremed.com

{2}------------------------------------------------

Quakertown, Pennsylvania 18951 (215) 538-2470

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 AvancePredicate	Mindray A5Predicate	Draeger ApolloPredicate	Oricare A9800CurrentSubmission	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%RH	15-90% Non-condensating	25-85% Non-condensating	15-90% Non-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 Brakefor Casters	Central Brake forCasters	Central Brake forCasters	Locking frontcasters	Substantially Equivalent

Oricare, Inc.

FDA Device Registration Number 3009129579 – K131790

5-3 +1-215-538-2470, kmontegna@Oricaremed.com, djamison@Oricaremed.com

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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 "(215) 538-2470". The address and phone number are in a smaller font size than the word "ORICARE".

・

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

Oricare, Inc.

FDA Device Registration Number 3009129579 – K131790

+1-215-538-2470, kmontegna@Oricaremed.com, djamison@Oricaremed.com 5-4

{4}------------------------------------------------

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
(215) 538-2470

5.13 Primary Predicate Device Comparison Table - Ventilator Operating Specifications
Item of comparison	GE AvancePredicate	Mindray A5Predicate	Draeger ApolloPredicate	Oricare A9800CurrentSubmission	Substantial Equivalence
Volume Control with tidal compensation	Yes	Yes	Yes	Yes	Substantially Equivalent
Pressure Control	Yes	Yes	Yes	Yes	Substantially Equivalent
Pressure Control with VolumeGuaranteed(PCV-VG)	Yes	Yes	NO	Yes	Substantially Equivalent
Synchronized Intermittent MandatoryVentilation (SIMV-VCV, SIMV-PCV)	Yes	Yes	No	Yes	Substantially Equivalent
Synchronized Intermittent MandatoryVentilation (SIMV-PCV-VG)	Yes	Yes	Not Offered	Not Offered	There is no patient safetyrisk by not offering thismode - 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 A9800offer Vt adjustment andfor this setting the A9800has 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 andA9800 offer Inspiredsettings and the A9800adjustment range Isslightly greater - SE

and the same of the same of the same of the same of the same of the same of the states of the states of the states of the states of the states of the states of the states of and the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the commen

Oricare, Inc.

FDA Device Registration Number 3009129579 – K131790

5-5 +1-215-538-2470, kmontegna@Oricaremed.com, djamison@Oricaremed.com

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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 AvancePredicate	Mindray A5Predicate	Draeger ApolloPredicate	Oricare A9800CurrentSubmission	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 - 15L/min	0 mL/min - 15L/min	0 and 0.2 - 18L/min	0 mL/min - 15L/min	Substantially Equivalent
O₂ flow accuracy	±5% or ±20mL/min	± 10% or 120 mL/min	± 10% or 120 mL/min	± 10% or 120mL /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 ISO15 mm ID taper	22 mm OD ISO15 mm ID taper	22 mm OD ISO15 mm ID taper	22 mm OD ISO15 mm ID taper	Substantially Equivalent
5.14 Predicate Device(s) Comparison Table - Breathing Circuit (Continued)
ltem of comparison	GE AvancePredicate	Mindray A5Predicate	Draeger ApolloPredicate	Oricare A9800Current Submission	SubstantialEquivalence
Inhalation port	22 mm OD ISO15 mm ID taper	22 mm OD ISO15 mm ID taper	22 mm OD ISO15 mm ID taper	22 mm OD ISO15 mm ID taper	Substantially Equivalent
Bag port	22 mm OD	22 mm OD	22 mm OD	22 mm OD	Substantially Equivalent
Bag-to-Ventilator switch	Bi-Stable	Bi-Stable	Bi-Stable	Bi-Stable	Substantially Equivalent
Bag-to-Ventilator control	Controlsventilator anddirection ofbreathing gas	Controls ventilatorand direction ofbreathing gas	Controls ventilatorand direction ofbreathing gas	Controls ventilatorand direction ofbreathing gas	Substantially Equivalent
APL valve range	0.8 to 70 cmH-O	0.8 to 70 cm H2O	0.8 to 70 cm H2O	0.8 to 70 cm H2O	Substantially Equivalent
Compliance compensation mechanicalmodes	Autocompensate	Auto compensate	Auto compensate	Auto compensate	Substantially Equivalent
Gas Supply Pressure Gages	Electronic	PneumaticMechanical	PneumaticMechanical	PneumaticMechanical	Substantially Equivalent
Gas Mixer	Electronic	PneumaticMechanical	PneumaticMechanical	PneumaticMechanical	Substantially Equivalent
Auxiliary Oxygen	No Blender	No Blender	No Blender	Blender	SAFETY FEATUREOricareA9800TheAnesthesia WorkstationincludesanAuxiliaryOz/Air Blender while thepredicate devices haveAuxiliary O2 only.TheA9800 .AuxOzlAirBlender when set to100%functionsidenticallytothepredicatedevice'sAuxiliary O2 Flow meter.A9800Thehastheadditional capability ofan O2/Air Blendertoallow the user to lowerthe Auxiliary O2 level100%.below10prevent Surgicalfireswhere a nasal cannulaor other open system isinuse,lowerconcentrations of 02 arepreferred per FDA, ASAand APSF initiatives.There is no patient risk.A9800Theissubstantially equivalentto the predicate device.

Oricare, Inc.

FDA Device Registration Number 3009129579 -- K131790

+1-215-538-2470, kmontegna@Oricaremed.com, djamison@Oricaremed.com 5-6

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1900 AM Drive Quakertown, Pennsylvania 18951

Oricare, Inc.

FDA Device Registration Number 3009129579 – K131790

+1-215-538-2470, kmontegna@Oricaremed.com, djamison@Oricaremed.com 5-7

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image shows the word "ORICARE" in bold, black letters, with a thin black line underneath. Below the line is the address "1900 AM Drive, Quakertown, Pennsylvania 18951" and the phone number "(215) 538-2470". The TM symbol is next to the word "ORICARE".

Item of comparison	GE AvancePredicate	Mindray A5Predicate	Draeger ApolloPredicate	Oricare A9800CurrentSubmission	SubstantialEquivalence
AGSS Type - Active	Adiustable Flow	Adjustable Flow	Adjustable Flow	Adjustable Flow	Substantially Equivalent
AGSS low flow indicator	Yes	Yes	Yes	Yes	Substantially Equivalent
AGSS connector	DISS evac	DISS evac	DISS evac	DISS evac	Substantially Equivalent
Substantial Equivalence Summary5.16

・

Anesthesia workstation with the legally marketed predicate device(s) (K123125, K123211, and K042607 ). The A9800 is substantially equivalent to the predicate device(s).

Oricare, Inc. FDA Device Registration Number 3009129579 – K131790 5-8 +1-215-538-2470, kmontegna@Oricaremed.com, djamison@Oricaremed.com

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Quakertown, Pennsylvania 18951 (215) 538-2470

Non-Clinical Tests - Harmonized Standards 5.17

The A9800 has passed all safety tests for demonstrated compliance with the harmonized standards below:

Standard	FDARecognition #	Title	TestingLaboratory
IEC 60601-1	5-4	Medical equipment/medical electricalequipment - Part 1: General requirementsfor basic safety and essential performance	3rd Party: TUV
IEC 60601-1-2	5-35	Medical Electrical Equipment - Part 1:General requirements for safety to collateralStandard: Electromagnetic Compatibilityrequirements and tests.	3rd Party: NationalTesting andInspection Center
IEC 60601-1-8	5-49	Medical Electrical Equipment - Part 1-8:General requirements for safety - collateralstandard: Alarm Systems	3rd Party: TUV
IEC 62366	5-50	Medical Devices - Application ofusability engineering to medicaldevices.	3rd Party: TUV
ISO 80601-2-13	Not Recognized	Medical Electrical Equipment Part 2-13:Particular Requirements for basic safetyand essential performance of an anestheticworkstation.	3rd Party: TUV
IEC 60601-1-6	Not Recognized	Medical Electrical Equipment Part 1-6:General requirements for safety - collateralstandard: Usability including IEC 62366:Application of usability engineering tomedical devices.	3rd Party: TUV

Oricare, Inc.

FDA Device Registration Number 3009129579 – K131790

ર-ત્વે +1-215-538-2470, kmontegna@Oricaremed.com, djamison@Oricaremed.com

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Quakertown, Pennsylvania 18951

(215) 538-2470

5.18 Non-Clinical Bench Tests
Waveform Analysis	A9800 to Avance waveform comparison report
Simulated Use Validation	Simulated Use Validation testing of anesthesia machine
Phasein	Phasein standard requirements report - EN60601-1 and 21647
ISTA	ISTA shipping test report
Gas Analyzer Test Report	A9800 Gas Analyzer report
RD-GMAP-M3-004	BDU/PSU - Main control board hardware test unit
RD-GMAP-M3-008	SBU - Sensor board hardware unit test
RD-GMAP-M3-010	KBD - Keyboard hardware unit test report
RD-GMAP-M3-014	EFM - E-flowmeter board hardware unit test report
RD-GMAP-M3-020	Integration test and prototype machine verification report
RD-GMAP-M3-042	Blender test report
RD-GMAP-M3-043	Breathing system manual/auto switch life cycle test report
RD-GMAP-M3-044	Breathing system test report to ISO8835-2
RD-GMAP-M3-047	ACGO Switch life cycle test report
RD-GMAP-M3-050	Hardware system Verification and Validation Report
RD-GMAP-M3-057	Breathing system Hi temperature steaming test report
RD-GMAP-M3-064	Breathing system heating test report
RD-GMAP-M3-066	Battery charge & discharge test report
RD-GMAP-FDA-020	AGSS Test to ISO 8835-3-2007
NAMSA-N112221	Summary Report and Biological Safety Assessment
NAMSA-V0014_130	Cytotoxicity
NAMSA-T0625_500	ISO Systemic Toxicity Study in Mice
NAMSA-T1251_800	ISO Intracutaneous Study in Rabbits
NAMSA-T1261_300	ISO Guinea Pig Maximization Sensitization Test
LSO Autoclave-SVS-ORC-01	Steam Sterilization Cycle Validation
Nelson Lab Disinfectant - 739231A	High Level Disinfection Validation Report

Oricare, Inc.

FDA Device Registration Number 3009129579 – K131790

5-10 +1-215-538-2470, kmontegna@Oricaremed.com, djamison@Oricaremed.com

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Image /page/10/Picture/0 description: The image shows the logo for "ORICARE" with the trademark symbol. Below the logo is the address "1900 AM Drive, Quakertown, Pennsylvania 18951". The phone number listed is (215) 538-2470.

5.19 Summary of Non-Clinical Tests as required by 807.92 (b)(1)(3)

The A9800 Anesthesia Workstation has been thoroughly tested. FDA recognized standards, FDA guidance documents, harmonized standards, verification and validation, software validation, usability validation, and risk management activities have taken place for the A9800 Anesthesia Workstation.

The A9800 Anesthesia Workstation will be manufactured in compliance with FDA and ISO quality system requirements. System validation and verification will demonstrate that the functional requirements and system specifications have been met prior to commercial release.

Based upon the design, intended use, indications for use, classification, usability and safety testing the A9800 Anesthesia Workstation is substantially equivalent to the listed predicate device(s) (K123125, K123211, and K042607 ).

No new issues of safety or effectiveness are introduced as a result of using this device.

5.20 Summary of Clinical Tests as required by 807.92 (b) (1) (2)

The A9800 Anesthesia Workstation, like the predicate device, did not require clinical trials. FDA recognized standards, FDA quidance documents, harmonized standards, verification and validation, software validation, usability validation, and risk management activities have taken place for the A9800 Anesthesia Workstation.

No new issues of safety or effectiveness are introduced as a result of using this device.

5.21 Conclusion

Oricare considers the A9800 Anesthesia Workstation to be substantially equivalent to the predicate device(s) (K123125, K123211, and K042607 ).

Oricare, Inc.

FDA Device Registration Number 3009129579 - K131790

5-11 +1-215-538-2470, kmontegna@Oricaremed.com, djamison@Oricaremed.com

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Image /page/11/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002

May 9, 2014

Oricare Incorporated Mr. Kurtis Montegna Quality Assurance & Regulatory Affairs Manager 1900 AM Drive Quakerstown, PA 18951

Re: K131790

Trade/Device Name: A9800 Anesthesia Workstation Regulation Number: 21 CFR 868.5160 Regulation Name: Gas machine for anesthesia or analgesia Regulatory Class: Class II Product Code: BSZ Dated: April 04, 2014 Received: April 10, 2014

Dear Mr. Montegna:

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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Page 2 - Mr. Montegna

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 device-related 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 contact the Division of Industry and Consumer Education 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. 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/McdicalDevices/Safety/ReportalProblem/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 Industry and Consumer Education 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 yours.

Image /page/12/Picture/8 description: The image shows the letters FDA in a stylized font. To the left of the letters, the text "Tejashri Purohit-Sheth, M.D." is written. To the right of the letters, the text "Tejashri Purohit-Sheth, M.D. Clinical Deputy Director, DAGRID/ODE/CDRH FOR" is written.

Erin 1. Keith, M.S. Acting 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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Indications for Use

K131790

Device Name: A9800 Anesthesia Workstation

Indications for Use:

Prescription use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (Part 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)

Todd D. Courtney -S 2014.05.08 17:00:22 -04'00'

Regulation Number and Section

§ 868.5160 Gas machine for anesthesia or analgesia.

(a)
Gas machine for anesthesia —(1)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.(2)
Classification. Class II (performance standards).(b)
Gas machine for analgesia —(1)Identification. 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).(2)
Classification. Class II (performance standards).