(325 days)
Not Found
No
The summary describes a traditional anesthesia workstation with electronic controls and monitoring, but there is no mention of AI or ML capabilities for decision support, data analysis, or adaptive control.
Yes
The device provides ventilatory support and anesthesia delivery, which are therapeutic interventions aimed at maintaining patient well-being and managing pain during medical procedures.
No
The A9800 Anesthesia Workstation is indicated for providing general inhalation anesthesia and ventilatory support, not for diagnosing medical conditions. While it monitors gases and displays patient data, this is for controlling anesthesia and ventilation rather than for diagnostic purposes.
No
The device description clearly details numerous hardware components, including a pneumatically driven system, bellows, electronic flow meters, a touch screen monitor, and an Anesthetic Gas Scavenging System (AGSS). It is described as a complete anesthesia workstation, not just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device provides "general inhalation anesthesia and ventilatory support for adolescents to adults in an operating room environment." This describes a device used directly on a patient for medical treatment and support, not for testing samples taken from the body.
- Device Description: The description focuses on the mechanical and electronic functions of delivering anesthesia and ventilation. It mentions monitoring gases within the breathing system and patient respiratory gas, but this is for monitoring the patient's physiological state during the procedure, not for diagnostic testing of biological samples.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The description of the A9800 does not mention any such function or interaction with biological samples for diagnostic purposes.
The device is an anesthesia workstation, which is a type of medical device used in patient care, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
BSZ
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
No patient contacting parts
Indicated Patient Age Range
Adolescents to adults
Intended User / Care Setting
Licensed clinicians, operating room environment, health care facility
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 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, 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.
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.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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 #3009129579 | ||||
| 1900 AM Drive | ||||
| Quakertown, Pennsylvania 18951 | ||||
| +1-215-538-2470 Phone | ||||
| 5.2 | Key Contacts | Kurtis Montegna | ||
| Quality Assurance & Regulatory Affairs Manager | ||||
| kmontegna@Oricaremed.com | ||||
| David Jamison | ||||
| Executive VP | ||||
| djamison@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 II | ||
| BSZ | ||||
| Panel 73: Anesthesiology | ||||
| Subpart F: Therapeutic Devices | ||||
| CFR 868.5160 Gas machine for anesthesia or analgesia | ||||
| K123125 | GE Datex-Ohmeda Avance | BSZ | ||
| 5.9 | Predicate Devices | K123211 | Mindray A5 Anesthesia | |
| 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 +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)
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 +1-215-538-2470, kmontegna@Oricaremed.com, djamison@Oricaremed.com
5
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 Avance | ||||
| Predicate | Mindray A5 | ||||
| Predicate | Draeger Apollo | ||||
| Predicate | Oricare A9800 | ||||
| Current | |||||
| 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% | ||||
| 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 Brake | ||||
| for Casters | Central Brake for | ||||
| Casters | Central Brake for | ||||
| Casters | Locking front | ||||
| casters | Substantially Equivalent |
Oricare, Inc.
FDA Device Registration Number 3009129579 – K131790
5-3 +1-215-538-2470, kmontegna@Oricaremed.com, djamison@Oricaremed.com
3
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 Avance | ||||
| Predicate | Mindray A5 | ||||
| Predicate | Draeger Apollo | ||||
| Predicate | Oricare A9800 | ||||
| Current | |||||
| 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 | |||||
| Guaranteed | |||||
| (PCV-VG) | Yes | Yes | NO | Yes | Substantially Equivalent |
| Synchronized Intermittent Mandatory | |||||
| Ventilation (SIMV-VCV, SIMV-PCV) | Yes | Yes | No | Yes | Substantially Equivalent |
| Synchronized Intermittent Mandatory | |||||
| Ventilation (SIMV-PCV-VG) | Yes | Yes | Not Offered | Not Offered | There is no patient safety |
| risk by not offering this | |||||
| 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 |
| offer Vt adjustment and | |||||
| for this setting the A9800 | |||||
| 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 |
| A9800 offer Inspired | |||||
| settings and the A9800 | |||||
| adjustment range Is | |||||
| slightly 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
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 | ||||
| Predicate | Mindray A5 | ||||
| Predicate | Draeger Apollo | ||||
| Predicate | Oricare A9800 | ||||
| Current | |||||
| 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 | ||||
| L/min | 0 mL/min - 15 | ||||
| L/min | 0 and 0.2 - 18 | ||||
| L/min | 0 mL/min - 15 | ||||
| L/min | Substantially Equivalent | ||||
| O₂ flow accuracy | ±5% or ±20 | ||||
| mL/min | ± 10% or 120 mL | ||||
| /min | ± 10% or 120 mL | ||||
| /min | ± 10% or 120 | ||||
| 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 | ||||
| 15 mm ID taper | 22 mm OD ISO | ||||
| 15 mm ID taper | 22 mm OD ISO | ||||
| 15 mm ID taper | 22 mm OD ISO | ||||
| 15 mm ID taper | Substantially Equivalent | ||||
| 5.14 Predicate Device(s) Comparison Table - Breathing Circuit (Continued) | |||||
| ltem of comparison | GE Avance | ||||
| Predicate | Mindray A5 | ||||
| Predicate | Draeger Apollo | ||||
| Predicate | Oricare A9800 | ||||
| Current Submission | Substantial | ||||
| Equivalence | |||||
| Inhalation port | 22 mm OD ISO | ||||
| 15 mm ID taper | 22 mm OD ISO | ||||
| 15 mm ID taper | 22 mm OD ISO | ||||
| 15 mm ID taper | 22 mm OD ISO | ||||
| 15 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 | Controls | ||||
| ventilator and | |||||
| direction of | |||||
| breathing gas | Controls ventilator | ||||
| and direction of | |||||
| breathing gas | Controls ventilator | ||||
| and direction of | |||||
| breathing gas | Controls ventilator | ||||
| and direction of | |||||
| breathing gas | Substantially Equivalent | ||||
| APL valve range | 0.8 to 70 cm | ||||
| H-O | 0.8 to 70 cm H2O | 0.8 to 70 cm H2O | 0.8 to 70 cm H2O | Substantially Equivalent | |
| Compliance compensation mechanical | |||||
| modes | Auto | ||||
| compensate | Auto compensate | Auto compensate | Auto compensate | Substantially Equivalent | |
| Gas Supply Pressure Gages | Electronic | Pneumatic | |||
| Mechanical | Pneumatic | ||||
| Mechanical | Pneumatic | ||||
| Mechanical | Substantially Equivalent | ||||
| Gas Mixer | Electronic | Pneumatic | |||
| Mechanical | Pneumatic | ||||
| Mechanical | Pneumatic | ||||
| Mechanical | Substantially Equivalent | ||||
| Auxiliary Oxygen | No Blender | No Blender | No Blender | Blender | SAFETY FEATURE |
| Oricare | |||||
| A9800 | |||||
| The | |||||
| Anesthesia Workstation | |||||
| includes | |||||
| an | |||||
| Auxiliary | |||||
| Oz/Air Blender while the | |||||
| predicate devices have | |||||
| Auxiliary O2 only. | |||||
| The | |||||
| A9800 . | |||||
| Aux | |||||
| OzlAir | |||||
| Blender when set to | |||||
| 100% | |||||
| functions | |||||
| identically | |||||
| to | |||||
| the | |||||
| predicate | |||||
| device's | |||||
| Auxiliary O2 Flow meter. | |||||
| A9800 | |||||
| The | |||||
| has | |||||
| the | |||||
| additional capability of | |||||
| an O2/Air Blender | |||||
| to | |||||
| allow the user to lower | |||||
| the Auxiliary O2 level | |||||
| 100%. | |||||
| below | |||||
| 10 | |||||
| prevent Surgical | |||||
| fires | |||||
| where a nasal cannula | |||||
| or other open system is | |||||
| in | |||||
| use, | |||||
| lower | |||||
| concentrations of 02 are | |||||
| preferred per FDA, ASA | |||||
| and APSF initiatives. | |||||
| There is no patient risk. | |||||
| A9800 | |||||
| The | |||||
| is | |||||
| substantially equivalent | |||||
| to the predicate device. |
Oricare, Inc.
FDA Device Registration Number 3009129579 -- K131790
+1-215-538-2470, kmontegna@Oricaremed.com, djamison@Oricaremed.com 5-6
6
1900 AM Drive Quakertown, Pennsylvania 18951
TM
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 Avance
Predicate | Mindray A5
Predicate | Draeger Apollo
Predicate | Oricare A9800
Current
Submission | Substantial
Equivalence |
|-----------------------------------------|------------------------|-------------------------|-----------------------------|----------------------------------------|----------------------------|
| 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 Summary
5.16 | | | | | |
・
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
8
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 | FDA
Recognition # | Title | Testing
Laboratory |
|----------------|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| IEC 60601-1 | 5-4 | Medical equipment/medical electrical
equipment - Part 1: General requirements
for basic safety and essential performance | 3rd Party: TUV |
| IEC 60601-1-2 | 5-35 | Medical Electrical Equipment - Part 1:
General requirements for safety to collateral
Standard: Electromagnetic Compatibility
requirements and tests. | 3rd Party: National
Testing and
Inspection Center |
| IEC 60601-1-8 | 5-49 | Medical Electrical Equipment - Part 1-8:
General requirements for safety - collateral
standard: Alarm Systems | 3rd Party: TUV |
| IEC 62366 | 5-50 | Medical Devices - Application of
usability engineering to medical
devices. | 3rd Party: TUV |
| ISO 80601-2-13 | Not Recognized | Medical Electrical Equipment Part 2-13:
Particular Requirements for basic safety
and essential performance of an anesthetic
workstation. | 3rd Party: TUV |
| IEC 60601-1-6 | Not Recognized | Medical Electrical Equipment Part 1-6:
General requirements for safety - collateral
standard: Usability including IEC 62366:
Application of usability engineering to
medical devices. | 3rd Party: TUV |
Oricare, Inc.
FDA Device Registration Number 3009129579 – K131790
ર-ત્વે +1-215-538-2470, kmontegna@Oricaremed.com, djamison@Oricaremed.com
9
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
·
10
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.
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.
5.21 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
11
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.
12
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
13
Indications for Use
K131790
Device Name: A9800 Anesthesia Workstation
Indications for 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.
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'