AURA ICP MONITORING SYSTEM

K172209 · Branchpoint Technologies, Inc. · GWM · May 18, 2018 · Neurology

Device Facts

• Record ID: K172209
• Device Name: AURA ICP MONITORING SYSTEM
• Applicant: Branchpoint Technologies, Inc.
• Product Code: GWM · Neurology
• Decision Date: May 18, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1620
• Device Class: Class 2

Intended Use

The Branchpoint AURA™ ICP Monitoring System is intended for use by a qualified neurosurgeon in the direct monitoring of intracranial pressure in intraparenchymal applications.

Device Story

AURA ICP Monitoring System provides direct intracranial pressure (ICP) monitoring; utilizes strain gage pressure sensor placed in brain parenchyma via burr hole; sensor receives power inductively from handheld AURA Monitor via antenna; sensor transmits ICP data to monitor via Bluetooth Low Energy; monitor displays numerical ICP; optional data receiver relays ICP waveform to standard bedside patient monitors via invasive blood pressure port; used by neurosurgeons in clinical settings; eliminates internal sensor batteries; benefits patient through wireless, battery-free sensor design; provides real-time ICP data for clinical decision-making.

Clinical Evidence

Bench testing only. Performance validated against ANSI/AAMI NS28:1988(r)2010. Testing included pressure measurement resolution, barometric compensation, system response time, wireless power/data transmission, electromagnetic compatibility, electrical safety, mechanical integrity, and biocompatibility (ISO 10993 series).

Technological Characteristics

Strain gage pressure sensor; polyurethane catheter (2.5cm x 2mm); inductive power coupling; Bluetooth Low Energy data transmission; handheld monitor with Li-ion battery; data receiver compatible with AAMI BP22 invasive blood pressure ports; ethylene oxide sterilization; stainless steel (DIN 1.4021, 1.4301, 1.4305) and thermoplastic elastomer components.

Indications for Use

Indicated for qualified neurosurgeons to perform direct intracranial pressure (ICP) monitoring in intraparenchymal applications.

Regulatory Classification

Identification

An intracranial pressure monitoring device is a device used for short-term monitoring and recording of intracranial pressures and pressure trends. The device includes the transducer, monitor, and interconnecting hardware.

Predicate Devices

• Camino Slim Line ™ System (K042728)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 18, 2018

Branchpoint Technologies, Inc. Nicholas Hu Chief Operating Officer Contact Address

Re: K172209

Trade/Device Name: AURA ICP Monitoring System Regulation Number: 21 CFR 882.1620 Regulation Name: Intracranial Pressure Monitoring Device Regulatory Class: Class II Product Code: GWM Dated: April 19, 2018 Received: August 25, 2017

Dear Nicholas Hu:

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.

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Michael J. Hoffmann -S

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K172209

Device Name AURA™ ICP Monitoring System

Indications for Use (Describe)

The Branchpoint AURA™ ICP Monitoring System is intended for use by a qualified neurosurgeon in the direct monitoring of intracranial pressure in intraparenchymal applications.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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# K172209 510(k) Summary

#### Submitter Information

Company Name: Contact Person: Address: Telephone Number: Date Prepared:

Branchpoint Technologies, Inc. Nicholas Hu 1 Technology Drive, Suite I-811, Irvine, CA 92618 [phone] May 18th, 2018

# Subject Device

| Trade Name: | AURA™ ICP Monitoring System |
|-----------------------|----------------------------------------------------------------------|
| Common or Usual Name: | Intracranial Pressure Monitor |
| Classification: | Class II, Intracranial Pressure Monitoring Device<br>21 CFR 882.1620 |
| Product Code: | GWM |

# Predicate Device

Primary Predicate:

Camino Slim Line ™ System K042728 21 CFR 882.1620, GWM

# Device Description

The Branchpoint AURA™ ICP Monitoring System is a device intended for monitoring intracranial pressure (ICP). The Branchpoint AURA™ ICP Monitoring System is composed of the following three packages:

Package 1) AURA™ Sensor Tray (Model SP101-A)

- . AURA™ Sensor (Model 10025G)
- Disposable Scalp Retractor (Model OS0001B) ●
- Disposable Drill Bit with Collar (Model 10008C)
- Disposable Torque Wrench (Model OS0004C)
- . Disposable Antenna Holster (Model 10007A)

Package 2) AURA™ Monitor Pack (Model TK101-A)

- AURA™ Monitor (Model T0011B)
- AURA™ Antenna (Model T0010A) .
- . 2x Lithium-lon 11v Rechargeable Batteries (Model T0032A)
- Two-bay battery charger (Model T0014A) ●

# Package 3) AURA™ Data Receiver Pack (Model DG101-A)

- . AURA™ Data Receiver (Model D0004B)
# Package 1 of The Branchpoint AURA™ ICP Monitoring System is comprised of components which are described below, all of which are intended for SINGLE-USE ONLY:

# AURA™ Sensor (Model 10025G)

The AURA™ Sensor is a strain gage pressure sensor that is placed at the standard location for ICP monitoring (Kocher's Point). The AURA™ Sensor is placed using the same procedure as predicate

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ICP monitors. The AURA™ Sensor has a catheter tip that extends into the parenchyma of the brain. The AURA™ Sensor does not contain a battery or power storage capacitor. It receives power inductively from the AURA™ Monitor (Model T0011B) through the AURA™ Antenna (Model T0010A). The exclusion of internal power storage in the AURA™ Sensor eliminates risks associated with batteries. The AURA™ Sensor is provided sterile (ethylene oxide) as part of the AURA™ Sensor Tray (Model SP101-A).

The AURA™ Sensor measures ICP and relays the data to the handheld AURA™ Monitor. The AURA™ Monitor is the primary user interface and displays a numerical ICP value on its screen. Optionally, the AURA™ Monitor also relays the ICP data to the AURA™ Data Receiver, which outputs the ICP waveform to standard patient bedside monitors.

#### Drill Bit with Collar (Model 10008C)

The drill bit with collar is used to drill the burr hole for the AURA™ Sensor. This is a class I device with product code HTW that is exempt from premarket notification per 21 CFR 888.4540 and is currently legally marketed in the United States. The drill bit has a diameter of 6.3 mm and has an adjustable collar to be used to help ensure proper drilling depth. The collar has a set-screw that can be adjusted by the user with the torque wrench for loosening and tightening. The drill bit and collar are manufactured from medical grade stainless steel (DIN 1.4021).

#### Torque Wrench (Model OS0004C)

The torque wrench allows the user to loosen and tighten the collar on the drill bit to limit the drilling depth. This is a class I device with product code HXC that is exempt from premarket notification per 21 CFR 888.4540 and is currently legally marketed in the United States. It is made of nickel plated chromium vanadium (DIN 1.4305).

# Scalp Retractor (Model OS0001B)

The scalp retractor is a skin retractor that can be used during the placement of the AURA™ Sensor. This is a class I device with product code GAD that is exempt from premarket notification per 21 CFR 878.4800 and is currently legally marketed in the United States. It is constructed from medical grade stainless steel (DIN 1.4301, 1.4305 and 1.4021).

#### Antenna Holster (Model 10007A)

The antenna holster is designed to hold an AURA™ Antenna securely in place over an AURA™ Sensor in all possible positions. It is made of thermoplastic elastomer and affixes to the skin with an adhesive (hydrocolloid).

# Package 2 of The Branchpoint AURA™ ICP Monitoring System is comprised of components which are described below:

#### AURA™ Monitor Pack (Model TK101-A)

The AURA™ Monitor Pack is provided non-sterile. The AURA™ Monitor (Model T0011B) handheld is the primary user interface device that connects to an AURA™ Antenna (Model T0010A). The AURA™ Antenna powers and receives ICP data streamed from the AURA™ Sensor. The AURA™ Monitor handheld controller displays numerical ICP on its screen. Optionally, the AURA™ Monitor can relay the ICP data to a nearby AURA™ Data Receiver. The AURA™ Monitor uses an externally replaceable lithium-ion battery pack that can be recharged in the charger provided in the AURA™

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Monitor Pack (Model TK101-A). A fully-charged battery is capable of running the AURA™ Monitor for at least 8 hours. These devices are intended for reuse.

# Package 3 of The Branchpoint AURA™ ICP Monitoring System is comprised of components which are described below:

### AURA™ Data Receiver Pack (DG101-A)

The AURA™ Data Receiver Pack is provided non-sterile. The AURA™ Data Receiver receives ICP waveform data relayed by the AURA™ Monitor and outputs them to existing 3rd party patient monitors. The AURA™ Data Receiver plugs directly into the patient monitor's invasive blood pressure port, a port that is governed by AAMI BP22: 1994 (R) 2011 Blood Pressure Transducers (FDA recognition number 3-44). There are various 3rd party adapter cables currently available on the market that will allow the AURA™ Data Receiver to various 3rd party patient monitors and the AAMI BP22 standard ensures compatibility across different brands and models. The AURA™ Data Receiver does not contain a battery and does not need to be recharged; it is able to run from the excitation voltage provided by the invasive blood pressure port. The AURA™ Data Receiver is intended for reuse.

#### Intended Use

The Branchpoint AURA™ ICP Monitoring System is intended for use by a qualified neurosurgeon in the direct monitoring of intracranial pressure in intraparenchymal applications.

# Comparison of Technological Characteristics & Intended Use to Predicate Device

The table below presents a summary of the technological characteristics of the AURA™ ICP Monitoring System in comparison to the predicate device. The indications for use for the predicate device is similar to the indications for use for the AURA™ ICP Monitoring System. There are no major technological differences between the AURA™ ICP Monitoring System and predicate systems that raise new issues of safety or effectiveness. Thus, the AURA™ ICP Monitoring System is substantially equivalent to the predicate devices.

| Characteristic | AURA™ ICP Monitoring<br>System<br>K172209 Subject Device | Camino Slim Line ™ System<br>K042728<br>Predicate Device |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Measured Variable | ICP | ICP and intracranial temperature |
| Clinical Application | Parenchymal pressure<br>measurement | Parenchymal and sub-dural pressure<br>and temperature measurement |
| Mechanism for ICP<br>measurement | Solid state pressure sensor<br>for direct measurement | Solid state pressure sensor for direct<br>measurement |
| Classification Regulation | 21 CFR § 882.1620 | 21 CFR § 882.1620 |
| Classification Name<br>(Product Code) | GWM | GWM |
| Intended Use | For use by a qualified<br>neurosurgeon in the direct<br>monitoring of intracranial<br>pressure in<br>intraparenchymal<br>applications. | For use by a qualified neurosurgeon in<br>the direct monitoring of intracranial<br>pressure in both sub-dural and<br>intraparenchymal applications. |
| Catheter Construction | Polyurethane | Polyurethane |

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| Characteristic | AURA™ ICP Monitoring<br>System<br>K172209 Subject Device | Camino Slim Line ™ System<br>K042728<br>Predicate Device |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| Catheter Dimensions | 2.5cm long x 2mm diameter | 10cm long x 1.35 diameter |
| Calibration Method | Stored calibration values in ICP sensor. | Stored calibration values in ICP sensor and manual zeroing. |
| Display Variables | ICP digital display and waveform | ICP digital display and waveform |
| Measurement Units for ICP | ICP in mmHg | ICP in mmHg |
| Sensor Connection to<br>Monitor | Data: Bluetooth low energy<br>(range = 7 m for monitor handheld and data receiver)<br><br>Power: Inductive coupling<br>(range = 1.5 cm for monitor antenna) | Direct, percutaneous cable connection |
| Sensor Power Source | Powered by monitor | Powered by monitor |
| Monitor Power Source | Battery | Battery or mains |
| Sterilization | Ethylene oxide (single use) | Ethylene oxide (single use) |
| Monitoring Duration | <30 Days | < 30 Days |
| Surgical Technique | Skin incision and burr hole | Skin incision and burr hole |

#### Non-Clinical Testing in Support of Substantial Equivalence and Device Performance

The following bench testing was conducted to support a determination of substantial equivalence to the predicate and to demonstrate performance. The non-clinical bench tests included:

- ICP Monitor performance testing prescribed by ANSI/AAMI NS28:1988(r)2010; ●
- Pressure measurement resolution testing; ●
- Barometric pressure compensation testing;
- System response time testing;
- Battery and charger performance testing;
- Electrical safety testing;
- Electromagnetic compatibility testing;
- Wireless power testing;
- Wireless data transmission testing;
- Wireless co-existence testing;
- Immunity to RFID testing;
- Specific absorption rate (SAR) simulation testing;
- Device mechanical integrity testing;
- Hardware reliability testing;
- Device insulation performance testing;
- Vibration and shock testing;
- Device operating temperature testing; ●
- Adhesion performance testing;
- Device environmental exposure testing;

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- . Labeling durability testing;
- System usability testing;
- . Audio and alarm tone testing;
- Software testing;
- . Sterilization validation testing; and
- . Shelf-life and packaging testing.

The non-clinical testing demonstrates that the AURA™ ICP Monitoring System meets pre-defined acceptance criteria and is as safe and effective as predicate devices.

#### Biocompatibility Testing

All patient contacting components of the AURA™ ICP Monitoring System were evaluated for biocompatibility. The type and nature of the patient contact for each of these components and their biocompatibility testing results are summarized below.

The AURA™ Sensor is placed subcutaneously above the skull and contacts bone and tissue, with the potential to contact cerebrospinal fluid. The contact duration of the AURA™ Sensor is expected to be over 24 hours and under 30 days. Biocompatibility testing was conducted on all patient contacting components of this device, which included the encapsulation, enclosure and catheter. The study results and conclusions for these tests are summarized below:

| Test | Results |
|-------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| MEM Elution<br>ISO 10993-5 | Non-cytotoxic: score of 0. |
| Sensitization Maximization Extract<br>ISO 10993-10 | Non-sensitizer: No irritation was found on any of the<br>negative control or test animals. |
| Intracutaneous<br>Reactivity<br>ISO 10993-10 | Non-Irritant: The test device score for both extracts<br>was 0. |
| Acute Systemic Injection<br>ISO 10993-11 | No systemic toxicity: No test or control animals<br>exhibited signs of toxicity. |
| Subacute and Subchronic Toxicity (IV)<br>ISO 10993-11 | No systemic toxicity: No systemic toxic effects were<br>observed. |
| Subacute and Subchronic Toxicity (IP)<br>ISO 10993-11 | No systemic toxicity: No systemic toxic effects were<br>observed. |
| Genotoxicity - Ames<br>ISO 10993-3 | Non-mutagenic: The test article did not cause an<br>increase in revertant colonies for any strain greater<br>than two-fold over negative control values. |
| Genotoxicity - Mutagenicity<br>ISO 10993-3 | Non-clastogenic & non-genotoxic: No statistical<br>significant differences (p ≥ 0.05) were noted<br>between the test and control extracts. |
| Genotoxicity - Mouse Lymphoma<br>ISO 10993-3 | Non-mutagenic & non-clastogenic: RTG was > 10%. |
| Subcutaneous Implantation<br>ISO 10993-6 | No systemic toxicity: Macroscopic reaction of the<br>test article was not significant as compared to<br>control. Microscopically, test article is classified as a<br>slight irritant as compared to control. |

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| Test | Results |
|-------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Brain Tissue Implantation<br>ISO 10993-6 | No systemic toxicity: Neurobehavioral, gross<br>pathological and clinical reactions caused by the test<br>article were not significant as compared to control.<br>Histologically, test article is classified as having<br>minimal or no reaction. |
| Mediated Material Pyrogenicity<br>ISO 10993-11 | Non pyrogenic: Temperature increase was < 0.5 °C<br>for all animals. |
| Indirect (extract) Hemolysis<br>ISO 10993-4<br>ASTM F756-17 | Non hemolytic: Test article hemolytic index was<br>0.00%. |

The Disposable Antenna Holster is placed on the scalp and contacts intact skin. The contact duration of the Disposable Antenna Holster is expected to be over 24 hours and under 30 days. Biocompatibility testing was conducted on the adhesive layer, which is the only patient contacting component. The study results and conclusions for these tests are summarized below:

| Test | Result |
|--------------------------------------------|------------------------------------------------------|
| MEM Extraction Cytotoxicity<br>ISO 10993-5 | Non-cytotoxic: score of 0. |
| Skin Irritation<br>ISO 10993-10 | No irritation: irritation index was 0. |
| Closed Patch Sensitization<br>ISO 10993-10 | No sensitization: no contact sensitization observed. |

The collective results of the biocompatibility testing demonstrate that the AURA™ ICP Monitoring System meets established specifications and is biocompatible.

# Conclusion

The body of testing summarized above indicates that the AURA™ ICP Monitoring System performs as intended and is substantially equivalent to predict devices. It is as safe and effective as the identified predicate.

#### Conformance to Standards

Standards to which the AURA™ ICP Monitoring System conforms are outlined below:

| Body | Standard ID | Standard Title | FDA<br>Recognition # |
|---------------------|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| AAMI<br>ANSI<br>ISO | 10993-1<br>2009/(R)2013 | Biological Evaluation Of Medical Devices - Part 1:<br>Evaluation And Testing Within A Risk Management<br>Process | 2-156 |
| AAMI<br>ANSI<br>ISO | 10993-3<br>2014 | Biological Evaluation Of Medical Devices - Part 3: Tests<br>For Genotoxicity, Carcinogenicity And Reproductive<br>Toxicity | 2-226 |
| AAMI<br>ANSI<br>ISO | 10993-5<br>2009(R)2014 | Biological Evaluation Of Medical Devices - Part 5: Tests<br>For In Vitro Cytotoxicity | 2-153 |
| Body | Standard ID | Standard Title | FDA<br>Recognition # |
| AAMI<br>ANSI<br>ISO | 10993-6<br>2007/(R)2014 | Biological Evaluation Of Medical Devices - Part 6: Tests<br>For Local Effects After Implantation | 2-120 |
| AAMI<br>ANSI<br>ISO | 10993-7<br>2008(R)2012 | Biological Evaluation Of Medical Devices - Part 7:<br>Ethylene Oxide Sterilization Residuals | 14-278 |
| AAMI<br>ANSI<br>ISO | 10993-10<br>2010/(R)2014 | Biological Evaluation Of Medical Devices - Part 10:<br>Tests For Irritation And Skin Sensitization | 2-173 |
| AAMI<br>ANSI<br>ISO | 10993-11<br>2006/(R)2010 | Biological Evaluation Of Medical Devices - Part 11:<br>Tests For Systemic Toxicity | 2-118 |
| AAMI<br>ANSI<br>ISO | 11135<br>2014 | Sterilization Of Health-Care Products - Ethylene Oxide -<br>Requirements For The Development, Validation And<br>Routine Control Of A Sterilization Process For Medical<br>Devices | 14-479 |
| AAMI<br>ANSI<br>ISO | 11607-1<br>2006/(R)2010 | Packaging For Terminally Sterilized Medical Devices -<br>Part 1: Requirements For Materials, Sterile Barrier<br>Systems And Packaging Systems [Including:<br>Amendment 1 (2014)] | 14-457 |
| AAMI<br>ANSI<br>ISO | 14161<br>2009/(R)2014 | Sterilization Of Health Care Products - Biological<br>Indicators: Guidance For The Selection, Use And<br>Interpretation Of Results | 14-285 |
| ISO | 14708-1<br>2014 | Implants for surgery -- Active implantable medical<br>devices -<br>Part 1: General requirements for safety, marking and<br>for information to be provided by the manufacturer | N/A; Not<br>Recognized |
| AAMI<br>ANSI<br>ISO | 14971<br>2007/(R)2010 | Medical Devices - Applications Of Risk Management To<br>Medical Devices | 5-70 |
| AAMI<br>ANSI<br>ISO | 15223-1<br>2012 | Medical Devices - Symbols To Be Used With Medical<br>Devices Labels, Labeling, And Information To Be<br>Supplied - Part 1: General Requirements | 5-91 |
| IEC | 60068-2-27<br>2008 | Environmental testing - Part 2-27: Tests - Test Ea and<br>guidance: Shock | N/A; Not<br>Recognized |
| AAMI<br>ANSI<br>ES | 60601-1<br>2005/(R)2012 | Medical Electrical Equipment - Part 1: General<br>Requirements For Basic Safety And Essential<br>Performance (IEC 60601-1:2005, MOD) | 19-4 |
| AAMI<br>ANSI<br>IEC | 60601-1-2<br>2007/(R)2012 | Medical Electrical Equipment - Part 1-2: General<br>Requirements For Basic Safety And Essential<br>Performance Collateral Standard: Electromagnetic<br>Compatibility - Requirements And Tests | 19-2 |
| Body | Standard ID | Standard Title | FDA<br>Recognition # |
| AAMI<br>ANSI<br>IEC | 60601-1-2<br>2014 | Medical Electrical Equipment - Part 1-2: General<br>Requirements For Basic Safety And Essential<br>Performance Collateral Standard: Electromagnetic<br>Disturbances -- Requirements And Tests | 19-12 |
| AIM | 7351731 | Medical Electrical Equipment and System<br>Electromagnetic Immunity Test for Exposure to Radio<br>Frequency Identification Readers - An AIM Standard | 19-21 |
| IEC | 60601-1-6<br>Edition 3.1<br>2013-10 | Medical Electrical Equipment - Part 1-6: General<br>Requirements For Basic Safety And Essential<br>Performance - Collateral Standard: Usability | 5-89 |
| AAMI<br>ANSI<br>IEC | 60601-1-8<br>2006 & A1:2012 | Medical Electrical Equipment - Part 1-8: General<br>Requirements For Basic Safety And Essential<br>Performance - Collateral Standard: General<br>Requirements, Tests And Guidance For Alarm Systems<br>In Medical Electrical Equipment And Medical Electrical<br>Systems | 5-92 |
| IEC<br>TR | 60878<br>Ed. 3.0 B:2015 | Graphical Symbols For Electrical Equipment In Medical<br>Practice | 5-104 |
| AAMI<br>ANSI<br>IEC | 62304<br>2006 | Medical Device Software - Software Life Cycle<br>Processes | 13-32 |
| AAMI<br>ANSI<br>IEC | 62366<br>2007/(R)2013 | Medical Devices - Application Of Usability Engineering<br>To Medical Devices | 5-67 |
| AAMI<br>ANSI | BP22<br>1994/(R)2011 | Blood Pressure Transducers | 3-44 |
| ASTM | D4169-16 | Standard Practice For Performance Testing Of Shipping<br>Containers And Systems | 14-499 |
| ASTM | F1886/F1886M-09 | Standard Test Method For Determining Integrity Of<br>Seals For Flexible Packaging By Visual Inspection | 14-288 |
| ASTM | F1980-16 | Standard Guide For Accelerated Aging Of Sterile<br>Barrier Systems For Medical Devices | 14-497 |
| ASTM | F2096-11 | Standard Test Method For Detecting Gross Leaks In<br>Packaging By Internal Pressurization (Bubble Test) | 14-359 |
| ASTM | F88/F88M-15 | Standard Test Method For Seal Strength Of Flexible<br>Barrier Materials | 14-482 |
| ISTA | 2A<br>2016) | International Safe Transit Association, ISTA 2 Series:<br>Partial simulation performance tests, packaged<br>products weighing 150 lbs. or less | N/A; Not<br>Recognized |
| AAMI | NS28<br>1988/(R)2010 | Intracranial Pressure Monitoring Devices | 17-1 |
| AAMI<br>ANSI | ST72<br>2011/(R)2016 | Bacterial Endotoxins ">– Test Methods, Routine<br>Monitoring, And Alternatives To Batch Testing | 14-360 |

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