(298 days)
The Branchpoint AURA™ ICP Monitoring System is intended for use by a qualified neurosurgeon in the direct monitoring of intracranial pressure in intraparenchymal applications.
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-Ion 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)
Here's a breakdown of the acceptance criteria and the study information for the AURA™ ICP Monitoring System, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary provides a list of non-clinical bench tests performed to support substantial equivalence and demonstrate device performance. For the direct ICP measurement, the relevant standard is ANSI/AAMI NS28:1988(r)2010. While specific numerical acceptance criteria and precise reported device performance values for ICP measurement itself are not detailed in the provided text beyond meeting the standard, the document states:
| Acceptance Criterion (Test Name) | Reported Device Performance |
|---|---|
| ICP Monitor performance testing (ANSI/AAMI NS28:1988(r)2010) | Meets pre-defined acceptance criteria (implied compliance with standard) |
| Pressure measurement resolution testing | Meets pre-defined acceptance criteria (implied satisfactory resolution) |
| Barometric pressure compensation testing | Meets pre-defined acceptance criteria (implied satisfactory compensation) |
| System response time testing | Meets pre-defined acceptance criteria (implied satisfactory response time) |
For Biocompatibility, specific results are provided:
| Test (ISO 10993 Series) | Acceptance Criterion (implicitly, "non-cytotoxic," "non-sensitizer," etc.) | Reported Device Performance |
|---|---|---|
| MEM Elution (ISO 10993-5) | Non-cytotoxic | Non-cytotoxic: score of 0. |
| Sensitization Maximization Extract (ISO 10993-10) | Non-sensitizer | Non-sensitizer: No irritation was found on any of the negative control or test animals. |
| Intracutaneous Reactivity (ISO 10993-10) | Non-Irritant | Non-Irritant: The test device score for both extracts was 0. |
| Acute Systemic Injection (ISO 10993-11) | No systemic toxicity | No systemic toxicity: No test or control animals exhibited signs of toxicity. |
| Subacute and Subchronic Toxicity (IV) (ISO 10993-11) | No systemic toxicity | No systemic toxicity: No systemic toxic effects were observed. |
| Subacute and Subchronic Toxicity (IP) (ISO 10993-11) | No systemic toxicity | No systemic toxicity: No systemic toxic effects were observed. |
| Genotoxicity - Ames (ISO 10993-3) | Non-mutagenic | Non-mutagenic: The test article did not cause an increase in revertant colonies for any strain greater than two-fold over negative control values. |
| Genotoxicity - Mutagenicity (ISO 10993-3) | Non-clastogenic & non-genotoxic | Non-clastogenic & non-genotoxic: No statistical significant differences (p ≥ 0.05) were noted between the test and control extracts. |
| Genotoxicity - Mouse Lymphoma (ISO 10993-3) | Non-mutagenic & non-clastogenic | Non-mutagenic & non-clastogenic: RTG was > 10%. |
| Subcutaneous Implantation (ISO 10993-6) | Acceptable tissue reaction | Macroscopic reaction not significant compared to control; microscopically, slight irritant. |
| Brain Tissue Implantation (ISO 10993-6) | Acceptable tissue reaction | Neurobehavioral, gross pathological, clinical reactions not significant; histologically, minimal or no reaction. |
| Mediated Material Pyrogenicity (ISO 10993-11) | Non pyrogenic | Non pyrogenic: Temperature increase was < 0.5 °C for all animals. |
| Indirect (extract) Hemolysis (ISO 10993-4, ASTM F756-17) | Non hemolytic | Non hemolytic: Test article hemolytic index was 0.00%. |
| For Disposable Antenna Holster (Adhesive layer): | ||
| MEM Extraction Cytotoxicity (ISO 10993-5) | Non-cytotoxic | Non-cytotoxic: score of 0. |
| Skin Irritation (ISO 10993-10) | No irritation | No irritation: irritation index was 0. |
| Closed Patch Sensitization (ISO 10993-10) | No sensitization | No sensitization: no contact sensitization observed. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text only discusses "non-clinical bench tests" and "biocompatibility testing." It does not describe any clinical studies involving human patient data, nor does it mention machine learning algorithms that would typically involve test sets of data from a specific country or collected retrospectively/prospectively. The testing described is primarily focused on hardware and material performance, as well as adherence to recognized standards. Therefore, information about test set sample size or data provenance in the context of AI/ML is not available in this document.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. This document describes a medical device clearance based on substantial equivalence through non-clinical bench testing and biocompatibility. It does not involve diagnostic image analysis or other applications where expert ground truth establishment for a test set would be relevant.
4. Adjudication Method for the Test Set
Not applicable, as no test set requiring expert adjudication is described in the provided document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This document does not mention any MRMC study. The device is an ICP monitoring system, not a diagnostic imaging AI tool that would typically be evaluated with MRMC studies comparing human reader performance.
6. Standalone (Algorithm Only) Performance Study
Not applicable. The AURA™ ICP Monitoring System is a hardware device for direct physiological measurement, not an algorithm being deployed in a standalone capacity without human interaction for interpretation or diagnosis.
7. Type of Ground Truth Used
The "ground truth" for the tests described is the established scientific and engineering principles, and the specific pass/fail criteria outlined in the referenced national and international standards (e.g., ANSI/AAMI NS28 for ICP performance, ISO 10993 series for biocompatibility). For example, a score of 0 for cytotoxicity or a temperature increase < 0.5 °C for pyrogenicity constitutes the ground truth for those specific tests.
8. Sample Size for the Training Set
Not applicable. This document describes the clearance of a hardware medical device based on non-clinical testing and substantial equivalence, not an AI/ML algorithm that would typically involve a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set for an AI/ML algorithm is described in the provided document.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 (949) 829-1868 May 18th, 2018
Subject Device
| Trade Name: | AURA™ ICP Monitoring System |
|---|---|
| Common or Usual Name: | Intracranial Pressure Monitor |
| Classification: | Class II, Intracranial Pressure Monitoring Device21 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 MonitoringSystemK172209 Subject Device | Camino Slim Line ™ SystemK042728Predicate Device |
|---|---|---|
| Measured Variable | ICP | ICP and intracranial temperature |
| Clinical Application | Parenchymal pressuremeasurement | Parenchymal and sub-dural pressureand temperature measurement |
| Mechanism for ICPmeasurement | Solid state pressure sensorfor direct measurement | Solid state pressure sensor for directmeasurement |
| Classification Regulation | 21 CFR § 882.1620 | 21 CFR § 882.1620 |
| Classification Name(Product Code) | GWM | GWM |
| Intended Use | For use by a qualifiedneurosurgeon in the directmonitoring of intracranialpressure inintraparenchymalapplications. | For use by a qualified neurosurgeon inthe direct monitoring of intracranialpressure in both sub-dural andintraparenchymal applications. |
| Catheter Construction | Polyurethane | Polyurethane |
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| Characteristic | AURA™ ICP MonitoringSystemK172209 Subject Device | Camino Slim Line ™ SystemK042728Predicate 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 toMonitor | Data: Bluetooth low energy(range = 7 m for monitor handheld and data receiver)Power: Inductive coupling(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 ElutionISO 10993-5 | Non-cytotoxic: score of 0. |
| Sensitization Maximization ExtractISO 10993-10 | Non-sensitizer: No irritation was found on any of thenegative control or test animals. |
| IntracutaneousReactivityISO 10993-10 | Non-Irritant: The test device score for both extractswas 0. |
| Acute Systemic InjectionISO 10993-11 | No systemic toxicity: No test or control animalsexhibited signs of toxicity. |
| Subacute and Subchronic Toxicity (IV)ISO 10993-11 | No systemic toxicity: No systemic toxic effects wereobserved. |
| Subacute and Subchronic Toxicity (IP)ISO 10993-11 | No systemic toxicity: No systemic toxic effects wereobserved. |
| Genotoxicity - AmesISO 10993-3 | Non-mutagenic: The test article did not cause anincrease in revertant colonies for any strain greaterthan two-fold over negative control values. |
| Genotoxicity - MutagenicityISO 10993-3 | Non-clastogenic & non-genotoxic: No statisticalsignificant differences (p ≥ 0.05) were notedbetween the test and control extracts. |
| Genotoxicity - Mouse LymphomaISO 10993-3 | Non-mutagenic & non-clastogenic: RTG was > 10%. |
| Subcutaneous ImplantationISO 10993-6 | No systemic toxicity: Macroscopic reaction of thetest article was not significant as compared tocontrol. Microscopically, test article is classified as aslight irritant as compared to control. |
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| Test | Results |
|---|---|
| Brain Tissue ImplantationISO 10993-6 | No systemic toxicity: Neurobehavioral, grosspathological and clinical reactions caused by the testarticle were not significant as compared to control.Histologically, test article is classified as havingminimal or no reaction. |
| Mediated Material PyrogenicityISO 10993-11 | Non pyrogenic: Temperature increase was < 0.5 °Cfor all animals. |
| Indirect (extract) HemolysisISO 10993-4ASTM F756-17 | Non hemolytic: Test article hemolytic index was0.00%. |
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 CytotoxicityISO 10993-5 | Non-cytotoxic: score of 0. |
| Skin IrritationISO 10993-10 | No irritation: irritation index was 0. |
| Closed Patch SensitizationISO 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 | FDARecognition # |
|---|---|---|---|
| AAMIANSIISO | 10993-12009/(R)2013 | Biological Evaluation Of Medical Devices - Part 1:Evaluation And Testing Within A Risk ManagementProcess | 2-156 |
| AAMIANSIISO | 10993-32014 | Biological Evaluation Of Medical Devices - Part 3: TestsFor Genotoxicity, Carcinogenicity And ReproductiveToxicity | 2-226 |
| AAMIANSIISO | 10993-52009(R)2014 | Biological Evaluation Of Medical Devices - Part 5: TestsFor In Vitro Cytotoxicity | 2-153 |
| Body | Standard ID | Standard Title | FDARecognition # |
| AAMIANSIISO | 10993-62007/(R)2014 | Biological Evaluation Of Medical Devices - Part 6: TestsFor Local Effects After Implantation | 2-120 |
| AAMIANSIISO | 10993-72008(R)2012 | Biological Evaluation Of Medical Devices - Part 7:Ethylene Oxide Sterilization Residuals | 14-278 |
| AAMIANSIISO | 10993-102010/(R)2014 | Biological Evaluation Of Medical Devices - Part 10:Tests For Irritation And Skin Sensitization | 2-173 |
| AAMIANSIISO | 10993-112006/(R)2010 | Biological Evaluation Of Medical Devices - Part 11:Tests For Systemic Toxicity | 2-118 |
| AAMIANSIISO | 111352014 | Sterilization Of Health-Care Products - Ethylene Oxide -Requirements For The Development, Validation AndRoutine Control Of A Sterilization Process For MedicalDevices | 14-479 |
| AAMIANSIISO | 11607-12006/(R)2010 | Packaging For Terminally Sterilized Medical Devices -Part 1: Requirements For Materials, Sterile BarrierSystems And Packaging Systems [Including:Amendment 1 (2014)] | 14-457 |
| AAMIANSIISO | 141612009/(R)2014 | Sterilization Of Health Care Products - BiologicalIndicators: Guidance For The Selection, Use AndInterpretation Of Results | 14-285 |
| ISO | 14708-12014 | Implants for surgery -- Active implantable medicaldevices -Part 1: General requirements for safety, marking andfor information to be provided by the manufacturer | N/A; NotRecognized |
| AAMIANSIISO | 149712007/(R)2010 | Medical Devices - Applications Of Risk Management ToMedical Devices | 5-70 |
| AAMIANSIISO | 15223-12012 | Medical Devices - Symbols To Be Used With MedicalDevices Labels, Labeling, And Information To BeSupplied - Part 1: General Requirements | 5-91 |
| IEC | 60068-2-272008 | Environmental testing - Part 2-27: Tests - Test Ea andguidance: Shock | N/A; NotRecognized |
| AAMIANSIES | 60601-12005/(R)2012 | Medical Electrical Equipment - Part 1: GeneralRequirements For Basic Safety And EssentialPerformance (IEC 60601-1:2005, MOD) | 19-4 |
| AAMIANSIIEC | 60601-1-22007/(R)2012 | Medical Electrical Equipment - Part 1-2: GeneralRequirements For Basic Safety And EssentialPerformance Collateral Standard: ElectromagneticCompatibility - Requirements And Tests | 19-2 |
| Body | Standard ID | Standard Title | FDARecognition # |
| AAMIANSIIEC | 60601-1-22014 | Medical Electrical Equipment - Part 1-2: GeneralRequirements For Basic Safety And EssentialPerformance Collateral Standard: ElectromagneticDisturbances -- Requirements And Tests | 19-12 |
| AIM | 7351731 | Medical Electrical Equipment and SystemElectromagnetic Immunity Test for Exposure to RadioFrequency Identification Readers - An AIM Standard | 19-21 |
| IEC | 60601-1-6Edition 3.12013-10 | Medical Electrical Equipment - Part 1-6: GeneralRequirements For Basic Safety And EssentialPerformance - Collateral Standard: Usability | 5-89 |
| AAMIANSIIEC | 60601-1-82006 & A1:2012 | Medical Electrical Equipment - Part 1-8: GeneralRequirements For Basic Safety And EssentialPerformance - Collateral Standard: GeneralRequirements, Tests And Guidance For Alarm SystemsIn Medical Electrical Equipment And Medical ElectricalSystems | 5-92 |
| IECTR | 60878Ed. 3.0 B:2015 | Graphical Symbols For Electrical Equipment In MedicalPractice | 5-104 |
| AAMIANSIIEC | 623042006 | Medical Device Software - Software Life CycleProcesses | 13-32 |
| AAMIANSIIEC | 623662007/(R)2013 | Medical Devices - Application Of Usability EngineeringTo Medical Devices | 5-67 |
| AAMIANSI | BP221994/(R)2011 | Blood Pressure Transducers | 3-44 |
| ASTM | D4169-16 | Standard Practice For Performance Testing Of ShippingContainers And Systems | 14-499 |
| ASTM | F1886/F1886M-09 | Standard Test Method For Determining Integrity OfSeals For Flexible Packaging By Visual Inspection | 14-288 |
| ASTM | F1980-16 | Standard Guide For Accelerated Aging Of SterileBarrier Systems For Medical Devices | 14-497 |
| ASTM | F2096-11 | Standard Test Method For Detecting Gross Leaks InPackaging By Internal Pressurization (Bubble Test) | 14-359 |
| ASTM | F88/F88M-15 | Standard Test Method For Seal Strength Of FlexibleBarrier Materials | 14-482 |
| ISTA | 2A2016) | International Safe Transit Association, ISTA 2 Series:Partial simulation performance tests, packagedproducts weighing 150 lbs. or less | N/A; NotRecognized |
| AAMI | NS281988/(R)2010 | Intracranial Pressure Monitoring Devices | 17-1 |
| AAMIANSI | ST722011/(R)2016 | Bacterial Endotoxins ">– Test Methods, RoutineMonitoring, And Alternatives To Batch Testing | 14-360 |
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§ 882.1620 Intracranial pressure monitoring device.
(a)
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.(b)
Classification. Class II (performance standards).