Use of the CODMAN MICROSENSOR Basic Kit is indicated when direct ICP monitoring is required. The kit is indicated for use in both subdural and intraparenchymal pressure monitoring applications only.

Use of the CODMAN MICROSENSOR Plastic/Metal Skull Bolt Kit is indicated when direct intracranial pressure (ICP) monitoring is required. The kit is indicated for use in both subdural and intraparenchymal pressure monitoring applications.

Use of the Ventricular Catheter Kit is indicated when direct intraventricular pressure monitoring is required. The kit is indicated for use in ICP monitoring and cerebrospinal fluid (CSF) drainage applications.

Device Description

The Microsensor monitors intracranial pressure (ICP) through either a stand-alone probe, or a probe coupled with an EVD catheter, and is intended to be used in conjunction with the Codman ICP Express (product code 82-6635) neuromonitoring platform products. The ICP Express and Codman Microsensor are intended for use in Intensive Care Units (ICUs). The Microsensor converts the pressure signal to a voltage signal. The monitor provides power to the Microsensor, interprets the voltage signal from the Microsensor, and displays the corresponding pressure measurements taken by the Codman Microsensor during a patient's treatment and during patient transport. There is no change to the Codman ICP Express monitor as a result of the probe modifications described in this submission.

The Codman Microsensor probe contains a small, thin and delicate pressure sensor used to measure the intracranial pressure. The sensing element uses a strain gauge located at the tip of the probe. The sensing element is protected by a titanium housing and is exposed to the environment via a silicone membrane. The sensor is connected via wires to a plastic connector housing, and the wires are snaked through a nylon catheter. The connector housing includes a compensation/calibration passive circuit on a Printed Circuit Board and has an electrical connector to attach the ICP Express monitoring box.

The Codman Microsensor Kits include components needed to facilitate the surgical implantation of the ICP Microsensor. The components that will be included with the proposed Codman Microsensor are currently cleared devices, and are identical to the components currently packaged within the current Codman Microsensor kits (i.e. via this 510k, there are no changes being made to the kit components, only the Microsensor is being updated). Each component and their function are described in the Description section of the Instructions for Use for each kit.

AI/ML Overview

The provided text describes the Codman Microsensor Kits, an intracranial pressure monitoring device, and the studies conducted to demonstrate its substantial equivalence to a predicate device. The information is presented in the context of a 510(k) premarket notification.

Here's an analysis of the acceptance criteria and the studies that prove the device meets them, based on the provided document:

Acceptance Criteria and Reported Device Performance

The document outlines acceptance criteria and performance through a series of bench tests. The relevant information is summarized in "Table 4. Verification and Validation Bench Tests" and implicitly stated through "PASS" results for each test.

Acceptance Criteria (Test Purpose/Method Summary)	Reported Device Performance (Results)
Long Term Accuracy: Confirm pressure accuracy, linearity, hysteresis, and sensitivity over time.	PASS
Long Term Drift: Confirm drift characteristic over time and evaluate for fluid ingress into the probe's sensing element. (Specifically, the comparison table notes "No greater than 5mmHg over 30 days" as the proposed device's drift, which is an improvement over the predicate's "No greater than 5mmHg/7days").	PASS
Temperature Sensitivity: Confirm sensitivity of pressure output to temperature changes.	PASS
Seal Integrity: Confirm no fluid ingress into the probe's sensing element.	PASS
Bond Strength: Confirm mechanical strength and meet pull force requirements.	PASS
Flexibility: Confirm flexibility (coiling) and its effect on pressure measurement.	PASS
Kink: Confirm kink resistance and its effect on pressure measurement.	PASS
Connector Cycles and Impedance: Confirm reliability of the connector by measuring input/output impedance after connect/disconnect simulation and meeting specifications.	PASS
Zero Offset: Confirm initial zero offset of the pressure sensor is within the specified value.	PASS
Heat Transfer: Confirm heat dissipation of the implantable portion does not exceed ANSI AAMI NS28(1988)-R(2010) recommended maximum temperature.	PASS
Frequency Response: Confirm frequency response (bandwidth) of the device.	PASS
Environmental: Confirm device is not affected by transportation (vibration, drops), can be stored at specified temp/humidity, and operates within expected environmental conditions.	PASS
Critical Dimensions: Confirm physical dimensions and that samples meet product drawing.	PASS
MRI Compatibility: Confirm functionality of the device before and after exposure to 1.5T MRI and 3T MRI.	PASS
MRI Safety: (Refer to Table 5, which lists specific ASTM standards.)	PASS
Radiopacity: Confirm device has a radiopaque feature detectable in an X-ray image.	PASS
CT Scan Compatibility: Confirm functionality before and after a CT scan exposure.	PASS
Over Pressure: Confirm device can withstand extreme pressures without damage.	PASS
Calibration Stability: Confirm sensitivity of probe calibration to impacts to the device's housing.	PASS
Sterilization: (EO Residual Testing per ISO 10993-7:2008 (R) 2012).	PASS
Biocompatibility: (Refer to Table 6 and 7, which list specific tests).	PASS
ICP Express Compatibility: Confirm device works as intended with the ICP Express Monitor.	PASS

Study Details:

Sample size used for the test set and the data provenance:
- The document does not specify the exact sample sizes (number of devices or measurements) used for each individual bench test listed in Table 4.
- Data Provenance: The studies are described as "Bench Testing" and "Biocompatibility Testing," implying laboratory-controlled experiments rather than human or animal subject data, except for some biocompatibility tests which use animal models. No country of origin for the data is explicitly mentioned, but the submission is to the U.S. FDA, and relevant standards like ASTM and ISO are cited. The studies are prospective in nature, conducted specifically for this submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable as the evaluation relies on physical and chemical measurements against engineering specifications and industry standards, not on expert interpretation of complex clinical data to establish a ground truth. The "ground truth" here is defined by established scientific principles and performance metrics.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This is not applicable as the studies are bench tests and biocompatibility evaluations, which involve objective measurements and adherence to predetermined standards rather than subjective human interpretation requiring adjudication.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an intracranial pressure monitoring transducer, not an AI-assisted diagnostic imaging device that would typically involve human readers or AI algorithms for interpretation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable. The device is a physical medical device (a pressure transducer), not a software algorithm or AI model.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the performance evaluation is based on engineering specifications, established physical measurement methods, and compliance with recognized industry standards (e.g., ASTM, ISO). For biocompatibility, it's based on biological responses in animal models and in vitro tests (cytotoxicity, sensitization, irritation, pyrogenicity, mutagenicity, implantation, hemolysis) against accepted safety thresholds.
The sample size for the training set:
- This is not applicable as the device is a physical medical device and does not involve AI or machine learning algorithms that require training sets.
How the ground truth for the training set was established:
- This is not applicable for the same reason as point 7.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 19, 2016

Codman & Shurtleff, Inc. Megan Palumbo Senior Regulatory Affairs Specialist 325 Paramount Dr. Raynham, Massachusetts 02767

Re: K153347

Trade/Device Name: Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit With Tuohyborst Adapter.codman Microsensor Metal Skull Bolt Kit. Codman Microsensor Ventricular Catheter Kit Regulation Number: 21 CFR 882.1620

Regulation Name: Intracranial Pressure Monitoring Device Regulatory Class: Class II Product Code: GWM Dated: July 19, 2016 Received: July 20, 2016

Dear Ms. Palumbo:

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 (reporting of medical device

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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" (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.

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,

William J.	Digitally signed by William J. Heetderks -A
Heetderks -A	DN: c=US, o=U.S. Government, ou=HHS,
	ou=NIH, ou=People,
	0.9.2342.19200300.100.1.1=0010149848,
	cn=William J. Heetderks -A
	Date: 2016.08.19 11:47:11 -04'00'

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) K153347

Device Name

Codman® Microsensor: 62-6631 Microsensor Basic Kit, 62-6632 Microsensor Plastic Skull Bolt Kit, 62-6633 Microsensor Ventricular Catheter Kit with Tuohy-Borst Adapter, 62-6638 Microsensor Metal Skull Bolt Kit, and 62-663 Microsensor Ventricular Catheter Kit

Indications for Use (Describe)

62-6631 Codman Microsensor Basic Kit:

Use of the CODMAN MICROSENSOR Basic Kit is indicated when direct ICP monitoring is required. The kit is indicated for use in both subdural and intraparenchymal pressure monitoring applications only.

62-6632 and 62-6638 Codman Microsensor Skull Bolt Kit (Plastic and Metal):

62-6633 Codman Microsensor Catheter Kit and

62-6653 Codman Microsensor Ventricular Catheter Kit with Tuohy-Borst Adapter:

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

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

Codman® Microsensor Kits

Date Prepared:	November 13, 2015
Company Name:	Codman & Shurtleff, Inc.325 Paramount DriveRaynham, MA 02767
Contact Person	Megan Palumbo, Pharm DSenior Regulatory Affairs SpecialistTelephone Number: (508) 828-3571Fax Number: (508) 977-6428
Device Proprietary Name:	Codman® Microsensor Kits
Device Common Name:	Intracranial Pressure Transducer
Classification Name:	Intracranial Pressure Monitoring Devices
Device Classification:	Class II (21 CFR 882.1620)
Product Code:	GWM
Type of 510(k) Submission:	Traditional 510(k)
Basis for Submission:	MR Labeling and Material Changes
Predicate Device(s):	K914479 K974088 K991222	Codman® Intracranial Pressure TransducerCodman® Intracranial Bolt (reference device)Codman® Microsensor Ventricular Catheter Kit(reference device)

Device Description

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treatment and during patient transport. There is no change to the Codman ICP Express monitor as a result of the probe modifications described in this submission.

Indications for Use

Table 2 describes the Indications for Use statement for each of the 5 proposed Codman Microsensor product codes:

Table 2. Codman Microsensor Kit Indications for Use
DeviceDescription	ProposedProductCode	Indications for Use
CodmanMicrosensorBasic Kit	62-6631	Use of the CODMAN MICROSENSOR Basic Kit is indicated when direct ICPmonitoring is required. The kit is indicated for use in both subdural andintraparenchymal pressure monitoring applications only.
CodmanMicrosensorSkull Bolt Kit(Plastic andMetal)	62-663262-6638	Use of the CODMAN MICROSENSOR Plastic/Metal Skull Bolt Kit is indicatedwhen direct intracranial pressure (ICP) monitoring is required. The kit is indicatedfor use in both subdural and intraparenchymal pressure monitoring applications.
CodmanMicrosensorCatheter Kit&CodmanMicrosensorVentricularCatheter Kitwith Tuohy-Borst Adapter	62-663362-6653	Use of the Ventricular Catheter Kit is indicated when direct intraventricularpressure monitoring is required. The kit is indicated for use in ICP monitoring andcerebrospinal fluid (CSF) drainage applications.

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Comparison to Predicate Device

Compared to the predicate device, the proposed Codman Microsensor Kit includes the modifications listed in Table 3 and 3A.

Table 3.
Comparison of Predicate and Proposed Codman Microsensor Kits
Characteristic	Predicate Codman Microsensor Kit(K914479)	Proposed Codman Microsensor Kit(This Submission)
FDA Product Code	GWM	Same as predicate
Classification	21 CFR 882.1620	Same as predicate
Classification Name	Device, Monitoring, Intracranial Pressure	Same as predicate
Indication for Use	82-6631, 82-6632 & 82-6638Indicated when direct ICP monitoring isrequired. The kit is indicated for use in bothsubdural and intraparenchymal pressuremonitoring applications only.82-6633, 82-6653Indicated when direct intraventricular pressuremonitoring is required. The kit is indicated foruse in ICP monitoring and cerebrospinal fluid(CSF) drainage applications.	Same as predicate:62-6631, 62-6632 & 62-6638Indicated when direct ICP monitoring isrequired. The kit is indicated for use in bothsubdural and intraparenchymal pressuremonitoring applications only.62-6633, 62-6653Indicated when direct intraventricular pressuremonitoring is required. The kit is indicated foruse in ICP monitoring and cerebrospinal fluid(CSF) drainage applications.
Contraindications	See Table 3A	See Table 3A
Device Materials
Printed Circuit Board(PCB) inside plasticconnector housing	PCB Material: FR4PCB Solder Mask Color: GreenPCB Finish: Leaded	ROHS Compliant:PCB Material: FR-370HRPCB Solder Mask Color: BluePCB Finish: Lead-Free
Solder Wire	Solder Wire, .015" K100LD "275"	ROHS Compliant:Lead-free Solder Wire, #66/275 K100LD,0.015"
Solder Wire	Solder Wire, .031" SN63PB37 RA CORE	ROHS Compliant:Lead-Free Solder Wire, #66/275 K100LD,0.031"
Thru-hole resistorlocated inside plasticconnector	METAL FILM,RN55C/D/E	ROHS Compliant:METAL FILM,CMF55,SERIES,ROHS
Epoxy Glue	Armstrong A-2/H-20	Loctite M-121HP
Catheter 100cm tubing	Besno Nylon 11, White	Besno Nylon 11, 2.5% Yellow
Sensor Top Label for theplastic connectorhousing.	Material: #30 High Gloss White PaperAdhesive: 3M 320/320 NR Acrylic AdhesiveBack	Same as Predicate Sensor Bottom Label:Material: 70# C1S Digital Top Coated lithopaper, 3.7-mil (DO7000)Adhesive: 2.0-mil acrylic adhesive (JDC item2369sl)Laminate: 1.5-mil polypropylene (STA item1206)
Sensor Bottom Label onplastic connectorhousing	Material: 70# C1S Digital Top Coated lithopaper, 3.7-mil (DO7000)Adhesive: 2.0-mil acrylic adhesive (JDC item2369sl)Laminate: 1.5-mil polypropylene (STA item1206)	Same as predicate
	Table 3.Comparison of Predicate and Proposed Codman Microsensor Kits
Characteristic	Predicate Codman Microsensor Kit(K914479)	Proposed Codman Microsensor Kit(This Submission)
Catheter Strain Relief	Clear Silicone	Same as predicate
Titanium Case	Titanium Grade 2	Same as predicate
Silicone Membrane	RTV-112	Same as predicate
Packaging Materials
Pouch (62-6631, 62-6632, 62-6638)	ТРТ 0260 Coated TYVEK sealed to TPF0501A film.	Same as predicate
Unit Box (62-6631, 62-6632, 62-6638)	Performa White350 g/m²	Same as predicate
Blister Lid (62-6633)	HCW-CR27 Coated Tyvek	Same as predicate
Blister Tray (62-6633)	PETG	Same as predicate
Unit Box (62-6633)	Solid bleached sulfate 20pt paper board	Same as predicate
Pouch (62-6653)	ТРТ 0260 Coated TYVEK sealed to TPF0501A film	Same as predicate
Unit Box (62-6653)	Solid bleached sulfate 20pt paper board	Same as predicate
Device Characteristics
MRI claim	None	1.5T and 3T Conditional
Sterilization	Ethylene Oxide	Same as predicate
Shelf Life	5 years	2 year
Energy Modality	5 volts DC when connected to the ICPmonitoring device	Same as predicate
Microsensor Dimensions	Length: 100cm nominalTip diameter: 1.3mm maxTubing diameter: 0.8mm maxCatheter length (ventricular kit): 38cm nominalCatheter diameter (ventricular kit): 3.5mm max	Same as predicate
Sensing Element	Strain gauge silicon microchip	Same as predicate
Functional PressureRange	-50mmHg to 250mmHg	Same as predicate
Functional Over PressureRange Without Damage	-700mmHg to 1250mmHg	Same as predicate
Input/Output Impedance	1000 ohms nominal	Same as predicate
Output Signal(sensitivity)	5uV/V/mmHg	Same as predicate
Zero Drift	No greater than 5mmHg/7days	No greater than 5mmHg over 30 days
Table 3A.Comparison of Predicate and Proposed Codman Microsensor Kits
Characteristic	Predicate Codman Microsensor Kit(K914479)	Proposed Codman Microsensor Kit(This Submission)
Labeling
Indication for Use	82-6631, 82-6632 & 82-6638Indicated when direct ICP monitoring isrequired. The kit is indicated for use in bothsubdural and intraparenchymal pressuremonitoring applications only.82-6633, 82-6653	Same as predicate:62-6631, 62-6632 & 62-6638Indicated when direct ICP monitoring isrequired. The kit is indicated for use in bothsubdural and intraparenchymal pressuremonitoring applications only.62-6633, 62-6653
Table 3A. Comparison of Predicate and Proposed Codman Microsensor Kits
Characteristic	Predicate Codman Microsensor Kit (K914479)	Proposed Codman Microsensor Kit (This Submission)
	Indicated when direct intraventricular pressure monitoring is required. The kit is indicated for use in ICP monitoring and cerebrospinal fluid (CSF) drainage applications.	Indicated when direct intraventricular pressure monitoring is required. The kit is indicated for use in ICP monitoring and cerebrospinal fluid (CSF) drainage applications.
Contraindications( differences are italicized )	82-6631:This kit is not designed, sold or intended for any use except as indicatedThis kit is not designed, sold or intended for use as a therapeutic deviceCompatibility of implantable catheter-tipped pressure transducers with magnetic resonance imaging (MRI) has not been determined.	62-6631:This kit is not designed, sold or intended for any use except as indicatedThis kit is not designed, sold or intended for use as a therapeutic device
	82-6632:Insertion of the skull bolt is contraindicated in children under one year of age.This kit is not designed, sold, or intended for any use except as indicated.This kit is not designed, sold, or intended for use as a therapeutic device.Compatibility of implantable catheter-tipped pressure transducers with magnetic resonance imaging (MRI) has not been determined.	62-6632:Insertion of the skull bolt is contraindicated in children less than one year of age.This kit is not designed, sold, or intended for any use except as indicated.This kit is not designed, sold, or intended for use as a therapeutic device.
	82-6633:Monitoring of intracranial pressure through the use of ventriculostomy techniques may be contraindicated (e.g., with conditions such as encephalitis, brain swelling secondary to trauma, diffuse encephalopathies, and Reye's syndrome). Ventriculostomy is contraindicated in patients with a coagulopathy.Use of the CODMAN MICROSENSOR Catheter Kit is contraindicated in children under one year of age.This device is not designed, sold, or intended for any use except as indicated.This device is not designed, sold, or intended for use as a therapeutic device.Compatibility of implantable catheter-tipped pressure transducers with magnetic resonance imaging (MRI) has not been determined.	62-6633:Ventriculostomy is contraindicated in patients with coagulopathy or active infection in the area of the catheter.Use of the Ventricular Catheter Kit is contraindicated in children less than one year of age.This kit is not designed, sold, or intended for any use except as indicated.
	82-6638:Insertion of the skull bolt is contraindicated in children under one year of age.This device is not designed, sold, or intended for any use except as indicated.This kit is not designed, sold, or intended for use as a therapeutic device.	62-6638:Use of the skull bolt is contraindicated in children less than one year of age.This kit is not designed, sold, or intended for any use except as indicated.This kit is not designed, sold, or intended for use as a therapeutic device.
Characteristic	Predicate Codman Microsensor Kit(K914479)	Proposed Codman Microsensor Kit(This Submission)
	Compatibility of implantable catheter-tipped pressure transducers with magnetic resonance imaging (MRI) has not been determined.
	82-6653:Ventriculostomy is contraindicated in patients with coagulopathy or active infection in the area of the catheter. Use of the CODMAN Ventricular Catheter Kit is contraindicated in children under one year of age.	62-6653:Ventriculostomy is contraindicated in patients with coagulopathy or active infection in the area of the catheter. Use of the Ventricular Catheter Kit is contraindicated in children less than one year of age. This kit is not designed, sold, or intended for any use except as indicated.
MRI claim	None	1.5T and 3T Conditional
Shelf Life	5 years	2 year

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Performance Data

The following performance data are provided in support of the substantial equivalence determination:

Bench Testing

Bench testing on the proposed device, the Codman Microsensor, included the Design Verification and Validation tests listed in Table 4:

Table 4. Verification and Validation Bench Tests
Test	Test Method Summary	Results
Long Term Accuracy	The purpose of this test is to confirm the pressure accuracy, linearity, hysteresis, and sensitivity of the device over time.	PASS:
Long Term Drift	The purpose of this test is to confirm the drift characteristic of the device over time. The report also evaluates if there is any fluid ingress into the probe's sensing element.	PASS:
Temperature Sensitivity	The purpose of this test is to confirm the sensitivity of the pressure output to temperature changes.	PASS:
Seal Integrity	The purpose of this test is to confirm that there is no fluid ingress into the probe's sensing element. Seal integrity refers to the mechanical barrier that prevents fluids to contact the electrical components of the pressure probe sensing elements.	PASS:
Bond Strength	The purpose of this test is to confirm the mechanical strength of the device and determine if it meets the pull force requirements.	PASS:
Flexibility	The purpose of this test is to confirm the flexibility of the device (coiling) and determine if it affects its ability to measure pressure.	PASS:
Kink	The purpose of this test is to confirm the kink resistance of the device and determine if it affects its ability to measure pressure.	PASS:
Connector Cycles and Impedance	The purpose of this test is to confirm the reliability of the device's connector by measuring the input and output impedance after a connect/ disconnect simulation and to confirm that the input and output impedance values meet specifications.	PASS:
Zero Offset	The purpose of this test is to confirm that initial zero offset of the pressure sensor is within the specified value.	PASS:
Heat Transfer	The purpose of this test is to confirm that the heat dissipation of the implantable portion of the device does not exceed the maximum temperature recommended in ANSI AAMI NS28(1988)-R(2010).	PASS:
Frequency Response	The purpose of this test is to confirm the frequency response (i.e., bandwidth) of the device	PASS:
Environmental	The purpose of this test is to confirm that the device are not affected by transportation conditions (e.g., vibration and drops), that it can be stored at the specified temperature and humidity levels, and that it can operate within the expected environmental conditions including temperature, humidity and altitude.	PASS:

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Table 4. Verification and Validation Bench Tests
Test	Test Method Summary	Results
Critical Dimensions	The purpose of this report is to confirm the physical dimensions of the device andconfirm that the samples used for design verification testing meet the productdrawing.	PASS:
MRI Compatibility	The purpose of this test is to confirm the functionality of the device before and afterexposure to 1.5T MRI and 3T MRI.	PASS:
MRI Safety	Refer to Table 5	Refer to Table 5
Radiopacity	The purpose of this test is to confirm that the device has a radiopaque feature that canbe detected in an X-ray image	PASS:
CT Scan Compatibility	The purpose of this test is to confirm the functionality of the device before and after aCT scanexposure	PASS:
Over Pressure	The purpose of this test is to confirm that the device can withstand extreme pressureswithout damage	PASS:
Calibration Stability	The purpose of this test is to confirm the sensitivity of the probe calibration to impactsto the device's housing	PASS:
MRI Safety	Refer to Table 5	Refer to Table 5
Sterilization	EO Residual Testing per ISO 10993-7:2008 (R) 2012	PASS:
Biocompatibility	Refer to Table 6 and 7	Refer to Table 6 and 7
ICP ExpressCompatibility	The purpose of this test is to confirm that the device will work as intended with theICP Express Monitor	PASS:

Test results demonstrated that the acceptance criteria were met, therefore, the Codman Microsensor conforms to expected device performance and intended use. Results of verification and validation testing have demonstrated that the proposed Codman Microsensor is substantially equivalent to the predicate Codman Intracranial Pressure Transducer, and that the modifications do not impact the safety or effectiveness of the proposed device.

Magnetic Resonance (MR) Testing

The safety test requirements of the ASTM MR standards for the proposed Codman Microsensor have been met through testing. The Codman Microsensor is MR-Conditional at 1.5 and 3.0 Tesla per the following standards listed in Table 5.

Table 5. ASTM Magnetic Resonance Standards
Test	Test Method	Results
Standard Practice for Marking Medical Devices and Other Items for Safetyin the Magnetic Resonance Environment	ASTM F2503-13	PASS
Standard Test Method for Measurement of Magnetically InducedDisplacement Force on Medical Devices in the Magnetic ResonanceEnvironment	ASTM F2052-15	PASS
Standard Test Method for Measurement of Radio Frequency InducedHeating Near Passive Implants During Magnetic Resonance Imaging	ASTM F2182-11a	PASS
Standard Test Method for Evaluation of MR Image Artifacts from PassiveImplants	ASTM F2119-07(R2013)	PASS
Standard Test Method for Measurement of Magnetically Induced Torque onMedical Devices in the Magnetic Resonance Environment	ASTM F2213-06(R2011)	PASS
Assessment of the safety of magnetic resonance imaging for patients with anactive implantable medical device	ISO 10974:2012	PASS

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Biocompatibility Testing

The biocompatibility evaluations for the Codman Microsensor were conducted in accordance with the FDA Blue Book Memorandum #G95-1 Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing May 1, 1995, and International Standard ISO 10993-1 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process as recognized by FDA. In addition, information on the yellow colorant recommended by the FDA in the 2013 Draft Guidance on use of ISO 10993-1 was obtained and a toxicological risk assessment of the constituents of the yellow colorant formulation was conducted.

Codman Microsensor Probe Tip and Tubing

The Codman Microsensor Probe Tip and Tubing are considered an implant device with prolonged contact (>24, but <30 days) to bone and tissue. Biocompatibility testing was completed with passing results. The following tests listed in Table 6 were conducted:

Table 6. Biocompatibility Tests Conducted – ICP Probe Tip and Tubing
TEST	Result
In Vitro Cytotoxicity – ISO MEM Elution	Non-cytotoxic
Guinea Pig Sensitization - ISO Maximization	Non-sensitizing
Intracutaneous/Irritation Reactivity – ISO Intracutaneous in Rabbits	Non-irritating
Acute Systemic Toxicity – ISO Systemic Toxicity in Mice	Non-toxic
Material Mediated Pyrogenicity – USP Rabbit Pyrogen	Non-pyrogenic
ISO Muscle Implantation Study in Rabbits (4 weeks)	Non-irritant
In Vitro Ames Bacterial Reverse Mutation Assay	Non-mutagenic
In Vitro Mouse Lymphoma Mutagenicity Assay	Non-mutagenic
In Vivo Mouse Peripheral Blood Micronucleus Assay	Non-clastogenic
ISO Systemic Toxicity Study in Rats Following Subcutaneous Implantation (4 weeks)	Non-toxic and Non-irritating
USP Physicochemical Tests (Aqueous Extracts)	PASS
Subacute Toxicity Study to Assess the Tissue Response to Codman Neuro's RoHS ICP Probe in the Rabbit Brain	PASS
ASTM In Vitro Hemolysis	PASS

Codman Microsensor Electrical Housing

The Codman Microsensor Electrical Housing is considered a surface device with prolonged contact (>24, but <30 days) to skin. Biocompatibility testing was completed with passing results. The following tests listed in Table 7 were conducted:

Table 7. Biocompatibility Tests Conducted – Electrical Housing Connector
TEST	Result
In Vitro Cytotoxicity – ISO MEM Elution	Non-cytotoxic
Guinea Pig Sensitization – ISO Maximization	Non-sensitizing
Intracutaneous/Irritation Reactivity – ISO Intracutaneous inRabbits	Non-irritating
USP Physicochemical Tests (Aqueous Extracts)	Met USP <661> limits (Pass)

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Sterilization

The Codman Microsensor Kits are sterilized using Ethylene Oxide sterilization and were validated and audited to assure a Sterility Assurance Level (SAL) 10°.

Animal Studies

No animal studies were required, as appropriate verification of the modified device was achieved based on the similarities of the proposed device to the predicate device, and from results of bench testing and the biocompatibility evaluation.

Clinical Studies

No clinical studies were required, as appropriate verification of the modified was achieved based on the similarities of the proposed device to the predicate device, and from results of bench testing and the biocompatibility evaluation.

Statement of Substantial Equivalence

Based upon the design, function, materials, intended use, and the testing performed for this submission, it is concluded that the proposed Codman Microsensor Kits are substantially equivalent to the predicate Codman Microsensor Kits (K914479) and do not raise new issues of safety and effectiveness.

Regulation Number and Section

§ 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).