Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit with Tuohy-Borst Adapter,Codman Microsensor Metal Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit

K153347 · Codman & Shurtleff, Inc. · GWM · Aug 19, 2016 · Neurology

Device Facts

• Record ID: K153347
• Device Name: Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit with Tuohy-Borst Adapter,Codman Microsensor Metal Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit
• Applicant: Codman & Shurtleff, Inc.
• Product Code: GWM · Neurology
• Decision Date: Aug 19, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1620
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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 Story

Codman Microsensor monitors intracranial pressure (ICP) via strain gauge sensor at probe tip. Input: pressure signal from patient brain tissue/ventricle. Transformation: sensor converts pressure to voltage signal; passive circuit in connector housing provides calibration. Output: voltage signal sent to Codman ICP Express platform for display. Used in ICUs by clinicians. Provides real-time pressure data to guide clinical management of neurological conditions. Benefits: enables continuous ICP monitoring and CSF drainage to manage intracranial hypertension.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including long-term accuracy, drift, seal integrity, bond strength, kink resistance, connector reliability, heat transfer, frequency response, and MRI compatibility/safety testing per ASTM F2503, F2052, F2182, F2119, F2213, and ISO 10974. Biocompatibility testing performed per ISO 10993.

Technological Characteristics

Strain gauge silicon microchip sensor; titanium Grade 2 housing; silicone membrane (RTV-112); nylon catheter. RoHS-compliant PCB (FR-370HR) and lead-free solder. Energy: 5V DC from ICP Express monitor. Dimensions: 1.3mm max tip diameter. Sterilization: Ethylene Oxide. MR-Conditional (1.5T/3T).

Indications for Use

Indicated for patients requiring direct intracranial pressure (ICP) monitoring (subdural, intraparenchymal, or intraventricular) and CSF drainage. Contraindicated in children <1 year of age; ventriculostomy contraindicated in patients with coagulopathy or active infection at catheter site.

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

• Codman Intracranial Pressure Transducer (K914479)
• Codman Intracranial Bolt (K974088)
• Codman Microsensor Ventricular Catheter Kit (K991222)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol featuring three stylized human profiles facing to the right, layered on top of each other.

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 [phone] or [phone] 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 [phone] or [phone] 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):

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.

62-6633 Codman Microsensor Catheter Kit and

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

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.

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

| <span> <b> ☑ </b> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|----------------------------------------------------------------------------------------|
| <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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## 510(k) SUMMARY

# Codman® Microsensor Kits

| Date Prepared: | November 13, 2015 | |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Name: | Codman & Shurtleff, Inc.<br>325 Paramount Drive<br>Raynham, MA 02767 | |
| Contact Person | Megan Palumbo, Pharm D<br>Senior Regulatory Affairs Specialist<br>Telephone Number: [phone]<br>Fax Number: [phone] | |
| 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<br>K974088<br>K991222 | Codman® Intracranial Pressure Transducer<br>Codman® Intracranial Bolt (reference device)<br>Codman® Microsensor Ventricular Catheter Kit<br>(reference device) |

### 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

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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.

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.

### 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 | | |
|------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Description | Proposed<br>Product<br>Code | Indications for Use |
| Codman<br>Microsensor<br>Basic Kit | 62-6631 | Use of the CODMAN MICROSENSOR Basic Kit is indicated when direct ICP<br>monitoring is required. The kit is indicated for use in both subdural and<br>intraparenchymal pressure monitoring applications only. |
| Codman<br>Microsensor<br>Skull Bolt Kit<br>(Plastic and<br>Metal) | 62-6632<br>62-6638 | Use of the CODMAN MICROSENSOR Plastic/Metal Skull Bolt Kit is indicated<br>when direct intracranial pressure (ICP) monitoring is required. The kit is indicated<br>for use in both subdural and intraparenchymal pressure monitoring applications. |
| Codman<br>Microsensor<br>Catheter Kit<br>&<br>Codman<br>Microsensor<br>Ventricular<br>Catheter Kit<br>with Tuohy-<br>Borst Adapter | 62-6633<br>62-6653 | Use of the Ventricular Catheter Kit is indicated when direct intraventricular<br>pressure monitoring is required. The kit is indicated for use in ICP monitoring and<br>cerebrospinal 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<br>(K914479) | Proposed Codman Microsensor Kit<br>(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 & 82-6638<br>Indicated when direct ICP monitoring is<br>required. The kit is indicated for use in both<br>subdural and intraparenchymal pressure<br>monitoring applications only.<br>82-6633, 82-6653<br>Indicated when direct intraventricular pressure<br>monitoring is required. The kit is indicated for<br>use in ICP monitoring and cerebrospinal fluid<br>(CSF) drainage applications. | Same as predicate:<br>62-6631, 62-6632 & 62-6638<br>Indicated when direct ICP monitoring is<br>required. The kit is indicated for use in both<br>subdural and intraparenchymal pressure<br>monitoring applications only.<br>62-6633, 62-6653<br>Indicated when direct intraventricular pressure<br>monitoring is required. The kit is indicated for<br>use in ICP monitoring and cerebrospinal fluid<br>(CSF) drainage applications. |
| Contraindications | See Table 3A | See Table 3A |
| Device Materials | | |
| Printed Circuit Board<br>(PCB) inside plastic<br>connector housing | PCB Material: FR4<br>PCB Solder Mask Color: Green<br>PCB Finish: Leaded | ROHS Compliant:<br>PCB Material: FR-370HR<br>PCB Solder Mask Color: Blue<br>PCB Finish: Lead-Free |
| Solder Wire | Solder Wire, .015" K100LD "275" | ROHS Compliant:<br>Lead-free Solder Wire, #66/275 K100LD,<br>0.015" |
| Solder Wire | Solder Wire, .031" SN63PB37 RA CORE | ROHS Compliant:<br>Lead-Free Solder Wire, #66/275 K100LD,<br>0.031" |
| Thru-hole resistor<br>located inside plastic<br>connector | METAL FILM,RN55C/D/E | ROHS Compliant:<br>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 the<br>plastic connector<br>housing. | Material: #30 High Gloss White Paper<br>Adhesive: 3M 320/320 NR Acrylic Adhesive<br>Back | Same as Predicate Sensor Bottom Label:<br>Material: 70# C1S Digital Top Coated litho<br>paper, 3.7-mil (DO7000)<br>Adhesive: 2.0-mil acrylic adhesive (JDC item<br>2369sl)<br>Laminate: 1.5-mil polypropylene (STA item<br>1206) |
| Sensor Bottom Label on<br>plastic connector<br>housing | Material: 70# C1S Digital Top Coated litho<br>paper, 3.7-mil (DO7000)<br>Adhesive: 2.0-mil acrylic adhesive (JDC item<br>2369sl)<br>Laminate: 1.5-mil polypropylene (STA item<br>1206) | Same as predicate |
| | Table 3.<br>Comparison of Predicate and Proposed Codman Microsensor Kits | |
| Characteristic | Predicate Codman Microsensor Kit<br>(K914479) | Proposed Codman Microsensor Kit<br>(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 |
| <b>Packaging Materials</b> | | |
| Pouch (62-6631, 62-<br>6632, 62-6638) | ТРТ 0260 Coated TYVEK sealed to TPF<br>0501A film. | Same as predicate |
| Unit Box (62-6631, 62-<br>6632, 62-6638) | Performa White<br>350 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 TPF<br>0501A film | Same as predicate |
| Unit Box (62-6653) | Solid bleached sulfate 20pt paper board | Same as predicate |
| <b>Device Characteristics</b> | | |
| 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 ICP<br>monitoring device | Same as predicate |
| Micro<br>sensor Dimensions | Length: 100cm nominal<br>Tip diameter: 1.3mm max<br>Tubing diameter: 0.8mm max<br>Catheter length (ventricular kit): 38cm nominal<br>Catheter diameter (ventricular kit): 3.5mm max | Same as predicate |
| Sensing Element | Strain gauge silicon microchip | Same as predicate |
| Functional Pressure<br>Range | -50mmHg to 250mmHg | Same as predicate |
| Functional Over Pressure<br>Range Without Damage | -700mmHg to 1250mmHg | Same as predicate |
| Input/Output Impedance | 1000 ohms nominal | Same as predicate |
| Output Signal<br>(sensitivity) | 5uV/V/mmHg | Same as predicate |
| Zero Drift | No greater than 5mmHg/7days | No greater than 5mmHg over 30 days |
| Table 3A.<br>Comparison of Predicate and Proposed Codman Microsensor Kits | | |
| Characteristic | Predicate Codman Microsensor Kit<br>(K914479) | Proposed Codman Microsensor Kit<br>(This Submission) |
| Labeling | | |
| Indication for Use | 82-6631, 82-6632 & 82-6638<br>Indicated when direct ICP monitoring is<br>required. The kit is indicated for use in both<br>subdural and intraparenchymal pressure<br>monitoring applications only.<br><br>82-6633, 82-6653 | Same as predicate:<br>62-6631, 62-6632 & 62-6638<br>Indicated when direct ICP monitoring is<br>required. The kit is indicated for use in both<br>subdural and intraparenchymal pressure<br>monitoring applications only.<br><br>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<br>( <i>differences are italicized</i> ) | <b>82-6631:</b><br>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. | <b>62-6631:</b><br>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 |
| | <b>82-6632:</b><br>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. | <b>62-6632:</b><br>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. |
| | <b>82-6633:</b><br>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. | <b>62-6633:</b><br>Ventriculostomy is contraindicated in patients with coagulopathy or active infection in the area of the catheter…