(273 days)
No
The device description focuses on a pressure sensor and its connection to a monitor, with no mention of AI or ML algorithms for data processing or interpretation. The performance studies are standard bench and safety tests, not related to AI/ML model validation.
No.
The device is used for monitoring intracranial pressure, not for treating a disease or condition.
Yes
Explanation: The device measures intracranial pressure (ICP), which is a physiological parameter used to diagnose and monitor neurological conditions. The measurement of this parameter provides information about the patient's condition, making it a diagnostic device.
No
The device description clearly details hardware components such as a pressure sensor, strain gauge, titanium housing, silicone membrane, wires, plastic connector housing, and a Printed Circuit Board. It also mentions surgical implantation and compatibility with a neuromonitoring platform, indicating a physical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "direct ICP monitoring" and "cerebrospinal fluid (CSF) drainage applications." This involves measuring pressure within the body (intracranial, intraventricular, subdural, intraparenchymal).
- Device Description: The description details a "pressure sensor used to measure the intracranial pressure" and how it's implanted and connected to a monitor. This is a device that interacts directly with the patient's internal environment.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices that are used to perform tests on samples taken from the human body, such as blood, urine, or tissue, outside of the body.
This device is an implantable or invasive medical device used for physiological monitoring, not for testing samples in a laboratory setting.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
GWM
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intracranial (subdural, intraparenchymal, intraventricular)
Indicated Patient Age Range
Contraindicated in children under one year of age for Skull Bolt Kits and Ventricular Catheter Kits.
Intended User / Care Setting
Intensive Care Units (ICUs)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing including:
- Long Term Accuracy: PASS
- Long Term Drift: PASS
- Temperature Sensitivity: PASS
- Seal Integrity: PASS
- Bond Strength: PASS
- Flexibility: PASS
- Kink: PASS
- Connector Cycles and Impedance: PASS
- Zero Offset: PASS
- Heat Transfer: PASS
- Frequency Response: PASS
- Environmental: PASS
- Critical Dimensions: PASS
- MRI Compatibility: PASS (before and after exposure to 1.5T MRI and 3T MRI)
- MRI Safety: PASS (ASTM F2503-13, ASTM F2052-15, ASTM F2182-11a, ASTM F2119-07(R2013), ASTM F2213-06(R2011), ISO 10974:2012)
- Radiopacity: PASS
- CT Scan Compatibility: PASS (before and after a CT scan exposure)
- Over Pressure: PASS
- Calibration Stability: PASS
- Sterilization: PASS (EO Residual Testing per ISO 10993-7:2008 (R) 2012)
- Biocompatibility: PASS (refer to Table 6 and 7)
- ICP Express Compatibility: PASS
Biocompatibility testing for Codman Microsensor Probe Tip and Tubing (implant device with prolonged contact to bone and tissue):
- 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
Biocompatibility testing for Codman Microsensor Electrical Housing (surface device with prolonged contact to skin):
- In Vitro Cytotoxicity – ISO MEM Elution: Non-cytotoxic
- Guinea Pig Sensitization – ISO Maximization: Non-sensitizing
- Intracutaneous/Irritation Reactivity – ISO Intracutaneous in Rabbits: Non-irritating
- USP Physicochemical Tests (Aqueous Extracts): Met USP limits (Pass)
Sterilization:
- Ethylene Oxide sterilization validated and audited to assure a Sterility Assurance Level (SAL) 10^-6.
Animal Studies: Not required.
Clinical Studies: Not required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
1
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
2
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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) SUMMARY
Codman® Microsensor Kits
| Date Prepared: | November 13, 2015 | |
|---|---|---|
| Company Name: | Codman & Shurtleff, Inc. | |
| 325 Paramount Drive | ||
| Raynham, MA 02767 | ||
| Contact Person | Megan Palumbo, Pharm D | |
| Senior Regulatory Affairs Specialist | ||
| Telephone Number: (508) 828-3571 | ||
| Fax 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 Transducer | |
| Codman® Intracranial Bolt (reference device) | ||
| Codman® Microsensor Ventricular Catheter Kit | ||
| (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
4
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 | ||
| Description | Proposed | |
| Product | ||
| Code | Indications for Use | |
| Codman | ||
| Microsensor | ||
| Basic Kit | 62-6631 | 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. | ||
| Codman | ||
| Microsensor | ||
| Skull Bolt Kit | ||
| (Plastic and | ||
| Metal) | 62-6632 | |
| 62-6638 | 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. | ||
| Codman | ||
| Microsensor | ||
| Catheter Kit | ||
| & | ||
| Codman | ||
| Microsensor | ||
| Ventricular | ||
| Catheter Kit | ||
| with Tuohy- | ||
| Borst Adapter | 62-6633 | |
| 62-6653 | 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. |
5
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 & 82-6638 | |
| Indicated when direct ICP monitoring is | ||
| required. The kit is indicated for use in both | ||
| subdural and intraparenchymal pressure | ||
| monitoring applications only. | ||
| 82-6633, 82-6653 | ||
| Indicated when direct intraventricular pressure | ||
| monitoring is required. The kit is indicated for | ||
| use in ICP monitoring and cerebrospinal fluid | ||
| (CSF) drainage applications. | Same as predicate: | |
| 62-6631, 62-6632 & 62-6638 | ||
| Indicated when direct ICP monitoring is | ||
| required. The kit is indicated for use in both | ||
| subdural and intraparenchymal pressure | ||
| monitoring applications only. | ||
| 62-6633, 62-6653 | ||
| Indicated when direct intraventricular pressure | ||
| monitoring is required. The kit is indicated for | ||
| use in ICP monitoring and cerebrospinal fluid | ||
| (CSF) drainage applications. | ||
| Contraindications | See Table 3A | See Table 3A |
| Device Materials | ||
| Printed Circuit Board | ||
| (PCB) inside plastic | ||
| connector housing | PCB Material: FR4 | |
| PCB Solder Mask Color: Green | ||
| PCB Finish: Leaded | ROHS Compliant: | |
| PCB Material: FR-370HR | ||
| PCB Solder Mask Color: Blue | ||
| PCB 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 resistor | ||
| located inside plastic | ||
| connector | 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 the | ||
| plastic connector | ||
| housing. | Material: #30 High Gloss White Paper | |
| Adhesive: 3M 320/320 NR Acrylic Adhesive | ||
| Back | Same as Predicate Sensor Bottom Label: | |
| Material: 70# C1S Digital Top Coated litho | ||
| paper, 3.7-mil (DO7000) | ||
| Adhesive: 2.0-mil acrylic adhesive (JDC item | ||
| 2369sl) | ||
| Laminate: 1.5-mil polypropylene (STA item |
-
|
| Sensor Bottom Label on
plastic connector
housing | Material: 70# C1S Digital Top Coated litho
paper, 3.7-mil (DO7000)
Adhesive: 2.0-mil acrylic adhesive (JDC item
2369sl)
Laminate: 1.5-mil polypropylene (STA item
1206) | 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 TPF
0501A film. | Same as predicate |
| Unit Box (62-6631, 62-
6632, 62-6638) | Performa White
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
0501A 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 ICP
monitoring device | Same as predicate |
| Micro
sensor Dimensions | Length: 100cm nominal
Tip diameter: 1.3mm max
Tubing diameter: 0.8mm max
Catheter length (ventricular kit): 38cm nominal
Catheter diameter (ventricular kit): 3.5mm max | Same as predicate |
| Sensing Element | Strain gauge silicon microchip | Same as predicate |
| Functional Pressure
Range | -50mmHg to 250mmHg | Same as predicate |
| Functional Over Pressure
Range 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 & 82-6638
Indicated when direct ICP monitoring is
required. The kit is indicated for use in both
subdural and intraparenchymal pressure
monitoring applications only.
82-6633, 82-6653 | Same as predicate:
62-6631, 62-6632 & 62-6638
Indicated when direct ICP monitoring is
required. The kit is indicated for use in both
subdural and intraparenchymal pressure
monitoring 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 |
6
7
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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 and | |
| confirm that the samples used for design verification testing meet the product | ||
| drawing. | PASS: | |
| MRI Compatibility | The purpose of this test is to confirm the functionality of the device before and after | |
| exposure 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 can | |
| be 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 a | |
| CT scan | ||
| exposure | PASS: | |
| Over Pressure | The purpose of this test is to confirm that the device can withstand extreme pressures | |
| without damage | PASS: | |
| Calibration Stability | The purpose of this test is to confirm the sensitivity of the probe calibration to impacts | |
| to 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 Express | ||
| Compatibility | The purpose of this test is to confirm that the device will work as intended with the | |
| ICP 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 Safety | ||
| in the Magnetic Resonance Environment | ASTM F2503-13 | PASS |
| Standard Test Method for Measurement of Magnetically Induced | ||
| Displacement Force on Medical Devices in the Magnetic Resonance | ||
| Environment | ASTM F2052-15 | PASS |
| Standard Test Method for Measurement of Radio Frequency Induced | ||
| Heating Near Passive Implants During Magnetic Resonance Imaging | ASTM F2182-11a | PASS |
| Standard Test Method for Evaluation of MR Image Artifacts from Passive | ||
| Implants | ASTM F2119-07 | |
| (R2013) | PASS | |
| Standard Test Method for Measurement of Magnetically Induced Torque on | ||
| Medical Devices in the Magnetic Resonance Environment | ASTM F2213-06 | |
| (R2011) | PASS | |
| Assessment of the safety of magnetic resonance imaging for patients with an | ||
| active 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 24, but 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.