(58 days)
Not Found
No
The device description focuses on mechanical and fluid dynamics principles for CSF drainage, with no mention of AI or ML algorithms for control, analysis, or prediction.
Yes
Explanation: The device is indicated for reducing intracranial pressure and CSF volume, which are therapeutic actions directed at treating a medical condition.
No
The device is designed to drain cerebrospinal fluid and reduce intracranial pressure, which are therapeutic actions, not diagnostic ones. It collects CSF to calculate a flow rate, but this is for controlled drainage, not for identifying a disease or condition.
No
The device description clearly outlines multiple hardware components including a ventricular catheter, patient drain line, base frame burette tube assembly, and a collection bag. The performance studies also include bench testing of these physical components.
Based on the provided information, the Codman EDS3 CSF External Drainage System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to drain cerebrospinal fluid (CSF) from the patient's body to reduce intracranial pressure and CSF volume. This is a therapeutic and monitoring function performed directly on the patient.
- Device Description: The device collects CSF from the patient and allows for controlled drainage. While it collects a biological fluid, it does not perform any tests or analyses on the fluid to diagnose a condition or provide information about the patient's health status. It's a drainage and collection system.
- Lack of Diagnostic Function: There is no mention of any component or process within the device that analyzes the CSF for diagnostic purposes (e.g., measuring chemical levels, detecting pathogens, etc.). The collection is for volume and flow rate monitoring, not for in-vitro analysis.
IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue, or CSF) in vitro (outside the body) to provide information for diagnostic, monitoring, or compatibility purposes. The Codman EDS3 System operates in vivo (within the body) for drainage and collection.
N/A
Intended Use / Indications for Use
Use of the Codman EDS3 CSF External Drainage System is indicated for draining cerebrospinal fluid (CSF) from the cerebral ventricles or the lumbar subarachnoid space as a means of reducing intracranial pressure and CSF volume when the insertion of a permanent, internal shunt is not indicated.
Product codes (comma separated list FDA assigned to the subject device)
JXG
Device Description
The Codman EDS3 CSF External Drainage System (Codman EDS3 System) is designed to collect cerebral spinal fluid (CSF) from the patient at a controlled rate based on differential pressure between the device and the patient. Collecting CSF from the patient is performed in efforts to reduce elevated intracranial pressure (ICP) post trauma.
The EDS3 device is comprised of four (4) main parts: ventricular catheter, patient drain line, base frame burette tube assembly and a collection bag.
The principle of operation of the proposed Codman EDS3 System is identical to the currently marketed Codman EDS3 System. The ventricular catheter is placed into one of the ventricles in the brain or in the subarachnoid space and is then connected to the patient drainage line. CSF flows from the brain through the patient line and enters into the 100 mL graduated burette tube assembly, where it is collected over a period of time to calculate a flow rate. The burette tube assembly can then be raised or lowered along the base frame, thereby adjusting the differential pressure to achieve the appropriate flow rate. Once the burette tube height is set, the collected CSF is then drained into the attached 700 ml collection bag.
The EDS3 System is a complete, disposable unit that is provided sterile and is available with or without a ventricular catheter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cerebral ventricles or the lumbar subarachnoid space
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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:
Visual Inspection, Functional Testing (Pressurized Leak and Flow Testing), Mechanical Testing (Tensile Strength and Torque Testing), Shelf Life, and Biocompatibility testing were performed to verify that the performance of the proposed device with adhesive Loctite 3924 is substantially equivalent to that of the current device, which uses adhesive Loctite 3341.
Animal Testing:
No animal studies were required as appropriate verification and validation of the design modifications were achieved based on the similarities of the proposed device to the predicate device, and from results of bench testing.
Clinical Testing:
No clinical studies were required as appropriate verification and validation of the design modifications were achieved based on the similarities of the proposed device to the predicate device, and from results of bench testing.
Key Results:
Visual Inspection: Pass
Pressurized Leak and Flow: Pass
Tensile and Torque Testing: Pass
Shelf Life: Pass
Biocompatibility: Pass Cytotoxicity Testing, Pass Irritation and Sensitization Testing, No evidence of systemic Toxicity, Pass Dermal Irritation Test, No evidence of Pyrogenic response, No evidence of potential to cause Hemolysis, Pass Physiochemical attributes review
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.
Not Found
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
§ 882.5550 Central nervous system fluid shunt and components.
(a)
Identification. A central nervous system fluid shunt is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus). Components of a central nervous system shunt include catheters, valved catheters, valves, connectors, and other accessory components intended to facilitate use of the shunt or evaluation of a patient with a shunt.(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 stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The symbol is enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 28, 2016
Codman & Shurtleff, Inc. Mr. Christopher Garete Regulatory Affairs Specialist II 325 Paramount Drive Raynham, Massachusetts 02767
Re: K162437
Trade/Device Name: Codman EDS3 CSF External Drainage System Regulation Number: 21 CFR 882.5550 Regulation Name: Central Nervous System Fluid Shunt and Components Regulatory Class: Class II Product Code: JXG Dated: September 28, 2016 Received: September 29, 2016
Dear Mr. Garete:
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 devicerelated 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.
1
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.
Carlos L. Pena -S
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) K162437
Device Name
Codman EDS3 CSF External Drainage System
Indications for Use (Describe)
Use of the Codman EDS3 CSF External Drainage System is indicated for draining cerebrospinal fluid (CSF) from the cerebral ventricles or the lumbar subarachnoid space as a means of reducing intracranial pressure and CSF volume when the insertion of a permanent, internal shunt is not indicated.
| 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
| I. Submitter | Codman & Shurtleff, Inc. |
|---|---|
| 325 Paramount Drive | |
| Raynham, MA 02767 |
Establishment Registration Number: 1226348
| Primary Contact: | Christopher Garete |
|---|---|
| Phone: | (508) 977-3869 |
| Fax: | (508) 977-6979 |
| Secondary Contact: | Nancy MacDonald |
| Secondary Contact. Nancy MacDonald | |
| Phone: | (508) 828-3038 |
| Fax: | (508) 977-6979 |
Date of Preparation: September 26, 2016
II. Device
| Device Proprietary Name | Codman EDS3 CSF External Drainage System |
|---|---|
| Common Name | External Drainage System |
| Classification Name | Central Nervous System Fluid Shunt and |
| Components | |
| (21 CFR 882.5550) | |
| Regulatory Classification | II |
| Product Code | JXG |
III. Predicate The predicate device for this submission is the Codman EDS3 CSF Device External Drainage System (K061568), which was cleared on September 29, 2006.
IV. Device The Codman EDS3 CSF External Drainage System (Codman EDS3 System) Description is designed to collect cerebral spinal fluid (CSF) from the patient at a controlled rate based on differential pressure between the device and the patient. Collecting CSF from the patient is performed in efforts to reduce elevated intracranial pressure (ICP) post trauma.
The EDS3 device is comprised of four (4) main parts: ventricular catheter, patient drain line, base frame burette tube assembly and a collection bag.
4
The principle of operation of the proposed Codman EDS3 System is identical to the currently marketed Codman EDS3 System. The ventricular catheter is placed into one of the ventricles in the brain or in the subarachnoid space and is then connected to the patient drainage line. CSF flows from the brain through the patient line and enters into the 100 mL graduated burette tube assembly, where it is collected over a period of time to calculate a flow rate. The burette tube assembly can then be raised or lowered along the base frame, thereby adjusting the differential pressure to achieve the appropriate flow rate. Once the burette tube height is set, the collected CSF is then drained into the attached 700 ml collection bag.
The EDS3 System is a complete, disposable unit that is provided sterile and is available with or without a ventricular catheter.
V. Indications The Indications for Use statement of the proposed device remains similar for Use to the predicate device. Two changes were made:
-
Anatomical locations of where CSF can be drained was added to the Indications and the statement
-
"fluids of similar characteristics" was removed to enhance clarity since fluid types falling into this category were not specified.
| Equivalence
Comparison | Codman EDS3 CSF
External Drainage System
(Predicate: K061568) | Codman EDS3 CSF
External Drainage System
(Subject of This
Submission) |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | Use of the Codman EDS3
CSF External Drainage
System is indicated for
draining cerebrospinal fluid
(CSF) and other fluids of
similar physical
characteristics as a means of
reducing intracranial pressure
and CSF volume when the
insertion of a permanent,
internal shunt is not indicated. | Use of the Codman EDS3 CSF
External Drainage System is
indicated for draining
cerebrospinal fluid (CSF) from
the cerebral ventricles or the
lumbar subarachnoid space as a
means of reducing intracranial
pressure and CSF volume when
the insertion of a permanent,
internal shunt is not indicated. |
5
The proposed Codman EDS3 CSF External Drainage System is identical VI. Comparison to Predicate to the currently marketed Codman EDS3 CSF External Drainage System Device (K061568) with the exception that this submission proposes use of adhesive Loctite 3924 instead of Loctite 3341 to bond the tubing lines to various components at several joints. The intended use, principle of operation, packaging, shelf life, sterilization method and SAL remain identical to the predicate device.
| Substantial Equivalence Comparison | |||||
|---|---|---|---|---|---|
| Characteristic | Codman EDS3 CSF | ||||
| External Drainage System | |||||
| (Predicate: K061568) | Codman EDS3 CSF | ||||
| External Drainage System | |||||
| (Subject of This | |||||
| Submission) | |||||
| Manufacturer | Codman & Shurtleff, Inc. | Identical | |||
| Classification Panel | Neurology | Identical | |||
| Classification | |||||
| Name | Central Nervous System Fluid | ||||
| Shunt and Components | |||||
| (21 CFR 882.5550) | Identical | ||||
| Indications for Use | Use of the Codman EDS3 | ||||
| CSF External Drainage | |||||
| System is indicated for | |||||
| draining cerebrospinal fluid | |||||
| (CSF) and other fluids of | |||||
| similar physical | |||||
| characteristics as a means of | |||||
| reducing intracranial pressure | |||||
| and CSF volume when the | |||||
| insertion of a permanent, | |||||
| internal shunt is not indicated. | Use of the Codman EDS3 | ||||
| CSF External Drainage | |||||
| System is indicated for | |||||
| draining cerebrospinal fluid | |||||
| (CSF) from the cerebral | |||||
| ventricles or the lumbar | |||||
| subarachnoid space as a | |||||
| means of reducing | |||||
| intracranial pressure and CSF | |||||
| volume when the insertion of | |||||
| a permanent, internal shunt is | |||||
| not indicated. | |||||
| Operating Principle | Drainage of CSF based on a | ||||
| differential pressure between | |||||
| the patient and the device. | Identical | ||||
| Implant | No | Identical | |||
| Single Use Only | Yes | Identical | |||
| Shelf Life | 3 years | Identical | |||
| Sterilization | |||||
| Method | EtO | Identical | |||
| Sterility Assurance | |||||
| Level (SAL) | 10-6 | Identical | |||
| Non-Pyrogenic | Yes | Identical | |||
| Packaging | PETG Blister Tray with heat- | ||||
| sealed lid placed into a unit | |||||
| box | Identical |
6
VII. Performance Data
There were no changes made that affect the Codman EDS3 CSF External Drainage System indications for use, principle of operation, manufacturing process, clinical utility, packaging, shelf life, and sterilization. The only difference between the predicate and proposed device is the use of Loctite 3924 instead of Loctite 3341 as the adhesive for bonding the tubing at joints to improve the tensile strength and performance of the tubing line connections.
Bench Testing:
Visual Inspection, Functional Testing (Pressurized Leak and Flow Testing), Mechanical Testing (Tensile Strength and Torque Testing), Shelf Life, and Biocompatibility testing were performed to verify that the performance of the proposed device with adhesive Loctite 3924 is substantially equivalent to that of the current device, which uses adhesive Loctite 3341.
Please see the Summary of Testing Table below for Acceptance Criteria and testing results.
| Summary of Testing | |||
|---|---|---|---|
| Test | Test Method / | ||
| Purpose | Acceptance Criteria | Result | |
| Visual Inspection | PIC-CL205063 | ||
| Ensure finished | |||
| product meets design | |||
| specifications. | Pass Visual Standards | Pass | |
| Pressurized Leak and | |||
| Flow | TM-TM095 | ||
| Ensure leak free | |||
| product assembly. | Pass Leak and Flow Test | Pass | |
| Tensile and Torque | |||
| Testing | TM-TM227 | ||
| TM-TM100234 | |||
| Ensure product meets | |||
| functional | |||
| specifications. | Pass Tensile and Torque | ||
| Strength Specification | Pass | ||
| Shelf Life | Ensure the product | ||
| remains functional | |||
| after sterilization and | |||
| 3 years of aging. | Meet functional criteria after 2x | ||
| EtO sterilization and 3 years of | |||
| aging | Pass | ||
| Biocompatibility | ISO 10993 | ||
| Evaluate the Loctite | Pass Cytotoxicity Testing | ||
| Pass Irritation and Sensitization | Pass |
7
| 3924 material to
ensure that it is a safe
substitute for Loctite
3341. | Testing
No evidence of systemic
Toxicity
Pass Dermal Irritation Test
No evidence of Pyrogenic
response
No evidence of potential to
cause Hemolysis
Pass Physiochemical attributes
review | |
|---------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
Animal Testing:
No animal studies were required as appropriate verification and validation of the design modifications were achieved based on the similarities of the proposed device to the predicate device, and from results of bench testing.
Clinical Testing:
No clinical studies were required as appropriate verification and validation of the design modifications were achieved based on the similarities of the proposed device to the predicate device, and from results of bench testing.
Conclusion:
Results from performance testing demonstrate that the modified device is suitable for its intended use and did not raise new issues of safety and effectiveness. Based on the indications for use, fundamental scientific technology and a comparison to the predicate device, the subject device Codman EDS3 CSF External Drainage System is substantially equivalent to the predicate device.