(55 days)
No
The device description and performance studies focus on mechanical and passive fluid drainage based on differential pressure, with no mention of AI or ML algorithms for control, analysis, or prediction.
Yes
The device is used for draining cerebrospinal fluid to reduce intracranial pressure and CSF volume, which are therapeutic interventions.
No
Explanation: The device is indicated for draining cerebrospinal fluid (CSF) to reduce intracranial pressure and CSF volume, and to measure and collect CSF. Its primary function is therapeutic and fluid management, not diagnostic. While it measures CSF, this is for controlling drainage rather than diagnosing a condition.
No
The device description clearly outlines physical components such as catheters, drainage lines, drip chambers, and collection bags, indicating it is a hardware-based system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to drain cerebrospinal fluid (CSF) from the cerebral ventricles or lumbar subarachnoid space to reduce intracranial pressure and CSF volume. This is a therapeutic and monitoring function performed directly on the patient.
- Device Description: The device is a system for physically draining fluid from the body. It includes catheters, drainage lines, a drip chamber, and a collection bag. These components are used for fluid management within the patient's body and collection of that fluid.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This device does not perform any diagnostic testing on collected samples. It is a system for managing and collecting the fluid itself.
The collection bag is used to measure and collect the CSF, but this is for monitoring the volume and flow rate of the drained fluid, not for performing a diagnostic test on the fluid's composition or properties.
N/A
Intended Use / Indications for Use
Use of the CODMAN EDS 3 CSF External Drainage System (EDS 3) 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.
Use the External Drainage System Collection Bag with the CODMAN EDS 3 External Drainage System to measure and collect cerebrospinal fluid (CSF).
Product codes
JXG
Device Description
The Codman EDS 3 CSF External Drainage System (Codman EDS 3 System) is designed to drain cerebral spinal fluid (CSF) 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 EDS 3 device is comprised of four (4) main parts: ventricular catheter, patient drain line, base frame drip chamber assembly, and a collection bag. Note: The collection bag is sold as part of the Codman EDS 3 System, as well as sold separately.
The principle of operation of the proposed Codman EDS 3 system is identical to the currently marketed Codman EDS 3 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 or lumbar region through the patient line and enters into the 100 mL graduated drip chamber assembly, where it is collected over a period of time to calculate a flow rate. The drip chamber assembly can then be raised or lowered along the base frame, thereby adjusting the differential pressure to achieve the appropriate flow rate. Once the drip chamber height is set, the collected CSF is then drained into the attached 700 mL collection bag.
The Codman EDS 3 CSF External Drainage System Collection Bag is a sterile, vented 700 mL capacity bag that is graduated in 50 mL increments for accurate measurement. A microbial-retentive atmospheric vent facilitates CSF flow into the bag. One bag is provided with the system and replacement bags are sold separately as an accessory to the drain.
The EDS 3 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:
- IV Pole Clamp Design Verification: Ensure new IV Pole Clamp can hold at least the same amount of weight as the predicate device. Result: Pass - proposed device design met the acceptance criteria and is therefore substantially equivalent to the predicate device.
- Collection Bag Design Verification: Ensure new Collection Bag connects to the EDS 3 system, is leak free, and exhibits at least the same tensile strength as the predicate device. Result: Pass - proposed device design met the acceptance criteria and is therefore substantially equivalent to the predicate device.
- Drainage Time Design Verification: Ensure drainage time for the new system meets design inputs specifications and is at least as fast as the predicate device. Result: Pass - proposed device design met the acceptance criteria and is therefore substantially equivalent to the predicate device.
- Design Validation / Simulated Use of EDS 3 System and Bag: Ensure finished product meets all user inputs and needs and inputs of the predicate device. Result: Pass - proposed device design met the acceptance criteria and is therefore substantially equivalent to the predicate device.
Sterilization Testing:
The Codman EDS 3 CSF External Drainage System and Collection Bags are sterilized using a validated ethylene oxide sterilization cycles. The sterilization cycle has been validated to ensure a sterility assurance level (SAL) of 10-6 in accordance with ISO 11135-1:2014.
Shelf Life Testing:
The Codman EDS 3 CSF External Drainage System and Collection Bags were subjected to accelerated aging. The aging studies established that the device and packaging remain functional and maintain sterility for up to 3 years.
Biocompatibility Testing:
Biocompatibility assessments were performed for the material changes (filter, tubing, thumbscrew, and collection bag). All material changes were made to non-patient contacting device components. The proposed materials were determined to be acceptable for their intended use and the final device continues to meet the requirements of ISO 10993-1:2009.
Animal Testing:
No animal studies were performed.
Clinical Testing:
No clinical studies were performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
October 16, 2017
Codman & Shurtleff, Inc. Christopher Garete Regulatory Affairs Specialist II 325 Paramount Drive Raynham, Massachusetts 02767
Re: K172537
Trade/Device Name: CODMAN EDS 3 CSF External Drainage System: External Drainage System Collection Bag Regulation Number: 21 CFR 882.5550 Regulation Name: Central Nervous System Fluid Shunt and Components Regulatory Class: Class II Product Code: JXG Dated: August 21, 2017 Received: August 22, 2017
Dear Mr. Christopher 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 of medical device-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.
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov
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 (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/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 (DICE) 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) K172537
Device Name
CODMAN EDS 3 CSF External Drainage System External Drainage System Collection Bag
Indications for Use (Describe)
Use of the CODMAN EDS 3 CSF External Drainage System (EDS 3) 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.
Use the External Drainage System Collection Bag with the CODMAN EDS 3 External Drainage System to measure and collect cerebrospinal fluid (CSF).
| 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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K172537 - 510(k) Summary
I. Submitter Codman & Shurtleff, Inc. 325 Paramount Drive Raynham, MA 02767
Fax:
Establishment Registration Number: 1226348
| Primary Contact: | Christopher Garete |
|---|---|
| Phone: | (508) 977-3869 |
| Fax: | (508) 977-6979 |
| Secondary Contact: | Megan Palumbo |
| Phone: | (508) 828-3571 |
(508) 977-6979
Date of Preparation: August 21, 2017
II. Device
| Device Proprietary Name | CODMAN EDS 3 CSF External Drainage System
External Drainage System Collection Bag |
|---------------------------|--------------------------------------------------------------------------------------|
| 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 Device
The predicate device for this submission is:
Codman EDS 3 CSF External Drainage System (K162437), which was cleared on October 28, 2016.
The Codman EDS 3 CSF External Drainage System (Codman EDS 3 IV. Device Description System) is designed to drain cerebral spinal fluid (CSF) 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 EDS 3 device is comprised of four (4) main parts: ventricular catheter, patient drain line, base frame drip chamber assembly, and a collection bag. Note: The collection bag is sold as part of the Codman EDS 3 System, as well as sold separately.
The principle of operation of the proposed Codman EDS 3 system is identical to the currently marketed Codman EDS 3 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 or lumbar region through the patient line and enters into the 100 mL graduated drip chamber assembly, where it is collected
4
over a period of time to calculate a flow rate. The drip chamber assembly can then be raised or lowered along the base frame, thereby adjusting the differential pressure to achieve the appropriate flow rate. Once the drip chamber height is set, the collected CSF is then drained into the attached 700 mL collection bag.
The Codman EDS 3 CSF External Drainage System Collection Bag is a sterile, vented 700 mL capacity bag that is graduated in 50 mL increments for accurate measurement. A microbial-retentive atmospheric vent facilitates CSF flow into the bag. One bag is provided with the system and replacement bags are sold separately as an accessory to the drain.
The EDS 3 system is a complete, disposable unit that is provided sterile and is available with or without a ventricular catheter.
The Indications for Use statement of the proposed devices remain identical
to those of the predicate devices.
| Equivalence
Comparison | Codman EDS 3 CSF
External Drainage System
(Predicate: K162437) | Codman EDS 3 CSF
External Drainage System
(Subject of This
Submission) |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| EDS 3 System
Indications for Use | Use of the CODMAN EDS 3
CSF External Drainage
System (EDS 3) 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.
Use the External Drainage
System Collection Bag with
the CODMAN EDS 3
External
Drainage System to measure
and collect
cerebrospinal fluid (CSF). | Same as predicate |
V. Indications for Use
VI. Comparison to Predicate Device
The proposed Codman EDS 3 CSF External Drainage System is identical to the currently marketed Codman EDS 3 CSF External Drainage System (K162437) except for the following changes proposed in this submission:
5
- a new filter membrane material in the burette cap .
- a wider pole clamp design with a shorter thumb screw
- a straightened and wider diameter base frame tube ●
- a new collection bag design .
The indications for use, principle of operation, clinical utility, packaging, and sterilization remain identical to the predicate devices. The proposed design is similar to that of the predicate device.
| Substantial Equivalence Comparison | |||
|---|---|---|---|
| Characteristic | Codman EDS 3 CSF | ||
| External Drainage System | |||
| and Bags (Predicate: | |||
| K162347) | Codman EDS 3 CSF | ||
| External Drainage System | |||
| and Bags (Subject of This | |||
| Submission) | |||
| Manufacturer | Codman & Shurtleff, Inc. | Same as predicate | |
| Classification Panel | Neurology | Same as predicate | |
| Classification | |||
| Name | Central Nervous System Fluid | ||
| Shunt and Components | |||
| (21 CFR 882.5550) | Same as predicate | ||
| Indications for Use | Use of the CODMAN EDS 3 | ||
| CSF External Drainage | |||
| System (EDS 3) 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. | |||
| Use the External Drainage | |||
| System Collection Bag with | |||
| the CODMAN EDS 3 | |||
| External | |||
| Drainage System to measure | |||
| and collect | |||
| cerebrospinal fluid (CSF). | Same as predicates | ||
| Operating Principle | Drainage of CSF based on a | ||
| differential pressure between | |||
| the patient and the device. | Same as predicate | ||
| Single Use Only | Yes | Same as predicate | |
| Shelf Life | 3 years (EDS3 System) | ||
| 5 years (Collection Bags) | 3 years (EDS3 System and | ||
| Collection Bags) | |||
| Sterilization | |||
| Method | EtO | Same as predicate | |
| Sterility Assurance | |||
| Level (SAL) | 10-6 | Same as predicate | |
| Non-Pyrogenic | Yes | Same as predicate | |
| Packaging | EDS 3 System: product is | ||
| placed in a blister tray, sealed | |||
| with a lid, and then placed | Same as predicate |
6
| into a unit box (EDS3
| System) |
|---|
| Collection Bags: the bags are |
| placed in blister tray sealed |
| with a lid, placed into a unit |
| box. Five (5) blisters per unit |
| box. |
VII. Performance Data
The following performance data has been provided in support of the substantial equivalence determination.
Bench Testing:
Design Verification and Design Validation were performed to verify that the performance of the proposed device is substantially equivalent to that of the predicate device. Please see the Summary of Bench Testing Table below.
| Summary of Bench Testing | ||
|---|---|---|
| Test | Test Method Summary | Result |
| IV Pole Clamp Design | ||
| Verification | Ensure new IV Pole Clamp | |
| can hold at least the same | ||
| amount of weight as the | ||
| predicate device. | Pass - proposed device | |
| design met the acceptance | ||
| criteria and is therefore | ||
| substantially equivalent to | ||
| the predicate device. | ||
| Collection Bag Design | ||
| Verification | Ensure new Collection Bag | |
| connects to the EDS 3 | ||
| system, is leak free, and | ||
| exhibits at least the same | ||
| tensile strength as the | ||
| predicate device. | Pass - proposed device | |
| design met the acceptance | ||
| criteria and is therefore | ||
| substantially equivalent to | ||
| the predicate device. | ||
| Drainage Time Design | ||
| Verification | Ensure drainage time for the | |
| new system meets design | ||
| inputs specifications and is at | ||
| least as fast as the predicate | ||
| device. | Pass - proposed device | |
| design met the acceptance | ||
| criteria and is therefore | ||
| substantially equivalent to | ||
| the predicate device. | ||
| Design Validation / | ||
| Simulated Use of EDS | ||
| 3 System and Bag | Ensure finished product | |
| meets all user inputs and | ||
| needs and inputs of the | ||
| predicate device. | Pass - proposed device | |
| design met the acceptance | ||
| criteria and is therefore | ||
| substantially equivalent to | ||
| the predicate device. |
Sterilization Testing:
The Codman EDS 3 CSF External Drainage System and Collection Bags are sterilized using a validated ethylene oxide sterilization cycles. The sterilization cycle has been validated to ensure a sterility assurance level (SAL) of 10-6 in accordance with ISO 11135-1:2014, "Sterilization of health care products - Ethylene Oxide Sterilization - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices."
Shelf Life Testing:
The Codman EDS 3 CSF External Drainage System and Collection Bags were subjected to accelerated aging. The aging studies established that the
7
device and packaging remain functional and maintain sterility for up to 3 years.
Biocompatibility Testing:
Biocompatibility assessments were performed for the material changes (filter, tubing, thumbscrew, and collection bag). All material changes were made to non-patient contacting device components. The proposed materials were determined to be acceptable for their intended use and the final device continues to meet the requirements of ISO 10993-1:2009, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process."
Animal Testing:
No animal studies were performed as appropriate verification and validation of the proposed device was achieved based on the comparison to the predicate device and from the results of the bench testing.
Clinical Testing:
No clinical studies were performed as appropriate verification and validation of the proposed device was achieved based on the comparison to the predicate device and from the results of the bench testing.
Conclusion:
Based on the intended use, fundamental scientific technology, comparison to the predicate device, and testing conducted, it is concluded that the subject device, the Codman EDS 3 CSF External Drainage System and Collection Bags are substantially equivalent to the predicate device and therefore do not raise different questions of safety and effectiveness.