(30 days)
Not Found
No
The device description and performance studies focus on mechanical components and fluid dynamics, with no mention of AI/ML algorithms or data processing for decision-making or analysis.
Yes
The intended use explicitly states "drainage is to be used as a therapeutic maneuver" and "Reduce intracranial pressure (ICP)". These indicate a therapeutic purpose beyond just monitoring.
Yes
The device is used to monitor CSF chemistry, cytology, and physiology, as well as intracranial pressure (ICP), which are diagnostic activities.
No
The device description clearly outlines physical components such as a drainage assembly, drainage bag, stopcock, chamber, and connection lines, indicating it is a hardware-based medical device for CSF drainage and monitoring.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The primary intended uses are draining CSF to reduce intracranial pressure, monitoring CSF flow, and providing temporary drainage. While it mentions monitoring CSF chemistry, cytology, and physiology, the device itself is a system for collecting and monitoring the flow and pressure of CSF. It doesn't perform the in vitro analysis of the CSF itself.
- Device Description: The description details a system for drainage and monitoring, including components like stopcocks, chambers, drainage bags, and pressure scales. These are all related to the physical handling and measurement of CSF flow and pressure in vivo or ex vivo as it's being drained, not for analyzing the chemical or cellular composition of the CSF in a laboratory setting.
- Lack of IVD Characteristics: There is no mention of reagents, assays, or any components typically associated with in vitro diagnostic testing of biological samples.
While the device facilitates the collection of CSF which could then be used for in vitro diagnostic testing, the device itself is a drainage and monitoring system, not an IVD.
N/A
Intended Use / Indications for Use
Draining CSF and monitoring CSF flow from the lateral ventricles or lumbar subarachnoid space is indicated in selected patients to:
- Reduce intracranial pressure (ICP), e.g. pre-, intra- or postoperative.
- Monitor CSF chemistry, cytology and physiology.
- Provide temporary CSF drainage in patients with infected cerebrospinal fluid shunts.
The monitoring of the intracranial pressure (ICP) is indicated in selected patients with:
- Severe head injury
- Subarachnoid hemorrhage graded III, IV or V preoperatively
- Reye's syndrome or similar encephalopathies
- Hydrocephalus
- Intracranial hemorrhage
- Miscellaneous problems when drainage is to be used as a therapeutic maneuver.
Monitoring can also be used to evaluate the status pre- and postoperative for space-occupying lesions.
Product codes
GWM, HCA
Device Description
The Medtronic External Drainage and Monitoring System EDMS is provided as a complete closed system for the drainage and monitoring of cerebrospinal fluid (CSF) flow from the lateral ventricles or the lumbar subarachnoid space. The system is offered in various kit configurations for various clinical applications. The EDMS Drainage Assembly is supplied pre-assembled, sterile and non-pyrogenic in a double wrap package system. A drainage bag with braided cord is also included with each EDMS kit.
The EDMS and components are intended for single (one time) use only and is not designed or intended to be re-used, re-processed, or re-sterilized. Some of the basic features include the following:
- a patient line stopcock with latex-free injection site and non-distensible patient connection line:
- a graduated chamber and hanging bracket for I.V. pole suspension;
- a drainage bag connection line with two slide clamps and latex-free injection site;
- a removable vented drainage bag with approximate volumetric graduations and drainage port;
- pressure scale tape.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Draining CSF and monitoring CSF flow from the lateral ventricles or 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)
Performance Data - Bench:
Test: Visual and Dimensional Inspection
Test Method Summary / Purpose: Visual and dimensional inspection demonstrates that the printed graduations meet volumetric capacity. Volumetric graduations are approximate.
Results: The EDMS device met the acceptance criteria for visual and dimensional inspection.
Test: Leakage of Drainage Bag
Test Method Summary / Purpose: The drainage bag must withstand being inverted without leaking.
Results: The EDMS device met the acceptance criteria for drainage bag leakage.
Test: Flow Initiation Pressure
Test Method Summary / Purpose: Record pressure at which flow initiates, for each drainage bag.
Results: The EDMS device met the acceptance criteria for flow initiation pressure.
Test: Drainage Bag Seal Weld
Test Method Summary / Purpose: Ensure there are no leaks in the drainage bag.
Results: The EDMS device met the acceptance criteria for drainage bag seal weld.
Test: Tensile Strength of Drainage Bag Inlet Port
Test Method Summary / Purpose: Evaluate the tensile strength of the drainage bag inlet port to failure.
Results: The EDMS device met the acceptance criteria for tensile strength of drainage bag inlet port.
Performance Data – Animal: The risk assessment of the proposed modifications to the disposable bag did not require animal testing. Determination of substantial equivalence for the design change is based upon the design verification bench testing.
Performance Data - Clinical: The risk assessment of the proposed modifications to the disposable bag did not require clinical testing. Determination of substantial equivalence for the design change is based upon the design verification bench testing.
Key results: The successful results of the testing demonstrated that the changes do not raise questions of safety and effectiveness, supporting the substantial equivalence to the predicate device.
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
§ 882.1620 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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 9, 2020
Medtronic, Inc. Jen Correa Manager, Regulatory Affairs 5290 California Avenue Irvine, California 92617
Re: K200630
Trade/Device Name: Medtronic External Drainage and Monitoring System (EDMS) Regulation Number: 21 CFR 882.1620 Regulation Name: Intracranial Pressure Monitoring Device Regulatory Class: Class II Product Code: GWM, HCA Dated: March 9, 2020 Received: March 10, 2020
Dear Jen Correa:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Xiaolin Zheng, Ph.D., M.S. Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K200630
Device Name
Medtronic External Drainage and Monitoring System (EDMS)
Indications for Use (Describe)
Draining CSF and monitoring CSF flow from the lateral ventricles or lumbar subarachnoid space is indicated in selected patients to:
-
- Reduce intracranial pressure (ICP), e.g. pre-, intra- or postoperative.
-
- Monitor CSF chemistry, cytology and physiology.
-
- Provide temporary CSF drainage in patients with infected cerebrospinal fluid shunts.
The monitoring of the intracranial pressure (ICP) is indicated in selected patients with:
-
- Severe head injury
-
- Subarachnoid hemorrhage graded III, IV or V preoperatively
-
- Reye's syndrome or similar encephalopathies
-
- Hydrocephalus
-
- Intracranial hemorrhage
-
- Miscellaneous problems when drainage is to be used as a therapeutic maneuver.
Monitoring can also be used to evaluate the status pre- and postoperative for space-occupying lesions.
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
Medtronic External Drainage and Monitoring System (EDMS)
510(k) Summary
April 6, 2020
- I. Company: Medtronic Neurosurgery 5290 California Ave Irvine, CA 92617 USA Contact: Jen Correa Manager, Regulatory Affairs Jennifer.L.Correa@medtronic.com Telephone Number: 949-297-5494
II. Establishment Registration Number: 3015531529
- III. Proprietary Trade Name: Medtronic External Drainage and Monitoring System (EDMS)
- IV. Regulatory Class: II
V. Primary Classification
Name: Intracranial pressure monitoring device Product Code: GWM Regulation: 21 CFR 882.1620 Secondary Classification: Name: Ventricular catheter Product Code: HCA Regulation: 21 CFR 882.4100
-
VI. Product Description: The Medtronic External Drainage and Monitoring System EDMS is provided as a complete closed system for the drainage and monitoring of cerebrospinal fluid (CSF) flow from the lateral ventricles or the lumbar subarachnoid space. The system is offered in various kit configurations for various clinical applications. The EDMS Drainage Assembly is supplied pre-assembled, sterile and non-pyrogenic in a double wrap package system. A drainage bag with braided cord is also included with each EDMS kit.
The EDMS and components are intended for single (one time) use only and is not designed or intended to be re-used, re-processed, or re-sterilized. Some of the basic features include the following: -
. a patient line stopcock with latex-free injection site and non-distensible patient connection line:
-
a graduated chamber and hanging bracket for I.V. pole suspension; ●
-
a drainage bag connection line with two slide clamps and latex-free injection site;
4
- a removable vented drainage bag with approximate volumetric graduations and drainage port; ●
- pressure scale tape.
VII. Indications for Use:
Draining CSF and monitoring CSF flow from the lateral ventricles or lumbar subarachnoid space is indicated in selected patients to:
- Reduce intracranial pressure (ICP), e.g. pre-, intra- or postoperative. 1.
-
- Monitor CSF chemistry, cytology and physiology.
-
- Provide temporary CSF drainage in patients with infected cerebrospinal fluid shunts.
The monitoring of the intracranial pressure (ICP) is indicated in selected patients with:
-
- Severe head injury
-
- Subarachnoid hemorrhage graded III, IV or V preoperatively
- Reye's syndrome or similar encephalopathies 3.
-
- Hydrocephalus
-
- Intracranial hemorrhage
-
- Miscellaneous problems when drainage is to be used as a therapeutic maneuver.
Monitoring can also be used to evaluate the status pre- and postoperative for spaceoccupying lesions.
- VIII. Summary of the Technological Characteristics: The proposed subject drainage bag shares the same technological characteristics as the original predicate drainage bag. The rest of the EDMS device has the same technological characteristics as the predicate device.
| | Subject Device | Predicate Device
K802100 |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
use/Indications
for Use | Draining CSF and monitoring CSF flow
from the lateral ventricles or lumbar
subarachnoid space is indicated in
selected patients to:
- Reduce intracranial pressure (ICP), e.g.
pre-, intra- or postoperative. - Monitor CSF chemistry, cytology and
physiology. - Provide temporary CSF drainage in
patients with infected cerebrospinal fluid
shunts.
The monitoring of the intracranial pressure
(ICP) is indicated in selected patients with: - Severe head injury | The monitoring of intracranial pressure
(ICP) is indicated on selected patients
with: - Severe head injury.
- Status pre- and postoperative for
space-occupying intracranial lesions. - Subarachnoid hemorrhage graded IV
or V preoperatively. - Reyes syndrome or similar
encephalopathies. - Hydrocephalus.
- Intracranial hemorrhage.
- Miscellaneous problems when
ventricular drainage is to be used as a
therapeutic maneuver. |
5
Subject Device | Predicate Device | |
---|---|---|
K802100 | ||
2. Subarachnoid hemorrhage graded III, IV | ||
or V preoperatively | ||
3. Reye's syndrome or similar | ||
encephalopathies | ||
4. Hydrocephalus | ||
5. Intracranial hemorrhage | ||
6. Miscellaneous problems when drainage is | ||
to be used as a therapeutic maneuver. | ||
Monitoring can also be used to evaluate the | ||
status pre- and postoperative for space- | ||
occupying lesions. | ||
Operating | ||
Principle | External drainage is temporary drainage of | |
cerebrospinal fluid (CSF) from the lateral | ||
ventricles of the brain, or the lumbar space of | ||
the spine, into an external collection bag. The | ||
Medtronic EDMS drains CSF by using a | ||
combination of gravity and intracerebral | ||
pressure. The drainage rate depends on the | ||
height at which the system is placed relative | ||
to the patient's anatomy. | Same | |
Anatomical | ||
Sites | Drainage and monitoring of CSF flow from | |
the lateral ventricles or lumbar subarachnoid | ||
space. | Same | |
Biocompatibility | No direct patient contact | |
In contact with CSF only | Same | |
Sterilization | ||
Method | Ethylene Oxide | Same |
Pyrogenicity | Non pyrogenic | Same |
Shelf life | 2 yr. | Same |
- IX. Identification of Legally Marketing Devices: The Intracranial Pressure Monitoring System, Becker Design, K802100.
- X. Discussion of the Performance Testing: In accordance with the risk assessment of the change it was determined that dimensional verification, and design verification testing of the bag was necessary. The successful results of the testing demonstrated that the changes do not raise questions of safety and effectiveness, supporting the substantial equivalence to the predicate device.
6
Performance Data - Bench
Test | Test Method Summary / Purpose | Results |
---|---|---|
Visual and | ||
Dimensional | ||
Inspection | Visual and dimensional inspection demonstrates that | |
the printed graduations meet volumetric capacity. | ||
Volumetric graduations are approximate. | The EDMS device met the | |
acceptance criteria for visual and | ||
dimensional inspection. | ||
Leakage of | ||
Drainage Bag | The drainage bag must withstand being inverted | |
without leaking. | The EDMS device met the | |
acceptance criteria for drainage | ||
bag leakage. | ||
Flow Initiation | ||
Pressure | Record pressure at which flow initiates, for each | |
drainage bag. | The EDMS device met the | |
acceptance criteria for flow | ||
initiation pressure. | ||
Drainage Bag | ||
Seal Weld | Ensure there are no leaks in the drainage bag. | The EDMS device met the |
acceptance criteria for drainage | ||
bag seal weld. | ||
Tensile Strength | ||
of Drainage Bag | ||
Inlet Port | Evaluate the tensile strength of the drainage bag | |
inlet port to failure. | The EDMS device met the | |
acceptance criteria for tensile | ||
strength of drainage bag inlet | ||
port. |
Performance Data – Animal
The risk assessment of the proposed modifications to the disposable bag did not require animal testing. Determination of substantial equivalence for the design change is based upon the design verification bench testing.
Performance Data - Clinical
The risk assessment of the proposed modifications to the disposable bag did not require clinical testing. Determination of substantial equivalence for the design change is based upon the design verification bench testing.
- XI. Conclusions: The information provided in this submission demonstrates that the subject device, the Medtronic EDMS, has the same intended use/indications for use as the predicate device and the differences in technological characteristics introduced by the proposed changes to the drainage bag do not raise any questions of safety and effectiveness. Based on the information provided in this submission the subject Medtronic EDMS device is considered substantially equivalent to the previously cleared predicate device.