(30 days)
No
The device description and performance studies focus on mechanical and fluid dynamics aspects of CSF drainage and monitoring. There is no mention of AI/ML in the intended use, device description, or performance evaluation.
Yes
Explanation: The device is used to reduce intracranial pressure and provide temporary CSF drainage, both of which are therapeutic interventions.
Yes
The device is designed for "Monitoring CSF chemistry, cytology, and physiology" and "Monitoring of intracranial pressure (ICP)", which are diagnostic functions.
No
The device description explicitly lists multiple hardware components, including patient connection lines, stopcocks, a mounting panel, injection sites, a drainage bag, a drip chamber, and drainage line slide clamps. This indicates it is a physical medical device system, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for draining and monitoring CSF flow and pressure, as well as monitoring CSF chemistry, cytology, and physiology. While it mentions monitoring CSF chemistry and cytology, the primary function is the physical drainage and pressure monitoring of CSF within the patient's body.
- Device Description: The device is a system for physically draining and monitoring CSF. It consists of tubes, stopcocks, a drip chamber, and a drainage bag. These are all components for managing fluid flow and pressure in vivo.
- Lack of In Vitro Activity: An IVD is a medical device intended to be used in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not perform any analysis or examination of specimens outside the body. While it can be used to collect CSF for later in vitro analysis, the device itself is not performing that analysis.
Therefore, the Becker External Drainage and Monitoring System is a device used for managing and monitoring physiological parameters within the patient, not for performing diagnostic tests on specimens outside the body.
N/A
Intended Use / Indications for Use
Draining and monitoring of 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.
Monitoring of intracranial pressure (ICP) is indicated in selected patients with:
- Severe head injury
- Subarachnoid hemorrhage graded III, IV. or V preoperatively
- Reyes 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 postoperatively for space-occupying lesions.
Product codes
GWM, HCA
Device Description
The Becker External Drainage and Monitoring System (Becker EDMS) provides the physician with a complete closed system for:
- Draining cerebrospinal fluid (CSF) from the lateral ventricles of the brain or the lumbar subarachnoid space.
- Monitoring CSF pressure and flow rate from the lateral ventricles of the brain and the lumbar subarachnoid space.
The Becker EDMS consists of a nondistensible blue or green striped (proximal end) patient connection line, patient line stopcock, mounting panel/main system section, two latex-free injection sites and a removable drainage bag with approximate volumetric graduations and microbial barrier air vent.
The main system section located on the mounting panel includes:
- Mounting bracket for height adjustment of system
- Optional self-adjusting cord with lock for adjustment of system height
- Main system stopcock with optional transducer attachment location
- Sliding, graduated, 50 cc drip chamber with drip former and conical bottom, and locking bracket
- Two drainage line slide clamps for flow monitoring and sampling
- Drainage bag connection line
- Needleless Injection Site (Interlink or Smartsite)
- Instructions for Use
The system does not contain any latex components.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
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.
Bench Performance Data:
- Visual and Dimensional Inspection: Visual and dimensional inspection demonstrates that the printed graduations meet volumetric capacity. Volumetric graduations are approximate. The Becker 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 Becker EDMS device met the acceptance criteria for drainage bag leakage.
- Flow Initiation Pressure: Record pressure at which flow initiates, for each drainage bag. The Becker EDMS device met the acceptance criteria for flow initiation pressure.
- Drainage Bag Seal Weld: Ensure there are no leaks in the drainage bag. The Becker 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 Becker EDMS device met the acceptance criteria for tensile strength of drainage bag inlet port.
Animal Performance Data: The risk assessment of the proposed modifications to the disposable bag did not require animal testing.
Clinical Performance Data: The risk assessment of the proposed modifications to the disposable bag did not require clinical testing.
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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
March 26, 2020
Medtronic, Inc. Nancy Hampton, Ph.D. Principal Regulatory Affairs Specialist 125 Cremona Drive Goleta, California 93117
Re: K200456
Trade/Device Name: Becker External Drainage and Monitoring System Regulation Number: 21 CFR 882.1620 Regulation Name: Intracranial Pressure Monitoring Device Regulatory Class: Class II Product Code: GWM, HCA Dated: February 20, 2020 Received: February 25, 2020
Dear Dr. Nancy Hampton:
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 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
1
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 mediation-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
2
Indications for Use
510(k) Number (if known) K200456
Device Name
Becker External Drainage and Monitoring System
Indications for Use (Describe)
Draining and monitoring of 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.
Monitoring of intracranial pressure (ICP) is indicated in selected patients with:
-
- Severe head injury
-
- Subarachnoid hemorrhage graded III, IV. or V preoperatively
-
- Reyes 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 postoperatively 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
Becker® External Drainage and Monitoring System
510(k) Summary
March 26, 2020
- I. Medtronic, Inc. Company: Medtronic Neurosurgery 125 Cremona Drive Goleta, California 93117 USA
- Contact: Nancy Hampton, PhD Principal Regulatory Affairs Specialist nancy.d.hampton@medtronic.com Telephone Number: 949-490-3773
- Establishment Registration Number: 2021898 II.
- III. Proprietary Trade Name: Becker® External Drainage and Monitoring System
- 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 Becker External Drainage and Monitoring System (Becker EDMS) provides the physician with a complete closed system for:
- Draining cerebrospinal fluid (CSF) from the lateral ventricles of the brain or the lumbar subarachnoid space.
4
- Monitoring CSF pressure and flow rate from the lateral ventricles of the brain and the lumbar subarachnoid space.
The Becker EDMS consists of a nondistensible blue or green striped (proximal end) patient connection line, patient line stopcock, mounting panel/main system section, two latex-free injection sites and a removable drainage bag with approximate volumetric graduations and microbial barrier air vent.
The main system section located on the mounting panel includes:
-
- Mounting bracket for height adjustment of system
- Optional self-adjusting cord with lock for adjustment of system height 2.
-
- Main system stopcock with optional transducer attachment location
- Sliding, graduated, 50 cc drip chamber with drip former and conical bottom, and locking 4. bracket
-
- Two drainage line slide clamps for flow monitoring and sampling
- Drainage bag connection line 6.
- Needleless Injection Site (Interlink or Smartsite) 7.
- Instructions for Use 8.
The system does not contain any latex components.
VII. Indications for Use:
Draining and monitoring of 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.
Monitoring of intracranial pressure (ICP) is indicated in selected patients with:
-
- Severe head injury
-
- Subarachnoid hemorrhage graded III, IV, or V preoperatively
-
- Reyes 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 postoperatively for space-occupying lesions.
VIII. Summary of the Technological Characteristics:
The proposed Becker EDMS modified disposable bag is a sterile nonpyrogenic single use component of the system that is removable from the Becker EDMS mounting panel. The bag has an approximate volume capacity of 600ml with approximate volumetric markings in 50mL increments, an inlet port, an outlet port and a hydrophobic/anti-microbial vent embedded into the body of the bag. The rest of the Becker EDMS system has the same technological characteristics as the predicate device.
5
| Subject Device | Predicate Device | |
|---|---|---|
| K984053 | ||
| Intended use / | ||
| Indications for | ||
| Use | Draining and monitoring of 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.
Monitoring of intracranial pressure (ICP)
is indicated in selected patients with: - Severe head injury
- Subarachnoid hemorrhage graded III,
IV, or V preoperatively - Reyes 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 postoperatively for
space-occupying lesions. | Draining and monitoring of 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;
Reyes syndrome or similar
encephalopathies;
hydrocephalus;
intracranial hemorrhage or miscellaneous
problems when drainage is to be used as a
therapeutic maneuver.
Monitoring can also be used to evaluate the
status pre-and postoperatively 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 Becker EDMS drains
CSF by using a combination of gravity
and intercerebral pressure. The drainage
rate depends on the height at which the
system is placed relative to the patient's
anatomy. | Same |
| Materials | There are no materials with direct patient
contact | 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 | Same |
| | Subject Device | Predicate Device
K984053 |
| Sterilization
Method | Ethylene Oxide | Same |
| Pyrogenicity | Non pyrogenic | Same |
| Shelf life | 2 years | Same |
6
- IX. Identification of Legally Marketing Predicate Devices: Medtronic PS Medical Becker External Drainage and Monitoring System, K984053.
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.
| 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 Becker 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 Becker EDMS device met | |
| the acceptance criteria for | ||
| drainage bag leakage. | ||
| Flow Initiation | ||
| Pressure | Record pressure at which flow initiates, for each | |
| drainage bag. | The Becker EDMS device met | |
| the acceptance criteria for flow | ||
| initiation pressure. | ||
| Drainage Bag | ||
| Seal Weld | Ensure there are no leaks in the drainage bag. | The Becker 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 Becker EDMS device met | |
| the acceptance criteria for tensile | ||
| strength of drainage bag inlet | ||
| port. |
Performance Data - Bench
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.
7
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 Becker 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 disposable bag do not raise questions of safety and effectiveness. Based on the information provided in this submission the subject Becker EDMS device is considered substantially equivalent to the previously cleared predicate device.