(244 days)
Empty
No
The device description and performance studies focus on mechanical and fluid dynamics aspects of a drainage system, with no mention of AI/ML terms or functionalities.
Yes.
The device's intended use is to drain cerebrospinal fluid to reduce intracranial pressure, which directly treats a medical condition.
No
This device is designed for drainage of cerebrospinal fluid (CSF) to reduce intracranial pressure, which is a therapeutic function, not a diagnostic one. It collects fluid but does not analyze it to provide diagnostic information.
No
The device description explicitly lists physical components such as tubing, drainage bag, drip chamber, and scale plate, 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 brain and lumbar space to reduce intracranial pressure. This is a therapeutic and monitoring function, not a diagnostic one.
- Device Description: The device is a system for collecting bodily fluid. It does not perform any tests or analyses on the fluid to diagnose a condition.
- Lack of Diagnostic Elements: There is no mention of any components or processes that would analyze the CSF for diagnostic purposes (e.g., chemical analysis, cellular analysis, etc.).
IVD devices are used to examine specimens derived from the human body (like blood, urine, or CSF) to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is purely for drainage and collection, which is a medical procedure, not a diagnostic test.
N/A
Intended Use / Indications for Use
External Drainage System allows for drainage of cerebrospinal fluid (CSF) from the lateral ventricles of the brain and the lumbar subarachnoid space in selected patients to reduce intracranial pressure (ICP).
Product codes
JXG
Device Description
The External Drainage System includes a tubing, drainage bag, drip chamber and scale plate. It is provided sterile and can be connected to a drainage catheter, which is connected to a patient line, via a luer connection and ultimately to a drainage bag. The drainage catheter is not included in the subject device. The External Drainage System provides a closed system for the drainage of cerebrospinal fluid (CSF) from the ventricles of the brain or the lumbar subarachnoid space. During the draining, the cerebrospinal fluid will be collected in a drainage bag.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lateral ventricles of the brain and 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)
The following test were performed to verify that the performance of the subject device is substantially equivalent to the performance of the predicate device. Testing included side-by-side comparison data with the predicate device.
Test Items and Results:
- Device size requirements: Pass
- Fluid leakage by pressure decay test: Pass
- The volume and scale of the drip chamber: Pass
- Integrity of air vent filter of the drip chamber: Pass
- Integrity of air vent filter of the drainage bag: Pass
- Packaging integrity: Pass
- Package sealing strength: Pass
- Sterility: Pass
- Endotoxin testing: Pass
Biocompatibility Test Summary:
- In vitro Cytotoxicity Test: Non-cytotoxic (Test article extracts showed no evidence of cytotoxicity.)
- Skin sensitization tests: Non-sensitizing (Test article extracts showed no evidence of causing skin sensitization in the guinea pig.)
- Intracutaneous reactivity test: Non-irritant (The test article extracts showed no evidence of intracutaneous reactivity in rabbit.)
- Acute systemic toxicity test: Non-toxic acutely (The test article extracts showed no evidence of acute systemic toxicity. No mortality during the study, all animals were clinically normal throughout the study, body weight data were acceptable.)
- Material mediated pyrogenicity test: Non-pyrogenic (The test article met the requirements for the absence of pyrogens.)
- In vitro hemolysis study: Non-hemolytic (Under the conditions of this study, the hemolytic index of test article was 0.8%.)
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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February 9, 2023
JMED(Shenzhen) Technology Limited Anna Xiao Regulatory Specialist 7#401, Zhongxing Road, Xiuxin Community, Kengzi Street, Pingshan District Shenzhen City, Guangdong 518122 China
Re: K221694
Trade/Device Name: 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: January 10, 2023 Received: January 10, 2023
Dear Anna Xiao:
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,
Digitally signed by Adam D. Adam D. Pierce -S Date: 2023.02.09 Pierce -S 17:41:33 -05'00'
Adam D. Pierce, Ph.D. Assistant 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) K221694
Device Name External Drainage System
Indications for Use (Describe)
External Drainage System allows for drainage of cerebrospinal fluid (CSF) from the lateral ventricles of the brain and the lumbar subarachnoid space in selected patients to reduce intracranial pressure (ICP).
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
Submission Sponsor 1
JMED (Shenzhen) Technology Limited 7#401, Zhongxing Road No.14, Xiuxin Community, Kengzi Street, Pingshan District, Shenzhen City, Guangdong, 518122, P. R. China Tel: 86-755-84513706 Email: registration(@jmedtech.com.cn
2 Submission Correspondent
Anna Xiao Regulatory Specialist JMED(Shenzhen) Technology Limited 7#401, Zhongxing Road No.14, Xiuxin Community, Kengzi Street,Pingshan District, Shenzhen City, Guangdong, 518122, P. R. China Tel: 86-755-84513706 Tel: 0086-13670075972 Email: yu.xiao(@jmedtech.com.cn
3 Date Prepared
February 6, 2023
4 Device Identification
Trade Name: External Drainage System Common Name: External Drainage System Regulation Name: Central Nervous System Fluid Shunt and Components Device Regulation: 21 CFR 882.5550 Device Classification: Class II Product Code: JXG
5 Predicate Device
510(k) Number: K191684 Trade Name: MoniTorr ICP™ External CSF Drainage and Monitoring System; LimiTorr™ Volume Limiting External CSF Drainage and Monitoring System
6 Device Description
The External Drainage System includes a tubing, drainage bag, drip chamber and scale plate. It is provided sterile and can be connected to a drainage catheter, which is connected to a patient line, via a luer connection and ultimately to a drainage bag. The drainage catheter is not included in the subject device. The External Drainage System
4
provides a closed system for the drainage of cerebrospinal fluid (CSF) from the ventricles of the brain or the lumbar subarachnoid space. During the draining, the cerebrospinal fluid will be collected in a drainage bag.
7 Indications For Use
External Drainage System allows for drainage of cerebrospinal fluid (CSF) from the lateral ventricles of the brain and the lumbar subarachnoid space in selected patients to reduce intracranial pressure (ICP).
8 Substantial Equivalence Discussion
Table 1 Comparisons between the subject device and the predicate device.
| Table 1 General Comparison | |||
|---|---|---|---|
| Item | Predicate Device | ||
| (K191684) | Subject Device | ||
| (K221694) | Comments | ||
| MoniTorr ICP™ External CSF Drainage and Monitoring System; | |||
| LimiTorr™ Volume Limiting External CSF Drainage and | |||
| Monitoring System | External Drainage System | ||
| Indications | |||
| for Use (IFU) | The MoniTorr ICP™ system | ||
| allows for drainage and monitoring | |||
| of CSF from the lateral ventricles | |||
| of the brain and the lumbar | |||
| subarachnoid space in selected | |||
| patients to reduce intracranial | |||
| pressure (ICP), to monitor CSF, to | |||
| provide temporary drainage of CSF | |||
| in patients with infected CSF | |||
| shunts, and the monitoring of ICP. |
The LimiTorr™ system allows for
drainage and monitoring of CSF
from the lateral ventricles of the
brain and the lumbar subarachnoid
space in selected patients to reduce
intracranial pressure (ICP), to
monitor CSF, to provide temporary
drainage of CSF in patients with
infected | External Drainage System
allows for drainage of
cerebral spinal fluid (CSF)
from the lateral ventricles of
the brain and the lumbar
subarachnoid space in
selected patients to reduce
intracranial pressure (ICP) | Similar
The IFU of
the predicate
device
contains
additional
claims not
applicable to
the subject
device. |
| | Predicate Device
(K191684) | Subject Device
(K221694) | |
| Item | MoniTorr ICP™ External CSF
Drainage and Monitoring System;
LimiTorr™ Volume Limiting
External CSF Drainage and
Monitoring System | External Drainage System | Comments |
| Sterility
Information | CSF shunts, and to monitor ICP. | | |
| | Provide sterile, single use. EO | Provide sterile, single use, EO | Identical |
| | Sterilized with sterility assurance
level (SAL) is $10^{-6}$ | Sterilized with sterility
assurance level (SAL) is $10^{-6}$ | |
| | LimiTorr Volume Limiting
External CSF Drainage and
Monitoring System: | | |
| Device
Components | Tubing (Patient line with
green strip, stopcock,
needleless sampling site). | Patient connection
Tubing (3-way stopcock with
injection port & sample port,
male luer connector, anti-
reflux valve, stopcock, female
luer connector, drip pot). | Similar
The main
device
components
are similar |
| | Drainage bag with an anti-reflux
valve, needleless sampling site). | Drainage bag (2-way
stopcock, hydrophobic
membrane, cord, cord lock). | |
| | Graduated burette
(Antimicrobial hydrophobic vent,
burette stopcock and blue cap). | Drip chamber with scale
plate, 3-way stopcock and
tubing. | |
| | MoniTorr ICP External CSF
Drainage and Monitoring System: | | |
| | Tuning (patient line with green
strip, stopcocks, red end cap,
injection site). | | |
| | Drainage bag with injection site
and anti-reflux valve. | | |
| | Graduated chamber, microbial
filter vent, drip former, pressure
level, chamber stopcock, panel
and injection site. | | |
| | Pole mount bracket assembly with
clamping screw. | | |
| | Predicate Device
(K191684) | Subject Device
(K221694) | |
| Item | MoniTorr ICP™ External CSF
Drainage and Monitoring System;
LimiTorr™ Volume Limiting
External CSF Drainage and
Monitoring System | External Drainage System | Comments |
| Device
Materials | The patient line, stopcock,
graduated burette and anti-reflux
valve may come in indirect contact
with the patient:
(1) Patient line: Not available
(2) Stopcock: HDPE and
polycarbonate
(3)Graduated burette: Not available
(4) Anti-reflux valve: Not available | The tubing ,3-way stopcock,
male luer connector and
anti-reflux valve may come in
indirect contact with the
patient:
(1) Tubing: PVC
(2) 3-way stopcock: PC
(3) Male luer connector: PC
(4) Anti-reflux valve: PC | Similar |
Table 1 General Comparison
5
6
The subject and predicate devices have similar intended use, sterilization method and device components. The differences among the devices do not impact the performance of the subject device.
9 Summary of Non-Clinical Performance Testing
The following test were performed to verify that the performance of the subject device is substantially equivalent to the performance of the predicate device. Testing included side-by-side comparison data with the predicate device. Please see the Summary of Testing Table 2 below for test results.
| Test Item | Test Methods | Results |
|---|---|---|
| Device size | ||
| requirements | To determine if the size of the | |
| device components is within | ||
| specifications. | Pass | |
| Fluid leakage by | ||
| pressure decay test | To establish that the tubing meets | |
| fluid leakage specifications. | Pass | |
| The volume and | ||
| scale of the drip | ||
| chamber | To determine if the volume and | |
| scale of the drip chamber is within | ||
| current specifications. | Pass | |
| Integrity of air vent | ||
| filter of the drip | ||
| chamber | To determine if the integrity of air | |
| vent filter of drip chamber is within | ||
| current specifications. | Pass |
Table 2 Performance Bench Test Results
7
| Integrity of air vent
filter of the drainage
bag | To determine if the integrity of air
vent filter of drainage bag is within
current specifications. | Pass |
|--------------------------------------------------------|----------------------------------------------------------------------------------------------------------|------|
| Packaging integrity | To determine if the packaging
integrity is within current
specifications. | Pass |
| Package sealing
strength | To determine if the sealing strength
of the package is within current
specifications. | Pass |
| Sterility | To determine if the sterility of the
device is within current
specifications for ethylene oxide. | Pass |
| Endotoxin testing | To determine if the endotoxin of the
device is within specifications of
2.15 EU/device. | Pass |
The External Drainage System is categorized as an externally communicating device in prolonged contact (>24 hour to 30 days) with CSF and indirect blood contact. The following test were completed in accordance with FDA biocompatibility guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process."
| Test item | Results | Conclusions |
|---|---|---|
| In vitro Cytotoxicity | ||
| Test | Test article extracts showed no evidence of | |
| cytotoxicity. | Non-cytotoxic | |
| Skin sensitization tests | Test article extracts showed no evidence of | |
| causing skin sensitization in the guinea pig. | Non-sensitizing | |
| Intracutaneous | ||
| reactivity test | The test article extracts showed no evidence of | |
| intracutaneous reactivity in rabbit. | Non-irritant | |
| Acute systemic toxicity | ||
| test | The test article extracts showed no evidence of | |
| acute systemic toxicity. |
- No mortality during the study
- All animals were clinically normal
throughout the study - Body weight data were acceptable | Non-toxic
acutely |
| Material mediated
pyrogenicity test | The test article met the requirements for the
absence of pyrogens. | Non-pyrogenic |
| Table 3 Biocompatibility Test Summary |
|---|
| --------------------------------------- |
8
| In vitro hemolysis
study | Under the conditions of this study, the
hemolytic index of test article was 0.8%. | Non-hemolytic |
| ----------------------------- | -------------------------------------------------------------------------------------- | --------------- |
|---|
5.10 Conclusion
The subject and predicate devices have similar indications for use and comparable technological characteristics. The differences in technological characteristics between the subject and predicate devices do not raise different questions on safety and effectiveness. The non-clinical performance data demonstrates that the subject device is substantially equivalent to the predicate device.