External Drainage System
Device Facts
| Record ID | K221694 |
|---|---|
| Device Name | External Drainage System |
| Applicant | Jmed(Shenzhen) Technology Limited |
| Product Code | JXG · Neurology |
| Decision Date | Feb 9, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.5550 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
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).
Device Story
External Drainage System (EDS) provides closed-system drainage of cerebrospinal fluid (CSF) from brain ventricles or lumbar subarachnoid space. Device components include tubing, 3-way stopcock with injection/sample ports, male luer connector, anti-reflux valve, drip chamber with scale plate, and drainage bag with hydrophobic membrane. System connects to a separately provided drainage catheter via luer connection. Used in clinical settings to manage intracranial pressure by collecting CSF in a drainage bag. Operation is manual; healthcare providers monitor drainage levels via the drip chamber scale. Benefits include controlled CSF removal to alleviate elevated intracranial pressure.
Clinical Evidence
No clinical data. Substantial equivalence supported by bench testing and biocompatibility evaluation. Bench testing verified device size, fluid leakage (pressure decay), drip chamber volume/scale accuracy, air vent filter integrity, and packaging/sterility. Biocompatibility testing (ISO 10993-1) confirmed non-cytotoxic, non-sensitizing, non-irritant, non-toxic, non-pyrogenic, and non-hemolytic status for prolonged contact (>24h to 30 days) with CSF.
Technological Characteristics
Externally communicating device for prolonged contact (>24h to 30 days) with CSF. Materials: PVC (tubing), Polycarbonate (stopcock, luer, anti-reflux valve). Components: tubing, 3-way stopcock, drip chamber, drainage bag with hydrophobic vent. Sterilization: Ethylene Oxide (SAL 10^-6). Standalone mechanical system; no energy source or software.
Indications for Use
Indicated for drainage of CSF from lateral ventricles or lumbar subarachnoid space in patients requiring reduction of intracranial pressure (ICP).
Regulatory Classification
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.
Predicate Devices
- MoniTorr ICP™ External CSF Drainage and Monitoring System; LimiTorr™ Volume Limiting External CSF Drainage and Monitoring System (K191684)
Submission Summary (Full Text)
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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
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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
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# 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
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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<br>(K191684) | Subject Device<br>(K221694) | Comments |
| | MoniTorr ICP™ External CSF Drainage and Monitoring System;<br>LimiTorr™ Volume Limiting External CSF Drainage and<br>Monitoring System | External Drainage System | |
| Indications<br>for Use (IFU) | The MoniTorr ICP™ system<br>allows for drainage and monitoring<br>of CSF from the lateral ventricles<br>of the brain and the lumbar<br>subarachnoid space in selected<br>patients to reduce intracranial<br>pressure (ICP), to monitor CSF, to<br>provide temporary drainage of CSF<br>in patients with infected CSF<br>shunts, and the monitoring of ICP.<br><br>The LimiTorr™ system allows for<br>drainage and monitoring of CSF<br>from the lateral ventricles of the<br>brain and the lumbar subarachnoid<br>space in selected patients to reduce<br>intracranial pressure (ICP), to<br>monitor CSF, to provide temporary<br>drainage of CSF in patients with<br>infected | External Drainage System<br>allows for drainage of<br>cerebral spinal fluid (CSF)<br>from the lateral ventricles of<br>the brain and the lumbar<br>subarachnoid space in<br>selected patients to reduce<br>intracranial pressure (ICP) | Similar<br><br>The IFU of<br>the predicate<br>device<br>contains<br>additional<br>claims not<br>applicable to<br>the subject<br>device. |
| | Predicate Device<br>(K191684) | Subject Device<br>(K221694) | |
| Item | MoniTorr ICP™ External CSF<br>Drainage and Monitoring System;<br>LimiTorr™ Volume Limiting<br>External CSF Drainage and<br>Monitoring System | External Drainage System | Comments |
| Sterility<br>Information | CSF shunts, and to monitor ICP. | | |
| | Provide sterile, single use. EO | Provide sterile, single use, EO | Identical |
| | Sterilized with sterility assurance<br>level (SAL) is $10^{-6}$ | Sterilized with sterility<br>assurance level (SAL) is $10^{-6}$ | |
| | LimiTorr Volume Limiting<br>External CSF Drainage and<br>Monitoring System: | | |
| Device<br>Components | Tubing (Patient line with<br>green strip, stopcock,<br>needleless sampling site). | Patient connection<br>Tubing (3-way stopcock with<br>injection port & sample port,<br>male luer connector, anti-<br>reflux valve, stopcock, female<br>luer connector, drip pot). | Similar<br>The main<br>device<br>components<br>are similar |
| | Drainage bag with an anti-reflux<br>valve, needleless sampling site). | Drainage bag (2-way<br>stopcock, hydrophobic<br>membrane, cord, cord lock). | |
| | Graduated burette<br>(Antimicrobial hydrophobic vent,<br>burette stopcock and blue cap). | Drip chamber with scale<br>plate, 3-way stopcock and<br>tubing. | |
| | MoniTorr ICP External CSF<br>Drainage and Monitoring System: | | |
| | Tuning (patient line with green<br>strip, stopcocks, red end cap,<br>injection site). | | |
| | Drainage bag with injection site<br>and anti-reflux valve. | | |
| | Graduated chamber, microbial<br>filter vent, drip former, pressure<br>level, chamber stopcock, panel<br>and injection site. | | |
| | Pole mount bracket assembly with<br>clamping screw. | | |
| | Predicate Device<br>(K191684) | Subject Device<br>(K221694) | |
| Item | MoniTorr ICP™ External CSF<br>Drainage and Monitoring System;<br>LimiTorr™ Volume Limiting<br>External CSF Drainage and<br>Monitoring System | External Drainage System | Comments |
| Device<br>Materials | The patient line, stopcock,<br>graduated burette and anti-reflux<br>valve may come in indirect contact<br>with the patient:<br>(1) Patient line: Not available<br>(2) Stopcock: HDPE and<br>polycarbonate<br>(3)Graduated burette: Not available<br>(4) Anti-reflux valve: Not available | The tubing ,3-way stopcock,<br>male luer connector and<br>anti-reflux valve may come in<br>indirect contact with the<br>patient:<br>(1) Tubing: PVC<br>(2) 3-way stopcock: PC<br>(3) Male luer connector: PC<br>(4) Anti-reflux valve: PC | Similar |
# Table 1 General Comparison
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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<br>requirements | To determine if the size of the<br>device components is within<br>specifications. | Pass |
| Fluid leakage by<br>pressure decay test | To establish that the tubing meets<br>fluid leakage specifications. | Pass |
| The volume and<br>scale of the drip<br>chamber | To determine if the volume and<br>scale of the drip chamber is within<br>current specifications. | Pass |
| Integrity of air vent<br>filter of the drip<br>chamber | To determine if the integrity of air<br>vent filter of drip chamber is within<br>current specifications. | Pass |
## Table 2 Performance Bench Test Results
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| Integrity of air vent<br>filter of the drainage<br>bag | To determine if the integrity of air<br>vent filter of drainage bag is within<br>current specifications. | Pass |
|--------------------------------------------------------|----------------------------------------------------------------------------------------------------------|------|
| Packaging integrity | To determine if the packaging<br>integrity is within current<br>specifications. | Pass |
| Package sealing<br>strength | To determine if the sealing strength<br>of the package is within current<br>specifications. | Pass |
| Sterility | To determine if the sterility of the<br>device is within current<br>specifications for ethylene oxide. | Pass |
| Endotoxin testing | To determine if the endotoxin of the<br>device is within specifications of<br>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<br>Test | Test article extracts showed no evidence of<br>cytotoxicity. | Non-cytotoxic |
| Skin sensitization tests | Test article extracts showed no evidence of<br>causing skin sensitization in the guinea pig. | Non-sensitizing |
| Intracutaneous<br>reactivity test | The test article extracts showed no evidence of<br>intracutaneous reactivity in rabbit. | Non-irritant |
| Acute systemic toxicity<br>test | The test article extracts showed no evidence of<br>acute systemic toxicity.<br>- No mortality during the study<br>- All animals were clinically normal<br>throughout the study<br>- Body weight data were acceptable | Non-toxic<br>acutely |
| Material mediated<br>pyrogenicity test | The test article met the requirements for the<br>absence of pyrogens. | Non-pyrogenic |
| Table 3 Biocompatibility Test Summary |
|---------------------------------------|
|---------------------------------------|
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| In vitro hemolysis<br>study | Under the conditions of this study, the<br>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.
