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 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.

AI/ML Overview

The provided text describes the acceptance criteria and study results for an "External Drainage System," which is a Class II medical device used for draining cerebrospinal fluid.

Here's an analysis of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Item	Test Method Description	Reported Device Performance
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
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
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, clinically normal animals, acceptable body weight data).	Non-toxic acutely
Material mediated pyrogenicity test	The test article met the requirements for the absence of pyrogens.	Non-pyrogenic
In vitro hemolysis study	Hemolytic index of test article was 0.8%.	Non-hemolytic

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample sizes (number of units tested) for each of the performance and biocompatibility tests. It broadly states that "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."

The data provenance is not explicitly mentioned in terms of country of origin or whether it was retrospective or prospective. However, based on the context of a 510(k) submission, these are non-clinical (bench and biocompatibility) tests conducted to demonstrate equivalence to a predicate device. This implies the tests were specifically designed and performed for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable to the data presented. The "ground truth" concept is typically relevant for studies involving diagnostic accuracy or clinical interpretation where expert consensus is needed to determine the true state of a condition. The tests described here are physical performance and biocompatibility assessments, not diagnostic or interpretive tasks. The "ground truth" for these tests is based on objective measurements and established scientific/regulatory standards.

4. Adjudication method for the test set

This information is not applicable for the same reasons as point 3. Adjudication methods like "2+1" or "3+1" are used in studies where human readers independently interpret data, and discrepancies need to be resolved. The tests here are objective measurements.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There is no mention of a multi-reader multi-case (MRMC) study or any AI assistance. This device is a physical medical device (External Drainage System), and the testing described is non-clinical performance and biocompatibility, not an AI-powered diagnostic tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

There is no mention of a standalone algorithm performance study. As stated above, this is a physical medical device, not an algorithm.

7. The type of ground truth used

For the performance tests (e.g., device size, fluid leakage, sterility), the "ground truth" is derived from pre-defined engineering specifications and regulatory standards. For biocompatibility tests, the "ground truth" regarding safety is established by validated laboratory assays (e.g., cytotoxicity assays, sensitization tests) and their interpretation against acceptable limits set by regulatory guidance (e.g., ISO 10993).

8. The sample size for the training set

This information is not applicable as this device is not an AI/machine learning system that requires training data.

9. How the ground truth for the training set was established

This information is not applicable as this device is not an AI/machine learning system that requires a training set.

Summary

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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: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

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)

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

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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

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 andMonitoring System	External Drainage System
Indicationsfor Use (IFU)	The MoniTorr ICP™ systemallows for drainage and monitoringof CSF from the lateral ventriclesof the brain and the lumbarsubarachnoid space in selectedpatients to reduce intracranialpressure (ICP), to monitor CSF, toprovide temporary drainage of CSFin patients with infected CSFshunts, and the monitoring of ICP.The LimiTorr™ system allows fordrainage and monitoring of CSFfrom the lateral ventricles of thebrain and the lumbar subarachnoidspace in selected patients to reduceintracranial pressure (ICP), tomonitor CSF, to provide temporarydrainage of CSF in patients withinfected	External Drainage Systemallows for drainage ofcerebral spinal fluid (CSF)from the lateral ventricles ofthe brain and the lumbarsubarachnoid space inselected patients to reduceintracranial pressure (ICP)	SimilarThe IFU ofthe predicatedevicecontainsadditionalclaims notapplicable tothe subjectdevice.
	Predicate Device(K191684)	Subject Device(K221694)
Item	MoniTorr ICP™ External CSFDrainage and Monitoring System;LimiTorr™ Volume LimitingExternal CSF Drainage andMonitoring System	External Drainage System	Comments
SterilityInformation	CSF shunts, and to monitor ICP.
	Provide sterile, single use. EO	Provide sterile, single use, EO	Identical
	Sterilized with sterility assurancelevel (SAL) is $10^{-6}$	Sterilized with sterilityassurance level (SAL) is $10^{-6}$
	LimiTorr Volume LimitingExternal CSF Drainage andMonitoring System:
DeviceComponents	Tubing (Patient line withgreen strip, stopcock,needleless sampling site).	Patient connectionTubing (3-way stopcock withinjection port & sample port,male luer connector, anti-reflux valve, stopcock, femaleluer connector, drip pot).	SimilarThe maindevicecomponentsare similar
	Drainage bag with an anti-refluxvalve, needleless sampling site).	Drainage bag (2-waystopcock, hydrophobicmembrane, cord, cord lock).
	Graduated burette(Antimicrobial hydrophobic vent,burette stopcock and blue cap).	Drip chamber with scaleplate, 3-way stopcock andtubing.
	MoniTorr ICP External CSFDrainage and Monitoring System:
	Tuning (patient line with greenstrip, stopcocks, red end cap,injection site).
	Drainage bag with injection siteand anti-reflux valve.
	Graduated chamber, microbialfilter vent, drip former, pressurelevel, chamber stopcock, paneland injection site.
	Pole mount bracket assembly withclamping screw.
	Predicate Device(K191684)	Subject Device(K221694)
Item	MoniTorr ICP™ External CSFDrainage and Monitoring System;LimiTorr™ Volume LimitingExternal CSF Drainage andMonitoring System	External Drainage System	Comments
DeviceMaterials	The patient line, stopcock,graduated burette and anti-refluxvalve may come in indirect contactwith the patient:(1) Patient line: Not available(2) Stopcock: HDPE andpolycarbonate(3)Graduated burette: Not available(4) Anti-reflux valve: Not available	The tubing ,3-way stopcock,male luer connector andanti-reflux valve may come inindirect contact with thepatient:(1) Tubing: PVC(2) 3-way stopcock: PC(3) Male luer connector: PC(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 sizerequirements	To determine if the size of thedevice components is withinspecifications.	Pass
Fluid leakage bypressure decay test	To establish that the tubing meetsfluid leakage specifications.	Pass
The volume andscale of the dripchamber	To determine if the volume andscale of the drip chamber is withincurrent specifications.	Pass
Integrity of air ventfilter of the dripchamber	To determine if the integrity of airvent filter of drip chamber is withincurrent specifications.	Pass

Table 2 Performance Bench Test Results

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Integrity of air ventfilter of the drainagebag	To determine if the integrity of airvent filter of drainage bag is withincurrent specifications.	Pass
Packaging integrity	To determine if the packagingintegrity is within currentspecifications.	Pass
Package sealingstrength	To determine if the sealing strengthof the package is within currentspecifications.	Pass
Sterility	To determine if the sterility of thedevice is within currentspecifications for ethylene oxide.	Pass
Endotoxin testing	To determine if the endotoxin of thedevice is within specifications of2.15 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 CytotoxicityTest	Test article extracts showed no evidence ofcytotoxicity.	Non-cytotoxic
Skin sensitization tests	Test article extracts showed no evidence ofcausing skin sensitization in the guinea pig.	Non-sensitizing
Intracutaneousreactivity test	The test article extracts showed no evidence ofintracutaneous reactivity in rabbit.	Non-irritant
Acute systemic toxicitytest	The test article extracts showed no evidence ofacute systemic toxicity.- No mortality during the study- All animals were clinically normalthroughout the study- Body weight data were acceptable	Non-toxicacutely
Material mediatedpyrogenicity test	The test article met the requirements for theabsence of pyrogens.	Non-pyrogenic

Table 3 Biocompatibility Test Summary
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In vitro hemolysisstudy	Under the conditions of this study, thehemolytic index of test article was 0.8%.	Non-hemolytic
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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.

Regulation Number and Section

§ 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).