(103 days)
The Duet EDMS is indicated for draining of CSF flow from the lateral ventricles or lumbar subarachnoid space 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.
The Medtronic Duet™ External Drainage and Monitoring System (Duet™ EDMS) is a complete draining and monitoring cerebrospinal system for externally fluid (CSF) and monitoring intracranial pressure (ICP). It can be used for both external ventricular and lumbar drainage.
The Duet™ EDMS is an external drainage and monitoring system that uses gravity to drain cerebrospinal fluid (CSF) from the patient's ventricles or lumbar space to an external drainage receptacle. The drainage flow of CSF into the Duet™ EDMS is uni-directional and gravity-driven; there is no recirculation of the CSF. The Duet's catheter is surgically attached to the patient before it is attached to the drainage system. An opening is made in the patient's skull lumbar region and a catheter is inserted into patient's ventricle or the lumbar or subarachnoid space. The catheter is then attached to the drainage system. The CSF or blood is drained and monitored until the patient is stabilized, the infection successfully treated, or a long-term drainage method is implemented.
The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the "Duet External Drainage and Monitoring System (EDMS)". It describes the device, its intended use, and its comparison to a predicate device. However, it does not contain information about an AI/ML-based device or a study involving human readers or ground truth established by experts/pathology.
The performance testing summarized in the document focuses on the physical and functional characteristics of the Duet EDMS (e.g., dimensional accuracy, torque strength, leak integrity, flow initiation pressure, and attachment strength) rather than diagnostic or prognostic accuracy of an AI model.
Therefore, many of the requested points, such as sample size for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth establishment for AI models, are not applicable and cannot be extracted from this document.
If you are looking for an example of an AI/ML-based medical device submission, this document is not suitable.
Despite the irrelevance of the document to AI/ML, I will attempt to frame the acceptance criteria and study as presented for this non-AI device:
Acceptance Criteria and Device Performance for Duet External Drainage and Monitoring System (EDMS)
The Duet External Drainage and Monitoring System (EDMS) is a non-AI/ML medical device. Its performance testing focused on demonstrating its physical and functional suitability for its intended use, rather than diagnostic accuracy or AI model performance.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the "Pass" results for each test. The study demonstrated that the device "passed" all these checks, indicating it met the pre-defined performance requirements for each test.
| Test Name | Acceptance Criteria (Implicit from "Pass" Result) | Reported Device Performance |
|---|---|---|
| Dimensional | Vertical/horizontal alignment of scale label, pressure scale lengths, patient line tubing ID/length, cord length, drainage path ID, and stopcock flow path diameter must meet specified dimensions. | Pass |
| Drip Chamber Graduations | Drip chamber graduations must show correct readings. | Pass |
| Main System Stopcock (MSS) Assembly Torque Applied to Arm of Stopcock | MSS assembly must withstand a specified peak torque without failure or detachment. | Pass |
| MSS Assembly Load Applied to Core of Stopcock Arm | MSS assembly must withstand a specified peak load without failure. | Pass |
| Clamp to I.V. Pole Attachment Strength | Clamp must securely attach to the I.V. pole. | Pass |
| Cord to I.V. Pole Attachment Strength | Cord and cord lock must maintain secure hanging of the system. | Pass |
| Drip Chamber to Back Panel Attachment Strength | Drip chamber/bag subassembly must securely attach to the panel. | Pass |
| Strength of Attached Junctions (Tubing to Luer) | Junctions of tubes to luer must be securely attached. | Pass |
| Bottom Cap to Stopcock Junction Torque | Stopcock/bottom cap bond must be secure. | Pass |
| Drip Assembly and Drainage Bag Vent Integrity | Drip assembly and drainage bag vent must withstand appropriate fluid pressures. | Pass |
| Tensile Strength of Drainage Bag Inlet Port | Drainage bag inlet port must exhibit sufficient tensile strength to failure. | Pass |
| Drainage Bag Seal Weld | Drainage bag must have no leaks. | Pass |
| Flow Initiation Pressure | Flow must initiate at a specified pressure for each drainage bag. | Pass |
| Drip Assembly Vent Test (Exposure of Vent to Blood Solution) | Drip assembly vent must allow drainage of blood and CSF flow with minimal resistance. | Pass |
| Drip Assembly Vent Integrity | Drip assembly vent must allow fluid withdrawal without compromising mechanical integrity. | Pass |
| Leakage of UV-Cure Bonds | No leakage from UV-cure bonds between patient line and drip chamber subassembly. | Pass |
| Leakage of Drainage Bag | Drainage bag must withstand inversion without leaking. | Pass |
| Drip Chamber Volume | Drip chamber fluid weight must be verifiable. | Pass |
| Attachment of I.V. Pole and Position of Adjustable Drip Chamber | Clamping thumbscrews and cord locks must not slip from initial positions. | Pass |
| Leakage of UV Cure Bonds (Air Pressure) | UV-cure bonds must withstand air pressure without leaks. | Pass |
| Attachment of Junctions (Axial Load) | Junctions must withstand a minimum 5-pound axial load. | Pass |
| Bottom Cap to Stopcock Junction Torque | Stopcock/bottom cap bond must withstand specified torque. | Pass |
| Hydrophobic Microbial Barrier Vent on the Drainage Bag | Material must demonstrate 99.9% Bacterial Filtration Efficiency (BFE). | Pass |
2. Sample Size and Data Provenance
- Sample Size for Test Set: The document does not specify the quantitative sample size for each individual performance test (e.g., number of devices tested for each parameter). It only states that "Testing demonstrated the performance of the device."
- Data Provenance: The document does not provide details about the country of origin of the data or whether the testing was retrospective or prospective in the context of patient data. The tests described are laboratory-based engineering performance tests conducted on the physical device.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Not applicable. The "ground truth" for these tests relates to engineering specifications and physical measurements, rather than clinical interpretation requiring expert consensus.
- Qualifications of Experts: Not applicable. Testing was likely conducted by engineers or technicians involved in product development and quality assurance, following established protocols.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The tests involve objective measurements and physical properties, which typically have clear pass/fail criteria based on engineering specifications, not subjective interpretation requiring adjudication.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the clinical performance of diagnostic or AI-assisted interpretation systems, which is not the function of the Duet EDMS.
6. Standalone (Algorithm Only) Performance
- Standalone Performance: No, a standalone performance study was not done. The Duet EDMS is a physical medical device, not a software algorithm.
7. Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" for the performance tests was based on engineering specifications, design requirements, and established physical measurement standards. For example, a dimension must be within a certain tolerance, a torque value must exceed a minimum, or a seal must not leak.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device does not involve machine learning; therefore, there is no "training set."
9. How Ground Truth for the Training Set Was Established
- Ground Truth Establishment for Training Set: Not applicable, as there is no training set for this non-AI device.
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March 10, 2025
Image /page/0/Picture/1 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Medtronic Neurosurgery Foram Shukla Regulatory Affairs Specialist 4620 N. Beach Street Fort Worth, Texas 76137
Re: K243676
Trade/Device Name: Duet External Drainage and Monitoring System (EDMS) Regulation Number: 21 CFR 882.5550 Regulation Name: Central Nervous System Fluid Shunt And Components Regulatory Class: Class II Product Code: JXG Dated: November 27, 2024 Received: February 6, 2025
Dear Foram Shukla:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
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Sincerely,
Digitally signed by Adam D. Adam D. Pierce -S Date: 2025.03.10 Pierce -S 13:56:42 -04'00'
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) K243676
Device Name
Duet External Drainage and Monitoring System (EDMS)
Indications for Use (Describe)
The Duet EDMS is indicated for draining of CSF flow from the lateral ventricles or lumbar subarachnoid space 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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510(k) Summary
March 7, 2025
| I. Company: | Medtronic Neurosurgery4620 N Beach Street,Fort Worth, Texas 79137 USA |
|---|---|
| Contact: | Foram ShuklaRegulatory Affairs Specialistforam.a.shukla@medtronic.comTelephone Number: 817-788-6400 |
| Alternate Contact: | Rishi SinhaSenior Regulatory Affairs Directorrishi.k.sinha@medtronic.com |
II. Proprietary Trade Name: Duet™ External Drainage and Monitoring System (EDMS)
Telephone Number: 720-890-2485
III. Regulatory Class: II
IV. Primary Classification:
Name: Central nervous system fluid shunt and components Regulation: 21 CFR 882.5550 Classification Product Code: JXG
V. Identification of Legally Marketed Predicate and Reference Devices
Predicate device: Becker External Drainage and Monitoring System (K200456) Reference device: Duet™ External Drainage and Monitoring System (K242034)
VI. Product Description
The Medtronic Duet™ External Drainage and Monitoring System (Duet™ EDMS) is a complete draining and monitoring cerebrospinal system for externally fluid (CSF) and monitoring intracranial pressure (ICP). It can be used for both external ventricular and lumbar drainage.
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K243676 Page 2 of 7
The Duet™ EDMS is an external drainage and monitoring system that uses gravity to drain cerebrospinal fluid (CSF) from the patient's ventricles or lumbar space to an external drainage receptacle. The drainage flow of CSF into the Duet™ EDMS is uni-directional and gravity-driven; there is no recirculation of the CSF. The Duet's catheter is surgically attached to the patient before it is attached to the drainage system. An opening is made in the patient's skull lumbar region and a catheter is inserted into patient's ventricle or the lumbar or subarachnoid space. The catheter is then attached to the drainage system. The CSF or blood is drained and monitored until the patient is stabilized, the infection successfully treated, or a long-term drainage method is implemented.
VII. Indications for Use
The Duet™ EDMS is indicated for 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 subject device and the predicate device have the same indications for use, intended use, fundamental technology and operating principle.
IX. Device Comparison
The tables below provide a summary of the device.
| Characteristic | Subject Device | Predicate Device |
|---|---|---|
| Device Name | Duet™ External Drainage and Monitoring System | Becker External Drainage and Monitoring System |
| ClassificationProcode | JXG | GWM |
| Characteristic | Subject Device | Predicate Device |
| 510k Number | K243676 | K200456 |
| Intended Use | Draining and monitoringcerebrospinal fluid (CSF) andmonitoring intracranial pressure(ICP). | Same |
| Indications forUse | The DuetTM EDMS is indicated fordraining and monitoring of CSF flowfrom the lateral ventricles or lumbarsubarachnoid space in selectedpatients to:Reduce intracranial pressure (ICP),e.g., pre-, intra- or postoperative. Monitor CSF chemistry, cytology,and physiology. Provide temporary CSF drainage inpatients with infected CSF shunts. Monitoring of intracranial pressure(ICP) is indicated in selected patientswith:Severe head injury Subarachnoid hemorrhage gradedIII, IV, or V preoperatively Reyes syndrome or similarencephalopathies Hydrocephalus Intracranial hemorrhage Miscellaneous problems whendrainage is to be used as atherapeutic maneuver. Monitoring can also be used toevaluate the status pre- andpostoperatively for space-occupyinglesions. | Draining and monitoring of CSF flowfrom the lateral ventricles or lumbarsubarachnoid space is indicated inselected patients to:Reduce intracranial pressure (ICP),e.g., pre-, intra- or postoperative. Monitor CSF chemistry, cytology,and physiology. Provide temporary CSF drainage inpatients with infected CSF shunts. Monitoring of intracranial pressure(ICP) is indicated in selected patientswith:Severe head injury Subarachnoid hemorrhage gradedIII, IV, or V preoperatively Reyes syndrome or similarencephalopathies Hydrocephalus Intracranial hemorrhage Miscellaneous problems whendrainage is to be used as atherapeutic maneuver. Monitoring can also be used toevaluate the status pre- andpostoperatively for space-occupyinglesions. |
| Characteristic | Subject Device | Predicate Device |
| Principle ofOperation | External drainage is temporarydrainage of cerebrospinal fluid (CSF)from the lateral ventricles of thebrain, or the lumbar space of thespine, into an external collection bag.The Duet™ EDMS drains CSF byusing a combination of gravity andintercerebral pressure. The drainagerate depends on the height at whichthe system is placed relative to thepatient's anatomy. | Same |
| Patient LineTubing | Visible Identification: Green stripedownside of tubing to indicatedrainage line. | Same |
| Drip ChamberAssembly | • Sliding, graduated 75 ml flowchamber with drip former, taperedbottom, and locking bracket.• "Window" frames desired pressuresetting. | • Sliding, graduated 50 ml flowchamber with drip former andconical bottom and locking bracket.• Pressure scale underlines desiredpressure setting. |
| Pressure Scales | • Unit of Measure: cmH2O andmmHg• Location: 4-way rotating pole scaleattached to panel• Scale markings are placed ontoRotating Scale Tube – one pressurescale showing per $1/4$ rotation. | • Unit of Measure: cmH2O andmmHg• Location: Printed directly ontoscale• Scales are side by side |
| HeightAdjustment Cord | Self-adjusting cord with lockingmechanism to adjust height ofdrainage system. | Same |
| DeviceAccessories | • ClearSite Laser Levels• Replacement Drainage Bag. | • Replacement Laser Level• Becker Quick-Attach Pole Clampwith Laser Level• Becker Quick-Attach Pole Clamp(without Laser Level)• Replacement Drainage Bag. |
| Characteristic | Subject Device | Predicate Device |
| Biocompatibility- Patient contactand duration | Prolonged (>24hrs - <30 days)external communicating device withblood path | Same |
| Shelf-life | 3 years | 2 years |
| MRI SafetyInformation | MR Conditional | MR Unsafe |
| Sterilizationmethod | Ethylene Oxide | Same |
Table 1: Subject to Predicate Device Comparison - Technological Characteristics
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X. Discussion of the Performance Testing
"Testing demonstrated the performance of the device for its intended use. The performance testing summarized in Table-2 has been conducted in support of the substantial equivalence determination for the proposed change. Results of verification and validation testing conducted on the Duet EDMS demonstrated that the subject device performed as designed, is suitable for its intended use and is substantially equivalent to the predicate device." The subject device is also identical to the reference device Duet™ External Drainage and Monitoring System (K242034).
| Test Name | Test Method Summary | Results |
|---|---|---|
| Dimensional | Measure the dimensions of the scale label vertical and horizontal alignment, pressure scale lengths, patient line tubing inner diameter (ID) and length, cord length, drainage path ID (from bottom of drip chamber), and stopcock flow path diameter. | Pass |
| Drip ChamberGraduations | Verify the correct readings on the drip chamber graduation. | Pass |
| Main System Stopcock(MSS) AssemblyTorque Applied to Armof Stopcock | Record the peak torque at which the MSS assembly fails or detaches from the panel. | Pass |
| MSS Assembly LoadApplied to Core ofStopcock Arm | Record peak load at which MSS assembly failed. | Pass |
| Test Name | Test Method Summary | Results |
| Clamp to I.V. PoleAttachment Strength | Ensure secure attachment of clamp to I.V. pole. | Pass |
| Cord to I.V. PoleAttachment Strength | Ensure cord and cord lock maintains secure hanging ofsystem. | Pass |
| Drip Chamber to BackPanel AttachmentStrength | Ensure secure attachment of drip chamber/bag subassembly topanel. | Pass |
| Strength of AttachedJunctions (Tubing toLuer) | Ensure secure attachment of junctions of tubes to luer. | Pass |
| Bottom Cap toStopcock JunctionTorque | Ensure secure bond of stopcock/bottom cap. | Pass |
| Drip Assembly andDrainage Bag VentIntegrity | Ensure that drip assembly and drainage bag vent can withstandappropriate fluid pressures. | Pass |
| Tensile Strength ofDrainage Bag Inlet Port | Evaluate the tensile strength of the drainage bag inlet port tofailure. | Pass |
| Drainage Bag SealWeld | Ensure there are no leaks in the drainage bag. | Pass |
| Flow Initiation Pressure | Record pressure at which flow initiates, for each drainage bag. | Pass |
| Drip Assembly VentTest (Exposure of Ventto Blood Solution) | Ensure that the drip assembly vent allows drainage of bloodand provide CSF flow through system with minimalresistance. | Pass |
| Drip Assembly VentIntegrity | Test the drip assembly vent to withdraw fluid withoutcompromising its mechanical integrity. | Pass |
| Leakage of UV-CureBonds | Record any leakage from the UV-cure bonds between thepatient line and drip chamber subassembly. | Pass |
| Leakage of DrainageBag | The drainage bag must withstand being inverted withoutleaking. | Pass |
| Drip Chamber Volume | Verify fluid weight in the drip chamber. | Pass |
| Test Name | Test Method Summary | Results |
| Attachment of I.V. Poleand Position ofAdjustable DripChamber | Visually verify that clamping thumbscrews (and cord locks)have not slipped from initial positions (using visual marks toidentify any slippage). | Pass |
| Leakage of UV CureBonds | The UV-cure bonds between the patient line and drip chambersubassembly should withstand air pressure without causingleaks. | Pass |
| Attachment of Junctions | Junctions must be able to withstand minimum of 5-pound loadin the axial direction. | Pass |
| Bottom Cap toStopcock JunctionTorque | Test the torque of the stopcock/bottom cap bond. | Pass |
| Hydrophobic MicrobialBarrier Vent on theDrainage Bag | The supplier for the material used as the drainage bag ventsconducted microbial barrier testing to demonstrate a 99.9%Bacterial Filtration Efficiency (BFE). | Pass |
Table-2: Performance Testing of Duet EDMS
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K243676 Page 6 of 7
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K243676 Page 7 of 7
XI. Biocompatibility Testing
Biocompatibility assessment was conducted based on Appendix A of the FDA guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. The Duet™ EDMS is categorized as a prolonged (>24h to 30 d) external communicating device with indirect blood path contact. The biocompatibility evaluation for the cytotoxicity, sensitization or intracutaneous reactivity, acute systemic toxicity, material-mediated pyrogenicity, subacute/subchronic toxicity, and indirect hemolysis endpoints was completed in accordance with FDA's biocompatibility guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"".
XII. Conclusion
The information provided in this submission demonstrates that the subject device Duet™ EDMS has the same intended use as the predicate devices. Based on the similarities of the device design, principles of operation, technological characteristics and results of the non-clinical performance testing, the subject device Duet™ EDMS is substantially equivalent to the cleared predicate device Becker External Drainage and Monitoring System (K200456).
§ 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).