(29 days)
The catheter is used for cerebrospinal fluid (CSF) shunting.
The ventricular catheter is part of the Miethke Shunt System. It is used to gain access to the cavities of the brain for shunting of excessive CSF.
The ventricular catheter will be offered in lengths of 18 cm or 25 cm with an inner diameter of 1.2 mm and an outer diameter of 2.5 mm. The ventricular catheter contains five stripe depth markers at 3, 5, 7, 10 and 13 cm from the catheter tip. The ventricular catheter is manufactured using barium sulfate filled silicone elastomer.
The purpose of this submission is to seek clearance for modifications to the ventricular catheter which is part of the Miethke Shunt System (K020728). This submission proposes the following modification:
- adding stripe depth markers at 4, 6, 8, 9, 11 and 12 cm and point markers at 1 cm intervals on both sides of the tubing starting at 3.5 cm to 12.5 cm from the catheter tip.
The ventricular catheter is designed to articulate with existing Miethke Shunt Systems, such as the M.blue Adjustable Shunt System, Miethke Shunt System GAV 2.0 and SA 2.0 Valves, proGAV 2.0 Adjustable Shunt System, proSA Progammable Shunt System, Miethke Shunt System miniNAV valve, Miethke Shunt System Gravity Assisted Valve (GAV), and the Miethke Shunt System (DSV, ShuntAssistant, paedi-GAV, connectors, and reservoirs) cleared by FDA (K192266/K190174/K161853/K141687/K120559/K110206/K103003/K062009/K031303/ K030698/K011030).
The provided text is a 510(k) summary for the Miethke Ventricular Catheter, which addresses a modification to an existing device rather than a new AI-powered diagnostic tool. Therefore, much of the requested information regarding AI study design, such as MRMC comparative effectiveness, standalone performance, training set details, and expert ground truth establishment, is not applicable to this document.
However, I can extract information related to the acceptance criteria and the study performed for this specific device, as it pertains to the physical catheter modification.
Here's the relevant information:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Device meets predefined acceptance criteria for radiopacity | All samples met predefined acceptance criteria. |
| Device performance as intended | The ventricular catheter performs as intended. |
| Substantial equivalence to predicate device | Demonstrated to be substantially equivalent to the predicate device. |
| No new issues of safety or effectiveness | The modification raises no new issues of safety or effectiveness. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document mentions "All samples" in relation to meeting acceptance criteria, implying a test set was used, but the exact number is not provided.
- Data Provenance: Not explicitly stated, but it is implied to be from non-clinical laboratory performance testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This device is a physical medical device (catheter) and the testing performed relates to its physical properties (radiopacity) rather than diagnostic accuracy requiring expert interpretation for ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. As mentioned above, this testing does not involve human interpretation or adjudication in the context of diagnostic accuracy.
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:
- Not Applicable. This is a physical medical device, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is a physical medical device, not an AI-powered diagnostic tool.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the radiopacity testing, the "ground truth" would be established by the physical measurements and standards defined in the ASTM F 640-12 standard test methods. This is an objective measurement rather than a subjective interpretation requiring expert consensus or pathology.
8. The sample size for the training set:
- Not Applicable. This is a physical medical device; there is no "training set" in the context of an AI algorithm.
9. How the ground truth for the training set was established:
- Not Applicable. There is no training set for this type of device.
Study Details:
- Study performed: Non-clinical laboratory performance testing.
- Standard used: ASTM F 640-12 standard test methods for determining radiopacity for Medical Use.
- Purpose: To demonstrate that the modification (additional depth markers) to the ventricular catheter maintains its intended performance, particularly regarding radiopacity, and is substantially equivalent to the predicate device.
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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: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 8, 2020
Aesculap, Inc. Kathy Racosky Project Manager I 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K200950
Trade/Device Name: Miethke Ventricular Catheter Regulation Number: 21 CFR 882.5550 Regulation Name: Central Nervous System Fluid Shunt and Components Regulatory Class: Class II Product Code: JXG, HCA Dated: April 9, 2020 Received: April 9, 2020
Dear Kathy Racosky:
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,
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
Enclosure
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Indications for Use
510(k) Number (if known) K200950
Device Name Miethke Ventricular Catheter
| Indications for Use (Describe) |
|---|
| The catheter is used for cerebrospinal fluid (CSF) shunting. |
| Type of Use (Select one or both, as applicable) | Registration Use (Part 21 CFR 201.1 Category I) Same-Tier Contracting Use (Part 21 CFR 201.1 Category II) |
|---|---|
| ------------------------------------------------- | -------------------------------------------------------------------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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Page 1 of 3
510(k) SUMMARY (as required by 21 CFR 807.92)
Ventricular Catheter
April 9, 2020
| COMPANY: | Aesculap ® , Inc.3773 Corporate ParkwayCenter Valley, PA 18034Establishment Registration Number: 2916714 |
|---|---|
| CONTACT: | Kathy A. Racosky610-984-9291 (phone)610-791-6882 (fax)kathy.racosky@aesculapimplants.com |
| TRADE NAME: | Miethke Ventricular Catheter |
| COMMON NAME: | Shunt, Central nervous System and Components |
| CLASSIFICATION: | Class II |
| CLASSIFICATION NAME: | Central Nervous System Fluid Shunt and ComponentsVentricular Catheter |
| REGULATION NUMBER: | 882.5550, 882.4100 |
| PRODUCT CODE: | JXG, HCA |
PREDICATE DEVICE
- Miethke Shunt System (K020728) ●
DEVICE DESCRIPTION
The ventricular catheter is part of the Miethke Shunt System. It is used to gain access to the cavities of the brain for shunting of excessive CSF.
The ventricular catheter will be offered in lengths of 18 cm or 25 cm with an inner diameter of 1.2 mm and an outer diameter of 2.5 mm. The ventricular catheter contains five stripe depth markers at 3, 5, 7, 10 and 13 cm from the catheter tip. The ventricular catheter is manufactured using barium sulfate filled silicone elastomer.
The purpose of this submission is to seek clearance for modifications to the ventricular catheter which is part of the Miethke Shunt System (K020728). This submission proposes the following modification:
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- adding stripe depth markers at 4, 6, 8, 9, 11 and 12 cm and point markers at 1 cm ● intervals on both sides of the tubing starting at 3.5 cm to 12.5 cm from the catheter tip.
The ventricular catheter is designed to articulate with existing Miethke Shunt Systems, such as the M.blue Adjustable Shunt System, Miethke Shunt System GAV 2.0 and SA 2.0 Valves, proGAV 2.0 Adjustable Shunt System, proSA Progammable Shunt System, Miethke Shunt System miniNAV valve, Miethke Shunt System Gravity Assisted Valve (GAV), and the Miethke Shunt System (DSV, ShuntAssistant, paedi-GAV, connectors, and reservoirs) cleared by FDA
(K192266/K190174/K161853/K141687/K120559/K110206/K103003/K062009/K031303/ K030698/K011030).
INDICATIONS FOR USE
The catheter is used for cerebrospinal fluid (CSF) shunting.
SUBSTANTIAL EQUIVALENCE and COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
The table below provides a summary of the device technological characteristics comparing the ventricular catheter to the predicate device. While the indications for use for the predicate device is slightly different than the proposed device, they both have the same intended use.
| Aesculap Miethke Shunt System | Ventricular Catheter | |
|---|---|---|
| K# | Predicate device (K020728) | Proposed device (K200950) |
| Indications | The Miethke Shunt system is intendedto shunt cerebrospinal fluid (CSF) fromthe lateral ventricles of the brain intothe peritoneum. | The catheter is used for cerebrospinalfluid (CSF) shunting. |
| Catheter Material | BaSO4 filled silicone elastomer | Same |
| Catheter BodyDimensions | 1.2 mm ID (0.050") x 2.5 mm OD (0.100") | Same |
| Catheter Length | 10, 18 and 25 cm | 18 and 25 cm |
| Catheter Markers | Numerical w/stripe at 3, 5, 7, 10 & 13cm | SameStripe at 4, 6, 8, 9 11 & 12 cmDot between 3.5-12.5 cm at 1 cmintervals |
| Ink markers | Tantalum powder | Same |
| Tip Configuration | Bullet shape with 16 inlet holes (4 rowsof 4 holes) | Same |
| Sterilization | Steam | Same |
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Page 3 of 3
PERFORMANCE DATA
Non-clinical laboratory performance testing was conducted in accordance with ASTM F 640-12 standard test methods for determining radiopacity for Medical Use. All samples met predefined acceptance criteria and the proposed device passed design verification test activities. The test results demonstrate that the ventricular catheter performs as intended and is substantially equivalent to the predicate device.
CONCLUSION:
The information provided in this submission demonstrates that the modification to the ventricular catheter is substantially equivalent to the marketed predicate device. The minor differences between the ventricular catheter and the predicate device raise no new issues of safety or effectiveness.
§ 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).