(267 days)
The Sophysa external CSF drainage catheters are intended to temporarily drain the Cerebrospinal Fluid (CSF), for less than 30 days (up to 29 days maximum).
The Sophysa external CSF drainage catheters are intended to temporarily drain the Cerebrospinal Fluid (CSF), for less than 30 days.
There are two types of external CSF drainage catheters:
- Ventricular catheters
- Lumbar catheters
The catheter is provided sterile and with accessories to facilitate the surgical procedures and connectors. The external CSF drainage catheters need to be connected to collection systems.
The provided FDA 510(k) clearance letter and summary discuss the "External CSF Drainage" device. However, this document does not contain information related to a study proving the device meets specific performance acceptance criteria in the context of medical imaging or AI/algorithm performance.
The document primarily focuses on demonstrating substantial equivalence to predicate devices through technical, clinical, and biological safety comparisons, along with non-clinical bench testing. It does not describe a study involving human readers, AI assistance, ground truth establishment, or specific diagnostic performance metrics (like sensitivity, specificity, AUC) that would typically be associated with performance acceptance criteria for an AI or imaging device.
Therefore, I cannot fulfill the request to provide:
- A table of acceptance criteria and reported device performance specific to diagnostic accuracy or AI performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness study results.
- Standalone algorithm performance.
- Type of ground truth used (expert consensus, pathology, outcomes data).
- Sample size for the training set.
- How ground truth for the training set was established.
The document details bench testing performed, which validates physical and mechanical properties of the device, but not its performance in a clinical diagnostic or AI-assisted setting.
The information available regarding acceptance criteria and testing from the provided document is as follows:
Acceptance Criteria (Implicit from Bench Testing):
| Performance Standard/Characteristic | Acceptance Criteria (Implicit from Tests) | Reported Device Performance (Summary) |
|---|---|---|
| Visual Inspection | (Not explicitly stated, but implies meeting design specifications) | Performed (Summary of Non-clinical testing) |
| Dimensional Analysis | (Not explicitly stated, but implies meeting design specifications) | Performed (Summary of Non-clinical testing) |
| Radiopacity | (Not explicitly stated, but implies visible under imaging) | Performed (Summary of Non-clinical testing) |
| Pressure / Flow Characteristics | (Not explicitly stated, but implies adequate CSF drainage) | Performed (Summary of Non-clinical testing) |
| Blockage / Hemorrhagic CSF Exposure | (Not explicitly stated, but implies resistance to blockage/degradation) | Performed (Summary of Non-clinical testing) |
| Air and Water Tightness | (Not explicitly stated, but implies no leakage) | Performed (Summary of Non-clinical testing) |
| Dynamic Breaking Strength | (Not explicitly stated, but implies resistance to fracture under use) | Performed (Summary of Non-clinical testing) |
| Catheter Tensile Strength | (Not explicitly stated, but implies resistance to pulling forces) | Performed (Summary of Non-clinical testing) |
| Kink Resistance | (Not explicitly stated, but implies resistance to kinking) | Performed (Summary of Non-clinical testing) |
| Catheter Fixation | (Not explicitly stated, but implies secure attachment) | Performed (Summary of Non-clinical testing) |
| Corrosion Resistance | (Not explicitly stated, but implies material integrity) | Performed (Summary of Non-clinical testing) |
| Guidewire Tensile Strength | (Not explicitly stated) | Performed (Summary of Non-clinical testing) |
| Guidewire Bending Strength | (Not explicitly stated) | Performed (Summary of Non-clinical testing) |
| Guidewire Breakage | (Not explicitly stated) | Performed (Summary of Non-clinical testing) |
| Tuohy Needle/Hub Connection Strength | (Not explicitly stated) | Performed (Summary of Non-clinical testing) |
| Sterility | Supplied sterile | Supplied sterile (Predicate Comparison Table) |
| Biocompatibility | Biocompatible materials | Biocompatible materials established by testing and rationale for Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Material-Mediated Pyrogenicity, Subacute/Subchronic Toxicity, Genotoxicity, Implantation (brain, 4 weeks, muscle 4 weeks), Indirect Hemolysis, Neurotoxicity (Predicate Comparison Table) |
| MRI Compatibility (Ventricular) | MR Safe | MR Safe (Predicate Comparison Table) |
| MRI Compatibility (Lumbar) | MR Conditional | MR Conditional due to metallic parts in Compression Hub (Predicate Comparison Table) |
| Shelf life | 5 years | Target shelf life (Predicate Comparison Table) |
| Performance Standards | ISO 7197, ISO 20697, ISO 20698, ISO 11070 | Substantially Equivalent (Predicate Comparison Table) |
Study Details from the document (focused on Substantial Equivalence and Bench Testing):
- Sample size used for the test set and the data provenance: Not applicable for diagnostic performance metrics. Bench testing was performed on "representative samples" of the product line. No information on data provenance (e.g., country of origin, retrospective/prospective) is associated with these bench tests.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for bench tests typically involves direct measurement against engineering specifications.
- Adjudication method: Not applicable for bench testing.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, not mentioned.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No, this is not an AI/algorithm-driven device for diagnosis.
- The type of ground truth used: For the bench tests, the "ground truth" would be the engineering specifications and established test methodologies (e.g., ISO standards) for physical and material properties. For biocompatibility, established ISO standards and toxicological assessments.
- The sample size for the training set: Not applicable (not an AI/ML device).
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document from the FDA is for a physical medical device (External CSF drainage catheters) and demonstrates its safety and effectiveness through substantial equivalence to existing devices and extensive bench testing of its physical and material properties. It does not describe a study involving AI, image analysis, or human reader performance, and therefore, cannot provide the information requested for such types of studies.
FDA 510(k) Clearance Letter - External CSF Drainage
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
June 20, 2025
Sophysa
Zheng XUE
Consultant
5 Rue Guy Moquet
Orsay, 91400
France
Re: K242974
Trade/Device Name: External CSF drainage
Regulation Number: 21 CFR 882.5550
Regulation Name: Central nervous system fluid shunt and components
Regulatory Class: Class II
Product Code: JXG
Dated: May 21, 2025
Received: May 21, 2025
Dear Zheng XUE:
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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K242974 - Zheng XUE Page 2
(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 QS 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 (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-reporting-combination-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 Rule"). 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-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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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K242974 - Zheng XUE Page 3
Sincerely,
Adam D. Pierce -S
Digitally signed by Adam D. Pierce -S
Date: 2025.06.20 15:27:32 -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
Page 4
FORM FDA 3881 (8/23) Page 1 of 1
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known): K242974
Device Name: External CSF Drainage
Indications for Use (Describe)
The Sophysa external CSF drainage catheters are intended to temporarily drain the Cerebrospinal Fluid (CSF), for less than 30 days (up to 29 days maximum).
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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K242974, Page 1 of 3
510(k) Summary
510(k) Number: K242974
Sponsor Information
Applicant Name: Sophysa
Address: 5 Rue Guy Moquet
ORSAY, FRANCE, 91400
Phone and Fax Number: +33 (0)1 69 35 35 00 (phone)
+33 (0)1 69 35 36 90 (fax)
Sophysa Person: Julie LOPEZ
Regulatory affairs director
Jlopez@sophysa.com
Submission contact Person: Zheng XUE
Consultant:
Zheng.xuecazenave@gmail.com
Date Prepared: 05-June-2025
Device Name and Classification
Trade/Proprietary Name: External CSF Drainage
Common Name: Central nervous system fluid shunt and components.
Classification Name: Shunt, Central Nervous System and Components
Regulation: 21 CFR 882.5550
Device Class: 2
Product Code: JXG
Predicate Device
Predicate: Phoenix Neuro Catheters FVPC2 and FVPC4, Sophysa (K853365)
Lumbar Drainage Catheter Kit, Codman (K964923)
Device Description
The Sophysa external CSF drainage catheters are intended to temporarily drain the Cerebrospinal Fluid (CSF), for less than 30 days.
There are two types of external CSF drainage catheters:
- Ventricular catheters
- Lumbar catheters
The catheter is provided sterile and with accessories to facilitate the surgical procedures and connectors. The external CSF drainage catheters need to be connected to collection systems.
Indications for Use
The Sophysa external CSF drainage catheters are intended to temporarily drain the Cerebrospinal Fluid (CSF), for less than 30 days (up to 29 days maximum).
Summary of Equivalence to Predicate Device
The External CSF drainage is substantially equivalent to Phoenix Neuro Catheters FVPC2 and FVPC4, Sophysa (K853365) and Lumbar Drainage Catheter Kit, Codman (K964923).
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K242974, Page 2 of 3
Table 1: Predicate Devices Comparison
| Predicates | Proposed Devices | Rational of why no new issues of safety and effectiveness |
|---|---|---|
| Clinical Equivalence | ||
| Indications for use | K853365: Temporary, external drainage of CSF following placement in the ventricles.K964923: The Lumbar Drainage Catheter Kit is indicated for temporary access to the lumbar subarachnoid region and, when used with other Codman devices, is designed to drain cerebrospinal fluid (CSF) as a means of reducing increased intracranial volume and pressure | The Sophysa external CSF drainage catheters are intended to temporarily drain the Cerebrospinal Fluid (CSF), for less than 30 days (up to 29 days maximum). |
| Single use | Single use | Single use |
| Sterility status | Supplied sterile | Supply sterile |
| Re-sterilization status | Cannot be re-sterilized | Cannot be re-sterilized |
| Technical Equivalence | ||
| Principle mode of action | K853365: The catheter is inserted into the ventricular space and fixed under the scalp by suturing. CSF flow is diverted into a compatible collection system.K964923: The catheter is inserted into the subarachnoid space and fixed to the subcutaneous tissue by suturing. CSF flow is diverted into a compatible collection system. | Same |
| Shape/Dimension | K853365: 23.5 cm long, 1.5 mm ID.K964923: 80 cm long, 0.76 mm ID. | Ventricular: 29-35cm long, 1.5- 2.3 mm IDLumbar: 90 cm long, 0.76 mm ID |
| Accessories | K853365: Stylet, luer lock connector, compression hub,K964923: Guidewire, Tuohy needle, luer adapter, suture tab | Ventricular: Stylet, trocar, luer-lock connector, suture tabLumbar: Guidewire, Tuohy needle, suture tab, compression hub |
| Performance Standards | - | ISO 7197, ISO 20697, ISO 20698, ISO 11070 |
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K242974, Page 3 of 3
| Predicates | Proposed Devices | Rational of why no new issues of safety and effectiveness |
|---|---|---|
| MRI compatibility | MRI Safe | Ventricular: MR SafeLumbar: MR Conditional due to the presence of metallic parts within the Compression Hub which connects to an external CSF drainage collection system. |
| Shelf life | - | 5 years |
| Biological Safety/Compatibility | ||
| Biocompatibility | Biocompatible materials | Biocompatible materials established by a combination of testing and rationale for the following:Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Material-Mediated Pyrogenicity, Subacute/Subchronic Toxicity, Genotoxicity, Implantation (brain, 4 weeks, muscle 4 weeks), Indirect Hemolysis, Neurotoxicity |
| Sterilization method | Ethylene Oxide | Ethylene Oxide |
| Primary packaging system | Tyvek pouch | Double peel-off packaging Tyvek pouch |
Summary of Non-clinical testing
The following bench testing has been performed on the representative samples of the External CSF drainage product line: Visual Inspection, Dimensional Analysis, Radiopacity, Pressure / Flow Characteristics, Blockage / Hemorrhagic CSF Exposure, Air and Water Tightness, Dynamic Breaking Strength, Catheter Tensile Strength, Kink Resistance, Catheter Fixation, Corrosion Resistance, Guidewire Tensile Strength, Guidewire Bending Strength, Guidewire Breakage, Tuohy Needle/Hub Connection Strength.
Statement of Substantial Equivalence
The information summarized above demonstrates that External CSF drainage is substantially equivalent to and is as safe and as effective as the legally marketed predicate device.
§ 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).