(165 days)
No
The device description focuses on the physical characteristics and mechanical function of a catheter. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is indicated for use in patients with acute respiratory failure requiring Veno-Venous Extracorporeal Membrane Oxygenation, which is a therapeutic intervention.
No
This device is a catheter used for venous drainage and reinfusion of blood in patients requiring Veno-Venous Extracorporeal Membrane Oxygenation (ECMO). It is a treatment device, not a diagnostic one.
No
The device description clearly outlines physical components such as catheters, introducers, dilators, and radiopaque markers, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a catheter used for venous drainage and reinfusion of blood via the jugular vein for Veno-Venous Extracorporeal Membrane Oxygenation (VV-ECMO). This is a therapeutic procedure involving direct interaction with the patient's circulatory system.
- Device Description: The description details a physical catheter, introducer, dilator, and related components designed for insertion into a blood vessel.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing. IVDs typically involve reagents, analyzers, or test kits used outside the body on patient samples.
This device is a medical device used for a therapeutic intervention, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The MC3 Crescent™ Jugular Dual Lumen Catheter is a single use, dual lumen catheter that provides both venous drainage and reinfusion of blood via the jugular vein and is indicated for use in adult and pediatric patients with acute respiratory failure requiring Veno-Venous Extracorporeal Membrane Oxygenation, where other available treatment options have failed and continued clinical deterioration is expected or the risk of death is imminent.
Product codes
PZS
Device Description
The MC3 Jugular Dual Lumen Catheters are dual lumen catheters supplied with an introducer to facilitate wire guided placement into the vasculature via percutaneous (Seldinger type) vascular access methods. The introducer is designed to follow a prepositioned standard guide wire (not included) or obturator (blunt end closed tip introducer) when following a surgical placement. The catheter is wire reinforced for flexibility and kink-resistance and includes depth marks. Both the introducer and catheter are made of radiopaque materials and the catheter also includes tantalum radiopaque markers at the infusion port, proximal and distal drainage holes, and the catheter tip. The catheter body contains an integrated suture site for use during securement. An optional suture collar is provided and can be used for supplemental securement only. A dilator is also included. The dilators are the same diameter of the catheter and are designed to be used for dilation of the vessel. These catheters are provided in a variety of sizes ranging from 13Fr (8.9 cm insertable length) to 32Fr (34 cm insertable length).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
jugular vein
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Performance: Substantial equivalence is demonstrated by performance characteristics on the bench, mechanical integrity, 30-day durability, and reliability for a longterm duration of use.
In vivo Evaluation: 7-day in vivo thrombogenicity evaluation demonstrates the subject device's performance over a long-term duration of use in a biologic test system.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.4100 Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure.
(a)
Identification. An extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary support (>6 hours) is a system of devices and accessories that provides assisted extracorporeal circulation and physiologic gas exchange of the patient's blood in patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. The main devices and accessories of the system include, but are not limited to, the console (hardware), software, and disposables, including, but not limited to, an oxygenator, blood pump, heat exchanger, cannulae, tubing, filters, and other accessories (e.g., monitors, detectors, sensors, connectors).(b)
Classification —Class II (special controls). The special controls for this device are:(1) The technological characteristics of the device must ensure that the geometry and design parameters are consistent with the intended use, and that the devices and accessories in the circuit are compatible;
(2) The devices and accessories in the circuit must be demonstrated to be biocompatible;
(3) Sterility and shelf-life testing must demonstrate the sterility of any patient-contacting devices and accessories in the circuit and the shelf life of these devices and accessories;
(4) Non-clinical performance evaluation of the devices and accessories in the circuit must demonstrate substantial equivalence of the performance characteristics on the bench, mechanical integrity, electromagnetic compatibility (where applicable), software, durability, and reliability;
(5) In vivo evaluation of the devices and accessories in the circuit must demonstrate their performance over the intended duration of use, including a detailed summary of the clinical evaluation pertinent to the use of the devices and accessories to demonstrate their effectiveness if a specific indication (patient population and/or condition) is identified; and
(6) Labeling must include a detailed summary of the non-clinical and in vivo evaluations pertinent to use of the devices and accessories in the circuit and adequate instructions with respect to anticoagulation, circuit setup, performance characteristics with respect to compatibility among different devices and accessories in the circuit, and maintenance during a procedure.
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May 3, 2021
MC3, Inc. Martha Rumford VP Regulatory 2555 Bishop Circle West Dexter, Michigan 48130
Re: K203409
Trade/Device Name: MC3 Crescent™ Jugular Dual Lumen Catheter Regulation Number: 21 CFR 870.4100 Regulation Name: Extracorporeal Circuit And Accessories For Long-Term Respiratory/Cardiopulmonary Failure Regulatory Class: Class II Product Code: PZS Dated: March 26, 2021 Received: March 29, 2021
Dear Martha Rumford:
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,
Nicole Gillette for Assistant Director (Acting) DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular 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) K203409
Device Name
MC3 Crescent™ Jugular Dual Lumen Catheter
Indications for Use (Describe)
The MC3 Crescent™ Jugular Dual Lumen Catheter is a single use, dual lumen catheter that provides both venous drainage and reinfusion of blood via the jugular vein and is indicated for use in adult and pediatric patients with acute respiratory failure requiring Veno-Venous Extracorporeal Membrane Oxygenation, where other available treatment options have failed and continued clinical deterioration is expected or the risk of death is imminent.
| 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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Image /page/3/Picture/0 description: The image shows the logo for MC3 Cardiopulmonary. The logo consists of a red abstract symbol on the left, followed by the letters "MC3" in dark blue. Below the letters, the word "Cardiopulmonary" is written in a smaller, lighter blue font. The logo is simple and modern, with a focus on the company's name and area of expertise.
510(k) Summary MC3 Jugular Dual Lumen Catheter
| Date Prepared: | May 3, 2021 |
|---|---|
| Sponsor Information: | |
| Owner/Applicant/Submitter: | MC3 Incorporated |
| 2555 Bishop Circle West | |
| Dexter, MI 48130 | |
| 1-734-995-9089 | |
| Registration number: 3011468686 | |
| Contact Person: | Martha Rumford |
| VP Regulatory | |
| 2555 Bishop Circle West | |
| Dexter, MI 48130 | |
| 734.995.9089 | |
| Device Names/Classification: | |
| Device Trade Name: | MC3 Crescent™ Jugular Dual Lumen Catheter |
| Device Common Name: | Dual Lumen ECMO Cannula |
| Regulation Name: | Extracorporeal circuit and accessories for long-term |
| respiratory/cardiopulmonary failure | |
| Regulation Number: | 21 CFR 870.4100 |
| Product Code: | PZS |
| Predicate Device: | Jugular Dual Lumen Catheter (K180151) |
| Reference Devices: | Origen Reinforced Dual Lumen Cannula (K113869) |
| Avalon Elite Bi-Caval Dual Lumen Catheter (K081820) |
Indications for Use:
The MC3 Crescent™ Jugular Dual Lumen Catheter is a single use dual lumen catheter, which provides both venous drainage and reinfusion of blood via the jugular vein, that is indicated for use in adult and pediatric patients with acute respiratory failure requiring Venous Extracorporeal Membrane Oxygenation where other available treatment options have failed and continued clinical deterioration is expected or the risk of death is imminent.
Indications for use of the dual lumen catheters remains the same as the predicate device.
Device Description:
The MC3 Jugular Dual Lumen Catheters are dual lumen catheters supplied with an introducer to facilitate wire guided placement into the vasculature via percutaneous (Seldinger type) vascular access methods. The introducer is designed to follow a prepositioned standard guide wire (not included) or obturator (blunt end closed tip introducer) when following a surgical placement. The catheter is wire reinforced
4
Image /page/4/Picture/0 description: The image contains the logo for MC3 Cardiopulmonary. The logo consists of a red abstract symbol on the left, followed by the text "MC3" in dark blue. Below "MC3" is the word "Cardiopulmonary" in a smaller font, also in dark blue. The logo appears to be for a medical or healthcare-related organization specializing in cardiopulmonary services.
for flexibility and kink-resistance and includes depth marks. Both the introducer and catheter are made of radiopaque materials and the catheter also includes tantalum radiopaque markers at the infusion port, proximal and distal drainage holes, and the catheter tip. The catheter body contains an integrated suture site for use during securement. An optional suture collar is provided and can be used for supplemental securement only. A dilator is also included. The dilators are the same diameter of the catheter and are designed to be used for dilation of the vessel. These catheters are provided in a variety of sizes ranging from 13Fr (8.9 cm insertable length) to 32Fr (34 cm insertable length).
Comparison of Technological Characteristics to Predicate Device:
The MC3 Dual Lumen Catheter product line is extended by scaling the design to include additional sizes. An optional blunt tipped introducer (obturator) and assembly stylet are added to the smallest diameter catheters. All materials and methods of manufacture are identical.
Class II Special Controls
The subject MC3 Crescent™ Jugular Dual Lumen Catheter has demonstrated conformance to the Special Controls outlined in 21 CFR 870.4100 in a manner equivalent to the Predicate Device. The following information outlines how we conform. Because this product is a line-extension, a risk assessment determined when previous testing is applicable to the new design. Special Controls met are:
- . Technological Characteristics: Geometry and design parameters are consistent with the devices intended use in extracorporeal life support procedures. The subject device is designed to be compatible with other extracorporeal circuit devices and accessories.
- . Biocompatibility: The subject device is demonstrated to be biocompatible as a prolonged use device in accordance with ISO 10993-1:2009 and GLP (21 CFR 58), and pursuant to FDA guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.""
- . Sterility and Shelf-life: Testing demonstrates the sterility of the subject device as provided and that it maintains its sterility, integrity, durability, and reliability over the stated Shelf-life of the device.
- . Non-clinical Performance: Substantial equivalence is demonstrated by performance characteristics on the bench, mechanical integrity, 30-day durability, and reliability for a longterm duration of use.
- . In vivo Evaluation: 7-day in vivo thrombogenicity evaluation demonstrates the subject device's performance over a long-term duration of use in a biologic test system.
- . Labeling: The instructions for use includes a detailed summary of the non-clinical and in vivo evaluations pertinent to the device's use in an extracorporeal circuit. Adequate instructions are also included with respect to anticoagulation, circuit setup, maintenance during a procedure, and performance characteristics relevant to compatibility among different devices and accessories in the circuit.
Conclusion: The information and data included in this 510(k) Notification demonstrate that the subject MC3 Crescent™ Jugular Dual Lumen Catheter is substantially equivalent to the Predicate Device for both venous drainage and reinfusion of blood via the jugular vein during extracorporeal life support procedures in patients with acute respiratory or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent.