(218 days)
No
The 510(k) summary describes a physical medical device (a central venous catheter) with antimicrobial properties. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies focus on physical and material properties, not computational performance.
Yes
The device is used for medical procedures such as drug infusion, blood sampling, and pressure monitoring, which are therapeutic or diagnostic healthcare interventions. The antimicrobial properties also aim to reduce catheter-related infections.
No
The device, a central venous catheter, is primarily indicated for providing temporary central venous access for various therapeutic and monitoring purposes such as drug infusion, blood sampling, blood product delivery, hyperalimentation, and central venous blood pressure monitoring. While "Central venous blood pressure monitoring (CVP)" could be considered a form of monitoring, it's not a standalone diagnostic device. It facilitates the measurement of a physiological parameter, but the device itself does not perform a diagnosis. Its core function is access and delivery, not generating diagnostic information.
No
The device description clearly describes a physical catheter with specific materials, dimensions, and antimicrobial properties, which is a hardware medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all related to providing physical access to the central venous system for various medical procedures (infusion, monitoring, sampling, etc.). None of these involve testing samples in vitro (outside the body) to diagnose a condition.
- Device Description: The description details a physical catheter designed for insertion into the body. While it has antimicrobial properties, these are intended to reduce colonization on the catheter itself, not to perform diagnostic tests on patient samples.
- Performance Studies: The performance studies focus on the physical and mechanical properties of the catheter, as well as the stability and function of the antimicrobial agents on the device. There are no studies related to the accuracy or performance of diagnostic tests.
An IVD device is typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This central venous catheter does not perform such a function.
N/A
Intended Use / Indications for Use
The SV Spectrum MRC Central Venous Catheter is indicated to provide short-term (
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).
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November 27, 2024
Image /page/0/Picture/1 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 logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
Spectrum Vascular Sharon Klugewicz Chief Operating Officer 50 Main Street Suite 1000 White Plains, New York 10606
Re: K241115
Trade/Device Name: SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV Central Venous Catheter Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: FOZ Dated: October 28, 2024 Received: October 29, 2024
Dear Sharon Klugewicz:
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.
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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" (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 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 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-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 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-regulatory
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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).
Sincerely,
David Walloscher
David Wolloscheck, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology 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) K241115
Device Name
SV Spectrum MRC Central Venous Catheter SV Spectrum MR Central Venous Catheter SV Central Venous Catheter
Indications for Use (Describe)
The SV Spectrum MRC Central Venous Catheter is indicated to provide short-term ( Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"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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SUBMITTER INFORMATION 1.
| Applicant: | Spectrum Vascular |
|---|---|
| Contact: | Sharon Klugewicz |
| Phone: | 516-425-4446 |
| Email: | sklugewicz@spectrumvascular.com |
| Address: | 50 Main Street, Suite 1000 |
| White Plains, NY 10606 |
2. CORRESPONDENT INFORMATION
| Contact: | Sharon Klugewicz |
|---|---|
| Title: | Chief Operating Officer / SVP Regulatory Affairs |
| Firm: | Spectrum Vascular |
3. DATE PREPARED: NOVEMBER 27, 2024
DEVICE INFORMATION 4.
| Device Name: | SV Spectrum MRC Central Venous Catheter |
|---|---|
| SV Spectrum MR Central Venous Catheter | |
| SV Central Venous Catheter | |
| Common Name: | Catheter, Intravascular |
| Regulation Number: | 880.5200 |
| Regulation Name: | Intravascular Catheter |
| Product Code: | FOZ |
| Regulatory Class: | Class II |
5. PREDICATE DEVICE INFORMATION
| Device Name: | Cook® Spectrum® 2 MRC Central Venous Catheter |
|---|---|
| Common Name: | Catheter, Intravascular |
| 510(k) Number: | K223648 |
| Manufacturer: | Cook Medical |
The predicate device has not been subject to a design related recall.
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DEVICE DESCRIPTION 6.
The SV Spectrum MRC Central Venous Catheter (CVC) is a single-use, antibiotic impregnated, antimicrobial coated, power injectable catheter that is percutaneously inserted into the vasculature using the Seldinger technique, and advanced over a wire guide until its tip is positioned above the superior vena cava-right atrium (SVC-RA) junction within the lower third of the SVC. The SV Spectrum MRC Central Venous Catheter, 7 Fr triple lumen CVC, is made from an aliphatic polyether-based polyurethane catheter shaft with a radiopaque constituent and a bonded soft distal tip. The catheter shaft is impregnated with Spectrum® (minocycline, rifampin) antimicrobial agents and coated with chlorhexidine antiseptic. The SV Spectrum MRC Central Venous Catheter is not intended for treatment of existing infections in patients; the presence of the three antimicrobial agents has been shown to reduce microbial colonization of the catheter.
The SV Spectrum MRC CVC has demonstrated efficacy against the following organisms:
- Staphylococcus aureus
- Staphylococcus epidermidis ●
- Enterococcus faecalis
- . Escherichia coli
- Klebsiella pneumoniae
- Acinetobacter baumanni .
- Candida albicans
- . Candida glabrata
The effectiveness was evaluated using in vitro methods. The antimicrobial activity of these agents is localized to the internal and external catheter surfaces.
The working length (15, 20, or 25 cm) of the catheter is measured from distal tip to the double bar line approximately 1.5 cm distal to the manifold. The catheter shaft features centimeter length markings. The proximal portion of the SV Spectrum MRC Central Venous Catheter, like the predicate catheter, has three extension tubes with injection-molded Luer hubs connected to a manifold. The injection-molded manifold with suture wings serves as the transition point for lumens of the extension tubes into each lumen of the catheter shaft. All three lumens are power injectable; the maximum flow rate is labeled on the hub of each extension tube.
The SV Spectrum MR Central Venous Catheter is identical to the SV Spectrum MRC Central Venous Catheter except that it is not coated with chlorohexidine antiseptic.
The SV Central Venous Catheter is identical to the SV Spectrum MRC Central Venous Catheter and SV Spectrum MR Central Venous Catheter except it is not impregnated with minocycline or rifampin, nor is it coated with chlorhexidine antiseptic.
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7. INDICATIONS FOR USE
The SV Spectrum MRC Central Venous Catheter is indicated to provide short-term (