SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV Central Venous Catheter

K241115 · Spectrum Vascular · FOZ · Nov 27, 2024 · General Hospital

Device Facts

• Record ID: K241115
• Device Name: SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV Central Venous Catheter
• Applicant: Spectrum Vascular
• Product Code: FOZ · General Hospital
• Decision Date: Nov 27, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The SV Spectrum MRC Central Venous Catheter is indicated to provide short-term (<30 days) central venous access intended for: Continuous or intermittent drug infusion Central venous blood pressure monitoring (CVP) Acute hyperalimentation Blood sampling Delivery of whole blood or blood products Simultaneous, separate infusion of drugs Power injection of contrast media (max 300 psi). The activity of the antimicrobial agents, minocycline, rifampin and chlorhexidine is located at the internal and external catheter surfaces and is not intended for treatment of existing infections. This combination of antimicrobials has been shown to reduce microbial colonization of the catheter. The effectiveness was evaluated using in vitro methods; no correlation between in vitro and clinical outcome has currently been ascertained. Controlled studies of this product have not been conducted in pregnant women, pediatic or neonatal patients. The use of this catheter should be weighed against any possible risk. Consider CDC Guidelines and institutional protocols for catheter exchange. The SV Spectrum MR Central Venous Catheter is indicated to provide short-term (<30 days) central venous access intended for: Continuous or intermittent drug infusion Central venous blood pressure monitoring (CVP) Acute hyperalimentation Blood sampling Delivery of whole blood or blood products Simultaneous, separate infusion of drugs and Power injection of contrast media (max 300 psi). The activity of the antimicrobial agents, minocycline and rifampin is localized at the internal catheter surfaces and helps to provide protection against catheter related bloodstream infections (CRBSI). It is not intended for treatment of existing infection. The device is a short- term use catheter. The SV Central Venous Catheter is indicated to provide short- term (<30 days) central venous access intended for: Continuous or intermittent drug infusion Central venous blood pressure monitoring (CVP) Acute hyperalimentation Blood sampling Delivery of whole blood or blood products Simultaneous, separate infusion of drugs and Power injection of contrast media (max 300 psi).

Device Story

Single-use, percutaneously inserted central venous catheter (CVC) for short-term vascular access; Seldinger technique used for placement; tip positioned at SVC-RA junction. Shaft made of aliphatic polyether-based polyurethane with radiopaque constituent and bonded soft distal tip. Three versions: MRC (minocycline/rifampin impregnated, chlorhexidine coated), MR (minocycline/rifampin impregnated), and uncoated SV CVC. Antimicrobial agents localized to surfaces to reduce microbial colonization/CRBSI; not for treating existing infections. Power injectable up to 300 psi. Used in clinical settings by healthcare professionals. Output is venous access for infusion, monitoring, and sampling. Benefits include reduced microbial colonization and clinical utility for acute care. Shelf life extended to 3 years.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing included ISO 10555-1/3 compliance, ASTM D4169 shipping container testing, and ASTM F2503 MR safety marking. Shelf-life validation (36 months) included package integrity, mechanical performance (tensile, power injection, burst, leakage, fatigue), drug stability, and antimicrobial efficacy against S. aureus, S. epidermidis, E. faecalis, E. coli, K. pneumoniae, A. baumannii, C. albicans, and C. glabrata.

Technological Characteristics

Aliphatic polyether-based polyurethane shaft; 7 Fr diameter; 15-25 cm length; 3 lumens. Radiopaque; bonded soft distal tip. Antimicrobial agents: minocycline (450 µg/cm), rifampin (450 µg/cm), chlorhexidine (350 µg/cm). Sterilization: E-beam and Ethylene Oxide (EO). No electrical components. No hydrophilic coating.

Indications for Use

Indicated for short-term (<30 days) central venous access for drug infusion, CVP monitoring, hyperalimentation, blood sampling, and power injection (max 300 psi). Contraindicated in patients with allergy/hypersensitivity to tetracyclines, rifampin, or chlorhexidine. Use in pregnant women, pediatric, or neonatal patients requires risk-benefit assessment.

Regulatory Classification

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.

Predicate Devices

• Cook® Spectrum® 2 MRC Central Venous Catheter (K223648)

Reference Devices

• SV Spectrum MR Central Venous Catheter (K033843)
• SV Central Venous Catheter (K081113)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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 (<30 days) central venous access intended for:

- Continuous or intermittent drug infusion
- · Central venous blood pressure monitoring (CVP)
- · Acute hyperalimentation
- · Blood sampling
- Delivery of whole blood or blood products
- · Simultaneous, separate infusion of drugs
- · Power injection of contrast media (max 300 psi)

The activity of the antimicrobial agents, minocycline, rifampin and chlorhexidine is located at the internal and external catheter surfaces and is not intended for treatment of existing infections. This combination of antimicrobials has been shown to reduce microbial colonization of the catheter. The effectiveness was evaluated using in vitro methods; no correlation between in vitro and clinical outcome has currently been ascertained. Controlled studies of this product have not been conducted in pregnant women, pediatic or neonatal patients. The use of this catheter should be weighed against any possible risk. Consider CDC Guidelines and institutional protocols for catheter exchange.

The SV Spectrum MR Central Venous Catheter is indicated to provide short-term (<30 days) central venous access intended for:

- · Continuous or intermittent drug infusion
- · Central venous blood pressure monitoring (CVP)
- Acute hyperalimentation
- · Blood sampling
- Delivery of whole blood or blood products
- · Simultaneous, separate infusion of drugs and
- · Power injection of contrast media (max 300 psi).

The activity of the antimicrobial agents, minocycline and rifampin is localized at the internal catheter surfaces and helps to provide protection against catheter related bloodstream infections (CRBSI). It is not intended for treatment of existing infection. The device is a short- term use catheter.

The SV Central Venous Catheter is indicated to provide short- term (<30 days) central venous access intended for:

- · Continuous or intermittent drug infusion
- · Central venous blood pressure monitoring (CVP)
- Acute hyperalimentation
- · Blood sampling
- Delivery of whole blood or blood products
- · Simultaneous, separate infusion of drugs and
- · Power injection of contrast media (max 300 psi).

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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#### SUBMITTER INFORMATION 1.

| Applicant: | Spectrum Vascular |
|------------|---------------------------------|
| Contact: | Sharon Klugewicz |
| Phone: | 516-425-4446 |
| Email: | [e-mail] |
| 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 (<30 days) central venous access intended for:

- . Continuous or intermittent drug infusion
- Central venous blood pressure monitoring (CVP) ●
- Acute hyperalimentation
- Blood sampling ●
- Delivery of whole blood or blood products
- Simultaneous, separate infusion of drugs ●
- . Power injection of contrast media (max 300 psi)

The activity of the antimicrobial agents, minocycline, rifampin and chlorhexidine is located at the internal and external catheter surfaces and is not intended for treatment of existing infections. This combination of antimicrobials has been shown to reduce microbial colonization of the catheter. The effectiveness was evaluated using in vitro methods; no correlation between in vitro and clinical outcome has currently been ascertained. Controlled studies of this product have not been conducted in pregnant women, pediatric or neonatal patients. The benefits of the use of this catheter should be weighed against any possible risk. Consider CDC Guidelines and institutional protocols for catheter exchange.

The SV Spectrum MR Central Venous Catheter is indicated to provide short-term (<30 days) central venous access intended for:

- Continuous or intermittent drug infusion ●
- Central venous blood pressure monitoring (CVP) ●
- Acute hyperalimentation ●
- Blood sampling ●
- Delivery of whole blood or blood products ●
- Simultaneous, separate infusion of drugs and
- . Power injection of contrast media (max 300 psi).

The activity of the antimicrobial agents, minocycline and rifampin is localized at the internal and external catheter surfaces and helps to provide protection against catheter related bloodstream infections (CRBSI). It is not intended for treatment of existing infection. The device is a shortterm use catheter.

The SV Central Venous Catheter is indicated to provide short- term (<30 days) central venous access intended for:

- Continuous or intermittent drug infusion ●

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- . Central venous blood pressure monitoring (CVP)
- Acute hyperalimentation .
- Blood sampling ●
- Delivery of whole blood or blood products .
- . Simultaneous, separate infusion of drugs and
- Power injection of contrast media (max 300 psi). .

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#### COMPARISON OF INTENDED USE AND TECHNOLOGICAL 8. CHARACTERISTICS WITH THE PREDICATE DEVICE

| | Predicate Device<br>Cook® Spectrum® 2<br>MRC Central Venous<br>Catheter (K223648) | Subject Device | | |
|-------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | SV Spectrum<br>MRC Central<br>Venous Catheter | SV Spectrum<br>MR Central<br>Venous<br>Catheter<br>(previously<br>cleared under<br>K033843) | SV<br>Central Venous<br>Catheter<br>(previously cleared<br>under K081113) |
| Regulation | 21 CFR 880.5200 | 21 CFR 880.5200 | 21 CFR 880.5200 | 21 CFR 880.5200 |
| Product Code | FOZ | FOZ | FOZ | FOZ |
| Classification | II | II | II | II |
| Indications<br>for Use<br>(General Use) | Indicated to provide<br>short-term (<30 days)<br>central venous access<br>intended for:<br>• Continuous or<br>intermittent drug<br>infusion<br>• Central venous<br>blood pressure<br>monitoring (CVP)<br>• Acute<br>hyperalimentation<br>• Blood sampling<br>• Delivery of whole<br>blood or blood<br>products | Indicated to provide<br>short-term (<30<br>days) central venous<br>access intended for:<br>• Continuous or<br>intermittent drug<br>infusion<br>• Central venous<br>blood pressure<br>monitoring<br>(CVP)<br>• Acute<br>hyperalimentation<br>• Blood sampling | Indicated to<br>provide short-term<br>(<30 days) central<br>venous access<br>intended for:<br>• Continuous or<br>intermittent<br>drug infusion<br>• Central venous<br>blood pressure<br>monitoring<br>(CVP)<br>• Acute<br>hyperalimentation<br>• Blood sampling | Indicated to provide<br>short-term (<30<br>days) central venous<br>access intended for:<br>• Continuous or<br>intermittent drug<br>infusion<br>• Central venous<br>blood pressure<br>monitoring<br>(CVP)<br>• Acute<br>hyperalimentation<br>• Blood sampling |
| | Predicate Device | Subject Device | | |
| | Cook® Spectrum® 2<br>MRC Central Venous<br>Catheter (K223648) | SV Spectrum<br>MRC Central<br>Venous<br>Catheter | SV Spectrum<br>MR Central<br>Venous<br>Catheter<br>(previously<br>cleared under<br>K033843) | SV<br>Central Venous<br>Catheter<br>(previously cleared<br>under K081113) |
| | • Simultaneous,<br>separate infusion of<br>drugs and<br>• Power injection<br>of contrast<br>media (max 300<br>psi). | • Delivery of whole<br>blood or blood<br>products<br>• Simultaneous,<br>separate infusion<br>of drugs<br>• Power injection of<br>contrast media<br>(max 300 psi). | • Delivery of<br>whole blood or<br>blood products<br>• Simultaneous,<br>separate<br>infusion of drugs<br>and<br>• Power injection of<br>contrast media<br>(max 300 psi). | • Delivery of whole<br>blood or blood<br>products<br>• Simultaneous,<br>separate infusion<br>of drugs and<br>• Power injection of<br>contrast media<br>(max 300 psi). |
| Indications for<br>Use<br>(Antimicrobial<br>Activity) | The activity of the<br>antimicrobial agents,<br>minocycline, rifampin<br>and chlorhexidine is<br>located at the internal<br>and external catheter<br>surfaces and is not<br>intended for treatment<br>of existing infections.<br>This combination of<br>antimicrobials has been<br>shown to reduce<br>microbial colonization of<br>the catheter. The<br>effectiveness was<br>evaluated using in vitro<br>methods; no correlation<br>between in vitro and<br>clinical outcome has<br>currently been<br>ascertained. | The activity of the<br>antimicrobial agents,<br>minocycline, rifampin<br>and chlorhexidine is<br>located at the internal<br>and external catheter<br>surfaces and is not<br>intended for<br>treatment of existing<br>infections. This<br>combination of<br>antimicrobials has<br>been shown to<br>reduce microbial<br>colonization of the<br>catheter. The<br>effectiveness was<br>evaluated using in<br>vitro methods; no<br>correlation between<br>in vitro and clinical<br>outcome has currently | The activity of the<br>antimicrobial agents,<br>minocycline and<br>rifampin, is localized<br>at the internal and<br>external catheter<br>surface and helps to<br>provide protection<br>against catheter<br>related bloodstream<br>infections (CRBSI).<br>It is not intended for<br>treatment of existing<br>infection. The device<br>is a short-term use<br>catheter | Not applicable |
| | Predicate Device | Subject Device | | |
| | Cook® Spectrum® 2<br>MRC Central Venous<br>Catheter (K223648) | SV Spectrum<br>MRC Central<br>Venous<br>Catheter | SV Spectrum<br>MR Central<br>Venous<br>Catheter<br>(previously<br>cleared under<br>K033843) | SV<br>Central Venous<br>Catheter<br>(previously cleared<br>under K081113) |
| | | been ascertained.<br>The benefits of the<br>use of this catheter<br>should be weighed<br>against any possible<br>risk. Consider CDC<br>Guidelines and<br>institutional protocols<br>for catheter exchange. | | |
| Special<br>Patient<br>Populations | IFU indicates controlled<br>studies of this product<br>have not been<br>conducted in pregnant<br>women, pediatric or<br>neonatal patients and<br>that the benefits of the<br>use of this catheter<br>should be weighed<br>against any possible<br>risk. Consider CDC<br>Guidelines and<br>institutional protocols for<br>catheter exchange. | IFU indicates<br>controlled studies of<br>this product have<br>not been conducted<br>in pregnant women,<br>pediatric or neonatal<br>patients due to<br>teratogenicity of<br>minocycline and<br>rifampin at systemic<br>doses and that the<br>benefits of the use of<br>this catheter should<br>be weighed against<br>any possible risk<br>Consider CDC<br>guidelines and<br>institutional protocols<br>for catheter<br>exchange. | IFU indicates<br>controlled studies<br>of this product have<br>not been<br>conducted in<br>pregnant women,<br>pediatric or<br>neonatal patients<br>and that the<br>benefits of the use<br>of this catheter<br>should be weighed<br>against any<br>possible risk.<br>Consider CDC<br>Guidelines and<br>institutional<br>protocols for<br>catheter exchange. | Not applicable |
| Contraindications | Patients with allergy or<br>hypersensitivity to<br>tetracyclines (including<br>minocycline), rifampin | Allergy, history of<br>allergy, or<br>hypersensitivity to<br>tetracyclines | Patients with allergy<br>or hypersensitivity to<br>tetracyclines<br>(including | |

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| or chlorohexidine. | (including |
|--------------------|------------|
|--------------------|------------|

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| | Predicate Device | Subject Device | | |
|--------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| | Cook® Spectrum® 2<br>MRC Central<br>Venous Catheter<br>(K223648) | SV Spectrum<br>MRC Central<br>Venous Catheter | SV Spectrum<br>MR Central<br>Venous<br>Catheter<br>(previously<br>cleared under<br>K033843) | SV<br>Central Venous<br>Catheter<br>(previously cleared<br>under K081113) |
| | Those who are<br>pregnant (due to<br>teratogenicity of<br>minocycline and<br>rifampin at systemic<br>doses).<br>Pediatrics. | Those who are<br>pregnant (due to<br>teratogenicity of<br>minocycline and<br>rifampin at systemic<br>doses).<br>Pediatrics. | Those who are<br>pregnant (due to<br>teratogenicity of<br>minocycline and<br>rifampin at systemic<br>doses). | Pediatrics. |
| Flow Rate | The flow rate may not<br>exceed 10 mL/sec for<br>the main lumen and 5<br>mL/sec for the two<br>smaller lumens. | The flow rate may not<br>exceed 10 mL/sec for<br>the main lumen and 5<br>mL/sec for the two<br>smaller lumens. | The flow rate may not<br>exceed 10 mL/sec for the main<br>lumen and 5 mL/sec<br>for the two smaller<br>lumens. | The flow rate may not<br>exceed 10 mL/sec for<br>the main lumen and 5<br>mL/sec for the two<br>smaller lumens. |
| Maximum<br>Pressure Limit<br>for Power<br>Injection | 300 psi | 300 psi | 300 psi | 300 psi |
| Concentration<br>of<br>Antimicrobials<br>on Catheter<br>Shaft<br>(µg/cm) | Minocycline: 450<br>Rifampin: 450<br>Chlorhexidine: 350 | Minocycline: 450<br>Rifampin: 450<br>Chlorhexidine: 350 | Minocycline: 450<br>Rifampin: 450<br>Not applicable for<br>chlorhexidine. | Not applicable |
| Device for One-<br>time Use | Yes | Yes | Yes | Yes |
| | Predicate Device | Subject Device | | |
| | Cook® Spectrum® 2<br>MRC Central Venous<br>Catheter (K223648) | SV Spectrum<br>MRC Central<br>Venous Catheter | SV Spectrum<br>MR Central<br>Venous<br>Catheter<br>(previously<br>cleared under<br>K033843) | SV<br>Central Venous<br>Catheter<br>(previously cleared<br>under K081113) |
| Catheter<br>Placement<br>Method | Percutaneous via<br>Seldinger technique | Percutaneous via<br>Seldinger technique | Percutaneous via<br>Seldinger technique | Percutaneous via<br>Seldinger technique |
| Catheter Tip<br>Target Anatomy | SVC-RA junction | SVC-RA junction | SVC-RA junction | SVC-RA junction |
| Catheter Tip<br>Location<br>Confirmation<br>Method | ECG/Ultrasound/<br>Fluoroscopy | ECG/Ultrasound/<br>Fluoroscopy | ECG/Ultrasound/<br>Fluoroscopy | ECG/Ultrasound/<br>Fluoroscopy |
| Hydrophilic<br>Coating | No hydrophilic<br>coating | No hydrophilic coating | No hydrophilic<br>coating | No hydrophilic coating |
| Catheter<br>Lumen<br>Design | Round | Round | Round | Round |
| Catheter Shaft<br>Markings | Yes | Yes | Yes | Yes |
| Catheter Tip | Bonded tip | Bonded tip | Bonded tip | Bonded tip |
| Catheter Shaft<br>Material | Polyurethane<br>(aliphatic polyether) | Polyurethane<br>(aliphatic polyether) | Polyurethane<br>(aliphatic polyether) | Polyurethane<br>(aliphatic polyether) |
| Number of<br>Catheter Lumens | Three | Three | Three | Three |
| Catheter Shaft<br>Outer Diameter | 7 Fr | 7 Fr | 7 Fr | 7 Fr |
| | Predicate Device | Subject Device | | |
| | Cook® Spectrum® 2<br>MRC Central Venous<br>Catheter (K223648) | SV Spectrum<br>MRC Central<br>Venous<br>Catheter | SV Spectrum<br>MR Central<br>Venous<br>Catheter<br>(previously<br>cleared under<br>K033843) | SV<br>Central Venous<br>Catheter<br>(previously cleared<br>under K081113) |
| Catheter<br>Shaft<br>Length | 15 to 25 cm | 15 to 25 cm | 15 to 25 cm | 15 to 25 cm |
| Extension<br>Tube Length | Distal: 7.8 +/- 0.2 cm<br>Medial: 12.9 +/- 0.8 cm<br>Proximal: 10.3 +/- 0.8 cm | Distal: 7.8 +/- 0.2 cm<br>Medial: 12.9 +/- 0.8 cm<br>Proximal: 10.3 +/- 0.8 cm | Distal: 7.8 +/- 0.2 cm<br>Medial: 12.9 +/- 0.8 cm<br>Proximal: 10.3 +/- 0.8 cm | Distal: 7.8 +/- 0.2 cm<br>Medial: 12.9 +/- 0.8 cm<br>Proximal: 10.3 +/- 0.8 cm |
| Extension<br>Tube<br>Diameter | ID (inches): 0.058-0.088<br>OD (inches): 0.061-0.091 | ID (inches): 0.058-0.088<br>OD (inches): 0.061-0.091 | ID (inches): 0.058-0.088<br>OD (inches): 0.061-0.091 | ID (inches): 0.058-0.088<br>OD (inches): 0.061-0.091 |
| Main<br>Accessory<br>Components | Wire Guide, dilator,<br>introducer needle,<br>syringe, and injection<br>caps | Wire Guide, dilator,<br>introducer needle,<br>syringe, and injection<br>caps | Wire Guide, dilator,<br>introducer needle,<br>syringe, and injection<br>caps | Wire Guide, dilator,<br>introducer needle,<br>syringe, and injection<br>caps |
| Wire Guide | Included as part of the<br>standard set or in a kit<br>tray. None for stand-alone catheter. | Included as part of the<br>standard set or in a kit<br>tray. None for stand-alone catheter. | Included as part of the<br>standard set or in a kit<br>tray. None for stand-alone catheter. | Included as part of the<br>standard set or in a kit<br>tray. None for stand-alone catheter. |
| Packaging | Two configurations<br>available:<br>• Kit tray with Tyvek<br>lid stock<br>• CVC catheter (in a<br>foil pouch) inside a<br>Tyvek outer pouch | • Kit tray with<br>Tyvek lid stock<br>• CVC catheter (in<br>a foil pouch)<br>inside a Tyvek<br>outer pouch | • Kit tray with<br>Tyvek lid stock<br>• CVC catheter<br>(in a foil pouch)<br>inside a Tyvek<br>outer pouch | Kit tray with Tyvek<br>lid stock |
| | Predicate Device | Subject Device | | |
| | Cook® Spectrum® 2<br>MRC Central Venous<br>Catheter (K223648) | SV Spectrum<br>MRC Central<br>Venous<br>Catheter | SV Spectrum<br>MR Central<br>Venous<br>Catheter<br>(previously<br>cleared under<br>K033843) | SV<br>Central Venous<br>Catheter<br>(previously cleared<br>under K081113) |
| Sterilization<br>Method | For packaging<br>configurations described<br>above:<br>• E-beam of foil pouch,<br>then EO of entire tray<br>• E-beam of foil pouch,<br>then EO of foil pouch<br>in Tyvek pouch | For packaging<br>configurations<br>described above:<br>• E-beam of foil<br>pouch, then EO of<br>entire tray<br>• E-beam of foil<br>pouch, then EO of<br>foil pouch in Tyvek<br>pouch | For packaging<br>configurations<br>described above:<br>• E-beam of foil<br>pouch, then EO<br>of entire tray<br>• E-beam of foil<br>pouch, then EO<br>of foil pouch in<br>Tyvek pouch | Ethylene Oxide (EO) |
| Sterility<br>Assurance<br>Level | $10^{-6}$ | $10^{-6}$ | $10^{-6}$ | $10^{-6}$ |
| Shelf-life | 6 months | 3 years | 3 years | 3 years |

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### Summary:

The SV Spectrum MRC Central Venous Catheter (MRC) that is the subject of this 510(k) is identical to the predicate Cook Spectrum 2 MRC Central Venous Catheter (K223648) in design and all device attributes, with the exception of extending the shelf life from the previously cleared 6-month shelf life to a 3-year shelf life. Testing is provided to support and demonstrate the performance of the SV Spectrum MRC Central Venous Catheter after 3 years of aging. The aged device met all acceptance criteria for device performance and thus, is Substantially Equivalent to the predicate device.

Spectrum Vascular also intends to market a version of the SV Spectrum MR catheter without the chlorhexidine coating, the SV Spectrum MR Central Venous Catheter, and an uncoated version without any drug impregnated or coating the device, the SV Central Venous Catheter. The only variation between the three versions listed are the impregnation of Minocycline and Rifampin on the MRC and MR versions, and the addition of a Chlorhexidine coating specific to the MRC version of the device. Testing on 3-year aged samples demonstrates performance to support clearance of all three devices with a 3-year shelf life.

The Cook Spectrum MR CVC, which is representative of the SV Spectrum MR CVC in terms of antimicrobial efficacy (only the name will change on the labeling), has an established 3-year shelf-life based on results from the 3-year real-time aged antimicrobial efficacy testing originally provided in K033843. The currently marketed MR CVC, and CVC (K081113), have been commercially available on

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the market with a 36-month shelf life for over 15 years and have not changed functionally. the Cook Spectrum MR CVC has been clinically validated in large scale studies, with no new concerns of safety and effectiveness.

Performance testing is provided below in Section 9.

#### 9. SUMMARY OF NON-CLINICAL PERFORMANCE TESTING

### Biocompatibility Testing

The medical device in its final finished form is identical to the Cook® Spectrum® 2 MRC Central Venous Catheter in formulation, processing, sterilization, and geometry and no other chemicals have been added (e.g., plasticizers, fillers, additives, cleaning agents, mold release agents).

### Electrical Safety

Not applicable. The device contains no electric components, generates no electrical emissions, and uses no electrical energy of any type.

### Electromagnetic Compatibility (EMC)

Not applicable. The device contains no electric components, generates no electrical emissions, and uses no electrical energy of any type.

#### Software

Not applicable. The device contains no software.

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### Performance Testing

Performance testing to the following standards was conducted:

- BS EN ISO 10555-1:2013 + A1:2017, Intravascular catheters Sterile and single-use . catheters. Part 1: General requirements
- BS EN ISO 10555-3:2013, Intravascular catheters Sterile and single-use catheters ● Part 3: Central venous catheters
- ASTM D4169-16, Standard Practice for Performance Testing of Shipping Containers . and Systems
- . ASTM F2503-20, Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment

### Shelf-Life Testing (aged product up to 36 months):

- Package Integrity
- Simulated Transport Testing
- Bubble Leak, Seal Strength and Visual Inspection ●
- Mechanical Performance Testing of the Catheter: Tensile, Power Injection and Static Burst, Liquid & Air Leakage, Bending Fatigue, Suture Retention Strength, Extension Tube Clamp Functionality, Shaft Diameter and Length
- . Drug Stability (Drug Content, Degradant and In vitro Diffusion, and Particulate Matter Testing)
- Anti-Microbial Function (Durability to assess antimicrobial effectiveness of gram positive, gram ● negative, and fungal organisms).

#### 10. CONCLUSION

The results of the performance testing described above demonstrate that the subject device is as safe and effective as the predicate device and supports a determination of substantial equivalence.