BD Intima II Closed IV Catheter System, BD Intima II PLUS Closed IV Catheter System

K200891 · Becton, Dickinson and Company · FOZ · Jun 2, 2021 · General Hospital

Device Facts

• Record ID: K200891
• Device Name: BD Intima II Closed IV Catheter System, BD Intima II PLUS Closed IV Catheter System
• Applicant: Becton, Dickinson and Company
• Product Code: FOZ · General Hospital
• Decision Date: Jun 2, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BD Intima II™ Closed IV Catheter System is inserted into a patient's vascular system for short-term use to monitor blood pressure or administer fluids intravascularly. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. The BD Intima II PLUS™ Closed IV Catheter System is inserted into a patient's vascular system for short-term use to monitor blood pressure or administer fluids intravascularly. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy.

Device Story

Closed system IV catheter; includes radiopaque Vialon™ polyurethane catheter, notched needle for flashback visualization (BD Instaflash™), septum, pinch clamp, extension tubing, and Luer connector. Integrated extension set available in single or dual-port configurations with PRN adapters or needleless connectors (MaxZero™). Used by clinicians for short-term vascular access; enables blood containment during insertion. Modifications include new configurations (26G needle, 2.8-inch tubing), pressure rating to 300psi for specific configurations, and component design updates. Device facilitates fluid delivery and pressure monitoring; benefits include reduced blood exposure during insertion and versatile configuration options.

Clinical Evidence

Bench testing only. Performance testing included needleless connector torque, leakage, microbial ingress, flow rate, back pressure, insertion force, droplet size/separation, activation, shelf-life, lie distance, needle sharpness, joint strength, burst/leak testing, and particulate matter. Biocompatibility testing per ISO 10993-1 included cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, pyrogenicity, subacute/subchronic toxicity, and haemocompatibility. MR compatibility evaluated per ASTM F2182-19.

Technological Characteristics

Single-winged polyurethane catheter; integrated extension set. Materials: Vialon™ (catheter), stainless steel (needle/wedge), polyisoprene (septum), POM (clamp), polycarbonate (PRN/MaxZero), PVC/TPU (tubing). Sterilization: Ethylene Oxide. Connectivity: None. Standards: ISO 10555-1, ISO 10555-5, USP <788>, ASTM F2182-19, ISO 10993-1.

Indications for Use

Indicated for patients requiring short-term vascular access for blood pressure monitoring or intravascular fluid administration. Use depends on vascular anatomy, procedure, infused fluids, and therapy duration.

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

• BD Intima II™ Closed IV Catheter System (K143610)
• BD Intima II PLUS™ Closed IV Catheter System (K172204)
• MaxZero™ Needleless Connector (K132413)

Submission Summary (Full Text)

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June 2, 2021

Becton, Dickinson and Company Kimberly Geisler Sr. Manager, Regulatory Affairs 9450 South State Street Sandy, Utah 84070

Re: K200891

Trade/Device Name: BD Intima II™ Closed IV Catheter System, BD Intima II PLUS™ Closed IV Catheter System Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: FOZ, FPA Dated: April 30, 2021 Received: May 3, 2021

Dear Kimberly Geisler:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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 mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Payal Patel Acting 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) K200891

#### Device Name

BD Intima II™ Closed IV Catheter System and BD Intima II PLUSTM Closed IV Catheter System

### Indications for Use (Describe)

The BD Intima II™ Closed IV Catheter System is inserted into a patient's vascular system for short-term use to monitor blood pressure or administer fluids intravascularly. These devices may be used for any patient with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy.

The BD Intima II PLUS™ Closed IV Catheter System is inserted into a patient's vascular system for short-term use to monitor blood pressure or administer fluids intravascularly. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-family: Arial, sans-serif;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span style="font-family: Arial, sans-serif;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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Becton Dickinson Infusion Therapy Systems Inc. 9450 South State Street Sandy, Utah 84070 USA

bd.com

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# 510(k) Summary (21 CFR §807.92) - K200891 BD Intima II™ Closed IV Catheter System and

## BD Intima II PLUS™ Closed IV Catheter System

| Submitter<br>Information | Submitter Name: | Becton Dickinson Infusion Therapy Systems Inc. |
|--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| | Submitter Address: | 9450 South State Street<br>Sandy, Utah 84070 |
| | Contact Person: | Kimberly Geisler<br>Sr. Manager, Regulatory Affairs<br>[e-mail]<br>[phone] (phone) |
| | Date of Preparation: | June 2, 2021 |
| Subject Device | Trade Name: | BD Intima IITM Closed IV Catheter System<br>BD Intima II PLUSTM Closed IV Catheter System |
| | Common Name: | Peripheral Intravascular or IV Catheter |
| | Regulation Number: | 21 CFR §880.5200 |
| | Regulation Name: | Intravascular Catheter |
| | Regulatory Class: | II |
| | Product Code: | FOZ (primary); FPA (secondary) |
| | Classification Panel: | General Hospital |
| Predicate Device 1 | Trade Name: | BD Intima IITM Closed IV Catheter System |
| | 510(k) Reference: | K143610, cleared 09 April 2015 |
| | Common Name: | Peripheral Intravascular or IV Catheter |
| | Regulation Number: | 21 CFR §880.5200 |
| | Regulation Name: | Intravascular Catheter |
| | Regulatory Class: | II |
| | Product Code: | FOZ |
| | Classification Panel: | General Hospital |
| Predicate Device 2 | Trade Name: | BD Intima II PLUSTM Closed IV Catheter System |
| | 510(k) Reference: | K172204, cleared 17 August 2017 |
| | Common Name: | Peripheral Intravascular or IV Catheter |
| | Regulation Number: | 21 CFR §880.5200 |
| | Regulation Name: | Intravascular Catheter |
| | Regulatory Class: | II |
| | Product Code: | FOZ |
| | Classification Panel: | General Hospital |
| Predicate Device 3 | Trade Name: | MaxZero™ Needleless Connector (MZ1000) |
| | 510(k) Reference: | K132413, cleared 29 August 2013 |
| | Common Name: | Intravascular Administration Set or Needleless<br>Connector |
| | Regulation Number:…