Who is the manufacturer of BD PureHub Disinfecting Cap?

Becton, Dickinson and Company filed the 510(k) submission for BD PureHub Disinfecting Cap (K193190).

What is the FDA product code for BD PureHub Disinfecting Cap?

QBP. It is classified under 21 CFR 880.5440 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for BD PureHub Disinfecting Cap?

510(k) clearance (submission type: Traditional).

What are the predicate devices for BD PureHub Disinfecting Cap?

Curos™ Port Protector (K111992).

Who can help prepare an FDA 510(k) submission like BD PureHub Disinfecting Cap?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

BD PureHub Disinfecting Cap

K193190 · Becton, Dickinson and Company · QBP · Nov 9, 2020 · General Hospital

Device Facts

Record ID	K193190
Device Name	BD PureHub Disinfecting Cap
Applicant	Becton, Dickinson and Company
Product Code	QBP · General Hospital
Decision Date	Nov 9, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.5440
Device Class	Class 2

Indications for Use

BD PureHub™ Disinfecting Caps are intended to be used as a disinfecting cleaner for swabbable needle-free luer connectors prior to access and to act as a physical barrier between line accesses. BD PureHub™ Disinfecting Cap will disinfect the needle-free luer connector one (1) minute after application and act as a physical barrier for up to seven (7) days, if not removed.

Device Story

BD PureHub Disinfecting Cap is a sterile, single-use device for needle-free luer connectors. It consists of a high-density polyethylene housing and a polyester urethane sponge saturated with 70% isopropyl alcohol (IPA). The device is applied to the luer connector, where the IPA acts as an antimicrobial agent to disinfect the surface within one minute. It remains in place to serve as a physical barrier against contamination for up to seven days. Used in healthcare facilities or home settings by clinicians or patients. The device is supplied in bulk or on IV pole strips. It provides a passive disinfection method, reducing the risk of catheter-related bloodstream infections by maintaining a sterile barrier between line accesses.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including in vitro antimicrobial efficacy testing against S. aureus, S. epidermidis, E. coli, P. aeruginosa, C. albicans, C. glabrata, and A. baumannii, demonstrating >4-log reduction. Additional bench testing included particulate matter ingress (USP 788), IPA concentration, device retention, air leakage, weld retention, packaging integrity, and biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, hemocompatibility).

Technological Characteristics

Materials: High-density polyethylene (HDPE) housing, polyester urethane sponge. Disinfectant: 70% Isopropyl Alcohol (IPA). Form factor: Cap for needle-free luer connectors. Sterilization: Gamma irradiation (ISO 11137-2:2013, SAL 10^-6). Shelf life: 3 years. No software or electronic components.

Indications for Use

Indicated for use as a disinfecting cleaner for swabbable needle-free luer connectors prior to access and as a physical barrier between line accesses in patients requiring intravascular access.

Regulatory Classification

Identification

An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.

Special Controls

*Classification.* Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.

Predicate Devices

Curos™ Port Protector (K111992)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains two logos. On the left is the logo for the Department of Health & Human Services - USA. On the right is the logo for the U.S. Food & Drug Administration (FDA). The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text. Becton, Dickinson and Company Samhitha Mohan Regulatory Affairs Specialist 1 Becton Drive Franklin Lakes, New Jersey 07417 March 11, 2022 Re: K193190 Trade/Device Name: BD PureHub Disinfecting Cap Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: QBP Dear Samhitha Mohan: The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated November 9, 2020. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under regulation 880.5440. Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Payal Patel, OHT3: Office of GastroRenal, Ob-Gyn, General Hospital and Urology Devices, 240-402-6029, Payal.Patel(@fda.hhs.gov. Sincerely, FDA Payal Patel Assistant Director for General Hospital Devices DHT3C: Division of Drug Delivery and General Hospital Devices and Human Factors OHT3: Office of GastroRenal, Ob-Gyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health {1}------------------------------------------------ Image /page/1/Picture/0 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue font. November 9, 2020 Becton, Dickinson and Company Samhitha Mohan Regulatory Affairs Specialist 1 Becton Drive Franklin Lakes, New Jersey 07417 Re: K193190 Trade/Device Name: BD PureHub™ Disinfecting Cap Regulatory Class: Unclassified Product Code: OBP Dated: October 8, 2020 Received: October 9, 2020 Dear Samhitha Mohan: 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 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 {2}------------------------------------------------ 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 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 (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Sapana Patel -S for 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 {3}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K193190 Device Name BD PureHub DisinfectingTM Cap Indications for Use (Describe) BD PureHub™ Disinfecting Caps are intended to be used as a disinfecting cleaner for swabbable needle-free luer connectors prior to access and to act as a physical barrier between line accesses. BD PureHub™ Disinfecting Cap will disinfect the needle-free luer connector one (1) minute after application and act as a physical barrier for up to seven (7) days, if not removed. | Type of Use (Select one or both, as applicable) | | |---------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------| | <div> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | 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: > 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." {4}------------------------------------------------ Image /page/4/Picture/2 description: The image shows the BD logo. The logo consists of two parts: a circular orange symbol on the left and the letters "BD" in blue on the right. The circular symbol features a stylized sun-like design with rays emanating from a central point. The letters "BD" are in a bold, sans-serif font. ## K193190 - 510(k) Summary (21 CFR §807.92) ## BD PureHub™ Disinfecting Cap | Submitter Information | Submitter Name: | Becton, Dickinson and Company | |--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------| | | Submitter Address: | 1 Becton Drive Franklin Lakes NJ 07417 | | | Contact Person: | Samhitha Mohan Staff Regulatory Affairs Specialist | | | Email Address: Phone Number: Fax Number: Date of Preparation: | Samhitha.Mohan@bd.com (201) 847-5204 (201) 847-5307 November 3, 2020 | | Subject Device | Trade Name: Common Name: Regulation Number: Device Class: Product Code: Classification Panel: | BD PureHub™ Disinfecting Cap Cap, Device Disinfectant Unclassified Unclassified QBP General Hospital | | Predicate Device | Trade Name: 510(k) Reference: Common Name: Regulation Number: Regulatory Class: Product Code: Classification Panel: | Curos™ Port Protector K111992 Cap, Device Disinfectant Unclassified Unclassified QBP General Hospital | | Device Description | BD PureHub™ Disinfecting Cap is a sterile, single use disinfectant cap designed for needle-free Luer connectors. It has high-density polyethylene housing and polyester urethane sponge saturated with 70% Isopropyl Alcohol (IPA) solution. PureHub™ disinfects needle-free Luer connectors one minute after application and acts as a physical barrier for up to seven days, if not removed. It is available in two packaging configurations - Bulk Single Unit and IV Pole Strip. | | | Indications for Use | BD PureHub™ Disinfecting Caps are intended to be used as a disinfecting cleaner for swabbable needle-free luer connectors prior to access and to act as a physical barrier between line accesses. | | {5}------------------------------------------------ BD PureHub™ Disinfecting Cap will disinfect the needle-free luer connector one (1) minute after application and act as a physical barrier for up to seven (7) days, if not removed. ## Technological Characteristics The following table provides a comparison between the subject and predicate device - | Attributes | Subject Device (BD PureHub™ Disinfecting Cap) | Predicate Device (Curos™ Port Protector) | Comparison | | |--------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | BD PureHub™ Disinfecting Caps are intended to be used as a disinfecting cleaner for swabbable needle- free luer connectors prior to access and to act as a physical barrier between line accesses. BD PureHub™ Disinfecting Cap will disinfect the needle- free luer connector one (1) minute after application and act as a physical barrier for up to seven (7) days, if not removed. | The Curos™ is intended for use on swab-able Luer access valves as a disinfecting cleaner prior to line access and to act as a physical barrier to contamination between line accesses. Curos™ will disinfect the valve three (3) minutes after application and act a s a physical barrier to contamination for up to seven (7) days (168 hours) if not removed. The effectiveness of Curos™ Protectors were tested in vitro against Staphylococcus aureus , Staphylococcus epidermis , Escherichia coli and Pseudomonas aeruginosa , candida glabrata , Canada albicans and was found to have >4-log reduction. The Curos™ Port Protector may be used in the home or healthcare facility. | With the exception of disinfection time and the microorganisms, the intended use is similar. In vitro antimicrobial efficacy testing was performed to support PureHub's disinfection time. The micro- oraganisms tested are identical to Curos™ Port Protector with the exception of the addition of antimicrobial efficacy testing conducted on Acinetobacter baumannii . The subject device does not list the microorganisms tested against in the indications for use. | | | Condition of Use (Environment) | Same as predicate | Home and health care facility | Identical | | | Cap Insertion Site | Same as predicate | Needle-free Luer connector | Identical | | | | | | | | | Device Components | | Same as predicate | Ribbed external cap housing Sponge with 70% IPA solution Foil lid | Identical | | User Population | | Same as predicate | General use | Identical | | Operating Principle | | Same as predicate | 70% IPA solution acts as an antimicrobial agent to disinfect needle-free Luer connector | Identical | | Device Materials | Cap Housing | High Density Polyethylene (HDPE) | Unknown | Material differences were assessed as per ISO 10993-1 | | | Sponge | Polyester Urethane | Unknown | | | | Disinfecta -nt Solution | Same as predicate | 70% IPA | | | | Colorant | Teal green | Translucent green | | | Packaging Configurations | | Same as predicate | Bulk Single Unit and IV Pole Strip | Identical | | Sterilization Method | | Same as predicate | Gamma Irradiation | Identical | | SAL | | Same as predicate | 10-6 | Identical | | Antimicrobial Efficacy | | Same as predicate | > 4-log reduction | Identical | | Minimum Disinfecting Time | | 1 minute | 3 minutes | Similar; reduced disinfecting time was assessed through antimicrobial efficacy testing. | | Target microorganisms for in vitro antimicrobial efficacy testing | | Staphylococcus aureus Staphylococcus epidermidis Escherichia coli Pseudomonas aeruginosa Candida albicans Candida glabrata Acinetobacter baumannii | Staphylococcus aureus Staphylococcus epidermidis Escherichia coli Pseudomonas aeruginosa Candida albicans Candida glabrata | Identical except for Acinetobacter baumannii. In vitro antimicrobial efficacy testing was performed for all the microorganisms | | Shelf Life | 3 years | 3 years | Identical | | {6}------------------------------------------------ {7}------------------------------------------------ ## Discussion: The intended use of the subject and predicate device are similar in that both disinfect needle-free Luer connector and act as a physical barrier. However, the disinfection time of PureHub™ (1 minute) is shorter than Curos™ Port Protector (3 minutes) and PureHub™ tests an additional microorganism (Acinetobacter baumannii) compared to Curos™ Port Protector. In vitro antimicrobial efficacy testing was performed for all the above mentioned microorganisms to demonstrate that the shorter disinfection time does not raise any new or different questions of safety and effectiveness. Additionally, since the predicate device materials were unknown, appropriate biocompatibility tests were performed as per ISO 10993-1 to ensure the safe use of PureHub™. The biocompatibility tests performed on the subject device are identified below. | | | | The predicate device has not been subjected to design-related call. | | | |--|--|--|---------------------------------------------------------------------|--|--| | | | | | | | | Non-Clinical Testing | BD has performed the following performance tests in accordance with 21 CFR §820.30 to demonstrate that the PureHub™ Disinfecting Cap performs equivalent to the predicate device. | |-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | The following tests were performed on the subject device to an internal specification or a Standard: In vitro Antimicrobial Efficacy Staphylococcus aureus Staphylococcus epidermidis Escherichia coli Pseudomonas aeruginosa Candida albicans Candida glabrata Acinetobacter baumannii Particulate Matter Ingress USP 788 70% IPA Weight and % Isopropyl Alcohol/Water Solution Concentration Cap to Connector Interface Device Retention to Luer activated valve (LAV) Material Compatibility of subject device and LAV Air Leakage Weld Retention Packaging Integrity Tensile Strength on IV Pole Strip PureHub™ Connector Air Leak Testing Physical Barrier Testing | | | As per ISO 10993-1:2009, the following biological tests were | {8}------------------------------------------------ | | performed: | |------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | • Cytotoxicity • Sensitization • Irritation or Intracutaneous Activity • Acute Systemic Toxicity • Material Mediated Pyrogenicity • LAL Endotoxin • Hemocompatibility • Subacute/Subchronic | | | Additionally, the following tests were performed – • Chemical Extractable Analysis • 70% IPA Ingress Testing | | | The BD PureHub™ Disinfecting Cap is sterilized by Gamma radiation. The sterilization process was validated in accordance with ISO 11137-2:2013 (VDmax25). | | | The subject device met all the predetermined acceptance criteria for the above listed performance tests and demonstrated substantial equivalence to the predicate device. | | Clinical Testing | Not applicable. | | Summary of Substantial Equivalence | The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The PureHub™ Disinfecting Cap is substantially equivalent to Curos™ Port Protector cleared under K111992 with respect to the indications for use, target population, treatment method and technological characteristics. |

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