(356 days)
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.
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.
The BD PureHub™ Disinfecting Cap is 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. It 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.
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly list "acceptance criteria" alongside specific numerical targets and then directly compare them to reported device performance in a single table for each test. Instead, it states that "The subject device met all the predetermined acceptance criteria for the above listed performance tests and demonstrated substantial equivalence to the predicate device."
However, we can infer some criteria and reported performance from the comparison table and the list of non-clinical tests:
| Acceptance Criteria (Inferred/Stated) | Reported Device Performance |
|---|---|
| Antimicrobial Efficacy: | |
| Disinfects needle-free luer connector | Disinfects in 1 minute |
| Reduces microorganism growth by > 4-log reduction (similar to predicate) | > 4-log reduction (tested against Staphylococcus aureus, Staphylococcus epidermidis, Escherichia coli, Pseudomonas aeruginosa, Candida albicans, Candida glabrata, Acinetobacter baumannii) |
| Physical Barrier: | |
| Acts as a physical barrier for up to 7 days | Acts as a physical barrier for up to 7 days |
| Biocompatibility (as per ISO 10993-1): | Met predetermined acceptance criteria for: Cytotoxicity, Sensitization, Irritation or Intracutaneous Activity, Acute Systemic Toxicity, Material Mediated Pyrogenicity, LAL Endotoxin, Hemocompatibility, Subacute/Subchronic. Additionally, Chemical Extractable Analysis was performed. |
| Sterilization Assurance Level (SAL): | 10⁻⁶ |
| Sterilization Method: | Gamma Irradiation (validated in accordance with ISO 11137-2:2013 (VDmax25)) |
| Shelf Life: | 3 years |
| Other Performance Tests: | Met all predetermined acceptance criteria for: 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. |
2. Sample Sizes Used for the Test Set and Data Provenance:
The document does not provide specific sample sizes for each non-clinical test. It lists the types of tests performed.
The data provenance is not explicitly stated in terms of country of origin or retrospective/prospective. The tests were performed "in accordance with 21 CFR §820.30" and various ISO standards, implying controlled laboratory conditions rather than human clinical trials.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not applicable as the study involved non-clinical performance and biocompatibility testing, not expert-adjudicated clinical ground truth. The "ground truth" for these tests would be established by the methodologies defined in the respective ISO standards (e.g., ISO 10993 for biocompatibility) and internal specifications.
4. Adjudication Method for the Test Set:
Not applicable. The tests are laboratory-based and follow standardized protocols, not human adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a physical disinfecting cap, not an AI-powered diagnostic or assistive tool for human readers.
6. Standalone Performance Study (i.e., algorithm only without human-in-the-loop performance):
Yes, a standalone study was performed, as the device is a physical product and its performance (e.g., antimicrobial efficacy, physical barrier, biocompatibility) was evaluated directly through laboratory testing without human intervention being part of the device's function.
7. Type of Ground Truth Used:
The ground truth for the non-clinical tests was established by:
- Established Test Methods and Standards: e.g., ISO 10993-1 for biocompatibility, ISO 11137-2:2013 (VDmax25) for sterilization, USP 788 for particulate matter.
- Defined Performance Criteria: For tests like antimicrobial efficacy, the "ground truth" is a measurable reduction in microorganism count (> 4-log reduction).
- Internal Specifications: Tests were performed "to an internal specification or a Standard."
8. Sample Size for the Training Set:
Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. (See #8)
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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
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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
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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
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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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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K193190 - 510(k) Summary (21 CFR §807.92)
BD PureHub™ Disinfecting Cap
| SubmitterInformation | Submitter Name: | Becton, Dickinson and Company |
|---|---|---|
| Submitter Address: | 1 Becton DriveFranklin LakesNJ 07417 | |
| Contact Person: | Samhitha MohanStaff Regulatory Affairs Specialist | |
| Email Address:Phone Number:Fax Number:Date of Preparation: | Samhitha.Mohan@bd.com(201) 847-5204(201) 847-5307November 3, 2020 | |
| Subject Device | Trade Name:Common Name:Regulation Number:Device Class:Product Code:Classification Panel: | BD PureHub™ Disinfecting CapCap, Device DisinfectantUnclassifiedUnclassifiedQBPGeneral Hospital |
| Predicate Device | Trade Name:510(k) Reference:Common Name:Regulation Number:Regulatory Class:Product Code:Classification Panel: | Curos™ Port ProtectorK111992Cap, Device DisinfectantUnclassifiedUnclassifiedQBPGeneral Hospital |
| Device Description | BD PureHub™ Disinfecting Cap is a sterile, single usedisinfectant cap designed for needle-free Luer connectors. Ithas high-density polyethylene housing and polyester urethanesponge saturated with 70% Isopropyl Alcohol (IPA) solution.PureHub™ disinfects needle-free Luer connectors one minuteafter application and acts as a physical barrier for up to sevendays, if not removed. It is available in two packagingconfigurations - Bulk Single Unit and IV Pole Strip. | |
| Indications for Use | BD PureHub™ Disinfecting Caps are intended to be used as adisinfecting cleaner for swabbable needle-free luer connectorsprior to access and to act as a physical barrier between lineaccesses. |
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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™ PortProtector) | Comparison | |
|---|---|---|---|---|
| Indications forUse | BD PureHub™Disinfecting Caps areintended to be usedas a disinfectingcleaner forswabbable needle-free luer connectorsprior to access andto act as a physicalbarrier between lineaccesses.BD PureHub™Disinfecting Cap willdisinfect the needle-free luer connectorone (1) minute afterapplication and actas a physical barrierfor up to seven (7)days, if notremoved. | The Curos™ is intendedfor use on swab-ableLuer access valves as adisinfecting cleanerprior to line access andto act as a physicalbarrier tocontamination betweenline accesses. Curos™will disinfect the valvethree (3) minutes afterapplication and act a sa physical barrier tocontamination for up toseven (7) days (168hours) if not removed.The effectiveness ofCuros™ Protectors weretested in vitro againstStaphylococcus aureus ,Staphylococcusepidermis , Escherichiacoli and Pseudomonasaeruginosa , candidaglabrata , Canadaalbicans and was foundto have >4-logreduction. The Curos™Port Protector may beused in the home orhealthcare facility. | With the exceptionof disinfection timeand themicroorganisms,the intended use issimilar. In vitroantimicrobialefficacy testingwas performed tosupport PureHub'sdisinfection time.The micro-oraganisms testedare identical toCuros™ PortProtector with theexception of theaddition ofantimicrobialefficacy testingconducted onAcinetobacterbaumannii . Thesubject devicedoes not list themicroorganismstested against inthe indications foruse. | |
| Condition of Use(Environment) | Same as predicate | Home and health carefacility | Identical | |
| Cap InsertionSite | Same as predicate | Needle-free Luerconnector | Identical | |
| DeviceComponents | Same as predicate | Ribbed external cap housing Sponge with 70% IPA solution Foil lid | Identical | |
| User Population | Same as predicate | General use | Identical | |
| OperatingPrinciple | Same as predicate | 70% IPA solution acts as an antimicrobial agent to disinfect needle-free Luer connector | Identical | |
| DeviceMaterials | CapHousing | High DensityPolyethylene (HDPE) | Unknown | Material differences were assessed as per ISO 10993-1 |
| Sponge | Polyester Urethane | Unknown | ||
| Disinfecta-ntSolution | Same as predicate | 70% IPA | ||
| Colorant | Teal green | Translucent green | ||
| PackagingConfigurations | Same as predicate | Bulk Single Unit and IV Pole Strip | Identical | |
| SterilizationMethod | Same as predicate | Gamma Irradiation | Identical | |
| SAL | Same as predicate | 10-6 | Identical | |
| AntimicrobialEfficacy | Same as predicate | > 4-log reduction | Identical | |
| MinimumDisinfectingTime | 1 minute | 3 minutes | Similar; reduced disinfecting time was assessed through antimicrobial efficacy testing. | |
| Targetmicroorganismsfor in vitroantimicrobialefficacy 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 |
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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-ClinicalTesting | BD has performed the following performance tests inaccordance with 21 CFR §820.30 to demonstrate that thePureHub™ Disinfecting Cap performs equivalent to thepredicate device. |
|---|---|
| The following tests were performed on the subject device to aninternal 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 |
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| 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 Gammaradiation. The sterilization process was validated in accordancewith ISO 11137-2:2013 (VDmax25). | |
| The subject device met all the predetermined acceptancecriteria for the above listed performance tests anddemonstrated substantial equivalence to the predicate device. | |
| Clinical Testing | Not applicable. |
| Summary ofSubstantialEquivalence | The differences between the predicate and the subject devicedo not raise any new or different questions of safety oreffectiveness. The PureHub™ Disinfecting Cap is substantiallyequivalent to Curos™ Port Protector cleared under K111992with respect to the indications for use, target population,treatment method and technological characteristics. |
§ 880.5440 Intravascular administration set.
(a)
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.(b)
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.