(356 days)
Not Found
No
The device is a physical cap with a disinfectant, and the description focuses on its material properties, disinfection efficacy, and physical barrier function. There is no mention of data processing, algorithms, or learning capabilities.
No.
The device is described as a disinfecting cleaner and physical barrier for needle-free luer connectors, not a device used in the treatment or diagnosis of a disease or condition for therapeutic purposes.
No
Explanation: The device is intended for disinfecting and acting as a physical barrier for needle-free luer connectors, not for diagnosing a condition or disease.
No
The device description clearly states it is a physical cap made of high-density polyethylene housing and a polyester urethane sponge saturated with IPA solution. It is a physical, hardware-based medical device.
Based on the provided information, the BD PureHub™ Disinfecting Cap is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to disinfect and act as a physical barrier for needle-free luer connectors prior to access. This is a direct action on a medical device used for patient care, not a test performed on a sample taken from the body.
- Device Description: The description focuses on its physical properties and its function as a disinfectant and barrier. It doesn't mention any components or processes related to analyzing biological samples.
- Performance Studies: The performance studies focus on antimicrobial efficacy, physical properties (like retention, leakage, material compatibility), and biological safety (biocompatibility). These are typical tests for a medical device that interacts with the patient or medical equipment, not for an IVD that analyzes samples.
- Key Metrics: The key metric mentioned is "> 4-log reduction (Antimicrobial Efficacy)", which is a measure of disinfection effectiveness, not a diagnostic metric like sensitivity or specificity.
IVDs are devices intended for use in vitro for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The BD PureHub™ Disinfecting Cap does not fit this definition. It is a device used to maintain the cleanliness and integrity of a medical access point.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
QBP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home and health care facility
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing:
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 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.
Key Results:
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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
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) | |
|---|---|
| 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
| 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. |