CapKlenZ
Device Facts
| Record ID | K192382 |
|---|---|
| Device Name | CapKlenZ |
| Applicant | Star Mountain Medical, Inc. |
| Product Code | QBP · General Hospital |
| Decision Date | Apr 20, 2020 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5440 |
| Device Class | Class 2 |
Indications for Use
When left in place for 3 minutes, CapKlenZ disinfects needleless luer access valves; thereafter the CapKlenZ provides a physical barrier to contamination up to 168 hours under normal conditions if not removed.
Device Story
CapKlenZ is a single-use disinfecting cap for needleless luer access valves. It consists of a polyethylene reservoir containing an absorbent material saturated with 70% isopropyl alcohol (IPA) and a non-DEHP, non-latex elastomer threaded membrane. The device is used in home and hospital settings by clinicians or patients. To operate, the user threads the needleless connector into the device; the internal membrane and absorbent material scrub the connector tip and expose it to 70% IPA. The device remains in place to provide a physical barrier against contamination for up to 168 hours. The device benefits patients by reducing the risk of catheter-related bloodstream infections through effective disinfection and maintenance of a sterile barrier. Output is the disinfected state of the connector, which the healthcare provider or patient verifies by visual inspection of the secure attachment.
Clinical Evidence
Bench testing only. Antimicrobial efficacy testing demonstrated ≥ 4 log reduction for 2 gram-positive, 2 gram-negative, and 3 fungus/yeast organisms at 3, 5, and 60 minutes. Microbial barrier testing confirmed 0% ingress of Pseudomonas aeruginosa over 168 hours. Biocompatibility testing (ISO 10993) and alcohol leakage studies (gas chromatography) confirmed safety. All tests performed at T=0 and T=2 years.
Technological Characteristics
Reservoir: Polyethylene. Membrane: Non-DEHP, non-latex elastomer. Antimicrobial: 70% Isopropyl Alcohol. Dimensions: 17.1mm diameter, 11.2mm height. Sterilization: Gamma irradiation (SAL 10^-6) per ISO 11137. Packaging: Extrusion laminated composite (polyester, polyethylene, aluminum foil).
Indications for Use
Indicated for disinfection of needleless luer access valves and providing a physical barrier to contamination for up to 168 hours. Intended for use in home and hospital settings.
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
- DualCap Solo™ (K123065)
Submission Summary (Full Text)
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April 20, 2020
Star Mountain Medical, Inc. % E.J. Smith Consultant Smith Associates 1468 Harwell Ave. Crofton, Maryland 21114
Re: K192382
Trade/Device Name: CapKlenZ Regulatory Class: Unclassified Product Code: QBP Dated: March 17, 2020 Received: March 23, 2020
Dear E.J. Smith:
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
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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 (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 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-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,
for Tina Kiang, Ph.D. 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) K192382
Device Name CapKlenZ
Indications for Use (Describe)
When left in place for 3 minutes, the CapKlenZ disinfects needleless luer access valves; thereafter the CapKlenZ provide a physical barrier to contamination up to 168 hours under normal conditions if not removed.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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### 1 - Company Information & Contact Person
| Company Name: | Star Mountain Medical, Inc. |
|------------------|----------------------------------------------------|
| Company Address: | 9005 Montana Ave. Ste. A |
| | El Paso, Texas 79925 |
| Telephone: | (915) 774-4321 |
| Fax: | (915) 774-4323 |
| Contact Person: | Cesar Rios, Quality Assurance & Regulatory Manager |
| Date Prepared: | 08/23/2019 |
#### 2 - Device Name & Classification
| Trade/Device Name: | CapKlenZ |
|------------------------------|-------------------------|
| Common Name: | Device Disinfectant Cap |
| Regulation Number: | Unclassified |
| Classification Product Code: | QBP |
| Regulatory Class: | Unclassified |
#### 3 - Predicate Device
Legally Marketed Substantially Equivalent Predicate Device
| Proprietary Name: | DualCap Solo™ |
|------------------------------|----------------------------|
| Company Name: | Catheter Connections, Inc. |
| Common Name: | Device Disinfectant Cap |
| Regulation Number: | Unclassified |
| Classification Product Code: | QBP |
| Regulatory Class: | Unclassified |
| 510(k) Number | K123065 |
### 4 - Device Description
CapKlenZ consists of a solid reservoir made of polyethylene, which contains an absorbent material and 70% isopropyl alcohol (70% IPA).
The opening of the reservoir is mechanically attached to a threaded membrane made of non-DEHP, non-latex elastomer, which lays in the internal geometry of the reservoir, this membrane is intended to be threaded to a needleless port connector and adapt to its shape. The reservoir and its contents are sealed with an extrusion laminated composite of polyester, polyethylene, aluminum foil, and a peelable sealant, which has to be removed before use.
Once the needleless port connector is threaded, the shape and elasticity of the threaded membrane, isolates the proximal end of the needleless port connector within the interior of the reservoir along with the absorbent material and 70% IPA. When the needleless port connector is threaded into the membrane, the circular movement of the connector scrubs its tip against the absorbent material and exposes it to 70% IPA in order to disinfect it.
The following table lists the model and size available for CapKlenZ.
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| Trade Name | Commercial<br>Model Number | Diameter | Height | Antimicrobial agent | Color |
|------------|----------------------------|------------------------|------------------------|-----------------------|-------|
| CapKlenZ | CK-MPF10-200 | 17.1 mm<br>(0.67 inch) | 11.2 mm<br>(0.44 inch) | 70% Isopropyl Alcohol | Blue |
Table 5.4 CapKlenZ Model and Size
### 5 - Intended Use
The CapKlenZ is designed to fit securely on needleless connectors. The reservoir contains 70% isopropyl alcohol, which disinfects the needleless port connector. It also contains a threaded membrane which acts as a barrier to prevent contamination of the needleless port connector.
### 6 - Indications for Use
When left in place for 3 minutes, CapKlenZ disinfects needleless luer access valves; thereafter the CapKlenZ provide a physical barrier to contamination up to 168 hours under normal conditions if not removed.
The Indications for use statement for CapKlenZ is not identical to the predicate device; however, the differences do not alter the intended use of the subject device nor do they raise new or different questions of safety and effectiveness. Both the subject device and predicate device have the same intended use.
| Table 5.6 Indications for Use Comparison Table | |
|------------------------------------------------|--|
|------------------------------------------------|--|
| Predicate Device IFU statement | Subject Device IFU statement |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| When left in place for five (5) minutes DualCap<br>Solo™ disinfects needleless luer access valves;<br>thereafter the caps provide a physical barrier to<br>contamination up to ninety-six (96) hours under<br>normal conditions if not removed. | When left in place for 3 minutes CapKlenZ<br>disinfects needleless luer access valves; thereafter<br>the CapKlenZ provides a physical barrier to<br>contamination up to 168 hours under normal<br>conditions if not removed. |
The major differences in the predicate IFU and the subject device IFU are:
- a) There is a decreased minimum exposure time, going from 5 minutes to 3 minutes disinfection time for luer access valves using CapKlenZ.
- b) There is an increase in time going from 96 hours to 168 hours, in which the CapKlenZ can be left in place, providing a physical barrier.
In order to support the change in disinfection time indicated in the Indications for Use of CapKlenZ. In-vitro antimicrobial efficacy and microbial barrier studies were completed on CapKlenZ to support three (3) minutes and 168 hours disinfection time.
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## 7 – Summary of Technological Characteristics Comparison
Based on a comparison of the indications for use, fundamental design, technology and principles of operation, materials, performance, sterilization, and packaging, it is determined that the CapKlenZ is substantially equivalent to the predicate device. Table 5.7 below provides a comparison of the CapKlenZ and the predicate.
| Technical<br>Characteristics<br>/ Principle of<br>Operation | CapKlenZ<br>Subject device | DualCap Solo™<br>510(k) number<br>K123065<br>Predicate device | Discussion |
|-------------------------------------------------------------|-------------------------------------------------------------------------------------|-----------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Diameter | 17.1 mm (0.67 inch) ±<br>0.2 mm (0.007 inch) | 11.0 mm (0.43 inch) | The difference in dimension<br>between the predicate device and<br>the subject device was evaluated per<br>ISO 594-2, Dimensional, physical<br>and functional attributes test. |
| Height | 11.2 mm (0.44 inch) ±<br>0.2 mm (0.007 inch) | 20.9 mm (0.82 inch) | The difference in dimension<br>between the predicate device and<br>the subject device was evaluated per<br>ISO 594-2, Dimensional, physical<br>and functional attributes test. |
| Reservoir<br>Material | Polyethylene | Polypropylene | The difference in material between<br>the predicate device and the subject<br>device was evaluated<br>per ISO 10993-1. |
| Internal<br>Membrane | Non-DEHP, non-latex<br>elastomer | Not Applicable | The difference in material and<br>design characteristic between the<br>predicate device and the subject<br>device was evaluated per ISO 594-<br>2, Dimensional, physical and<br>functional attributes test, and ISO<br>10993-1. |
| Absorbent<br>Material | Polyethylene | Unknown | The difference in material between<br>the predicate device and the subject<br>device was evaluated<br>per ISO 10993-1. |
| Antimicrobial<br>agent | 70% Isopropyl Alcohol | 70% Isopropyl Alcohol | No Difference |
| Site Use | Needleless Luer Access<br>Valves | Needleless Luer Access<br>Valves | No Difference |
| User population | Home and hospital use | Home and hospital use | No Difference |
| Packaging | Individual | Pole Strips | No Difference |
| Sterilization | Gamma Irradiated | Gamma Irradiated | No Difference |
| Additional Claims | This device does not<br>contain natural rubber<br>latex or<br>Diethylhexylphthalate | This device is NOT<br>made with Natural<br>Rubber Latex.<br>DEHP Free | No Difference |
| | Table 5.7 Comparison of the CapKlenZ and the Predicate Device | |
|--|---------------------------------------------------------------|--|
| | | |
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### 8 – Non-Clinical Testing
The following bench tests were performed to evaluate the design elements and performance characteristics of the CapKlenZ and to demonstrate substantial equivalence to the predicate device. The CapKlenZ met the predetermined acceptance criteria. Tests results show that the CapKlenZ is substantially equivalent to the predicate device.
### 8.1- Performance Testing
Table 5.8.1 below provides a summary of the bench testing performed on CapKlenZ on baseline (T=0) and aged devices (T=2 vears).
| Test # | Test Name | Applicable Standard<br>or Internal Test<br>Method | Test Results | |
|--------|----------------------------------------------------|---------------------------------------------------|--------------|------|
| 1 | Dimensional, physical and functional<br>attributes | Internal Test Method | T=0<br>T=2 | Pass |
| 2 | Disassembly Force | Internal Test Method | T=0<br>T=2 | Pass |
| 3 | Air Leakage | Internal Test Method | T=0<br>T=2 | Pass |
| 4 | Liquid Leakage | Internal Test Method | T=0<br>T=2 | Pass |
| 5 | Packaging Integrity (Seal Peel Strength) | ASTM F88/88M-15 | T=0<br>T=2 | Pass |
| 6 | Packaging Integrity (Bubble Test) | ASTM F2096-11 | T=0<br>T=2 | Pass |
| 7 | Unscrewing Torque | ISO 594-2 | T=0<br>T=2 | Pass |
| 8 | Ease of Assembly | ISO 594-2 | T=0<br>T=2 | Pass |
| 9 | Resistance to Overriding | ISO 594-2 | T=0<br>T=2 | Pass |
| 10 | Stress Cracking | ISO 594-2 | T=0<br>T=2 | Pass |
| 11 | Shipping and Transit | ISTA 3A | T=0<br>T=2 | Pass |
Table 5.8.1 Bench Testing performed on CapKlenZ
### 8.2 - Antimicrobial Efficacy Testing
Star Mountain Medical, Inc. provided non-clinical performance test data in order to demonstrate the pre-defined acceptance criteria for a disinfecting device. This acceptance criteria is defined as a bacteria count reduction of ≥ 4 log of 2 selected gram positive bacteria, 2 selected gram negative bacteria, and 3 selected fungus/yeast micro-organisms for 3 time points from 3 minutes up to 60 minutes (1 hour).
Table 5.8.2 provides a summary of the antimicrobial efficacy testing performed on baseline (T=0) and aged devices (T=2 years).
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| | | Acceptance<br>Criteria<br>(bacterial count<br>reduction ( $\Delta$ Log)) | Time point exposure (bacterial<br>count reduction ( $\Delta$ Log)) | | |
|--------------------------|---------------|--------------------------------------------------------------------------|--------------------------------------------------------------------|--------------|---------------|
| Organism | Description | (bacterial count<br>reduction ( $\Delta$ Log)) | 3<br>minutes | 5<br>minutes | 60<br>minutes |
| Staphylococcus aureus | Gram Positive | $\geq$ 4.0 | Pass | Pass | Pass |
| Staphylococcus epidermis | Gram Positive | $\geq$ 4.0 | Pass | Pass | Pass |
| Escherichia coli | Gram Negative | $\geq$ 4.0 | Pass | Pass | Pass |
| Pseudomonas aeruginosa | Gram Negative | $\geq$ 4.0 | Pass | Pass | Pass |
| Candida albicans | Fungus/Yeast | $\geq$ 4.0 | Pass | Pass | Pass |
| Candida glabrata | Fungus/Yeast | $\geq$ 4.0 | Pass | Pass | Pass |
| Candida auris | Fungus/Yeast | $\geq$ 4.0 | Pass | Pass | Pass |
Table 5.8.2 Antimicrobial efficacy testing performed on CapKlenZ T=0 and T=2.
### 8.3 - Microbial Barrier Testing
Microbial barrier testing was performed to demonstrate that the CapKlenZ acts as a physical barrier for microbial ingress under worst-case conditions using an external bioaerosol of Pseudomonas aeruginosa.
Table 5.8.3 below provides a summary of the microbial barrier testing performed on baseline (T=0) and aged devices (T=2 years).
| Organism | Description | Acceptance<br>Criteria<br>(% Microbial Ingress) | Time point exposure<br>(% Microbial Ingress) | | |
|-------------------------------|---------------|-------------------------------------------------|----------------------------------------------|----------|-----------|
| | | | 1 hour | 24 hours | 168 hours |
| <i>Pseudomonas aeruginosa</i> | Gram Negative | 0 | Pass | Pass | Pass |
Table 5.8.3 Microbial Barrier testing performed on CapKlenZ T=0 and T=2.
### 8.4 – Alcohol in the fluid path Testing
The amount of the alcohol that may leak into an attached IV line due to use of the CapKlenZ was evaluated using as reference the methodology described by Sauron et. al., 2015, "Using isopropyl alcohol impregnated disinfection caps in the neonatal intensive care unit can cause alcohol toxicity" and using a representative selection of different brands of needleless luer access valves in terms of materials and design. Alcohol quantification was measured by gas chromatography, observational data and functional data were performed as well to determine whether the CapKlenZ changed the appearance, and, or, the function of the needleless luer access valve.
Table 5.8.4 describes a summary of the Alcohol in the fluid path testing.
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| Circuit Type | Temperature | Isopropyl alcohol<br>dosage mean<br>(mmol/L) | Visual<br>Inspection | Functional<br>Inspection |
|------------------|-------------|----------------------------------------------|----------------------|--------------------------|
| Active Circuits | 23°C | 0.00748 | Pass | Pass |
| | 35°C | 0.00780 | Pass | Pass |
| Passive Circuits | 23°C | Not Applicable | Pass | Pass |
Table 5.8.4 Alcohol in the fluid path testing performed on CapKlenZ
### 8.5 -Discussion
The performance testing results demonstrated that the subject device is capable to perform as the predicate device for the intended use. The differences in diameter, height, reservoir, internal membrane, and absorbent material of the subject device compared to the predicate device were evaluated by conducting performance testing per ISO 594-2 and antimicrobial efficacy testing.
### 9 - Biocompatibility Testing
The CapKlenZ is classified as an "externally communicating device, blood path indirect, prolonged duration". Biocompatibility testing was performed in accordance with ISO 10993 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process'' (2009).
Table 5.9 below describes the testing performed to determine the biocompatibility.
| Biological Effect | Test | Compliance Standard |
|--------------------------------------------|-----------------------------------------------------------------------|---------------------|
| Cytotoxicity | L929 MEM Elution | ISO 10993-5 |
| Sensitization | Murine Local Lymph Node Assay | ISO 10993-10 |
| Irritation or Intracutaneous<br>Reactivity | Intracutaneous Injection Assay | ISO 10993-10 |
| Acute Systemic Toxicity | Acute Systemic Injection Assay | ISO 10993-11 |
| Pyrogenicity | Material-Mediated Rabbit-Pyrogen<br>Bacterial endotoxin testing (LAL) | ISO 10993-11 |
| Hemocompatibility | Hemolysis (Indirect) in Rabbit Blood<br>(ASTM Method) | ISO 10993-4 |
| Subacute/Subchronic Toxicity | Subchronic IV Toxicity in mice<br>Subacute IP Toxicity in mice | ISO 10993-11 |
| Particulate Matters in Injections | Particulate Matters in Injections | USP <788> |
#### Table 5.9 Biocompatibility Testing
## 10 - Sterilization Testing Summary
CapKlenZ is sterilized using a validated Gamma sterilization process which complies with ANSI/AAMI/ISO 1137-1:2006/(R) 2015&A1:2013 Sterilization of health care products -Radiation - Part 1: Requirements for development validation, and routine control of a sterilization process for medical devices, ANSI/AAMI/ISO 11137-2:2013 Sterilization of health care products - Radiation Part 2: Establishing the sterilization dose, and ANSI/AAMI/ISO 11137:2006 (R) 2010. Sterilization of health care products- Radiation
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Part 3: Guidance on dosimetric aspects. Packaging ensures that the fluid path contacting components are delivered sterile.
Table 5.10 below provides a summary of the sterilization performed on CapKlenZ.
#### Table 5.10 Sterilization Testing
| Validation<br>Sterilization Process | Sterility Assurance Level<br>(SAL) | Validation<br>Result |
|-------------------------------------|------------------------------------|----------------------|
| Gamma Radiation | 10⁻⁶ | Pass |
### 11 – Conclusion
The modifications to the design, dimensions, and materials of the subject device met the performance requirements. The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness.
The CapKlenZ is substantially equivalent to the DualCap Solo™ cleared under K123065 in intended use, target population, treatment method, use environment, and technological characteristics.
