(234 days)
Not Found
No
The device description and performance studies focus on mechanical and chemical disinfection, with no mention of AI or ML.
No.
The device is intended to disinfect medical equipment (needleless luer access valves) rather than to treat a disease/condition or affect the structure/function of the body.
No
The device is described as disinfecting and providing a physical barrier to contamination for medical equipment, specifically needleless luer access valves. It does not state that it is used to diagnose or detect any medical conditions or diseases.
No
The device description clearly outlines physical components made of polyethylene, elastomer, and a laminated composite, containing an absorbent material and 70% isopropyl alcohol. This indicates a hardware-based device, not software-only.
Based on the provided information, the CapKlenZ device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to disinfect and provide a physical barrier to contamination for needleless luer access valves. This is a direct action on a medical device used in patient care, not a test performed on a sample taken from the human body.
- Device Description: The device contains an absorbent material and 70% isopropyl alcohol, which are used for disinfection. It physically attaches to a luer access valve. This aligns with a device used for disinfection and barrier protection, not for analyzing a biological sample.
- Performance Studies: The performance studies focus on antimicrobial efficacy (killing microorganisms) and microbial barrier testing (preventing microorganisms from entering). These are relevant to disinfection and barrier function, not to diagnostic testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
Therefore, the CapKlenZ is a device intended for disinfection and barrier protection of medical equipment, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
QBP
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.
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 hospital use
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)
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.
Performance Testing:
Bench testing performed on CapKlenZ on baseline (T=0) and aged devices (T=2 years) including:
- Dimensional, physical and functional attributes (Internal Test Method) - Pass
- Disassembly Force (Internal Test Method) - Pass
- Air Leakage (Internal Test Method) - Pass
- Liquid Leakage (Internal Test Method) - Pass
- Packaging Integrity (Seal Peel Strength) (ASTM F88/88M-15) - Pass
- Packaging Integrity (Bubble Test) (ASTM F2096-11) - Pass
- Unscrewing Torque (ISO 594-2) - Pass
- Ease of Assembly (ISO 594-2) - Pass
- Resistance to Overriding (ISO 594-2) - Pass
- Stress Cracking (ISO 594-2) - Pass
- Shipping and Transit (ISTA 3A) - Pass
Antimicrobial Efficacy Testing:
Non-clinical performance test data demonstrating a bacteria count reduction of ≥ 4 log for 2 selected gram positive bacteria (Staphylococcus aureus, Staphylococcus epidermis), 2 selected gram negative bacteria (Escherichia coli, Pseudomonas aeruginosa), and 3 selected fungus/yeast micro-organisms (Candida albicans, Candida glabrata, Candida auris) for 3 time points: 3 minutes, 5 minutes, and 60 minutes (1 hour). All organisms passed the ≥ 4 log reduction criteria at all time points for both T=0 and T=2 years.
Microbial Barrier Testing:
Demonstrated that the CapKlenZ acts as a physical barrier for microbial ingress under worst-case conditions using an external bioaerosol of Pseudomonas aeruginosa. Tested at 1 hour, 24 hours, and 168 hours for both T=0 and T=2 years, resulting in 0% Microbial Ingress (Pass).
Alcohol in the fluid path Testing:
Evaluated the amount of alcohol that may leak into an attached IV line. Alcohol quantification was measured by gas chromatography. Observational and functional data were performed to determine whether CapKlenZ changed the appearance and/or function of the needleless luer access valve.
- Active Circuits (23°C): Isopropyl alcohol dosage mean 0.00748 mmol/L, Visual Inspection: Pass, Functional Inspection: Pass
- Active Circuits (35°C): Isopropyl alcohol dosage mean 0.00780 mmol/L, Visual Inspection: Pass, Functional Inspection: Pass
- Passive Circuits (23°C): Not Applicable, Visual Inspection: Pass, Functional Inspection: Pass
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Bacteria count reduction of ≥ 4 log.
0% Microbial Ingress.
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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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
2
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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3
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.
4
| Trade Name | Commercial
Model Number | Diameter | Height | Antimicrobial agent | Color |
|------------|----------------------------|------------------------|------------------------|-----------------------|-------|
| CapKlenZ | CK-MPF10-200 | 17.1 mm
(0.67 inch) | 11.2 mm
(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 | |
| Solo™ disinfects needleless luer access valves; | |
| thereafter the caps provide a physical barrier to | |
| contamination up to ninety-six (96) hours under | |
| normal conditions if not removed. | 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. |
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.
5
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
Characteristics
/ Principle of
Operation | CapKlenZ
Subject device | DualCap Solo™
510(k) number
K123065
Predicate device | Discussion |
|-------------------------------------------------------------|-------------------------------------------------------------------------------------|-----------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Diameter | 17.1 mm (0.67 inch) ±
0.2 mm (0.007 inch) | 11.0 mm (0.43 inch) | The difference in dimension
between the predicate device and
the subject device was evaluated per
ISO 594-2, Dimensional, physical
and functional attributes test. |
| Height | 11.2 mm (0.44 inch) ±
0.2 mm (0.007 inch) | 20.9 mm (0.82 inch) | The difference in dimension
between the predicate device and
the subject device was evaluated per
ISO 594-2, Dimensional, physical
and functional attributes test. |
| Reservoir
Material | Polyethylene | Polypropylene | The difference in material between
the predicate device and the subject
device was evaluated
per ISO 10993-1. |
| Internal
Membrane | Non-DEHP, non-latex
elastomer | Not Applicable | The difference in material and
design characteristic between the
predicate device and the subject
device was evaluated per ISO 594-
2, Dimensional, physical and
functional attributes test, and ISO
10993-1. |
| Absorbent
Material | Polyethylene | Unknown | The difference in material between
the predicate device and the subject
device was evaluated
per ISO 10993-1. |
| Antimicrobial
agent | 70% Isopropyl Alcohol | 70% Isopropyl Alcohol | No Difference |
| Site Use | Needleless Luer Access
Valves | Needleless Luer Access
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
contain natural rubber
latex or
Diethylhexylphthalate | This device is NOT
made with Natural
Rubber Latex.
DEHP Free | No Difference |
| Table 5.7 Comparison of the CapKlenZ and the Predicate Device | ||
|---|---|---|
6
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
or Internal Test
Method | Test Results | |
|--------|----------------------------------------------------|---------------------------------------------------|--------------|------|
| 1 | Dimensional, physical and functional
attributes | Internal Test Method | T=0
T=2 | Pass |
| 2 | Disassembly Force | Internal Test Method | T=0
T=2 | Pass |
| 3 | Air Leakage | Internal Test Method | T=0
T=2 | Pass |
| 4 | Liquid Leakage | Internal Test Method | T=0
T=2 | Pass |
| 5 | Packaging Integrity (Seal Peel Strength) | ASTM F88/88M-15 | T=0
T=2 | Pass |
| 6 | Packaging Integrity (Bubble Test) | ASTM F2096-11 | T=0
T=2 | Pass |
| 7 | Unscrewing Torque | ISO 594-2 | T=0
T=2 | Pass |
| 8 | Ease of Assembly | ISO 594-2 | T=0
T=2 | Pass |
| 9 | Resistance to Overriding | ISO 594-2 | T=0
T=2 | Pass |
| 10 | Stress Cracking | ISO 594-2 | T=0
T=2 | Pass |
| 11 | Shipping and Transit | ISTA 3A | T=0
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).
7
| | | Acceptance
Criteria
(bacterial count
reduction ( $\Delta$ Log)) | Time point exposure (bacterial
count reduction ( $\Delta$ Log)) | | |
|--------------------------|---------------|--------------------------------------------------------------------------|--------------------------------------------------------------------|--------------|---------------|
| Organism | Description | (bacterial count
reduction ( $\Delta$ Log)) | 3
minutes | 5
minutes | 60
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
Criteria
(% Microbial Ingress) | Time point exposure
(% Microbial Ingress) | | |
|-------------------------------|---------------|-------------------------------------------------|----------------------------------------------|----------|-----------|
| | | | 1 hour | 24 hours | 168 hours |
| Pseudomonas aeruginosa | 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.
8
| Circuit Type | Temperature | Isopropyl alcohol
dosage mean
(mmol/L) | Visual
Inspection | Functional
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 | ||
| Reactivity | Intracutaneous Injection Assay | ISO 10993-10 |
| Acute Systemic Toxicity | Acute Systemic Injection Assay | ISO 10993-11 |
| Pyrogenicity | Material-Mediated Rabbit-Pyrogen | |
| Bacterial endotoxin testing (LAL) | ISO 10993-11 | |
| Hemocompatibility | Hemolysis (Indirect) in Rabbit Blood | |
| (ASTM Method) | ISO 10993-4 | |
| Subacute/Subchronic Toxicity | Subchronic IV Toxicity in mice | |
| Subacute IP Toxicity in mice | ISO 10993-11 | |
| Particulate Matters in Injections | Particulate Matters in Injections | USP |
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
9
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
Sterilization Process | Sterility Assurance Level
(SAL) | Validation
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.