(463 days)
Not Found
No
The device is a physical cap with a disinfectant. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is described as an active cleaning and disinfecting device for needleless vascular access ports, intended to reduce the risk of infection by disinfecting the port and acting as a protective barrier. It prevents infection, but does not treat a disease once it occurs.
No
Explanation: The device is intended for cleaning and disinfecting needleless vascular access ports and acting as a protective barrier. It does not perform any diagnostic functions like detecting or identifying a medical condition.
No
The device description clearly outlines a physical device made of plastic and foam, containing a liquid disinfectant (70% Isopropyl Alcohol). It is a sterile, single-use device with mechanical features for attachment and removal. This is a hardware device with a chemical component, not a software-only device.
Based on the provided information, the ACTIV Cap is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for cleaning and disinfecting a needleless vascular access port prior to IV access and acting as a protective barrier. This is a direct action on a medical device (the port) and not on a biological sample taken from the body.
- Device Description: The description details a physical device with a disinfectant (IPA) that is applied to the external surface of the access port. It does not involve analyzing or testing any biological material.
- Performance Studies: The performance studies focus on the device's ability to disinfect the port (microbial inactivation), maintain sterility, and function mechanically. There are no studies related to analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The description does not mention any components or processes typically associated with IVDs, such as reagents, assays, sample collection, or analysis of biological markers.
In summary, the ACTIV Cap is a device designed to maintain the cleanliness and reduce the risk of infection at a vascular access port, which is a medical device used for administering fluids or medications. It does not perform any diagnostic testing on biological samples.
N/A
Intended Use / Indications for Use
ACTIV Cap is intended for use on a needleless vascular access port as an active cleaning and disinfecting device prior to IV access and to act as a passive, protective barrier for up to 7 days if not removed. ACTIV Cap disinfects needleless vascular access ports in one (1) minute after application and achieves at least a >5-log reduction as tested in vitro against 6 organisms - Staphylococcus aureus, Staphylococcus epidermis, Escherichia coli, Pseudomonas aeruginosa, Candida glabrata, and Candida albicans.
Product codes (comma separated list FDA assigned to the subject device)
QBP
Device Description
The Subject Device is a sterile, single-use device that is used to clean and disinfect needleless vascular access ports and then act as a cover for the access port between uses. Covering between uses maintains the port's cleanliness. The Subject Device is made of a plastic inner threaded housing snapped into an outer cap and incorporates a foam substrate that protrudes into the central bore of the inner housing and is moistened with the active disinfectant, 70% Isopropyl Alcohol (IPA). The IPA-filled cap is sealed with a poly/foil film to prevent excessive loss of the active ingredient and maintain the sterile barrier.
The Subject Device reduces the risk of unintentional removal by requiring a slight compression force (i.e., pinching) on the cap's side to remove, which force causes the outer housing to engage the inner housing so as to allow the inner and outer housings to be rotated in unison in order to attach and remove the Subject Device from a threaded needleless vascular access port. Without compression, once secured to a needleless vascular access port the Subject Device's outer housing can be rotated in relation to the inner housing and needleless vascular access port to further clean the surface of the access port.
Once the Subject Device is installed on a needless vascular access port, the device passively disinfects the contacting surfaces with the 70% IPA moistened foam.
Ten (10) sealed devices are assembled onto a card hanger that can be hung in an IV pole. Twenty (20) assembled cards are packaged into an inner carton. The instructions for use are printed on the outside on the inner carton. Twenty-four (24) inner cartons are packaged into a corrugated shipper. The packaging shipper is sterilized by gamma irradiation to a Sterility Assurance Level (SAL) of 10-6.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Needleless vascular access port surfaces that the device contacts.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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)
Biocompatibility: Evaluated for Cytotoxicity, Sensitization, Intracutaneous Reactivity, Material Medicated Pyrogen, Systemic toxicity, Hemocompatibility, and Leachables/Extractables. Results: Acceptable - Not considered to have a cytotoxic effect, did not elicit sensitization reactions, no irritation was observed, non-pyrogenic, no acute systemic toxicity was observed, non-hemolytic, and organic/inorganic constituents detected do not pose significant systemic risks.
Sterilization Validation (Gamma, VDmax25): Achieved Acceptable SAL 10-6 with bioburden 21-35 CFUs and no positive product sterility.
Transportation Challenger: Acceptable - No damage to the device or its sterile barrier.
Endotoxin: Acceptable - 1.0 lbs.
Functionality/Needleless Connector Displacement: Acceptable - None of the devices installed on each needleless valve type were observed with a leak when submerged in water.
Resistance to Separation from Axial Load: Acceptable - None of the devices separated below the minimum specification of 7.86 lb.
Microbial Inactivation: Evaluated against S. aureus, S. epidermidis, E. coli, P. aeruginosa, C. albicans, and C. glabrata. Acceptable - At 1-minute and 7-day contact exposure minimum of 5 log reduction achieved at a 99.9% confidence level.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Microbial inactivation: >5-log reduction at 1-minute and 7-day contact exposure, at a 99.9% confidence level.
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
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April 5, 2024
Cleansite Medical, Inc. Neal Hartman VP, Regulatory Affairs/Quality Assurance 125 Highway 101 Solana Beach, California 92075
Re: K223914
Trade/Device Name: ACTIV™ Cap Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular administration set Regulatory Class: Class II Product Code: QBP Dated: April 1, 2024 Received: April 2, 2024
Dear Neal Hartman:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
David Walloschek
David Wolloscheck, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn,
2
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) K223914
Device Name ACTIVTM Cap
Indications for Use (Describe)
ACTIV Cap is intended for use on a needleless vascular access port as an active cleaning and disinfecting device prior to IV access and to act as a passive, protective barrier for up to 7 days if not removed. ACTIV Cap disinfects needleless vascular access ports in one (1) minute after application and achieves at least a >5-log reduction as tested in vitro against 6 organisms - Staphylococcus aureus, Staphylococcus epidermis, Escherichia coli, Pseudomonas aeruginosa, Candida glabrata, and Candida albicans.
| 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) | ☐ |
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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4
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K223914 - 510(K) SUMMARY
Submitter Information
| Company Name: | Cleansite Medical, Inc. |
|---|---|
| Company Address: | 125 Highway 101 |
| Solana Beach, CA 92075 | |
| Company Phone: | 858.735.7090 |
| Primary Contact: | Neal Hartman |
| Director, Regulatory Affairs/Quality Assurance | |
| nealenhartman@gmail.com | |
| Secondary Contact: | Dan Chambers |
| CEO | |
| dan@cleansitemed.com | |
| Date: | April 2, 2024 |
| Device Identification | |
| Device Trade Name: | ACTIV™ Cap |
| Common Name: | Device Disinfectant Cap |
| Common Name: | Device Disinfectant Cap |
|---|---|
| Classification Name(s): | Intravascular administration set |
| Regulation(s): | 21 CFR 880.5440 |
| Device Class: | 2 |
| Product Code(s): | QBP |
| Review Panel: | General Hospital |
ldentification of Predicate Devices
The Subject Device is substantially equivalent to the following legally marketed, predicate device:
| Device Name | Classification Name/Regulation | Product
Code | 510(K)
Number | Clearance
Date |
|-------------------------|----------------------------------------|-----------------|------------------|-------------------|
| Curos Port
Protector | Cap, Device Disinfectant/ Unclassified | QBP | K111992 | 1/12/2012 |
5
Device Description
The Subject Device is a sterile, single-use device that is used to clean and disinfect needleless vascular access ports and then act as a cover for the access port between uses. Covering between uses maintains the port's cleanliness. The Subject Device is made of a plastic inner threaded housing snapped into an outer cap and incorporates a foam substrate that protrudes into the central bore of the inner housing and is moistened with the active disinfectant, 70% Isopropyl Alcohol (IPA). The IPA-filled cap is sealed with a poly/foil film to prevent excessive loss of the active ingredient and maintain the sterile barrier.
The Subject Device reduces the risk of unintentional removal by requiring a slight compression force (i.e., pinching) on the cap's side to remove, which force causes the outer housing to engage the inner housing so as to allow the inner and outer housings to be rotated in unison in order to attach and remove the Subject Device from a threaded needleless vascular access port. Without compression, once secured to a needleless vascular access port the Subject Device's outer housing can be rotated in relation to the inner housing and needleless vascular access port to further clean the surface of the access port.
Once the Subject Device is installed on a needless vascular access port, the device passively disinfects the contacting surfaces with the 70% IPA moistened foam.
Ten (10) sealed devices are assembled onto a card hanger that can be hung in an IV pole. Twenty (20) assembled cards are packaged into an inner carton. The instructions for use are printed on the outside on the inner carton. Twenty-four (24) inner cartons are packaged into a corrugated shipper. The packaging shipper is sterilized by gamma irradiation to a Sterility Assurance Level (SAL) of 10-6.
Indications for Use
ACTIV Cap is intended for use on a needleless vascular access port as an active cleaning and disinfecting device prior to IV access and to act as a passive, protective barrier for up to 7 days if not removed. ACTIV Cap disinfects needleless vascular access ports in one (1) minute after application and achieves at least a >5-log reduction as tested in vitro against 6 organisms - Staphylococcus aureus, Staphylococcus epidermis. Escherichia coli, Pseudomonas aeruqinosa, Candida glabrata, and Candida albicans.
Comparison of Technological Characteristics with Predicate Device
| Comparison
| Feature | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| Device name | ACTIV™ Cap | Curos Port Protector | |
| Manufacturer | CleanSite Medical, Inc. | Ivera Medical (3M) | |
| Comparison | |||
| Feature | Subject Device | Predicate Device | Comparison |
| Indications | |||
| for Use | ACTIV Cap is intended for use on | ||
| a needleless vascular access port | |||
| as an active cleaning and | |||
| disinfecting device prior to | |||
| IV access and to act as a | |||
| passive, protective barrier for up | |||
| to 7 days if not removed. ACTIV | |||
| Cap disinfects needleless | |||
| vascular access ports in one (1) | |||
| minute after application and | |||
| achieves at least a >5-log | |||
| reduction as tested in vitro | |||
| against 6 organisms - | |||
| Staphylococcus aureus, | |||
| Staphylococcus epidermis, | |||
| Escherichia coli, Pseudomonas | |||
| aeruginosa, Candida glabrata, | |||
| and Candida albicans. | 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 as 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 | |||
| epidermidis, Escherichia coli and | |||
| Pseudomonas aeruginosa, | |||
| Candida glabrata, Candida | |||
| albicans and was found to have |
4 log reduction. The Curos Port
Protector may be used in the
home or healthcare facility. | The Subject Device's microbial
inactivation results demonstrate
higher levels of effectiveness in
the reduction of
microorganisms than the
Predicate with contact to the
disinfectant only. |
| Connection
Site | Needleless Access Ports | Needleless Access Ports | No Difference |
| Cap Materials | Molded Cap: HDPE/EVA Molded
Insert: HDPE Foam:
Polyurethane | Molded Cap: HDPE Molded
Insert: HDPE Foam: Polyurethane | The Subject Device is a blend of
two (2) materials for the molded
cap versus the Predicate.
Biocompatibility evaluations were
conducted that demonstrate the
biological safety of the Subject
Device. |
| Disinfectant
- Active
Ingredient | 70% Isopropyl Alcohol | 70% Isopropyl Alcohol | No Difference |
| Minimum
Disinfectant
Time | One (1) Minute | Three (3) Minutes | The Subject Device's microbial
inactivation results demonstrate
the indicated minimum
disinfectant time meets the
acceptance criteria. The shorter
disinfection time does not affect
the safety or effectiveness of the
Subject Device compared to the
Predicate. |
| Maximum
Disinfectant
Time | Seven (7) Days | Seven (7) Days | No Difference |
| Disinfectant
Delivery | IPA Reservoir (via foam sponge
compression) | IPA Reservoir (via foam sponge
compression | No Difference |
| Cap Length | 0.54 inches | 0.36 Inches | Minor increase in length. Does
not impact intended use. |
| Cap Diameter | 0.61 inches | 0.54 inches | Minor increase in diameter. Does
not impact intended use. |
| Comparison
Feature | Subject Device | Predicate Device | Comparison |
| Requires
compression
(Squeezing)
during
installation/
removal? | Yes | No | The Subject Device has a
cleaning feature that also reduces
the risk of unintended device
removal by requiring compression
force (i.e., pinching) on the cap's
side to attach and remove the
Subject Device from a needleless
vascular access port. Without
compression, a user can rotate
the cap's outer housing
independently of its inner housing
and the access port to which it is
attached.
The requirement to compress the
Subject Device versus the
predicate adds additional level of
safety/efficacy from unintentional
detachment from the needleless
access port, where contamination
to the access site could occur or
choke hazard from ingesting the
disinfecting cap that is a specific
concern with pediatrics.
If the Subject Device is not able to
be removed from needleless
access port, it could delay
treatment at that access site.
Usability studies were conducted
that demonstrated users can
adequately remove the Subject
Device from needleless access
ports. |
| Provided Sterile | Yes | Yes | No Difference |
| Single Use
Device | Yes | Yes | No Difference |
| Plastic
Housing to
remain in
place | Yes | Yes | No Difference |
| User Population | Hospital Use | Home and Hospital Use | Use environment was limited to
healthcare facilities. Efficacy and
performance are not impacted. |
| Shelf-Life | 6-Months | 2-Years | Currently, the Predicate has a
longer demonstrated shelf-life.
The shelf-life of the Subject
Device will be increased when
successful stability testing is
completed. Safety and efficacy
will be confirmed during
subsequent stability assessments. |
6
7
8
Summary of Testing Performed
| Test
Interval | Evaluation | Performance
Standard | Results |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| T=0 | Biocompatibility - Externally
Communicating Medical Device,
Indirect Blood Path
- Cytotoxicity
- Sensitization
- Intracutaneous Reactivity
- Material Medicated Pyrogen
- Systemic toxicity
- Hemocompatibility
- Leachables/Extractables | ISO 10933-1 (FDA
No. 2-258) | Acceptable - Not considered to have a
cytotoxic effect. - Did not elicit sensitization
reactions. - No irritation was observed.
- Non-pyrogenic
- No acute systemic toxicity was
observed. - Non-hemolytic
- The organic/inorganic
constituents detected in the
Subject Device do not pose
significant systemic risks to the
patient. |
| T=0 | Sterilization Validation (Gamma,
VDmax25) | ISO-11137-2 (FDA
No. 14-409) | Acceptable - SAL 10-6
- Bioburden: 21-35 CFUs
- Product Sterility: No positives |
| T=0 | Transportation Challenger | ASTM D4169 (FDA
No. 14-499)
ASTM D4322 (FDA
No. 5-99). | Acceptable - No Damage to the device or its
sterile barrier. |
| T=0 | Endotoxin | ANSI/AAMI ST72
(FDA No. 14-541) | Acceptable -
| Acceptable - Met all acceptance criteria with
regard to subvisible particulates
greater than 10 microns |
| T=0 | Torque to Needleless Access Port | N/A | Reference Only - Comparable to predicate device |
| T=0 | IPA Ingress | N/A | Acceptable - The results show that the
average IPA dosages were
below the 14 mmol/L ("mM")
"critical concentration"
calculated for neonatal patients
in the Sauron article |
| T=0
T=6
Months | Packaging Integrity - Visual Inspection
- Bubble Emission
- Seal Peel Strength | ASTM
F1886/F1886M
(FDA No. 14-501)
ASTM F2096 (FDA
No. 14-482)
ASTM F88/F88M
(FDA No. 14-482 | Acceptable - No visual defects observed.
- No air leak at test pressure
- Seal strength >1.0 lbs.. |
| Test
Interval | Evaluation | Performance
Standard | Results |
| T=0
T=6
Months | Functionality/Needleless Connector
Displacement | N/A | Acceptable - None of the devices installed on
each needleless valve type
were observed with a leak
when submerge in water. |
| T=0
T=6
Months | Resistance to Separation from Axial
Load | ISO 80369-7 (FDA
No. 5-133) | Acceptable - None of the devices separated
below the minimum
specification of 7.86 lb. |
| T=0
T=6
Months | Microbial Inactivation - Evaluated
against the following microorganism:
S. aureus, S. epidermidis, E. coli, P.
aeruginosa, C. albicans, and C.
glabrata | N/A | Acceptable - At 1-minute and 7-day contact
exposure minimum of 5 log
reduction achieved at a 99.9%
confidence level. |
Assessments were performed that include the following:
9
Results of the evaluations demonstrate that the Subject Device meets the safety and performance requirements as it relates to its indication for use.
Conclusions Drawn from Nonclinical Evaluation
The results of the evaluation demonstrate that the Subject Device is substantially equivalent to the Predicate as it pertains to the indications for use and device performance.