ACTIV™ Cap

K223914 · Cleansite Medical, Inc. · QBP · Apr 5, 2024 · General Hospital

Device Facts

• Record ID: K223914
• Device Name: ACTIV™ Cap
• Applicant: Cleansite Medical, Inc.
• Product Code: QBP · General Hospital
• Decision Date: Apr 5, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Pediatric

Intended 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.

Device Story

Sterile, single-use device for needleless vascular access ports; consists of plastic housing with internal foam substrate moistened with 70% Isopropyl Alcohol (IPA). Device functions as active disinfectant (1-minute contact time) and passive protective barrier (up to 7 days). Features compression-based locking mechanism (pinching) to prevent unintentional removal; allows independent rotation of outer housing for cleaning without compression. Used in hospital settings by clinicians. Benefits include reduced risk of contamination at access site and mitigation of accidental detachment/choking hazards. Packaged on card hangers for IV pole mounting.

Clinical Evidence

Bench testing only. Evaluated biocompatibility (ISO 10933-1), sterilization (ISO 11137-2), packaging integrity (ASTM F1886, F2096, F88), and mechanical performance (ISO 80369-7). Microbial inactivation testing demonstrated >5-log reduction against 6 organisms (S. aureus, S. epidermidis, E. coli, P. aeruginosa, C. glabrata, C. albicans) at 1-minute and 7-day intervals. IPA ingress testing confirmed dosage below neonatal critical concentration.

Technological Characteristics

Materials: HDPE/EVA molded cap, polyurethane foam. Energy: Passive chemical disinfection (70% IPA). Dimensions: 0.54" length, 0.61" diameter. Connectivity: None. Sterilization: Gamma irradiation (SAL 10^-6). Standards: ISO 10933-1, ISO 11137-2, ASTM D4169, ASTM D4322, ANSI/AAMI ST72, USP <788>, ISO 80369-7.

Indications for Use

Indicated for use on needleless vascular access ports in hospital settings as an active cleaning/disinfecting device prior to IV access and as a passive protective barrier for up to 7 days.

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

• Curos Port Protector (K111992)

Submission Summary (Full Text)

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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).

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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 ([e-mail]) or phone [phone] 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,

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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) 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) | <span style="font-family: DejaVu Sans, sans-serif;">✖</span> |
|----------------------------------------------|--------------------------------------------------------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | <span>☐</span> |

> Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

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# K223914 - 510(K) SUMMARY

### Submitter Information

| Company Name: | Cleansite Medical, Inc. |
|-----------------------|-------------------------------------------------------------------------------------------|
| Company Address: | 125 Highway 101<br>Solana Beach, CA 92075 |
| Company Phone: | 858.735.7090 |
| Primary Contact: | Neal Hartman<br>Director, Regulatory Affairs/Quality Assurance<br>[e-mail] |
| Secondary Contact: | Dan Chambers<br>CEO<br>[e-mail] |
| 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<br>Code | 510(K)<br>Number | Clearance<br>Date |
|-------------------------|----------------------------------------|-----------------|------------------|-------------------|
| Curos Port<br>Protector | Cap, Device Disinfectant/ Unclassified | QBP | K111992 | 1/12/2012 |

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#### 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<br>Feature | Subject Device | Predicate Device | Comparison |
|-------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device name | ACTIV™ Cap | Curos Port Protector | |
| Manufacturer | CleanSite Medical, Inc. | Ivera Medical (3M) | |
| Comparison<br>Feature | Subject Device | Predicate Device | Comparison |
| Indications<br>for Use | ACTIV Cap is intended for use on<br>a needleless vascular access port<br>as an active cleaning and<br>disinfecting device prior to<br>IV access and to act as a<br>passive, protective barrier for up<br>to 7 days if not removed. ACTIV<br>Cap disinfects needleless<br>vascular access ports in one (1)<br>minute after application and<br>achieves at least a >5-log<br>reduction as tested in vitro<br>against 6 organisms -<br>Staphylococcus aureus,<br>Staphylococcus epidermis,<br>Escherichia coli, Pseudomonas<br>aeruginosa, Candida glabrata,<br>and Candida albicans. | The Curos is intended for use on<br>swab-able luer access valves as a<br>disinfecting cleaner prior to line<br>access and to act as a physical<br>barrier to<br>contamination between line<br>accesses. Curos will disinfect the<br>valve three (3) minutes after<br>application and act as a physical<br>barrier to contamination for up to<br>seven<br>(7) days (168 hours) if not<br>removed. The effectiveness of<br>Curos Protectors were tested in<br>vitro against Staphylococcus<br>aureus, Staphylococcus<br>epidermidis, Escherichia coli and<br>Pseudomonas aeruginosa,<br>Candida glabrata, Candida<br>albicans and was found to have<br>>4 log reduction. The Curos Port<br>Protector may be used in the<br>home or healthcare facility. | The Subject Device's microbial<br>inactivation results demonstrate<br>higher levels of effectiveness in<br>the reduction of<br>microorganisms than the<br>Predicate with contact to the<br>disinfectant only. |
| Connection<br>Site | Needleless Access Ports | Needleless Access Ports | No Difference |
| Cap Materials | Molded Cap: HDPE/EVA Molded<br>Insert: HDPE Foam:<br>Polyurethane | Molded Cap: HDPE Molded<br>Insert: HDPE Foam: Polyurethane | The Subject Device is a blend of<br>two (2) materials for the molded<br>cap versus the Predicate.<br>Biocompatibility evaluations were<br>conducted that demonstrate the<br>biological safety of the Subject<br>Device. |
| Disinfectant<br>- Active<br>Ingredient | 70% Isopropyl Alcohol | 70% Isopropyl Alcohol | No Difference |
| Minimum<br>Disinfectant<br>Time | One (1) Minute | Three (3) Minutes | The Subject Device's microbial<br>inactivation results demonstrate<br>the indicated minimum<br>disinfectant time meets the<br>acceptance criteria. The shorter<br>disinfection time does not affect<br>the safety or effectiveness of the<br>Subject Device compared to the<br>Predicate. |
| Maximum<br>Disinfectant<br>Time | Seven (7) Days | Seven (7) Days | No Difference |
| Disinfectant<br>Delivery | IPA Reservoir (via foam sponge<br>compression) | IPA Reservoir (via foam sponge<br>compression | No Difference |
| Cap Length | 0.54 inches | 0.36 Inches | Minor increase in length. Does<br>not impact intended use. |
| Cap Diameter | 0.61 inches | 0.54 inches | Minor increase in diameter. Does<br>not impact intended use. |
| Comparison<br>Feature | Subject Device | Predicate Device | Comparison |
| Requires<br>compression<br>(Squeezing)<br>during<br>installation/<br>removal? | Yes | No | The Subject Device has a<br>cleaning feature that also reduces<br>the risk of unintended device<br>removal by requiring compression<br>force (i.e., pinching) on the cap's<br>side to attach and remove the<br>Subject Device from a needleless<br>vascular access port. Without<br>compression, a user can rotate<br>the cap's outer housing<br>independently of its inner housing<br>and the access port to which it is<br>attached.<br>The requirement to compress the<br>Subject Device versus the<br>predicate adds additional level of<br>safety/efficacy from unintentional<br>detachment from the needleless<br>access port, where contamination<br>to the access site could occur or<br>choke hazard from ingesting the<br>disinfecting cap that is a specific<br>concern with pediatrics.<br>If the Subject Device is not able to<br>be removed from needleless<br>access port, it could delay<br>treatment at that access site.<br>Usability studies were conducted<br>that demonstrated users can<br>adequately remove the Subject<br>Device from needleless access<br>ports. |
| Provided Sterile | Yes | Yes | No Difference |
| Single Use<br>Device | Yes | Yes | No Difference |
| Plastic<br>Housing to<br>remain in<br>place | Yes | Yes | No Difference |
| User Population | Hospital Use | Home and Hospital Use | Use environment was limited to<br>healthcare facilities. Efficacy and<br>performance are not impacted. |
| Shelf-Life | 6-Months | 2-Years | Currently, the Predicate has a<br>longer demonstrated shelf-life.<br>The shelf-life of the Subject<br>Device will be increased when<br>successful stability testing is<br>completed. Safety and efficacy<br>will be confirmed during<br>subsequent stability assessments. |

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# Summary of Testing Performed

| Test<br>Interval | Evaluation | Performance<br>Standard | Results |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| T=0 | Biocompatibility - Externally<br>Communicating Medical Device,<br>Indirect Blood Path<br>- Cytotoxicity<br>- Sensitization<br>- Intracutaneous Reactivity<br>- Material Medicated Pyrogen<br>- Systemic toxicity<br>- Hemocompatibility<br>- Leachables/Extractables | ISO 10933-1 (FDA<br>No. 2-258) | Acceptable<br>- Not considered to have a<br>cytotoxic effect.<br>- Did not elicit sensitization<br>reactions.<br>- No irritation was observed.<br>- Non-pyrogenic<br>- No acute systemic toxicity was<br>observed.<br>- Non-hemolytic<br>- The organic/inorganic<br>constituents detected in the<br>Subject Device do not pose<br>significant systemic risks to the<br>patient. |
| T=0 | Sterilization Validation (Gamma,<br>VDmax25) | ISO-11137-2 (FDA<br>No. 14-409) | Acceptable<br>- SAL 10-6<br>- Bioburden: 21-35 CFUs<br>- Product Sterility: No positives |
| T=0 | Transportation Challenger | ASTM D4169 (FDA<br>No. 14-499)<br>ASTM D4322 (FDA<br>No. 5-99). | Acceptable<br>- No Damage to the device or its<br>sterile barrier. |
| T=0 | Endotoxin | ANSI/AAMI ST72<br>(FDA No. 14-541) | Acceptable<br>- <0.0215 EU/device |
| T=0 | Particulates | USP <788> | Acceptable<br>- Met all acceptance criteria with<br>regard to subvisible particulates<br>greater than 10 microns |
| T=0 | Torque to Needleless Access Port | N/A | Reference Only<br>- Comparable to predicate device |
| T=0 | IPA Ingress | N/A | Acceptable<br>- The results show that the<br>average IPA dosages were<br>below the 14 mmol/L ("mM")<br>"critical concentration"<br>calculated for neonatal patients<br>in the Sauron article |
| T=0<br>T=6<br>Months | Packaging Integrity<br>- Visual Inspection<br>- Bubble Emission<br>- Seal Peel Strength | ASTM<br>F1886/F1886M<br>(FDA No. 14-501)<br>ASTM F2096 (FDA<br>No. 14-482)<br>ASTM F88/F88M<br>(FDA No. 14-482 | Acceptable<br>- No visual defects observed.<br>- No air leak at test pressure<br>- Seal strength >1.0 lbs.. |
| Test<br>Interval | Evaluation | Performance<br>Standard | Results |
| T=0<br>T=6<br>Months | Functionality/Needleless Connector<br>Displacement | N/A | Acceptable<br>- None of the devices installed on<br>each needleless valve type<br>were observed with a leak<br>when submerge in water. |
| T=0<br>T=6<br>Months | Resistance to Separation from Axial<br>Load | ISO 80369-7 (FDA<br>No. 5-133) | Acceptable<br>- None of the devices separated<br>below the minimum<br>specification of 7.86 lb. |
| T=0<br>T=6<br>Months | Microbial Inactivation - Evaluated<br>against the following microorganism:<br>S. aureus, S. epidermidis, E. coli, P.<br>aeruginosa, C. albicans, and C.<br>glabrata | N/A | Acceptable<br>- At 1-minute and 7-day contact<br>exposure minimum of 5 log<br>reduction achieved at a 99.9%<br>confidence level. |

Assessments were performed that include the following:

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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.