(463 days)
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 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.
The provided text is a 510(k) summary for the Cleansite Medical ACTIV™ Cap. This document is a premarket notification to the FDA, demonstrating substantial equivalence to a legally marketed predicate device. As such, it primarily focuses on non-clinical testing and comparison to achieve regulatory clearance rather than a comprehensive clinical study to prove device effectiveness in a real-world setting with human subjects.
The document does not describe a study that proves the device meets acceptance criteria in the context of clinical effectiveness or a multi-reader multi-case (MRMC) study. Instead, it details non-clinical (laboratory) performance testing to show substantial equivalence to a predicate device and demonstrate safety and basic function.
Therefore, the following information cannot be extracted from the provided text:
- Sample size used for the test set and data provenance (retrospective or prospective): The document refers to laboratory tests, not a clinical test set with human data.
- Number of experts used to establish ground truth and qualifications: Ground truth for a clinical study would typically involve medical professionals interpreting patient data, which is not applicable here.
- Adjudication method: Not applicable for non-clinical lab tests.
- Multi-reader multi-case (MRMC) comparative effectiveness study and effect size: This type of study involves human readers, which is not described.
- Standalone (algorithm only) performance: Not applicable as this is a physical medical device, not an AI algorithm.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth, in a clinical sense, is not established or used. The "ground truth" for the non-clinical tests is the established laboratory standard and organism counts.
- Sample size for the training set: Not applicable as this is not an AI/machine learning device requiring a training set.
- How the ground truth for the training set was established: Not applicable.
However, I can provide the acceptance criteria and reported device performance from the "Summary of Testing Performed" table, along with information available about the context of these tests.
Acceptance Criteria and Reported Device Performance (Non-Clinical)
The device's performance is evaluated against various non-clinical standards and internal criteria to demonstrate safety and basic functional equivalence to a predicate device. The "Summary of Testing Performed" table outlines these criteria and the results.
1. Table of Acceptance Criteria and the Reported Device Performance:
| Test Interval | Evaluation Category | Performance Standard / Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| T=0 | Biocompatibility | ISO 10933-1 (FDA No. 2-258) - Absence of cytotoxicity, sensitization, intracutaneous reactivity, material medicated pyrogen, systemic toxicity, hemocompatibility. Constituents should not pose significant systemic risks. | 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- Organic/inorganic constituents detected do not pose significant systemic risks to the patient. |
| T=0 | Sterilization Validation (Gamma, VDmax25) | ISO-11137-2 (FDA No. 14-409) - Sterility Assurance Level (SAL) of 10^-6. | 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). Acceptance: No damage to the device or its sterile barrier. | Acceptable- No Damage to the device or its sterile barrier. |
| T=0 | Endotoxin | ANSI/AAMI ST72 (FDA No. 14-541). Acceptance: Low endotoxin levels. | Acceptable- <0.0215 EU/device |
| T=0 | Particulates | USP <788>. Acceptance: Met all criteria with regard to subvisible particulates greater than 10 microns. | 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. | Reference Only- Comparable to predicate device |
| T=0 | IPA Ingress | N/A - Acceptance: Average IPA dosages below 14 mmol/L ("mM") "critical concentration" calculated for neonatal patients in the Sauron article. | 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 | ASTM F1886/F1886M (FDA No. 14-501), ASTM F2096 (FDA No. 14-482), ASTM F88/F88M (FDA No. 14-482). Acceptance: No visual defects, no air leak at test pressure, seal strength >1.0 lbs. | Acceptable- No visual defects observed.- No air leak at test pressure- Seal strength >1.0 lbs. |
| T=0, T=6 Months | Functionality/Needleless Connector Displacement | N/A - Acceptance: No leaks when submerged in water for devices installed on needleless valve types. | 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). Acceptance: None of the devices separated below the minimum specification of 7.86 lb. | Acceptable- None of the devices separated below the minimum specification of 7.86 lb. |
| T=0, T=6 Months | Microbial Inactivation | N/A - Acceptance: At least a >5-log reduction at 1-minute and 7-day contact exposure, against S. aureus, S. epidermidis, E. coli, P. aeruginosa, C. albicans, and C. glabrata, at a 99.9% confidence level. (This is based on the Indications for Use statement). | Acceptable- At 1-minute and 7-day contact exposure minimum of 5 log reduction achieved at a 99.9% confidence level. |
2. Sample Sized Used for the Test Set and the Data Provenance:
The document describes non-clinical, laboratory-based performance testing rather than a clinical "test set" from patient data. The "sample sizes" for these tests would refer to the number of device units or test replicates used in each specific lab procedure. These specific numbers are not provided in the summary but would be detailed in the full test reports referenced by the standards (e.g., ISO, ASTM, USP).
- Data Provenance: The data comes from in vitro (laboratory) testing performed on the device itself, not from human subjects or clinical settings, therefore it is not retrospective or prospective in the clinical sense. The tests are performed on the device components and assembled units under controlled lab conditions. The "country of origin of the data" is not specified but would typically be associated with the testing labs.
3. Number of Experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable. The "ground truth" for non-clinical performance tests is established by documented industry standards (ISO, ASTM, USP) and the measurable outcomes of the tests (e.g., bacterial log reduction, force measurements, chemical concentration). These tests are performed by qualified lab technicians and scientists, not "experts" in the sense of clinical reviewers establishing diagnostic ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods are relevant for clinical studies that involve expert review of ambiguous or complex patient data. Here, the results are quantitative measurements against defined standards.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a physical medical device (an antiseptic cap for IV ports), not an AI-assisted diagnostic or therapeutic tool that would involve human readers or AI algorithms.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc.):
The "ground truth" for the performance claims (e.g., microbial inactivation) in this context is the measured log reduction of specified microorganisms in in vitro laboratory tests, compared against the predefined acceptance criterion of ">5-log reduction". For other tests, the "ground truth" is adherence to established engineering, material, and sterilization standards (e.g., ISO, ASTM, USP as listed).
8. The sample size for the training set:
Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established:
Not applicable. This is not an AI/machine learning device.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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 (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,
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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) | ✖ |
|---|---|
| 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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Image /page/4/Picture/0 description: The image contains the logo for CleanSite Medical. The word "CleanSite" is in a bold, sans-serif font and is placed on a blue background. Below "CleanSite" is the word "Medical" in a smaller, sans-serif font.
K223914 - 510(K) SUMMARY
Submitter Information
| Company Name: | Cleansite Medical, Inc. |
|---|---|
| Company Address: | 125 Highway 101Solana Beach, CA 92075 |
| Company Phone: | 858.735.7090 |
| Primary Contact: | Neal HartmanDirector, Regulatory Affairs/Quality Assurancenealenhartman@gmail.com |
| Secondary Contact: | Dan ChambersCEOdan@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 | ProductCode | 510(K)Number | ClearanceDate |
|---|---|---|---|---|
| Curos PortProtector | 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
| ComparisonFeature | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| Device name | ACTIV™ Cap | Curos Port Protector | |
| Manufacturer | CleanSite Medical, Inc. | Ivera Medical (3M) | |
| ComparisonFeature | Subject Device | Predicate Device | Comparison |
| Indicationsfor Use | ACTIV Cap is intended for use ona needleless vascular access portas an active cleaning anddisinfecting device prior toIV access and to act as apassive, protective barrier for upto 7 days if not removed. ACTIVCap disinfects needlelessvascular access ports in one (1)minute after application andachieves at least a >5-logreduction as tested in vitroagainst 6 organisms -Staphylococcus aureus,Staphylococcus epidermis,Escherichia coli, Pseudomonasaeruginosa, Candida glabrata,and Candida albicans. | The Curos is intended for use onswab-able luer access valves as adisinfecting cleaner prior to lineaccess and to act as a physicalbarrier tocontamination between lineaccesses. Curos will disinfect thevalve three (3) minutes afterapplication and act as a physicalbarrier to contamination for up toseven(7) days (168 hours) if notremoved. The effectiveness ofCuros Protectors were tested invitro against Staphylococcusaureus, Staphylococcusepidermidis, Escherichia coli andPseudomonas aeruginosa,Candida glabrata, Candidaalbicans and was found to have>4 log reduction. The Curos PortProtector may be used in thehome or healthcare facility. | The Subject Device's microbialinactivation results demonstratehigher levels of effectiveness inthe reduction ofmicroorganisms than thePredicate with contact to thedisinfectant only. |
| ConnectionSite | Needleless Access Ports | Needleless Access Ports | No Difference |
| Cap Materials | Molded Cap: HDPE/EVA MoldedInsert: HDPE Foam:Polyurethane | Molded Cap: HDPE MoldedInsert: HDPE Foam: Polyurethane | The Subject Device is a blend oftwo (2) materials for the moldedcap versus the Predicate.Biocompatibility evaluations wereconducted that demonstrate thebiological safety of the SubjectDevice. |
| Disinfectant- ActiveIngredient | 70% Isopropyl Alcohol | 70% Isopropyl Alcohol | No Difference |
| MinimumDisinfectantTime | One (1) Minute | Three (3) Minutes | The Subject Device's microbialinactivation results demonstratethe indicated minimumdisinfectant time meets theacceptance criteria. The shorterdisinfection time does not affectthe safety or effectiveness of theSubject Device compared to thePredicate. |
| MaximumDisinfectantTime | Seven (7) Days | Seven (7) Days | No Difference |
| DisinfectantDelivery | IPA Reservoir (via foam spongecompression) | IPA Reservoir (via foam spongecompression | No Difference |
| Cap Length | 0.54 inches | 0.36 Inches | Minor increase in length. Doesnot impact intended use. |
| Cap Diameter | 0.61 inches | 0.54 inches | Minor increase in diameter. Doesnot impact intended use. |
| ComparisonFeature | Subject Device | Predicate Device | Comparison |
| Requirescompression(Squeezing)duringinstallation/removal? | Yes | No | The Subject Device has acleaning feature that also reducesthe risk of unintended deviceremoval by requiring compressionforce (i.e., pinching) on the cap'sside to attach and remove theSubject Device from a needlelessvascular access port. Withoutcompression, a user can rotatethe cap's outer housingindependently of its inner housingand the access port to which it isattached.The requirement to compress theSubject Device versus thepredicate adds additional level ofsafety/efficacy from unintentionaldetachment from the needlelessaccess port, where contaminationto the access site could occur orchoke hazard from ingesting thedisinfecting cap that is a specificconcern with pediatrics.If the Subject Device is not able tobe removed from needlelessaccess port, it could delaytreatment at that access site.Usability studies were conductedthat demonstrated users canadequately remove the SubjectDevice from needleless accessports. |
| Provided Sterile | Yes | Yes | No Difference |
| Single UseDevice | Yes | Yes | No Difference |
| PlasticHousing toremain inplace | Yes | Yes | No Difference |
| User Population | Hospital Use | Home and Hospital Use | Use environment was limited tohealthcare facilities. Efficacy andperformance are not impacted. |
| Shelf-Life | 6-Months | 2-Years | Currently, the Predicate has alonger demonstrated shelf-life.The shelf-life of the SubjectDevice will be increased whensuccessful stability testing iscompleted. Safety and efficacywill be confirmed duringsubsequent stability assessments. |
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Summary of Testing Performed
| TestInterval | Evaluation | PerformanceStandard | Results |
|---|---|---|---|
| T=0 | Biocompatibility - ExternallyCommunicating Medical Device,Indirect Blood Path- Cytotoxicity- Sensitization- Intracutaneous Reactivity- Material Medicated Pyrogen- Systemic toxicity- Hemocompatibility- Leachables/Extractables | ISO 10933-1 (FDANo. 2-258) | Acceptable- Not considered to have acytotoxic effect.- Did not elicit sensitizationreactions.- No irritation was observed.- Non-pyrogenic- No acute systemic toxicity wasobserved.- Non-hemolytic- The organic/inorganicconstituents detected in theSubject Device do not posesignificant systemic risks to thepatient. |
| T=0 | Sterilization Validation (Gamma,VDmax25) | ISO-11137-2 (FDANo. 14-409) | Acceptable- SAL 10-6- Bioburden: 21-35 CFUs- Product Sterility: No positives |
| T=0 | Transportation Challenger | ASTM D4169 (FDANo. 14-499)ASTM D4322 (FDANo. 5-99). | Acceptable- No Damage to the device or itssterile barrier. |
| T=0 | Endotoxin | ANSI/AAMI ST72(FDA No. 14-541) | Acceptable- <0.0215 EU/device |
| T=0 | Particulates | USP <788> | Acceptable- Met all acceptance criteria withregard to subvisible particulatesgreater 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 theaverage IPA dosages werebelow the 14 mmol/L ("mM")"critical concentration"calculated for neonatal patientsin the Sauron article |
| T=0T=6Months | Packaging Integrity- Visual Inspection- Bubble Emission- Seal Peel Strength | ASTMF1886/F1886M(FDA No. 14-501)ASTM F2096 (FDANo. 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.. |
| TestInterval | Evaluation | PerformanceStandard | Results |
| T=0T=6Months | Functionality/Needleless ConnectorDisplacement | N/A | Acceptable- None of the devices installed oneach needleless valve typewere observed with a leakwhen submerge in water. |
| T=0T=6Months | Resistance to Separation from AxialLoad | ISO 80369-7 (FDANo. 5-133) | Acceptable- None of the devices separatedbelow the minimumspecification of 7.86 lb. |
| T=0T=6Months | Microbial Inactivation - Evaluatedagainst 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 contactexposure minimum of 5 logreduction achieved at a 99.9%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.
§ 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.