(197 days)
The OnGuard®2 Chemfort™ Closed Administration is a single use, sterile Closed System Transfer Device (CSTD) that mechanically prohibits the release of drugs, including antineoplastic and hazardous drugs, in vapor, aerosol or liquid form during administration, thus minimizing exposure of individuals, healthcare personnel, and the environment to hazardous drugs.
OnGuard®2 Chemfort™ Closed Administration prevents the introduction of microbial and airborne contaminants into the drug or fluid path for up to 7 days.
The OnGuard®2 Chemfort™ Closed Administration (CADM) devices allow drug transfer to the IV bag and drug administration to the patient. The use of elastomeric seals in CADM prevents hazardous drugs contamination of healthcare professionals, the patient and the environment.
The OnGuard®2 Chemfort™ Closed Administration contains four devices that connect between infusion containers and primary sets:
- Bag Adaptor Chemfort™ Port (BACP)
- Closed Y Inline Set (Y-Set)
- Closed IV Secondary Set (Secondary)
- Closed Adaptor Spike Port (CASP)
CADM devices are an addition to the cleared Chemfort™ system (K192866). CADM provides closed system protection during the following procedures:
-
- Drug transfer to a container (e.g. IV bag) through the Chemfort™ Syringe Adaptor (K192866) and CADM Bag Adaptor Chemfort™ Port (BACP).
-
- Drug administration, with one of the CADM sets after it is attached to the BACP and creates a closed system.
The provided text describes the OnGuard®2 Chemfort™ Closed Administration (CADM) device, a single-use, sterile Closed System Transfer Device (CSTD). It focuses on demonstrating its substantial equivalence to a predicate device (K192866) by comparing indications for use, technological characteristics, and performance data.
Here's an analysis of the acceptance criteria and the study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of "acceptance criteria" versus "reported device performance." Instead, it lists the performance tests conducted and states that the device "comply with the following standards and that they function as intended" or "met the USP acceptance criteria," or "All tests passed according to the predetermined acceptance criteria." It implies compliance rather than detailing specific numerical criteria and results for each test.
However, based on the Performance Data and Biocompatibility sections, we can infer the tested areas and the general outcome:
| Category | Test Performed | Reported Device Performance/Acceptance |
|---|---|---|
| General Device Performance | Air & Fluid Tightness | Conducted to evaluate differences in Chemfort™ port location. Implied successful compliance. |
| Bidirectional flow | Conducted to evaluate differences in Chemfort™ port location. Implied successful compliance. | |
| Leakage (ISO 8536-4) | Compliance ensured with ISO 8536-4:2010. | |
| Tensile Strength (ISO 8536-4) | Compliance ensured with ISO 8536-4:2010. | |
| Closure Piercing Device (ISO 8536-4) | Compliance ensured with ISO 8536-4:2010. | |
| Flow Rate (ISO 8536-4) | Compliance ensured with ISO 8536-4:2010. | |
| Tubing, Drip Chamber & Drip Tube, Flow Regulator & Protective Cap (ISO 8536-4) | Compliance ensured with ISO 8536-4:2010. | |
| Positive Pressure Liquid Leakage (ISO 80369-7) | Compliance ensured with ISO 80369-7:2016. | |
| Sub-atmospheric Pressure Air Leakage (ISO 80369-7) | Compliance ensured with ISO 80369-7:2016. | |
| Stress Cracking (ISO 80369-7) | Compliance ensured with ISO 80369-7:2016. | |
| Resistance to Separation from Axial Load (ISO 80369-7) | Compliance ensured with ISO 80369-7:2016. | |
| Resistance to Separation from Unscrewing & Resistance to Overriding (ISO 80369-7) | Compliance ensured with ISO 80369-7:2016. | |
| Particulate Matter | Particulate Matter in Injections (USP <788>) | Met the USP acceptance criteria. |
| Biocompatibility | Cytotoxicity, Sensitization, Irritation/Intracutaneous reactivity, Acute systemic toxicity, Material mediated pyrogenicity, Subacute/subchronic toxicity, Hemolysis (ISO 10993-1) | All parts in contact with patient comply with ISO 10993-1 requirements. Specific tests were conducted. |
| Sterility | Sterility Assurance Level (SAL) | Achieved a SAL of at least 10^-6 through Ethylene Oxide (EtO) gas sterilization, validated by 'overkill' (half cycle) approach. |
| Residuals of Ethylene Oxide (EtO) and Ethylene Chlorhydrine (ECH) | Complied with requirements of ISO 10993-7:2008 for prolonged exposure devices (Category B). | |
| Bacterial Endotoxins Test (LAL) | Less than 20 EU per device for 10 samples (in pool). | |
| Shelf-Life & Packaging | Accelerated Aging (ASTM F1980-16) | Functional and packaging integrity tests passed according to predetermined acceptance criteria after accelerated aging equivalent to 3 years. |
| Package Integrity (ISTA 3A, ASTM F88/F88-15, ASTM F1929-15) | Deemed acceptable for protection of product and sterility maintenance after environmental conditioning and simulated transportation. Passed seal strength and dye penetration tests. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document explicitly mentions a sample size only for the Bacterial Endotoxins Test, where "10 samples (in pool)" were used. For other performance tests and biocompatibility, specific sample sizes are not provided in the summary.
- Data Provenance: The document does not specify the country of origin of the data. It's a regulatory submission from Simplivia Healthcare LTD. located in Israel. The studies appear to be device performance and laboratory tests rather than clinical studies on human subjects, so the "retrospective or prospective" designation is not directly applicable in the typical sense of clinical data. These are prospective engineering and biological tests conducted for regulatory compliance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to the type of studies described. The "ground truth" for these tests (e.g., whether a device leaks, its tensile strength, or if it is cytotoxic) is established by adherence to recognized international standards (ISO, USP, ASTM) and validated laboratory methods, not by expert consensus in interpreting complex data like medical images.
4. Adjudication Method for the Test Set
Not applicable. As noted above, these are objective performance and laboratory tests against predefined standards, not subjective assessments requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document describes laboratory and engineering performance tests of a medical device, not a comparative effectiveness study involving human readers or AI algorithms.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No. This device is a physical medical device (Closed System Transfer Device), not an AI algorithm. Therefore, the concept of "standalone algorithm performance" is not applicable.
7. Type of Ground Truth Used
The ground truth used for these studies is defined by:
- International Standards: e.g., ISO 8536-4, ISO 80369-7, ISO 10993-1, ISO 10993-7, ISO 14971.
- Pharmacopeial Standards: e.g., USP <788>.
- Industry Standards: e.g., ASTM F1980-16, ASTM F88/F88-15, ASTM F1929-15, ISTA 3A.
- Predetermined Acceptance Criteria: The document frequently refers to tests passing "according to the predetermined acceptance criteria," implying established limits or thresholds for each test based on these standards.
8. Sample Size for the Training Set
Not applicable. This document is about a physical medical device, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, there is no AI algorithm training set mentioned.
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Simplivia Healthcare LTD. Shay Shaham VP QA / RA North Industrial Zone Kiryat Shmona, 1101801 Israel
Re: K210707
Trade/Device Name: OnGuard®2 Chemfort™ Closed Administration (CADM) Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: ONB Dated: August 19, 2021 Received: August 24, 2021
Dear Shay Shaham:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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,
For Payal Patel Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices. and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K210707
Device Name OnGuard®2 Chemfort™ Closed Administration (CADM)
Indications for Use (Describe)
The OnGuard®2 Chemfort™ Closed Administration is a single use, sterile Closed System Transfer Device (CSTD) that mechanically prohibits the release of drugs, including antineoplastic and hazardous drugs, in vapor, aerosol or liquid form during administration, thus minimizing exposure of individuals, healthcare personnel, and the environment to hazardous drugs.
OnGuard®2 Chemfort™ Closed Administration prevents the introduction of microbial and airborne contaminants into the drug or fluid path for up to 7 days.
| 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) |
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K210707 510(k) SUMMARY
| Preparation Date: | September 23, 2021 |
|---|---|
| Submitter Name | Simplivia Healthcare LTD.North Industrial ZoneKiryat Shmona, 1101801Israel |
| Contact Person: | Shay ShahamVP QA / RA |
| Telephone Number:E-mail Address:Fax: | (972) 4 6908826Shay.Shaham@simplivia.com(972) 74 7652161 |
| Trade Name: | OnGuard®2 Chemfort™ Closed Administration (CADM) |
| Common Name: | Closed Antineoplastic and Hazardous Drug Reconstitution andTransfer System |
| Regulation Name: | Intravascular Administration Set |
| Regulation Number: | 21CFR 880.5440 |
| Product Code: | ONB |
| Device Class: | Class II |
| Predicate Device: | K192866, Chemfort™ Closed System Transfer Device (CSTD) |
Device Description:
The OnGuard®2 Chemfort™ Closed Administration (CADM) devices allow drug transfer to the IV bag and drug administration to the patient. The use of elastomeric seals in CADM prevents hazardous drugs contamination of healthcare professionals, the patient and the environment.
The OnGuard®2 Chemfort™ Closed Administration contains four devices that connect between infusion containers and primary sets:
- Bag Adaptor Chemfort™ Port (BACP) -
- -Closed Y Inline Set (Y-Set)
- Closed IV Secondary Set (Secondary) -
- Closed Adaptor Spike Port (CASP) -
CADM devices are an addition to the cleared Chemfort™ system (K192866). CADM provides closed system protection during the following procedures:
-
- Drug transfer to a container (e.g. IV bag) through the Chemfort™ Syringe Adaptor (K192866) and CADM Bag Adaptor Chemfort™ Port (BACP).
-
- Drug administration, with one of the CADM sets after it is attached to the BACP and creates a closed system.
The main differences and unique features between the subject device and the predicate:
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- In the Chemfort™ system (K192866) the infusion set's spike is connected to an IV bag via the ● Chemfort™ Bag Adaptor SP's (BASP) tail. This is a one-time connection which remains sealed during the entire administration procedure (and after). The CADM set's Syringe Adaptor component allows the healthcare professional to have the option for safe disconnection of the patient's IV set after the drug was administrated, and then re-connecting it to a new IV bag containing saline or a new drug for administration via a new CADM BACP device, while keeping the closed system.
- The CADM BACP (K210707) device consists of a distal Chemfort™ port which serves as both the ● drug transfer to the IV bag path and the infusion outflow path (drug administration), while the predicate device Chemfort™ BASP (K192866) has a Chemfort™ port for drug transfer and a separate path for drug administration.
Each of the OnGuard®2 Chemfort™ Closed Administration devices are available separately.
| Characteristics | Subject Device- K210707OnGuard®2 Chemfort™ ClosedAdministration (CADM) | Predicate Device- K192866Chemfort™ Closed System TransferDevice (CSTD) | |
|---|---|---|---|
| Indication forUse | The OnGuard®2 Chemfort™ ClosedAdministration is a single use, sterileClosed System Transfer Device (CSTD)that mechanically prohibits the release ofdrugs, including antineoplastic andhazardous drugs, in vapor, aerosol or liquidform during administration, thusminimizing exposure of individuals,healthcare personnel, and the environmentto hazardous drugs.OnGuard®2 Chemfort™ ClosedAdministration prevents the introduction ofmicrobial and airborne contaminants intothe drug or fluid path for up to 7 days. | Chemfort™ is a Closed System TransferDevice (CSTD) that mechanically prohibitsthe release of drugs, includingantineoplastic and hazardous drugs, invapor, aerosol or liquid form duringpreparation, reconstitution, compoundingand administration, thus minimizingexposure of individuals, healthcarepersonnel, and the environment tohazardous drugs.Chemfort™ prevents the introduction ofmicrobial and airborne contaminants intothe drug or fluid path for up to 7 days. | |
| PrescriptionOnly or Overthe Counter | Prescription Only | Prescription Only | |
| Proposed Device- K210707OnGuard®2 Chemfort™Closed Administration | Predicate Device- K192866Chemfort™ Closed SystemTransfer Device (CSTD) | Equivalence topredicate | |
| Indications foruse | The OnGuard®2 Chemfort™Closed Administration is a singleuse, sterile Closed SystemTransfer Device (CSTD) thatmechanically prohibits the releaseof drugs, including antineoplasticand hazardous drugs, in vapor,aerosol or liquid form duringadministration, thus minimizingexposure of individuals,healthcare personnel, and theenvironment to hazardous drugs.OnGuard®2 Chemfort™ ClosedAdministration prevents theintroduction of microbial andairborne contaminants into thedrug or fluid path for up to 7 days. | Chemfort™ is a Closed SystemTransfer Device (CSTD) thatmechanically prohibits therelease of drugs, includingantineoplastic and hazardousdrugs, in vapor, aerosol or liquidform during preparation,reconstitution, compounding andadministration, thus minimizingexposure of individuals,healthcare personnel, and theenvironment to hazardous drugs.Chemfort™ prevents theintroduction of microbial andairborne contaminants into thedrug or fluid path for up to 7days. | Different - thedifference is inthe productnameChemfort™System versusOnGuard®2Chemfort™ClosedAdministrationand an additionof "is a singleuse, sterile" |
| Target users | Pharmacists or other healthcareprofessionals | Pharmacists or other healthcareprofessionals | Same |
| Environment ofuse | Hospitals, compounding centresand clinics | Hospitals, compounding centresand clinics | Same |
| Components | Bag Adaptor Chemfort™ Port(BACP)Closed Y Inline Set (Y Set)Closed Adaptor Spike Port(CASP)Closed Secondary IV Set(Secondary) | Vial Adaptor 20 mm with 13mm Vial ConverterVial Adaptor 28 mmVial Adaptor 32 mmSyringe AdaptorSyringe Adaptor LockLuer Lock AdaptorBag Adaptor SP | Different device(CADM will beadded to theChemfort™System) |
| Spike & bodydesign | The BACP spike itself and the spike body (finger placement) designare based on the Bag Adaptor SP (BASP) design cleared underK192866 | Same | |
| Chemfort™ Portlocation | BACP- the Chemfort™ port islocated in the distal part of thedevice | BASP- the Chemfort™ port islocated in the middle of thedevice | Different - seecomment 1 |
| Drug delivery tobag | Through BACP Chemfort™ port | Through BASP Chemfort™ port | Same |
| Drugadministrationto patient | Through BACP Chemfort™ portand the connected CADM IV set | Through BASP tail, located inthe distal part of the device andthe connected IV set | Different - Seecomment 2 |
| Residual volume | BACP residual volume is <0.01% of 1 L saline bag | BACP residual volume is <0.01% of 1 L saline bag | Same |
| Interaction withother devices | For most uses, the OnGuard®2Chemfort™ Closed Administrationdevices will connect to an IVsolution container and a primary | For most uses, the Vial Adaptorwill connect to a vial, theSyringe Adaptor will connect toa syringe, the Luer LockAdaptor will connect to a | Similarconnections toChemfort™System'sdevices |
| Proposed Device- K210707OnGuard®2 Chemfort™Closed Administration | Predicate Device- K192866Chemfort™ Closed SystemTransfer Device (CSTD) | Equivalence topredicate | |
| administration set. A connectionalso can be made with:- Syringe Adaptor (SA)(K192866)- Syringe Adaptor Lock (SAL)(K192866) | needless injection site, the BagAdaptor SP will connect to anIV solution container and aprimary administration set.A connection also can be madewith- Syringe Adaptor (K192866)- Syringe Adaptor Lock(K192866) | ||
| Re-use capability | All devices can be used up to 10times, but once connected to anon-Chemfort™ device (such asIV bag) they can't bedisconnected | All devices can be used up to 10times, but once connected to anon-Chemfort™ device (such asdrug vial) they can't bedisconnected | Same |
| Principles ofOperation | Multi-component system, devicesare intended to be used as asystem, manually manipulated | Multi-component system,devices are intended to be usedas a system, manuallymanipulated | Same |
| Interaction withpatient | No direct interaction - interactionwith the patient is achieved by thepassage of IV fluids through thecentral tubing of theadministration set | No direct interaction -interaction with the patient isachieved by the passage of IVfluids through the central tubingof the administration set | Same |
| Interconnectingfeatures | Mechanical snap connections | Mechanical snap connections | Same |
| Technology | All of the devices are sealed withresealing septum. When devicesare joined together the twoseptums are pressed and thenpierced by needle (from theChemfort™ system's SA or SALdevice), thus creating a securedfluid path. | All of the devices are sealedwith resealing septum. Whendevices are joined together thetwo septums are pressed andthen pierced by needle (from theChemfort™ system's SA orSAL device), thus creating asecured fluid path. | Same |
| Safety features | Needle tip protectorSeptum to septum contactSpike cap | 0.2 micron venting membraneCharcoal clothNeedle tip protectorSeptum to septum contactSpike cap | Similar-Needle tipprotectorSeptum toseptum contactSpike cap |
| Sterilizationmethod | Ethylene Oxide validated cycleSAL 10-6 | Ethylene Oxide validated cycleSAL 10-6 | Same |
| Biocompatibility | All parts that are in contact withpatient comply with therequirements of ISO 10993-1 | All parts that are in contact withpatient comply with therequirements of ISO 10993-1 | Same |
| Shelf life | 3 years | 3 years | Same |
| Prescription use | Rx only | Rx only | Same |
| Proposed Device- K210707OnGuard®2 Chemfort™Closed Administration | Predicate Device- K192866Chemfort™ Closed SystemTransfer Device (CSTD) | Equivalence topredicate | |
| Meets theNIOSHand ISOPPdefinition of aCSTD | Yes | Yes | Same |
Intended Use / Indications for Use
Discussions of differences in Indications for Use statement
There are only editorial differences to the indications for use statement between the predicate and the subject device which do not change the indications.
Summary of Technological Characteristics
The table below includes a comparison of the technological characteristics between the new device and those of the predicate device:
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Discussions of differences in technological characteristics
-
Comment 1- The physical location of the predicate device's Chemfort™ port is different than that of the proposed device. The port of the Bag Adaptor SP (K192866) is located in the middle of the device body, in the distal part there is a tail to connect to an IV set, whereas in the proposed device, Bag Adaptor CP (K210707), the port is located in the distal part of the device.
Tests conducted to evaluate the difference: air & fluid tightness, bidirectional flow. -
Comment 2- In the predicate device, Bag Adaptor SP (K192866), drug administration is performed by connecting an IV set to the tail, located in the distal part of the device. In the proposed device, Bag Adaptor CP (K210707), the Chemfort™ port also serves for drug administration by connecting one of CADM sets to the port located in the distal part BACP.
Tests conducted to evaluate the difference: tests according to ISO 8536-4, specifically; leakage, tensile strength, and flow rate.
Performance Data
Simplivia Healthcare conducted several performance tests to demonstrate that the OnGuard(®2 Chemfort" Closed Administration devices comply with the following standards and that they function as intended.
- ISO 8536-4:2010, Infusion equipment for medical use -Part 4: Infusion sets for single use, . gravity feed.
- o Tests conducted to ensure compliance with the standard: leakage, tensile strength, closure piercing device, flow rate, tubing, drip chamber & drip tube, flow regulator & protective сар.
- ISO 80369-7:2016, Small-bore connectors for liquids and gases in healthcare applications -Part 7: Connectors for intravascular or hypodermic applications.
- Tests conducted to ensure compliance with the standard: positive pressure liquid leakage, O sub-atmospheric pressure air leakage, stress cracking, resistance to separation from axial load, resistance to separation from unscrewing & resistance to overriding.
- USP <788> Particulate Matter in Injections ●
- Particulate matter testing was conducted in accordance USP <788> and met the USP o acceptance criteria.
- ISO 14971:2007, Medical devices- Application of risk management to medical devices ●
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Biocompatibility
In accordance with ISO 10993-1, the CADM devices are classified as: Blood path, indirect, Contact Duration: Prolonged (24hrs to 30days). The following testing was conducted:
- . Cytotoxicity
- Sensitization .
- Irritation or Intracutaneous reactivity ●
- Acute systemic toxicity .
- . Material mediated pyrogenicity
- Subacute/subchronic toxicity
- Hemolvsis ●
Sterility, Shipping and Shelf-Life
- The OnGuard®2 Chemfort™ Closed Administration devices are supplied sterile for single-use. . The devices are sterilized by Ethylene Oxide (EtO) gas to achieve a sterility assurance level (SAL) of at least 10-6. The process underwent a full sterilization validation according to the 'overkill' (half cycle) approach.
- Residuals of Ethylene Oxide (EtO) and Ethylene Chlorhydrine (ECH) were tested after aeration . and were found to comply with the requirements of ISO 10993-7:2008 for prolonged exposure devices (Category B).
- The bacterial endotoxins test (LAL) was performed using the kinetic turbidimetric methods for 10 samples (in pool) and was found to be less than 20 EU per device.
- A shelf life of three vears has been established using the FDA recognized standard ASTM ● F1980-16 "Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices", by exposing sterilized samples of CADM devices to accelerated aging equivalent to 3 years. Following the accelerated aging performance, functional and packaging integrity tests were performed. All tests passed according to the predetermined acceptance criteria.
- . Package integrity testing, after environmental conditioning and simulated transportation in accordance with ISTA 3A, was conducted on the final, packaged, and sterile devices. All packaging deemed acceptable for protection of product and sterility maintenance.
Sterile Barrier Packaging Testing was performed on the proposed device and were found to be in compliance according to the following standards:
- 0 Seal strength ASTM F88/F88-15
- Dye penetration ASTM F1929-15 o
Conclusions
Simplivia Healthcare's OnGuard®2 Chemfort™ Closed Administration has the same intended use, indications for use, similar technological characteristics and principles of operation as its predicate device, K192866. Performance data demonstrated that the OnGuard®2 Chemfort™ Closed
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Administration is as safe and effective as its predicate and does not raise any new safety and effectiveness issues. Thus, Simplivia Healthcare's OnGuard®2 Chemfort™ Closed Administration is substantially equivalent to its predicate device, K192866.
§ 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.