(197 days)
K192866, Chemfort™ Closed System Transfer Device (CSTD)
Not Found
No
The summary describes a mechanical closed system transfer device and does not mention any AI or ML components or functionalities.
No.
This device is designed to prevent the release of hazardous drugs and the introduction of contaminants during drug administration, rather than to treat a medical condition or disease.
No
The device description and intended use clearly state that it is a Closed System Transfer Device (CSTD) for administering drugs and preventing contamination, not for diagnosing medical conditions.
No
The device description clearly outlines physical components (Bag Adaptor, Y Inline Set, IV Secondary Set, Adaptor Spike Port) and their mechanical function in preventing drug release and contamination. There is no mention of software as a component or primary function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a Closed System Transfer Device (CSTD) for mechanically prohibiting the release of drugs during administration. This is a drug delivery and containment function, not a diagnostic function.
- Device Description: The description details components for connecting to IV bags and administering drugs, again focusing on drug handling and delivery.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) or to provide information about a patient's health status or disease.
- Performance Studies: The performance studies focus on aspects like sterility, biocompatibility, shelf life, and package integrity, which are relevant to a medical device for drug administration, not an IVD. There are no studies related to diagnostic accuracy (sensitivity, specificity, etc.).
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not perform any of these functions.
N/A
Intended Use / Indications for Use
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.
Product codes
ONB
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:
- 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Target users: Pharmacists or other healthcare professionals
Environment of use: Hospitals, compounding centres and clinics
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)
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 cap. - ISO 80369-7:2016, Small-bore connectors for liquids and gases in healthcare applications -Part 7: Connectors for intravascular or hypodermic applications.
o 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 Particulate Matter in Injections
o Particulate matter testing was conducted in accordance USP and met the USP acceptance criteria. - ISO 14971:2007, Medical devices- Application of risk management to medical devices
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 years 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:
- Seal strength ASTM F88/F88-15
- Dye penetration ASTM F1929-15
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K192866, Chemfort™ Closed System Transfer Device (CSTD)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
0
Image /page/0/Picture/0 description: The image 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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
2
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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3
K210707 510(k) SUMMARY
| Preparation Date: | September 23, 2021 |
|---|---|
| Submitter Name | Simplivia Healthcare LTD. |
| North Industrial Zone | |
| Kiryat Shmona, 1101801 | |
| Israel | |
| Contact Person: | Shay Shaham |
| VP QA / RA | |
| Telephone Number: | |
| E-mail Address: | |
| Fax: | (972) 4 6908826 |
| Shay.Shaham@simplivia.com | |
| (972) 74 7652161 | |
| Trade Name: | OnGuard®2 Chemfort™ Closed Administration (CADM) |
| Common Name: | Closed Antineoplastic and Hazardous Drug Reconstitution and |
| Transfer 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:
4
- 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- K210707
OnGuard®2 Chemfort™ Closed
Administration (CADM) | Predicate Device- K192866
Chemfort™ Closed System Transfer
Device (CSTD) | |
|------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for
Use | 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. | Chemfort™ is a Closed System Transfer
Device (CSTD) that mechanically prohibits
the release of drugs, including
antineoplastic and hazardous drugs, in
vapor, aerosol or liquid form during
preparation, reconstitution, compounding
and administration, thus minimizing
exposure of individuals, healthcare
personnel, and the environment to
hazardous drugs.
Chemfort™ prevents the introduction of
microbial and airborne contaminants into
the drug or fluid path for up to 7 days. | |
| Prescription
Only or Over
the Counter | Prescription Only | Prescription Only | |
| | Proposed Device- K210707
OnGuard®2 Chemfort™
Closed Administration | Predicate Device- K192866
Chemfort™ Closed System
Transfer Device (CSTD) | Equivalence to
predicate |
| Indications for
use | 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. | Chemfort™ is a Closed System
Transfer Device (CSTD) that
mechanically prohibits the
release of drugs, including
antineoplastic and hazardous
drugs, in vapor, aerosol or liquid
form during preparation,
reconstitution, compounding and
administration, thus minimizing
exposure of individuals,
healthcare personnel, and the
environment to hazardous drugs.
Chemfort™ prevents the
introduction of microbial and
airborne contaminants into the
drug or fluid path for up to 7
days. | Different - the
difference is in
the product
name
Chemfort™
System versus
OnGuard®2
Chemfort™
Closed
Administration
and an addition
of "is a single
use, sterile" |
| Target users | Pharmacists or other healthcare
professionals | Pharmacists or other healthcare
professionals | Same |
| Environment of
use | Hospitals, compounding centres
and clinics | Hospitals, compounding centres
and 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 13
mm Vial Converter
Vial Adaptor 28 mm
Vial Adaptor 32 mm
Syringe Adaptor
Syringe Adaptor Lock
Luer Lock Adaptor
Bag Adaptor SP | Different device
(CADM will be
added to the
Chemfort™
System) |
| Spike & body
design | The BACP spike itself and the spike body (finger placement) design
are based on the Bag Adaptor SP (BASP) design cleared under
K192866 | | Same |
| Chemfort™ Port
location | BACP- the Chemfort™ port is
located in the distal part of the
device | BASP- the Chemfort™ port is
located in the middle of the
device | Different - see
comment 1 |
| Drug delivery to
bag | Through BACP Chemfort™ port | Through BASP Chemfort™ port | Same |
| Drug
administration
to patient | Through BACP Chemfort™ port
and the connected CADM IV set | Through BASP tail, located in
the distal part of the device and
the connected IV set | Different - See
comment 2 |
| Residual volume | BACP residual volume is Particulate Matter in Injections ●
- Particulate matter testing was conducted in accordance USP and met the USP o acceptance criteria.
- ISO 14971:2007, Medical devices- Application of risk management to medical devices ●
8
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
9
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.