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Found 692 results
510(k) Data Aggregation
(267 days)
Antineoplastic And Hazardous Drug Reconstitution And Transfer System
Regulation(s): 880.5860; 880.5570; 880.5440
None | Same |
Page 9
Page 5 of 6
Comment 1
The product code ONB under the regulation 880.5440
The VaporShield™ is a sterile, single-use, closed system transfer device (CSTD), incorporating a preassembled Drug Vial holder (DVH) and Syringe (1mL, 22GA). The preassembled device is intended for medication draw from a drug vial only. After medication draw, the DVH is removed from the syringe, and the syringe is used for direct injection of hazardous and non-hazardous medication via subcutaneous or intramuscular administration. The syringe incorporates a safety mechanism which automatically retracts the needle inside the device for drug containment, and prevention of accidental needlesticks and device reuse. The VaporShield mechanically prevents drug transfer external to the device to minimize individual and environmental drug exposure. The VaporShield is intended for use by medical professionals who prepare/administer injection(s) to adults and adolescents in healthcare facilities. The device is not intended for neonates (<28 days old), infants (< 2 yrs old), or children (> 2 yrs. old – 12 yrs. old). The VaporShield Device is not intended for Compounding, Reconstitution, Phlebotomy, Intravenous injection, Intraperitoneal injection, or Intrathecal injection.
The VaporShield closed system transfer device (CSTD) is sterile, for single use, and is intended for direct injection of hazardous or nonhazardous drugs. A single configuration includes a 1 mL syringe, 22G cannula, and is pre-assembled with a Drug Vial Holder (DVH). Preassembly of the syringe and drug vial holder components are interlocked via a flex tab snap-fit connection. During drug draw, the DVH ensures a stable connection between the drug vial and syringe. The VaporShield has three (3) settings, two for needle length, and one (1) for safety. The DVH can be removed from the syringe when the syringe is placed in locked setting.
The VaporShield includes a safety mechanism that is manually activated by full plunger depression. When activated, the safety mechanism retracts the needle inside the plunger rod for containment, preventing accidental needlestick, and disallowing device reuse.
Syringe is intended for parenteral injection (subcutaneous / intramuscular).
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(184 days)
Trade/Device Name: ProSeal™ Transfer Injector (421120, 421130, 421140)
Regulation Number: 21 CFR 880.5440
System |
| Regulation Number: | Set, Administration, Intravascular |
| Regulation Name: | 21 CFR 880.5440
System |
| Regulation Number: | Set, Administration, Intravascular |
| Regulation Name: | 21 CFR 880.5440
days, when used as intended. | Similar |
| Primary product code and regulation number | ONB 21 CFR 880.5440
| ONB 21 CFR 880.5440 | Same |
| Intended user population/ intended use environment | Adequately
The ProSeal™ Transfer Injector is a component of the ProSeal™ Closed System drug Transfer Device (CSTD) system. The ProSeal™ CSTD mechanically prohibits environmental contaminants from entering the system and the escape of drug or vapor concentrations from the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols, and spills. The ProSeal™ system also prevents the introduction of microbial contaminations into the drug or fluid path for up to 7 days when used as intended.
The ProSeal™ Transfer Injector is a fully encapsulated syringe unit that that supports the use of ProSeal™ Injector Plus (K240171) in hazardous drug handling. The integrated ProSeal™ Injector Plus which incorporates a female connector, is permanently attached onto the syringe body, thus preventing accidental disconnections. It houses a shielded needle to prevent the risk of accidental needle sticks. All ProSeal™ Transfer Injector subcomponents are not made with DEHP*, latex nor BPA and substantiated for safe use with antineoplastic and hazardous drugs.
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(225 days)
Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]
Regulation Number: 21 CFR 880.5440
administration set |
| Classification Name | Set, Administration, Intravascular |
| Regulation Number | 880.5440
Product Name: nSet+ Stabilization Set
Part Number: 6426733
The nSet+ Stabilization Set is for single use only. The nSet+ Extension Set may be used for direct injection, intermittent infusion, continuous infusion or aspiration. The nSet+ Extension Set may be used with power injector procedures to a maximum pressure of 325 psi at a flow rate of 10 ml per second.
Product Name: nSet+ Stabilization Set with nSyte Needle Free Connector (NFC)
Part Number: 6426731
The nSet+ Stabilization Set with nSyte needle free connector is for single use only. The nSet+ Extension Set may be used for direct injection, intermittent infusion, continuous infusion or aspiration. The nSet+ Stabilization Set may be used with power injector procedures to a maximum pressure of 325 psi at a flow rate of 10 ml per second.
Product Name: nSyte Needle Free Connector (NFC)
Part Number: 6426727
The nSyte needle free connector is for single use only. The nSyte needle free connector may be used for direct injection, intermittent infusion, continuous infusion or aspiration. The nSyte needle free connector may be used with power injector procedures to a maximum pressure of 325 psi at a flow rate of 10 ml per second.
Product Name: nSet+ Stabilization Set
Part Number: 6426733
Description: The nSet+ Stabilizing Set is a sterile, single patient use, add-on medical device used in peripheral vascular access systems. The nSet+ Stabilizing Set includes a stabilization base, an extension tube, a tube pinch clamp, and terminates with locking ISO 80369-7 connectors on each end, capped. It is sold individually blister packed with fifty (50) total units per carton and is labeled with a shelf life of one year.
Product Name: nSet+ Stabilization Set with nSyte Needle Free Connector (NFC)
Part Number: 6426731
Description: The nSet+ Stabilizing Set with nSyte Needle Free Connector is a sterile, single patient use, add-on medical device used in peripheral vascular access systems. The nSet+ Stabilizing Set includes a stabilization base, an extension tube, a tube pinch clamp, an nSyte Needle Free Connector, and terminates with a locking ISO 80369-7 male connector, capped. It is sold individually blister packed with fifty (50) total units per carton and is labeled with a shelf life of one year.
Product Name: nSyte Needle Free Connector (NFC)
Part Number: 6426727
Description: The nSyte Needle Free Connector is a sterile, single patient use, add-on medical device used in peripheral vascular access systems.
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(267 days)
92121
Re: K250325
Trade/Device Name: BD Alaris Pump Infusion Set
Regulation Number: 21 CFR 880.5440
Intravascular Administration Set
Classification Panel: General Hospital
Regulation Number: 21 CFR 880.5440
Intravascular Administration Set
Classification Panel: General Hospital
Regulation Number: 21 CFR 880.5440
The BD Alaris™ Pump Infusion Set is indicated for pump use by experienced healthcare professionals within healthcare facilities through intravenous, intra arterial and subcutaneous routes for adults, pediatrics and neonates or irrigation of fluid spaces for adults. Based on clinical discretion these sets can be used for temporary intravenous gravity infusion.
The subject BD Alaris™ Pump Infusion Set is a single-use infusion set incorporating a spiked drip chamber on the proximal end, which is inserted into a fluid container, and a male luer lock connector on the distal end which connects to a patient's access device. The spike cap and the male luer lock cap maintain sterility of the fluid path prior to use. The BD Alaris™ Pump Infusion Set is supplied fluid-path sterile using gamma irradiation and is non-pyrogenic. The subject BD Alaris™ Pump Infusion Set incorporates a pump segment designed to interface with the BD Alaris™ Pump Module for administration of fluids, medications, and parenteral nutrition through clinically acceptable routes of administration.
The BD Alaris™ Pump Infusion Set is available in six (6) configurations incorporating variations of the following components: roller clamp, pinch clamp, slide clamp, SmartSite™ Y-site(s), back check valve, and inline filter.
N/A
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(260 days)
Illinois 60093
Re: K250345
Trade/Device Name: Medline Bag Decanter
Regulation Number: 21 CFR 880.5440
** General Hospital & Personal Use
Regulatory Class: Class II
Regulation Number: 21 CFR 880.5440
(WUXI) | N/A |
| Product Code | LHI | LHI | Same |
| Regulation Number | 880.5440 | 880.5440 | Same |
Intended for the aseptic dispensing of solutions from IV containers. For use in transferring IV fluids/medication from a bag to an IV fluid administration device.
The Medline Bag Decanter is a non-pyrogenic, single use, disposable device, which is supplied sterile. The device comprises of a one-piece transfer device with protective flexible caps at either end. The device is an injection molded hollow tube with a spiked end used to access the source container and withdraw fluid. The spike component is designed with a built-in splash guard. The device is designed for use in transferring IV fluids/medication from a bag to an IV fluid administration device.
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(29 days)
Device Name:** Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor
Regulation Number: 21 CFR 880.5440
Device Name:** Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor
Regulation Number: 21 CFR 880.5440
VP QA/RA, Simplivia Healthcare Ltd. |
| Product Code: | ONB |
| Regulation Number: | 21 CFR 880.5440
Code:** ONB
Regulation Name: Intravascular administration set
Regulation Number: 21 CFR 880.5440
Chemfort® 28-day 20 mm Vial Adaptor 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 preparation, reconstitution, compounding and administration, thus minimizing exposure of individuals, healthcare personnel, and the environment to hazardous drugs.
Chemfort® 28-day 20 mm Vial Adaptor prevents the introduction of microbial and airborne contaminants into the drug or fluid path for up to 28 days or 10 activations.
The Chemfort® Closed System Transfer Device (CSTD) is a system of components that allows the reconstitution of liquid or pre-dissolved powder drugs into infusion bags, flexible bottles or syringes. Single, partial or multiple vials can be used for each infusion solution container. The Chemfort® CSTD prevents contamination of the user or the environment by the drug through the use of elastomeric seals and an active carbon filter.
The components of the predicate Chemfort® CSTD system are:
- 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
Each of the Chemfort® system components is available separately.
This submission introduces a new version of the 20mm Vial Adaptor to the Chemfort® CSTD system, called the Chemfort® 28-day 20 mm Vial Adaptor, as a range extension. This new Vial Adaptor differs from the predicate Vial Adaptor only with respect to the usage time limitation, which is extended from 7 to 28 days, but with the same limit of 10 activations. This change is reflected in the Indications for Use statement and the device labeling.
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(132 days)
To allow multiple needleless accesses to an injection medication vial for the purpose of facilitating the withdrawal or addition of drugs/solutions from or to the vial.
Not Found
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(109 days)
Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S)
Regulation Number: 21 CFR 880.5440
Fluid Transfer Set
Regulation Number: 21 CFR 880.5440
Regulation Name: Intravascular administration
-----|-------------------------------------------|-------------------|
| Regulation Number | 21 CFR 880.5440
| 21 CFR 880.5440 | Same |
| Product Code | LHI | LHI | Same |
| Premarket Notification | New Device
Microtek decanters are intended for the aseptic transfer of solutions (eg. IV fluids and medications) from IV containers
- Bag decanters are for use in transferring IV fluids and medication from a bag to an IV fluid administration device.
- Vial decanters are for use in transferring IV fluids and medications from a vial to an IV fluid administration device.
- Transfer devices are for use in transferring IV fluids and medications from a vial or medication container to an IV fluid administration device.
Microtek decanters are suitable for adult and pediatric patients. The use of decanters is at the discretion of the healthcare professional.
Microtek decanters and transfer devices are provided sterile and for use in a single procedure only. They consist of a hollow tube with protective removable caps at either end. The injection molded hollow tube has at least one spiked end used to access the source container to initiate fluid transfer. The vial decanter includes a built-in splash guard.
Decanters and transfer devices are designed to transfer medical fluids (e.g.: medications and solutions) between various containers.
| Model Number(s) | Description | Container Configuration | Overall Length (of finished device without caps) | Materials |
|---|---|---|---|---|
| 2000S | C-Flo Bag Decanter, Sterile | Bag to an IV fluid administration device | 8.25" | PMMA |
| 2002S | Bag Decanter II, Sterile | Bag to an IV fluid administration device | 8.25" | HIPS825 |
| 2006S | Vial Decanter, Sterile | Vial to an IV fluid administration device | 6" | HIPS825, ABS |
| 2008S | Transfer Device, Sterile | Vial or medication container to an IV fluid administration device | 3" | ABS |
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(245 days)
Optima Connecting Set (C83-O); BD PhaSeal™ Optima Spike Set (C180-O)
Regulation Number: 21 CFR 880.5440
- Closed Antineoplastic and Drug Reconstitution and Transfer System
Regulation Number: 21 CFR 880.5440 - Closed Antineoplastic and Drug Reconstitution and Transfer System
Regulation Number: 21 CFR 880.5440 - Closed Antineoplastic and Drug Reconstitution and Transfer System
Regulation Number: 21 CFR 880.5440
Number | 21 CFR 880.5440 | 21 CFR 880.5440 | Identical |
| FDA Regulation Name | Intravascular Administration
The BD PhaSeal™ Optima system is an airtight and leakproof closed system drug transfer device (CSTD) that mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols and spills. The BD PhaSeal™ Optima system also prevents microbial ingress for up to 168 hours.
BD PhaSeal™ Optima Closed System Transfer Devices (CSTD) are sterile, single use closed system drug transfer devices intended for the reconstitution and transfer of antineoplastic or other hazardous drugs in the healthcare setting. The BD PhaSeal™ Optima system is comprised of four devices—Protector, Injector, Connector, and Infusion Adapter.
The closed transfer of liquid drugs takes place through a double membrane utilizing self-sealing elastomeric membranes that are tightly fitted together through the collet-style fitting on each of the BD PhaSeal™ Optima system devices. During use, the single lumen cannula of the Injector perforates the double membranes for the transfer of liquids. When the cannula is retracted, the membranes seal to prevent the transfer of environmental contaminants into the system and/or escape of drug or vapor concentrations outside the system, thereby minimizing the individual and environmental exposure to drug vapor, aerosols, leaks and spills. The BD PhaSeal™ Optima system prevents microbial ingress for up to 168 hours. Performance of the self-sealing membrane has been substantiated for up to 10 penetrations.
The BD PhaSeal™ Optima Connecting Set (C83-O) is a sterile, single patient use sterile device that enables the administration of non-hazardous and hazardous parenteral drugs when used with the devices that have the compatible mating component - the BD PhaSeal™ Optima Spike Set and/or Connector. The BD PhaSeal™ Optima Connecting Set will be utilized by healthcare workers who administer parenteral hazardous drugs.
The BD PhaSeal™ Optima Spike Set (C180-O) is a sterile, single patient use sterile bag access device that enables the preparation and administration of non-hazardous and hazardous parenteral drugs when used with devices that have the compatible mating component - the BD PhaSeal™ Optima Injector and/or Connecting Set. The BD PhaSeal™ Optima Spike Set will be utilized by healthcare workers who prepare and administer parenteral hazardous drugs.
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(77 days)
Re: K251814
Trade/Device Name: EZ™ IV Administration Set
Regulation Number: 21 CFR 880.5440
Set |
| Regulation Number: | Set, Administration, Intravascular |
| Regulation Name: | 21 CFR 880.5440
Set |
| Regulation Number: | Set, Administration, Intravascular |
| Regulation Name: | 21 CFR 880.5440
a patient's vascular system. | Same |
| Primary product code and regulation number | FPA 21 CFR 880.5440
The Administration Sets are intravenous administration sets intended for delivery of medications and fluids from a container into a patient's vascular system.
The EZ™ IV Administration Set is a gravity, single use, disposable, intravenous administration set designed to deliver fluids from a container into a patient's vascular system. The device includes a vented bag spike (air vent 0.1µm) integrated to a drip chamber (not made with DEHP*) featuring a 5-μm particulate filter, a roller clamp, flexible IV tubing (not made with DEHP*), and one (1), two (2) or three (3) needle-free valve (NFV) Y-site connectors. It also features a Luer connector and a priming cap with a 3-μm filter.
The EZ™ IV Administration Set may be used in combination with standard IV therapy devices commonly used throughout the healthcare settings, such as bag spike, Luer lock adaptor, syringe (MLL) (without needle), and IV extension sets. It is configured to achieve the intended use when used with these standard complementary products.
*DEHP – Di (2-ethylhexyl) phthalate (DEHP), a plasticizer to make PVC soft and flexible. It is a substance known to cause cancer or reproductive toxicity.
The provided FDA 510(k) clearance letter and summary for the EZ™ IV Administration Set (K251814) describe the device's acceptance criteria and the studies conducted to demonstrate substantial equivalence to a predicate device. However, this document primarily focuses on demonstrating substantial equivalence rather than proving the device meets specific acceptance criteria for a novel device. It also describes a medical device rather than a software or AI-driven device, so several of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, training set details) are not applicable.
Here's an analysis based on the provided text, focusing on the available information:
Acceptance Criteria and Device Performance for EZ™ IV Administration Set (K251814)
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the EZ™ IV Administration Set are primarily defined by adherence to recognized international and national standards for intravascular administration sets and specific functional performance metrics derived from these standards. The reported device performance indicates compliance with these standards.
| Characteristic Compared | Acceptance Criteria (Standard Reference) | Reported Device Performance (Subject Device) |
|---|---|---|
| Performance Testing | Conformance with: - ISO 8536-4:2019 - ISO 22413:2021 - ISO 10993-1:2018 - ANSI/AAMI CN27:2021 - ISO 80369-7:2021 - ISO 80369-20:2015 - FDA Guidance for Intravascular Administration Sets | Comprehensive performance verification & validation testing performed; met the intended use. |
| Air-inlet device tests | ISO 8536-4:2019 | Conformed to standard. |
| Flow rate test | ISO 8536-4:2019 | Conformed to standard. |
| Piercing device penetration force test | ISO 22413:2021 | Conformed to standard. |
| Protective cap removal test | ISO 8536-4:2019 | Conformed to standard. |
| Drip chamber and drip tube tests | ISO 8536-4:2019 | Conformed to standard. |
| Leak integrity tests | ISO 8536-4:2019 (air leakage under positive pressure, air leakage under negative pressure and fluid leakage) | Conformed to standard. |
| Tensile strength test | ISO 8536-4:2019 | Conformed to standard. |
| Particulate contamination level | ISO 8536-4:2019, Annex A, A.2 USP <788> Particulate Matter in Injections | Met contamination index, N≤90. Conformed to standard. |
| Drops/mL | 20 gtt/mL (as per Predicate) | 20 gtt/mL |
| Tubing transparency | Sufficiently clear to observe air/water interface (normal/corrected vision) | Conformed to standard. |
| Connector type | External Fitting Male Luer Lock (ISO 80369-7:2021) | Conformed to standard. |
| Sterile barrier packaging | Medical grade paper and plastic film, heat sealed | Conformed to standard. |
| Sterilization process | Ethylene Oxide (EO), SAL 10⁻⁶ | Ethylene Oxide (EO), SAL 10⁻⁶. Complies with ISO 11135:2014. |
| Shelf-life validation | 3 years (36 months) via ASTM 1980-21 | 3 years (36 months) validated. |
| Biocompatibility | ISO 10993-1:2018 (Externally Communicating Device, Blood Path Indirect, Prolonged Contact) (Specific ISO 10993 parts for various tests) | Met biological safety specifications. |
| EO residues limits | ISO 10993-7:2008 & amendments | Conformed to standard. |
| Shipping | ASTM D 4169-16 | Simulated shipping testing performed on K151650/S004. |
| Package integrity | ASTM F1980-21, ASTM F88/F88M-21, ASTM F1929-23, EN 868-5:2009 | Testing performed on K151650. |
| Pyrogen tests | ANSI/AAMI ST72/2019, USP <151>, USP <161>, USP <85> | Testing performed on K151650 and "will be conducted on every lot." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify the exact sample sizes (number of devices/batches) used for each specific performance test mentioned (e.g., flow rate, leak integrity, tensile strength). The studies are focused on product characteristics and compliance with engineering standards, not clinical patient data.
- Data Provenance: Not explicitly stated for each test. The submitter is "Epic Medical Pte. Ltd." based in Singapore, suggesting the testing data likely originated from or was managed by facilities associated with this company. The testing is for a medical device component, not a diagnostic algorithm, so there is no patient data involved in these performance tests.
- Retrospective or Prospective: Not applicable, as these are engineering and materials performance tests conducted on the physical device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable to this type of device submission. The "ground truth" here is defined by objective engineering specifications and international standards, rather than expert consensus on medical images or diagnoses. Qualification involves expertise in medical device testing, engineering, and regulatory compliance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for subjective assessments, typically in clinical readings or evaluations where human interpretation introduces variability. These are objective physical and chemical tests on a medical device.
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 is a physical medical device (IV administration set), not an AI-powered diagnostic tool, and therefore no MRMC studies were conducted or are relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance tests conducted on the EZ™ IV Administration Set is based on established international and national standards and their specific test methods and acceptance criteria. This includes standards like ISO 8536-4 for infusion sets, ISO 10993 for biocompatibility, and USP <788> for particulate matter. These standards provide objective, measurable criteria for device performance and safety.
8. The sample size for the training set
Not applicable. This pertains to the training of an algorithm or AI model. This submission is for a physical medical device.
9. How the ground truth for the training set was established
Not applicable. As above, this is for a physical medical device and does not involve a training set for an algorithm.
Summary of Study that Proves Device Meets Acceptance Criteria:
The study that proves the EZ™ IV Administration Set meets its acceptance criteria is a comprehensive set of performance verification and validation tests conducted on the subject device and, in some cases, leveraging data from the predicate device (K230343/S001) or an existing device (K151650 and K151650/S004).
These tests address:
- Functional Performance: Evaluated against ISO 8536-4:2019, ISO 22413:2021, and FDA guidance documents, covering aspects like flow rate, leak integrity, piercing device penetration force, protective cap removal, drip chamber performance, and tensile strength.
- Connection Integrity: Evaluated against ANSI/AAMI CN27:2021 (for luer-activated valves) and ISO 80369 series (for small-bore connectors like Luer lock).
- Biocompatibility: Evaluated against ISO 10993 series (e.g., -5, -10, -11, -17, -18, -23) to assess cytotoxicity, sensitization, systemic toxicity, hemolysis, pyrogenicity, and chemical characterization. This classification was for "Externally Communicating Device, Blood Path Indirect, Prolonged Contact (>24 hr to 30 d)."
- Sterility and Shelf-Life: Compliance with ISO 11135:2014 for Ethylene Oxide sterilization, ASTM D 4169-16 for shipping, and ASTM F1980-21 for accelerated aging (shelf-life validation of 3 years). Package integrity, pyrogen, and EO residue tests were also part of this.
- Material Composition: Analysis and risk assessment were conducted given differences in materials between the subject and predicate devices, leveraging biocompatibility and chemical characterization data.
The submitter states that "All performance testing demonstrated and confirmed the safety and effectiveness of the Subject device" and that the results "met the intended use." They explicitly noted for material and dimension differences that "analytical and functional testing were conducted" and "the results...demonstrated that the performance of the Subject devices met the intended use. Therefore, the differences were considered not significant." This body of evidence constitutes the study proving the device meets its acceptance criteria, which are primarily compliance with the listed international and national standards.
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