(371 days)
Not Found
No
The summary describes a mechanical drug transfer device with no mention of AI or ML capabilities.
No.
This device is designed to safely transfer drugs by minimizing exposure to hazardous substances and preventing microbial contamination, rather than directly treating a medical condition or restoring a bodily function.
No
The device description and intended use clearly state that the ProSeal™ CSTD is a drug transfer device designed to mitigate exposure to hazardous drugs and prevent microbial contamination. It does not mention any function related to diagnosing diseases or conditions.
No
The device description clearly outlines physical components (Vial Adaptor, Injector, Connector, Assembly Fixture) and mechanical functions (double membrane septum, cannula), indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to mechanically prohibit environmental contaminants and the escape of drug or vapor concentrations during the preparation, reconstitution, compounding, and administration of drugs. This is a drug delivery and containment function, not a diagnostic function.
- Device Description: The device is described as a closed system drug transfer device for handling drugs. It facilitates the transfer of liquids and prevents contamination. This aligns with drug handling, not diagnostic testing.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide information about a patient's health status, disease, or condition.
- Performance Studies: The performance studies focus on biocompatibility, sterilization, leak integrity, vapor containment, and microbial ingress. These are relevant to the safe handling and transfer of drugs, not to diagnostic accuracy or performance.
In vitro diagnostics are devices used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening. The ProSeal™ CSTD does not perform this function.
N/A
Intended Use / Indications for Use
The ProSeal™ Closed System drug Transfer Device (CSTD) mechanically prohibits environmental contaminants from entering the system and the escape of drug or vapor concentrations from 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.
Product codes (comma separated list FDA assigned to the subject device)
ONB
Device Description
The ProSeal™ CSTD is a sterile, single-use, closed system drug transfer device for preparation, reconstitution, compounding and administration of antineoplastic and hazardous drugs intended for use in clinical settings by trained healthcare providers and/or pharmacists.
The ability to prevent microbial ingress for up to 7 days should not be interpreted as modifying. extending, or superseding manufacturer's labeling recommendations for the storage and expiration dating. Refer to drug manufacturer's recommendations and USP compounding guidelines for shelf life and sterility information.
The ProSeal™ CSTD consists of three system components and one accessory:
- ProSeal Vial Adaptor (adaptor to the drug vial)
- ProSeal Injector (adaptor to the Luer Lock tip syringe)
- ProSeal Connector (adaptor for the injection site of IV lines)
- ProSeal Assembly Fixture (an accessory that is non-sterile reusable mechanical ● device to enable the user to consistently and simply attach the ProSeal Vial Adaptor onto the drug vial)
The closed transfer of liquid takes place as follows:
- Sterile air contained inside a flexible chamber integrated into the ProSeal Vial ● Adaptor provides pressure equalization of the drug vial in a closed system.
- A double membrane septum utilizing self-sealing elastomeric membranes tightly fits together when the system components engage. A cannula perforates the double membrane for the transfer of liquid. When the cannula is retracted, the membranes seal off the transfer of environmental contaminants into the system and/or escape of drug or vapor concentrations outside the system (tested for 10X transfers performed in 7 days), thereby minimizing the individual and environmental exposure to drug vapor, aerosols, and spills, and also minimizing the risk of microbial contamination.
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
Clinical Setting by trained healthcare providers and/or pharmacists
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)
The following non-clinical data were provided in support of the substantial equivalence determination:
- Biocompatibility studies per ISO 10993-1:2009
- o Cytotoxicity
- Sensitization o
- Intracutaneous reactivity O
- Acute systemic toxicity O
- Hemocompatibility O
- Material mediated pyrogenicity O
- Chemical characterization/Toxicological Risk Assessment o
- Performance testing in accordance with the following standards was conducted on the system components as applicable:
- ISO 11137-1:2006, "Sterilization of Healthcare Products Radiation - Part 1 Requirements for the Development, Validation, and Routine Control of a Sterilization Process for Medical Devices"
- ISO 11137-2:2013, "Sterilization of Healthcare Products Part 2 Establishing the . Sterilization Dose"
- ISO 11135:2014, "Sterilization of health care product - Ethylene Oxide - Requirement, validation and routine control of a sterilization process for medical devices"
- AAMI TIR28:2016, "Product Adoption and process equivalence for ethylene oxide sterilization"
- USP , Bacterial Endotoxin test ●
- ASTM F1980-16, "Standard guide for accelerated aging of sterile barrier systems for ● medical devices"
- ISO 8536-2:2010, "Infusion Equipment for medical use Part 2: Closures for infusion ● bottles"
- ISO 7864:2016, "Sterile hypodermic needles for single use Requirements and test ●
- methods"
- USP , "Particulate Matter in Injections" ●
- ISO 23908:2011, "Sharps injury protection Requirements and test methods Sharps ● protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling"
- ISO 80369-7:2016, "Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications"
- The following performance tests were conducted to internal specifications:
- volume of pressure equalization ●
- leak integrity ●
- vapor containment testing with titanium tetrachloride (visual indicator) ●
- Fluorescein testing - dry connections
- microbial ingress testing
- Assembly fixture validation ●
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.
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
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August 7, 2020
Epic Medical Pte. Ltd. % Roshana Ahmed Senior Director, Regulatory Affairs, Medical Devices G&L Scientific, Inc. 25 Independence Blvd. Warren, New Jersey 07059
Re: K192075
Trade/Device Name: ProSeal CSTD Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: ONB Dated: July 7, 2020 Received: July 8, 2020
Dear Roshana Ahmed:
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
1
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 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 medical devices and radiation-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 Acting 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) K192075
Device Name
ProSealTM Closed System drug Transfer Device (CSTD)
Indications for Use (Describe)
The ProSeal™ Closed System drug Transfer Device (CSTD) mechanically prohibits environmental contaminants from entering the system and the escape of drug or vapor concentrations from 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.
| Type of Use (Select one or both, as applicable) | ||||
|---|---|---|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
K192075
I. Submitter
Epic Medical Pte. Ltd. 105 Cecil Street #20-04 The Octagon, Singapore 069534. Phone: +65 9635 2618 / +66 81 761 5292 Contact Person: Mr. Freddie Lee, Chief Executive Officer
U.S. Contact
Roshana Ahmed, M.A., RAC Sr. Director Regulatory Affairs Medical Devices
G&L Scientific Inc. 25 Independence Blvd. Warren, NJ, 07059 Email: rahmed@gandlscientific.com Phone: 657-248-7361
Date Prepared: August 6, 2020
II. Device
| Device Proprietary Name: | ProSeal™ Closed System drug Transfer Device (CSTD) |
|---|---|
| Common or Usual Name: | Closed System drug Transfer Device (CSTD) |
| Classification Name: | Intravascular Administration Set |
| Regulation Number: | 21 CFR 880.5440 |
| Product Code: | ONB |
| Device Classification: | II |
III. Predicate Device
BD PhaSeal® Closed System Drug Transfer Device, K123213, Becton Dickinson & Company
4
IV. Device Description
The ProSeal™ CSTD is a sterile, single-use, closed system drug transfer device for preparation, reconstitution, compounding and administration of antineoplastic and hazardous drugs intended for use in clinical settings by trained healthcare providers and/or pharmacists.
The ability to prevent microbial ingress for up to 7 days should not be interpreted as modifying. extending, or superseding manufacturer's labeling recommendations for the storage and expiration dating. Refer to drug manufacturer's recommendations and USP compounding guidelines for shelf life and sterility information.
The ProSeal™ CSTD consists of three system components and one accessory:
- ProSeal Vial Adaptor (adaptor to the drug vial)
- ProSeal Injector (adaptor to the Luer Lock tip syringe)
- ProSeal Connector (adaptor for the injection site of IV lines)
- ProSeal Assembly Fixture (an accessory that is non-sterile reusable mechanical ● device to enable the user to consistently and simply attach the ProSeal Vial Adaptor onto the drug vial)
The closed transfer of liquid takes place as follows:
- Sterile air contained inside a flexible chamber integrated into the ProSeal Vial ● Adaptor provides pressure equalization of the drug vial in a closed system.
- A double membrane septum utilizing self-sealing elastomeric membranes tightly fits together when the system components engage. A cannula perforates the double membrane for the transfer of liquid. When the cannula is retracted, the membranes seal off the transfer of environmental contaminants into the system and/or escape of drug or vapor concentrations outside the system (tested for 10X transfers performed in 7 days), thereby minimizing the individual and environmental exposure to drug vapor, aerosols, and spills, and also minimizing the risk of microbial contamination.
V. Indications for Use
The ProSeal™ Closed System drug Transfer Device (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 when used as intended for up to 7 days.
5
VI. Comparison of Technological Characteristics
The ProSeal™ CSTD and the predicate device share the following characteristics:
- similar system components, including an assembly fixture which enables the user to . attach the vial adaptor to the drug vial;
- use of closed system technology;
- use of an integrated pressure equalization chamber;
- same interface between system components;
- use of luer lock connection to fit to syringe and external IV line;
- use of sharps protection features;
- same materials of construction for vial access spike and cannula; and
- same sterilization method for the syringe access and IV line access device components. ●
The ProSeal™ CSTD and the predicate device are technologically different with respect to the materials of construction for the fluid path and the sterile barrier, as well as the sterilization method for the Vial Access Device component of the system.
The table below compares key technological features between the subject and predicate devices.
| Comparison
| Element | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| ProSeal™ CSTD | BD PhaSeal® Closed System | ||
| Drug Transfer Device | |||
| (K123213) | |||
| Indications for | |||
| Use Statement | The ProSeal™ Closed System drug Transfer Device (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 PhaSeal 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 or vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols and spills. The Phaseal system also prevents microbial ingress. | Same |
| Intended User | |||
| Population | Trained healthcare providers or pharmacists | Trained healthcare providers or pharmacists | Same |
| Comparison | |||
| Element | Subject Device | ||
| ProSeal™ CSTD | Predicate Device | ||
| BD PhaSeal® Closed System | |||
| Drug Transfer Device | |||
| (K123213) | Comparison | ||
| Intended Use | |||
| Environment | Clinical Setting | Clinical Setting | Same |
| Intended Drug | Antineoplastic and hazardous | ||
| drug | Antineoplastic and hazardous | ||
| drug | Same | ||
| Intended Drug | |||
| Vial Size | ProSeal Vial Adaptor | ||
| Standard vial with 20 mm and | |||
| 28mm neck diameter | PhaSeal Protector | ||
| Standard vial with 13 mm, | |||
| 20mm, and 28mm neck diameter | Different | ||
| The subject | |||
| device is not | |||
| intended for | |||
| use with drug | |||
| vials with a | |||
| 13 mm neck | |||
| diameter. | |||
| This does not | |||
| raise new | |||
| questions of | |||
| safety and | |||
| effectiveness. | |||
| Intended | |||
| Syringe | ProSeal Injector | ||
| Male Luer Lock tip | PhaSeal Injector | ||
| Male Luer Lock tip | Same | ||
| Intended | |||
| Administration | |||
| Site | ProSeal Connector | ||
| Female Luer Lock injection site | |||
| on IV line | PhaSeal Connector | ||
| Female Luer Lock injection site | |||
| on IV line | Same | ||
| Single Use | Single Use Only | Single Use Only | Same |
| Rx | Rx Only | Rx Only | Same |
| System | |||
| Components | ProSeal Vial Adaptor | ||
| ProSeal Injector | |||
| ProSeal Connector | |||
| ProSeal Assembly Fixture | PhaSeal Protector | ||
| PhaSeal Injector | |||
| PhaSeal Connector | |||
| PhaSeal Assembly Fixture | Same | ||
| System | |||
| Components | |||
| Interface | Self-Sealing Elastomeric | ||
| Membrane on all system | |||
| components. | Self-Sealing Elastomeric | ||
| Membrane on all system | |||
| components. | Same | ||
| Drug Vial | |||
| Interface | ProSeal Vial Adaptor | ||
| Snap lock and elastomeric | |||
| membrane | PhaSeal Protector | ||
| Snap lock and elastomeric | |||
| membrane | Same | ||
| Pressure | |||
| Equalization | |||
| Chamber | Integrated into ProSeal Vial | ||
| Adaptor | Integrated into PhaSeal Protector | Same | |
| Flexible film | Flexible film | Same | |
| 20 ml | 20 ml | Same | |
| Subject Device | Predicate Device | ||
| Comparison | |||
| Element | BD PhaSeal® Closed System | ||
| Drug Transfer Device | |||
| (K123213) | Comparison | ||
| ProSeal™ CSTD | |||
| 50 mL | |||
| 60 mL | 50 mL | ||
| 60 mL | |||
| Drug Vial | |||
| Perforator | ProSeal Vial Adaptor | ||
| Plastic | PhaSeal Protector | ||
| Stainless Steel or Plastic | Same | ||
| Injector | |||
| Perforator | ProSeal Injector | ||
| Stainless Steel Cannula | PhaSeal Injector | ||
| Stainless Steel Cannula | Same | ||
| Connection to | |||
| External | |||
| Standard | |||
| Syringe | ProSeal Injector | ||
| Female Luer Lock | PhaSeal Injector | ||
| Female Luer Lock | Same | ||
| Connection to | |||
| IV Line | ProSeal Connector | ||
| Male Luer Lock | PhaSeal Connector | ||
| Male Luer Lock or Spike Port | Same | ||
| Needle Safety | |||
| Feature | Needle inaccessible to user when | ||
| engaged and disengaged | Needle inaccessible to user when | ||
| engaged and disengaged | Same | ||
| Sterile Barrier | |||
| Packaging | Coated medical paper and plastic | ||
| forming film, heat sealed | Tyvek® and plastic forming film, | ||
| heat sealed | Similar | ||
| Sterilization, | |||
| Vial Access | |||
| Device | Gamma, SAL 10-6 | EO, SAL 10-6 | Different |
| Use of | |||
| gamma | |||
| versus EO | |||
| does not | |||
| raise any | |||
| new | |||
| questions of | |||
| safety or | |||
| effectiveness. | |||
| Sterilization, | |||
| Syringe Access | EO, SAL 10-6 | EO, SAL 10-6 | Same |
| Sterilization, | |||
| IV Line Access | |||
| Device | EO, SAL 10-6 | EO, SAL 10-6 | Same |
| Shelf-Life | 35 months | 3 years | Similar |
Technological comparison
6
7
8
There are slight differences between the subject and predicate devices with respect to the indications for use statement; however, these differences do not alter the overall intended use of the subject device. Both devices are Closed System drug Transfer Devices which protect the drug inside the system from environmental contamination; protect healthcare providers from exposure to drug vapor, aerosols, and spills; protect from microbial ingress into the system; and are intended to be used for drug preparation and administration.
The subject and predicate devices are technologically different with respect to the materials of construction for the fluid path and the sterile barrier, the as well as the sterilization method for the Vial Access Device component of the system. In addition, the subject device is not intended for use with drug vials that have a 13 mm neck diameter. These technological differences do not raise different questions of safety or effectiveness and are addressed by performance data identified below.
Performance Data VII.
The following non-clinical data were provided in support of the substantial equivalence determination.
- Biocompatibility studies per ISO 10993-1:2009
- o Cytotoxicity
- Sensitization o
- Intracutaneous reactivity O
- Acute systemic toxicity O
- Hemocompatibility O
- Material mediated pyrogenicity O
- Chemical characterization/Toxicological Risk Assessment o
Performance testing in accordance with the following standards was conducted on the system components as applicable:
- . ISO 11137-1:2006, "Sterilization of Healthcare Products Radiation - Part 1 Requirements for the Development, Validation, and Routine Control of a Sterilization Process for Medical Devices"
- ISO 11137-2:2013, "Sterilization of Healthcare Products Part 2 Establishing the . Sterilization Dose"
- . ISO 11135:2014, "Sterilization of health care product - Ethylene Oxide - Requirement, validation and routine control of a sterilization process for medical devices"
- AAMI TIR28:2016, "Product Adoption and process equivalence for ethylene oxide sterilization"
- USP , Bacterial Endotoxin test ●
- ASTM F1980-16, "Standard guide for accelerated aging of sterile barrier systems for ● medical devices"
9
- ISO 8536-2:2010, "Infusion Equipment for medical use Part 2: Closures for infusion ● bottles"
- ISO 7864:2016, "Sterile hypodermic needles for single use Requirements and test ●
- methods"
- USP , "Particulate Matter in Injections" ●
- ISO 23908:2011, "Sharps injury protection Requirements and test methods Sharps ● protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling"
- ISO 80369-7:2016, "Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications"
The following performance tests were conducted to internal specifications:
- volume of pressure equalization ●
- leak integrity ●
- vapor containment testing with titanium tetrachloride (visual indicator) ●
- Fluorescein testing - dry connections
- microbial ingress testing
- Assembly fixture validation ●
VIII. Conclusion
The information provided above supports that the ProSeal™ CSTD is substantially equivalent to the predicate device. Although minor technological differences with respect to the materials of construction for the fluid path and the sterile barrier, the sterilization method for the Vial Access Device component of the system, and the drug vial sizes exists between the subject and predicate devices, the performance testing supports that these differences do not raise any new questions of safety and effectiveness. Therefore, it is concluded that the ProSeal™ CSTD is substantially equivalent to the predicate device.