(235 days)
TEVADAPTOR® is a Closed System Drug Transfer Device (CSTD) that mechanically prohibits the release of the drug in vapor, aerosol or liquid form during preparation and administration, and prevents the introduction of microbial and airborne contaminants into the drug or fluid path, allowing the system to minimize exposure of individuals, healthcare personnel, and the environment to hazardous drugs.
The TEVADAPTOR® Closed Drug Reconstitution and Transfer System, developed by Teva Medical, is a closed system to be used by pharmacists or other healthcare professionals to prepare drugs, including cytotoxic drugs, for infusion, injection, or instillation. The TEVADAPTOR® Closed Drug Reconstitution and Transfer System is a system of components that allow the safe 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 TEVADAPTOR® Closed Drug Reconstitution and Transfer System prevents contamination of the user or the environment by the drug through the use of elastomeric seals and an active carbon filter. Sterility of the drug in the vial is maintained because any air entering the vial during pressure equalization enters through of a hydrophobic acrylic copolymer membrane with a pore size of 0.2 micron.
The components of the TEVADAPTOR® system are:
- Vial Adaptor 20 mm with 13 mm Vial Converter
- Vial Adaptor 28 mm
- Syringe Adaptor
- Spike Port Adaptor
- Connecting Set
- Luer Lock Adaptor
Each of the above component parts is sold separately.
The provided document is a 510(k) summary for the TEVADAPTOR® Closed Drug Reconstitution and Transfer System. It describes the device, its intended use, and the tests performed to demonstrate its substantial equivalence to predicate devices, focusing on meeting the definition of a Closed System Drug Transfer Device (CSTD). However, it does not detail specific acceptance criteria for performance metrics in a table or present a study comparing device performance against those criteria in a quantitative manner that would allow for a direct comparison as requested.
The document discusses various bench tests and compliance with applicable standards to demonstrate the device meets the criteria for a CSTD, but it does not provide acceptance criteria values, performance values, sample sizes for test sets, data provenance, expert involvement for ground truth, or adjudication methods for any specific performance study. It also does not mention an MRMC comparative effectiveness study or a standalone algorithm-only performance study.
Instead, the document focuses on demonstrating that the device prevents the release of drugs and maintains sterility, aligning with the definition of a CSTD. The "studies" mentioned are bench tests and validations against standards rather than clinical performance studies with quantitative outcomes.
Therefore, much of the requested information cannot be extracted directly from this document.
Here's a breakdown of what can be inferred or explicitly stated based on the provided text:
1. A table of acceptance criteria and the reported device performance:
This information is not explicitly provided in the document in a table format with specific quantitative acceptance criteria and corresponding reported performance values. The document states that "A number of bench tests have been carried out to confirm compliance with applicable standards and demonstrate that the subject device meets the criteria for a Closed Drug Reconstitution and Transfer System, in accordance with the requirements of FDA Product Code ONB." It lists the types of tests performed and gives a general conclusion that the device meets the NIOSH and ISOPP definition of a CSTD. Specific pass/fail criteria or performance metrics for each test are not listed.
2. Sample sized 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 sample sizes for any of the bench tests mentioned (e.g., Bidirectional flow, Airtightness test, Fluid tightness test, Microbiological ingress test, Filter efficiency test).
- Data Provenance: The manufacturer is Teva Medical Ltd. in Kiryat Shmona, ISRAEL. The studies are bench tests, implying they were conducted in a lab setting, likely by the manufacturer or a contract lab. The document does not specify if the data is retrospective or prospective, but for bench tests, this distinction is less relevant than for clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the "studies" are bench tests demonstrating physical and mechanical properties, sterility, and biocompatibility, not clinical evaluations requiring expert interpretation for ground truth. Ground truth for these tests would be defined by the physical properties being measured and the standards referenced.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable for the bench tests described.
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:
This information is not applicable. The device is a Closed System Drug Transfer Device, not an AI-powered diagnostic tool requiring human reader comparison.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. The device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
The ground truth for the bench tests mentioned would be based on physical measurements, chemical analysis, microbiological assays, and compliance with established industry standards (e.g., ISO 11135-1:2007 for sterilization, ISO 10993 series for biocompatibility). For example, for the "Microbiological ingress test," the ground truth would be the confirmed presence or absence of microbial contamination based on laboratory methods. For "Fluid tightness test," the ground truth would be the absence of fluid leakage under defined conditions.
8. The sample size for the training set:
This information is not applicable. The device is a physical medical device, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
This information is not applicable as there is no training set for a physical medical device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 23, 2015
Teva Medical Ltd. C/O Mr. Roger Gray VP Quality and Regulatory Donawa Lifescience Consulting Piazza Albania 10 00153 ROME, ITALY
Re: K141448
Trade/Device Name: TEVADAPTOR® Closed Drug Reconstitution and Transfer System Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular administration set Regulatory Class: II Product Code: ONB Dated: December 22, 2014 Received: December 24, 2014
Dear Mr. Gray:
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. 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.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina
Kiang -S
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K141448
Device Name
TEVADAPTOR Closed Drug Reconstitution and Transfer System
Indications for Use (Describe)
TEVADAPTOR is a Closed System Drug Transfer Device (CSTD) that mechanically prohibits the release of the drug in vapor, aerosol or liquid form during preparation and administration, and prevents the introduction of microbial and airborne contaminants into the drug or fluid path, allowing the system to minimize exposure of individuals, healthcare personnel, and the environment to hazardous drugs.
| 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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510(k) Summary in accordance with 21 CFR 807.92(c)
| Device Name: | TEVADAPTOR® Closed Drug Reconstitution and Transfer System |
|---|---|
| Type of 510(k) submission: | Abbreviated |
| Date of Submission: | 27 May 2014 |
| Manufacturer: | Teva Medical Ltd., MIGADA PlantNorth Industrial ZoneKiryat Shmona 10258ISRAEL |
| FDA Registration Number: | 9611423 |
| Owner/Operator Number: | 9001925 |
| 510(k) Owner: | Teva Medical Ltd., MIGADA PlantNorth Industrial ZoneKiryat Shmona 10258ISRAEL |
| Phone:Fax: | +972 (0)46 908822+972 (0)39 267865 |
| 510(k) Submitter and Contact: | Mr Roger GrayVP Quality and RegulatoryDonawa Lifescience ConsultingPiazza Albania 1000153 RomeItalyPhone:+39 06 578 2665+30 06 574 3786Fax:Email:rgray@donawa.com |
| FDA Product Code: | ONB |
| FDA Regulation Number: | 880.5440 |
| FDA Classification Name: | Closed antineoplastic and hazardous drug reconstitution andtransfer system |
| Classification Panel: | General Hospital |
| Common Name: | Closed System Drug Transfer Device (CSTD) |
| FDA Classification: | Class II |
| FDA Identification: | An intravascular administration set is a device used toadminister fluids from a container to a patient's vascular systemthrough a needle or catheter inserted into a vein. The devicemay include the needle or catheter, tubing, a flow regulator, a |
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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.
Indications for Use: TEVADAPTOR® is a Closed System Drug Transfer Device (CSTD) that mechanically prohibits the release of the drug in vapor, aerosol or liquid form during preparation and administration, and prevents the introduction of microbial and airborne contaminants into the drug or fluid path, allowing the system to minimize exposure of individuals, healthcare personnel, and the environment to hazardous drugs.
Device Description:
It is common practice in healthcare facilities to have parenteral drugs reconstituted and compounded into infusion or injection containers according to specific physician's prescriptions. Those operations are normally performed in compounding centers, by or under the supervision of a pharmacist, or in the wards by authorized healthcare personnel.
The TEVADAPTOR® Closed Drug Reconstitution and Transfer System, developed by Teva Medical, is a closed system to be used by pharmacists or other healthcare professionals to prepare drugs, including cytotoxic drugs, for infusion, injection, or instillation.
The TEVADAPTOR® Closed Drug Reconstitution and Transfer System is a system of components that allow the safe 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 TEVADAPTOR® Closed Drug Reconstitution and Transfer System prevents contamination of the user or the environment by the drug through the use of elastomeric seals and an active carbon filter. Sterility of the drug in the vial is maintained because any air entering the vial during pressure equalization enters through of a hydrophobic acrylic copolymer membrane with a pore size of 0.2 micron.
The components of the TEVADAPTOR® system are:
- Vial Adaptor 20 mm with 13 mm Vial Converter
- . Vial Adaptor 28 mm
- Syringe Adaptor
- Spike Port Adaptor
- Connecting Set
- Luer Lock Adaptor
Each of the above component parts is sold separately.
The materials used in the manufacture of the components of the TEVADAPTOR® Closed Drug Reconstitution and Transfer System are, in the main, identical, and processed in an identical manner, to those used in the predicate device TEVADAPTOR® System that was the subject of K071741, cleared by FDA on 24 September 2007. For any materials not previously used, technical and safety information has been assessed.
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A risk Assessment was carried out for the TEVADAPTOR® on the basis of ISO 14971:2007 and Teva Medical standard operating procedures. The process included evaluation of the risks and mitigation activities.
A number of bench tests have been carried out to confirm compliance with applicable standards and demonstrate that the subject device meets the criteria for a Closed Drug Reconstitution and Transfer System, in accordance with the requirements of FDA Product Code ONB.
The bench tests carried were:
- Bidirectional flow
- Vial adaptor to syringe adaptor force test
- Vial adaptor to vial force test
- Airtightness test
- . Fluid tightness test
- Luer connector test
- Microbiological ingress test
- Filter efficiency test
The results of the bench tests confirm that the TEVADAPTOR® Closed Drug Reconstitution and Transfer System meet the NIOSH and ISOPP definition of a closed system transfer device (CSTD), which is:
"A drug transfer device that mechanically prohibits the transfer of environmental contaminants into the system and the escape of hazardous drug or vapor concentrations outside the system."
The TEVADAPTOR® components are supplied sterile. The devices are sterilized by Ethylene Oxide (EtO), validated according to standard ISO 11135-1:2007, 'Medical devices - Validation and routine control of ethylene oxide sterilization'. The validation was conducted according to the 'overkil' (half cycle) approach. Routine process monitoring is by use of biological indicators. The sterility assurance level (SAL) reached as a result of these processes is 10 °. Residuals of ethylene oxide and ethylene chlorhydrine (ECH) were tested after aeration and found to be in compliance with the requirements of standard ISO 10993-7:2008 for prolonged exposure devices (more than 24 hours and up to 30 days).
A shelf life of three years was established for the components of the TEVADAPTOR® Drug Reconstitution and Transfer System. This shelf life was established by exposing sterilized samples of TEVADAPTOR® components to real-time aging for three years.
With reference to Annex A of ISO 10993-1:2009 and to FDA Blue Book Memo (G95-1), biocompatibility tests performed to demonstrate biocompatibility of the subject devices were:
- . Cytotoxicity (ISO 10993-5:2009)
- Sensitization (ISO 10993-10:2009)
- Irritation or intracutaneous reactivity (ISO 10993-10:2009)
- . Acute systemic toxicity (ISO 10993-11:2006)
- Haemocompatibility (ISO 10993-4:2006)
- Pyrogenicity (ISO 10993-11:2006)
Material characterization tests were also conducted on the subject device components as follows:
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- Determination of extractable species by Infrared spectroscopy for three extracts (PW, IPA and Hexane)
- Physicochemical Tests for Plastics (Non-Aqueous), Non-Volatile Residue
- Physicochemical Tests for Plastics (Aqueous), Non-Volatile Residue
- Determination of Extractable Semi-Volatile Organic Compounds by GC/MS for three extracts (PW, IPA and Hexane)
- . Determination of Extractable Elements by Inductively Coupled Plasma/Mass Spectroscopy (ICP/MS)
- Ultra Performance Liquid Chromatography/Mass Spectrometry (UPLC/MS) for three extracts ● (PW, IPA and Hexane)
- . Infusion Equipment for Medical Use, ISO 8536-4:2010, Annex B, Chemical Tests
The conclusion of the biocompatibility and material characterization tests is that the components of the TEVADAPTOR® System are biocompatible, and that the amount of leachables and extractables as identified by the chemical tests does not alter or adversely affect the biocompatibility of the device components.
Comparison with predicate device:
The predicate devices selected for comparison with the TEVADAPTOR® Closed Drug Reconstitution and Transfer System are identified as follows:
| Predicate Device 1 (PD 1): | TEVADAPTOR® Closed Drug Reconstitution and Transfer System |
|---|---|
| 510(k) Sponsor: | Teva Medical, Migada, Israel |
| 510(k) Number: | K071741 |
| Clearance Date: | 24 September 2007 |
| FDA Product Code: | LHI |
| Classification Name: | Set, I.V., Fluid Transfer |
| Regulation No: | 880.5440 |
| Predicate Device 2 (PD 2): | BD PhaSeal Closed System Drug Transfer Device |
| 510(k) Sponsor: | Becton Dickinson & Co, New Jersey, USA |
| 510(k) Number: | K123213 and K130197 |
| Clearance Date: | 09 January 2013 and 27 February 2013 |
| FDA Product Code: | ONB |
| Classification Name: | Closed antineoplastic and hazardous drug reconstitution and transfersystem |
| Regulation No: | 880.5440 |
| Predicate Device 3 (PD 3): | ChemoLock Closed System Drug Transfer Device |
| 510(k) Sponsor: | ICU Medical Inc., Utah, USA |
| 510(k) Number: | K131549 |
| Clearance Date: | 26 July 2013 |
| FDA Product Code: | ONB |
| Classification Name: | Closed antineoplastic and hazardous drug reconstitution and transfersystem |
| Regulation No: | 880.5440 |
The subject device and one or more of the predicate devices share many identical features and parameters. Differences exist in the following areas:
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- . The subject device includes an additional, with respect to PD 1, Vial Adaptor designed to fit vials with a 28 mm neck size.
- . The following aspects of the subject device Vial Adaptor are modified from that of PD 1:
- The connecting lug windows are closer to the body of the component; O
- o The length of the connecting lugs is reduced;
- o The spike slit is longer.
- . Pressure equalization in the subject device during reconstitution and withdrawal of drug from a vial is achieved by means of a double filter venting mechanism, instead if by an internal balloon, as is the case with PD 2 and PD 3.
Substantial Equivalence Conclusion:
Based on the information contained in this submission, it is concluded that the TEVADAPTOR®, Closed Drug Reconstitution and Transfer System is substantially equivalent to the identified predicate devices already in interstate commerce within the USA.
§ 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.