(68 days)
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.
The PhaSeal® System is a sterile single-use closed system drug transfer device. The closed transfer of liquid takes place through a double membrane utilizing self-sealing elastomeric membranes, tightly fitted together through a bayonet fitting on all PhaSeal components. A single lumen cannula perforates the double membranes for the transfer of liguid. 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, thereby minimizing the individual and environmental exposure to drug vapor, aerosols and spills and also minimizing the risk of microbial contamination.
The PhaSeal Injector is one component of the PhaSeal system. It is a luer device adaptor that may be fitted to a syringe or IV tubing. It is used to gain dry and leak-proof access to a drug container or administration device which has been sealed with a PhaSeal Protector or Connector. Liquid transfer takes place through tightly fitting elastomeric double membranes to minimize exposure to potentially hazardous drug aerosols and spills occurring during reconstitution, administration and disposal processes.
This document describes the performance and acceptance criteria for the BD PhaSeal Closed System Transfer Device - Injector, as summarized from the provided text.
1. Table of Acceptance Criteria and Reported Device Performance:
The document outlines design verification tests to demonstrate substantial equivalence to the predicate device. The acceptance criteria are implicit in the "Equivalent to Predicate" or "Per ISO 10993" results for each characteristic.
| Characteristic | Test Performed | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | Per ISO 10993 | Compliance with ISO 10993 | Per ISO 10993 |
| Membrane Leakage | Dye Leak Test | Leakage performance equivalent to predicate | Equivalent to Predicate |
| Membrane Fragmentation | Fragmentation Test | Fragmentation performance equivalent to predicate | Equivalent to Predicate |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for the "Dye Leak Test" or "Fragmentation Test." It mentions "Design Verification tests were performed based on the risk analysis performed," suggesting a controlled testing environment, but no specific sample numbers are given. The data provenance is internal to BD Medical - Medical Surgical Systems, likely conducted in a laboratory setting for device validation. It is a prospective study in the sense that the tests were performed specifically to verify the modified device's performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the given text. The tests appear to be objective performance tests (dye leak, fragmentation) rather than expert-dependent assessments requiring ground truth establishment by human experts. Biocompatibility (ISO 10993) is likely assessed by trained laboratory personnel in accordance with the standard, not necessarily clinical "experts" in the sense of radiologists or similar.
4. Adjudication Method for the Test Set:
This information is not applicable as the tests performed (Biocompatibility, Membrane Leakage, Membrane Fragmentation) are objective measurements or adherence to standards, not subjective assessments requiring adjudication by multiple readers.
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 Transfer Device (CSTD), a physical medical device, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study with human readers and AI assistance is irrelevant to its purpose and performance evaluation.
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 product and does not involve an algorithm or AI.
7. The Type of Ground Truth Used:
For the performance tests:
- Biocompatibility: The "ground truth" would be adherence to the established scientific and regulatory standards outlined in ISO 10993 for biological evaluation of medical devices.
- Membrane Leakage & Fragmentation: The "ground truth" or reference for performance is the predicate device (BD PhaSeal® Connector, Injector, Protector - K123213). The goal was to prove "equivalence," meaning the modified device should perform as well as the predicate device in these specific functional tests.
8. The Sample Size for the Training Set:
This information is not applicable. The described study is a design verification for 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 for the same reason as above (no training set).
{0}------------------------------------------------
Date Prepared: 4 March 2014
Submitted By: John Roberts Regulatory Affairs Specialist BD Medical - Medical Surgical Systems l Becton Drive Franklin Lakes, NJ 07417 Tel: 201 847 5473; Fax: 201 847 5307
2. Device Name:
l.
Trade Name: Common Name: Classification:
BD PhaSeal Closed System Transfer Device - Injector Closed antineoplastic & hazardous drug reconstitution & transfer system Classification Name: Intravascular administration set Class II. 21 C.F.R. § 880.5440
3. Predicate Device
BD PhaSeal® Connector, Injector, Protector - K123213
4. Device Description:
The PhaSeal® System is a sterile single-use closed system drug transfer device. The closed transfer of liquid takes place through a double membrane utilizing self-sealing elastomeric membranes, tightly fitted together through a bayonet fitting on all PhaSeal components. A single lumen cannula perforates the double membranes for the transfer of liguid. 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, thereby minimizing the individual and environmental exposure to drug vapor, aerosols and spills and also minimizing the risk of microbial contamination.
The PhaSeal Injector is one component of the PhaSeal system. It is a luer device adaptor that may be fitted to a syringe or IV tubing. It is used to gain dry and leak-proof access to a drug container or administration device which has been sealed with a PhaSeal Protector or Connector. Liquid transfer takes place through tightly fitting elastomeric double membranes to minimize exposure to potentially hazardous drug aerosols and spills occurring during reconstitution, administration and disposal processes.
5. Intended Use
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.
{1}------------------------------------------------
6. Technological Characteristics
The technological characteristics referenced in Table 1: Technological Characteristics below have been modified from the predicate device. The results of design verification demonstrate that these characteristics are substantially equivalent to the predicate device. All other the technological characteristics of the subject device are identical to those of the predicate devices.
Table 1: Technological Characteristics
| Subject | Predicate (K123213) | Modified Device(N30C, N35, N35C) | Equiv. |
|---|---|---|---|
| Injector membrane | Thermoplastic Elastomer (TPE) | TPE w/ silicone lubricant | Yes |
7. Performance
Design Verification tests were performed based on the risk analysis performed, and the results of these tests demonstrate that the BD PhaSeal Closed System Transfer Device -Injector (N30C, N35, N35C) performed in an equivalent manner to the predicate device and is safe and effective when used as intended. Design Verification testing included the following:
Table 2: Design Verification Testing
| Characteristic | Test Performed | Result |
|---|---|---|
| Biocompatibility | Per ISO 10993 | Per ISO 10993 |
| Membrane Leakage | Dye Leak Test | Equivalent to Predicate |
| Membrane Fragmentation | Fragmentation Test | Equivalent to Predicate |
8. Conclusion
Based on comparison to the predicate device and the results of design verification testing, the modified BD PhaSeal® Closed System Drug Transfer Device - Injector (N30C, N35, N35C) is as safe, as effective, and performs as well as the legally marketed predicate device.
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three wings, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002
May 14, 2014
Becton, Dickinson and Company Mr. John Roberts Regulatory Affairs Specialist 1 Becton Drive MC237 FRANKLIN LAKES, NJ 07417
Re: K140591
Trade/Device Name: BD PhaSeal Closed System Transfer Device - Injector Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular administration set Regulatory Class: II . Product Code: ONB Dated: April 17, 2014 Received: April 21, 2014
Dear Mr. Roberts,
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.
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.
{3}------------------------------------------------
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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mary Si Bunner -S
Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K140591
Device Name
BD PhaSeal Closed System Transfer Device - Injector
Indications for Use (Describe)
The PhaSeal system is an airtight and leakproof closed system drug (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.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FOR FOR FOR FOR FOR FOR FOR A BOOK FOR FOR FOR FOR FOR
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Image /page/4/Picture/13 description: The image shows the logo for the Food and Drug Administration (FDA). The letters "FDA" are displayed in a bold, sans-serif font. The logo is simple and recognizable, and it is often used on products that have been approved by the FDA. The logo is a symbol of safety and quality.
Digitally signed by Richard C. Chapman Date: 2014.05.14 07:44:46 -04'00'
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
§ 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.