(68 days)
Not Found
No
The description focuses on the mechanical function of a closed system drug transfer device and does not mention any AI or ML components.
No.
The device is described as a closed system drug transfer device (CSTD) designed to prevent exposure to hazardous drugs and microbial contamination during transfer, not to treat a medical condition.
No
The device is a closed system drug transfer device designed to minimize exposure to hazardous drugs and prevent microbial contamination during drug transfer. It does not perform any diagnostic functions.
No
The device description clearly outlines physical components like membranes, cannulas, and bayonet fittings, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the PhaSeal system is a "closed system drug transfer device (CSTD)" designed to minimize exposure to hazardous drugs and prevent microbial ingress during drug preparation and administration. This is a function related to drug handling and safety, not diagnostic testing.
- Device Description: The description details the mechanical components and how they facilitate the transfer of liquid drugs while maintaining a closed system. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes (biomarkers, pathogens, etc.)
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.
The device's purpose is to ensure the safe and contained transfer of drugs, which falls under the category of medical devices used in drug delivery and handling, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes
ONB
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.
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
Not Found
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)
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:
Biocompatibility - Per ISO 10993
Membrane Leakage - Dye Leak Test - Equivalent to Predicate
Membrane Fragmentation - Fragmentation Test - Equivalent to Predicate
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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
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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.
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Digitally signed by Richard C. Chapman Date: 2014.05.14 07:44:46 -04'00'
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