(30 days)
Not Found
No
The description focuses on mechanical components and their function in creating a closed system for drug transfer. There is no mention of any computational or data-driven processes that would indicate the use of AI or ML.
No.
A therapeutic device is one that treats or prevents a disease. This device is described as a closed system drug transfer device (CSTD) designed to prevent exposure to hazardous drugs and microbial contamination during drug transfer, not to treat a condition.
No
Explanation: The device is described as a closed system drug transfer device that prevents contamination and exposure to hazardous drugs. Its function is to facilitate the safe transfer of drugs, not to diagnose a medical condition.
No
The device description clearly outlines physical components like membranes, cannulas, and adapters, indicating it is a hardware-based system. There is no mention of software as the primary or sole component.
Based on the provided information, the PhaSeal system is not an In Vitro Diagnostic (IVD) device.
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 to the diagnosis of diseases or conditions using samples from the human body.
- Device Description: The description details the mechanical components and how they facilitate the safe transfer of liquids (drugs). It focuses on preventing contamination and exposure, not on analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information.
Therefore, the PhaSeal system falls under the category of a medical device used for drug handling and safety, not an IVD.
N/A
Intended Use / Indications for 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 contractions outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols and spills. The PhaSeal system also prevents microbial ingress.
Product codes (comma separated list FDA assigned to the subject device)
ONB
Device Description
The PhaSeal® System is a sterile single-used closed system drug transfer device. The closed transfer of liguid 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 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, thereby minimizing the individual and environmental exposure to drug vapor, aerosols and spills and also minimizing the risk of microbial contamination.
The PhaSeal Protector is one component of the PhaSeal system. It is a drug vial adapter that is fitted to the drug vial and is used as a docking station between the drug vial and the BD PhaSeal Injector. In addition the Protector equilibrates the pressure difference which occurs when fluid or air is added or removed from the drug vial. 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)
Not Found
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
K-130197
510(K) Summary of Safety and Effectiveness
Date Prepared: 25 January 2013
FEB 2 7 2013
Submitted By: 1 . John Roberts
Regulatory Affairs Specialist BD Medical - Medical Surgical Systems 1 Becton Drive Franklin Lakes, NJ 07417 Tel: 201 847 5473; Fax: 201 847 5307
2. Device Name:
BD PhaSeal Closed System Transfer Device - P55 Trade Name: Closed antineoplastic & hazardous drug reconstitution & transfer system Common Name: Classification Name: Intravascular administration set Classification: 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-used closed system drug transfer device. The closed transfer of liguid 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 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, thereby minimizing the individual and environmental exposure to drug vapor, aerosols and spills and also minimizing the risk of microbial contamination.
The PhaSeal Protector is one component of the PhaSeal system. It is a drug vial adapter that is fitted to the drug vial and is used as a docking station between the drug vial and the BD PhaSeal Injector. In addition the Protector equilibrates the pressure difference which occurs when fluid or air is added or removed from the drug vial. 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 contractions outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols and spills. The PhaSeal system also prevents microbial ingress.
1
and the comments of the comments of the country of
SMDA INFORMATION XII.
A. 510(k) Summary
A 510(k) summary is provided in Attachment XII.1. This 510(k) Summary meets the requirements identified in 21 CFR §807.92.
. . . .
Pre-Market Notification Truthful and Accurate Statement B.
As required per 807.87(k), an Accurate and Truthful Statement is provided in Attachment XII.2. .
.
2
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features the department's name encircling a stylized symbol. The symbol is a graphic representation of an eagle or bird-like figure, with flowing lines suggesting movement or flight.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 27, 2013
Mr. John Roberts Regulatory Affairs Specialist Becton, Dickinson and Company 1 Becton Drive MC237 FRANKLIN LAKES, NJ 07417
Re: K130197
Trade/Device Name: PhaSeal® - A Closed System Transfer Device - P55 Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: ONB Dated: January 25, 2013 Received: January 28, 2013
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.
3
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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,
for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
4
Indications for Use Statement
K130197 510(k) Number (if known):
PhaSeal® - A Closed System Transfer Device - P55 Device Name:
Indications for 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 contractions outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols and spills. The PhaSeal system also prevents microbial ingress.
| Prescription Use | X |
|---|---|
| (Part 21 CFR 801 Subpart D) | |
| AND/OR | |
| Over-The-Counter Use | |
| (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER
PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page of
Gail G. Gantt
Digitally s
DN: c=US,
ou=FDA,
0.9.2342.1
Digitally signed by Gail G. Gantt Pennle, co=Gail G. Gantt. 42:19200300.100.1.1=1300087388
(Division Sign-Off) Division of Anesthesiology, General Hospital ction Control, Dental Devic
510(k) Number: K130197
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