(29 days)
Not Found
No
The 510(k) summary describes a mechanical system for safe drug handling and administration, with no mention of AI or ML technologies.
No
The device is described as a port for IV administration and a component of a closed system for handling parenteral drugs, particularly cytotoxic drugs, to prevent leakage. Its function is to facilitate drug transfer and minimize exposure, not to treat a disease or condition itself.
No
The device is described as a "closed system for handling of parenteral drugs" and a "port for IV administration," designed for "safe handling of medications," particularly to "prevent leakage" and "minimize exposure to potentially hazardous drug aerosols and spills." These functions relate to drug delivery and safety, not the diagnosis of a condition.
No
The device description clearly describes physical components (Y-site Line, Connector, elastomeric membranes, injection cannula) used for drug administration, indicating it is a hardware device, not software only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a port for IV administration of drugs to a patient. This is a therapeutic or drug delivery function, not a diagnostic one.
- Device Description: The description focuses on the mechanism for safely transferring drugs into a patient's IV line, emphasizing the prevention of leakage and exposure to hazardous drugs. This aligns with drug administration, not in vitro testing.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosis or monitoring of a disease state.
IVD devices are used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is solely related to the delivery of medication.
N/A
Intended Use / Indications for Use
The Y-site Line serves as the port for IV administration with PhaSeal if there is no Luer Lock fitting, for Connector Luer Lock in the patients IV line. The Y-site Line has a built in Connector which makes it possible to administer drugs into the patient using the sealed double membrane technique.
Product codes
LHI
Device Description
PhaSeal is a closed system for handling of parenteral drugs where the component devices are dedicated to each other to create the system. These single use devices are designed to promote safe handling of medications, particularly cytotoxic drugs. Leakage of drug into the environment is effectively avoided during all three phases of drug handling when the PhaSeal system is used: the preparation of the drug, the administration of the drug to the patient, and waste handling.
All drug transferring utilizes a double membrane technique. Each component device is sealed off with an elastomeric membranes are joined together and transfer is made via a specially cut injection cannula. When the component devices of the system are separated after transfer, the membranes act as tight seals that prevent leakage.
The Y-site Line serves as the port for IV administration with PhaSeal if there is no Luer Lock fitting, for Connector Luer Lock in the patients IV line. The Y-site Line has a built in Connector which makes it possible administer drugs into the IV line of the patient using the PhaSeal Injector. Liquid transfer takes place through tightly fitting elastomeric membranes to minimize exposure to potentially hazardous drug aerosols and spills that occur during the 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
K060866
Exhibit 8
APD 18 2006
Special 510(k) Summary
Carmel Pharma AB Company name:
PhaSeal® - closed system for the preparation and administration of Product Name: parenteral drugs
Device name:
Y-site Line
PhaSeal is a closed system for handling of parenteral drugs where the component devices are dedicated to each other to create the system. These single use devices are designed to promote safe handling of medications, particularly cytotoxic drugs. Leakage of drug into the environment is effectively avoided during all three phases of drug handling when the PhaSeal system is used: the preparation of the drug, the administration of the drug to the patient, and waste handling.
All drug transferring utilizes a double membrane technique. Each component device is sealed off with an elastomeric membranes are joined together and transfer is made via a specially cut injection cannula. When the component devices of the system are separated after transfer, the membranes act as tight seals that prevent leakage.
PhaSeal, Y-site Line
The Y-site Line serves as the port for IV administration with PhaSeal if there is no Luer Lock fitting, for Connector Luer Lock in the patients IV line. The Y-site Line has a built in Connector which makes it possible administer drugs into the IV line of the patient using the PhaSeal Injector. Liquid transfer takes place through tightly fitting elastomeric membranes to minimize exposure to potentially hazardous drug aerosols and spills that occur during the administration and disposal processes.
Comparison of Predicate Devices/Equivalence
The device is substantially equivalent to previously cleared PhaSeal devices included in 510(k) Number K980381.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 28 2006
Mr. Kjell Andreasson Vice President Quality Assurance and Regulatory Affairs Carmel Pharma AB Aminogatan 30, Molndal, Box 5352 Goteborg, Sweden SE 402 28
Re: K060866
Trade/Device Name: PhaSeal Y-Site Line-Intravascular Administration Set Regulation Number: 880,5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: LHI Dated: March 27, 2006 Received: March 30, 2006
Dear Mr. Andreasson:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
2
Page 2 - Mr. Andreasson
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Exhibit 3
Indications for Use
510(k) Number (if known): K060866
PhaSeal Y-site Line - Intravascular Administration Set Device name:
Indications for use:
The Y-site Line serves as the port for IV administration with PhaSeal if there is no Luer Lock fitting, for Connector Luer Lock in the patients IV line. The Y-site Line has a built in Connector which makes it possible to administer drugs into the patient using the sealed double membrane technique.
Prescription Use: Yes (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use: No (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device evaluation (ODE)
Anthong D. hme
· Joneral Huspitul,
K46.0866