(29 days)
Not Found
No
The device description focuses on mechanical components and a double membrane technique for drug transfer, with no mention of AI or ML.
No
The device is described as a "closed system for the preparation and administration of parenteral drugs," and its components facilitate drug preparation, transfer, and administration. It does not directly treat or diagnose a disease or condition, but rather aids in the safe handling of medications.
No
The device is described as a "closed system for the preparation and administration of parenteral drugs," focusing on safe drug handling and preventing leakage, not on diagnosing medical conditions.
No
The device description clearly outlines multiple physical components (Infusion Adapter, Protection Cap, Secondary Set, Extension Set) that are part of the PhaSeal system. These are hardware components designed for the preparation and administration of parenteral drugs.
Based on the provided information, the PhaSeal system and its components are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states the system is for the "preparation and administration of parenteral drugs." This involves handling and delivering medications to a patient's body, not analyzing samples in vitro (outside the body) to diagnose a condition.
- Device Description: The description focuses on the mechanical aspects of the system for safe drug handling and transfer, particularly for cytotoxic drugs. It describes a "closed system" and a "double membrane technique" for preventing leakage during preparation, administration, and waste handling. This is related to drug delivery and safety, not diagnostic testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information. The system's function is purely related to the physical handling and delivery of drugs.
Therefore, the PhaSeal system falls under the category of medical devices used for drug administration, not IVD devices.
N/A
Intended Use / Indications for Use
The Infusion Adapter serves as the connecting part between the IV bag and an external IV line. (Example IV regulators.) The Infusion Adapter has a built in Connector which makes it possible to admix drugs into the infusion solution using the sealed double membrane technique.
The Protection Cap is intended to be used as a mechanical cover for the membrane in the bayonet fitting of PhaSeal devices The Protection Cap mates with the other PhaSeal components equipped with the bayonet fitting. One end of the Protection Cap has a male bayonet fitting and in the other a female bayonet fitting.
The Secondary Set is a non-vented infusion set used when drug is handled as an admixture and is administered via Intravenous infusion. The Secondary Set has a built in Connector which makes it possible to admix drugs into the infusion solution using the sealed PhaSeal technique.
The Extension Set serves as the port for bolus injection with PhaSeal if there is no Luer Lock fitting, for Connector Luer Lock in the patients IV line. The Extension Set has a built in Connector which makes it possible inject drugs into the IV line of the patient using the sealed double membrane technique.
Product codes (comma separated list FDA assigned to the subject device)
LHI
Device Description
PhaSeal is a closed system for preparation and administration 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 administration of the drug to the patient, and waste handling.
All drug transferring utilizes a patented double membrane technique. Each component devices is sealed off with an elastomeric membrane cover. The 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 Infusion Adapter Intravascular Administration Set
The Infusion Adapter serves as a the connecting part between the IV bag and an external IV line. (Example IV regulators.) The Infusion Adapter has a built in Connector which makes it possible to admix drugs into the infusion solution using the sealed double membrane technique. -
· PhaSeal Protection Cap Special accessories
The Protection Cap is intended to be used as a mechanical cover for the membrane in the bayonet fitting of PhaSeal devices The Protection Cap mates with the other PhaSeal components equipped with the bayonet fitting. One end of the Protection Cap has a male bayonet fitting and in the other a female bayonet fitting. -
· PhaSeal Secondary Set Intravascular Administration Set
The Secondary Set is a non-vented infusion set used when drug is handled as an admixture and is administered via Intravenous infusion. The Secondary Set has a built in Connector which makes it possible to admix drugs into the infusion solution using the sealed PhaSeal technique. -
· PhaSeal Extension Set Intravascular Administration Set
The Extension Set serves as the port for bolus injection with PhaSeal if there is no Luer Lock fitting, for Connector Luer Lock in the patients IV line. The Extension Set has a built in Connector which makes it possible inject drugs into the IV line of the patient using the sealed double membrane technique.
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.
Codan Medlon, IV Administration Set -- Catalog Rev 3/1/93 B&P, preamendment device, Carmel Pharma ab, PhaSeal, a closed system for parenteral drugs, K972527
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
K98038
SUMMARY OF SAFETY AND EFFECTIVENESS DATA
Carmel Pharma AB
MAR - 3 1998
PhaSeal® closed system for the preparation and administration of parenteral drugs
Carmel Pharma Contact Person
Britt Novén Manager, Regulatory Affairs Carmel Pharma AB Box 5352 S-402 28 Göteborg, Sweden +46 31-703 04 00 Phone: Fax: +46 31-703 04 00 (Visitors: Flöjelbergsgatan 16B, Mölndal)
Device Name
PhaSeal® closed system for the preparation and administration of parenteral drugs.
Infusion Adapter Protection Cap Secondary Set Extension Set
Predicate Devices
- Codan Medlon, IV Administration Set -- Catalog Rev 3/1/93 B&P, preamendment device .
- Carmel Pharma ab, PhaSeal, a closed system for parenteral drugs, K972527 .
Product Description, Function, Safety and Efficacy
PhaSeal is a closed system for preparation and administration 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 administration of the drug to the patient, and waste handling.
All drug transferring utilizes a patented double membrane technique. Each component devices is sealed off with an elastomeric membrane cover. The 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 Infusion Adapter Intravascular Administration Set
The Infusion Adapter serves as a the connecting part between the IV bag and an external IV line. (Example IV regulators.) The Infusion Adapter has a built in Connector which makes it possible to admix drugs into the infusion solution using the sealed double membrane technique.
1
1780581
-
· PhaSeal Protection Cap Special accessories
The Protection Cap is intended to be used as a mechanical cover for the membrane in the bayonet fitting of PhaSeal devices The Protection Cap mates with the other PhaSeal components equipped with the bayonet fitting. One end of the Protection Cap has a male bayonet fitting and in the other a female bayonet fitting. -
· PhaSeal Secondary Set Intravascular Administration Set
The Secondary Set is a non-vented infusion set used when drug is handled as an admixture and is administered via Intravenous infusion. The Secondary Set has a built in Connector which makes it possible to admix drugs into the infusion solution using the sealed PhaSeal technique. -
· PhaSeal Extension Set Intravascular Administration Set
The Extension Set serves as the port for bolus injection with PhaSeal if there is no Luer Lock fitting, for Connector Luer Lock in the patients IV line. The Extension Set has a built in Connector which makes it possible inject drugs into the IV line of the patient using the sealed double membrane technique.
Comparison of Predicate Devices/Equivalence
● PhaSeal Infusion Adapter
Is substantially equivalent to Codan Medlon Inc. Vented Set (C 302 and C430) and Carmel Pharma ab, Infusion Set in that they all use similar components and provide a pathway to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. (Neither device provides the needle or catheter.)
. PhaSeal Protection Cap
Is substantially equivalent the Codan Medlon Inc. (BC 103) Special Accessories Luer Lock Plug in both being a protection and mechanical cover for a connections to IV systems. Protection Cap is substantially equivalent with Carmel Pharma ab Connector in design, the bayonet fitting and material.
PhaSeal Secondary Set .
Is substantially equivalent to Codan Medlon Inc. Vented Set (C 302) and Carmel Pharma ab, Infusion Set in that they all use similar components and provide a pathway to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. (Neither device provides the needle or catheter.)
● PhaSeal Extension Set
Is substantially equivalent to Codan Medloc Inc. Vented Set (BC 589) and Carmel Pharma ab, Infusion Set in that they all use similar components and provide a pathway to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. (Neither device provides the needle or catheter.)
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three heads, representing health, services, and people. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", which is arranged in a circular fashion around the figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 3 1998
Mr. Britt Novén Manager, Regulatory Affairs Carmel Pharma AB Box 5352 S-402 28 Göteborg, Sweden
K980381 Re : PhaSeal® closed system for the preparation Trade Name: and administration of parenteral drugs Regulatory Class: II Product Code: LHI January 30, 1998 Dated: February 2, 1998 Received:
Dear Mr. Novén:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual reqistration, 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does
3
Page 2 - Mr. Novén
not affect any obligation you might have under sections 531
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to Other general information on your responsibilities under the Act may be wor obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fde.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
A. Timothy Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
4
27. Indications for Use Statement:
510(k) Number (if known):
Device Name: PhaSeal® closed system for the preparation and administration of parenteral drugs
Indications for Use:
PhaSeal Infusion Adapter - Intravascular Administration Set
The Infusion Adapter serves as the connecting part between the IV bag and an external IV line. (Example IV regulators.) The Infusion Adapter has a built in Connector which makes it possible to admix drugs into the infusion solution using the sealed double membrane technique.
PhaSeal Protection Cap - Special accessories
The Protection Cap is intended to be used as a mechanical cover for the membrane in the bayonet fitting of PhaSeal devices The Protection Cap mates with the other PhaSeal components equipped with the bayonet fitting. One end of the Protection Cap has a male bayonet fitting and in the other a female bayonet fitting.
PhaSeal Secondary Set - Intravascular Administration Set
The Secondary Set is a non-vented infusion set used when drug is handled as an admixture and is administered via Intravenous infusion. The Secondary Set has a built in Connector which makes it possible to admix drugs into the infusion solution using the sealed PhaSeal technique.
PhaSeal Extension Set - Intravascular Administration Set
The Extension Set serves as the port for bolus injection with PhaSeal if there is no Luer Lock fitting, for Connector Luer Lock in the patients IV line. The Extension Set has a built in Connector which makes it possible inject drugs into the IV line of the patient using the sealed double membrane technique.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
Patricia Crescenti
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number X98038
Over the Counter Use