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.

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.

AI/ML Overview

The provided text is a 510(k) summary for the PhaSeal® closed system for the preparation and administration of parenteral drugs. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study. Therefore, much of the requested information regarding acceptance criteria, study design, and ground truth cannot be extracted directly from this type of regulatory submission.

Here's an analysis based on the provided text, highlighting what is and isn't available:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not provide a table of acceptance criteria or quantitative performance metrics typically associated with a clinical study. The submission focuses on demonstrating substantial equivalence in function and components to already marketed predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a clinical "test set" in the context of a performance study. No sample sizes for testing or data provenance (country, retrospective/prospective) are mentioned, as the basis of the submission is a comparison to predicate devices, not a de novo performance evaluation.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable or available. Ground truth establishment for a test set implies a performance study (e.g., diagnostic accuracy), which is not detailed in this 510(k) submission.

4. Adjudication Method for the Test Set

This information is not applicable or available, as no performance study with a test set requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Reader Improvement

This information is not applicable or available. The submission does not detail any comparative effectiveness study, especially one involving human readers with and without AI assistance. The PhaSeal system is a physical medical device, not an AI-powered diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable or available. The PhaSeal system is a physical device, not an algorithm.

7. The Type of Ground Truth Used

This information is not applicable or available. The submission doesn't describe establishing ground truth for a performance study. Instead, it relies on the known safety and efficacy of the predicate devices.

8. The Sample Size for the Training Set

This information is not applicable or available. There is no mention of a "training set" as this is not an algorithm-based device.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable or available, as there is no training set described.

Summary of what the document DOES provide, relevant to its purpose:

The document explains the function of the PhaSeal system components (Infusion Adapter, Protection Cap, Secondary Set, Extension Set) and argues for their substantial equivalence to existing predicate devices based on:

Similar components: "all use similar components"
Similar function: "provide a pathway to administer fluids from a container to a patient's vascular system" or "a protection and mechanical cover for a connections to IV systems."

This 510(k) submission is a regulatory filing aimed at demonstrating that the new device is as safe and effective as a legally marketed predecessor, not a detailed report of a clinical performance study with specific acceptance criteria.

Summary

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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

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.

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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.)

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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

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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

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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

Regulation Number and Section

§ 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.