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.

AI/ML Overview

This document is a 510(k) summary for the PhaSeal Y-site Line, an intravascular administration set. It primarily focuses on demonstrating substantial equivalence to a previously cleared device (K980381) rather than presenting a performance study with detailed acceptance criteria and a comprehensive study report as one might find for a novel device undergoing extensive clinical trials.

Therefore, the requested information elements related to specific acceptance criteria, detailed study design, expert ground truth, and AI-specific metrics (like MRMC studies) are not fully present in the provided text because this type of submission is for a device deemed substantially equivalent to an already approved one.

However, I can extract the available information and point out where the requested details are absent.

Description of Device and Comparison to Predicate

The PhaSeal Y-site Line is a component of the PhaSeal closed system for handling parenteral drugs, particularly cytotoxic drugs. It serves as a port for IV administration when a Luer Lock fitting is not available in the patient's IV line. It uses a built-in connector that works with the PhaSeal Injector, utilizing a double membrane technique designed to prevent leakage of hazardous drug aerosols and spills.

The device is considered substantially equivalent to previously cleared PhaSeal devices included in 510(k) Number K980381. This claim of substantial equivalence replaces the need for extensive de novo performance studies in this specific 510(k) submission. Therefore, detailed acceptance criteria and a specific performance study in the manner requested are not explicitly outlined for this particular submission entry (K060866) beyond the general safety and efficacy implied by substantial equivalence to its predicate.

Requested Information Based on Provided Document:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance (based on documentation)
Prevention of leakage/spills: (Central to PhaSeal system functionality)	"Leakage of drug into the environment is effectively avoided during all three phases of drug handling..."
Safe handling of medications: (General objective)	"These single use devices are designed to promote safe handling of medications, particularly cytotoxic drugs."
Functionality with PhaSeal Injector: (Device-specific)	"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."
Material/Component Compatibility & Biocompatibility: (Standard for medical devices)	Not explicitly detailed in this summary, but required for predicate.
Sterility: (Standard for intravascular devices)	Not explicitly detailed in this summary, but required for predicate.
Durability/Integrity: (Functionality over time)	Not explicitly detailed in this summary, but required for predicate.

Note: The document states, "The device is substantially equivalent to previously cleared PhaSeal devices included in 510(k) Number K980381." This means the foundational acceptance criteria and performance data would have been established and met by the predicate device. This specific 510(k) (K060866) relies on demonstrating that the Y-site Line performs equivalently.

2. Sample size used for the test set and the data provenance

Not explicitly stated in this 510(k) summary. Since this is a substantial equivalence submission, a new, independent performance study with a specific "test set" and sample size as described for a de novo device is not presented. The "data" refers to the established performance of the predicate device (K980381).
Data Provenance: The predicate device (PhaSeal system) was developed by Carmel Pharma AB (Molndal, Goteborg, Sweden). The provided text does not specify the country of origin of testing data for the predicate, nor whether it was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/not explicitly stated in this 510(k) summary. This type of information is typically for diagnostic devices, particularly those involving image interpretation where expert consensus is needed to establish "ground truth." This device is an administration set. The "ground truth" for its safety and effectiveness would be established through engineering validation, material testing, and potentially clinical use data of the predicate, as opposed to expert interpretation of data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/not explicitly stated in this 510(k) summary. This concept is generally applied to diagnostic studies where multiple readers interpret data and discrepancies are adjudicated.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an intravascular administration set, not an AI-powered diagnostic tool. Therefore, MRMC studies and AI assistance metrics are irrelevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical medical device, not an algorithm, so "standalone" performance in this context is irrelevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For this type of device (intravascular administration set), the "ground truth" for its performance, safety, and effectiveness would be established through a combination of:
- Engineering specifications and tests: Demonstrating the physical integrity of the component, the sealing mechanism (double membrane), burst pressure, leak tests, and flow rates.
- Biocompatibility testing: Compliance with ISO 10993 standards.
- Sterilization validation: Ensuring the device is sterile.
- Clinical performance data (for the predicate): Evidence from the predicate device (K980381) demonstrating its effectiveness in preventing drug exposure during preparation, administration, and waste handling in actual use, likely supported by observational studies or post-market surveillance.
None of these specific details are provided in this 510(k) summary. The summary relies on the overarching claim of substantial equivalence to K980381.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that would require a "training set."

9. How the ground truth for the training set was established

Not applicable. As above, no training set is involved.

Summary

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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, Y-site Line

Comparison of Predicate Devices/Equivalence

The device is substantially equivalent to previously cleared PhaSeal devices included in 510(k) Number K980381.

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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.

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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

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Exhibit 3

Indications for Use

510(k) Number (if known): K060866

PhaSeal Y-site Line - Intravascular Administration Set Device name:

Indications for use:

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

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.