The indication for use is admixing of drug into an IV container and administration/transfer of drug from the container to an external IV line, while minimizing exposure to potentially hazardous drugs aerosols and spills that can occur during the admixing, administration and disposal process.

Device Description

The Injector is a sterile device for single-use within the PhaSeal® closed transfer device system for preparation and administration of parenteral drugs.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Infusion Adapter C100, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria Category	Specific Test Performed	Reported Device Performance
General Performance	Verify integrity of the device and compatibility with other PhaSeal components	Passed
	Pulling force test (in connection to other PhaSeal components)	Passed
	Torque test (in connection to other PhaSeal components)	Passed
	Liquid flow test	Passed
	Air tightness test	Passed
	Handling tests	Passed
Material Testing	Functional and mechanical properties on product after 24h of chemical exposure with Etopside, Taxo, and Busulfan	Passed
	Functional and mechanical properties on product after 72h of chemical exposure with Etopside, Taxo, and Busulfan	Passed
Biocompatibility	Systemic Injection test	Passed
	Cytotoxicity test	Passed
	Hemolysis test	Passed
	Dermal sensitization test	Passed
	Intracutaneous test	Passed
	Physicochemical tests - plastic	Passed

Study Details

Based on the provided text, the device in question, the Infusion Adapter C100, is being submitted for 510(k) clearance, which typically involves demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical studies with human subjects in the same way a novel drug or high-risk device might. The information provided heavily focuses on performance and material testing for safety and functionality.

Here's a breakdown of the requested information based on the document:

1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size: The document does not specify the exact sample size for each test. It states "Performance testing refer to verify integrity of the device and compatibility with the relevant other PhaSeal components." and lists various tests. For the material testing, it refers to "product after 24h and 72h of chemical exposure." Typical 510(k) submissions for devices like this involve a sufficient number of units to demonstrate statistical reliability for the specific tests (e.g., n=3 or n=10 per test) but these numbers are not explicitly stated.
Data Provenance: Not explicitly stated, but the submitter Carmel Pharma AB is located in Mölndal, Sweden. It is highly likely the testing was conducted either internally at their facilities or by contract testing laboratories, which could be in Sweden or other countries. The document does not specify if the data is retrospective or prospective, but as these are laboratory performance and material tests, they would be conducted prospectively for the submission.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable in the context of this device and submission type. The "ground truth" for these types of tests (e.g., pulling force, liquid flow, biocompatibility) is established by predefined engineering specifications, industry standards, and regulatory requirements, not by expert consensus on interpreting data like imaging. The "experts" involved would be engineers, material scientists, and toxicologists conducting and interpreting the tests against established criteria. Their qualifications are implicitly assumed to be appropriate for performing these specific tests within standard laboratory practices.

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

This concept of "adjudication" (e.g., 2+1, 3+1) is typically associated with clinical studies where multiple human readers or evaluators independently assess patient data and their disagreements are resolved. For the performance and material testing described here, adjudication is not applicable. The results are objective measurements against predefined pass/fail criteria.

4. 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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic medical devices, particularly those involving human interpretation of images or other subjective data, often in the context of AI assistance. The Infusion Adapter C100 is a drug delivery accessory, and its evaluation focuses on physical performance, material compatibility, and biocompatibility, not on human interpretation or AI assistance.

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

No, a standalone (algorithm-only) performance study was not done. This device is a physical medical device, not a software algorithm.

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

The "ground truth" for the performance tests outlined here consists of predefined engineering specifications, industry standards, and regulatory requirements. For example, a successful "pulling force" test means the device withstood a certain force without separating or failing, as specified in its design requirements. For biocompatibility, the ground truth is adherence to internationally recognized standards for biological evaluation of medical devices (e.g., ISO 10993 series), where specific test results (e.g., absence of cytotoxicity) are considered "passing."

7. The sample size for the training set

This question is not applicable. This device is a physical product and does not involve AI or machine learning models that require a "training set" of data.

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

This question is not applicable, as there is no training set for this device.

Summary

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KI10023 1981

ATTACHMENT 5

APR 1 2 2011

510(K) SUMMARY

Summarv of Safety and Effectiveness

In accordance with 21 CFR 807.92, the following information constitutes the Carmel Pharma ab summary for the Infusion Adapter C100 included in:

PhaSeal® - A Closed System Drug Transfer Device for Preparation and Administration of Parenteral Drugs

SUBMITTER'S NAME: Carmel Pharma AB . ้า Aminogatan 30 ADDRESS: SE-43153 Mölndal Sweden . . . . . . . . . . . ..............................................................................................................................................................................

CONTACT PERSON: TELEPHONE NUMBER: FAX NUMBER: DATE OF SUBMISSION:

Kiell Andreasson +46 31 7030400 +46 31 7030404 December 10, 2010

1. Identification of device

Proprietary Name:	PhaSeal Infusion Adapter
Common Name:	I.V.-Fluid-Transfer-Set
Classification Status:	Class II per 21 CFR 880.5440
Product code:	LHI

2. Equivalent devices

Infusion Adapter C100 is previously cleared in K023747.

Description of the Device 3.

The Injector is a sterile device for single-use within the PhaSeal® closed transfer device system for preparation and administration of parenteral drugs.

Intended use. 4.

The intended use of this device is to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein.

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K110023 pg 2

Technological characteristics, comparison to predicate device. 5.

Infusion Adapter

…

: \

Subject	C100	C100 K023747	Equiv.
Indication for use	The indication for use isadmixing of drug into an IVcontainer andadministration/transfer of drugfrom the container to anexternal IV line, whileminimizing exposure topotentially hazardous drugsaerosols and spills that canoccur during the admixing,administration and disposalprocess.	The Infusion Adapter serves asthe connecting part between theIV bag and an external IV line(e.g. IV regulators). The InfusionAdapter has a built in Connectorwhich makes it possible to admixdrugs into the infusion solutionusing the sealed PhaSeal doublemembrane technique	Yes
Intended use	The intended use of this deviceis to administer fluids from acontainer to a patient's vascularsystem through a needle orcatheter inserted into the vein.	The intended use of this device isto administer fluids from one acontainer to a patient's vascularsystem through a needle orcatheter inserted to a vein. Theinfusion adapter mates with thePhaSeal injector bayonet fittingwhich prevents drug spillage intothe environment	Yes
Flushing of systemprior to use	No	Yes
Material	Spike port: TPESpike housing: PPSpike Cap: PP	Spike port: TPESpike housing: ABSSpike Cap: PP	Yes
Fitting connection	Spike housing: to Injector andto infusion bagSpike port: to external spikeincluded in an administrationset	Spike housing: to Injector andto infusion bagSpike port: to external spikeincluded in an administrationset	Yes
Sterilization method	EtO	EtO	Yes

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Summary of design control activities 6.

Performance testing – general performance

Modification	Test Performed	Passed
Performance testing refer to verify integrity of thedevice and compatibility with the relevant otherPhaSeal components.	Pulling force, torque test inconnection to other PhaSealcomponents, liquid flow, airtightness, handling tests,	Yes

Material testing – specific requirements

Modification	Test Performed	Passed
Specific requirements refer to integrity of thematerial in combination with the aggressivechemicals.	Functional and mechanicalproperties on product after 24hand 72h of chemical exposurewith Etopside, Taxo andBusulfani	Yes

Biocompatibility

な

Modification	Test Performed	Passed
The Infusion Adapter is indirect invasive,duration normally 1-2 hours, may be 24-48hours if patient is hospitalised.	Systemic Injection test,Cytotoxicity, Hemolysis, Dermalsensitization, Intracutaneous testand Physicochemical tests -plastic.	Yes

7. Discussion of performance testing.

The tests performed show that that Infusion Adapter C100 fulfil the stated requirements and therefore comply with the claims of the intended use.

8. Conclusion

Based on comparison to the predicate device, we come to the conclusion that the Infusion Adapter C100 included in the PhaSeal System, is substantially equivalent to previously cleared predicate devices and presents no new concerns about safety and effectiveness.

p47

12110023

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread, with three stripes representing the feathers. The eagle is facing to the right.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002

Mr. Kjell Andreasson Manager, Regulatory Affairs Carmel Pharma AB Aminogatan 30 Mölndal SWEDEN S431 53

APR 1 2 2011

Re: K110023

Trade/Device Name: Infusion Adapter C100 Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: LHI Dated: March 1, 2011 Received: March 8, 2011

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. 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.

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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); 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.

hh fo

Anthony Watson, B.S., M.S., M.B.A. 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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Attachment 1

Indications for Use Statement

510(k) Number (if known)	K110023
Device Name	Infusion Adapter C100
Indications for Use	The indication for use is admixing of drug into an IV container and administration/transfer of drug from the container to an external IV line, while minimizing exposure to potentially hazardous drugs aerosols and spills that can occur during the admixing, administration and disposal process.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: Yes (Per 21 CFR 801. 109)

OR Over-The-Counter Use: No

RC. 4/8/11

(Division Sign-Off)

(Division Sign-Off)
Division of Anesthesiology, General Hospita
Infection Control and Dental Devices
510(k) Number:

K 110023 Page 1 of 1

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.