The indication for use of the PhaSeal system and included components are reconstitution and transfer of drug solutions from one container to another while minimizing exposure to potentially hazardous drugs aerosols and spills that can occur during the reconstitution, administration and disposal process.

Device Description

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

AI/ML Overview

The provided document describes the 510(k) summary for the Carmel Pharma ab's Injector N34, N35, N35C and Connector C35, C45, which are components of the PhaSeal® - A Closed System Drug Transfer Device for Preparation and Administration of Parenteral Drugs. The device relies on demonstrating substantial equivalence to previously cleared predicate devices rather than meeting specific quantitative acceptance criteria through a clinical study.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This submission is a 510(k) for substantial equivalence, not a performance study with quantitative acceptance criteria against specific metrics. The "acceptance criteria" here are qualitative, focusing on whether the new devices are "substantially equivalent" to predicate devices. The performance is demonstrated by comparing technological characteristics and intended use.

Acceptance Criteria (Substantial Equivalence)	Reported Device Performance (Comparison to Predicate)
Intended Use: Device's purpose is the same as the predicate.	Injector N34, N35, N35C: Intended use (injecting/withdrawing fluids from drug vials, then into IV sets/containers) is identical to predicate N30 (K972527) and N31 (K001368). Connector C35, C45: Intended use (connecting PhaSeal Injector to IV administration set parts, minimizing drug spillage) is identical to predicate C40 (K972527).
Technological Characteristics: Key features are similar or present acceptable differences.	Injector N34 vs. Predicate N30: Cannula (pencil point vs. cut), Needle safety lock (ErgoMotion™ vs. latch), Fitting connection (Luer rotation vs. no rotation), Sterilization method (EtO vs. EtO). All deemed "Yes" for equivalence. Injector N35/N35C vs. Predicate N31: Cannula (pencil point vs. cut), Needle safety lock (ErgoMotion™ vs. latch), Fitting connection (Luer Lock rotation vs. no rotation), Sterilization method (EtO vs. EtO). All deemed "Yes" for equivalence. Connector C35 vs. Predicate C40: Bayonet fitting (reduced notches - no click vs. notches - with a "click"), Length (26 mm vs. 26 mm), Sterilization method (EtO vs. EtO). All deemed "Yes" for equivalence. Connector C45 vs. Predicate C40: Bayonet fitting (reduced notches - no click vs. notches - with a "click"), Length (34 mm for CLAVE connection vs. 26 mm), Sterilization method (EtO vs. EtO). All deemed "Yes" for equivalence.
Safety and Effectiveness: Do not raise new questions of safety or effectiveness.	The submission concludes that "Based on comparison to the predicate device, we come to the conclusion that the Injectors N34, N35, N35C and Connectors C35, C45 included in the PhaSeal System, are substantially equivalent to previously cleared predicate devices and present no new concerns about safety and effectiveness."

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

The document does not describe a specific "test set" in the context of a performance study with a sample size of clinical cases or data points. This is a submission for substantial equivalence based on bench testing and comparison of technical specifications to predicate devices. Therefore:

Sample size for the test set: Not applicable, as there's no clinical "test set" described. The testing mentioned is "performance testing" which likely refers to engineering/bench tests rather than clinical data.
Data provenance: Not applicable. There is no clinical data (e.g., country of origin, retrospective/prospective) used to prove performance in the context of this 510(k) summary.

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

Not applicable. This is a technical comparison for substantial equivalence, not a study involving expert-established ground truth for a test set of medical conditions.

4. Adjudication Method for the Test Set

Not applicable. There is no clinical test set requiring adjudication.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No. The document does not describe a Multi Reader Multi Case (MRMC) comparative effectiveness study, nor does it quantify an effect size of human readers improving with or without AI assistance. The device is a physical medical device (injectors and connectors), not an AI-powered diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the Loop Performance) Study

No. The document does not describe any standalone algorithm performance study. The device is a physical medical device.

7. Type of Ground Truth Used

Not applicable. Since there is no clinical "test set" and outcome evaluation in the traditional sense, there is no ground truth (e.g., pathology, outcomes data) as would be used in a diagnostic study. The "ground truth" for this 510(k) is the established safety and effectiveness of the predicate devices to which the new devices are compared.

8. Sample Size for the Training Set

Not applicable. This is a submission for a physical medical device, not an algorithm that requires a training set.

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

Not applicable. As there is no training set for an algorithm, the concept of establishing ground truth for it does not apply.

Summary

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K092782

ATTACHMENT 5

DEC - 7 2009

510(K) SUMMARY

Summary of Safety and Effectiveness

In accordance with 21 CFR 807.92, the following information constitutes the Carmel Pharma ab summary for the Injector N30, N31, N34, N35 and N35C and Connector C35, C40 and C45 included in:

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

SUBMITTER'S NAME:	Carmel Pharma ab
ADDRESS:	Aminogatan 30SE 431 53 MolndalSweden.

CONTACT PERSON: TELEPHONE NUMBER: FAX NUMBER: DATE OF SUBMISSION: Kjell Andreasson +46 31 7030400 +46 31.7030404 September 4, 2009

Identification of device 1.

Proprietary Name: Common Name: Classification Status: Product code:

PhaSeal Injector and Connector I.V. Fluid Transfer Set Class II per 21 CFR 880.5440 LHI.

2. Equivalent devices

Injector N30 and N31 and Connector C40 cleared in K972527 and K001368.

Description of the Device 3.

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

4. Indication for use

The intended use of the Injectors is to inject fluids into, and to withdraw fluids from a drug vial, and then to inject fluids into a primary or secondary IV administration set, or into an IV container.

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The Connector is a connector between the PhaSeal Injector and parts of an IV administration set up such as a stopcock or an admixture channel of the spike for the IV container. The PhaSeal elastomeric membrane seals with the elastomeric membranes of other PhaSeal components to help prevent drug spillage.

Technological characteristics, comparison to predicate device. 5.

Injector Luer N34

Subject	N34	Predicate N30, K972527	Equiv.
Intended use	The intended use of the Injectors is to inject fluids into, and to withdraw fluids from a drug vial, and then to inject fluids into a primary or secondary IV administration set, or into an IV container.	The intended use of the Injectors is to inject fluids into, and to withdraw fluids from a drug vial, and then to inject fluids into a primary or secondary IV administration set, or into an IV container.	Yes
Cannula	Stainless steel - pencil point cannula	Stainless steel - cut cannula	Yes
Needle safety lock	Safety sleeve “ErgoMotion™”	Safety latch	Yes
Fitting connection	Luer - rotation	Luer - no rotation	Yes
Sterilization method	EtO	EtO	Yes

Injector Luer Lock N35-and N35C (including a cap)

Subject	Modified N35 and N35C	Predicate N31, K001368	Equiv
Intended use	The intended use of the Injectors isto inject fluids into, and towithdraw fluids from a drug vial,and then to inject fluids into aprimary or secondary IVadministration set, or into an IVcontainer.	The intended use of the Injectorsis to inject fluids into, and towithdraw fluids from a drug vial,and then to inject fluids into aprimary or secondary IVcontainer.	Yes
Cannula	Stainless steel - pencil pointcannula	Stainless steel - cut cannula	Yes
Needle safety lock	Safety sleeve "ErgoMotionTM"	Safety latch	Yes
Fitting connection	Luer Lock -rotation	Luer Lock - no rotation	Yes
Sterilization method	EtO	EtO	Yes

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Subject	Connector C35	Predicate C40, K972527	Equiva
Intended use	This device is a connector betweenthe PhaSeal Injector and parts ofan IV administration set up such asa stopcock or an admixturechannel of the spike for the IVcontainer. The PhaSeal elastomericmembrane seals with theelastomeric membranes of otherPhaSeal components to helpprevent drug spillage.	This device is a connectorbetween the PhaSeal Injector andparts of an IV administration setup such as a stopcock or anadmixture channel of the spikefor the IV container. The PhaSealelastomeric membrane seals withthe elastomeric membranes ofother PhaSeal components tohelp prevent drug spillage	Yes
Bayonet fitting	reduced notches - no click	notches - with a "click"	Yes
Length	26 mm	26 mm	Yes
Sterilization method	EtO	EtO	Yes

Connector Luer Lock C35

and and the mail of the state of the state of the mail of the

Connector Luer Lock C45

Subject	Connector C45	Predicate C40, K972527
Intended use	This device is a connector betweenthe PhaSeal Injector and parts ofan IV administration set up such asa stopcock or an admixturechannel of the spike for the IVcontainer. The PhaSeal elastomericmembrane seals with theelastomeric membranes of otherPhaSeal components to helpprevent drug spillage.	This device is a connectorbetween the PhaSeal Injector andparts of an IV administration setup such as a stopcock or anadmixture channel of the spikefor the IV container. The PhaSealelastomeric membrane seals withthe elastomeric membranes ofother PhaSeal components tohelp prevent drug spillage	Yes
Bayonet fitting	reduced notches - no click	notches - with a “click”	Yes
Length	34 mm to provide for CLAVEconnection	26 mm	Yes
Sterilization method	EtO	EtO	Yes

Discussion of performance testing. 6.

The Injectors and Connectors have been tested and found in compliance with applicable requirements and standards specifications.

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7. Conclusion

Based on comparison to the predicate device, we come to the conclusion that the Injectors N34, N35, N35C and Connectors C35, C45 included in the PhaSeal System, are substantially equivalent to previously cleared predicate devices and present no new concerns about safety and effectiveness.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with outstretched wings, positioned to the right. To the left of the bird is a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in all capital letters.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Mr. Kjell Andreasson President Quality Assurance and Regulatory Affairs Carmel Pharma AB Aminogatan 30 SE 431 53 Molndal SWEDEN

DEC - 7 2009

K092782 Re:

Trade/Device Name: Injector Luer N34 Injector Luer Lock N35 Iniector Luer Lock N35C Connector Luer Lock C35 Connector Luer Lock C45 Regulation Number: 21 CFR 880.5440

Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: LHI Dated: September 4, 2009 Received: September 10, 2009

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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Wh for

Susan Runner, D.D.S., M.A. Acting Division 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)
Device Name	Injector Luer N34Injector Luer Lock N35Injector Luer Lock N35CConnector Luer Lock C35Connector Luer Lock C45
Indications for Use	The indication for use of the PhaSeal system and included components are reconstitution and transfer of drug solutions from one container to another while minimizing exposure to potentially hazardous drugs aerosols and spills that can occur during the reconstitution, 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) Over-The-Counter Use: No

wing and (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: Kool3 2222

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.