K Number

Device Name

INJECTOR LUER, MODEL N34, INJECTOR LUER LOCK, MODEL N35, INJECTOR LUER LOCK, N35C, CONNECTOR LUER LOCK, MODEL C35,

Manufacturer

CARMEL PHARMA AB.

Date Cleared

2009-12-07

(88 days)

Product Code

LHI PHA

Regulation Number

880.5440

Intended 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.

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K972527, K001368

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a mechanical drug transfer system and does not mention any AI or ML components or functionalities.

Therapeutic

No
The device is described as a system for reconstituting and transferring drug solutions, specifically designed to minimize exposure to hazardous drugs during the preparation, administration, and disposal process. It is a drug handling and transfer device, not a device used for treating a medical condition or disease.

Diagnostic

No
The device is described as a system for reconstituting and transferring drug solutions, minimizing exposure to hazardous drugs aerosols and spills. There are no indications, either in the "Intended Use / Indications for Use" or "Device Description" sections, that it is used for diagnosing a disease or condition. Its purpose is drug handling, not diagnosis.

SaMD (Software as a Medical Device)

The device description explicitly states it is a "sterile device for single-use" and mentions "Injectors and Connectors," which are physical components, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly describes the device's function as a system for reconstituting and transferring drug solutions while minimizing exposure to hazardous drugs. This is a drug delivery and handling function, not a diagnostic function performed on biological samples in vitro.
Device Description: The description reinforces its role in the preparation and administration of parenteral drugs within a closed system.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.

The device is a medical device used in the preparation and administration of drugs, not for diagnosing a condition.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications 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.

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.

Product codes (comma separated list FDA assigned to the subject device)

LHI

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.

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)

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

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.

K972527, K001368

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

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.

Summary

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 30
SE 431 53 Molndal
Sweden.

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

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 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 IVcontainer.	Yes
Cannula	Stainless steel - pencil point
cannula	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

Subject	Connector C35	Predicate C40, K972527	Equiva
Intended use	This device 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.	This device 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	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 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.	This device 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	Yes
Bayonet fitting	reduced notches - no click	notches - with a “click”	Yes
Length	34 mm to provide for CLAVE
connection	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.

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.

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.

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

Attachment 1

	Indications for Use Statement
510(k) Number (if known)
Device Name	Injector Luer N34
Injector Luer Lock N35
Injector Luer Lock N35C
Connector Luer Lock C35
Connector 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