The ConceptoMed Luer-Jack device is a sterile syringe without needle intended for single use by health care professionals for general purpose aspiration or injection of fluids immediately after filling. The device is intended to be used only in combination with female 6% Luer slip connectors.

Device Description

The Luer-Jack Slip 10ml is a five-piece, single use syringe without needle, with a 6% (Luer) male slip connector. The device includes a three-piece syringe with a plastic barrel with graduated scale, a stopper and a plastic plunger rod. Upon the barrel is a single-handed needle hub release system in two pieces. The Luer-Jack is used as a general syringe except when disconnecting from a compatible female 6% (Luer) connector. For disconnection the hub release system mounted upon the barrel is used. The Luer-Jack will be delivered sterilized by irradiation) in a hard blister pack (the Steri-Tilt™).

AI/ML Overview

The provided text describes the acceptance criteria and the summary of performance testing for the ConceptoMed Luer-Jack Slip 10ml device, a sterile syringe, in comparison to a predicate device (BD Single use, Hypodermic Syringe).

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Acceptance Criteria	Reported Device Performance
System use		"PASS" on all criteria
Sterilization	Valid sterilization documentation	"PASS"
Manufacturing and assembly in cleanroom	Cleanroom for ISO-class 8	"PASS"
Safety functions		"PASS" on all criteria
Connector compatibility	1. Designed for Luer connections2. Designed with connectors with 6% female Luer fittings	"PASS"
Catch mechanism	Functional catch mechanism	"PASS"
Usability		"PASS" on all criteria
One-hand handling and usability of blister	A Use of gloves during handlingB Use in combination with a PVC	"PASS"
Regulatory	-----------------------------
Standard for syringes	Conformance to EN ISO 7886-1:1993	"PASS"
Biocompatibility	Conformance to EN ISO 10993-1:2009/AC:2010	"PASS"
Packaging safe for sterilization	1) Existence of Packaging and labelling specification. Compliance with Packforsk Std-40-101 2001 Transport tests (including air transportation)2) Packaging material intended for irradiation sterilization	"PASS"
Lifetime and reliability		"PASS" on all criteria
Shelf life	Shelf life of 4 years	"PASS"
Mechanical requirements		"PASS" on all criteria
Drop test	No damage of the packages, and full functionality of device	"PASS"
Press fit test	Withstand a pulling force of 20 N	"PASS"
Mechanical strength	a) Full function of the Lever after 15 full cyclesb) A mechanical report shall conclude sufficient mechanical strength	"PASS"
No interference when connected	Functionality after 70N push force	"PASS"
Surface contact	Ability to use with a PVC	"PASS"
Functionality		"PASS" on all criteria
Transparency of Lever and Collar	Visual control of graduation lines	"PASS"

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

The document does not explicitly state the specific sample sizes used for each performance test. It broadly states that "Design Verification tests were performed based on the risk analysis." The data provenance (e.g., country of origin, retrospective/prospective) is also not specified for these tests.

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

This information is not provided in the document. The testing appears to be primarily laboratory-based engineering and compliance testing rather than clinical studies requiring expert ground truth establishment in the traditional sense.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the nature of the tests (engineering and regulatory compliance), an adjudication method as typically used in clinical studies with human evaluators would not be applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported. This document pertains to the 510(k) clearance of a medical device (syringe), which typically relies on demonstrating substantial equivalence through technical and performance testing rather than comparative human efficacy studies. The comparison to the predicate device focuses on design, materials, and meeting established performance standards.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable. The Luer-Jack Slip 10ml is a physical syringe, not an artificial intelligence algorithm. Therefore, "standalone" performance in the context of AI does not apply. The performance tests are for the physical device itself.

7. The Type of Ground Truth Used

For the individual performance characteristics, the "ground truth" is defined by the acceptance criteria (e.g., "functional catch mechanism," "Shelf life of 4 years," "Withstand a pulling force of 20 N"). These are objective and measurable standards, not expert consensus, pathology, or outcomes data in a clinical sense.

8. The Sample Size for the Training Set

This question is not applicable. The Luer-Jack Slip 10ml is a physical syringe, not an artificial intelligence algorithm that requires a "training set." The development process involved design verification and testing against established standards.

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

This question is not applicable, as there is no "training set" in the context of this device.

Summary

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

January 11, 2017

ConceptoMed AS Marit Martinsen OA Manager Hattvikveien 2 Ballstad, N-8373 NORWAY

Re: K162057

Trade/Device Name: ConceptoMed Luer-Jack Slip 10ml Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: October 8, 2016 Received: October 14, 2016

Dear Marit Martinsen:

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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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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,

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Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K162057

Device Name ConceptoMed Luer-Jack Slip 10ml

Indications for Use (Describe)

Indications and Intended Use:

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for ConceptoMed. The logo consists of a blue abstract shape on the left, resembling a stylized water droplet or leaf. To the right of the shape is the company name, "ConceptoMed", written in a blue sans-serif font.

510(k) SUMMARY

Summary of Safety and Effectiveness For Luer-Jack Slip

In accordance with 21 CFR 807.92, the following information constitutes the ConceptoMed AS summary for the Luer-Jack Slip 10ml.

SUBMITTER'S NAME:	ConceptoMed AS
ADDRESS:	Hattvikveien 28373 BallstadNorway
CONTACT PERSON:	Marit Martinsen, Director QA & Regulatory,ConceptoMed AS
TELEPHONE NUMBER:	+47 905 14 690
E-MAIL		marit.martinsen@conceptomed.no
DATE OF SUBMISSION:		January 4, 2017
1.	Subject Device	Trade Name:Common Name:Regulation Number:Regulation Name:Regulatory Class:Product Code:Classification Panel:	ConceptoMed Luer-Jack Slip 10mlLuer-Jack Slip 10ml21 CFR §880.5860Piston syringeIIFMFGeneral Hospital
2.	PredicateDevice	Trade Name:	BD Single use, Hypodermic Syringe
		510(k) Reference:Common Name:Regulation Number:Regulation Name:Regulatory Class:Product Code:Classification Panel:	K110771BD Single use, Hypodermic Syringe21 CFR §880.5860Piston syringeIIFMFGeneral Hospital

3. Description of the Device

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ConceptoMed

For disconnection the hub release system mounted upon the barrel is used. The Luer-Jack will be delivered sterilized by irradiation) in a hard blister pack (the Steri-Tilt™).

Indications for use 4.

The ConceptoMed AS Luer-Jack device is a sterile syringe without needle intended for single use by health care professionals for general purpose aspiration or injection of fluids immediately after filling. The device is intended to be used only in combination with female 6% Luer slip connectors.

5. Technological characteristics, comparison to predicate device.

The subject is a sterile syringe without needle intended for single use by health care professionals for general purpose aspiration or injection of fluids immediately after filling. The subject is intended to be used only in combination with female 6% Luer slip connectors.

The Device is claimed to be Substantially Equivalent (SE) to the device BD Single Use, Hypodermic Syringe, manufactured by Becton, Dickinson and Company (Predicate Device).

The syringe used in the Luer-Jack is manufactured under the same conditions as the predicate device (K110771) apart from packaging and sterilization as the syringe is delivered in bulk to ConceptoMed.

Based on the intended use, the Luer-Jack Slip 10 ml is considered Substantially Equivalent to the predicate device, given that:

a) The Luer-Jack Slip 10 ml has the same similar intended use as the predicate device, the only minor difference is the addition of the Luer-Jack component designed to aid the clinician with one-handed removal.
b) The Luer-Jack Slip 10 ml barrel and plunger rod (including rubber piston) use the identical design and identical materials as the predicate device.
c) The Luer-Jack Slip 10 ml and the predicate device meet the requirements for manual use as defined by ISO 7886-1.
d) The Luer-Jack Slip 10 ml and the predicate device component materials comply with ISO 10993-1 as applicable to the intended use of the device.
e) The Luer-Jack Slip 10 ml and the predicate device are sterilized to an SAL of 10° via an E-Beam irradiation process.

But differs when it comes to:

be of similar design; ।
The Luer-Jack Slip 10 ml has an integrated hub release system.
be of similar material; i
The Luer-Jack Slip 10ml integrated hub release system is manufactured from biocompatible MABS-polymer.
। have similar principles of operation
The subject and the predicate device are both operated as general syringes. The subject may be disconnected from female hubs with a traditional two-handed operation. However, the integrated hub release system may also be used for a one-handed disconnection.

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ConceptoMed

Summary of performance testing. 6.

Design Verification tests were performed based on the risk analysis. The results of these tests demonstrate that the Luer-Jack Slip 10ml performed in an equivalent manner to the predicate device and is safe and effective when used as intended.

Design Verification testing included the following performance testing with "PASS" on all criteria:

Performance Characteristic	Acceptance Criteria
System use
Sterilization	Valid sterilization documentation
Manufacturing and assembly in cleanroom	Cleanroom for ISO-class 8
Safety functions
Connector compatibility	1. Designed for Luer connections2. Designed with connectors with 6% female Luer fittings
Catch mechanism	Functional catch mechanism
Usability
One-hand handling and usability of blister	A Use of gloves during handlingB Use in combination with a PVC
Regulatory
Standard for syringes	Conformance to EN ISO 7886-1:1993
Biocompatibility	Conformance to EN ISO 10993-1:2009/AC:2010
Packaging safe for sterilization	1) Existence of Packaging and labellingspecification. Compliance with Packforsk Std-40-1012001 Transport tests (including air transportation)2) Packaging material intended for irradiationsterilization
Lifetime and reliability
Shelf life	Shelf life of 4 years
Mechanical requirements
Drop test	No damage of the packages, andfull functionality of device
Press fit test	Withstand a pulling force of 20 N
Mechanical strength	a) Full function of the Lever after 15 full cyclesb) A mechanical report shall conclude sufficientmechanical strength
No interference when connected	Functionality after 70N push force
Surface contact	Ability to use with a PVC
Functionality
Transparency of Lever and Collar	Visual control of graduation lines

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Image /page/6/Picture/0 description: The image features the logo for ConceptoMed. The logo consists of a stylized, abstract shape in blue on the left, resembling a water droplet or a stylized leaf. To the right of the shape is the company name "ConceptoMed" in a sans-serif font, also in blue. The color of the text transitions from a darker blue on the left to a lighter blue on the right.

The Device will be marketed as a piston syringe with one-handed disconnection option only.

7. Conclusion

The Luer-Jack has been verified to meet the established performance criteria above. The predicate device is a well known and well documented device, the Luer-Jack performs comparably to the predicate device that is currently marketed for the same intended use.

Based on the clinical performance as well as biocompatibility characteristics, the Luer-Jack was found substantially equivalent to the predicate device.

Regulation Number and Section

§ 880.5860 Piston syringe.

(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).