(169 days)
Not Found
No
The device description and performance studies focus on mechanical and functional aspects of a syringe with a specific disconnection mechanism. There is no mention of AI or ML in the document.
No.
The device is described as a "sterile syringe without needle intended for single use by health care professionals for general purpose aspiration or injection of fluids". A syringe for general aspiration or injection of fluids is a diagnostic or procedural tool, not a therapeutic device.
No
The device is a sterile syringe for aspiration or injection of fluids; it does not perform any diagnostic function.
No
The device description clearly outlines a physical, five-piece syringe with a barrel, stopper, plunger rod, and a needle hub release system. It is a hardware device intended for aspiration or injection of fluids.
Based on the provided information, the ConceptoMed Luer-Jack device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for general purpose aspiration or injection of fluids immediately after filling." This describes a device used for administering or withdrawing substances from the body, not for testing samples in vitro (outside the body) to diagnose a condition.
- Device Description: The description details a syringe, which is a tool for handling fluids in a clinical setting, not for performing diagnostic tests on biological samples.
- Lack of IVD Characteristics: The document does not mention any components or functions related to analyzing biological samples, detecting analytes, or providing diagnostic information.
- Predicate Device: The predicate device is a "BD Single use, Hypodermic Syringe," which is also a general-purpose medical device for fluid handling, not an IVD.
Therefore, the ConceptoMed Luer-Jack device falls under the category of a general medical device used for fluid management, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FMF
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™).
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
health care professionals
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)
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:
System use
Sterilization: Valid sterilization documentation
Manufacturing and assembly in cleanroom: Cleanroom for ISO-class 8
Safety functions
Connector compatibility: 1. Designed for Luer connections 2. 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 handling B 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 labelling specification. Compliance with Packforsk Std-40-101 2001 Transport tests (includes air transportation) 2) Packaging material intended for irradiation sterilization
Lifetime and reliability
Shelf life: Shelf life of 4 years
Mechanical requirements
Drop test: No damage of the packages, and full functionality of device
Press fit test: Withstand a pulling force of 20 N
Mechanical strength: a) Full function of the Lever after 15 full cycles b) A mechanical report shall conclude sufficient mechanical 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
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.
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
§ 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).
0
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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.
1
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
2
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:
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.
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 2 | ||
| 8373 Ballstad | |||
| Norway | |||
| CONTACT PERSON: | Marit Martinsen, Director QA & Regulatory, | ||
| ConceptoMed AS | |||
| TELEPHONE NUMBER: | +47 905 14 690 | ||
| 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 10ml | ||
| Luer-Jack Slip 10ml | |||
| 21 CFR §880.5860 | |||
| Piston syringe | |||
| II | |||
| FMF | |||
| General Hospital | |||
| 2. | Predicate | ||
| Device | Trade Name: | BD Single use, Hypodermic Syringe | |
| 510(k) Reference: | |||
| Common Name: | |||
| Regulation Number: | |||
| Regulation Name: | |||
| Regulatory Class: | |||
| Product Code: | |||
| Classification Panel: | K110771 | ||
| BD Single use, Hypodermic Syringe | |||
| 21 CFR §880.5860 | |||
| Piston syringe | |||
| II | |||
| FMF | |||
| General Hospital |
3. Description of the Device
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.
4
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.
5
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 connections |
- 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 handling
B 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 labelling
specification. Compliance with Packforsk Std-40-101
2001 Transport tests (including air transportation)
- Packaging material intended for irradiation
sterilization |
| Lifetime and reliability | |
| Shelf life | Shelf life of 4 years |
| Mechanical requirements | |
| Drop test | No damage of the packages, and
full functionality of device |
| Press fit test | Withstand a pulling force of 20 N |
| Mechanical strength | a) Full function of the Lever after 15 full cycles
b) A mechanical report shall conclude sufficient
mechanical 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 |
6
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.