(81 days)
The ConceptoMed Luer-Jack device is a sterile syringe without needle intended for single use by health care professionals for general purpose aspiration of fluids immediately after filling. The device is intended to be used only in combination with female 6% Luer connectors.
The LuerJack is a five-piece, single use syringe without needle, with a male 6% (Luer) connector in 3 ml, 5 ml, 10ml, 20 ml Luer Slip and 10 ml Luer Lock syringe sizes. The device includes a three-piece slip syringe (the Reference Device) with a barrel with graduated volume scale, a stopper and a plunger rod. Onto the barrel is a single-handed hub release system in two pieces monunted. The hub release system provides a single-handed connector release system for all Subject Devices and the additional locking function for the LuerJack Lock syringe.
The LuerJack is used as a general syringe except when disconnecting from a compatible female 6% (Luer) connector. The LuerJack is delivered sterilized by irradiation) in a syringe only configuration. The LuerJack is used as a general syringe except when disconnecting from a compatible female 6% (Luer) connector. For disconnection of an attached connector, the hub release system mounted onto the barrel is used.
This document describes the Luer-Jack Slip/Lock syringe, a medical device, and the testing conducted to demonstrate its substantial equivalence to predicate devices. It is not an AI/ML powered device, therefore, some of the requested information (like number of experts, AI effect size, training set) is not applicable.
Here's the breakdown of the acceptance criteria and the study as presented in the document:
1. Table of acceptance criteria and reported device performance:
| Performance Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| System Use | ||
| Sterilization | Valid sterilization documentation | "PASS" on all criteria (implying valid documentation) |
| Manufacturing and assembly in cleanroom | Cleanroom for ISO-class 8 | "PASS" on all criteria (implying compliance) |
| Safety Functions | ||
| Catch mechanism | Functional catch mechanism | "PASS" on all criteria (implying functional) |
| Connector compatibility | Designed to fit female 6% Luer connectors | "PASS" on all criteria (implying designed to fit) |
| Functional Testing | ||
| Sustaining Force (ISO 7886-1:1997 - Annex G) | Per ISO 7886-1:1997 | "PASS" on all criteria (implying conformance) |
| Break-Out Force (ISO 7886-1:1997 - Annex G) | Per ISO 7886-1:1997 | "PASS" on all criteria (implying conformance) |
| Pump Sticktion/ Force (ISO 7886-2:1996 - Annex C) | Per ISO 7886-2:1997 | "PASS" on all criteria (implying conformance) |
| Stopper Seal (ISO 7886-1:1997 - Annex D) | Per ISO 7886-1:1997 | "PASS" on all criteria (implying conformance) |
| Autoclavability (ISO 7886-1:1997 - Annex D) | Per ISO 7886-1:1997 | "PASS" on all criteria (implying conformance) |
| Chemical Testing (Extractables) | ||
| Zinc | Per ISO 7886-1:1997 | "PASS" on all criteria (implying conformance) |
| Lead, Tin, Iron | Per ISO 7886-1:1997 | "PASS" on all criteria (implying conformance) |
| Cadmium | Per ISO 7886-1:1997 | "PASS" on all criteria (implying conformance) |
| pH shift | Per ISO 7886-1:1997 | "PASS" on all criteria (implying conformance) |
| Biocompatibility | ||
| Cytotoxicity | Conformance to EN ISO 10993-5:2009 | "PASS" on all criteria (implying conformance) |
| Sensitization | Conformance to EN ISO 10993-10:2010 | "PASS" on all criteria (implying conformance) |
| Irritation or Intra cutaneous reactivity | Conformance to EN ISO 10993-10:2010 | "PASS" on all criteria (implying conformance) |
| Acute Systemic Toxicity | Conformance to EN ISO 10993-11:2009 | "PASS" on all criteria (implying conformance) |
| Material-Mediated Pyrogenicity | Conformance to EN ISO 10993-11:2009 | "PASS" on all criteria (implying conformance) |
| Packaging Safe for Sterilization | ||
| 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" on all criteria (implying compliance) |
| Lifetime and Reliability | ||
| Shelf life | Valid shelf life on blister and device | "PASS" on all criteria (implying valid shelf life) |
| Mechanical Requirements | ||
| Drop test | No damage of the packages and full functionality of device | "PASS" on all criteria (implying no damage and full functionality) |
| Mechanical strength | a) Full function of the Lever after 15 full cycles b) A mechanical report shall conclude sufficient mechanical strength | "PASS" on all criteria (implying full function after 15 cycles and sufficient strength) |
| Initial force level before Lever press down | Initial force of 2N needed before click and release activation | "PASS" on all criteria (implying 2N force met) |
| Complete functional performance requirements from ISO 80369-7 | Leakage, separation force, unscrewing and overriding torque | "PASS" on all criteria (implying conformance to ISO 80369-7) |
2. Sample size used for the test set and the data provenance:
The document mentions "Design Verification tests were performed based on the risk analysis." However, it does not specify the exact sample sizes used for each individual test. It also does not provide information on the data provenance (e.g., country of origin, retrospective or prospective) beyond stating that "Design Verification tests were performed." Given this is a physical medical device, not an AI/ML algorithm, the concept of "data provenance" as typically applied to algorithms is not directly relevant here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the device is a physical medical device, not an AI/ML system requiring expert-established ground truth. The "ground truth" for these performance tests is defined by the objective standards themselves (e.g., ISO, EN ISO standards).
4. Adjudication method for the test set:
This information is not applicable as the device is a physical medical device, not an AI/ML system requiring adjudication of expert opinions. The performance is measured against established technical standards.
5. 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:
This information is not applicable as the device is a physical medical device and not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable as the device is a physical medical device, not an algorithm.
7. The type of ground truth used:
The ground truth for this device's performance is based on objective technical standards and regulatory requirements, primarily the ISO and EN ISO standards mentioned in the acceptance criteria. For example, "Per ISO 7886-1:1997" defines the ground truth for the sustaining force.
8. The sample size for the training set:
This information is not applicable as this is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
This information is not applicable as this is a physical medical device, not an AI/ML algorithm.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name in a circular arrangement around a stylized caduceus symbol. The caduceus is depicted with three intertwined figures, representing health, services, and humanity. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 8, 2017
ConceptoMed AS Marit Martinsen Director QA & Regulatory Hattvikveien 2 Ballstad N-8373 NORWAY
Re: K171805
Trade/Device Name: Luer-Jack Slip 3 ml, Luer-Jack Slip 5 ml, Luer-Jack Slip 20 ml, Luer-Jack Lock 10 ml Regulation Number: 21 CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: Class II Product Code: FMF Dated: August 3, 2017 Received: August 10, 2017
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. Isting 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 (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 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/Resourcesfor You/Industry/default.htm. 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 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,
Tara A. Ryan -S
for Lori A. Wiggins, MPT, CLT 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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Change Control Table, Change History
Change Control Table
| Version | Document Author | Document Approver | Date Approved |
|---|---|---|---|
| 1.00 | Name, Title, Office | Name, Title, Office | MM/DD/YYYY |
Complete Change Control Table (all versions) retained in SWIFT Docs.
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K171805
Device Name LuerJack Slip 3 ml. 5 ml. 20 ml LuerJack Lock 10 ml
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 of fluids immediately after filling. The device is intended to be used only in combination with female 6% Luer 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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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
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510(K) Summary K171805
| 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-MAILDATE OF SUBMISSION: | marit.martinsen@conceptomed.noJuly 31, 2017 | ||
| 1. Subject Device | Trade Name:Common Name:Regulation Number:Regulation Name:Regulatory Class:Product Code:Classification Panel: | Subject Device 1 – LuerJack Slip 3 mlSubject Device 2 – LuerJack Slip 5 mlSubject Device 3 – LuerJack Slip 20 mlSubject Device 4 – LuerJack Lock 10 mlLuerJack Slip/ LuerJack Lock21 CFR §880.5860Piston syringeIIFMFGeneral Hospital | |
| 2. PredicateDevices | Predicate Device:Trade Name:510(k) Reference:Common Name:Regulation Number:Regulation Name:Regulatory Class:Product Code:Classification Panel: | ConceptoMed Luer-Jack Slip 10 mlK162057Luer-Jack Slip 10 ml21 CFR §880.5860Piston syringeIIFMFGeneral Hospital |
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| Reference Device | |
|---|---|
| Trade Name: | BD Single use, Hypodermic Syringe |
| 510(k) Reference: | K110771 |
| Common Name: | BD Single use, Hypodermic Syringe |
| Regulation Number: | 21 CFR §880.5860 |
| Regulation Name: | Piston syringe |
| Regulatory Class: | II |
| Product Code: | FMF |
| Classification Panel: | General Hospital |
Description of the Device 3.
The LuerJack is a five-piece, single use syringe without needle, with a male 6% (Luer) connector in 3 ml, 5 ml, 10ml, 20 ml Luer Slip and 10 ml Luer Lock syringe sizes. The device includes a three-piece slip syringe (the Reference Device) with a barrel with graduated volume scale, a stopper and a plunger rod. Onto the barrel is a single-handed hub release system in two pieces monunted. The hub release system provides a single-handed connector release system for all Subject Devices and the additional locking function for the LuerJack Lock syringe.
The LuerJack is used as a general syringe except when disconnecting from a compatible female 6% (Luer) connector. The LuerJack is delivered sterilized by irradiation) in a syringe only configuration. The LuerJack is used as a general syringe except when disconnecting from a compatible female 6% (Luer) connector. For disconnection of an attached connector, the hub release system mounted onto the barrel is used.
4. Indications for use
The LuerJack device is a sterile syringe without needle intended for single use by healthcare 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 connectors.
5. Technological characteristics; comparison to predicate device
The Subject Devices are equivalent to the Predicate Device (K162057) in intended use and performance characteristics.
The Subject Devices are assembled and sterilized under the same conditions as the Predicate Device.
Disconnection of attached devices is identical for both the Subject Devices and the Predicate Device.
Subject Device 1. 2 and 3 are equivalent to the Predicate Device in materials and design.
Subject Device 4 (LuerJack Lock 10 ml) is different from the Predicate in terms of materials. The difference is the added Petrolatum between the collar and lever.
Subject Device 4 (LuerJack Lock 10 ml) is different from the Predicate in terms of design. The difference in design is the added 205° protrusion with an integrated
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locking mechanism.
| Element ofComparison | Subject Device | Primary Predicate Device(PD1) | |
|---|---|---|---|
| Indications forUse/ Intended Use | The LuerJack is a sterilesyringe without needleintended for single use byhealthcare professionals forgeneral purpose aspiration orinjection of fluids immediatelyafter filling. The device isintended to be used only incombination with female 6%Luer connectors. | The LuerJack is a sterilesyringe without needleintended for single use byhealthcare professionals forgeneral purpose aspiration orinjection of fluids immediatelyafter filling. The device isintended to be used only incombination with female 6%Luer slip connectors. | |
| Barrel size | 3 ml, 5 ml, 20 ml slip –identical to reference deviceK11077110 ml – identical to predicatedevice K162057 | 10 ml slip – identical to subjectdevice | |
| Syringe materials | Barrel | Polypropylene | Polypropylene |
| BarrelLubricant | Silicone | Silicone | |
| Plunger Rod | Polypropylene | Polypropylene | |
| Stopper | Rubber | Rubber | |
| StopperLubricant | Silicone | Silicone | |
| Only SubjectDevice 4 –OutsideBarrelLubricant | Petrolatum (Vaseline) | N/A | |
| Sterilization Method | E-Beam | E-Beam | |
| SAL | 10-6 | 10-6 |
Reference device K110771 used for comparison to the different syringe barrel sizes 3 ml, 5 ml, 20 ml slip - which are identical to the additional sizes of the subject device.
6. Summary of performance testing.
Design Verification tests were performed based on the risk analysis. The results of these tests demonstrate that the Subject Device performed in an equivalent manner to the Predicate Devices and is safe and effective when used as intended.
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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 | |
| Catch mechanism | Functional catch mechanism |
| Connector compatibility | Designed to fit female 6% Luer connectors |
| Functional testing | |
| Sustaining Force (ISO 7886-1:1997 - Annex G) | Per ISO 7886-1:1997 |
| Break-Out Force (ISO 7886-1:1997 - Annex G) | Per ISO 7886-1:1997 |
| Pump Sticktion/ Force (ISO 7886-2:1996 - Annex C) | Per ISO 7886-2:1997 |
| Stopper Seal (ISO 7886-1:1997 - Annex D) | Per ISO 7886-1:1997 |
| Autoclavability (ISO 7886-1:1997 - Annex D) | Per ISO 7886-1:1997 |
| Chemical testing (Extractables) | |
| Zinc | Per ISO 7886-1:1997 |
| Lead, Tin, Iron | Per ISO 7886-1:1997 |
| Cadmium | Per ISO 7886-1:1997 |
| pH shift | Per ISO 7886-1:1997 |
| Biocompatibility | |
| Cytotoxicity | Conformance to EN ISO 10993-5:2009 |
| Sensitization | Conformance to EN ISO 10993-10:2010 |
| Irritation or Intra cutaneous reactivity | Conformance to EN ISO 10993-10:2010 |
| Acute Systemic Toxicity | Conformance to EN ISO 10993-11:2009 |
| Material-Mediated Pyrogenicity | Conformance to EN ISO 10993-11:2009 |
| Packaging safe for sterilization | 1) Existence of Packaging and labelling specification. Compliance with Packforsk Std-40-101 2001 Transport tests (including airtransportation)2) Packaging material intended for irradiation sterilization |
| Lifetime and reliability | |
| Shelf life | Valid shelf life on blister and device |
| Mechanical requirements | |
| Drop test | No damage of the packages and full |
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| functionality of device | ||
|---|---|---|
| Mechanical strength | a) Full function of the Lever after 15 full cyclesb) A mechanical report shall conclude sufficientmechanical strength | |
| Initial force level before | Initial force of 2N needed before click and | |
| Lever press down | release activation | |
| Complete functionalperformance requirementsfrom ISO 80369-7 | Leakage, separation force, unscrewing andoverriding torque |
The Device will be marketed as a piston syringe with one-handed disconnection option.
7. Substantial Equivalence
The LuerJack Slip 3 ml, 5 ml and 20 ml and the LuerJack Lock 10 ml are equivalent to that of the Predicate ConceptoMed Luer-Jack Slip 10 ml in intended use, principles of operation, technology, materials and performance characteristics.
8. Conclusion
The LuerJack Slip 3 ml, 5 ml and 20 ml and the LuerJack Lock 10 ml has been verified to meet the established performance criteria above. The LuerJack Slip 3 ml, 5 ml and 20 ml and the LuerJack Lock 10 ml performs as intended and comparably to the legally marketed Predicate Device.
§ 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).