(15 days)
Not Found
No
The device description and performance studies focus on mechanical and fluid dynamics properties, with no mention of AI or ML.
No.
The device is described as an access device for medication vials, intended for withdrawal and/or injection of fluid, but it does not directly administer therapy or provide a therapeutic effect itself.
No
The ViaLok™ is a device for accessing medication vials to inject or withdraw fluid. It does not perform any diagnostic function.
No
The device description clearly outlines a physical, disposable medical device made of molded plastic components (spike, luer access, shroud, caps) intended for accessing medication vials. There is no mention of software in the description or intended use.
Based on the provided information, the ViaLok™ device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the device is for "access to a medication vial without the use of a needle" for "withdrawal and/or injection of fluid." This describes a device used for handling and administering medications, not for testing biological samples outside the body.
- Device Description: The description focuses on the mechanical aspects of accessing a vial and transferring fluids. There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
- Performance Studies: The performance studies listed are related to the physical and functional characteristics of the device (attachment force, flow rate, leak tests, luer standards, biocompatibility), not to the accuracy or performance of a diagnostic test.
- Predicate Device: The predicate device, the "Single Dose Dispensing Pin," is also a device for accessing medication vials, not an IVD.
In Vitro Diagnostics (IVDs) are devices intended for use in the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The ViaLok™ does not fit this definition.
N/A
Intended Use / Indications for Use
The ViaLok™ is a stand-alone, single-use, disposable device which permits access to a medication vial without the use of a needle. The device is intended for use by healthcare professionals in a wide variety of healthcare environments, including hospitals, healthcare facilities, and pharmacies.
The ViaLok™ is indicated for use with standard medication vials and mating luer access devices for withdrawal and/or injection of fluid.
Product codes (comma separated list FDA assigned to the subject device)
LHI
Device Description
The ViaLok™ Non-vented (ViaLok™) is a sterile, stand-alone, single-use, disposable device which permits access to a medication vial without the use of a needle. The ViaLok™ is inserted into a stopper of a medication vial. The healthcare provided uses the ViaLok™ to inject or withdrawal fluid from the vial. The ViaLok™ includes four product configurations in this submission:
- ViaLok™ Non-vented, 20mm with female luer .
- ViaLok™ Non-vented, 20mm with male luer .
- ViaLok™ Non-vented, 13mm with female luer
- ViaLok™ Non-vented, 13mm with male luer .
The ViaLok™ is offered in two sizes: 20mm and 13mm. The ViaLokTM is configured to mate with standard medication vial enclosure sizes (20mm and 13mm). Each ViaLok™ size configuration is offered in female and male luer versions.
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
healthcare professionals in a wide variety of healthcare environments, including hospitals, healthcare facilities, and pharmacies.
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 following tests were conducted on the ViaLok™ and Single Dose Dispensing Pin to demonstrate equivalency of the performance characteristics:
- . Attachment Force
- Flow Rate .
- Pressurization Leak Test .
- Vacuum Leak Test ●
- Luer Leakage (Air Ingress) .
- Luer Leakage (Fluid Ingress) .
- Priming Volume ●
- Detachment Force
- ISO 594-2 Test Methods (ViaLok™ tested only)
- o Luer Leakage (Air Ingress)
- Luer Leakage (Fluid Ingress) o
- Luer Attachment O
- Luer Separation Force 0
- Unscrewing Torque O
- Resistance to Overriding o
- O Stress Cracking
- Biocompatibility ISO 10993 (ViaLokTM tested only)
- Cytotoxicity by Elution Test (Cytotoxicity) o
- Intracutaneous Reactivity (Irritation or Intracutaneous Reactivity) 0
- Maximization Test for Delayed Hypersensivity (Sensitization) O
- Acute Systemic Toxicity (Systemic Toxicity (Acute)) O
- Evaluation of Hemocompatibility : Interaction with Blood O (Hemocompatibility)
Test results demonstrated that the ViaLok™ is as effective, and performs at least as safely and effectively as the legally marketed device (ALARIS Medical Systems, Inc. Single Dose Dispensing Pin).
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
§ 880.5440 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.
0
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5.1.
510(k) Summary MAY - 3 2012 - 3 Submitter Information Company Name: Yukon Medical, LLC Company Address: 4819-400 Emperor Blvd. Durham, NC 27703 (919) 595-8250 Company Phone: Company Fax: (919) 595-8251 Contact Person: Carl Dupper, Director of Engineering and Quality Yukon Medical Phone: 919-595-8257 Fax: 919-595-8251 Email: cdupper@yukonmedical.com Prepared By: Kristin Benokraitis, Director of Quality and Programs Gilero, LLC 4022 Stirrup Creek Drive Suite 300 Durham, NC 27703 Phone: 919-595-8223 Fax: 919-595-8221
Email: kristinb@gilero.com
Date Summary Prepared:
December 6, 2011
5.2. Device Identification
ViaLok™ Non-vented Trade/Proprietary Name:
Common Name:
Vial Access Device
Classification Name:
Intravascular Administration Set 21 CFR 880.5440, Class II
Classification Panel Product Code:
General Hospital LHI, I.V. Fluid Transfer Set
1
Predicate Device 5.3.
The ViaLok™ is substantially equivalent to the following predicate device:
| Device | Manufacturer | 510(k) | Date Cleared |
|---|---|---|---|
| Single Dose | |||
| Dispensing Pin | ALARIS Medical | ||
| Systems, Inc. | K013087 | November 13, 2001 |
5.4. Device Description
The ViaLok™ Non-vented (ViaLok™) is a sterile, stand-alone, single-use, disposable device which permits access to a medication vial without the use of a needle. The ViaLok™ is inserted into a stopper of a medication vial. The healthcare provided uses the ViaLok™ to inject or withdrawal fluid from the vial. The ViaLok™ includes four product configurations in this submission:
- ViaLok™ Non-vented, 20mm with female luer .
- ViaLok™ Non-vented, 20mm with male luer .
- ViaLok™ Non-vented, 13mm with female luer
- ViaLok™ Non-vented, 13mm with male luer .
The ViaLok™ is offered in two sizes: 20mm and 13mm. The ViaLokTM is configured to mate with standard medication vial enclosure sizes (20mm and 13mm). Each ViaLok™ size configuration is offered in female and male luer versions.
5.5. Intended Use
The ViaLok™ is a stand-alone, single-use, disposable device which permits access to a medication vial without the use of a needle. The device is intended for use by healthcare professionals in a wide variety of healthcare environments, including hospitals, healthcare facilities, and pharmacies.
The ViaLok™ is indicated for use with standard medication vials and mating luer access devices for withdrawal and/or injection of fluid.
The indications statement for the ViaLok™ differs from the indications statement of the predicate device (presented in 510k K013087) in that the ViaLok™ calls 'out that the device is used with "mating luer access devices for withdrawal and/or injection of fluid". The Single Dose Dispensing Pin refers to a specific type of mating luer access device by stating that it is used with "needleless syringes for withdrawal and/or injection of fluid". The ViaLok™ uses the term "mating luer access device" because the ViaLok™ is offered in both male and female luer. Mating luer access devices are therefore not limited to syringes. This difference does not affect the ability of users to use the devices safely and effectively.
2
5.6. Predicate Device Comparison - Technical Characteristics
A direct comparison of the technical characteristics of the ViaLokTM and the predicate device, ALARIS Medical Systems, Inc. Single Dose Dispensing Pin (K013087), demonstrates equivalency. The ViaLok™ device is made up of a spike, luer access and a shroud. The Single Dose Dispensing Pin is made up of a spike and luer access. The spike is used to penetrate a standard medication vial stopper and provide a fluid path.
The purpose of the ViaLok™ shroud is to secure the device to a standard medication vial after the stopper is penetrated. The ViaLok™ shroud is considered a minor characteristic difference from the predicate device and does not introduce any new safety or efficacy concerns.
The Single Dose Dispensing Pin can be used with standard medication vials containing a stopper enclosure. The ViaLok™ offers a product configuration compatible with the 13mm and a product configuration compatible with 20mm standard medication vials containing a stopper enclosure.
The ViaLok™ is molded methyl methacrylate acrylonitrile butadiene styrene copolymer (MABS). The ViaLok™ may be provided with a cap which is molded from a low density polyethylene (female luer) or a high density polyethylene (male luer). The ViaLok™ and protective caps do not contain natural rubber latex.
The ViaLok™ has been tested and meets the biological requirements outlined in ISO 10993-1, ISO 10993-4, ISO 10993-5, ISO 10993-9, ISO 10993-10, and ISO 10993-11. A summary of these test results is provided in Section 15 -Biocompatibility.
The material content of the predicate device (Single Dose Dispensing Pin) is unknown.
- 5.7. Predicate Device Comparison - Performance Characteristics The performance data supplied in this submission demonstrates that the ViaLokTM meets all specified requirements and is substantially equivalent to the predicate device.
Performance data for the predicate device (ALARIS Medical Systems, Inc. Single Dose Dispensing Pin) was not available. Therefore, samples of the predicate device were tested along with the ViaLokTM.
The following tests were conducted on the ViaLok™ and Single Dose Dispensing Pin to demonstrate equivalency of the performance characteristics:
- . Attachment Force
- Flow Rate .
3
- Pressurization Leak Test .
- Vacuum Leak Test ●
- Luer Leakage (Air Ingress) .
- Luer Leakage (Fluid Ingress) .
- Priming Volume ●
- Detachment Force
- ISO 594-2 Test Methods (ViaLok™ tested only)
- o Luer Leakage (Air Ingress)
- Luer Leakage (Fluid Ingress) o
- Luer Attachment O
- Luer Separation Force 0
- Unscrewing Torque O
- Resistance to Overriding o
- O Stress Cracking
- Biocompatibility ISO 10993 (ViaLokTM tested only)
- Cytotoxicity by Elution Test (Cytotoxicity) o
- Intracutaneous Reactivity (Irritation or Intracutaneous Reactivity) 0
- Maximization Test for Delayed Hypersensivity (Sensitization) O
- Acute Systemic Toxicity (Systemic Toxicity (Acute)) O
- Evaluation of Hemocompatibility : Interaction with Blood O (Hemocompatibility)
Test results demonstrated that the ViaLok™ is as effective, and performs at least as safely and effectively as the legally marketed device (ALARIS Medical Systems, Inc. Single Dose Dispensing Pin).
5.8. Conclusion
Based on comparisons of the device's intended use, technology and performance characteristics, the ViaLok™ is substantially equivalent to the indicated predicate device.
4
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 eagle or bird symbol, with three overlapping, curved lines forming its body and wings. The bird is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Yukon Medical, LLC C/O Mr. Mark Job Responsible Third Party Official Regulatory Technology Services. LLC 1394 25th Street, NW Buffalo, Minnesota 55313
Re: K121182 ·
Trade/Device Name: ViaLok™ Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: LHI Dated: April 17, 2012 Received: April 18, 2012
Dear Mr. Job:
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.
MAY - 3 2012
5
Page 2 - Mr. Job
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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Anthony
Anthony D. Watson, B.S., M.S., M.B.A.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use Statement 4.
510(k) Number (if known): 《12-118 レ
Device Name: ViaLok™
Indications for Use: The ViaLok™ is a stand-alone, single-use, disposable device which permits access to a medication vial without the use of a needle. The device is intended for use by healthcare professionals in a wide variety of healthcare environments, including hospitals, healthcare facilities, and pharmacies.
The ViaLok™ is indicated for use with standard medication vials and mating luer access devices for withdrawal and/or injection of fluid.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Evaluation (ODE)
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
4-1