(22 days)
Not Found
No
The device description and performance studies focus on mechanical and microbiological properties, with no mention of AI or ML.
No
This device is for reconstitution or dispensing of medication, not for direct therapeutic application to a patient. Its purpose is to facilitate the preparation and handling of medications, including chemotherapy agents, by healthcare professionals.
No
The device is described as being for reconstitution or dispensing of medication, and for retaining vapors and maintaining sterility of vial medications. It is not mentioned anywhere that it is used for diagnosis.
No
The device description explicitly details the physical components and materials of the SmartSite® VialShield, indicating it is a hardware device. The performance studies also focus on physical characteristics and material compatibility.
Based on the provided information, the SmartSite® VialShield is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the reconstitution or dispensing of medication from vials. This is a process related to drug preparation and administration, not the examination of specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description focuses on the mechanical and microbiological closure of the device to retain vapors and maintain sterility of the medication. It describes a device used in the handling of drugs, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, detecting analytes, or providing diagnostic information. The device's function is purely related to the safe and sterile handling of medication vials.
Therefore, the SmartSite® VialShield falls under the category of a medical device used in the preparation and administration of drugs, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SmartSite® VialShield is intended for use by healthcare professionals in a wide variety of healthcare environments including hospitals, healthcare facilities, and pharmacies for reconstitution or dispensing of medication. The SmartSite® VialShield is indicated for use with rubber-stopper medication vials for reconstitution or dispensing of medications, including chemotherapy agents.
Product codes (comma separated list FDA assigned to the subject device)
LHI
Device Description
The SmartSite® VialShield is intended for use by healthcare professionals in a wide variety of healthcare environments including hospitals, healthcare facilities, and pharmacies for reconstitution or dispensing of medication. The SmartSite® VialShield is indicated for use with rubber-stopper medication vials for reconstitution or dispensing of medications, including chemotherapy agents.
The SmartSite® VialShield is a mechanically closed device, designed to retain vapors produced from medications in the attached vial.
The SmartSite® VialShield is microbiologically closed. When used in a USP compliant pharmaceutical compounding and storage environment, the VialShield is capable of maintaining the sterility of vial medications for up to 7 days.
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 performance data supplied with this submission demonstrates that the SmartSite® Vialshield meets all specified requirements and is substantially equivalent to the predicate device.
Since limited performance data for the predicate SmartSite® Vented Vial Access Device was available, some performance characteristics of the predicate device were tested along with the subject SmartSite® Vialshield device.
The following tests were conducted on the Vented Single Vial Access Device to demonstrate equivalency of the performance characteristics to the predicate device(s):
- Misuse Leak Test
- Filter Recovery Test (verification of hydrophobicity)
- Priming Volume
- Detachment Force (Horizontal)
- Detachment Force (Vertical)
- Priming Volume
- Filter Integrity
- Biocompatibility ISO 10993 (SmartSite® VialShield tested only)
- Cytotoxicity by Elution Test (Cytotoxicity)
- Intracutaneous Reactivity (Irritation or Intracutaneous Reactivity)
- Maximization Test for Delayed Hypersensivity (Sensitization)
- Acute Systemic Toxicity (Systemic Toxicity (Acute))
- Evaluation of Hemocompatibility: Interaction with Blood (Hemocompatibility)
- Chemotherapy and Hazardous Drug Compatibility
Both the subject and predicate devices contain the SmartSite® needle free valve, which has been previously validated for ISO-594 compliance, microbial ingress, leakage, and multiple/extended activation.
Additional testing on the subject SmartSite® Vialshield has been done to ensure that the mechanically closed and microbiologically closed technical characteristics of the subject SmartSite® Vialshield, not present on the predicate device, raise no new concerns about the safety and efficacy when compared to the predicate device
- Expansion chamber air capture
- [device] retains introduced vapors
- Maintains drug sterility for 7 days (Approved protocol and acceptance criteria for the subject SmartSite® Vialshield only)
Test results demonstrate that the subject SmartSite® Vialshield is as safe and effective as the legally marketed devices designated as predicate device.
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
.
5.2.
Product Code:
510(k) Summary ડ.
5.1. Submitter Information
| Company Name: | Yukon Medical, LLC |
|---|---|
| Company Address: | 2200 Gateway Centre Blvd |
| Suite 208 | |
| Morrisville, NC 27560 | |
| Company Phone: | (919) 595-8250 |
| Company Fax: | (919) 595-8251 |
| Contact Person: | Carl Dupper, Director, Technical Operations |
| Yukon Medical | |
| Phone: 919-595-8257 | |
| Fax: 919-595-8251 | |
| Email: cdupper@yukonmedical.com | |
| Prepared By: | James Fentress, Product Development Engineer |
| Gilero, LLC | |
| 4022 Stirrup Creek Drive Suite 300 | |
| Durham, NC 27703 | |
| Phone: 919-595-8236 | |
| Fax: 919-595-8221 | |
| Email: jfentress@gilero.com | |
| Date Summary Prepared: | August 1, 2013 |
| Device Identification | |
| Trade/Proprietary Name: | SmartSite® VialShield |
| Common Name: | Vial Access Device |
| Classification Name: | Intravascular Administration Set |
| 21 CFR 880.5440, Class II | |
| Classification Panel | General Hospital |
LHI, I.V. Fluid Transfer Set
1
5.3. Predicate Device
The Closed Vial Access Device is substantially equivalent to the following predicate device:
| Device | Manufacturer | 510(k) | Date Cleared |
|---|---|---|---|
| SmartSite® Vented Vial | |||
| Access Device | Cardinal Health, | ||
| Alaris Products | K052790 | December, 23, | |
| 2005 |
5.4. Device Description
The SmartSite® VialShield is intended for use by healthcare professionals in a wide variety of healthcare environments including hospitals, healthcare facilities, and pharmacies for reconstitution or dispensing of medication. The SmartSite® VialShield is indicated for use with rubber-stopper medication vials for reconstitution or dispensing of medications, including chemotherapy agents.
The SmartSite® VialShield is a mechanically closed device, designed to retain vapors produced from medications in the attached vial.
The SmartSite® VialShield is microbiologically closed. When used in a USP compliant pharmaceutical compounding and storage environment, the VialShield is capable of maintaining the sterility of vial medications for up to 7 days.
ર્ડ. Intended Use
The SmartSite® VialShield is intended for use by healthcare professionals in a wide variety of healthcare environments including hospitals, healthcare facilities, and pharmacies for reconstitution or dispensing of medication. The SmartSite® VialShield is indicated for use with rubber-stopper medication vials for reconstitution or dispensing of medications, including chemotherapy agents.
The indications statement for the SmartSite® VialShield is the same as its predicate device, Cardinal Health (Now CareFusion) SmartSite® Vented Vial Access Device (K052790).
Predicate Device Comparison - Technical Characteristics 5.6.
Equivalency of technical characteristics is demonstrated through a direct comparison of the Vented Single Vial Access Device and the predicate devices listed in the table below.
2
| Technical Characteristic | Device | |
|---|---|---|
| Subject Device: | Predicate Device: | |
| SmartSite® | ||
| VialShield | SmartSite® Vented Vial | |
| Access Device | ||
| Spike | Yes | Yes |
| Locking Shroud | Yes | Yes |
| Luer Access | SmartSite® Needle | |
| Free Valve | SmartSite® Needle Free | |
| Valve | ||
| Hydrophobic Filter | Yes | Yes |
Spike
The spike is used to penetrate a standard medication vial stopper and provide fluid and filtered air paths.
The subject device and the predicate (SmartSite® Vented Vial Access Device) both have equivalent dual lumen spikes; one lumen for fluid transfer and the other which allows for pressure equalization with vented air.
Locking Shroud
The purpose of the locking shroud is to secure the device to a standard medication vial after the stopper is penetrated. Both the subject and predicate device utilize a locking shroud with retention tabs to ensure device security atop a vial.
Luer Access
All configurations of the subject device and predicate device use the same needle free valve for Luer access to the device: the SmartSite® needle-free access valve.
Hydrophobic Filter
Both the subject and predicate device use a hydrophobic filter membrane in their respective designs. This filter serves four purposes in both devices: 1) The filter prevents particulates from leaving the devices when air is introduced; 2) The filter prevents contaminants in the surrounding environment from entering the secured drug vial; 3) The filter prevents liquid from leaving the device during misuse conditions, where the devices are inverted when liquid is injected; 4) The filter allows the air pressure in the vial to acclimate with ambient air pressure, preventing the build-up of pressure in the vial.
Materials
The subject SmartSite® Vialshield device is constructed of polymeric components:
- . Upper and Lower Housings: Polycarbonate
3
- 0 Check Valves: Silicone
- . Lubricant: Silicone
- Hydrophobic Filter Membrane: PTFE, Polyester .
- Loctite 3341: UV adhesive ●
- Barrier Film: Polyether Polyurethane .
- SmartSite® valve, including: .
- O Body: Acrylic
- 0 Cap: Polyurethane
- o Piston: Silicone
- o Lubricants: Silicone
The subject SmartSite® Vialshield device is provided with a molded polyethylene cap, considered part of the packaging, made using low density polyethylene.
The subject SmartSite® Vialshield materials do not contain natural rubber latex. .
The subject SmartSite® VialShield has been tested and meets the biological requirements outlined in ISO 10993-1. A summary of these test results is provided in Section 15 - Biocompatibility.
5.7. Predicate Device Comparison - Performance Characteristics
The performance data supplied with this submission demonstrates that the SmartSite® Vialshield meets all specified requirements and is substantially equivalent to the predicate device.
Since limited performance data for the predicate SmartSite® Vented Vial Access Device was available, some performance characteristics of the predicate device were tested along with the subject SmartSite® Vialshield device.
The following tests were conducted on the Vented Single Vial Access Device to demonstrate equivalency of the performance characteristics to the predicate device(s):
- o Misuse Leak Test
- o Filter Recovery Test (verification of hydrophobicity)
- Priming Volume .
- Detachment Force (Horizontal) .
- Detachment Force (Vertical) o
- . Priming Volume
- . Filter Integrity
- Biocompatibility ISO 10993 (SmartSite® VialShield tested only) . O Cytotoxicity by Elution Test (Cytotoxicity)
4
- Intracutaneous Reactivity (Irritation or Intracutaneous O Reactivity)
- Maximization Test for Delayed Hypersensivity (Sensitization) o
- O Acute Systemic Toxicity (Systemic Toxicity (Acute))
- Evaluation of Hemocompatibility: Interaction with Blood o (Hemocompatibility)
- Chemotherapy and Hazardous Drug Compatibility .
Both the subject and predicate devices contain the SmartSite® needle free valve, which has been previously validated for ISO-594 compliance, microbial ingress, leakage, and multiple/extended activation.
Additional testing on the subject SmartSite® Vialshield has been done to ensure that the mechanically closed and microbiologically closed technical characteristics of the subject SmartSite® Vialshield, not present on the predicate device, raise no new concerns about the safety and efficacy when compared to the predicate device
- Expansion chamber air capture .
- . [device] retains introduced vapors
- Maintains drug sterility for 7 days (Approved protocol and acceptance . criteria for the subject SmartSite® Vialshield only)
Test results demonstrate that the subject SmartSite® Vialshield is as safe and effective as the legally marketed devices designated as predicate device.
ર.8. Conclusion
Test results demonstrate that the SmartSite® Vialshield is as effective, and performs at least as safely and effectively as the legally marketed devices designated as predicate devices.
Based on comparisons of the device's intended use, technology and performance characteristics, the SmartSite® Vialshield is substantially equivalent to the indicated predicate devices.
Any differences between the SmartSite® Vialshield and the equivalent predicate devices have no significant influence on safety or effectiveness.
5
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wavy lines extending from its body, representing the department's commitment to health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 4, 2013
Yukon Medical. LLC Mr. Todd Korogi President 2200 Gateway Centre Boulevard, Suite 208 MORRISVILLE NC 27560
Re: K132863
Trade/Device Name: SmartSite® VialShield Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Sct Regulatory Class: II Product Code: LHI Dated: September 18, 2013 Received: September 19, 2013
Dear Mr. Korogi:
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. Iisting 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 vour 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.
6
Page 2 - Mr. Korogi
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 device-related 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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,
Mary S. Runner -S
Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
510{k} Notification Yukon Medical, LLC SmartSite® ViaiShield
4.0 Indications for Use Statement
510(k) Number (if known): __K132863
Device Name: SmartSite® VialShield
Indications for Use:
The SmartSite® VialShield is intended for use by healthcare professionals in a wide variety of healthcare environments including hospitals, healthcare facilities, and pharmacies for reconstitution or dispensing of medication. The SmartSite® VialShield is indicated for use with rubber-stopper medication vials for reconstitution or dispensing of medications, including chemotherapy agents.
Prescription Use × (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)
FDA
Richard C. Chapman 2013.10.03 13:52:58 -04'00'
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