(70 days)
Not Found
No
The device description and performance studies focus on mechanical and filtration properties, with no mention of AI or ML.
No
The device is described as "Vented Vial Adapter Transfer Device" and its intended use is for "the transfer and mixing of drugs contained in a vial," which is a functional purpose, not a therapeutic one. It facilitates the administration or preparation of therapeutic substances but does not directly provide therapy itself.
No
This device is described as a "Transfer Device" intended for "transfer and mixing of drugs contained in a vial." Its function is to facilitate drug preparation and administration, not to diagnose a medical condition.
No
The device description clearly outlines physical components (vial adapter body, piercing spike, filter) and describes physical performance testing (penetration force, detachment force, bursting pressure, leakage), indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for the transfer and mixing of drugs contained in a vial." This describes a device used for handling and preparing medications, not for performing diagnostic tests on biological samples.
- Device Description: The description focuses on the physical components and function related to transferring and filtering air during drug preparation. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of Diagnostic Elements: The description does not mention any components or functions related to detecting, measuring, or analyzing substances in biological samples (like blood, urine, tissue, etc.), which are characteristic of IVD devices.
- Performance Studies: The performance studies listed are related to the physical and functional integrity of the device for drug transfer (penetration force, detachment force, filter testing, leakage, biocompatibility). They do not involve evaluating diagnostic accuracy or performance metrics like sensitivity, specificity, etc., which are crucial for IVDs.
In summary, the Vented Vial Adapter Transfer Device is a medical device used for drug preparation and transfer, not for performing in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
The Vented Vial Adapter Transfer Device is intended for the transfer and mixing of drugs contained in a vial.
Product codes
LHI
Device Description
The proposed device, Vented Vial Adapter Transfer Device - 13mm, is intended for use in healthcare facilities or in home environment by the patient or care-giver to aid and support prescribed treatment and therapy.
The proposed device consists of two integrated parts, the 13mm vial adapter body intended to be attached to a standard 13 mm drug vial. The other end is intended to be connected to a Female Luer connection. The vial adapter body contains the dual lumen piercing spike and the second part of the device is an assembled 0.2um hydrophobic air path filter (100% expanded PTFE membrane over Non-woven polyester membrane support). This enables keeping an equilibrium pressure between the drug vial and the ambient pressure, filtering the inserted/ released air through 0.2um air filter. The proposed device does not contain any medicinal substances.
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 facilities or in home environment by the patient or care-giver
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
The modifications to the proposed device were evaluated within the Medimop design control system. A risk assessment was performed to ensure that the proposed device modifications did not introduce any new potential risks. The following tests (Product functionality according to IFU, Total penetration force, detachment force from drug vial, filter bursting pressure, wet filter test, cap detachment from body, internal stress level, system leakage and biocompatibility) were performed on the proposed device, Vented Vial Adapter Transfer Device 13 mm, as a result of the risk assessment to ensure the all potential risks associated with the device modifications were mitigated to acceptable levels.
- Dimension change to 13mm
- o Addition of 'Tight Grip' feature
- Reverse air filter direction ●
- Use ultrasonic welding for cap attachment to body ●
Performance Testing Summary:
- Product Functionality Performance test according to IFU - Tested to internal performance standards
- Filter Bursting Pressure - Tested to internal performance standards
- Flow Rate Testing - Tested to internal performance standards
- Cap/valve-housing detachment from body Test - Tested to internal performance standards
- Internal stress level for assembled product - Tested to internal performance standards
- Biocompatibility - Tested per ISO 10993-1
All testing met the required acceptance criteria.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are connected and appear to be part of a single, flowing design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 4, 2016
Medimop Medical Projects Ltd. Ilanit Goldgraber Director of Regulatory Affairs 17 Hatidhar Street Ra'anana. 4366519 ISRAEL
Re: K160503
Trade/Device Name: Vented Vial Adapter Transfer Device - 13mm Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: LHI Dated: April 1, 2016 Received: April 4, 2016
Dear Ilanit Goldgraber:
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 (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,
Tina Kiang
-S
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K160503
Device Name
Vented Vial Adapter Transfer Device - 13mm
Indications for Use (Describe)
The Vented Vial Adapter Transfer Device is intended for the transfer and mixing of drugs contained in a vial.
| 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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3
Vented Vial Adapter Transfer Device - 13mm
510(K) SUMMARY
Device: Vented Vial Adapter Transfer Device - 13mm
Company Name:
Medimop Medical Projects Ltd 17 Hatidhar St Ra'anana 4366519 Israel Phone: 972-9-7757122 Fax: 972-9-7485916
Contact Person:
Ilanit Goldgraber Director of RA Phone: 972-9-7778666 Fax: 972-9-7485916 E-mail: ilanit.goldgraber@westpharma.com
US Agent:
Kevin Lentz Sr. Director RA West Pharmaceutical Services, Inc. 530 Herman O. West Drive Exton, PA 19341 Phone: (610) 594-4353 Email: kevin.lentz@westpharma.com
Preparation date: 5/4/2016
Classification:
| Classification Name: | Intravascular Administration Set |
|---|---|
| Trade Name: | Vented Vial Adapter Transfer Device - 13mm |
| Common/Usual Name: | Vented Vial Adapter 13mm |
| Product Code: | LHI |
| Regulation No.: | 880.5440 |
| Class: | II |
| Panel Identification: | General Hospital Panel |
| Predicate Devices: | Vented Vial Adapter Transfer Device, cleared by 510(K) K062482 |
4
Vented Vial Adapter Transfer Device - 13mm
Device Description:
The proposed device, Vented Vial Adapter Transfer Device - 13mm, is intended for use in healthcare facilities or in home environment by the patient or care-giver to aid and support prescribed treatment and therapy.
The proposed device consists of two integrated parts, the 13mm vial adapter body intended to be attached to a standard 13 mm drug vial. The other end is intended to be connected to a Female Luer connection. The vial adapter body contains the dual lumen piercing spike and the second part of the device is an assembled 0.2um hydrophobic air path filter (100% expanded PTFE membrane over Non-woven polyester membrane support). This enables keeping an equilibrium pressure between the drug vial and the ambient pressure, filtering the inserted/ released air through 0.2um air filter. The proposed device does not contain any medicinal substances.
Indications for use:
The Vented Vial Adapter Transfer Device is intended for the transfer and mixing of drugs contained in a vial.
Substantial Equivalence
The proposed device, Vented Vial Adapter Transfer Device - 13mm, has the same indications for use and principle of operation as the predicate device, Vented Vial Adapter Transfer Device, from Medimop Medical Projects, Ltd, cleared by 510(k) number K062482.
The following modifications have been made to the Vented Vial Adapter Transfer Device originally cleared by 510(K) K062482:
- o Dimension of body connection modified to fit a 13mm vial
- Air Filter Reversal in order to avoid clogging of the filter if the diluent is injected in ● upright position and, by that, to improve the usability of the device. The hydrophobic side of the filter is now facing the vent path.
- The vial adapter body was redesigned to include "tight grip" feature to improve adherence of the vial adapter to the 13mm vial. Subsequently the geometry of the individual blister package was modified to adapt the "tight grip" modification (larger internal diameter)
- The cap is attached to the body by ultrasonic welding instead of a snap fit ●
5
Vented Vial Adapter Transfer Device – 13mm
Technological Characteristics and Substantial Equivalence:
The Medimop Vented Vial Adapter Transfer Device - K062482 has been cleared for the transfer and mixing of drugs contained in vials and is being selected as the predicate device for this proposed device. The predicate and proposed devices are designed and manufactured by the same organization and share the same materials and function. The proposed device expands the dimensional and functional attributes of the predicate 20mm vial adapter for use with smaller 13mm vials.
The predicate and proposed devices share the same principle of operation and fundamental technology when utilizing the Vented Vial Adapter device. The Vented Vial Adapter allows the connection of any standard accessory with a Luer connection to be connected to a vial. Once mixing of the diluent and the drug is complete, the drug solution can be transferred using the vial adapter. The determination that the drug solution is ready for use is based on drug manufacturer recommendations. The vial adapter is a single use device and should be disposed of after use.
| Areas for
comparison | Claimed Substantially
Equivalent Product
Vented Vial Adapter
K062482 | Proposed Device
Vented Vial Adapter –
13mm
K160503 | Comparison |
|------------------------------|-------------------------------------------------------------------------------|------------------------------------------------------------------------|------------|
| Indication for
Use | Intended for the transfer
and mixing of drugs
contained in vials | Intended for the transfer
and mixing of drugs
contained in vials | Identical |
| Sterilization
Method | Gamma | Gamma | Identical |
| Sterility
Assurance Level | SAL 10⁻⁶ | SAL 10⁻⁶ | Identical |
| Single use | Yes | Yes | Identical |
| Material | Polycarbonate | Polycarbonate | Identical |
| Expiration Date | 5 years | 3 years | Modified |
| Body Diameter | 30.4mm to fit 20mm Vials
Image: Vented Vial Adapter | 18.5mm to fit 13mm Vials
Image: Vented Vial Adapter | Modified |
6
Vented Vial Adapter Transfer Device - 13mm
| Areas for
comparison | Claimed Substantially
Equivalent Product
Vented Vial Adapter
K062482 | Proposed Device
Vented Vial Adapter -
13mm
K160503 | Comparison |
|---------------------------------|-------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|------------|
| Air Filtration | 0.2 micron hydrophobic
Filter
Oval centered hole | 0.2 micron hydrophobic
Filter
Round centered hole
Reversed direction of flow | Modified |
| Cap Assembly | Assembly Attached
Mechanically | Assembly Attached
Ultrasonically | Modified |
| Vial Adapter Fit
(Vial Side) | Snap Fit to Vial | Snap Fit to Vial
Reduced Diameter to
improve grip of 13mm
Vials (i.e. "Tight Grip"
Feature) | Modified |
| Piercing Spike | Plastic - Dual Lumen | Plastic - Dual Lumen | Identical |
Performance Testing:
The modifications to the proposed device were evaluated within the Medimop design control system. A risk assessment was performed to ensure that the proposed device modifications did not introduce any new potential risks. The following tests (Product functionality according to IFU, Total penetration force, detachment force from drug vial, filter bursting pressure, wet filter test, cap detachment from body, internal stress level, system leakage and biocompatibility) were performed on the proposed device, Vented Vial Adapter Transfer Device 13 mm, as a result of the risk assessment to ensure the all potential risks associated with the device modifications were mitigated to acceptable levels.
- Dimension change to 13mm
- o Addition of 'Tight Grip' feature
- Reverse air filter direction ●
- Use ultrasonic welding for cap attachment to body ●
7
Vented Vial Adapter Transfer Device – 13mm
| Performance Testing Summary | |
|---|---|
| Test Name | Testing Standard |
| Product Functionality Performance | |
| test according to IFU | Tested to internal performance standards |
| Filter Bursting Pressure | Tested to internal performance standards |
| Flow Rate Testing | Tested to internal performance standards |
| Cap/valve-housing detachment | |
| from body Test | Tested to internal performance standards |
| Internal stress level for | |
| assembled product | Tested to internal performance standards |
| Biocompatibility | Tested per ISO 10993-1 |
All testing met the required acceptance criteria.
Conclusion
The evaluation of the proposed device, Vented Vial Adapter Transfer Device - 13mm, does not raise any additional concerns regarding safety and effectiveness and is considered to be substantially equivalent to the predicate device, Vented Vial Adapter Transfer Device, 510(k) K062482.