(80 days)
Not Found
No
The device description and performance studies focus on the mechanical and biocompatibility aspects of a physical connector for drug reconstitution, with no mention of AI or ML.
No
The device is described as a connecting part for reconstituting and admixing drugs from a vial into an infusion solution. It functions as an accessory to prepare medication for administration, rather than directly providing a therapeutic effect itself.
No
The device is described as a connecting part to admix drugs from a vial into an infusion solution, aiding and supporting treatment, not for diagnosis.
No
The device description explicitly states it consists of physical components like a piercing spike, twist-off connector, and integrated vial adapter, and the performance studies involve bench testing of these physical attributes.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to serve as a connecting part between an IV line and a drug vial for reconstitution and admixing. This is a device used in the administration of medication, not for diagnostic testing of samples taken from the body.
- Device Description: The description focuses on the physical components for connecting and transferring substances, not on analyzing biological samples.
- Lack of Diagnostic Elements: There is no mention of analyzing blood, urine, tissue, or any other biological sample for diagnostic purposes.
- Performance Studies: The performance studies focus on the physical integrity, functionality, and biocompatibility of the device for its intended use in drug administration, not on diagnostic accuracy or performance.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is entirely related to the preparation and administration of therapeutic substances.
N/A
Intended Use / Indications for Use
The proposed device, Vial2Bag™ Direct Connect is indicated to serve as a connecting part between the IV bag and an external IV line. The integrated vial adapter is used to reconstitute and admix drugs from a vial into the infusion solution.
Product codes
LHI
Device Description
The proposed device, Vial2Bag" Direct Connect, consists of the Vial2Bag" piercing spike and cover, the twist-off connector and an integrated Vial Adapter for access to the drug/solution vial. It does not contain any medicinal substances and can be used with standard drug vials. It is intended for use in healthcare facilities or in home environment by a care-giver to aid and support prescribed treatment and therapy.
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 a 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing was performed to verify design requirements and to mitigate any potential risks. All bench testing was performed following double EtO sterilization to ensure that the sterilization process does not have a detrimental effect on the proposed device, Vial2Bag™ Direct Connect performance. The following tests were completed and all of them passed the established acceptance criteria.
- Air leakage test
- Vial adapter detachment force from Vial2Bag™ body.
- Vial adapter breaking torque
- Vial adapter total vial penetration force.
- Vial adapter detachment force from vial
- Vial adapter spike damage
Biocompatibility Tests:
The proposed device, Vial2Bag™ Direct Connect, is classified as an external communicating device with prolonged indirect blood contact (24 hours to 30 days). The following tests were performed. All the tests passed the established acceptance criteria.
- Cytotoxicity (MEM Elution -ISO)
- Sensitization (ISO Guinea Pig Maximization Sensitization Test)
- Irritation / Intracutaneous (ISO Intracutaneous Study in Rabbits)
- Hemocompatibility (In Vitro Hemolysis Study Extraction Method)
- Acute Systemic Toxicity (ISO Systemic Toxicity Study in Mice)
- Material Mediated Pyrogenicity (USP Rabbit Pyrogen Extraction Method)
- Bacterial Pyrogenicity (LAL Test Method)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
510(K) SUMMARY 5
Vial2Bag™ Direct Connect Device:
Company Name:
Medimop Medical Projects Ltd 17 Hatidhar St Ra'anana 4366519 Israel Phone: 972-9-7778666 Fax: 972-9-7485916
Contact person:
Ilanit Goldgraber Director of Regulatory Phone: 972-9-7778666 Fax: 972-9-7485916 E-mail: ilanit.goldgraber@westpharma.com
US Agent:
Kevin Lentz Director of Regulatory/PDS group West Pharmaceutical Services, Inc 530 Herman O. West Drive Exton, PA 19341 Phone: (610) 594-4353 E-mail: kevin.lentz@westpharma.com
....
Preparation date: March 17, 2014
1
Classification:
Classification name: IV Administration Set Trade name: Vial2Bag™ Direct Connect Common/usual name: Vial2Bag" Direct Connect Product Code: LHI Regulation No.: 880.5440 Class: II Panel identification: General Hospital Panel
Predicate Devices:
Vial2Bag" from Medimop Medical Projects, Ltd, cleared by 510(k) number K072759
Mixject Dispensing Pin (Vial Adapter) from Medimop Medical Projects, Ltd cleared by 510(k) number K001293
Device Description:
The proposed device, Vial2Bag" Direct Connect, consists of the Vial2Bag" piercing spike and cover, the twist-off connector and an integrated Vial Adapter for access to the drug/solution vial. It does not contain any medicinal substances and can be used with standard drug vials. It is intended for use in healthcare facilities or in home environment by a care-giver to aid and support prescribed treatment and therapy.
Indications for use:
The proposed device, Vial2Bag™ Direct Connect is indicated to serve as a connecting part between the IV bag and an external IV line. The integrated vial adapter is used to reconstitute and admix drugs from a vial into the infusion solution.
Substantial equivalence
The proposed device. Vial2Bag™ Direct Connect has the same intended use, materials of construction and principle of operation as the predicate devices. Vial2Bag™ device (K072759) and the Mixject Dispensing Pin (Vial Adapter) (K001293) manufactured by Medimop Medical Projects Ltd. Therefore, the Vial2Bag™ Direct Connect is substantially equivalent to the predicate devices.
17 March 2014
2
Vial2Bag™ Direct Connect
Performance Testing
Bench testing was performed to verify design requirements and to mitigate any potential risks. All bench testing was performed following double EtO sterilization to ensure that the sterilization process does not have a detrimental effect on the proposed device, Vial2Bag™ Direct Connect performance. The following tests were completed and all of them passed the established acceptance criteria.
- Air leakage test ●
- Vial adapter detachment force from Vial2Bag™ body .
- Vial adapter breaking torque �
- Vial adapter total vial penetration force .
- Vial adapter detachment force from vial �
- Vial adapter spike damage
Biocompatibility Tests
The proposed device. Vial2Bag™ Direct Connect, is classified as an external communicating device with prolonged indirect blood contact (24 hours to 30 days). The following tests were performed. All the tests passed the established acceptance criteria.
- Cytotoxicity (MEM Elution -ISO) .
- Sensitization (ISO Guinea Pig Maximization Sensitization Test) .
- . Irritation / Intracutaneous (ISO Intracutaneous Study in Rabbits)
- Hemocompatibility (In Vitro Hemolysis Study Extraction Method) .
- Acute Systemic Toxicity (ISO Systemic Toxicity Study in Mice) ●
- · Material Mediated Pyrogenicity (USP Rabbit Pyrogen Extraction Method)
- Bacterial Pyrogenicity (LAL Test Method) .
Conclusion
ﺭ
Evaluation of the proposed device. Vial2Bag™ Direct Connect does not raise any additional concerns regarding safety and effectiveness. Therefore, it is considered substantially equivalent to the predicate devices, the Vial2Bag" device (K072759) and the Mixject Dispensing Pin (Vial Adapter) (K001293).
3
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 12, 2014
Medimop Medical Projects Limited Mr. Ilanit Goldgraber 17 Hatidhar Street Ra'anana 4366519 ISRAEL
Re: K140730
Trade/Device Name: Vial2Bag Direct™ Connect Regulation Number: 21 CFR 880.5440 Regulation Name: Vial2Bag Direct™ Connect Regulatory Class: II Product Code: LHI Dated: March 17, 2014 Received: March 24, 2014
Dear Mr. 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.
4
Page 2 - Mr. Goldgraber
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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Mary-S.Runner-S
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
5
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K140730
Device Name
-Vial2Bag™ Direct Connect-
Indications for Use (Describe)
The Vial2Bag™ Direct Connect is indicated to serve as a connecting part between the IV line. The integrated vial adapter makes it possible to reconstitute and admix drugs from a vial into the infusion solution.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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