(76 days)
The Vial2Bag is indicated to serve as a cornecting part between the IV bag and an external IV Line. The Vial2Bag has a built in connector which makes it possible to admix drugs into the infusion solution using a Swabable Valve.
The Vial2Bag is designed to serve as a connecting part between the IV bag and an external IV Line while allowing safe and easy transfer of drugs/diluents from and into an IV bag. The product allows quick transfer of the contents of a syringe or vial into an IV bag. The Vial2Bag is an assembly of three components a spike, a Swabable valve and a twist-off.
The provided text describes the "Vial2Bag" device and its 510(k) submission, confirming its substantial equivalence to predicate devices. However, the document does not contain a detailed study demonstrating quantitative acceptance criteria or specific performance metrics.
Here's an breakdown of the information that can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Not available in the provided text.
The document states: "All finished products are tested and must meet all required release specifications prior to distribution. The array of testing required for release include but are not limited to; Physical testing and visual examination (in-process and finished product)." However, it does not specify what these "required release specifications" or "acceptance criteria" are, nor does it report any quantitative performance data (e.g., flow rate, leak rates, durability metrics, etc.) for the Vial2Bag or the predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
Not available in the provided text.
The document mentions "testing" but does not specify sample sizes for any tests, nor does it describe the origin of any data (e.g., country of origin, retrospective or prospective nature).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable.
This information is relevant for studies involving the interpretation of data where a medical expert's judgment forms the ground truth (e.g., image analysis, diagnosis). The Vial2Bag is a medical device for fluid transfer, and its evaluation would typically involve engineering and functional testing rather than expert interpretation for ground truth.
4. Adjudication Method for the Test Set
Not applicable.
As expertise-based ground truth is not relevant for this device, adjudication methods are also not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a MRMC comparative effectiveness study was not done.
The document focuses on substantial equivalence based on indications for use, design, material, sterility, and packaging compared to predicate devices. It does not describe any study involving human readers or an AI component, nor does it discuss human performance improvement with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No, a standalone study was not done.
This device does not have an algorithm or AI component, so a standalone performance study in that context is not relevant.
7. Type of Ground Truth Used
Functional and Safety Testing.
While not explicitly called "ground truth" in the AI/data science sense, the "ground truth" for this device would be established through:
- Physical testing and visual examination: Ensuring the device meets its design specifications, is free from defects, and functions as intended (e.g., no leaks, proper connection, sterile).
- Material compatibility testing: Adherence to ISO 10993-1 and/or USP VI requirements.
- Sterility testing: Ensuring the product is sterile.
These are established standards and laboratory test results, not expert consensus, pathology, or outcomes data in the typical clinical study sense.
8. Sample Size for the Training Set
Not applicable.
A training set is relevant for machine learning algorithms. This device does not involve such algorithms.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
As there is no training set for an algorithm, this question is not relevant.
In summary, the provided submission focuses on establishing substantial equivalence to previously cleared predicate devices for regulatory approval, rather than demonstrating performance against specific quantitative acceptance criteria through a detailed clinical or performance study with reported metrics.
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Image /page/0/Picture/0 description: The image shows a logo for MEDIMOP MEDICAL PROJECTS Ltd. The logo features the letters "MOP" in a bold, sans-serif font, with a globe-like image placed behind the letters. Below the letters, the word "MEDIMOP" is written in a similar font, and below that, the full name of the company, "MEDICAL PROJECTS Ltd.", is written in a smaller font.
17 Hatidhar St., P.O.B 2499 Ra`anana 43665 Israel Tel. + 972 (9) 7757122 Fax. +972 (9) 7485916 E-mail: info@medimop.com www.medimop.com
DEC 1 3 2007
1
510(k) summary for the VIAL2BAG
(as required by section 807.92)
510(k) Notification submitted by:
Medimop Medical Projects Ltd. 17 Hatidhar St. P.O. Box 2499 Ra'anana 43665 Israel Phone: + 972 (9) 7757122 Fax: +972 (9) 7485916
Nachum Naveh Manager, Quality Assurance and Regulatory Affairs
August 24, 2007
Vial2Bag
General Hospital Class II, 80LHI Per 21 CFR 880.5440 Intravascular administration set
Same as Trade name
ROBERTSITE VIAL ADAPTER 510(k) No. K040634 Halkey-Roberts
PHASEAL INFUSION ADAPTER 510(k) No. K980381 Carmel Pharma
TEVADAPTOR, DRUG RECONSTITUTION AND TRANSFER SYSTEM 510(k) No. K051669 Teva
Medimop Medical Projects Ltd. 17 Hatidhar St. P.O. Box 2499 Ra'anana 43665 Israel
Contact person:
Date Summary Prepared
Trade Name:
Classification name:
Common device name:
Predicate devices:
Manufacturer:
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Image /page/1/Picture/0 description: The image shows a logo for MEDIMOP MEDICAL PROJECTS LTD. The logo features the letters "MOP" in large, bold font, with a globe image in the center. Below the letters, the word "MEDIMOP" is written in a smaller, sans-serif font, and below that, the words "MEDICAL PROJECTS LTD." are written in an even smaller font.
17 Hatidhar St., P.O.B 2499 Ra`anana 43665 Israel Tel. + 972 (9) 7757122 Fax. +972 (9) 7485916 E-mail: info@medimop.com www.medimop.com
Material:
The Vial2Bag is composed of materials that were tested in accordance with the ISO 10993-1 standard and/or USP VI requirements and were determined suitable for the Indications for Use of this product.
Device Description:
The Vial2Bag is designed to serve as a connecting part between the IV bag and an external IV Line while allowing safe and easy transfer of drugs/diluents from and into an IV bag. The product allows quick transfer of the contents of a syringe or vial into an IV bag.
The Vial2Bag is an assembly of three components a spike, a Swabable valve and a twist-off.
Indications for Use:
The Vial2Bag is indicated to serve as a connecting part between the IV bag and an external IV Line. The Vial2Bag has a built in connector which makes it possible to admix drugs into the infusion solution using a Swabable Valve.
Technological comparison to Predicate Device:
The Vial2Bag has Indications for Use identical to the PhaSeal Infusion Adapter and similar to the TEVADAPTOR-all are intended for admixing drugs and diluents and add it to the contents of an IV bag. All products have multiple access valves and piercing spikes, which enable the users to create a direct passage from vials to IV bags (and vice-versa), in a sterile manner.
The Vial2Bag allows any standard accessory with a luer connection to be connected to the IV bag. Once mixing of the diluent and the drug is complete the drug solution can be transferred into the IV bag. This can be repeated several times. The Vial2Bag assembly is a single use device and should be disposed of with the IV bag.
All devices are packaged sterile and designed ergonomically.
Any differences between the Vial2Bag and the equivalent devices have no significant influence on safety or effectiveness.
Safety and Effectiveness:
All finished products are tested and must meet all required release specifications prior to distribution. The array of testing required for release include but are not limited to; Physical testing and visual examination (in-process and finished product).
Conclusion:
It is our conclusion that the Vial2Bag and its predicates are substantially equivalent in their Indications for Use, design, material, sterility and packaging.
The Vial2Bag is to be used in a similar manner to the predicate devices and introduces no new issues of safety and effectiveness.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is a symbol of medicine and healing. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular fashion around the caduceus symbol.
DEC 1 3 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medimop Medical Projects, Limited C/O Mr. Ari Y. Sobel Director, Regulatory Affairs West Pharmaceutical Services 101 Gordon Drive Lionville, Pensylvania 19341
Re: K072759
Trade/Device Name: Vial2Bag Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: LHI Dated: September 17, 2007 Received: September 28, 2007
Dear Mr. Sobel:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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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Page 2 - Mr. Sobel
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: Vial2Bag
Indications for Use: The Vial2Bag is indicated to serve as a cornecting part between the IV bag and an external IV Line. The Vial2Bag has a built in connector which makes it possible to admix drugs into the infusion solution using a Swabable Valve.
Caitlin
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K072759
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PI.EASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page _ of
CONFIDENTIAL Medimop Medical Projects Ltd.
VIAL2BAG: 510(k) Submission September 17, 2007
App. 9 - Page 2 of 2
§ 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.