(71 days)
Not Found
No
The device description and the "Mentions AI, DNN, or ML" section explicitly state that AI/ML is not found. The device is a mechanical transfer device.
No
Explanation: This device is for transferring and mixing drugs, not for treating or diagnosing a medical condition in a patient. It is an accessory to drug preparation.
No
This device is described as a "Transfer and Mixing of drugs contained in vials" device, facilitating the movement of liquid drugs and diluents between syringes and vials. It does not perform any diagnostic function.
No
The device description explicitly details physical components (Hydrophobic medium, body with double lumen spike, cap with lucr connection) and their function in transferring liquids, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Transfer and Mixing of drugs contained in vials." This describes a process related to preparing and administering medications, not performing diagnostic tests on biological samples.
- Device Description: The description details a device for transferring liquids between syringes and vials, specifically mentioning diluents and powdered drugs. This aligns with drug reconstitution and preparation, not diagnostic testing.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (like blood, urine, tissue), detecting analytes, or providing diagnostic information.
- Predicate Devices: The listed predicate devices (MIXJECT® DISPENSING PIN, MIX2VIAL TRANSFER DEVICE, CHEMO MINI SPIKE PLUS, TAKY SPIKE PLUS) are all devices used for drug transfer and preparation, not IVDs.
In summary, the Vented Vial Adapter Transfer Device is designed for handling and preparing medications, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Vented Vial Adapter Transfer Device is intended for the transfer and mixing of drugs contained in vials.
Product codes (comma separated list FDA assigned to the subject device)
LHI
Device Description
The Vented Vial Adapter Transfer Device is designed for the purpose of allowing safe and easy transfer of liquid drugs from and into vials while keeping the process in pressure equilibrium with the ambient pressure. The product allows quick transfer of the contents of a syringe, typically containing diluents, into a drug (in the form of powder) vial and easy aspiration of the dissolved drug back into a syringe, or any other standard accessory.
The Vented Vial Adapter Transfer Device is an assembly of three components. A Hydrophobic medium (optional) is attached to the "body" with the double lumen spike (penetrating the rubber stopper) and a cap (with a lucr connection) is attached to the subassembly.
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
Not Found
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)
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, visual examination (in-process and finished product).
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.
K963583, K001293, K031861, K983794, K974198
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
K062482 page lot 3
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
Image /page/0/Picture/2 description: The image shows a logo for MEDIMOP MEDICAL PROJECTS Ltd. The logo features the letters "MOP" in large, bold font, with a textured globe-like image placed within the "O". Below the large letters, the word "MEDIMOP" is printed in a smaller, sans-serif font, and below that is the text "MEDICAL PROJECTS Ltd." in an even smaller font.
NOV – 3 2006
510(k) summary for the VENTED VIAL ADAPTER TRANSFER DEVICE
(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 |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Ari Y. Sobel
Director, Quality and Regulatory Affairs |
| Date Summary Prepared | July 18, 2006 |
| Trade Name: | Vented Vial Adapter Transfer Device |
| Classification name: | General Hospital Class II, 80LHI
Per 21 CFR 880.5440 Intravascular administration set |
| Common device name: | Same as Trade name |
| Predicate devices: | MIXJECT® DISPENSING PIN
510(k) No. K963583
Medimop Medical Projects Ltd.
MIXJECT® DISPENSING PIN
510(k) No. K001293
Medimop Medical Projects Ltd.
MIX2VIAL TRANSFER DEVICE
510(k) No. K031861
Medimop Medical Projects Ltd.
CHEMO MINI SPIKE PLUS
510(k) No. K983794
B. Braun Incorporated
TAKY SPIKE PLUS
510(k) No. K974198
Clinico |
| Manufacturer: | Medimop Medical Projects Ltd.
17 Hatidhar St.
P.O. Box 2499
Ra'anana 43665
Israel |
pp 10, 1 of 3
Appendix 10
1
Image /page/1/Picture/0 description: The image shows a logo for MEDIMOP MEDICAL PROJECTS Ltd. The logo features the letters 'M' and 'P' in a bold, sans-serif font, with a crescent moon-like shape in between them. 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, sans-serif font.
KO62482
17 Hatidhar St., P.O.B 249 Ra`anana 43665 Israel Tel. + 972 (9) 7757122 Fax. +972 (9) 7485916 E-mail: info@medimop.com www.medimop.com
Material:
The Vented Vial Adapter Transfer Device is composed of materials that were tested in accordance with the ISO 10993-1 standard and/or USP V1 requirements and were determined suitable for the Indications for Use of this product.
Device Description:
The Vented Vial Adapter Transfer Device is designed for the purpose of allowing safe and easy transfer of liquid drugs from and into vials while keeping the process in pressure equilibrium with the ambient pressure. The product allows quick transfer of the contents of a syringe, typically containing diluents, into a drug (in the form of powder) vial and easy aspiration of the dissolved drug back into a syringe, or any other standard accessory.
The Vented Vial Adapter Transfer Device is an assembly of three components. A Hydrophobic medium (optional) is attached to the "body" with the double lumen spike (penetrating the rubber stopper) and a cap (with a lucr connection) is attached to the subassembly.
Indications for Use:
The Vented Vial Adapter Transfer Device is intended for the transfer and mixing of drugs contained in vials.
Technological comparison to Predicate Device:
The Vented Vial Adapter Transfer Device has Indications for Use similar to the predicate devices – all are intended for transferring and mixing drugs and diluents contained in vials. All products have piercing spikes, which enable the users to create a direct passage to and from vials, in a sterile manner.
The Vented Vial Adapter Transfer Device allows the connection 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 is ready for use and may be aspirated into an accessory (e.g. syringe). This is similar to Medimop's Mixject dispensing pin (K963583). The adapter vial assembly is a single use device and should be disposed of after use.
All devices are packaged sterile and designed ergonomically. A filter may be included, so as to assure purity of the dissolved drug prior to its injection.
Any differences between the Vented Vial Adapter Transfer Device solution 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, visual examination (in-process and finished product).
App 10. 2 of 3
Appendix 10
2
Image /page/2/Picture/0 description: The image shows handwritten text on a white background. The text "K062482" is on the left side of the image, and the text "page 3 of 3" is on the right side of the image. The text appears to be written in black ink.
Image /page/2/Picture/1 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 stylized globe or sphere design incorporated into the letter "O". Below the letters, the word "MEDIMOP" is printed in a smaller font, and below that, the words "MEDICAL PROJECTS Ltd." are printed 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
Conclusion:
It is our conclusion that the Vented Vial Adapter Transfer Device and its predicates are substantially equivalent in their Indications for Use, design, material, sterility and packaging.
The Vented Vial Adapter Transfer Device is to be used in a similar manner to the predicate devices and introduces no new issues of safety and effectiveness.
App 10, 3 of 3
Appendix 10
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Ari Y. Sobel Director, Quality & Regulatory Affairs Medimop Medical Projects, Limited 17 Hatidhar Street P.O. Box 2499 Ra'anana 43665 ISRAEL
NOV - 3 2006
Re: K062482
Trade/Device Name: Vented Vial Adapter Transfer Device Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: LHI Dated: August 15, 2006 Received: August 24, 2006
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 8010 tarter addition, FDA may publish further announcements concerning your device in the Federal Register.
4
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 (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.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D.
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
5
Indications for Use
510(k) Number (if known):
Device Name: Vented Vial Adapter Transfer Device
Indications for Use: Transfer and Mixing of drugs contained in vials
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)
Antony U. m
f Anascheciology, General Hospital, Control, Dental Devices
Page _ of _
CONFIDENTIAL Medimop Medical Projects Ltd.
VENTED VIAL ADAPTER TRANSFER DEVICE: 510(K) Submission August 15, 2006