(195 days)
Not Found
No
The summary describes a mechanical device for drug reconstitution and transfer, with no mention of AI or ML capabilities.
No
The device is a needle-free transfer device used for reconstitution and transfer of drugs, not for therapeutic administration or direct treatment of a disease or condition. It is an accessory to drug administration.
No
The device is described as a needle-free transfer device used for reconstitution and transfer of fertility drugs. Its intended use and device description focus on drug preparation and administration, not on diagnosing medical conditions.
No
The device description clearly states it is a "needless transfer device" and a "single use sterile device," indicating it is a physical hardware component used for drug reconstitution and transfer.
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 reconstitution and transfer of drugs for administration to a patient. This is a process related to preparing medication for treatment, not for diagnosing a condition.
- Device Description: The device is described as a "needless transfer device" for reconstituting lyophilized drugs for injection. This function is focused on drug preparation and delivery, not on analyzing samples from the body to provide diagnostic information.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) or to provide information about a patient's health status or disease.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device's function falls outside of that scope.
N/A
Intended Use / Indications for Use
Allow needle-free withdrawal, reconstitution and transfer of Bravelle® (urofolitropin for injection, purified) and/or Menopur® (menotropins for injection, USP) and diluent from vials into an injection syringe for administration on a single patient during a single procedure.
Product codes (comma separated list FDA assigned to the subject device)
LHI
Device Description
The device is a needless transfer device which enables reconstitution of one diluent vial and up to five vials of the fertility drugs Bravelle®, or Menopur® manufactured by Ferring using one MP Vial Adapter 13 mm.
The device is a single use sterile device which will be included into Ferring Pharmaceutical's Bravelle® and/or Menopur® drug kits to assist in the reconstitution of these lyophilized drugs for injection using one reconstitution diluent vial.
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)
Bench testing was performed to demonstrate the ability of the proposed MP Vial Adapter 13mm to effectively reconstitute and transfer Bravelle® and/or Menopur® fertility drugs.
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
Confidential
Name:
:
Traditional 510(k)
510(k) Summary 1. Submitter Information Medimop Medical Projects Ltd . ..
| Address: | 17 Hatidhar St
Ra'anana 4366519
Israel |
|-------------------|----------------------------------------------|
| Telephone Number: | 972-9-7778666 |
| Fax Number: | 972-9-7485916 |
AUG 0 8 2013
| Contact person: | Ilanit Goldgraber |
|---|---|
| Director of RA | |
| Telephone Number: | 972-9-7778666 Extension 219 |
| Fax Number: | 972-9-7485916 |
| E-mail: | ilanit.goldgraber@westpharma.com |
Deborah M. Thomas US Agent: West Pharmaceutical Services, Inc. 530 Herman O. West Drive Address: Exton, PA 19341-1147
| Telephone Number: | (610) 594-3105 |
|---|---|
| Fax Number: | (610) 594-3004 |
| Email: | debbie.thomas@westpharma.com |
| Date Prepared: | 23 January 2013 |
2. Device Name
| Device Trade Name: | MP Vial Adapter 13mm |
|---|---|
| Common Name: | MP Vial Adapter 13mm |
| Classification name: | IV Administration Set |
1
3. Classification
| Product Code: | LHI |
|---|---|
| Regulation No.: | 880.5440 |
| Class: | II |
| Panel identification: | General Hospital Panel |
4. Predicate Devices
- Mixiect with Spray Head (K122023) .
- Mixject Dispensing Pin 13mm (K963583) .
- Q-Cap needle-Free Reconstitution 13mm Vial Adapter (K043304) .
5. Device description
The device is a needless transfer device which enables reconstitution of one diluent vial and up to five vials of the fertility drugs Bravelle®, or Menopur® manufactured by Ferring using one MP Vial Adapter 13 mm.
The device is a single use sterile device which will be included into Ferring Pharmaceutical's Bravelle® and/or Menopur® drug kits to assist in the reconstitution of these lyophilized drugs for injection using one reconstitution diluent vial.
6. Indications for use
Allow needle-free withdrawal, reconstitution and transfer of Bravelle® (urofolitropin for injection, purified) and/or Menopur® (menotropins for injection, USP) and diluent from vials into an injection syringe for administration on a single patient during a single procedure.
7. Technological Characteristics and Substantial Equivalence
The MP Vial Adapter 13mm material of construction and design is the vial adapter subcomponent of the previously cleared Medimop Mixject with spray head (K122023). The proposed devices performance, packaging and sterilization are the same to that of a previously cleared Medimop 13mm Dispensing Pin (Vial Adapter - K963583). The only
CONFIDENTIAL
2
change to the proposed device is the indication for use which is being updated for use with the Ferring Pharmaceutical's fertility drugs Bravelle® and/or Menopur® and is equivalent to that of the previously cleared Q-Cap (K043304) and is therefore substantially equivalent to the predicate devices.
8. Nonclinical Testing
Bench testing was performed to demonstrate the ability of the proposed MP Vial Adapter 13mm to effectively reconstitute and transfer Bravelle® and/or Menopur® fertility drugs.
9. Conclusion
Comparative analysis of technological characteristics between proposed and predicate devices and results of verification testing performed demonstrate that the subject device is substantially equivalent to the legally marketed predicate devices. Any differences between the proposed and predicate devices do not raise any additional concerns regarding safety and effectiveness and may therefore be considered substantially equivalent to the predicate devices.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
August 08, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Medimop Medical Projects, Limited Mr. Hanit Goldgraber Director of Regulatory Affairs 17 Hatidhar Street RA'ANANA ISRAEL 4366519
Re: K130179
Trade/Device Name: MP Vial Adapter 13 mm Regulation Number: 21 CFR 880.5440 Regulation Name: Set, I.V. Fluid Transfer Regulatory Class: II Product Code: LHI Dated: June 12, 2013 Received: July 11, 2013
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 10 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 go to http://www.fda.gov/About/DA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/McdicalDcyices/Safety/ReportaProblem/dcfault.hum 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,
Kwame O. Ulmer -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
5
MP Vial Adapter 13mm
Confidential
'
Indications for Use
510(k) Number (if known): K130179
Device Name: MP Vial Adapter 13 mm
Indications for Use:
Allow needle-free withdrawal, reconstitution and transfer of Bravelle® (urofolitropin for injection, purified) and/or Menopur® (menotropins for injection, USP) and diluent from vials into an injection syringe for administration on a single patient during a single procedure.
Prescription Use X (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)
| (Division Sign-Off)
Division of Anesthesiology, General Hospital
| Infection Control, Dental Devices | Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|---|
| 510(k) Number: | K130179 |
| Richard C. Chapman | |
| 2013.08.06 | |
| 11:50:18 -04'00' | |
| Page 1 of 1 |
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