(101 days)
Not Found
No
The provided text describes a mechanical system for drug transfer and reconstitution and does not mention any AI or ML components.
No
The device is described as a "Drug Reconstitution and Transfer System" used by healthcare professionals to prepare drugs. Its function is to prevent exposure to hazardous drugs, not to treat a medical condition in a patient.
No
This device is described as a "contained system to be used by pharmacists or other healthcare professionals to prepare drugs... for intravenous infusion or injection." Its function is drug reconstitution and transfer, not diagnosis.
No
The device description clearly outlines multiple physical components (Vial Adaptor, Syringe Unit, Spike Adaptor 1, Spike Adaptor W, Luer Lock Adaptor) and describes it as a "closed system for drug transfer and reconstitution," indicating a hardware-based device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "prepare drugs, including cytotoxic drugs, for intravenous infusion or injection." This describes a process of handling and preparing medications for administration to a patient, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a system for transferring and reconstituting drugs, focusing on maintaining a closed system to prevent exposure to hazardous substances. This aligns with drug preparation and administration, not diagnostic testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
Therefore, the EQUASHIELD™ Drug Reconstitution and Transfer System falls under the category of a medical device used for drug preparation and administration, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The EQUASHIELD™ Drug Reconstitution and Transfer System is a contained system to be used by pharmacists or other healthcare professionals to prepare drugs, including cytotoxic drugs, for intravenous infusion or injection.
Product codes
LHI
Device Description
EQUASHIELD™ is a closed system for drug transfer and reconstitution. The EQUASHIELD™ system consists of an adaptor to the medication vial (Vial Adaptor), a proprietary piston syringe (Syringe Unit), an adaptor for connection to the infusion bag for injection (Spike Adaptor 1), an adaptor for connection to the infusion bag for withdrawal (Spike Adaptor W) and an adaptor to the Luer Lock (Luer Lock Adaptor).
The EQUASHIELD™ system is a closed system - it prohibits the escape of hazardous drugs and vapors to the surrounding environment, by air-tight enclosing of air and all contaminants within the system.
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
pharmacists or other healthcare professionals
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
Performance Testing - bench tests. A series of bench tests were performed to ensure that the device performs as intended. All testing results demonstrated satisfactory performance.
Performance Testing - Simulated clinical test. A simulated clinical test was performed in order to evaluate the Plastmed EQUASHIELD™ System and to ensure it performs its intended use as a closed drug transfer system. The simulated test has demonstrated that the EQUASHIELD™ system performs its intended use.
Both bench tests and simulated clinical test have shown that the device performs its intended use.
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.
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0.8 26 efen Industrial Pari 1959. Israe +972 4 9873737 x: +972 4 9873001
FEB - 2 2009
510(K) SUMMARY
510(k) Number K_
Applicant's Name: Plastmed Ltd.
Tefen Industrial Park
P.O.B 26, ISRAEL
Tel: (972)4-987-3737
Fax: (972)4-987-3001
Contact Person:
Tefen Industrial Park
Elissa Burg
P.O.B 26, ISRAEL , 24959
Tel (972)4-987-3737; Fax (972)4-987-3001
EQUASHIELDTM system
Closed drug transfer system
Trade Name:
Common name:
Classification:
Name: Intravascular administration set Product Code: LHI Regulation No: 880.5440 Class: II Classification Panel: General hospital
Predicate Devices:
Substantial equivalence to the following predicate device is claimed:
-
PhaSeal closed system for the preparation and administration of parenteral drugs; Carmel Pharma AB K972527
-
TEVADAPTOR; Migada Plant K051669
-
Texium™ Syringe; Cardinal Health, Aleris® Products K071108
Plastmed Ltd. | EQUASHIELD TM 510k Notification
1
Plastmed Ltd.
Building No. 7
P.O.B 26
Tefen Industrial Park
24959, Israel
Tel: +972 4 9873737
Fax: +972 4 9873001
Device Description:
EQUASHIELD™ is a closed system for drug transfer and reconstitution. The EQUASHIELD™ system consists of an adaptor to the medication vial (Vial Adaptor), a proprietary piston syringe (Syringe Unit), an adaptor for connection to the infusion bag for injection (Spike Adaptor 1), an adaptor for connection to the infusion bag for withdrawal (Spike Adaptor W) and an adaptor to the Luer Lock (Luer Lock Adaptor).
The EQUASHIELD™ system is a closed system - it prohibits the escape of hazardous drugs and vapors to the surrounding environment, by air-tight enclosing of air and all contaminants within the system.
Indication for Use Statement:
The EQUASHIELD™ Drug Reconstitution and Transfer System is a contained system to be used by pharmacists or other healthcare professionals to prepare drugs, including cytotoxic drugs, for intravenous infusion or injection
Performance Validation: Performance Testing - bench tests
A series of bench tests were performed to ensure that the device performs as intended. All testing results demonstrated satisfactory performance.
Performance Testing - Simulated clinical test
A simulated clinical test was performed in order to evaluate the Plastmed EQUASHIELD™ System and to ensure it performs its intended use as a closed drug transfer system. The simulated test has
Plastmed Ltd. | EQUASHIELD TM 510k Notification
2
Image /page/2/Picture/0 description: The image shows the logo for "Plastmed, a medical device company". The logo is in black and white and features a stylized font. The word "Plastmed" is in a larger font than the words "A Medical Device Company".
x; +972 4 9873001
demonstrated that the EQUASHIELD™ system performs its intended
use.
Tests conclusion:
Both bench tests and simulated clinical test have shown that the device performs its intended use.
Materials:
Materials of the EQUASHIELD™ device are biocompatible in accordance with ISO 10993-1.
Substantial Equivalence:
We have demonstrated that the EQUASHIELD ™ meets its labeled performance claims, and that it is substantially equivalent to the predicate devices.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" are arranged in a circle around the eagle. The logo is black and white.
FEB -2 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Elissa Burg Quality Assurance and Regulatory Assurance Manager Plastmed Limited Building No. 7 P.O.B 26 Tefen Industrial Park ISRAEL 24959
Re: K083152
Trade/Device Name: EQUASHIELD™ System Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: LHI Dated: December 25, 2008 Received: December 29, 2008
Dear Ms. Burg:
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.
4
Page 2 - Ms. Burg
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,
Anthony D. Anzalone, for
Ginette Y. Michaud, M.D. Acting 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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Image /page/5/Picture/0 description: The image shows the logo for Plastmed, a medical device company. The logo is in black and white, with the word "Plastmed" in large, bold letters. Below the company name is the phrase "A Medical Device Company" in smaller letters. The logo is simple and professional, and it conveys the company's focus on medical devices.
Plastmen I to Tefen Industrial Park +972 4 9873 4 1972 4 9873001
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name: EQUASHIELD TM System
Indications for Use:
The EQUASHIELD™ Drug Reconstitution and Transfer System is a contained system to be used by pharmacists or other healthcare professionals to prepare drugs, including cytotoxic drugs, for intravenous infusion or injection.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-off) Division of Division of General, Restorative and Neurological Devices
510(k) Number
Hall Sar
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: Korg152
Plastmed Ltd. | EQUASHIELD TM 510k Notification