(130 days)
No
The device description and performance studies focus on mechanical protection and do not mention any AI/ML capabilities.
No.
The device is described as a "reconstitution and transfer system" for preparing drugs and a "Protective Plug" to protect connector ports, not for treating any medical condition or disease.
No
The device is described as a system for preparing and transferring drugs, and an accessory (Protective Plug) for protecting the system's connector ports during transport. Its function is to prevent physical damage and maintain the integrity of the drug preparation system, not to diagnose medical conditions or analyze health parameters.
No
The device description clearly indicates it is a physical "plug" or "cork" that mechanically blocks connector openings. There is no mention of software functionality.
Based on the provided information, the EQUASHIELD™ System and its Protective Plug accessory are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to prepare drugs, including cytotoxic drugs, for intravenous infusion or injection. This is a drug preparation and delivery system, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device description focuses on the mechanical function of the system and the protective plug in preventing contamination and damage during transportation. This is related to the safe handling and preparation of drugs, not diagnostic testing.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples, detecting analytes, or providing diagnostic information. There is no mention of reagents, assays, or any process that would be characteristic of an IVD.
The device is clearly intended for the safe handling and preparation of drugs for administration to patients, which falls under the category of medical devices used in drug delivery and preparation, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The EQUASHIELD™ System 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.
The EQUASHIELD™ System has an additional Protective Plug accessory which functions as a feature that mechanically prohibits the entrance of any objects into the EQUASHIELD™ System by physically blocking and protecting the system's connector ports.
Product codes
LHI
Device Description
The EQUASHIELD™ System Protective Plug is used as a "cork" for blocking EQUASHIELD™ connector openings, thus providing the system with further protection, mainly during the transportation and conveying of the EQUASHIELD™ System together with other accompanied items (used routinely by the hospital), where EQUASHIELD™ components might be squeezed in a transportation container together with other items which could accidently cause damage due to penetration of such items into the EQUASHIELD™ System's connector ports. The Protective Plug is inserted into the EQUASHIELD™ connector ports' openings and mechanically prohibits entrance of any accompanied items.
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
A conveyance simulation was performed by exposing the new device to the actual use conditions. Then, it was tested with accordance to the specification requirements in order to verify that the EQUASHIELD The Protective Plug device performs as intended and without compromising the safe use of the entire EOUASHIELD™ system (K083152) and EQUASHIELD The Luer Lock Connector Pair (K091389) which were used as predicate devices.
The tests that were conducted included: Visual tests; detachment tests; fluid flow through the entire system.
All functional tests results, post mimicking the actual conditions, met the specification predetermined acceptance criteria and demonstrated that the EQUASHIELD™ System components functioned appropriately after Protective Plug assembly and detachment and that it prevented the penetration of accompanying parts into EQUASHIELD™ ports during conveying.
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.
0
Image /page/0/Picture/0 description: The image shows the logo for EQ Ashield Medical Ltd. The logo is black and white and features the text "EQ" with a curved line underneath. To the right of "EQ" is the text "ASHIELD Medical Ltd."
Bequashield com
Section 13-510(K) SUMMARY
NOV 1 9 2010
510(K) SUMMARY EQUASHIELD™ SYSTEM PROTECTIVE PLUG
Date of summary: October 31, 2010
510(k) Number K101940/S2
- Applicant's Name: EQUASHIELD Medical Ltd. Tefen Industrial Park P.O.B 12, ISRAEL Tel: (972)4-987-3737 Fax: (972)4-987-3001
- Contact Person: Elissa Burg Tefen Industrial Park P.O.B 12, ISRAEL , 24959 Tel: +972-4-987-3737; Fax: +972-4-987-3001 Email: elissa@equashield.com Trade Name: EQUASHIELDTM System Protective Plug
Common name: Closed drug transfer system
Classification: Name: Intravascular administration set Product Code: LHI Regulation No: 880.5440 Class: II Classification Panel: General hospital
New EQUASHIELD™ System Protective Plug is substantially equivalent to Predicate Devices: the original EQUASHIELD™ System for the preparation and administration of parenteral drugs, cleared under 510(k) number K083152 and to the EQUASHIELD™ Luer Lock Connector Pair cleared under 510(k) number K091389.
EQUASHIELD Medical Ltd. | Protective Plug Special 510k, Appendix D Page 2 of 5 - CONFIDENTIAL -
1
Image /page/1/Picture/0 description: The image shows the logo for EQ Ashield Medical. The logo consists of the letters "EQ" in bold, followed by a curved line that connects to the word "Ashield" in bold. Below "Ashield" is the word "Medical" in a smaller font size. The logo is simple and professional, and it is likely used to represent a medical company.
Elissa Burg
Tel: +972 4 9873737
Fax: +972 4 9873001
elissa@equashield.com
Device Description:
The EQUASHIELD™ System Protective Plug is used as a "cork" for blocking EQUASHIELD™ connector openings, thus providing the system with further protection, mainly during the transportation and conveying of the EQUASHIELD™ System together with other accompanied items (used routinely by the hospital), where EQUASHIELD™ components might be squeezed in a transportation container together with other items which could accidently cause damage due to penetration of such items into the EQUASHIELD™ System's connector ports. The Protective Plug is inserted into the EQUASHIELD™ connector ports' openings and mechanically prohibits entrance of any accompanied items.
Indication for Use Statement:
The EQUASHIELD™ System 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.
The EQUASHIELD™ System has an additional Protective Plug accessory which functions as a feature that mechanically prohibits the entrance of any objects into the EQUASHIELD™ System by physically blocking and protecting the system's connector ports.
Technological characteristics and Substantial Equivalence:
The comparison table provided in our original submission's section 10 provides a detailed comparison between our new device and its predicates in order to support substantial equivalence.
The comparison table refers to:
Intended use; System components; Characteristics; Principles of operation; Technological characteristics; Sharps injury prevention feature; Target users; Intended environment of use; sterilization; materials and biocompatibility.
The table shows that in some features the Protective Plug is equivalent (due to the addition of the Protective Plug) to the predicates and in other features it is identical.
EQUASHIELD Medical Ltd. | Protective Plug Special 510k, Appendix D Page 3 of 5 - CONFIDENTIAL -
2
Image /page/2/Picture/0 description: The image shows the logo for EQ Shield Medical. The logo is in black and white and features the text "EQ ASHIELD" in a bold, sans-serif font. The "A" in "ASHIELD" is connected to the "Q" in "EQ" by a curved line. Below "ASHIELD" is the word "Medical" in a smaller font.
Tel: +972 4 98737 Fax: +972 4 9873001 a@equashield.com
The new device differs from the predicates only in the fact that it is used as an additional accessory to the entire system and provides an additional benefit in protecting the system components' ports.
In all other features the new device is identical to the predicates as following described:
Both new and predicate devices are the same in terms of components design, materials, device characteristics, mechanical features, connections type, performances and technology features as the legally marketed EQUASHIELD™ System (K083152) and EQUASHIELD 101 Luer Lock Connector Pair (K091389).
Therefore we have concluded that the EQUASHIELD™ System with Protective Plug accessory is substantially equivalent to the original EQUASHIELD™ System that was previously cleared under 510(k) number K083152 and the EQUASHIELD™ Luer Lock Connector Pair that was cleared under 510(k) number K091389.
The evaluation and tests results of the differences raised, showed that the new EQUASHIELD™ Protective Plug accessory is as safe and as effective as the predicate devices.
Non clinical performance data:
A conveyance simulation was performed by exposing the new device to the actual use conditions. Then, it was tested with accordance to the specification requirements in order to verify that the EQUASHIELD The Protective Plug device performs as intended and without compromising the safe use of the entire EOUASHIELD™ system (K083152) and EQUASHIELD The Luer Lock Connector Pair (K091389) which were used as predicate devices.
The tests that were conducted included: Visual tests; detachment tests; fluid flow through the entire system.
All functional tests results, post mimicking the actual conditions, met the specification predetermined acceptance criteria and demonstrated that the EQUASHIELD™ System components functioned appropriately after Protective Plug assembly and detachment and that it prevented the penetration of accompanying parts into EQUASHIELD™ ports during conveying.
We therefore believe that the tests results support all our labeling claims, substantial equivalency requirements and device's intended use.
EQUASHIELD Medical Ltd. | Protective Plug Special 510k. Appendix D Page 4 of 5 - CONFIDENTIAL -
3
Image /page/3/Picture/0 description: The image shows the logo for EQ Ashield Medical Ltd. The logo features the letters "EQ" in a bold, sans-serif font, with a curved line extending from the bottom of the "Q" to the base of the "A" in "Ashield." The words "Medical Ltd." are printed in a smaller font size below "Ashield."
Flieca Rur Tel: +972 4 9873737 Fax: +972 4 9873001 elissa@equashield.com
Conclusions:
The evaluation of EQUASHIELD Medical's new device's performance tests demonstrated that the device performs as intended and that it is as safe and as effective as the predicate devices.
In the light of the above, we believe it is substantially equivalent to EQUASHIELD Medical's legally marketed devices; EQUASHIELD™ System (K083152) and the EQUASHIELD™ Luer Lock Connector Pair (K091389) and appropriate for its intended use.
4
Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, topped by a cross. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Elissa Burg Quality Assurance and Regulatory Affairs Manager Equashield Medical Limited Tefen Industrial Park P.O. B. 12, Israel, 24959
NOV 1 9 2010
Re: K101940
Trade/Device Name: EQUASHIELD™ System with Protective Plug Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: LHI Dated: November 3, 2010 Received: November 5, 2010
· 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. 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.
5
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); 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/AboutFDA/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/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,
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
6
Image /page/6/Picture/0 description: The image shows the logo for EQ Ashield Medical. The logo consists of the letters "EQ" in bold, followed by a curved line that connects to the word "ASHIELD" in bold. Below the word "ASHIELD" is the word "Medical" in a smaller font. The logo is simple and modern, and the use of bold fonts makes it easy to read.
issamenuashield com
Appendix D - Indications for Use Statement
INDICATIONS FOR USE STATEMENT
NOV 1 9 2010
510(k) Number (if known):KJOl Y YO
Device Name: EQUASHIELD TM System with Protective Plug
Indications for Use:
The EQUASHIELD™ System 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.
The EQUASHIELD™ System has an additional Protective Plug accessory which functions as a feature that mechanically prohibits the entrance of any objects into the EQUASHIELD™ System by physically blocking and protecting the system's connector ports.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-off)
Division of Division of General, Restorative and Neurological Devices
11/17/10
510(k) Number
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devices Division of Antonio Dental Devices
EQUASHIELD Medical Ltd. | Protective Plug ? nal 510k - CONFIDENTIAL Page 1 of 1