(77 days)
Not Found
No
The device description and performance studies focus on mechanical functionality and fluid dynamics, with no mention of AI or ML.
No.
The device is described as being for fluid flow directional control and providing access ports, and its typical uses are pressure monitoring, intravenous fluid administration, and transfusion. These functions manage fluid flow and access, but do not directly treat or diagnose a disease or condition, which are characteristic of a therapeutic device.
No
The device is described as a stopcock and manifold used for fluid flow directional control and administration of solutions (e.g., IV fluid administration, transfusion), not for diagnosing a condition or disease.
No
The device description clearly outlines physical components (stopcocks, manifolds, Safe2 Rotator, male luer, threaded rotator, male connector) and their mechanical function (fluid flow control, preventing kinks and twists). The performance studies focus on bench tests evaluating physical properties like twisting force and pressure resistance. There is no mention of software as a component or its function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "fluid flow directional control and for providing access port(s) for administration of solutions." This describes a device used for managing fluids within the body or for administering substances into the body, not for testing samples taken from the body to diagnose conditions.
- Device Description: The description focuses on the mechanical function of the stopcocks and manifolds for fluid management and preventing kinks in IV sets. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic, monitoring, or screening purposes. This device's function is entirely related to the in vivo administration and management of fluids.
N/A
Intended Use / Indications for Use
Elcam Stopcocks and Manifolds with Safe2 Rotator are indicated for fluid flow directional control and for providing access port(s) for administration of solutions. Typical uses include pressure monitoring, intravenous fluid administration and transfusion.
Product codes
FMG
Device Description
Elcam Stopcocks and Manifolds with Safe2 Rotator are an additional variation in the Elcam's Stopcocks and Manifolds product-family.
The Safe2 Rotator component is male luer with a mounted and internally threaded rotator that is fixed on the stopcocks body with a modified male connector. Both components create a uniform straight fluid path.
The device uniqueness is that the Safe2 Rotator can freely rotate on the stopcock male connector axis preventing the formation of kinks and twists in the IV sets during or following manipulations. In addition, the rotation ability of the Safe2 Rotator provides health care providers with a convenient access to a stopcock side (vertical) port during injection and aspiration.
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
Testing related to functionality of Elcam Stopcocks and Manifold with Safe2 Rotator has been conducted in a series of non-clinical tests. It has demonstrated that the modified device is as safe and effective as its predicate.
Following is a list of the bench tests that were conducted following risk management process to evaluate the effect of the design modification:
Compliance with the functional requirements of ISO 594-2 (lock fitting)
- Initial twisting force
- Secondary twisting force
- Liquid pressure resistance
- Disconnection force
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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JUL 3 0 2014
Page 1 of 3
Image /page/0/Picture/3 description: The image shows the logo for Elcam Medical. The logo consists of a stylized "E" symbol to the left of the text "Elcam MEDICAL". Below the text is the tagline "Where everything connects".
Special 510(k) summary for Elcam Medical Stopcocks and Manifolds with Safe2 Rotator
In accordance with 21 CFR 807.92 the following summary of information is provided
1. Date prepared:
May 07, 2014
2. Contact information for the 510(k) submission:
Owner: Elcam Medical ACAL Kibbutz BarAm, Merom HaGalil 1386000, Israel T: (972) - 4698-8120/1 F: (972) - 4698-0777 Email: sales@elcam.co.il
Contact Mrs. Natasha Branzburg person: Q.A. and R.A. Engineer Elcam Medical ACAL T: (972) - 77-2568-625 F: (972) - 4698-0777 Email: natasha.ev@elcam.co.il
Elcam Mr. Amir Halperin Medical's President of Elcam Medical, Inc. U.S. agent: 2 University Plaza, Suite 620, Hackensack, NJ 07601, USA T: (201) 457-1120 F: (201) 457-1125 Email: amir.halperin@elcam-medical.com
3. Device name:
Proprietary/ Trade name: Elcam Stopcocks and Manifolds with Safe2 Rotator
Common/ usual name: Stopcocks and manifolds with male luer lock rotator.
Classification: Elcam Stopcocks and Manifolds with Safe2 Rotator have been classified as Class II devices under the following classification names:
el: 972-4-698-8120/1/2 www.elcam-medical.com Fax: 972-4-698-0777 Baram 13860, Israel | sales@eicam.co.il Elcam Stopcocks El Lucomed Mass Injectech
1
Image /page/1/Picture/1 description: The image shows the logo for Elcam Medical. The logo consists of a stylized letter "E" on the left, followed by the words "Elcam" and "MEDICAL" stacked on top of each other. Below the words is the tagline "Where everything connects."
| Classification name | Product code | 21 CFR ref. | Panel |
|---|---|---|---|
| Intravascular | |||
| administration set | FMG | 880.5440 | General Hospital |
4. Predicate Device
Elcam Stopcocks and Manifolds with Safe2 Rotator were found to be substantially equivalent to Elcam's stopcocks and manifold.
Elcam's stopcocks and manifolds are legally marketed devices which are cleared under 510(k) number K022895.
Device Description 5.
Elcam Stopcocks and Manifolds with Safe2 Rotator are an additional variation in the Elcam's Stopcocks and Manifolds product-family.
The Safe2 Rotator component is male luer with a mounted and internally threaded rotator that is fixed on the stopcocks body with a modified male connector. Both components create a uniform straight fluid path.
The device uniqueness is that the Safe2 Rotator can freely rotate on the stopcock male connector axis preventing the formation of kinks and twists in the IV sets during or following manipulations. In addition, the rotation ability of the Safe2 Rotator provides health care providers with a convenient access to a stopcock side (vertical) port during injection and aspiration.
6. Intended use
Elcam Stopcocks and Manifolds with Safe2 Rotator are indicated for fluid flow directional control and for providing access port(s) for administration of solutions. Typical uses include pressure monitoring, intravenous fluid administration and transfusion.
7. Technological characteristics and substantial equivalence
Elcam Stopcocks and manifolds with Safe2 Rotator are substantially equivalent to Elcam stopcocks and manifolds cleared under 510(k) number K022895. This new stopcocks variation has the same indication for use, principle of operation.
overall shape, sterilization method and shelf life as its predicate. Without changing the way of use from the health care provider perspective, Safe2
Rotator component ensures a secured connection of the stopcocks with other tubing set components preventing inadvertent disconnection and allows performing easy injection/ aspiration through the male luer by twisting the rotator towards a health care provider.
There were no new questions regarding Elcam Stopcocks and Manifolds with Safe2 Rotator safety and effectiveness that were raised due to this modification. Therefore, the modified and the original devices were judged as substantially equivalent.
Image /page/1/Picture/17 description: The image shows contact information and brand names. The contact information includes a telephone number (972-4-698-8120/1/2), fax number (972-4-698-0777), website (www.elcam-medical.com), physical address (Baram 13860, Israel), and email address (sales@elcam.co.il). The brand names listed are Elcam Stopcocks, Lucomed, and Injectech.
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Image /page/2/Picture/1 description: The image shows the logo for Elcam Medical. The logo consists of a stylized "E" symbol to the left of the word "Elcam" in a bold, sans-serif font. Below "Elcam" is the word "MEDICAL" in a similar font, and below that is the tagline "Where everything connects."
8. Performance data
Testing related to functionality of Elcam Stopcocks and Manifold with Safe2 Rotator has been conducted in a series of non-clinical tests. It has demonstrated that the modified device is as safe and effective as its predicate.
Following is a list of the bench tests that were conducted following risk management process to evaluate the effect of the design modification:
Compliance with the functional requirements of ISO 594-2 (lock fitting) ı
- Initial twisting force
- Secondary twisting force
- Liquid pressure resistance
- Disconnection force
Conclusion 9.
The evaluation of our modified device performances demonstrated that it meets its specifications, labeling claims and that it is as safe and as effective as the predicate devices.
Image /page/2/Picture/12 description: This image contains contact information for Elcam Medical. The image includes the telephone number 972-4-698-8120/1/2 and fax number 972-4-698-0777. The website is www.elcam-medical.com and the email address is sales@elcam.co.il. The address is Baram 13860, Israel.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002
July 30, 2014
Elcam Medical ACAL Natasha Branzburg Q.A. and R.A. Engineer Kibbutz Bar-Am MP Merom Hagalil lsrael 13860
Re: K141254
Trade/Device Name: Eleam Stopcocks and Manifolds with Safe2 Rotator Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular administration set Regulatory Class: II Product Code: FMG Dated: July 6, 2014 Received: July 9, 2014
Dear Mrs. Branzburg:
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.
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Page 2 - Mrs. Branzburg
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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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,
MarySRunner-S
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K141254
Device Name
Elcam Stopcocks and Manifolds with Safe2 Rotator
Indications for Use (Describe)
Elcam Stopcocks and Manifolds with Safe2 Rotator are indicated for fluid flow directional control and for providing access port(s) for administration of solutions.
Typical uses include pressure monitoring, intravenous fluid administration and transfusion.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
्रिंग पु 11 FOR FDA USE ONLY . 110 134 r - . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ﺔ ﻓ Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Digitally signed by Richard C. Chapman -S Date: 2014.07.29 13:06:05 -04'00'
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