(155 days)
No
The device description and performance studies focus on the mechanical and antimicrobial properties of the stopcock, with no mention of AI or ML technology.
No.
The device's intended use is for fluid flow control and administration of solutions, with an antimicrobial feature to prevent contamination on the device itself, not to treat patient infections.
No
The device is described as being for fluid flow directional control and providing access ports for administration of solutions, such as for pressure monitoring, intravenous fluid administration, and transfusion. It also has an antimicrobial feature to reduce contamination. There is no mention of it being used to diagnose conditions or diseases.
No
The device description clearly indicates it is a physical stopcock/manifold made of materials with an antimicrobial agent, not a software program.
Based on the provided text, 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 in vivo (within the body) for managing fluids and medications.
- Typical Uses: The typical uses listed are "pressure monitoring, intravenous fluid administration and transfusion." These are all procedures performed directly on a patient.
- Device Description: The description details a stopcock or manifold with ports for "medications injection, IV administration and blood sampling." These are all actions related to patient care and not laboratory testing of samples in vitro.
- Antimicrobial Feature: While the device has an antimicrobial feature, its purpose is to prevent contamination on the device itself during its use in patient care, not to perform a diagnostic test on a sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) to provide diagnostic information about a patient's health status. The device does not perform any kind of test or assay.
In summary, the device is a medical device used for managing fluid flow and access during patient treatment, not for performing diagnostic tests on samples outside the body.
N/A
Intended Use / Indications for Use
Elcam Antimicrobial Stopcock [or Manifold] is 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.
Elcam Antimicrobial Stopcock [or Manifold] has a feature of an antimicrobial agent using a compound containing silver.
The inclusion of an antimicrobial agent into the material formulation is intended to prevent/reduce the growth of contaminants on the device.
The device is NOT intended to be used as a treatment for patient infections.
Product codes (comma separated list FDA assigned to the subject device)
FMG
Device Description
Elcam Antimicrobial Stopcock [or Manifold] is identical to Elcam conventional legally marketed Stopcocks. A model of typical Stopcock is illustrated in Figure 1, section 11, page 33 of this submission.
Stopcocks and Manifolds have port(s) that provide access for medications injection, IV administration and blood sampling. The Stopcock usually has three ports and a handle that directs the fluid flow. It has one female side port that is used for medication injection or blood sampling. Both opposite ports (female/male) are connected to the IV line. The Manifold is assembled from two to five stopcocks bonded to each other to create a "stopcocks line" so the Manifold can have between two to five side ports for injection or sampling. Naturally, when the port is open, it can be a potential portal of entry for microorganisms into the device fluid path.
Elcam's Antimicrobial Stopcock [or Manifolds] provides an effective solution in preventing/reducing bacterial colonization in the device.
The antimicrobial agent is based on silver like in Medex's antimicrobial stopcock legally marketed device, cleared by 510(k) number K954970.
All body/fluid contact materials that composed the Antimicrobial Stopcock were tested widely for chemical and biocompatibility in accordance to FDA's Memorandum - #G95 1, May 1, 1995 and ISO 10993-1:2003 - Biological evaluation of medical devices - Part 1: Evaluation and testing with acceptable results.
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)
Standard testing related to functionality (mechanically and microbiologically) of the new device has been conducted on Elcam Antimicrobial Stopcock. Extensive tests were performed with a variety of organisms in order to establish the new device effectiveness by demonstrating significant reduction of bacteria levels (at least 2 log). Mechanical tests were performed according to Elcam conventional stopcock specification with acceptable results.
Tests results are supporting all labeling claims and substantial equivalency. Biocompatibility and chemical tests, material characterization and risk assessment were performed on the patient-contact and fluid path materials of Elcam's Antimicrobial Stopcock with satisfactory results.
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
K05 3405
Image /page/0/Picture/1 description: The image shows the logo for Elcam Medical. The text "Elcam Medical" is written in a simple, sans-serif font. To the right of the text is a stylized logo consisting of a vertical line and a partial circle, resembling the letters "l" and "c". The logo is simple and modern.
SarAm 13860 11736 1-377-4499-8120112 icam@elcam.co.i eicam-medical.com
MAY 11 2006
510(K) SUMMARY FOR ELCAM ANTIMICROBIAL STOPCOCK [OR MANIFOLD]
DATE PREPARED: APRIL 3, 2006
510(K) OWNER NAME 1.
Elcam Medical ACAL Kibbutz BarAm, Merom HaGalil 13860, Israel
Submitter & Contact person name: Ms. Tali Hazan - R.A Specialist Telephone: 972-4-6988875, Fax: 972-4-6980777, E-mail: tali(@elcam.co.il
ELCAM MEDICAL'S U.S AGENT: Elcam Medical, Inc. 2 University Plaza, Suite 620, Hackensack, NJ 07601, USA
Contact Person: Mr. Ehud Raivitz - CEO Telephone: 201-457-1120, Fax: 201-457-1125, E-mail: ehud@elcam-medical.com
2. DEVICE NAME
Common/Usual Name: Antimicrobial Stopcock for Manifold] Proprietary/Trade name: Elcam B-Stop Classification: Elcam Antimicrobial Stopcock has been classified as Class II devices under the following classification names:
Classification Name | Product Code | 21 CFR Ref. | Panel |
---|---|---|---|
Stopcock, I.V. Set | FMG | 880.5440 | General Hospital |
3. PREDICATE DEVICES
Elcam's Antimicrobial Stopcock for Manifold] is substantially equivalent to Elcam's Stopcocks and Manifolds cleared under 510(k) number K022895.
For the antimicrobial feature, it is substantially equivalent to Medex's MX531-1LT Antimicrobial IV Set Stopcock and MX491T Antimicrobial Luer Lock Plug cleared under 510(k) number K954970.
1
4. DEVICE DESCRIPTION
Elcam Antimicrobial Stopcock [or Manifold] is identical to Elcam conventional legally marketed Stopcocks. A model of typical Stopcock is illustrated in Figure 1, section 11, page 33 of this submission.
1053405
Stopcocks and Manifolds have port(s) that provide access for medications injection, IV administration and blood sampling. The Stopcock usually has three ports and a handle that directs the fluid flow. It has one female side port that is used for medication injection or blood sampling. Both opposite ports (female/male) are connected to the IV line. The Manifold is assembled from two to five stopcocks bonded to each other to create a "stopcocks line" so the Manifold can have between two to five side ports for injection or sampling. Naturally, when the port is open, it can be a potential portal of entry for microorganisms into the device fluid path.
Elcam's Antimicrobial Stopcock [or Manifolds] provides an effective solution in preventing/reducing bacterial colonization in the device.
The antimicrobial agent is based on silver like in Medex's antimicrobial stopcock legally marketed device, cleared by 510(k) number K954970.
All body/fluid contact materials that composed the Antimicrobial Stopcock were tested widely for chemical and biocompatibility in accordance to FDA's Memorandum - #G95 1, May 1, 1995 and ISO 10993-1:2003 - Biological evaluation of medical devices - Part 1: Evaluation and testing with acceptable results.
ട. INTENDED USE
Elcam Antimicrobial Stopcock [or Manifold] is 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.
Elcam Antimicrobial Stopcock [or Manifold] has a feature of an antimicrobial agent using a compound containing silver.
The inclusion of an antimicrobial agent into the material formulation is intended to prevent/reduce the growth of contaminants on the device.
The device is NOT intended to be used as a treatment for patient infections.
- 5.1 The indications for Antimicrobial Stopcock [or Manifold] and its predicate devices are the same except for the following:
2
K053405 page 3 of 4
- 5.1.1 Elcam's legally marketed Stopcocks indication for use does not include the antimicrobial feature as no antimicrobial agent exists in these devices.
- 5.1.2 Medex's Antimicrobial IV set Stopcock and Antimicrobial luer lock plug indication for use has additional reference to the luer lock plug component. Elcam does not refer to the plug separately but as possible device variation.
· Elcam plugs do not include the antimicrobial agent and continue to function traditionally.
These two exceptions are not critical to the intended therapeutic use of the device and do not affect the safety and effectiveness of the device.
Note: Due to the similarity between Elcam's Stopcocks and Manifolds, henceforth the word Stopcock is referring also to Manifolds and may be used interchangeably unless specifically mentioned otherwise.
Q. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
Elcam's Antimicrobial Stopcock is substantially equivalent to Elcam's conventional legally marketed Stopcock cleared by 510(k) number K022895 and to Medex's legally marketed Antimicrobial Stopcock cleared by 510(k) number K954970. Elcam conventional stopcock does not have the antimicrobial feature. Medex's Antimicrobial Stopcock completes the new device substantial equivalency. Elcam's new product and the predicate devices have the same indication for use, same basic shape, design, characteristics, materials, manufacturing technology and same antimicrobial agent (silver ions) mechanism. Elcam's Antimicrobial Stopcock combines the two predicate devices into one device that has an added value to the product therapeutic use and helping to protect the patient from device-related infections.
In both, the antimicrobial new device and Medex predicate device, the antimicrobial agent is incorporated into the stopcock raw material and the devices were tested widely for their intended use.
3
K053405 Page 4 of 4
NONE CLINICAL PERFORMANCE DATA 7.
Standard testing related to functionality (mechanically and microbiologically) of the new device has been conducted on Elcam Antimicrobial Stopcock. Extensive tests were performed with a variety of organisms in order to establish the new device effectiveness by demonstrating significant reduction of bacteria levels (at least 2 log). Mechanical tests were performed according to Elcam conventional stopcock specification with acceptable results.
Tests results are supporting all labeling claims and substantial equivalency. Biocompatibility and chemical tests, material characterization and risk assessment were performed on the patient-contact and fluid path materials of Elcam's Antimicrobial Stopcock with satisfactory results.
8. CONCLUSIONS
The evaluation of Elcam Antimicrobial Stopcock non-clinical tests demonstrates that the device is as safe, as effective, and performs as well as or better than the predicate devices.
4
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 11 2006
Ms. Tali Hazan Regulatory Affairs Specialist Elcam Medical, A.C.A.L. Kibbutz BarAm Merom HaGalil 13860 ISRAEL
Re: K053405
Trade/Device Name: Antimicrobial Stopcock [or Manifold], B-Stop Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FMG Dated: March 9, 2006 Received: March 14, 2006
Dear Ms. Hazan:
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.
5
Page 2 - Ms. Hazan
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 vour 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Clus
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
Enclosure
6
Elcam Medical
BarAm 13860 Israel Tel: 972-4-698-8120/1/2 Fax: 972-4-698-0777 elcam@elcam.co.it eicam-medical.com
Indications for Use
510(k) Number (if known): _K053405
Device Name: Antimicrobial Stopcock [or Manifold]
Indications for Use: Elcam Antimicrobial Stopcock [or Manifold] is 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.
Elcam Antimicrobial Stopcock [or Manifold] has a feature of an antimicrobial agent using a compound containing silver.
The inclusion of an antimicrobial agent into the material formulation is intended to prevent/reduce the growth of contaminants on the device.
The device is NOT intended to be used as a treatment for patient infections.
Prescription Use | ✓ |
---|---|
(Part 21 CFR 801 Subpart D) |
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
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Elcam Medical 510(k) Elcam Antimicrobial Stopcock [or Manifold]
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CONFIDENTIAL Page 1