(73 days)
Elcam Closed Swabable Stopcock and MRVLS 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 Medical's Closed Swabable Stopcock and MRVLS is a similar version of Elcam legally marketed stopcock. cleared under 510(k) number K022895.
The Closed Swabable Stopcock includes an addition of a component that functions as a closed luer-activated valve.
The valve enables the female port (luer) to be closed when it is not in use and saves the need to close it with a cap, in order to avoid leakage and/or port's contamination. Once a male luer is introduced into the closed port the fluid path automatically opens to allow injection or blood sampling. Once the male luer is taken out, the female port is automatically closed.
The valve actually serves as a needleless injection site integrated in the stopcock. The only change from the end user point of view is the need to swab the valve's top (injection site) with aseptic fluid such as alcohol prior to male luer insertion.
The MRVLS (Minimal Residual Volume Luer-activated Swabable-stopcock) feature, is an additional option that can be added to the Closed Swabable Stopcock, described above, and provides a stopcock with a minimal residual volume.
Conventional stopcocks are made of a body and a handle with a fluid path bore that allows the fluid to flow only through the handle. Therefore, it leaves other areas in the stopcock without a continuous flow through the stopcock fluid path and especially through the side port female luer. The MRVLS feature enables fluid flow around the handle so the fluid constant flow accesses the entire stopcock's internal volume and enables a continuous flow through the stopcock fluid path and through the side female luer during the medical procedure. This feature significantly reduces the "residual volume" in the stopcock and helps to keep the cleanliness of the stopcock's fluid path when it is in use.
The feature of minimal residual volume is achieved thanks to a modification in the stopcock handle design, which changes the fluid path and a flow guide formed therein.
The minimal residual volume design, together with the luer-activated valve creates the Minimal Residual Volume Luer-activated Swabable-stopcock (MRVLS).
This document outlines a Special 510(k) Summary for Elcam Medical's Closed Swabable Stopcock and MRVLS (Minimal Residual Volume Luer-activated Swabable-stopcock). The information provided focuses on demonstrating substantial equivalence to a predicate device, rather than an independent performance study of a new medical device with explicit acceptance criteria and corresponding study results in the traditional sense.
Therefore, the requested information categories may not directly apply as they would for a novel device where diagnostic performance (e.g., sensitivity, specificity) is being evaluated. This submission focuses on non-clinical performance data to show the modified device is as safe and effective as its predicate.
Here's an attempt to populate the requested table and answer the questions based solely on the provided document, acknowledging the limitations for an "acceptance criteria" and "study" as typically understood for diagnostic AI/ML devices:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria (Implied from text) | Reported Device Performance (Summary from text) |
|---|---|---|
| Biocompatibility | Compliance with FDA's Memorandum – #G95-1 (May 1, 1995) and ISO 10993-1:2003. | All body/fluid contact materials were tested and showed "acceptable results." |
| Material Characterization | Validation of colorant/raw materials for intended use; Evaluation for biocompatibility. | Colorant and raw materials are "all validated to their intended use and evaluated for biocompatibility." |
| Risk Assessment | Satisfactory risk assessment (implied). | Risk assessment performed on patient-contact and fluid path materials showed "satisfactory results." |
| Functional Performance | Device meets Elcam's legally marketed device specification for the modified stopcock. | "The modified device was tested with accordance to Elcam's legally marketed device specification and all acceptance criteria were met." |
| Substantial Equivalence | Device is as safe and as effective as the predicate device (K022895) and does not affect its intended use or alter fundamental scientific technology. | "The evaluation... demonstrates that the device is as safe, as effective, and performs as well as or better than the predicate device. Therefore, we believe it is substantially equivalent..." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify sample sizes for any of the non-clinical tests (biocompatibility, material characterization, functional performance, risk assessment). These are typically bench tests or material tests, not observational or interventional studies with patient data.
Data provenance (country of origin, retrospective/prospective) is not applicable or specified since the tests described are non-clinical, likely conducted in a laboratory setting. The company is based in Israel.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable. The device is a medical accessory (stopcock), not a diagnostic device where expert ground truth would be established from patient data. Performance is evaluated against engineering specifications and industry standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods are typically used in clinical studies where multiple human readers interpret data, and discrepancies need to be resolved. The described tests are non-clinical and rely on objective measurements and established protocols.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. An MRMC study is relevant for evaluating the performance of AI-assisted diagnostic tools. This submission is for a medical device (stopcock) and does not involve AI or human "readers" in the context of diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical medical accessory, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests described:
- Biocompatibility: Ground truth is established by adherence to and successful completion of tests outlined in ISO 10993-1:2003 and FDA guidance, with acceptable results.
- Material Characterization: Ground truth is established by material specifications and validation against intended use.
- Functional Performance: Ground truth is the device meeting Elcam's own "legally marketed device specification."
8. The sample size for the training set
This is not applicable. There is no mention of a "training set" as this is not an AI/ML device. The tests performed are for the physical device's non-clinical performance.
9. How the ground truth for the training set was established
This is not applicable, as there is no training set for an AI/ML device.
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Image /page/0/Picture/1 description: The image shows the logo for Elcam Medical. The logo consists of the words "Elcam Medical" stacked on top of each other, with the letters "l" and "c" stacked on top of each other to the right of the words. There is a black circle above the "l" and "c". The logo is black and white.
APR 1 3 2006
SPECIAL 510(K) SUMMARY FOR ELCAM'S CLOSED SWABABLE STOPCOCK (OR MRVLS)
DATE PREPARED: APRIL 7, 2006
510(K) OWNER NAME 1.
Elcam Medical ACAL Kibbutz BarAm, Merom HaGalil 13860, Israel
Submitter 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: Closed Swabable Stopcock and *MRVLS Proprietary/Trade name: Closed Swabable Stopcock and MRVLS MRVLS = Minimal Residual Volume Luer-activated Swabable-stopcock
Classification: Elcam's Closed Swabable Stopcock (or MRVLS) 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 Closed Swabable Stopcock (or MRVLS) is substantially equivalent to Elcam's Stopcocks and Manifolds cleared under 510(k) number K022895.
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Image /page/1/Picture/1 description: The image shows the logo for Elcam Medical. The logo consists of the words "Elcam Medical" stacked on top of each other on the left side of the image. To the right of the words is a stylized graphic that appears to be the letters "I" and "C" with a circle above them. The logo is black and white.
4. DEVICE DESCRIPTION
Modified Device and change Description: Elcam Medical's Closed Swabable Stopcock and MRVLS is a similar version of Elcam legally marketed stopcock. cleared under 510(k) number K022895.
The Closed Swabable Stopcock includes an addition of a component that functions as a closed luer-activated valve.
The valve enables the female port (luer) to be closed when it is not in use and saves the need to close it with a cap, in order to avoid leakage and/or port's contamination. Once a male luer is introduced into the closed port the fluid path automatically opens to allow injection or blood sampling. Once the male luer is taken out, the female port is automatically closed.
The valve actually serves as a needleless injection site integrated in the stopcock. The only change from the end user point of view is the need to swab the valve's top (injection site) with aseptic fluid such as alcohol prior to male luer insertion.
The MRVLS (Minimal Residual Volume Luer-activated Swabable-stopcock) feature, is an additional option that can be added to the Closed Swabable Stopcock, described above, and provides a stopcock with a minimal residual volume.
Conventional stopcocks are made of a body and a handle with a fluid path bore that allows the fluid to flow only through the handle. Therefore, it leaves other areas in the stopcock without a continuous flow through the stopcock fluid path and especially through the side port female luer. The MRVLS feature enables fluid flow around the handle so the fluid constant flow accesses the entire stopcock's internal volume and enables a continuous flow through the stopcock fluid path and through the side female luer during the medical procedure. This feature significantly reduces the "residual volume" in the stopcock and helps to keep the cleanliness of the stopcock's fluid path when it is in use.
The feature of minimal residual volume is achieved thanks to a modification in the stopcock handle design, which changes the fluid path and a flow guide formed therein.
The minimal residual volume design, together with the luer-activated valve creates the Minimal Residual Volume Luer-activated Swabable-stopcock (MRVLS).
Elcam Medical BarAm 13860, Israel Tel: 972-4-698-8120/1/2, Fax: 972-4-698-0777 sales@elcam.co.il
..............................................................................................................................................................................
Elcam Medical Special 510(k) revised Summary Elcam Closed Swabable Stopcock and MRVLS
April 7, 2006
CONFIDENTIAL Page 2 of 4
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Image /page/2/Picture/1 description: The image shows a logo for Elcam Medical. The logo consists of the words "Elcam Medical" stacked on top of each other, with the letters "IC" in a stylized font to the right of the words. There is a black circle above the "IC" letters. The logo is in black and white.
The colorant and raw materials changed and/or added are all validated to their intended use and evaluated for biocompatibility.
All body/fluid contact materials that compose the modified device: Closed Swabable Stopcock and MRVLS were tested for 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.
ડ. INTENDED USE
Elcam Closed Swabable Stopcock (or MRVLS) 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.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.
Elcam's Closed Swabable Stopcock (or MRVLS) is substantially equivalent to Elcam's conventional legally marketed Stopcock cleared by 510(k) number K022895. Elcam's new product and the predicate devices have the same indication for use, same basic shape, characteristics, materials, manufacturing technology and design.
The modified device differs from the predicate device in some characteristics such as the addition of the valve assembly and the design change in the MRVLS handle. These differences are not affecting the device's intended use or alter the device's fundamental scientific technology. The device is, therefore, as safe and as effective as the predicate device.
7. NONE CLINICAL PERFORMANCE DATA
Tests results are supporting all labeling claims and substantial equivalency. The modified device was tested with accordance to Elcam's legally marketed device specification and all acceptance criteria were met.
Biocompatibility and chemical tests, material characterization and risk assessment were performed on the patient-contact and fluid path materials of Elcam's modified device with satisfactory results.
Elcam Medical BarAm 13860, Israel Tel: 972-4-698-8120/1/2, Fax: 972-4-698-0777 sales@elcam.co.il
.............................................................................................................................................................................. Elcam Medical Special 510(k) revised Summary Elcam Closed Swabable Stopcock and MRVLS
April 7, 2006
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Image /page/3/Picture/1 description: The image shows the logo for Elcam Medical. The logo consists of the words "Elcam Medical" in a bold, sans-serif font, with the word "Elcam" stacked above the word "Medical". To the right of the words is a stylized graphic that appears to be the letters "i" and "c" with a circle above them.
8. CONCLUSIONS
The evaluation of Elcam's Closed Swabuble Stopcock (or MRVLS) non-clinical tests demonstrates that the device is as safe, as effective, and performs as well as or better than the predicate device. Therefore, we believe it is substantially equivalent to the Elcam's legally marketed device.
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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread. The eagle is facing to the right.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 3 2006
Ms. Tali Hazan Elcam Medical A.C.A.L. Kibbutz BarAm D.N. Merom Hagalil, 13860 Israel
Re: K060231
Trade/Device Name: Closed Swabable Stopcock and Minimal Residual Volume Luer - activated Swabable-stopcock Regulation Number: 880.5440 Regulation Name: Intravascular administration set Regulatory Class: II Product Code: FMG Dated: March 13, 2006 Received: March 16, 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 (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 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 Ms. Tali 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 continue 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 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Clive
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
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Indications for Use
510(k) Number (if known):
Device Name: Closed Swabable Stopcock and MRVLS)
MRVLS - Minimal Residual Volume Luer-activated Swabable-Stopcock
Indications for Use: Elcam Closed Swabable Stopcock and MRVLS 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.
Prescription Use Prescription Ose ------------------------------------------------------------------------------------------------------------------------------------------------------------- Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1_of_1
(Posted November 13, 2003)
Anthony D. Watson
,
, General Hospital
Control Dental Devices
K4E0231
§ 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.