(69 days)
No
The description focuses on mechanical design features and the inclusion of an antimicrobial agent, with no mention of AI or ML.
No
Explanation: The intended use explicitly states that the device is "NOT intended to be used as a treatment for patient infections," indicating it does not provide therapy. Its purpose is for fluid flow control and administration, with an antimicrobial feature to prevent/reduce contaminant growth, not to treat a disease or condition.
No
This device is described as a stopcock for fluid flow control and administration of solutions, and its function is to prevent/reduce the growth of contaminants. It does not perform any diagnostic functions by detecting or identifying conditions or diseases.
No
The device description clearly details physical components like stopcocks, valves, and handles, and mentions material formulations and physical design features. There is no mention of software as a component or the primary function of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "fluid flow directional control and for providing access port(s) for administration of solutions." Typical uses are listed as "pressure monitoring, intravenous fluid administration and transfusion." These are all related to managing fluids within the patient's body or administering substances to the patient, not for testing samples taken from the body.
- Device Description: The description focuses on the mechanical function of the stopcock, the antimicrobial properties of the material, and the design features for preventing contamination and facilitating flushing. There is no mention of analyzing samples or providing diagnostic information.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a patient's health status, diagnose conditions, or monitor treatment. This device does not perform any such function.
The antimicrobial agent is incorporated into the device material to prevent contamination of the device itself, not to perform a diagnostic test on a patient sample.
N/A
Intended Use / Indications for Use
Elcam Antimicrobial Closed Stopcocks (DSS and TSS) 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.
Both configurations have 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
FMG
Device Description
Elcam Medical's Antimicrobial Closed Stopcocks (DSS and TSS) are a similar version of Elcam legally marketed stopcocks, cleared under 510(k) numbers K053405 and K060231, as identified in paragraph number 3 above. Our Antimicrobial DSS and TSS combine two or three features of our legally marketed devices into one product contains these two or three protection lines as following described:
The Double Safe Stopcock (DSS) consists of our antimicrobial stopcock combined with our closed swabable luer-activated valve stopcock.
The closed swabable valve functions as a microbial barrier and the antimicrobial agent, impregnated in the stopcock body acts to prevent/reduce the growth of contaminants.
This configuration presents a stopcock with two protection lines; (1) impregnated antimicrobial agent; (2) closed swabable valve.
The Triple Safe Stopcock (TSS) consists of the same platform of the antimicrobial stopcock together with our legally marketed MRVLS (Minimal Residual Volume Luer-activated Swabable stopcock) design. The two protection lines described above for the DSS exist in the TSS yet, the TSS has a third protection line which is the unique design of the MRVLS handle enables fluid flow around the handle and thus enables more thorough and continuous flushing of the entire stopcock fluid path. This configuration presents a stopcock with three protetion lines:
(1) impregnated antimicrobial agent; (2) closed swabable valve; (3) MRVLS handle unique design.
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)
Design verification 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 previously performed for all patient-contact and fluid path materials consisting Elcam's modified device with satisfactory results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
OCT 02 2008
Image /page/0/Picture/2 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 consisting of a vertical rectangle with a circle above it, next to a letter "C" shape.
SPECIAL 510(K) SUMMARY FOR ELCAM ANTIMICROBIAL CLOSED STOPCOCKS (DSS AND TSS)
DATE PREPARED: JULY 21, 2008
-
- 510(K) OWNER NAME
Elcam Medical ACAL Kibbutz BarAm, Merom HaGalil 13860, Israel
- 510(K) OWNER NAME
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: Antimicrobial Closed Stopcocks (DSS and TSS) Proprietary/Trade name: Double Safe Stopcock (DSS) and Triple S afe Stopcock (TSS) "Stopcock = the word "Stopcock" applies also to "Manifolds"
Classification: Elcam's Antimicrobial Closed Swabable Stopcock and TSS 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 Closed Stopcocks (DSS and TSS) are substantially equivalent to Elcam's Antimicrobial Stopcock (B-Stop) cleared under 510(k) number K053405 and to Elcam's Closed Swabable Stopcock and MRVLS (Minimal Residual Volume Luer-activated Swabable stopcock) cleared under 510(k) number K060231.
1
Image /page/1/Picture/0 description: The image shows a logo for Elcam Medical. The logo consists of the letters 'i' and 'c' stacked on top of each other, with a circle above the 'i'. The words 'Elcam Medical' are written in a bold, sans-serif font to the left of the stacked letters. The logo is black and white.
4. MODIFIED DEVICE DESCRIPTION
Elcam Medical's Antimicrobial Closed Stopcocks (DSS and TSS) are a similar version of Elcam legally marketed stopcocks, cleared under 510(k) numbers K053405 and K060231, as identified in paragraph number 3 above. Our Antimicrobial DSS and TSS combine two or three features of our legally marketed devices into one product contains these two or three protection lines as following described:
The Double Safe Stopcock (DSS) consists of our antimicrobial stopcock combined with our closed swabable luer-activated valve stopcock.
The closed swabable valve functions as a microbial barrier and the antimicrobial agent, impregnated in the stopcock body acts to prevent/reduce the growth of contaminants.
This configuration presents a stopcock with two protection lines; (1) impregnated antimicrobial agent; (2) closed swabable valve.
The Triple Safe Stopcock (TSS) consists of the same platform of the antimicrobial stopcock together with our legally marketed MRVLS (Minimal Residual Volume Luer-activated Swabable stopcock) design. The two protection lines described above for the DSS exist in the TSS yet, the TSS has a third protection line which is the unique design of the MRVLS handle enables fluid flow around the handle and thus enables more thorough and continuous flushing of the entire stopcock fluid path. This configuration presents a stopcock with three protetion lines:
(1) impregnated antimicrobial agent; (2) closed swabable valve; (3) MRVLS handle unique design.
2
Image /page/2/Picture/0 description: The image shows a logo for Elcam Medical. The logo is black and white and features the letters "i" and "c" stacked on top of each other. The letter "i" is a simple vertical line with a circle above it, and the letter "c" is a curved line that opens to the right. Below the letters "i" and "c" is the word "Elcam" in a bold, sans-serif font, and below that is the word "Medical" in the same font.
ડ. INTENDED USE
Elcam Antimicrobial Closed Stopcocks (DSS and TSS) 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.
Both configurations have 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.
6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
Elcam's DSS and TSS are substantially equivalent to Elcam's legally marketed stopcocks cleared under 510(k) number K053405 and K060231, Elcam's new product and the predicate devices have the same indication for use, same shape, characteristics, materials, manufacturing technology and design. The modified device configurations provide even more protections than the predicates by combining all protection lines together.
There are no differences 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
Design verification 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 previously performed for all patient-contact and fluid path materials consisting Elcam's modified device with satisfactory results.
3
Image /page/3/Picture/0 description: The image shows a logo for Elcam Medical. The logo consists of the letters 'ic' stacked vertically, with the word 'Elcam' above the word 'Medical' to the left of the letters. The letters and words are in a bold, sans-serif font.
8. CONCLUSIONS
The evaluation of Elcam's Antimicrobial Closed Stopcocks (DSS and TSS), non-clinical tests demonstrate that the modified devices are as safe and as effective as the predicate devices. Therefore, we believe it is substantially equivalent to the Elcam's legally marketed devices identified as predicates.
Elcam Medical BarAm 13860, Israel Tel: 972-4-698-8120/1/2, Fax: 972-4-698-0777 sales@elcam.co.il
www.elcam-medical.com 2006年2月24日 12:24 ・ 13:57 ・ 19:57 ・ 19:50 ・ 19:11 ・ 19:11 ・ 19:11 ・ 19:11 ・ 19:11 ・ 19:11 ・ 19:11 ・ 19:11 ・ 19:11 ・ 19:11 ・ 19:11 ・ 19:11 ・ 19:11 ・ 19:11 ・ 19:11 ・ 19:11 ・ 19
Image /page/3/Picture/5 description: The image contains two circular shapes. The shape on the left has the letters 'com' inside of it. The shape on the right is a circle with a dotted line.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Elcam Medical Special 510(k) July 22, 2008 Elcam Antimicrobial Closed Stopcocks – DSS and TSS
CONFIDENTIAL Page 44 of 46
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 02 2008
Ms. Tali Hazan Regulatory Affairs Specialist Elcam Medical A.C.A.L. Kibbutz Bar-AM D.N. Merom Hagalil ISRAEL 13860
Re: K082106
Trade/Device Name: Antimicrobial Closed Stopcocks (*DSS and *TSS) Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FMG Dated: September 7, 2008 Received: September 11, 2008
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 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,
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
Indications for Use
510(k) Number (if known): .
Device Name: _ Antimicrobial Closed Stopcocks ( DSS and TSS)__
*DSS - Double Safe Stopcock *TSS - Triple Safe Stopcock
Indications for Use: Elcam Antimicrobial Closed Stopcocks (DSS and TSS) 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.
Both configurations have 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 __ V Prescription Use _____________________________________________________________________________________________________________________________________________________________ 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)
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: KOE210 Co
Elcam Medical Special 510(k) Elcam Antimicrobial Closed Stopcocks - DSS and TSS
CONFIDENTIAL Page 17 of 46