(39 days)
Not Found
No
The device description focuses on mechanical components and fluid flow control, with no mention of AI/ML terms or functionalities.
Yes
The device is described as "a flow control and a conduit device for I.V fluids delivery to the patient's vascular system," which includes "delivering I.V drugs or fluids" and allowing "sampling, bolus injection". These are therapeutic interventions.
No
The device is described as a flow control and conduit device for I.V. fluid delivery, sampling, bolus injection, and elimination of reflux. Its function is to manage the flow of fluids, not to diagnose medical conditions or analyze patient data for diagnostic purposes.
No
The device description clearly outlines physical components such as a body, ports, handles, elastomer, UV adhesive, check valve, rotor, and lubricant, indicating it is a hardware device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states the device is for "I.V fluids delivery to the patient's vascular system." This involves direct interaction with the patient's body for therapeutic purposes (delivering fluids and drugs).
- Device Description: The description details a manifold with ports, valves, and connections designed to manage the flow of fluids into the patient's bloodstream.
- Anatomical Site: The specified anatomical site is the "patient's vascular system."
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) for the purpose of providing information for diagnosis, monitoring, or screening.
IVDs are used outside the body to analyze samples. This device is used inside the body to deliver substances.
N/A
Intended Use / Indications for Use
Elcam Induction & Sampling Manifold or Stopcock is a one or multiple ports product, which is indicated to serve as a flow control and a conduit device for I.V fluids delivery to the patient's vascular system. The product is intended for delivering I.V drugs or fluids, allowing gravity feed, sampling, bolus injection and elimination of reflux of fluids during operation.
Product codes (comma separated list FDA assigned to the subject device)
FPA, FMG
Device Description
All information referring Elcam I&S Manifold respectively refers to Elcam I&S Stopcock as well.
Elcam I&S Manifold is composed of a body that fits for number of ports assembly (by bonding) and handles which are assembled into the ports bodies.
Between each handle and port body an Elastomer is placed to function as a pressure activated valve. A small amount of UV Adhesive is applied in order to bond the product body to the female side ports. A check valve is assembled to the product body end (which is connected to the I.V Set) in order to eliminate back flow (reflux). A Rotor is assembled to the male luer (which is connected toward the patient) in order to enable connection locking. A small amount of lubricant is applied between the Elastomer and the port body.
Same concept can be available for one single Stopcock (single I&S Stopcock will not include Check Valve unless otherwise required by end user).
Elcam I&S Manifold will be available in a wide variety of configurations for use according to particular situation and the clinician's preference.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's vascular system
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 relating functionality of the new product has been conducted on Elcam I&S Manifold, including testing related to product label claims and testing comparing performance with the predicate devices.
A biocompatibility assessment was performed on the patient-contact and fluid path materials of Elcam I&S Manifold 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
Ko32393
SEP 1 2 2003
Image /page/0/Picture/2 description: The image shows the text "Bloom Medical" in a faded, distressed font. The text is horizontally oriented and appears to be part of a logo or heading. The overall impression is one of a vintage or worn aesthetic.
510(k) Summary for Elcam Induction & Sampling Manifold for Stopcock)
1. SPONSOR
Elcam Medical ACAL Kibbutz BarAm Merom HaGalil 13860 Israel
Submitter & Contact person name: Tali Hazan - R.A Coordinator Contact Person: Shachar Regev - Q.A Manager
Telephone: 972-4-6988875/098 Fax: 972-4-6980777 E-mail: tali@elcam.co.il or sregev@elcam.co.il
U.S AGENT
Elcam Medical, Inc. 7600 North 15th St., Suite 217 Phoenix, AZ 85020
Bruce Ward -- General Manager Contact Person:
Telephone: 602-216-6940 Fax: (1) 602-678-1166 E-mail: bward@elcam-medical.com
2. DEVICE NAME
Common/Usual Name: Induction & Sampling Manifold Proprietary/Trade name: Induction & Sampling Manifold Classification Name: Elcam Induction & Sampling Manifold has been classified as Class II devices under the following classification names:
| Name | Product Code | 21 CFR Ref. | Panel |
|---|---|---|---|
| Intravascular Administration Set | FPA | 880.5440 | General Hospital |
…………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………… Elcam Medical 510(k) July 22, 2003 Elcam Induction & Sampling Manifold -- APPENDIX E --
CONFIDENTIAL Page E-1
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3. PREDICATE DEVICES
Elcam's I&S Manifold is substantially equivalent to Porex (KippGroup) 2 & 3 Port Manifold with back check valve,
Part Number: MTPC-XXX-XX. 510(k) No. K000152 cleared on 29-February-2000.
It is also substantially equivalent to Elcam's Manifold, which was submitted by MDCI on behalf of Elcam Plastic (Kibbutz BarAm, Merom Hagalil, Israel) for Elcam Stopcocks and Manifolds. 510(k) No. K022895 cleared on 03-September-2002.
Note: Elcam Plastic has changed its name on January-2003 to Elcam Medical ACAL. No other change took place as a result of the Name Change.
4. DEVICE DESCRIPTION
All information referring Elcam I&S Manifold respectively refers to Elcam I&S Stopcock as well.
Elcam I&S Manifold is composed of a body that fits for number of ports assembly (by bonding) and handles which are assembled into the ports bodies.
Between each handle and port body an Elastomer is placed to function as a pressure activated valve. A small amount of UV Adhesive is applied in order to bond the product body to the female side ports. A check valve is assembled to the product body end (which is connected to the I.V Set) in order to eliminate back flow (reflux). A Rotor is assembled to the male luer (which is connected toward the patient) in order to enable connection locking. A small amount of lubricant is applied between the Elastomer and the port body.
Same concept can be available for one single Stopcock (single I&S Stopcock will not include Check Valve unless otherwise required by end user).
Elcam I&S Manifold will be available in a wide variety of configurations for use according to particular situation and the clinician's preference.
న్. INTENDED USE
Elcam Induction & Sampling Manifold or Stopcock is a one or multiple ports product, which is indicated to serve as a flow control and a conduit device for I.V fluids delivery to the patient's vascular system. The product is intended for delivering I.V drugs or fluids, allowing gravity feed, sampling, bolus injection and elimination of reflux of fluids during operation.
Image /page/1/Picture/15 description: The image shows a CE marking with the number 0483 underneath it. To the right of the CE marking are the text "ISO 13485" and "ISO 9001", stacked on top of each other. The CE marking and the ISO texts are enclosed in square brackets.
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Image /page/2/Picture/0 description: The image shows the text "Elcom Medical". The text is written in a simple, sans-serif font. The letters are slightly faded and have a grainy texture, giving the image a vintage or aged appearance. The background is plain and white, which makes the text stand out.
TECHNOLOGICAL CARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.
Elcam's Induction & Sampling Manifold [or Stopcock] and Porex (KippGroup) 2 & 3 Port Manifold with back check valve and Elcam's Manifold, have the same indication for use. They have the same basic shape and use luer fittings. Elcam I&S Manifolds and Stopcocks have additional properties, which combine the two predicate devices into the Elcam I&S Manifold. Questions regarding new product safety and effectiveness were not raised due to non-identical technological characteristics.
7. PERFORMANCE TESTING
. -
- Standard testing relating functionality of the new product has been conducted on Elcam I&S Manifold, including testing related to product label claims and testing comparing performance with the predicate devices.
A biocompatibility assessment was performed on the patient-contact and fluid path materials of Elcam I&S Manifold with satisfactory results.
Image /page/2/Picture/7 description: The image shows a CE marking with the number 0483 below it. To the right of the CE marking are the text "ISO 13485" and "ISO 9001", stacked on top of each other. The entire image is surrounded by a square bracket.
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines representing the wings and body, and two wavy lines below representing the tail or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 2 2003
Elcam Medical ACAL C/O Ms. Shachar Regev Quality Assurance Manager Elcam Medical, Incorporated 7600 North 15th Street Suite 217 Phoenix, Arizona 85020
Re: K032393
Trade/Device Name: Induction and Sampling Manifold (or Stopcock) Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FMG Dated: July 22, 2003 Received: August 8, 2003
Dear Ms. Regev:
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.
4
Page 2 -Ms. Regev
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 Office of Compliance at (301) 594-4618. 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/dsma/dsmamain.html
Sincerely yours,
Susan Purser
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Device Name: Induction & Sampling Manifold [or Stopcock]
Indication for use:
Elcan Induction & Sampling Manifold for Stopcock] is a one or multiple ports product, which is indicated to serve as a flow control and a conduit device for I.V fluids delivery to the patient's vascular system. The product is intended for delivering I.V drugs or fluids, allowing gravity feed, sampling, bolus injection and elimination of reflux of fluids during operation.
Pulitan Lucente
(Division Sign-Off Division of Anesthesiology, General Hosp Infection Control, Dental Devices
510(k) Number: K032392
...
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NECESSARY
(Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
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CONFIDENTIAL Page iv