(184 days)
Not Found
No
The description focuses on the mechanical function of a valve and does not mention any computational or data-driven processes indicative of AI/ML.
No
The device is described as an accessory for angiography, intended to prevent blood loss and facilitate fluid/guidewire introduction during procedures. It does not exert a therapeutic effect on the patient.
No
The device is an accessory for angiographic procedures, specifically a valve to prevent blood loss and facilitate the introduction of guide wires and fluid. Its description focuses on mechanical function and fluid dynamics, not on gathering information about a patient's health condition or making a diagnosis.
No
The device description clearly describes a physical, mechanical valve with a septum, luer-lock connections, and an accessory called a 'Stylet'. There is no mention of software as a component or the primary function of the 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 it's an "Angiographic accessory intended for use as self-sealing Hemostatic luer activated valve for angiography and other high-pressure applications." This describes a device used during a medical procedure (angiography) to manage blood flow and introduce other instruments or fluids.
- Device Description: The description details its mechanical function in preventing blood loss and allowing the introduction of guide wires and fluids into the body via a catheter.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens outside of the body (in vitro) to provide information for diagnosis, monitoring, or screening. It doesn't analyze blood, tissue, or other bodily fluids in a laboratory setting.
Therefore, this device falls under the category of a medical device used in vivo (within the body) during a procedure, not an IVD.
N/A
Intended Use / Indications for Use
The device is an Angiographic accessory intended for use as self-sealing Hemostatic luer activated valve for angiography and other high-pressure applications.
Product codes
DQO
Device Description
The H-Flow Valve developed by Elcam Medical ACAL can be connected, by a standard male luer-lock, to any standard Angiographic catheter. The device has a septum that prevents blood loss when nothing is connected to the female port of the device. Common guide-wires (in diameter of 0.014" to 0.038") can be introduced via the device (through the slit septum) without the need to open the valve and without bleeding due to the intra-catheter human arterial pressure. When connecting a standard male luer to the device's female port (for injection of contrast media or flushing with saline), the septum opens (with the aid of the actuator) to allow fluid flow.
An accessory called 'Stylet' is added to the device and has two purposes: a) to make sure the slit is open prior to initial use. b) To aid with insertion of small and angled guide wires.
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)
Performance tests related to functionality and biocompatibility of both new and predicate device were performed. Tests results showed that the product met all established acceptance criteria and therefore has equivalent performances capabilities and properties.
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
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).
0
JUN 3 0 2004
Image /page/0/Picture/1 description: The image contains the word "Electri" on the left side. On the right side of the image, there is a symbol that looks like the letter "k". The text and symbol are grainy and appear to be made of small dots. The image is in black and white.
510(k) Summary
- Company Name -1. Elcam Medical ACAL Kibbutz BarAm Merom Hagalil 13860 Israel
| Contact Name: | Shachar Regev |
|---|---|
| Q.A Manager | |
| Telephone: +972-4-698-8098 | |
| Fax: +972-4-632-0777 | |
| E-mail: sregev@elcam.co.il |
Submitter and Contact Name:
Tali Hazan R.A Coordinator Telephone: +972-4-698-8875 Fax: +972-4-632-0777 E-mail: tali@elcam.co.il
US Agent: Bruce Ward General Manager Phone: (602) 216-6940 Fax: (602) 678-1166 E-mail: bward@elcam-medical.com
Date prepared: June 8, 2004
2. Device Name -
Proprietary name: None Common / Usual Name: H-Flow Valve Trade Name: H-Flow Valve
1
16634043
Image /page/1/Picture/1 description: The image is a low-resolution scan of a document. The text is difficult to read, but it appears to be a combination of letters and numbers. The image is grainy and has a lot of noise.
The device has been classified in Class II under the following classification:
| Classification name | Product Code | Regulation No. | Panel Identification |
|---|---|---|---|
| Catheter, Intravascular, | |||
| Diagnostic | DQO | 870.1200 | Cardiovascular |
| Devices Panel |
3. Predicate Device -
Floswitch® HP, Boston Scientific Corp. 2710 Orchard Pkwy. , San Jose, CA 95113, cleared under 510(k) no. K913871.
Description of the Device -4.
The H-Flow Valve developed by Elcam Medical ACAL can be connected, by a standard male luer-lock, to any standard Angiographic catheter. The device has a septum that prevents blood loss when nothing is connected to the female port of the device. Common guide-wires (in diameter of 0.014" to 0.038") can be introduced via the device (through the slit septum) without the need to open the valve and without bleeding due to the intra-catheter human arterial pressure. When connecting a standard male luer to the device's female port (for injection of contrast media or flushing with saline), the septum opens (with the aid of the actuator) to allow fluid flow.
An accessory called 'Stylet' is added to the device and has two purposes: a) to make sure the slit is open prior to initial use. b) To aid with insertion of small and angled guide wires.
ર. Indications for Use -
The device is an Angiographic accessory intended for use as self-sealing Hemostatic luer activated valve for angiography and other high-pressure applications.
2
Image /page/2/Picture/1 description: The image contains the words "Elcam Medical" in a light gray font. The text is positioned on the left side of the image. To the right of the text is a dark gray graphic that appears to be a stylized letter or symbol.
6. Substantial Equivalence -
The H-Flow Valve has the same intended use as the Floswitch® HP, cleared under 510(k) no. K913871 and has equivalent performance characteristics. Both products are valves activated; the H-Flow Valve is activated by connection to the male luer while the Floswitch® HP is activated by an on/off switch.
All other technological characteristics are similar and the functional performance tests performed on both devices show equivalent performance capabilities.
The evaluation of the H-Flow Valve does not raise any additional concerns regarding safety and effectivity and may therefore be considered substantially equivalent to the predicate device.
7. Performance Testing -
Performance tests related to functionality and biocompatibility of both new and predicate device were performed. Tests results showed that the product met all established acceptance criteria and therefore has equivalent performances capabilities and properties.
8. Conclusion -
The evaluation of the H-Flow Valve does not raise any additional concerns regarding safety and effectivity and may therefore be considered substantially equivalent to the predicate device.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 3 0 2004
ELCAM Medical ACAL c/o Mr. Tali Hazan Kibbutz BarAm M.P. Merom HaGalil 13860 Israel
K034043 Re:
Trade/Device Name: H-Flow Valve Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: II Product Code: DQO Dated: June 9, 2004 Received: June 15, 2004
Dear Mr. Hazan:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use sualed in the encreated of the enactment date of the Medical Device Amendments, or to conninered pror to "Hay 2011 11:12 provisions of the Federal Food, Drug, de nees marthere been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, mererors, mains 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.
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
4
Page 2 - Mr. Tali Hazan
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Declons of Persons of Sevice as described in your Section 510(k) This letter will anow you to begin manieting of substantial equivalence of your device to a legally prematication: "The PDF Intelligstification 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 If you desire specific ac not 10. Jour (301) 594-4646. Additionally, for questions on the contact the Office of Compilance at (301) 29 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 promotion and advertising or your is not the d, "Misbranding by reference to premarket 4057. Allso, prease note 1019.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, Itsponsibilities under the Ace inst 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,
Davia R. Vichner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Image /page/5/Picture/0 description: The image shows a black and white abstract pattern. The pattern consists of small, repeating shapes that create a textured effect. The pattern is concentrated in the upper left corner and gradually fades towards the lower right, creating a gradient effect. The lower right portion of the image is mostly white, providing a contrast to the patterned area.
Indications for Use
| 510(k) Number (if known): | K034043 |
|---|---|
| Device Name: | H-Flow Valve |
| Indications for Use: | The device is an Angiographic accessory intended for use as self-sealing Hemostatic luer activated valve for angiography and other high-pressure applications. |
Prescription Use _ (Part 21 CFR 801 Subpart D)
AND/OR
Over the Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE):
DONNA R. Vachner
Page 1 of 1
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_KO34043
Additional Information on K034043
Appendix C Indication For Use and Labels
Page 3 of 8