H-FLOW VALVE

K034043 · Elcam Medical Acal · DQO · Jun 30, 2004 · Cardiovascular

Device Facts

• Record ID: K034043
• Device Name: H-FLOW VALVE
• Applicant: Elcam Medical Acal
• Product Code: DQO · Cardiovascular
• Decision Date: Jun 30, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

Intended Use

The device is an Angiographic accessory intended for use as self-sealing Hemostatic luer activated valve for angiography and other high-pressure applications.

Device Story

H-Flow Valve is an angiographic accessory connecting to standard angiographic catheters via male luer-lock. Device features a slit septum preventing blood loss; allows passage of guide-wires (0.014" to 0.038") without valve opening or bleeding due to arterial pressure. Connection of a standard male luer to the female port mechanically opens the septum via an actuator, enabling fluid flow (contrast media or saline). Includes a 'Stylet' accessory to ensure slit patency and assist insertion of small/angled guide-wires. Used by clinicians in angiographic procedures to maintain hemostasis while allowing device/fluid access.

Clinical Evidence

Bench testing only. Performance testing evaluated functionality and biocompatibility. Results demonstrated that the device met all established acceptance criteria and exhibited equivalent performance capabilities to the predicate device.

Technological Characteristics

Hemostatic luer-activated valve; features slit septum and internal actuator; includes stylet accessory. Dimensions accommodate 0.014" to 0.038" guide-wires. Connects to standard male luer-lock. Mechanical operation; no energy source or software.

Indications for Use

Indicated for use as a self-sealing hemostatic luer-activated valve during angiography and other high-pressure clinical applications requiring catheter access.

Regulatory Classification

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.

Predicate Devices

• Floswitch® HP (K913871)

Submission Summary (Full Text)

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JUN 3 0 2004

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## 510(k) Summary

- Company Name -1. Elcam Medical ACAL Kibbutz BarAm Merom Hagalil 13860 Israel

| Contact Name: | Shachar Regev |
|---------------|----------------------------|
| | Q.A Manager |
| | Telephone: [phone] |
| | Fax: [phone] |
| | E-mail: [e-mail] |

Submitter and Contact Name:

Tali Hazan R.A Coordinator Telephone: [phone] Fax: [phone] E-mail: [e-mail]

US Agent: Bruce Ward General Manager Phone: [phone] Fax: [phone] E-mail: [e-mail]

Date prepared: June 8, 2004

### 2. Device Name -

Proprietary name: None Common / Usual Name: H-Flow Valve Trade Name: H-Flow Valve

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16634043

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The device has been classified in Class II under the following classification:

| Classification name | Product Code | Regulation No. | Panel Identification |
|----------------------------------------|--------------|----------------|---------------------------------|
| Catheter, Intravascular,<br>Diagnostic | DQO | 870.1200 | Cardiovascular<br>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.

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K634043

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#### 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.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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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

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# 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 [phone]. 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 [phone] or [phone] 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

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## 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

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(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_KO34043

Additional Information on K034043

Appendix C Indication For Use and Labels

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