(184 days)
The device is an Angiographic accessory intended for use as self-sealing Hemostatic luer activated valve for angiography and other high-pressure applications.
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.
The provided text describes a 510(k) summary for the "H-Flow Valve" manufactured by Elcam Medical ACAL. While it states that "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," it does not provide specific details on the acceptance criteria themselves, nor the specific results or methodology of the study.
Therefore, I cannot directly populate the requested table or answer most of the questions as the specific information is not present in the provided text.
Here's an attempt to answer based on the given information, highlighting what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| NOT SPECIFIED | "met all established acceptance criteria" |
| NOT SPECIFIED | "equivalent performances capabilities and properties" to the predicate device (Floswitch® HP) |
Notes:
- The document states that performance tests were conducted and the device met all established acceptance criteria. However, the specific criteria (e.g., maximum leakage rate, pressure resistance, flow rates, number of cycles) and the quantitative results achieved by the H-Flow Valve are not detailed.
- The comparison is against a predicate device, Floswitch® HP, implying that the acceptance criteria would be based on demonstrating equivalence or non-inferiority to the predicate's known performance.
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not specified.
- Data provenance: Not specified (e.g., country of origin, retrospective/prospective). The tests were performed to demonstrate substantial equivalence to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable as the provided document pertains to a medical device's performance testing for functional and biocompatibility characteristics, not a diagnostic algorithm or imaging study requiring expert ground truth for classification.
4. Adjudication method for the test set
This section is not applicable for the same reasons as point 3.
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 section is not applicable as the document describes a physical medical device (valve), not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This section is not applicable as the document describes a physical medical device (valve), not a software algorithm.
7. The type of ground truth used
For functional performance testing of a physical device, the "ground truth" would typically refer to objective measurements obtained through standardized testing methods, comparing the device's performance against predefined specifications or against the performance of a predicate device. The document mentions "functionality and biocompatibility tests" but does not detail the specific ground truth or reference standards used.
8. The sample size for the training set
This section is not applicable as the document describes a physical medical device (valve), not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
This section is not applicable as the document describes a physical medical device (valve), not a machine learning model.
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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: +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
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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,Diagnostic | DQO | 870.1200 | CardiovascularDevices 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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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 (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
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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
Page 3 of 8
§ 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).