The Pull Tab Squeeze Flush (PTFS) an attachment to a catheter – transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of el vinning backleakage and waveform damping.

The PTSF is currently made in four models - 3 ml and 30 ml each with or without tee connector.

Device Description

The Pull Tab Squeeze Flush (PTSF) is a continuous flush device that contains an orifice used to provide a continuous fixed flow rate of IV solution to facilitate arterial pressure monitoring and to maintain patency.

The device also includes a mechanism which, when activated, provides a fast flush flow rate used to prime the device and monitoring kit. The fast flush rate continues to flow as long as the fast flush mechanism is mechanically activated. The fast flush also provides a means to flush the monitoring kit following blood sampling and to allow measurement of the system's dynamic response. The PTSF device is capable of creating a square wave signal in the pressure line to the transducer whenever the fast flush mechanism is activated and quickly released or the tab is squaezed or and released quickly.

The device consists of rigid transparent lure connections for adapting to standard male and/or female lures, a flow restrictor, and a fast flush mechanism. It is available in two nominal flow rates, 3ml/hr and 30 ml/hr. The fast flush mechanism clip may be removed to enable patient mounting of the device.

AI/ML Overview

The provided document is a 510(k) summary for the Pull Tab Squeeze Flush (PTSF) device. It asserts substantial equivalence to a pre-amendment predicate device (Intraflo®). However, the document does not contain specific acceptance criteria or details of a study that proves the device meets such criteria. Instead, it relies on the predicate device's established history and general statements about material similarity, intended use, and indications for use.

Therefore, most of the requested information cannot be extracted from this document, as a formal study with acceptance criteria, sample sizes, and ground truth establishment is not described.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

Cannot be provided. The document states: "No additional safety and performance testing is necessary." and "No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for Continuous flush catheters." It relies on the predicate's long history of use.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Cannot be provided. No specific test set or study data is mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Cannot be provided. No ground truth establishment for a test set is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Cannot be provided. No test set or adjudication process is mentioned.

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

Cannot be provided. This device is a mechanical medical device, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Cannot be provided. This request is irrelevant as the device is not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Cannot be provided. No ground truth is discussed as no new performance study was deemed necessary. The argument for safety and effectiveness is based on the predicate device's market history.

8. The sample size for the training set

Cannot be provided. There is no mention of a training set as this is not an AI/ML device.

9. How the ground truth for the training set was established

Cannot be provided. There is no mention of a training set or ground truth establishment.

Summary of Device Information from the Document:

While the specific information requested about acceptance criteria and studies is not present, here's what is stated in the document regarding the device's basis for clearance:

Device Acceptance Criteria and Performance (Based on Predicate Equivalence, Not New Study):

Acceptance Criteria (Implied by Predicate)	Reported Device Performance (Implied by Predicate)
Continuous fixed flow rate of IV solution	Provides continuous fixed flow rate of IV solution to facilitate arterial pressure monitoring and maintain patency. Available in 3ml/hr and 30ml/hr.
Fast flush flow rate capability	Provides fast flush flow rate to prime device, or flush following blood sampling, and for dynamic response measurement.
Square wave signal generation	Capable of creating a square wave signal in the pressure line when activated.
Absence of clotting, backleakage, damping	Permits continuous intravascular flushing for the purpose of eliminating clotting, backleakage, and waveform damping.
Sterility Assurance Level	Established history of meeting 10^-6 SAL. Packaged in peel pouches, conforming with ISO 10993.
Biocompatibility	Conforming with ISO 10993 (implied by predicate's long use and new material vendor's existing use in other ICU Medical devices).

Rationale for Substantial Equivalence (instead of new study):

The document argues that the Pull Tab Squeeze Flush (PTSF) is substantially equivalent to the predicate Intraflo® device due to:

Same intended use.
Same indications for use.
Same functions as the predicate device.
Similar technological characteristics: Both are continuous flush devices that incorporate a fast flush mechanism (pull tab).
Material similarity: Components made from the same materials with one exception (different vendor for silastic sleeve, which ICU Medical uses on other disposable devices).
Predicate's long history: "ICU Medical Intraflo has been sold for more than three decades and is proven technology. No additional safety and performance testing is necessary."

This type of 510(k) submission relies heavily on the established safety and effectiveness of a predicate device, and thus often does not include new, comprehensive performance studies with defined acceptance criteria for the new device if the changes are deemed minor and do not raise new questions of safety or effectiveness.

Summary

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ICU MEDICAL INC. 4455 Atherton Drive Salt Lake Citv. Utah Phone: (801) 264 - 1332 Fax: (801) 264 - 1755 Tracy S. Best, Sr. Regulatory Affairs Specialist Preparation Date: June 05, 2007

SEP 1 9 2007

Special 510(K) - Summary for the:

Trade Name:	Pull Tab Squeeze Flush
Common Name:	Continuous flush catheter
Classification Name:	Continuous flush catheter, 21 CFR 870.1210, Class II Device

Legally Marketed Predicate Devices for Substantial Equivalence:

*Pre-Amendment Device - Intraflo® - Sorenson Medical -- (now ICU Medical Inc.)

Rationale for SE:

The Intraflo® is a pre-amendment device developed by Sorenson Medical and subsequently now owned by ICU Medical, Inc. The Intraflo® is a device that has been utilized since 1976 for use as a continuous flush device that incorporates a pull tab which, when pulled sends a square wave to calibrate the cardiac monitoring devices.

Description of Submitted Device:

Summary for Pull Tab Squeeze Flush

Page 1 of 2

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Intended Uses of the Pull Tab Squeeze Flush:

The Pull Tab Squeeze Flush (PTFS) an attachment to a catheter - transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, backleakage and waveform damping.

The PTSF is currently made in four models - 3 ml and 30 ml each with or without tee connector.

Technological Characteristics and Substantial Equivalence:

Similarities:

The current and proposed devices have the same intended use. 1.
The current and proposed devices have the same indications for use. 2.
The current and proposed devices contain the components made from the same materials 3. with the one exception noted below.

Differences:

1. The proposed device contains an external squeeze clip (non-patient contacting) to activate the fast flush mechanism in addition to the existing pull tab.
The proposed device will use a different material vendor for the silastic slecve which ICU 2. uses on other disposable devices we sell.

Safety and Performance:

ICU Medical Intraflo has been sold for more than three decades and is proven technology. No additional safety and performance testing is necessary. ICU Medical's Sterility Assurance Level, (SAL) has an established history of meeting the 10 t level. The devices are packaged in peel pouches and they ensure conformity with ISO 10993, including minimizing residual gases.

Performance Standards:

No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for Continuous flush catheters. Continuous flush catheters are regulated within 21 CFR 870.1210.

Conclusion:

The materials, performance, and operational features of both the submitted device and the preamendment device are substantially equivalent to one another and are safe and effective for their intended use.

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Public Health Service

Image /page/2/Picture/2 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" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 9 2007

ICU Medical, Inc. c/o Mr. Tracy Best Senior Regulatory Affairs Specialist 4455 Atherton Drive Salt Lake City, UT 84123

Re: K070979 Pull Tab Squeeze Flush Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA Dated: August 22, 2007 Received: August 23, 2007

Dear Mr. Best:

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.

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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) 276-0120. 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 vours.

Ashley B. Boan

for

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): K070979

Device Name: Pull Tab Squeeze Flush (PTSF)

Indications for Use:

The PTSF is currently made in four models - 3 ml and 30 ml each with or without tee connector.

Prescription Use XX (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)

Ashley Boane for BDZ
(Division Sign Off)

Division of Cardiovascular Devices

510(k) Number K070979

Page 1 of

Regulation Number and Section

§ 870.1210 Continuous flush catheter.

(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).