The CardiacAssist Transseptal Cannula Set is intended for transseptal catheterization of the left atrium via the femoral vein for the purpose of providing a means for temporary (six hours or less) left ventricular bypass when connected to a suitable extracorporeal blood pump unit which returns blood to the patient via the femoral artery or other appropriate site.

Device Description

The Transseptal Cannula Set consists of three components: (1) 21 Fr. Transseptal Cannula, (2) 13 Fr. Obturator, and (3) 14/21 Fr. Two-stage Dilator, that accept a 0.035 in. guidewire.

The 21 Fr. Transseptal Cannula (Figure 1) allows for drainage of the left atrium during ventricular bypass. It has 14 side holes in addition to the tip opening for inflow at the distal end, a barbed fitting at the proximal end, and insertion depth markings from 40 to 62 cm measured from the distal end. The Transseptal Cannula also includes a Suture Wing and 2 Suture Rings to provide a means for securing it to the patient.

The 13 Fr. Obturator (Figure 2) is used to advance the Cannula to the right atrium from the inguinal area and then across the atrial septum into the left atrium. It contains a luer hub and aspiration side holes at both the distal and proximal ends to facilitate de-airing and to allow for use of contrast material to facilitate final positioning of the Cannula. It also contains a radiopaque marker band proximal to the Cannula drainage holes when the Obturator is inserted in the Cannula.

The 14/21 Fr. Dilator (Figure 3) is provided for pre-dilation of the fossa ovalis once left atrial access is achieved via standard transseptal technique.

AI/ML Overview

The provided text describes a 510(k) submission for the "CardiacAssist-Transseptal Cannula Set". This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials. Therefore, the device performance data provided is primarily based on bench testing.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Functional Performance (Flow vs. Pressure Drop (HQ))	"The Transseptal Cannula HQ and kink radius performance after six hour use was substantially better than that of the Elecath cannula." (Implies it met or exceeded the predicate, which would be the acceptance criterion.)
Functional Performance (Kink Radius Performance)	"The Transseptal Cannula HQ and kink radius performance after six hour use was substantially better than that of the Elecath cannula." (Implies it met or exceeded the predicate, which would be the acceptance criterion.)
Mechanical Strength (Tensile Strength)	"The results of the tensile strength ... indicated that the device exceeded the design requirements." (Implies meeting or exceeding predefined design specifications for strength.)
Integrity (Leak Testing)	"The results of the ... leak testing indicated that the device exceeded the design requirements." (Implies meeting or exceeding predefined design specifications for leak prevention.)
Biocompatibility	"The biocompatibility test results indicated that the transseptal Cannula Set successfully met the requirements of FDA's Blue Book Memorandum #G95-1 guidance and ISO 10993-1." (Implies meeting the specific biological safety standards for medical devices.)

2. Sample Size Used for the Test Set and the Data Provenance:

The document describes bench testing rather than human clinical trials. Therefore, information about human "test sets" or "data provenance" (e.g., country of origin, retrospective/prospective) is not applicable in the context of this 510(k) submission for bench testing. The "test set" would consist of multiple units of the manufactured device subjected to various engineering and materials tests. The document does not specify the exact number of units tested for each criterion, but it implies a sufficient number were tested to draw conclusions.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

This is not applicable as the data presented is from bench testing, not from human studies requiring expert interpretation of diagnostic images or clinical outcomes. The "ground truth" for these tests are objective measurements against established engineering specifications and international standards (e.g., ISO 10993-1).

4. Adjudication Method for the Test Set:

This is not applicable for bench testing. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where multiple human readers or experts provide interpretations that need to be reconciled. Bench tests rely on objective measurements and established protocols.

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 is not applicable. The device is a physical medical instrument (a cannula set), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or AI-related comparative effectiveness is irrelevant to this submission.

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

This is not applicable. The device is a physical medical instrument, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

For the bench tests described:

Functional Performance (Flow vs. Pressure Drop, Kink Radius): The ground truth would be established by comparing the device's performance against the predicate device (Elecath cannula) and/or predetermined engineering specifications. The statement "substantially better than that of the Elecath cannula" indicates the predicate's performance served as a baseline or "ground truth" for comparison.
Mechanical Strength (Tensile Strength) and Integrity (Leak Testing): The ground truth would be predefined engineering design requirements and specifications.
Biocompatibility: The ground truth is compliance with recognized international standards and FDA guidance documents (FDA Blue Book Memorandum #G95-1 and ISO 10993-1).

8. The Sample Size for the Training Set:

This is not applicable. The device is a physical medical instrument, and the testing described is bench testing, not machine learning or AI where "training sets" are used.

9. How the Ground Truth for the Training Set was Established:

This is not applicable for the same reasons as #8.

Summary

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K030398

്ത് CardiacAssist, Inc.

MAY 2 3 2003

510(k) Summary

Date February 4, 2003

Applicant

CardiacAssist, Inc. 240 Alpha Drive Pittsburgh, PA 15238 Telephone: 412-963-7770 Fax: 412-963-0800

Contact: Tim Krauskopf Title: Sr. Vice President e-mail: tkrauskopf(@cardiacassist.com

Device

Trade/Proprietary Name: CardiacAssist-Transseptal Cannula Set Common Name: Transseptal Cannula Classification Name: Catheter Cannula

Predicate Device

Elecath Percutaneous Left Atrial Cannulation Set (K854511)

Device Description

The Transseptal Cannula Set consists of three components: (1) 21 Fr. Transseptal Cannula, (2) 13 Fr. Obturator, and (3) 14/21 Fr. Two-stage Dilator, that accept a 0.035 in. guidewire.

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Image /page/1/Figure/0 description: The image shows a medical device, specifically a CardiacAssist, Inc. product. The device appears to be a catheter or similar instrument, featuring a central hub with multiple ports or connections. The catheter tube is marked with numerical gradations, possibly indicating depth or measurement markers.

Figure 1. 21 Fr. Transseptal Cannula

Image /page/1/Figure/3 description: The image shows a long, thin object that appears to be a tool or instrument. It has a cylindrical shape with a wider, more complex structure at one end, possibly a handle or connector. The object is divided into sections, with a break in the middle suggesting it might be extendable or modular. The overall impression is of a precision instrument, possibly used in engineering or a related field.

Figure 2. 13 Fr. Obturator

The 14/21 Fr. Dilator (Figure 3) is provided for pre-dilation of the fossa ovalis once left atrial access is achieved via standard transseptal technique.

Figure 3. 14/21 Fr. Dilator

Intended Use

The Transseptal Cannula Set is intended for transseptal catheterization of the left atrium via the femoral vein for the purpose of providing a means for temporary (six hours or less) left ventricular bypass when connected to a suitable extracorporeal blood pump unit which returns blood to the patient via the femoral artery or other appropriate site.

Comparison of Technological Characteristics

The Transseptal Cannula Set contains a polyurethane Transseptal Cannula with a Suture Wing and two Suture Rings, a polyurethane Obturator, and a polyethylene Two-stage

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്ത് CardiacAssist, Inc.

Dilator. An introducer needle, transseptal puncture kit and guidewire are to be provided by the user. The Elecath device contains a vinyl transseptal cannula and a stainless steel obturator with an extension plus an introducing catheter and needle, guidewire, and transseptal needle.

Performance Data

Testing of the Transseptal Cannula Set was completed for flow vs. pressure drop (HQ) and kink radius performance, tensile strength, leak testing and biocompatibility. The Transseptal Cannula HQ and kink radius performance after six hour use was substantially better than that of the Elecath cannula. The results of the tensile strength and leak testing indicated that the device exceeded the design requirements. The biocompatibility test results indicated that the transseptal Cannula Set successfully met the requirements of FDA's Blue Book Memorandum #G95-1 guidance and ISO 10993-1.

Conclusions

The Transseptal Cannula Set is substantially equivalent to the Elecath Percutaneous Left Atrial Cannulation Set

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines suggesting hair or movement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 3 2003

Cardiac Assist, Inc. c/o Mr. Tim Krauskopf Sr. Vice President 240 Alpha Drive Pirsburgh, PA 15238

Re: K030398

Cardiac Assist Transseptal Cannula Set Regulation Number: 21 CFR 870.1300 Regulation Name: Catheter cannula Regulatory Class: Class II (two) Product Code: DQR Dated: April 15, 2003 Received: April 16, 2003

Dear Mr. Krauskopf:

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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Page 2 – Mr. Tim Krauskopf

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) 594-4646. 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 vours.

R. De Zutter, M.D.

ram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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്ത് CardiacAssist, Inc.

Indications For Use

510(k) Number: KO30398

Device Name: CardiacAssist Transseptal Cannula Set

Indications For Use:

Deuth

510(k) Number K050378

Prescription Use Only

Regulation Number and Section

§ 870.1300 Catheter cannula.

(a)
Identification. A catheter cannula is a hollow tube which is inserted into a vessel or cavity; this device provides a rigid or semirigid structure which can be connected to a tube or connector.(b)
Classification. Class II (performance standards).