The IBC Cardiac Suction Wand is intended for use by a Cardiac Surgeon during open heart surgery for the collection of blood and other fluids from the sterile surgical field for filtering and return to the patient via the Cardiotomy line. It is also intended for use by surgeons for the removal of waste fluids from the surgical field.

Device Description

The IBC Cardiac Suction Wand is a single use, sterile, disposable surgical instrument intended for the collection of blood and other fluids from the surgical field for return the cardiotomy system during open heart surgery.

AI/ML Overview

The provided 510(k) summary for the IBC Cardiac Suction Wand does not include specific acceptance criteria or details of a study proving the device meets acceptance criteria in the way typically expected for performance-based medical device studies. Instead, this submission focuses on demonstrating substantial equivalence to a predicate device.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document presents a "Table of Comparison" which outlines characteristics of the new device (IBC Cardiac Suction Wand) and the predicate device (Research Medical Intracardiac Sucker). This table serves as the primary means to demonstrate that the new device meets the implicit acceptance criteria of being "substantially equivalent" to an already legally marketed device.

CHARACTERISTIC	IBC CARDIAC SUCTION WAND	RESEARCH MEDICAL INTRACARDIAC SUCKER	Acceptance Criteria (Implicit)	Performance (IBC Cardiac Suction Wand)
Components	4	4	Must have comparable number and function of components	4
Tube	Passivated Stainless Steel	Passivated Stainless Steel	Material must be identical or clinically equivalent	Passivated Stainless Steel
Handle	Overmolded Plastic	Overmolded Plastic	Material must be identical or clinically equivalent	Overmolded Plastic
Tubing Adapter	Overmolded Plastic	Molded and Bonded Plastic	Material/construction must be clinically equivalent (differences noted as cosmetic)	Overmolded Plastic
Cardiac Tip	Molded Plastic Bonded	Molded Plastic Bonded	Material/construction must be identical or clinically equivalent	Molded Plastic Bonded
Proximal Bend Angle	35 Degrees	35 Degrees	Geometric specifications must be identical or clinically equivalent	35 Degrees
Distal Bend Angle	35 Degrees	35 Degrees	Geometric specifications must be identical or clinically equivalent	35 Degrees
Blood Compatibility	Non-Hemolytic	Non-Hemolytic	Must demonstrate non-hemolytic properties	Non-Hemolytic
Sterilization	Ethylene Oxide	Ethylene Oxide	Sterilization method must be identical or validated as equivalent	Ethylene Oxide
Toxicity	Tripartite Guidelines	Tripartite Guidelines	Must meet toxicity guidelines (e.g., ISO 10993 or equivalent)	Tripartite Guidelines

Discussion of Similarities and Differences: The submission explicitly states: "The IBC Cardiac Suction Wand is in most ways identical to the Research Medical Intracardiac Sucker." It acknowledges minor differences in the stainless steel tube (larger flow diameter, electropolished) and the tubing adapter construction ("overmolded" vs. "molded and bonded"), but asserts these differences are "primarily cosmetic" and do not affect the intended use or safety/effectiveness. This assertion implicitly serves as the "proof" that the device meets acceptance criteria, specifically non-inferiority to the predicate device.

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

Sample Size: The document does not describe a specific test set or clinical study with a defined sample size in the traditional sense (e.g., number of patients, number of devices tested in a clinical setting). The "testing" appears to be based on design specifications, material comparisons, and adherence to recognized standards for biocompatibility and sterilization.
Data Provenance: Not applicable, as there's no clinical trial data presented. The "data" consists of design specifications and characteristics of the device itself and its predicate.

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

Number of Experts: Not applicable. There is no mention of external experts consolidating ground truth for a test set. The ground truth for this type of submission is the documented performance and characteristics of the legally marketed predicate device, and the manufacturer's own assessment that their new device aligns with these.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable, as there is no test set in the clinical evaluation sense that would require adjudication.

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

MRMC Study: No. This device is a surgical instrument (suction wand), not an AI-powered diagnostic or imaging tool. An MRMC study is completely irrelevant to this device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Standalone Performance: No, not applicable. This is a physical surgical instrument, not an algorithm.

7. The Type of Ground Truth Used

Type of Ground Truth: The ground truth used is the documented characteristics, safety, and effectiveness of the legally marketed predicate device, the Research Medical Intracardiac Sucker. The IBC Cardiac Suction Wand demonstrates substantial equivalence by showing its own characteristics align with this established predicate. Additional "ground truth" comes from adherence to established standards for materials (e.g., passivated stainless steel, non-hemolytic materials), sterilization (Ethylene Oxide), and toxicity testing (Tripartite Guidelines).

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This device does not use machine learning or AI models, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set: Not applicable. There is no training set for this type of device.

Summary

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K9603156

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510(k) SUMMARY

NOV 1 4 1997

IBC Cardiac Suction Wand

The IBC Cardiac Suction Wand is a single use, sterile, disposable surgical instrument intended for The IBC Cardiac Suction Wand is a single use, steller, the got the cardiotomy
the collection of blood and other fluids from the surgical field for return the cardiotomy the collection of blood and other fituits from the surged into the Research Medical
system during open heart surgery. It is substantially equivalent to the Research Medical system during open neart surgery.
Intracardiac Sucker marketed by Research Medical, Inc..

TABLE OF COMPARISON

CHARACTERISTIC	IBC CARDIAC SUCTION WAND	RESEARCH MEDICAL INTRACARDIAC SUCKER
Components	4	4
Tube	Passivated Stainless Steel	Passivated Stainless Steel
Handle	Overmolded Plastic	Overmolded Plastic
Tubing Adapter	Overmolded Plastic	Molded and Bonded Plastic
Cardiac Tip	Molded Plastic Bonded	Molded Plastic Bonded
Proximal Bend Angle	35 Degrees	35 Degrees
Distal Bend Angle	35 Degrees	35 Degrees
Blood Compatibility	Non-Hemolytic	Non-Hemolytic
Sterilization	Ethylene Oxide	Ethylene Oxide
Toxicity	Tripartite Guidelines	Tripartite Guidelines

DISCUSSION OF SIMILARITIES AND DIFFERENCES

The IBC Cardiac Suction Wand is in most ways identical to the Research Medical Intracardiac
t of the contraction of the first individual different, the IPC stainless steel tu The IBC Cardian Suction Wald is slighty different, the IBC stainless steel tube has a larger Sucker. The blue tint of the nation is sugmiss of the USC whing adapter is overnolded flow diameter and is electropolished as well as passwards, afterences are primarily
and the Research Medical is molded and bonded. The net effect of these for visibility pur and the Research Medical is molded and vonces. "In the extract tissues for visibility purposes.
cosmetic. Occasionally, surgeons use the suction want recommended cosmetic. Occasionally, surgeons use the sactive which is not recommended.

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Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is a stylized image of a human figure embracing a bird. The figure is composed of three curved lines, and the bird is composed of four curved lines.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. H. David Shockley, Jr. Official FDA Correspondence International Biophysics Corporation 4020 S. Industrial Drive Suite 160 Austin, Texas 78744

NOV 1 4 1997

Re: K963756 IBC Cardiac Suction Wand Regulatory Class: II (Two) Product Code: DTS Dated: August 13, 1997 Received: August 18, 1997

Dear Mr. Shockley:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval) , 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. H. David Shockley

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html."

Sincerely yours,

Thomas J. Callahon

Thomas J. Callable Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K16353671

Page_1________________________________________________________________________________________________________________________________________________________________________

K963756 : 510(k) Number (if known):_

Device Name: IBC Cardiac Suction Wand

Indications For Use:

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off)_

Division of Cardiovascular, Respiratory, and Neurological Devices K963756 510(k) Number_

Prescription Use / (Per 21 CFR 801.109) ೧೯

Over-The-Counter Use_

(Optional Format 1-2-96)

Regulation Number and Section

§ 870.4420 Cardiopulmonary bypass cardiotomy return sucker.

(a)
Identification. A cardiopulmonary bypass cardiotomy return sucker is a device that consists of tubing, a connector, and a probe or tip that is used to remove blood from the chest or heart during cardiopulmonary bypass surgery.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.