IBC CARDIAC SUCTION WARD

K963756 · International Biophysics Corp. · DTS · Nov 14, 1997 · Cardiovascular

Device Facts

• Record ID: K963756
• Device Name: IBC CARDIAC SUCTION WARD
• Applicant: International Biophysics Corp.
• Product Code: DTS · Cardiovascular
• Decision Date: Nov 14, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4420
• Device Class: Class 2

Intended Use

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 Story

Single-use, sterile, disposable surgical instrument; used by cardiac surgeons during open heart surgery. Device collects blood and fluids from surgical field for return to patient via cardiotomy system; also used for waste fluid removal. Composed of passivated stainless steel tube, overmolded plastic handle, and cardiac tip. Provides suction functionality; occasionally used by surgeons for tissue retraction. Benefits include fluid management and visibility during cardiac procedures.

Clinical Evidence

No clinical data; bench testing only. Device evaluated for blood compatibility (non-hemolytic) and toxicity per Tripartite Guidelines.

Technological Characteristics

Materials: Passivated stainless steel tube, overmolded plastic handle/adapter, molded plastic cardiac tip. Design: 35-degree proximal and distal bend angles. Sterilization: Ethylene Oxide. Connectivity: None. Software: None.

Indications for Use

Indicated for use by cardiac surgeons during open heart surgery for collection of blood and fluids from the surgical field for return to the patient via cardiotomy line, and for removal of waste fluids from the surgical field.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Research Medical Intracardiac Sucker

Submission Summary (Full Text)

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1463156

IBC

# 510(k) SUMMARY

NOV 14 1997

# IBC Cardiac Suction Wand

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 through the cardiotomy system during open heart surgery. It is substantially equivalent to the Research Medical 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 Sucker. The blue tint of the handle is slightly different, the IBC stainless steel tube has a larger flow diameter and is electropolished as well as passivated, the IBC tubing adapter is overmolded and the Research Medical is molded and bonded. The net effect of these differences are primarily cosmetic. Occasionally, surgeons use the suction wand to retract tissues for visibility purposes. The IBC tube provides additional strength for this practice which is not recommended.

INTERNATIONAL BIOPHYSICS CORPORATION • 4020 S. INDUSTRIAL DRIVE, SUITE 160 • AUSTIN, TEXAS 78744 • 512 326-3244 • FAX [phone]

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
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 14 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html."

Sincerely yours,

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

Enclosure

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Page 1 of 1

510(k) Number (if known): K963756

Device Name: IBC Cardiac Suction Wand

Indications For Use:

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.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)


(Division Sign-Off)

Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number K963756

Prescription Use ☑ (Per 21 CFR 801.109)

OR

Over-The-Counter Use ☐

(Optional Format 1-2-96)