(423 days)
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No
The 510(k) summary describes a simple surgical suction wand and makes no mention of AI, ML, image processing, or any data-driven performance metrics typically associated with AI/ML devices.
No.
The device is intended for collecting blood and fluids during surgery for filtering and return, and for removing waste fluids, which are supportive functions during a medical procedure rather than directly treating a disease or condition.
No
The device is described as a surgical instrument for collecting blood and fluids during open heart surgery, and there is no mention of it being used for diagnosis or generating diagnostic information. Its purpose is to facilitate the surgical procedure by managing fluids and returning blood to the patient.
No
The device description clearly states it is a "single use, sterile, disposable surgical instrument" and a "surgical instrument," indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the collection of blood and fluids from the surgical field during open heart surgery for filtering and return to the patient, or for the removal of waste fluids. This is a surgical instrument used in vivo (within the body) or on the surgical field, not for testing samples in vitro (outside the body).
- Device Description: The description reinforces that it's a surgical instrument for collecting fluids from the surgical field.
- Lack of IVD Characteristics: There is no mention of analyzing samples, performing tests on biological specimens, or providing diagnostic information based on laboratory analysis.
IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information about a person's health, diagnose conditions, or monitor treatment. This device's function is purely for fluid management during surgery.
N/A
Intended Use / Indications for Use
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.
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.
Product codes (comma separated list FDA assigned to the subject device)
DTS
Device Description
The IBC Cardiac Suction Wand is a single use, sterile, disposable surgical instrument.
Components: 4
Tube: Passivated Stainless Steel
Handle: Overmolded Plastic
Tubing Adapter: Overmolded Plastic
Cardiac Tip: Molded Plastic Bonded
Proximal Bend Angle: 35 Degrees
Distal Bend Angle: 35 Degrees
Blood Compatibility: Non-Hemolytic
Sterilization: Ethylene Oxide
Toxicity: Tripartite Guidelines
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Cardiac / Heart
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Cardiac Surgeon during open heart surgery.
Surgeons for the removal of waste fluids from the surgical field.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
K9603156
Image /page/0/Picture/1 description: The image shows the letters IBC in a stylized font. Each letter has a globe design within it. The letters are large and bold, and the globe design is intricate with visible continents and grid lines. The overall design gives a sense of international reach or global communication.
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.
1
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.
2
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
3
K16353671
Page_1________________________________________________________________________________________________________________________________________________________________________
K963756 : 510(k) Number (if known):_
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) ાં. ત
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)