IBC FLOPUMP WITH GBS COATING by GISH BIOMEDICAL, INC.

The IBC FloPump with GBS™ Coating centrifugal blood pump is indicated for use only with the Medtronic Bio-Medicus Bio Console® to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support at flow rates of up to seven (7.0) LPM for periods up to six (6.0) hours.

Device Description

The IBC FloPump with GBS™ Coating (a non leaching heparin based coating) centrifugal blood pump has been designed to utilize the constrained forced-vortex pumping principle. In action, blood is allowed through a vortex created by the rotation of a series of smooth surfaced rotating cones. Energy is transferred from the cones to the blood in the form of pressure and velocity as the blood is gently accelerated toward the outlet of the pump.

The IBC FloPump with GBS™ Coating centrifugal blood pump is fabricated from sturdy, thromboresistant, biocompatible polycarbonate materials which are mounted on precision bearings for dependable operation. The non-occlusive hemodynamic design of the pump promotes laminar flow, allowing for improved blood handling capabilities and decreasing trauma which may be associated with extracorporeal circulatory support during cardiopulmonary bypass.

The IBC FloPump with GBS™ Coating centrifugal blood pump couples to a safetylocked magnetic drive unit called the Medtronic Bio-Medicus Bio Console® purnp speed controller, which serves as the hardware component of the extracorporeal blood delivery system.

AI/ML Overview

This document is a 510(k) premarket notification for the IBC FloPump with GBS™ Coating, a centrifugal blood pump. It claims substantial equivalence to predicate devices, but the provided text does not contain acceptance criteria or detailed study results proving the device meets specific performance criteria.

The document states:

"The IBC FloPump with GBS™ Coating has been subjected to extensive safety, performance, and validations prior to release. Final testing for the systems includes various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications. Safety tests have further been performed to ensure the device complies with applicable industry and safety standards."
"A review of literature pertaining to the safety and effectiveness has been conducted. Appropriate safeguards have been incorporated in the design of IBC FloPump with GBS™ Coating."
"The conclusion drawn from these tests is that IBC FloPump with GBS™ Coating is equivalent in safety and efficacy to its predicated devices."

However, it does not provide any specific quantitative acceptance criteria or the reported device performance against such criteria. It also does not detail the methodology of any studies conducted, including sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot fully answer your request based on the provided text.

Here's a breakdown of what information is missing or cannot be inferred from the provided text, in relation to your request:

A table of acceptance criteria and the reported device performance: This information is not present. The document generally states that "various performance tests" and "safety tests" were done, but no specific criteria or results are given.
Sample sized used for the test set and the data provenance: Not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
Adjudication method for the test set: Not mentioned.
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 device is a blood pump, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study with human readers assisting AI or vice versa is not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a medical device, not an algorithm.
The type of ground truth used: Not mentioned.
The sample size for the training set: Not applicable, as this is a medical device, not an AI/ML algorithm.
How the ground truth for the training set was established: Not applicable.

Summary of available information related to the device and its testing:

Device Name: IBC FloPump with GBS™ Coating (Centrifugal Pump)
Intended Use: Pumping blood through an extracorporeal bypass circuit for extracorporeal circulatory support at flow rates up to 7.0 LPM for up to 6.0 hours, only with the Medtronic Bio-Medicus Bio Console®.
Testing Conducted (General Statement): "Extensive safety, performance, and validations prior to release." "Various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications." "Safety tests have further been performed to ensure the device complies with applicable industry and safety standards."
Conclusion: The device is "equivalent in safety and efficacy to its predicated devices." This is a claim of substantial equivalence for 510(k) clearance, rather than a detailed report of meeting specific, pre-defined acceptance criteria with quantified results.
Predicate Devices: IBC FloPump (K983272) and Vision Hollow Fiber Oxygenator with GBS™ coating (K023381). The comparison section states the new device "has the same device characteristics as the predicate devices."

To provide a complete answer to your request, specific test reports, protocols, and results would be needed, which are not provided in this 510(k) summary.

Summary

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Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR part 807.92.

1. Company making the submission:

	Company	Correspondent (contract):
Name:	Gish Biomedical, Inc.	Delphi Consulting Group
Address:	22942 Arroyo Vista	11874 South Evelyn Circle
	Rancho Santa Margarita, CA	Houston, TX 77071-3404
	92688-2600
Telephone:	949-635-6240 voice	832-285-9423 voice
	949-635-6294 fax	775-429-9524 fax
		harvey@delphiconsulting.com
Contact:	Edward F. Waddell	J. Harvey Knauss
	Director RA/QA	Consultant

2. Device:

Proprietary Name:	IBC FloPump with GBS™ Coating
Common Name:	Centrifugal Pump
Classification Name:	Nonroller-type cardiopulmonary bypass blood pump

1. Predicate Devices:
  IBC FloPump. International Biophysics Corporation, K983272. Pump. Vision Hollow Fiber Oxygenator with GBS™ coating, K023381. Coating.
1. Classifications Names & Citations:
21 CFR 870.4360, Nonroller-type cardiopulmonary bypass blood pump, Class III, 5. KFM, Cardiovascular.
1. Description:

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capabilities and decreasing trauma which may be associated with extracorporeal circulatory support during cardiopulmonary bypass.

1. Indications for use:
  The IBC FloPump with GBS™ Coating centrifugal blood pump is indicated for use only with the Medtronic Bio-Medicus Bio Console® to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support at flow rates of up to seven (7.0) LPM for periods up to six (6.0) hours.
1. Contraindications:
  For heparin coated devices, heparin has been reported, on rare occasions, to induce thrombocytopenia. Since patients undergoing cardiopulmonary bypass are routinely systemically heparinized, and although the amount of heparin contributed by this device is very small in comparison to the typical dose given, caution should be exercised when using this device in patients with known or suspected heparin sensitivity.
1. Comparison:
  The IBC FloPump with GBS™ Coating has the same device characteristics as the predicate devices.
1. Test Data:
  The IBC FloPump with GBS™ Coating has been subjected to extensive safety, performance, and validations prior to release. Final testing for the systems includes various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications. Safety tests have further been performed to ensure the device complies with applicable industry and safety standards.
1. Literature Review:
  A review of literature pertaining to the safety and effectiveness has been conducted. Appropriate safeguards have been incorporated in the design of IBC FloPump with GBS™ Coating.
1. Conclusions:
  The conclusion drawn from these tests is that IBC FloPump with GBS™ Coating is equivalent in safety and efficacy to its predicated devices.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 4 2003

Gish Biomedical, Inc. c/o Mr. J. Harvey Knauss Delphi Consulting Group 11874 South Evelyn Circle Houston, TX 77071

Re: K031300

IBC FloPump with GBS™ Coating Regulation Number: 21 CFR 870.4360 Regulation Name: Nonroller type cardiopulmonary bypass blood pump Regulatory Class: Class II (two) Product Code: KFM Dated: Undated Received: April 24, 2003

Dear Mr. Knauss:

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. J. Harvey Knauss

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 yours,

K. Zuckerman, 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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510(k) Number K_031306

Device Name: IBC FloPump with GBS™ Coating

Indications for use:

Prescription Device:

Federal Law (US) restricts this device to sale by or on the order of a physician.

PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF
NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
OR	Over-The-Counter Use

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number	K031300
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(Optional Format 1-2-96)

Regulation Number and Section

§ 870.4360 Nonroller-type blood pump.

(a)
Nonroller-type cardiopulmonary and circulatory bypass blood pump —(1)Identification. A nonroller-type cardiopulmonary and circulatory bypass blood pump is a prescription device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either:(i) Full or partial cardiopulmonary bypass (
i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or(ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.
(2)
Classification —Class II (special controls). The special controls for this device are:(i) Non-clinical performance testing must perform as intended over the intended duration of use and demonstrate the following: Operating parameters, dynamic blood damage, heat generation, air entrapment, mechanical integrity, and durability/reliability;
(ii) The patient-contacting components of the device must be demonstrated to be biocompatible;
(iii) Sterility and shelf life testing must demonstrate the sterility of patient-contacting components and the shelf life of these components; and
(iv) Labeling must include information regarding the duration of use, and a detailed summary of the device- and procedure-related complications pertinent to use of the device.
(b)
Nonroller-type temporary ventricular support blood pump —(1)Identification. A nonroller-type temporary ventricular support blood pump is a prescription device that uses any method resulting in blood propulsion to provide the temporary ventricular assistance required for support of the systemic and/or pulmonary circulations during periods when there is ongoing or anticipated hemodynamic instability due to immediately reversible alterations in ventricular myocardial function resulting from mechanical or physiologic causes. Duration of use would be less than 6 hours.(2)
Classification. Class III (premarket approval).(c)
Date premarket approval application (PMA) or notice of completion of product development protocol (PDP) is required. A PMA or notice of completion of a PDP is required to be filed with FDA on or before September 8, 2015, for any nonroller-type temporary ventricular support blood pump that was in commercial distribution before May 28, 1976, or that has, on or before September 8, 2015, been found to be substantially equivalent to any nonroller-type temporary ventricular support blood pump that was in commercial distribution before May 28, 1976. Any other nonroller-type temporary ventricular support blood pump shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.