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K Number
K024065
Device Name
SOFT VENOUS RESERVOIR (SVRXX) WITH GBS COATING
Manufacturer
GISH BIOMEDICAL, INC.
Date Cleared
2003-03-05

(86 days)

Product Code
DTN
Regulation Number
870.4400
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Gish Soft Venous Reservoirs with GBS™ Coating are indicated to collect systemic venous and cardiotomy return blood during cardiopulmonary bypass procedures. It is designed to operate at flow rates of one (1.0) to six (6.0) liters per minute for periods up to six (6.0) hours.
Device Description
The Gish Soft Venous Reservoirs with GBS™ Coating consist of a bag with three fluid ports and two aspiration ports and are intended to prevent venous air from entering the extracorporeal circuit. The design of the Soft Venous Reservoir reduces blood stagnation and will collapse if emptied; a built in safety mechanism that minimizes accidental air delivery to the oxygenator. Each Soft Venous Reservoir contains one 12" venous inlet (blue) with integral temperature port and luer port, one 3/8" cardiotomy inlet (white), one 3/8" arterial outlet (red) and two 1/8" aspiration ports with attached 3-way stopcocks. The components of this system which have contact with the fluid path are sterile and nonpyrogenic. All materials of the Soft Venous Reservoirs are biocompatible and coated with a proprietary coating. The Gish the Soft Venous Reservoirs with GBS™ Coating may be purchased separately or pre-connected with tubing and other components of an extracorporeal circuit.
More Information

K955046

Not Found

No
The description focuses on the physical components and function of a blood reservoir for cardiopulmonary bypass, with no mention of AI or ML.

No
The device is described as collecting systemic venous and cardiotomy return blood during cardiopulmonary bypass procedures and preventing venous air from entering the extracorporeal circuit, which are critical support functions during medical procedures but not therapeutic healing or treatment.

No

The device is designed to collect and manage blood during cardiopulmonary bypass procedures, preventing air from entering the circulatory system, rather than diagnosing a medical condition.

No

The device description clearly outlines physical components (bag, ports, stopcocks) and materials, indicating it is a hardware device, not software-only.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is to collect blood during cardiopulmonary bypass procedures. This is a therapeutic/surgical procedure, not a diagnostic test performed on samples outside the body.
  • Device Description: The description details a physical device for managing blood flow within an extracorporeal circuit. It does not describe a test or assay for analyzing biological samples to diagnose a condition.
  • Lack of Diagnostic Elements: There is no mention of analyzing blood components, detecting biomarkers, or providing diagnostic information.

IVD devices are used to examine specimens (like blood, urine, tissue) from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely related to managing blood flow during a surgical procedure.

N/A

Intended Use / Indications for Use

The Gish Soft Venous Reservoirs with GBS™ Coating are indicated to collect systemic venous and cardiotomy return blood during cardiopulmonary bypass procedures. It is designed to operate at flow rates of one (1.0) to six (6.0) liters per minute for periods up to six (6.0) hours.

Product codes

DTN

Device Description

The Gish Soft Venous Reservoirs with GBS™ Coating consist of a bag with three fluid ports and two aspiration ports and are intended to prevent venous air from entering the extracorporeal circuit. The design of the Soft Venous Reservoir reduces blood stagnation and will collapse if emptied; a built in safety mechanism that minimizes accidental air delivery to the oxygenator. Each Soft Venous Reservoir contains one 12" venous inlet (blue) with integral temperature port and luer port, one 3/8" cardiotomy inlet (white), one 3/8" arterial outlet (red) and two 1/8" aspiration ports with attached 3-way stopcocks.

The components of this system which have contact with the fluid path are sterile and nonpyrogenic.

All materials of the Soft Venous Reservoirs are biocompatible and coated with a proprietary coating.

The Gish the Soft Venous Reservoirs with GBS™ Coating may be purchased separately or pre-connected with tubing and other components of an extracorporeal circuit.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

The Gish Soft Venous Reservoirs 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.

Key Metrics

Not Found

Predicate Device(s)

K955046

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 870.4400 Cardiopulmonary bypass blood reservoir.

(a)
Identification. A cardiopulmonary bypass blood reservoir is a device used in conjunction with short-term extracorporeal circulation devices to hold a reserve supply of blood in the bypass circulation.(b)
Classification. Class II (special controls), except that a reservoir that contains a defoamer or filter is classified into the same class as the defoamer or filter. The device, when it is a cardiopulmonary bypass blood reservoir that does not contain defoamers or blood filters, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

0

Summary

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

MAR 0 5 2003

    1. Company making the submission:
CompanyorCorrespondent (contract):
Name:Gish BioMedical, Inc.Delphi Consulting Group
Address:22942 Arroyo Vista11874 South Evelyn Circle
Rancho Santa MargaritaHouston, TX 77071-3404
CA 92688-2600
Telephone:949-635-6240 voice832-285-9423 voice
949-635-6294 fax775-429-9524 fax
Contact:Edward F. Waddellharvey@delphiconsulting.com
Director RA/QAJ. Harvey Knauss
Consultant

2. Device:

Proprietary Name:Soft Venous Reservoir SVR with GBS™ Coating
Common Name:Soft Venous Reservoir
Classification Name:Reservoir, Blood, Cardiopulmonary Bypass
    1. Predicate Devices:
      Gish Soft Venous Reservoir, Gish Biomedical, Inc., K955046.
    1. Classifications Names & Citations:
      21 CFR 870.4400, Reservoir, Blood, Cardiopulmonary Bypass, Class II, DTN, Cardiovascular.
    1. Description:
      The Gish Soft Venous Reservoirs with GBS™ Coating consist of a bag with three fluid ports and two aspiration ports and are intended to prevent venous air from entering the extracorporeal circuit. The design of the Soft Venous Reservoir reduces blood stagnation and will collapse if emptied; a built in safety mechanism that minimizes accidental air delivery to the oxygenator. Each Soft Venous Reservoir contains one 12" venous inlet (blue) with integral temperature port and luer port, one 3/8" cardiotomy inlet (white), one 3/8" arterial outlet (red) and two 1/8" aspiration ports with attached 3-way stopcocks.

The components of this system which have contact with the fluid path are sterile and nonpyrogenic.

All materials of the Soft Venous Reservoirs are biocompatible and coated with a proprietary coating.

The Gish the Soft Venous Reservoirs with GBS™ Coating may be purchased separately or pre-connected with tubing and other components of an extracorporeal circuit.

1

    1. Indications for use:
      The Gish Soft Venous Reservoirs with GBS™ Coating are indicated to collect systemic venous and cardiotomy return blood during cardiopulmonary bypass procedures. It is designed to operate at flow rates of one (1.0) to six (6.0) liters per minute 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 svstemically 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 Soft Venous Reservoirs with GBS™ Coating have the same device characteristics as the predicate devices.
    1. Test Data:
      The Gish Soft Venous Reservoirs 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.
    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 Gish Soft Venous Reservoirs with GBS™ Coating.
    1. Conclusions:
      The conclusion drawn from these tests is that Gish Soft Venous Reservoirs with GBS™ Coating is equivalent in safety and efficacy to its predicate device.

2

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes extending from its back, representing health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 0 5 2003

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

Re: K024065

Gish Soft Venous Reservoirs SVR with GBSTM Coating. Regulation Number: 21 CFR 870.4400 Regulation Name: Reservoir, Blood, Cardiopulmonary Bypass Regulatory Class: Class II (two) Product Code: DTN Dated: February 6, 2003 Received: February 10, 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. Iisting 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.

3

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 (OS) 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. 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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,

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

Enclosure

4

024065 510(k) Number K_______________________________________________________________________________________________________________________________________________________________

Device Name: Gish Soft Venous Reservoirs SVR with GBS™ Coating

Indications for use:

The Gish Soft Venous Reservoirs with GBS™ Coating are indicated to collect systemic venous and cardiotomy return blood during cardiopulmonary bypass procedures. It is designed to operate at flow rates of one (1.0) to six (6.0) liters per minute for periods up to six (6.0) hours.

Prescription Device: Yes

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use____________________
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OR

Over-The-Counter Use____________________
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(Per 21 CFR 801.109)

(Division Sign-Off)

Division of Cardiovas510(k) Number K061265

(Optional Format 1-2-96)