GISH ATR2900 AND CAP35 SERIES RESERVOIRS WITH GBS COATING

K051606 · Gish Biomedical, Inc. · DTN · Aug 12, 2005 · Cardiovascular

Device Facts

• Record ID: K051606
• Device Name: GISH ATR2900 AND CAP35 SERIES RESERVOIRS WITH GBS COATING
• Applicant: Gish Biomedical, Inc.
• Product Code: DTN · Cardiovascular
• Decision Date: Aug 12, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Gish ATR2900 Series Reservoirs with GBS™ Coating are indicated for use: - During cardiopulmonary bypass surgery to filter and defoam intrathoracic suctioned blood prior to its return to the extracorporeal circuit. - During general surgery procedures other than cardiopulmonary bypass, for collection and filtration of suctioned blood. During these procedures, the reservoir must be used in conjunction with appropriate cell-washing techniques. - Once intraoperative use is completed, for the collection and autotransfusion of the same patients post operative blood using components available separately in the SVP400 or SVP450 STAT-VAC Conversion Pack, ATR200 or ATR250 Supplemental Drainage Set, ATR500 Wound drainage Postoperative Pack or ATR600 Supplemental Wound Drainage Line Set. - With or without a water seal when used for postoperative autotransfusion, depending on user preference and application. The SVP400, SVP450 and STAT-VAC provide a water seal for use with ATR2900. The attending physician is solely responsible for the decision to use or not to use a water seal.. The Gish CAP35 Series Reservoirs with GBS™ Coating with integral water seal/water manometer are indicated for use during cardiopulmonary bypass surgery to filter/defoam intrathoracic suctioned blood prior to its return to the extracorporeal circuit. The CAP35 Series Reservoirs are indicated for the collection and autotransfusion of the same patients postoperative shed blood, using components available separately in the CAP400 or CAP450 Postoperative Conversion Pack and ATR200 or ATR250 Supplemental Drainage Set. The Gish CAP400/450 Pack is indicated for use exclusively with the Gish CAP Series Products: The Gish CAP400/450 Pack provides components used to convert the Gish CAP systems from intraoperative to post operative use.

Device Story

Cardiotomy reservoir system; collects, filters, and defoams suctioned blood during cardiopulmonary bypass or general surgery; enables postoperative autotransfusion. Device consists of polycarbonate housing, lid with inlet ports, and defoamer/filter cartridge. Removes particulate matter >160 µm (standard) or >20 µm (DF models). CAP series includes integral water seal/manometer for pleural drainage. Used in clinical settings by surgical staff. Converts from intraoperative to postoperative use via accessory conversion packs. Benefits include blood salvage and reduced need for donor blood.

Clinical Evidence

Bench testing only; no clinical data presented. Performance validated through extensive safety and functional testing to ensure compliance with specifications.

Technological Characteristics

Polycarbonate housing; defoamer/filter cartridge; GBS™ coating (heparin-based); integral water seal/manometer (CAP series). Filtration capacity: 160 µm or 20 µm. Standalone device; non-electronic.

Indications for Use

Indicated for patients undergoing cardiopulmonary bypass or general surgery requiring collection and filtration of suctioned blood; also indicated for postoperative autotransfusion of shed blood. Contraindicated in patients with known or suspected heparin sensitivity.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Gish ATR2900DF Reservoir
• Gish 35DF Reservoir

Submission Summary (Full Text)

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510(k) Submission, ATR2900 Series and CAP35 Series Reservoir with Gish Biomedical, Inc., Rancho Santa Margarita, CA 92688

# 510(k) Summary

**Date:** June 15, 2005

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 | or | Correspondent (contract): |
|------------------------|-------------------------------------------------------------------------------------------|----|---------------------------------------------------------------------------------------------------------|
| Name:<br>Address: | Gish Biomedical, Inc.<br>22942 Arroyo Vista<br>Rancho Santa<br>Margarita<br>CA 92688-2600 | | Delphi Consulting Group<br>11874 South Evelyn Circle<br>Houston, TX 77071-3404 |
| Telephone:<br>Contact: | 949-635-6240 voice<br>949-635-6294 fax<br>Edward F. Waddell<br>Director RA/QA | | 832-285-9423 voice<br>832-615-3550 fax<br>J. Harvey Knauss<br>Consultant<br>[e-mail] |

#### 2. Device:

| Proprietary Name: | Gish CAP35 Reservoir with GBS™ Coating |
|----------------------|----------------------------------------------------------|
| | Gish CAP35DF Reservoir with GBS™ Coating |
| | Gish ATR2900 Reservoir with GBS™ Coating |
| | Gish ATR2900DF Reservoir with GBS™ Coating |
| Common Name: | Cardiotomy Reservoir |
| Classification Name: | 21 CFR 870.4400 Reservoir, Blood, Cardiopulmonary Bypass |

#### 3. Predicate Devices:

Gish ATR2900DF Reservoir Gish 35DF Reservoir

## 4. Classifications Names & Citations:

- 5. 21 CFR 870.4400 Reservoir, Blood, Cardiopulmonary Bypass, Product Code DTN, Classification Advisory Committee - Cardiovascular.
#### 6. Description:

The ATR2900 Reservoirs and the CAP35 Reservoirs with GBS™ Coating are r no ATTLES and defoam suctioned blood and remove particulate matter greater than 160 um (ATR2900 and CAP35) or 20 µm (ATR2900DF and CAP35DF). The integral water seal/water manometer chambers of the ATR2900 and CAP35 series

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accommodate pleural drainage applications. The CAP series also includes a accommodate plearar arainage application. One stage is for cardiotomy blood and CAPVRF version with a 2 Stage filter of end of the other stage which is for venous return blood (which is significantly cleaner).

The ATR2900 Reservoirs and the CAP35 Reservoirs with GBS™ Coating may be The ATR2900 Reservers and the United accessory Postoperative Conversion Packs.

Each device consists of a blood reservoir and a defoamer/filter cartridge. The blood Each device bonolote of a bicarbonate housing with sealed lid. The lid includes inlet reservoir container is a poryeding of the defoamer/filter compartments. Additional luer and "quick prime" inlets allow direct addition to the reservoir. The lid also includes over quick prime "inicto allow all out an out and es. The defoamer/filter cartridge pressunzation and oxooo nasuanent for filtration of cardiotomy blood as it enters the reservoir.

#### 7. Indications for use:

The Gish ATR2900 Series Reservoirs with GBS™ Coating are indicated for use:

- During cardiopulmonary bypass surgery to filter and defoam intrathoracic 1. suctioned blood prior to its return to the extracorporeal circuit.
- During general surgery procedures other than cardiopulmonary bypass, for 2. collection and filtration of suctioned blood. During these procedures, the reservoir must be used in conjunction with appropriate cell-washing techniques.
- Once intraoperative use is completed, for the collection and autotransfusion of 3. Oneo intraoperative blood using components available separately the Same pakisme post on SVP450 STAT-VAC Conversion Pack, ATR200 or ATR250 Supplemental Drainage Set, ATR500 Wound drainage Postoperative Pack or ATR600 Supplemental Wound Drainage Line Set.
- With or without a water seal when used for postoperative autotransfusion, 4. depending on user preference and application. The SVP400, SVP450 and STAT-VAC provide a water seal for use with ATR2900. The attending physician is solely responsible for the decision to use or not to use a water seal..

The Gish CAP35 Series Reservoirs with GBS™ Coating with integral water seal/water manometer are indicated for use during cardiopulmonary bypass surgery to filter/defoam intrathoracic suctioned blood prior to its return to the extracorporeal circuit. The CAP35 Series Reservoirs are indicated for the collection and autotransfusion of the same patients postoperative shed blood, using components available separately in the CAP400 or CAP450 Postoperative Conversion Pack and ATR200 or ATR250 Supplemental Drainage Set.

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The Gish CAP400/450 Pack is indicated for use exclusively with the Gish CAP Series rne Gish CAP400/450 Pack provides components used to convert the Gish CAP systems from intraoperative to post operative use.

#### 8. Contraindications:

For heparin coated devices, heparin has been reported, on rare occasions, to induce r or nepart ocation a 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.

#### 9. Comparison:

Differences -- None.

#### 10. Test Data:

The Gish ATR2900 Reservoirs and the CAP35 Reservoirs with GBS™ Coating have 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.

#### 11. 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 ATR2900 Reservoirs and the CAP35 Reservoirs with GBS™ Coating.

#### 12. Conclusions:

The conclusion drawn from these tests is that Gish ATR2900 Reservoirs and the CAP35 Reservoirs with GBS™ Coating are equivalent in safety and efficacy to its predicated devices.

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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a representation of the human form, with three curved lines forming a body and head.

AUG 1 2 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Gish Biomedical Inc. c/o Mr. J. Harvey Knauss Delphi Consulting Group 11874 South Evelyn Circle Houston, TX 77071-3404

Re: K051606

Gish ATR2900 and CAP35 Series Reservoirs with GBS™ Coating Regulation Number: 21 CFR 870.4400 Regulation Name: Cardiopulmonary Bypass Blood Reservoir Regulatory Class: Class II Product Code: DTN Dated: June 15, 2005 Received: June 16, 2005

Dear Mr. Knauss:

We have reviewed your Section 510(k) premarket notification of intent to market the device We nave reviewed your Security (10).) premainer is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) is regary manological Device Americal Device Ameralments, or to commerce prior to May 28, 1976, the enaounters with the provisions of the Federal Food. Drug, devices that have been recalismed in accessaries approval approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a presisions of the Act . The You may, therefore, market the device, subject to the general controls provisions of the Act. The You may, therefore, market me device, basjon of the more of registration, listing of general controls provisions of the rice, 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 If your device is classified (see above) and existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional controller "Entroling thing of the 898. In addition, FDA may be found in the Ood of I sents 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 Please be advised that I DA 3 issuated of a buice complies with other requirements of the Act that I DA has made a decommunisions administered by other Federal agencies. You must of any I cacal statutes and regulations, including, but not limited to: registration and listing (21 Compry with an the Act 31equirements, and manufacturing practice requirements as set CFK Fart 607), labeling (21 CFR Part 820); and if applicable, the electronic 101th in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (seting your device as described in your Section 510(k) This icter will anow you to ocgin mailioning of substantial equivalence of your device to a legally prematicated predicated on: "The Promotings of cation 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 If you desire specific davice for your accept [phone]. Also, please note the regulation entitled, Connect the Office of Come to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on your response Assistance at its toll-free number [phone] or Manufacturers, International and Octess http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Aimmermasfor

Bram 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_051606

Device Name: Gish ATR2900 and CAP35 Series Reservoirs with GBS™ Coating

#### Indications for use:

The Gish ATR2900 Series Reservoirs with GBS™ Coating are indicated for use:

- During cardiopulmonary bypass surgery to filter and defoam intrathoracic 1. suctioned blood prior to its return to the extracorporeal circuit.
- During general surgery procedures other than cardiopulmonary bypass, for 2. collection and filtration of suctioned blood. During these procedures, the reservoir must be used in conjunction with appropriate cell-washing techniques.
- Once intraoperative use is completed, for the collection and autotransfusion of the 3. same patients post operative blood using components available separately in the SVP400 or SVP450 STAT-VAC Conversion Pack, ATR200 or ATR250 Supplemental Drainage Set, ATR500 Wound drainage Postoperative Pack or ATR600 Supplemental Wound Drainage Line Set.
- With or without a water seal when used for postoperative autotransfusion, 4. depending on user preference and application. The SVP400, SVP450 and STAT-VAC provide a water seal for use with ATR2900. The attending physician is solely responsible for the decision to use or not to use a water seal..

The Gish CAP35 Series Reservoirs with GBS™ Coating with integral water seal/water manometer are indicated for use during cardiopulmonary bypass surgery to filter/defoam intrathoracic suctioned blood prior to its return to the extracorporeal circuit. The CAP35 Series Reservoirs are indicated for the collection and autotransfusion of the same patients postoperative shed blood, using components available separately in the CAP400 or CAP450 Postoperative Conversion Pack and ATR200 or ATR250 Supplemental Drainage Set.

The Gish CAP400/450 Pack is indicated for use exclusively with the Gish CAP Series Products: The Gish CAP400/450 Pack provides components used to convert the Gish CAP systems from intraoperative to post operative use.

## Prescription Device: Yes

## OTC NO

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

B. Simmons

(Division Sign-Off) Division of Cardiovascular Devices 510(k) Number /

(Optional Format 1-2-96)