(57 days)
Gish ATR2900DF Reservoir, Gish 35DF Reservoir
Not Found
No
The device description and intended use focus on mechanical filtration and defoaming of blood, with no mention of AI or ML technologies.
Yes
The device is used in medical procedures (cardiopulmonary bypass, general surgery) to filter, defoam, and collect blood for reinfusion, which directly addresses a medical condition or ailment.
No
The device is primarily used for filtering and defoaming blood, and for collecting and autotransfusing blood during and after surgery. It does not perform any diagnostic functions by analyzing or interpreting patient data to identify or monitor medical conditions.
No
The device description clearly details physical components such as a blood reservoir, defoamer/filter cartridge, bicarbonate housing, sealed lid, inlets, and outlets, indicating it is a hardware device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The Gish ATR2900 and CAP35 Series Reservoirs are used to filter and process blood during or after surgery for reinfusion into the same patient. This is a direct interaction with the patient's blood within a surgical or post-operative setting, not an in vitro examination for diagnostic purposes.
- The intended uses described are related to blood processing and autotransfusion, not diagnostic testing. The device's function is to prepare blood for return to the patient, not to analyze it for diagnostic information.
- The device description focuses on mechanical processes like filtering and defoaming. This aligns with a medical device used for blood handling, not an IVD which would typically involve chemical, biological, or immunological reactions for analysis.
Therefore, the Gish ATR2900 and CAP35 Series Reservoirs are considered medical devices, specifically for blood processing and autotransfusion, rather than In Vitro Diagnostics.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
DTN
Device 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 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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Gish ATR2900DF Reservoir, Gish 35DF Reservoir
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
§ 870.4400 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
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: | |||
| Address: | Gish Biomedical, Inc. | ||
| 22942 Arroyo Vista | |||
| Rancho Santa | |||
| Margarita | |||
| CA 92688-2600 | Delphi Consulting Group | ||
| 11874 South Evelyn Circle | |||
| Houston, TX 77071-3404 | |||
| Telephone: | |||
| Contact: | 949-635-6240 voice | ||
| 949-635-6294 fax | |||
| Edward F. Waddell | |||
| Director RA/QA | 832-285-9423 voice | ||
| 832-615-3550 fax | |||
| J. Harvey Knauss | |||
| Consultant | |||
| harvey@delphiconsulting.com |
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:
-
- 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
1
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.
2
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.
3
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.
4
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 (240) 276-0120. 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 (800) 638-2041 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
5
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)