Intersept Filtered Cardiotomy Reservoir

K151110 · Medtronic, Inc. · DTN · May 27, 2015 · Cardiovascular

Device Facts

• Record ID: K151110
• Device Name: Intersept Filtered Cardiotomy Reservoir
• Applicant: Medtronic, Inc.
• Product Code: DTN · Cardiovascular
• Decision Date: May 27, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4400
• Device Class: Class 2

Intended Use

The Intersept filtered cardiotomy reservoir is indicated for use in the cardiopulmonary bypass circuit during surgery for: · an air/fluid separation chamber; - · a temporary storage reservoir for priming solution and blood; - · the filtration of particulates from bank blood and filtration of blood recovered from the field by suction: - · the addition of medications or other fluids. The Intersept filtered cardiotomy reservoir is also indicated for use after open heart surgery for: • the post-operative collection of autologous blood from the chest and the aseptic return of blood to the patient for volume replacement.

Device Story

Single-use cardiotomy reservoir; 2,600 ml capacity; 2 LPM max flow. Functions as air/fluid separation chamber, storage for priming solution/blood, and filtration unit for bank/field-recovered blood. Features eight access ports (suction, pre/post-defoamer, vent). Contains open-cell polyurethane defoamer and 20-micron microaggregate filter with polyester sleeve. Used in OR during cardiopulmonary bypass or post-operatively for autotransfusion. Operated by perfusionists or clinical staff. Filters particulates; allows medication/fluid addition; enables aseptic return of autologous blood to patient for volume replacement. Benefits patient by reducing particulate load and facilitating blood salvage.

Clinical Evidence

Bench testing only. Testing included filtration efficiency, blood trauma, and biocompatibility assessments. All tests passed.

Technological Characteristics

Single-use reservoir; 2,600 ml capacity; 2 LPM max flow. Materials: Polypropylene frame, open-cell polyurethane defoamer, 20-micron microaggregate filter, polyester sleeve. Eight luer/0.6 cm ID access ports. Sterile, non-pyrogenic fluid path. Mechanical filtration and air/fluid separation principle.

Indications for Use

Indicated for patients undergoing cardiopulmonary bypass surgery or post-operative autologous blood collection. Contraindicated in cases of lung air leaks, chest wall perforations, infection, malignancy, gross contamination (bone cement, etc.), aspiration of non-parenteral agents, open chest with vacuum, post-protamine administration, return to surgery, or use of unregulated vented chest tubes.

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

• Intersept® Cardiotomy Reservoir with Filter

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol consists of three stylized human profiles facing right, stacked on top of each other, with a ribbon-like element flowing beneath them.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 27, 2015

Medtronic, Inc. Chelsea Pioske Regulatory Affairs Specialist 7611 Northland Drive Minneapolis, Minnesota 55428

Re: K151110

Trade/Device Name: Intersept Filtered Cardiotomy Reservoir Regulation Number: 21 CFR 870.4400 Regulation Name: Cardiopulmonary Bypass Blood Reservoir Regulatory Class: Class II Product Code: DTN. DTP Dated: April 24, 2015 Received: April 27, 2015

Dear Chelsea Pioske:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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

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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

M.A. Hilleman

for 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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# Indications for Use

510(k) Number (if known) K151110

Device Name

Intersept™ Filtered Cardiotomy Reservoir

Indications for Use (Describe)

The Intersept filtered cardiotomy reservoir is indicated for use in the cardiopulmonary bypass circuit during surgery for: · an air/fluid separation chamber;

- · a temporary storage reservoir for priming solution and blood;
- · the filtration of particulates from bank blood and filtration of blood recovered from the field by suction:
- · the addition of medications or other fluids.

The Intersept filtered cardiotomy reservoir is also indicated for use after open heart surgery for:

• the post-operative collection of autologous blood from the chest and the aseptic return of blood to the patient for volume replacement.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary

| Date Prepared: | April 23, 2015 |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant: | Medtronic, Inc.<br>Medtronic Perfusion Systems<br>7611 Northland Drive<br>Minneapolis, MN 55428<br>Establishment Registration Number: 2184009 |
| Contact Person: | Chelsea Pioske<br>Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
| Alternate Contact: | Susan Fidler<br>Senior Regulatory Affairs Manager<br>Medtronic Perfusion Systems<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Trade Name: | Intersept™ Filtered Cardiotomy Reservoir |
| Classification Name: | Reservoir, Blood, Cardiopulmonary Bypass; Defoamer,<br>Cardiopulmonary Bypass |
| Regulation Number: | 21 CFR 870.4400, 21 CFR 870.4230 |
| Product Classification: | Class II |
| Product Code: | DTN, DTP |

Name of Predicate Device: Intersept® Cardiotomy Reservoir with Filter

#### Device Description

The Intersept™ Filtered Cardiotomy Reservoir is a single-use, device with a sterile, nonpyrogenic fluid path. The maximum capacity of each reservoir is 2,600 ml. The maximum recommended flow rate is 2 liters per minute (LPM).

Each reservoir has eight luer or 1/4" (0.6 cm) ID access ports;

- four suction access ports .
- two pre-defoamer and two post-defoamer access ports. One of the post-defoamer access . ports is intended for use as a vent.

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Each Intersept™ Filtered Cardiotomy Reservoir contains an open cell polyurethane defoamer with a 20 micron microaggregate filter covered with a polyester sleeve.

## Indications for Use

The Intersept filtered cardiotomy reservoir is indicated for use in the cardiopulmonary bypass circuit during surgery for:

- an air/fluid separation chamber; .
- a temporary storage reservoir for priming solution and blood;
- the filtration of particulates from bank blood and the storage and filtration of blood ● recovered from the field by suction;
- . the addition of medications or other fluids.

The Intersept filtered cardiotomy reservoir is also indicated for use after open heart surgery for:

- the post-operative collection of autologous blood from the chest and the aseptic return of ● blood to the patient for volume replacement.
## Contraindications

This product used for any other purposes than for the indicated use is the responsibility of the user.

The cardiotomy reservoir is contraindicated for use in post-operative chest drainage/autotransfusion procedures when:

- . there is an air leak in the lung or gross perforations to the chest wall exist;
- pericardial, mediastinal, pulmonary or systemic infection or malignancy is present;
- gross contamination (e.g., bone cement, lymphatic failure, perforated intestine) is present ● or suspected:
- aspirating blood from a site containing topical hemostatic agents, bactericidal wound irritants or antibiotics not intended for parenteral administration;
- the chest is open and vacuum is applied;
- protamine has been administered prior to the reservoir being removed from the bypass circuit;
- the patient is returned to surgery for any reason;
- vented chest tubes not incorporating vent flow regulation such as stopcock are used.

# Comparison to Predicate Devices

A comparison of the Intersept™ Filtered Cardiotomy Reservoir to the predicate device (the Intersept® Cardiotomy Reservoir with Filter) indicates the following similarities:

- Intended Use: The intended use is the same as predicate device. ●
- Design: The overall design is the same as the predicate.
- Materials: The material types used are the same as the predicate.
- Principles of Operation and Technology: The principles of operation are the same as the predicate device.
- . Performance: The performance is substantially equivalent to the predicate and/or reference device.

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#### Summary of Testing

Testing has demonstrated that the Intersept™ Filtered Cardiotomy Reservoir is substantially equivalent to the predicate.

The following tests were conducted:

| Component | Base Material Changes | Verification/Validation | Results |
|-----------|-------------------------|-------------------------|---------|
| Frame | Current: Polypropylene | Filtration Efficiency | Pass |
| Frame | | Blood Trauma | Pass |
| Frame | Proposed: Polypropylene | Biocompatibility | Pass |

## Conclusion

The data included in this submission is sufficient to demonstrate substantial equivalence of the Intersept™ Filtered Cardiotomy in terms of safety and effectiveness as compared to the predicate device, the Intersept® Cardiotomy Reservoir with Filter.