AUTOLOG AUTOTRANSFUSION SYSTEM

K093535 · Medtronic, Inc. · CAC · Mar 22, 2010 · Anesthesiology

Device Facts

• Record ID: K093535
• Device Name: AUTOLOG AUTOTRANSFUSION SYSTEM
• Applicant: Medtronic, Inc.
• Product Code: CAC · Anesthesiology
• Decision Date: Mar 22, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5830
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The autoLog is intended for use in the collection, concentration, washing, and reinfusion of autologous blood. Such areas of application may include, but are not necessarily limited to, the following: - General, Cardiovascular, Orthopedic, Vascular, Plastic/Reconstructive, Obstetric/Gynecologic and Neurosurgical - Postoperative treatment areas

Device Story

Centrifugal autotransfusion system; collects peri-operative/post-operative autologous blood into anticoagulant-treated reservoir; processes blood via centrifugation to separate red cells from plasma; washes red cells with normal saline to remove debris; pumps packed red cells to transfer bag for patient reinfusion. Used in clinical settings (OR, postoperative areas) by trained personnel. System modifications include manifold material change from PVC to PETG. Benefits include reduced need for allogeneic blood transfusion.

Clinical Evidence

No clinical data. Substantial equivalence established via bench testing, including biocompatibility, software validation, manifold bond integrity, fan guard cooling, and lipid removal characterization.

Technological Characteristics

Centrifugal autotransfusion apparatus. Fluid path materials include PETG (manifold) and materials previously cleared in disposable bowl. System utilizes centrifugation and saline wash cycle. Software-controlled operation. Sterilization processes identical to predicate.

Indications for Use

Indicated for collection, concentration, washing, and reinfusion of autologous blood in patients undergoing general, cardiovascular, orthopedic, vascular, plastic/reconstructive, obstetric/gynecologic, or neurosurgical procedures, including postoperative treatment.

Regulatory Classification

Identification

An autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma.

Predicate Devices

• autoLog® Autotransfusion System (K982755)

Submission Summary (Full Text)

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K0933535-

autoLog® Autotransfusion System Traditional 510(k)

# 510(k) Summary

| Date Prepared: | November 13, 2009 | |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Submitter: | Medtronic Perfusion Systems<br>7611 Northland Drive<br>Minneapolis, MN 55428<br>Establish Registration Number: 2184009 | MAR 2 2 2010 |
| Contact Person: | Caralee Walton<br>Senior Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] | |

# Device Name and Classification:

| Trade Name: | autoLog® Autotransfusion System |
|--------------------|---------------------------------|
| Common Name: | Autotransfusion Apparatus |
| Regulation Number: | 21 CFR 868.5830 |
| Product Code: | CAC |
| Classification: | Class II |

# Predicate Devices

autoLog® Autotransfusion System (K982755)

## Device Description

The autoLog® Autotransfusion System is an autotransfusion apparatus (including disposable kit). The system is a centrifugal unit that is used to collect autologous blood peri-operatively and post-operatively into a collection reservoir with an appropriate amount of anticoagulant. This autologous blood is then processed by centrifugation, separating the red cells from the plasma. Contaminating debris is subsequently washed out by the introduction of normal saline in a wash cycle. The resulting packed red cells, suspended in normal saline, are pumped to a transfer bag, and may be reinfused to the patient.

### Indications for Use

The autoLog is intended for use in the collection, concentration, washing, and reinfusion of autologous blood. Such areas of application may include, but are not necessarily limited to, the following:

- General, Cardiovascular, Orthopedic, Vascular, Plastic/Reconstructive, . Obstetric/Gynecologic and Neurosurgical
- Postoperative treatment areas

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# Comparison to Predicate Devices

A comparison of the modified product and the currently marketed autoLog® Autotransfusion System indicates the following similarities to the system which received 510(k) clearance:

- Same indicated use .
- Same operating principle �
- . Same disposables (wash kit)
- Same shelf life for disposables .
- Same fluid path (patient-contacting) materials, while the manifold material is . changing from PVC to PETG, the PETG material is already in use in the disposable bowl
- Patient-contacting devices are packaged and sterilized using identical materials and . processes

#### Intended Use

There is no change to the intended use of the device.

#### Labeling

The Instructions for Use modifications include an itemized list of recovered and removed materials.

## Summary of Performance Data

Biocompatibility and software validation test data were used to establish the performance characteristics of the modifications to this device. Clinical testing was not required to establish substantial equivalence. The following performance tests were conducted:

- Biocompatibility Testing .
- Software Testing .
- . Manifold Bond Integrity Testing
- Fan Guard Cooling Testing .
- Lipid Removal Characterization Testing �

#### Conclusion

The modifications to the autoLog® Autotransfusion System described in this submission result in a substantially equivalent device because the fundamental scientific principle, labeling and the intended use are unchanged as a result of these device modifications.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

MAR 2 2 2010

Medtronic Inc. c/o Ms. Caralee Walton Senior Regulatory Affairs Specialist 8200 Coral Sea Street NE Mounds View, MN 55112

Re: K093535

> autoLog® Autotransfusion System Regulation Number: 21 CFR 868.5830 Regulation Name: Autotransfusion Apparatus Regulatory Class: Class II Product Code: CAC Dated: January 25, 2010 Received: January 26, 2010

Dear Ms. Walton:

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.

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Page 2 - Ms. Caralee Walton

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Duna R. Lahner

B:

D

o 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 Statement

510(k) Number (if known): _ K.0935355

Device Name: autoLog® Autotransfusion System

Indications for Use:

The autoLog is intended for use in the collection, concentration, washing, and reinfusion of autologous blood. Such areas of application may include, but are not necessarily limited to, the following:

- General, Cardiovascular, Orthopedic, Vascular, . Plastic/Reconstructive, Obstetric/Gynecologic and Neurosurgical
- Postoperative treatment areas .

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

uma R. be lunes

(Division Sign-Off) (Division of Cardiovascular Devices

510(k) Number K093535

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