XVAC

K110782 · Sorin Group Italia S.R.L. · CAC · Apr 7, 2011 · Anesthesiology

Device Facts

• Record ID: K110782
• Device Name: XVAC
• Applicant: Sorin Group Italia S.R.L.
• Product Code: CAC · Anesthesiology
• Decision Date: Apr 7, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5830
• Device Class: Class 2

Intended Use

The XVAC is intended for use in autotransfusion, for the aspiration of shed blood (which is subsequently processed and reinfused to the patient) in the operating room or patient care areas.

Device Story

XVAC is an AC-powered vacuum module for autotransfusion; used in operating rooms or patient care areas to aspirate shed blood for processing and reinfusion. Device features housing, cooling fan, and two aspiration pumps (one for intraoperative, one for postoperative mode). System integrates software, control/monitoring sensors, and user interface (display, LEDs, speaker, touch panel). Enhances predicate Dideco Vacuum Pump by adding digital control and monitoring capabilities. Healthcare providers operate the device to manage vacuum levels during blood collection; output assists in blood salvage procedures, potentially reducing need for donor blood.

Clinical Evidence

Bench testing only. Evidence includes electrical testing, electromagnetic compatibility testing, and performance testing demonstrating compliance with specifications.

Technological Characteristics

AC-powered vacuum pump; dual-pump configuration (intraoperative/postoperative modes); integrated software, control/monitoring sensors, and user interface (display, LEDs, speaker, touch panel).

Indications for Use

Indicated for patients requiring autotransfusion via aspiration of shed blood for subsequent processing and reinfusion in operating rooms or patient care areas.

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

• Dideco Vacuum Pump (K936220)

Submission Summary (Full Text)

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K110782

APR - 7 2011

APR - 7 2011

| XVAC |
|---------------------------|
| Sorin Group Italia S.r.l. |

| Traditional 510(k) |
|--------------------|
| March 18, 2011 |

**510(k) SUMMARY**

| SUBMITTER: | Sorin Group Italia S.r.l.<br>86, Via Statale 12 Nord<br>41037 Mirandola (MO) Italy |
|----------------------|------------------------------------------------------------------------------------|
| CONTACT PERSON: | Luigi Vecchi<br>Phone: [phone]<br>Fax: [phone] |
| DATE PREPARED: | March 18, 2011 |
| DEVICE TRADE NAME: | XVAC |
| COMMON NAME: | Vacuum module |
| CLASSIFICATION NAME: | Apparatus, Autotransfusion |
| PREDICATE DEVICE: | Dideco Vacuum Pump (K936220) |

## DEVICE DESCRIPTION:

PREDICATE DEVICE:

バイ

The XVAC vacuum module is an enhancement of the predicate Dideco Vacuum Pump. Similar to the predicate device, the main components are the housing, the aspiration pump (with the exception that XVAC includes two different pumps: one for intraoperative mode and one for postoperative mode), and cooling fan.

The main modifications consist in the newly designed system that integrates software, control and monitoring sensors and an user interface (display, LEDs, speaker and touch panel).

# INDICATION FOR USE:

The XVAC is intended for use in autotransfusion, for the aspiration of shed blood (which is subsequently processed and reinfused to the patient) in the operating room or patient care areas.

## TECHNOLOGICAL CHARACTERISTICS:

Sorin makes the claim of substantial equivalence to cited predicate based on intended use, fundamental technological characteristics, and principles of operation.

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Traditional 510(k) XVAC March 18, 2011 Sorin Group Italia S.r.I.

Sorin Group Italia Srl believes that the XVAC is substantially equivalent to the Dideco Vacuum Pump. Any differences do not raise any new issues of safety and effectiveness.

### IN VITRO TEST RESULTS:

Testing supplied in the 510(k) premarket notification for the XVAC includes electrical testing, electromagnetic compatibility testing, and performance testing that demonstrates compliance with performance specifications.

#### CONCLUSIONS:

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

The XVAC is substantially equivalent to the Dideco Vacuum Pump in terms of functionality. Similar to the predicate device the XVAC is an AC powered vacuum pump that provides adjustable vacuums and is indicated for the aspiration of shed blood in the operating rooms or patient care areas.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

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

Sorin Group Italia S.r.l. c/o Mr. Barry Sall Principal Consultant 195 West Street Waltham, MA 02451

APR - / 2011

Re: K110782

XVAC Regulation Number: 21 CFR 868.5830 Regulation Name: Autotransfusion Apparatus Regulatory Class: Class II Product Code: CAC Dated: March 18, 2011 Received: March 21, 2011

Dear Mr. Sall:

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 - Mr. Barry Sall

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/CDRHOffices/ucm11.5809.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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

ina R. kahner

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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XVAC Sorin Group Italia S.r.l. Traditional 510(k) March 18, 2011

K川078Z

Device Name: XVAC

Indications for Use:

The XVAC is intended for use in autotransfusion, for the aspiration of shed blood (which is subsequently processed and reinfused to the patient) in the operating room or patient care areas.

Prescription Use _ X (Part 21 CFR 801 Subpart D)

AND/OR

Over-the-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duna R. Lane

(Division Sign-Off) Division of Čardiovascular Devices

510(k) Number K 110782

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