(17 days)
No
The summary describes a vacuum pump with software, sensors, and a user interface, but there is no mention of AI, ML, or related concepts. The modifications focus on integrating control and monitoring, not intelligent algorithms.
No.
The device's intended use is for autotransfusion, specifically for the aspiration of shed blood during surgery, which is then processed and reinfused. While it plays a role in blood management, it is not directly treating or curing a disease or medical condition, but rather facilitating a surgical procedure.
No
Explanation: The device is intended for autotransfusion, specifically for aspirating, processing, and reinfusing shed blood. This is a therapeutic and blood management function, not a diagnostic one.
No
The device description explicitly states that the XVAC includes hardware components such as housing, aspiration pumps, cooling fan, display, LEDs, speaker, and touch panel, in addition to software.
Based on the provided information, the XVAC device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the XVAC is for the aspiration of shed blood for autotransfusion. This is a process that occurs in vivo (within the patient's body) and involves processing and reinfusing the blood back into the same patient.
- Device Description: The description details a vacuum module with pumps, software, and a user interface. This aligns with a medical device used for blood collection and processing, not for analyzing biological samples in vitro.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples (like blood, urine, tissue, etc.) outside of the body to provide information about a patient's health status, diagnose a condition, or monitor treatment.
IVD devices are specifically designed for testing biological samples in vitro to provide diagnostic information. The XVAC's function is to collect and process blood for reinfusion, which is a therapeutic procedure, not a diagnostic one.
N/A
Intended Use / 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.
Product codes
CAC
Device Description
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).
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
Operating room or patient care areas.
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
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Dideco Vacuum Pump (K936220)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5830 Autotransfusion apparatus.
(a)
Identification. An autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma.(b)
Classification. Class II (performance standards).
0
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.
86, Via Statale 12 Nord
41037 Mirandola (MO) Italy |
|----------------------|------------------------------------------------------------------------------------|
| CONTACT PERSON: | Luigi Vecchi
Phone: 011 39 0535 29811
Fax: 011 39 0535 25229 |
| 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 (800) 638-2041 or (301) 796-7100 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
4
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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