(17 days)
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.
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).
The provided text describes the XVAC vacuum module, an autotransfusion apparatus. Here's an analysis based on your request:
Acceptance Criteria and Study for K110782 (XVAC)
This 510(k) submission for the XVAC demonstrates substantial equivalence to a predicate device (Dideco Vacuum Pump - K936220), rather than establishing new clinical performance criteria for a novel device. Therefore, the "acceptance criteria" here relate to demonstrating that the new device is as safe and effective as the predicate, based on performance specifications and regulatory compliance, rather than specific clinical outcome metrics or diagnostic accuracy.
The provided document does not detail specific quantitative acceptance criteria or a clinical study in the way one might expect for a diagnostic AI device. Instead, it refers to compliance with performance specifications through "electrical testing, electromagnetic compatibility testing, and performance testing."
Here's the information structured as requested, with explanations where direct answers are not available in the text:
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Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria Reported Device Performance Compliance with electrical safety standards. Electrical testing demonstrates compliance. (Specific standards or quantitative results not provided in this summary.) Compliance with electromagnetic compatibility (EMC) standards. Electromagnetic compatibility testing demonstrates compliance. (Specific standards or quantitative results not provided in this summary.) Functionality and performance meeting specifications for aspiration pump operation (intraoperative and postoperative modes). Performance testing demonstrates compliance with performance specifications. The device is a "AC powered vacuum pump that provides adjustable vacuums," similar to the predicate. (Specific performance metrics like vacuum levels, flow rates, or duration are not provided in this summary, but these would be part of the underlying "performance specifications" tested). Intended use: aspiration of shed blood in autotransfusion in operating room or patient care areas. The device's intended use is identical to the predicate device, confirming its suitability for this purpose. Substantial equivalence to the predicate device (Dideco Vacuum Pump K936220) regarding safety and effectiveness. 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." This claim is supported by the aforementioned testing. -
Sample size used for the test set and the data provenance
- Sample Size: Not applicable in the context of a 510(k) for a hardware device like this. There is no "test set" of patient data or images. The "testing" refers to bench testing of the device itself.
- Data Provenance: Not applicable. The testing is device-based, not data-based.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This is not an AI diagnostic device that requires expert ground truth labeling.
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Adjudication method for the test set
- Not applicable.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is not an AI device.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a medical device (vacuum module), not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the performance testing, the "ground truth" would be established by engineering specifications and recognized national/international standards for electrical safety, EMC, and pump performance. These specifications define the expected operational parameters and safety limits against which the device's performance is measured.
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The sample size for the training set
- Not applicable. There is no AI model being trained.
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How the ground truth for the training set was established
- Not applicable.
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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 Nord41037 Mirandola (MO) Italy |
|---|---|
| CONTACT PERSON: | Luigi VecchiPhone: 011 39 0535 29811Fax: 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
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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
11
§ 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).