The Preassembled Surgical Wash Set is intended for use with specific Autotransfusion machines which are identified on the primary label. It contains the basic components necessary to process blood collected during open heart or other surgical procedures for autotransfusion.

Device Description

The Preassembled Surgical Wash Set is sterile, non-pyrogenic device designed for blood collection from the operating field or from the extracorporeal circuit, washing, concentrating and reinfusion of the blood products to the patient. The Preassembled Surgical Wash Set is composed of a rotary separation chamber (i.e. bowl) and bags connected with the appropriate the a connectors to fit the intended autotransfusion equipment.

The device may be offered in different configurations based on the specific autotransfusion machine for which it is designed. The basic components and the intended use remain the same.

The device is a modified version of the unmodified device, Preassembled Surgical Wash Set.

AI/ML Overview

The provided document describes a 510(k) submission for a modified "Preassembled Surgical Wash Set." The study conducted is a non-clinical in vitro test comparing the modified device to the unmodified predicate device to demonstrate substantial equivalence, rather than a study defining acceptance criteria for a new AI or diagnostic device based on performance metrics like sensitivity or specificity.

Therefore, many of the requested categories (like number of experts, adjudication methods, MRMC studies, standalone performance for AI, and specific ground truth types) are not applicable to this type of device and study. The information provided focuses on the physical and functional characteristics of a medical device used for blood processing.

Here's an attempt to answer the questions based on the available information, noting when a question is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present a table with specific quantitative acceptance criteria or performance metrics directly. Instead, the "acceptance criterion" essentially was that the modified device would perform "in a manner substantially equivalent to the unmodified Preassembled Surgical Wash Set with respect to biocompatibility and the functional parameters." The reported performance is that the "results of these tests met established specifications" and the device "performs in a manner substantially equivalent to the unmodified Preassembled Surgical Wash Set."

Acceptance Criteria Category	Specific Criteria (Implicitly based on predicate device performance)	Reported Device Performance
Biocompatibility	Meet ISO 10993-1:2003 requirements	Met established specifications
Functional Parameters	Perform equivalently to the unmodified device (blood processing operations like washing, concentrating)	Performs in a manner substantially equivalent to the unmodified device
Sterility	Sterile	Demonstrated effectiveness of production techniques to assure sterility
Non-pyrogenicity	Non-pyrogenic	Demonstrated effectiveness of production techniques to assure non-pyrogenicity

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify a numerical sample size for the in vitro tests. It mentions that "all the tests were performed on sterile wash sets where only the bowl was aged (accelerated aging up to 3 + 1 years)." It also states that "For comparative purpose the modified and unmodified Preassembled Surgical Wash Sets were compared." This implies at least one modified set and one unmodified set were tested for each scenario, but a specific quantity is not given.
Data Provenance: The study was conducted in-house by the manufacturer ("internal methods developed by the manufacturer"). The country of origin would be Italy (where Sorin Group Italia is located). It is an in vitro study, not a human-data-based study (prospective or retrospective).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable. This study is a non-clinical, in vitro comparison of a physical medical device. Ground truth, in the context of expert review for diagnostic or AI devices, is not relevant here. The "ground truth" is established by the physical and chemical properties and functional performance of the devices as measured by internal test methods.

4. Adjudication Method for the Test Set

Not applicable. See explanation for #3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This study is for a physical medical device (wash set), not an AI or diagnostic tool involving human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

Not applicable. This pertains to an AI algorithm; the device being studied is a physical wash set.

7. The Type of Ground Truth Used

The "ground truth" for this engineering and functional performance study is implicitly the established specifications and performance of the predicate (unmodified) device, against which the modified device was compared. This is based on in vitro measurements and comparisons of physical properties, biocompatibility, and functional operation (blood processing).

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI study; therefore, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. See explanation for #8.

Summary

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Special 510(k) October 29, 2010

K103202

510(k) SUMMARY

SUBMITTER:

Sorin Group Italia 86, Via Statale 12 Nord 41037 Mirandola (MO) Italy

NOV 2 3 2010

CONTACT PERSON:

Luigi Vecchi · Phone: 39 0535 29811 Fax: 39 0535 25229

October 29, 2010

DATE PREPARED:

DEVICE TRADE NAME: Preassembled Surgical Wash Set

COMMON NAME:

Washing Set for Autotransfusion System

Apparatus, Autotransfusion

UNMODIFIED DEVICE:

CLASSIFICATION NAME:

PREDICATE DEVICE :

Preassembled Surgical Wash Set (#K872161)

Preassembled Surgical Wash Set for Dideco Electa Autotransfusion System (#K020647).

Preassembled Surgical Wash Set for ABMS/Compact Advanced Autotransfusion Equipment (#K982650).

Bowl Set for XTRA Autotransfusion System (#K101586).

DEVICE DESCRIPTION:

The device may be offered in different configurations based on the specific autotransfusion machine for which it is designed. The basic components and the intended use remain the same.

The device is a modified version of the unmodified device, Preassembled Surgical Wash Set.

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The modifications consist of: the removal of the silicone treatment from the inner surface of the bowl; the removal of "Y" adaptor resulting in minor modifications to the configuration of the circuit; a general updating of the labeling.

The modified device has an unchanged intended use, materials (with the exception of the removal of the silicone treatment from the inner surface of the bowl), sterjilization process, operating principles, control mechanisms, and fundamental scientific technology.

INDICATION FOR USE:

The device is intended for use with specific Autotransfusion machines which are identified on the primary label. It contains the basic components necessary to nroess blood collected during open heart or other surgical procedures for autotransfusion.

TECHNOLOGICAL CHARACTERISTICS:

The modified Preassembled Surgical Wash Set has the same operating principles and control mechanisms when compared to the unmodified device.

With the exception of the removal of the silicone treatment, the modified Preassembled Surgical Wash Set utilizes the same materials. Minor changes have been introdumed in the circuit configuration due to the removal of the "Y" adaptor (#K872159) which is an accessory used to connect the wash set to a cardiotomy reservoir.

No change to the intended use has been made as a result of these modifications.

There are no differences in packaging type and material between unmodified and the modified Preassembled Surgical Wash Set.

The Preassembled Surgical Wash Set is ethylene oxide sterilized and has a nonpyrogenic fluid path. It is for single use only.

NON CLINICAL TEST RESULTS:

Applicable tests were carried out in accordance with the requirements of ISO 10993-1:2003 and the FDA May 1st, 1995 Memorandum on the use of the ISO 10993 stadard for biocompatibility testing of raw materials.

The results of the testing met established specifications.

IN VITRO TEST RESULTS:

In vitro testing was performed in order to provide the data necessary to demonstrate both the substantial equivalence with the unmodified device and also to comply with safety and effectiveness requirements.

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The tests were performed according to internal methods developed by the manufacturer.

Since the main modification to the unmodified device is the removal of silicone treatment from the inner surface of the bowl all the tests were performed on sterile wash sets where only the bowl was aged (accelerated aging up to 3 + 1 years). For comparative purpose the modified and unmodified Preassembled Surgical Wash Sets were compared.

The devices were installed on the proper Autotransfusion machine and were tested according to the autotransfusion procedures used by the equipment for blood processing. The results of these tests met established specifications.

CONCLUSIONS:

The modified Preassembled Surgical Wash Set performs in a manner substantially equivalent to the unmodified Preassembled Surgical Wash Set with respect to biocompatibility and the functional parameters. Additional testing has also demonstrated the effectiveness of production techniques to assure that the device is sterile and nonpyrogenic.

In conclusion test result of this study suggests the Preassembled Surgical Wash Set is equivalent to the unmodified Preassembled Surgical Wash Set with respect to device function.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The logo is black and white.

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

PAREXEL Consulting LLC c/o Mr. Barry S. Sall Principal Consultant 195 West Street Waltham, MA 02451

NOV 2 3 2010

Re: K103202

Preassembled Surgical Wash Set Regulation Number: 21 CFR 870.5830 Regulation Name: Autotransfusion Apparatus Regulatory Class: Class II (two) Product Code: CAC Dated: October 29, 2010 Received: November 1, 2010

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 S. 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/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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Dunia R. Vahmen

Image /page/4/Picture/7 description: The image shows a black and white close-up of a signature. The signature appears to be stylized and cursive. The signature is on a white background.

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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510(k) Number (if known): K 103202

NOV 2 3 2010

Device Name: Preassembled Surgical Wash Set Indication for Use:

Prescription Use × (Part 21CFR 801 Subpart D)

Over-the- Counter Use AND/OR (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)

una R. balme

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_K10 3202

CONFIDENTIAL

Regulation Number and Section

§ 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).