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 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.

AI/ML Overview

This document is a 510(k) summary for the autoLog® Autotransfusion System. It details the device, its intended use, and a comparison to a predicate device. This submission primarily focuses on modifications to an already cleared device, K982755.

Here's an analysis of the provided text in relation to your questions:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in a quantitative manner for specific performance metrics (e.g., cell recovery rate, leukocyte removal). Instead, it states that the device is substantially equivalent to a predicate device because the fundamental scientific principle, labeling, and intended use are unchanged. The performance "criteria" are met by demonstrating that modifications do not adversely affect the established performance characteristics.

Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility	Biocompatibility testing performed. (No specific quantitative results reported in this summary, but implies it met the necessary standards for patient contact.)
Software Functionality and Safety	Software validation testing performed. (Implies the software performs as intended and is safe.)
Manifold Bond Integrity	Manifold Bond Integrity Testing performed. (Implies the new manifold material (PETG) or its bonding is as robust as the previous PVC.)
Fan Guard Cooling Effectiveness	Fan Guard Cooling Testing performed. (Implies adequate cooling is maintained.)
Lipid Removal Characterization	Lipid Removal Characterization Testing performed. (Implies the device's ability to remove lipids is maintained or characterized, though no specific performance metric is given for comparison.)
Device remains substantially equivalent to predicate autoLog® Autotransfusion System (K982755) in: Indicated useOperating principleDisposables (wash kit)Shelf life for disposablesFluid path (patient-contacting) materialsPackaging and sterilization methods for patient-contacting devices	The submission states, "The modifications... 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." (This is the overarching "performance" claim based on the conducted tests.)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document explicitly states: "Clinical testing was not required to establish substantial equivalence."
Therefore, there is no "test set" in the context of clinical patient data, and thus no sample size, country of origin, or retrospective/prospective designation for clinical studies. The "test set" for the non-clinical performance data (biocompatibility, software, etc.) would be specific to each test and is not detailed in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as no clinical testing was performed and therefore no ground truth established by experts in a clinical context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no clinical testing was performed and no expert ground truth established for a test set.

5. 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-assisted diagnostic device, nor was there any clinical comparative effectiveness study involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a medical device for autotransfusion, not a standalone diagnostic algorithm. The "software testing" mentioned refers to the internal software components of the device, not an external algorithm performing a diagnostic function.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical performance tests mentioned (Biocompatibility, Software, Manifold Bond Integrity, Fan Guard Cooling, Lipid Removal Characterization), the "ground truth" would be established by:

Industry standards and regulatory guidelines: For biocompatibility (e.g., ISO 10993 series).
Design specifications and established engineering principles: For software functionality, bond integrity, and cooling effectiveness.
Internal characterization methods and scientific principles: For lipid removal.

There is no "expert consensus, pathology, or outcomes data" in the clinical sense, as clinical studies were not performed.

8. The sample size for the training set

Not applicable. This device does not use an AI or machine learning model that requires a "training set" of data.

9. How the ground truth for the training set was established

Not applicable, as no training set was used.

Summary

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K0933535-

autoLog® Autotransfusion System Traditional 510(k)

510(k) Summary

Date Prepared:	November 13, 2009
Submitter:	Medtronic Perfusion Systems7611 Northland DriveMinneapolis, MN 55428Establish Registration Number: 2184009	MAR 2 2 2010
Contact Person:	Caralee WaltonSenior Regulatory Affairs SpecialistPhone: (763) 514-9851Fax: (651) 367-8360Email: caralee.a.walton@medtronic.com

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

Indications for Use

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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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three heads facing right, representing the department's focus on individuals, families, and communities. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

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

Sincerely yours,

Duna R. Lahner

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:

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

Page 5 of 116

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).