(52 days)
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 limited to, the following:
- General, Cardiovascular, Orthopedic, Vascular, Plastic/Reconstructive, Obstetric/Gynecologic and . Neurosurgical
- . Postoperative treatment areas
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.
Here's an analysis of the provided text regarding the autoLog Autotransfusion System and its acceptance criteria and study:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes a modification to an existing device, the autoLog Autotransfusion System (K972894), specifically allowing for "the use of an adjustable external vacuum regulator." As such, the submission focuses on demonstrating that this modification does not introduce new risks or alter the fundamental performance of the device. Consequently, the "acceptance criteria" are framed around maintaining the performance equivalence to the predicate device.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| No functional differences between the predicate and the modified device exist | "A qualification was done to confirm that no functional differences between the predicate and the modified device exist." |
| No changes affecting the biocompatibility of the system's disposables | "There are no changes that affect the biocompatability... of the system's disposables." |
| No changes affecting the sterility of the system's disposables | "There are no changes that affect the... sterility of the system's disposables." |
| All other features, specifications, and operating principles remain identical to the predicate device | "Except for the ability to adjust the vacuum delivered to the reservoir bag, all other features, specifications, operating principles and materials of the device are identical." |
| Intended Use remains unchanged | "The intended use of the device has not changed from 510k # K972894." |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "A qualification was done to confirm that no functional differences between the predicate and the modified device exist. This testing was specific to the changes proposed." However, specific details regarding the sample size used for this test set are not provided in the summary. The document does not specify the country of origin of the data or whether it was retrospective or prospective. Given the nature of the modification (mechanical/performance testing of a vacuum regulator), it is highly probable this was laboratory-based testing rather than clinical data involving patients.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable in the context of this 510(k) submission. The "ground truth" here is the functionality and performance of the device components, not a diagnostic interpretation that would require expert consensus. The testing would have involved engineering and quality assurance personnel.
4. Adjudication Method for the Test Set
This information is not applicable for the type of qualification testing described. Adjudication methods like 2+1 or 3+1 are typically used for clinical studies involving human interpretation or subjective assessments. The testing described here would involve objective measurements and comparisons.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for medical imaging or diagnostic AI devices where human readers interpret cases with and without AI assistance. The submitted device is an autotransfusion system, not an imaging or diagnostic device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone (algorithm only) performance study was not done. This concept is relevant for AI or software-as-a-medical-device (SaMD) where an algorithm makes a determination. The autoLog Autotransfusion System is a physical medical device; its "performance" is assessed through functional and safety testing of its mechanical and operational characteristics.
7. The Type of Ground Truth Used
The "ground truth" for this modification essentially revolved around engineering specifications and established performance characteristics of the predicate device. The testing aimed to confirm that the modified device's performance, particularly regarding vacuum regulation, met pre-defined engineering standards and did not deviate from the predicate's established safe and effective operation. It was not based on expert consensus, pathology, or outcomes data in the clinical sense.
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable to this device and its modification. Training sets are used in machine learning and AI development. This submission describes a mechanical modification to an existing medical device, not the development or training of an algorithm.
9. How the Ground Truth for the Training Set Was Established
Since there is no "training set" in the context of this device, this question is not applicable.
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| AUG 20 1998 | 510K Summary | K98275 | |
|---|---|---|---|
| Submitted by: | Medtronic Blood Management18501 E. Plaza DriveParker, CO 80134-9061 USA | ||
| Manufacturing Facility: | Medtronic Blood Management18501 E. Plaza DriveParker, CO 80134-9061 USA | ||
| Submitted Device: | Modification to existing device: This submission would allow the use of anadjustable external vacuum regulator. | ||
| Trade Name: autoLog Autotransfusion SystemCommon Name: Autotransfusion Apparatus | |||
| Device Classification: | Class II | ||
| 21 CFR § 868.5830 "Autotransfusion Apparatus", which is identified as, "anautotransfusion apparatus is a device used to collect and reinfuse the blood lostby a patient due to surgery or trauma." | |||
| Product Description: | The description of the device remains the same as 510k # K972894. | ||
| "The autoLog Autotransfusion System is an autotransfusion apparatus (includingdisposable kit). The system is a centrifugal unit that is used to collect autologousblood peri-operatively and post-operatively into a collection reservoir with anappropriate amount of anticoagulant. This autologous blood is then processed bycentrifugation, separating the red cells from the plasma. Contaminating debris issubsequently washed out by the introduction of normal saline in a wash cycle. Theresulting packed red cells, suspended in normal saline, are pumped to a transfer bag,and may be reinfused to the patient." | |||
| Intended Use: | The intended use of the device has not changed from 510k # K972894. It remainsas follows: | ||
| "The autoLog is intended for use in the collection, concentration, washing, andreinfusion of autologous blood. Such areas of application may include, but are notlimited to, the following: | |||
| General, Cardiovascular, Orthopedic, Vascular, Plastic/Reconstructive,Obstetric/Gynecologic and Neurosurgical | |||
| Postoperative treatment areas" |
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| Performance Standards: | Per section 514 of the Food, Drug and Cosmetics Act, there are no specificperformance standards established for this device. |
|---|---|
| Statement of SubstantialEquivalence - PredicateDevice: | This device is substantially equivalent to the autoLog Autotransfusion System(K972894). The modification concerns the use of an external adjustable vacuumregulator in place of the current internal non-adjustable vacuum regulator. Exceptfor the ability to adjust the vacuum delivered to the reservoir bag, all other features,specifications, operating principles and materials of the device are identical. Thereare no changes that affect the biocompatability or the sterility of the system'sdisposables. |
| Testing: | A qualification was done to confirm that no functional differences between thepredicate and the modified device exist. This testing was specific to the changesproposed. |
.
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 20 1998
Mr. Stephen McKelvey QA Project Manager Medtronic Blood Management 18501 East Plaza Drive Parker, CO 80134-9061
Re : K982755 autoLog Autotransfusion System Regulatory Class: II (Two) Product Code: CAC Dated: June 26, 1998 Received: June 29, 1998
Dear Mr. McKelvey:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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, Druq, and Cosmetic Act (Act). 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, labelinq, and prohibitions aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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Page 2 - Mr. Stephen McKelvey
This letter will allow you to beqin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" Other general information on your (21CFR 807.97). responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsma/dsmamain.html."
Sincerely yours,
Thomas J. Callahon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INTENDED USE STATEMENT
510(k) Number (if known): ¥ 98 2755
Device Name:
autoLog Autotransfusion System
Indications For Use:
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 limited to, the following:
- General, Cardiovascular, Orthopedic, Vascular, Plastic/Reconstructive, Obstetric/Gynecologic and . Neurosurgical
- . Postoperative treatment areas
The intended use of this premarket notification has not changed from the autoLog 510(k) - K972894.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Seeee E. Campbell
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number_1 982755
Prescriptive Use
OR
Over-the-Counter Use
§ 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).