(265 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™ is an autotransfusion apparatys (including disposable kit). The system is a centrifugal unit that is used to collect autologous blood peri-operatively and ppst-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 that may be reinfused to the patient.
The Medtronic autoLog™ Autotransfusion System is a Class II device (21 CFR § 868.5830) intended for the collection, concentration, washing, and reinfusion of autologous blood during peri-operative and post-operative procedures.
The provided document does not contain a comprehensive list of acceptance criteria with numerical targets. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices (Sequestra and ELMD 500 autotransfusion apparatus) based on comparative features and functional testing.
However, based on the information provided, we can infer the primary acceptance criteria:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from comparison to predicate devices) | Reported Device Performance (autoLog™) |
|---|---|
| Microprocessor Controlled | Yes |
| Automatic Operation | Yes |
| Manual Operation | Yes |
| Blood Level Sensor | Yes |
| Air Bubble Detector | Yes |
| Centrifuge Drive (Direct) | Direct |
| Digital Display | Yes |
| Construction (Metal) | Metal |
| Built-in Vacuum | Yes |
| Waste Bag Capacity (10 liters) | 10 liters |
| Voltage (Multi-voltage compatibility) | 100/110/220/240 |
| Operating Humidity (up to 95%) | 10-95% |
| Functional Equivalence (as demonstrated by testing) | System and software performance confirmed through: system/software risk analysis, functional system qualification, and "system black box testing". |
Note on Quantitative Differences:
While many features are equivalent, some quantitative differences exist with predicate devices like Centrifuge Speed (autoLog™: 10000 RPM vs. Predicates: 1000-5600 RPM), Number of Programs (autoLog™: 1 vs. Predicates: 5 or 6), Data Input (autoLog™: Push Button vs. Predicates: Touch Screen), and Blood Pump Flow (autoLog™: 0-1000 ml/min vs. Predicates: 50-500 ml/min or 10-1000 ml/min). However, these differences were deemed not to raise new questions of safety or effectiveness by the FDA, as evidenced by the substantial equivalence determination.
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in terms of patient data or samples. The testing described is focused on the device's functional performance:
- Sample Size: Not applicable in the context of clinical or patient data.
- Data Provenance: Not applicable. The testing is internal to Medtronic Blood Management, likely conducted in a laboratory or simulated environment, rather than involving external data sources.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for the functional and software performance tests was based on the device's design specifications and expected operational behavior. There is no indication of expert panel review for establishing ground truth in the context of clinical outcomes.
4. Adjudication method for the test set
Not applicable. The testing described (risk analysis, functional qualification, black box testing) suggests an engineering and software validation approach, not a clinical trial needing adjudication of results.
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. The autoLog™ is an autotransfusion apparatus, not an AI-assisted diagnostic or imaging system. Therefore, MRMC studies and "human reader improvement with AI" are irrelevant in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is an automated medical apparatus, meaning it operates autonomously based on its programming for the processing of blood. So, in a sense, its primary function is "standalone" once initiated. The testing described (system/software risk analysis, functional system qualification, "system black box testing") evaluates this standalone performance. However, this is not in the context of an "algorithm" operating without human input in the way a diagnostic AI would be. Human operators manage the device and reinfuse the processed blood to the patient.
7. The type of ground truth used
The "ground truth" for the device's performance was established via design specifications and functional verification. This would involve:
- Engineering specifications: Defining expected centrifuge speeds, pump flow rates, sensor functionality, etc.
- Software requirements: Defining how the microprocessor should control each stage of the process (collection, concentration, washing, pumping).
- Risk analysis: Ensuring the system operates safely and effectively within predefined parameters.
8. The sample size for the training set
Not applicable. This device is not an AI/ML product developed using training data. Its functionality is based on direct engineering design and programming.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
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KG72894
APR 2 7 1998 510(k) SUMMARY Submitted by: Medtronic Blood Management 18501 E. Plaza Drive Parker. Colorado 80134 Manufacturing Facility: Medtronic Blood Management 18501 E. Plaza Drive Parker. Colorado 80134 Submitted Device: autoLog™ Autotransfusion System Trade Name: Common Name: Autotransfusion Apparatus Device Classification: Class II 21 CFR § 868.5830 "Autotransfusion Apparatus" which is identified as, "an autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma." Product Description: The autoLog™ is an autotransfusion apparatys (including disposable kit). The system is a centrifugal unit that is used to collect autologous blood peri-operatively and ppst-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 that may be reinfused to the patient. Intended 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
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| Performance Standards: | Per section 514 of the Food , Drug and Cosmetics Act, there are no specific performance standards for this device. |
|---|---|
| ------------------------ | -------------------------------------------------------------------------------------------------------------------- |
The autoLog™ is substantially equivalent to the Sequestra and Statement of substantial : the ELMD 500 autotransfusion apparatus in construction and equivalence - Predicate Device function.
| FEATURES | AUTOLOG | ELMD 500 | SEQUESTRA | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Microprocessor Controlled | Yes | Yes | Yes | ||||||||||||||||||||
| Automatic Operation | Yes | Yes | Yes | ||||||||||||||||||||
| Number of Programs | 1 | 5 | 6 | ||||||||||||||||||||
| Manual Operation | Yes | Yes | Yes | ||||||||||||||||||||
| Continuous Wash Program | Yes | No | Yes | ||||||||||||||||||||
| Blood Level Sensor | Yes | Yes | Yes | ||||||||||||||||||||
| Air Bubble Detector | Yes | Yes | Yes | ||||||||||||||||||||
| Centrifuge Drive | Direct | Direct | Direct | ||||||||||||||||||||
| Centrifuge Speed (RPM) | 10000 | 1000-5600 | 1000-5600 | ||||||||||||||||||||
| Digital Display | Yes | Yes | Yes | ||||||||||||||||||||
| Data Input | Push Button | Touch Screen | Touch Screen | ||||||||||||||||||||
| Blood Pump Flow (ml/min) | 0-1000 | 50-500 | 10-1000 | ||||||||||||||||||||
| Bowl Size (ml) | 135 | 125, 225, 375 | 125, 225, 375 | ||||||||||||||||||||
| I.V. Poles | 1 | 2 | 2 | ||||||||||||||||||||
| Construction | Metal | Metal | Metal | ||||||||||||||||||||
| Built in Vacuum | Yes | No | Yes | ||||||||||||||||||||
| Waste Bag (liters) | 10 | 10 | 10 | ||||||||||||||||||||
| Voltage | 100/110/220/ | 100/110/220/ | 100/110/220/ | ||||||||||||||||||||
| 240 | 240 | 240 | Operating Current | 0.8-1.6 amps | 4/2 amps | 4/2 amps | 50/60 Hz | 50/60 Hz | 50/60 Hz | Power Disspation (watts) | 200 | 500 | 500 | Operating Temperature Range | 10-30 C | 10-27 C | 10-27 C | Operating Humidity | 10-95% | up to 95% | up to 95% | ||
| 240 | 240 | 240 | |||||||||||||||||||||
| Operating Current | 0.8-1.6 amps | 4/2 amps | 4/2 amps | ||||||||||||||||||||
| 50/60 Hz | 50/60 Hz | 50/60 Hz | |||||||||||||||||||||
| Power Disspation (watts) | 200 | 500 | 500 | ||||||||||||||||||||
| Operating Temperature Range | 10-30 C | 10-27 C | 10-27 C | ||||||||||||||||||||
| Operating Humidity | 10-95% | up to 95% | up to 95% |
COMPARISON TO PREDICATE DEVICES
Testing:
Testing was done to confirm system and software performance. These included, but were not limited to; system/software risk analysis, functional system qualification, and "system black box testing".
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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 stylized eagle with three heads facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 27 1998
Ms. Joyce Thomas Quality Systems and Regulatory Affairs Manager Medtronic Blood Management 18501 E. Plaza Drive Parker, CO 80134-9061
Re : K972894 autoLog™ Autotransfusion Regulatory Class: II (Two) Product Code: CAC Dated: March 10, 1998 Received: March 11, 1998
Dear Ms. Thomas:
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 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). 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 Regulations, 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 regulation (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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. 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 regulations.
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Page 2 - Ms. Joyce Thomas
This letter will allow you to begin 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" (21 CFR 807.97). Other general information on your 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.gov/cdrh/dsmamain.html."
Sincerely yours,
Thomas J. Callihan
Thomas J. Callanan, 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):
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 .
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dece & Dece C.
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices K 972894
Prescriptive Use
OR
510(k) Number_
Over-the-Counter Use - - -
AutoLog 510(k) submission
§ 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).