(245 days)
Not Found
No
The description focuses on the device's function as a microprocessor-controlled peristaltic pump and does not mention any AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is used in extracorporeal circulation of blood for arterial regional perfusion and cardiopulmonary bypass procedures, which are medical interventions aimed at treating or supporting bodily functions.
No
Explanation: The device is described as a pump used for extracorporeal circulation of blood, a therapeutic procedure, not for diagnosing a medical condition.
No
The device description explicitly states it is a "microprocessor controlled 2-roller peristaltic pump," indicating it is a hardware device with embedded software, not a software-only medical device.
Based on the provided information, the Sarns 9000 Universal Roller Pump is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for "extracorporeal circulation of blood for arterial regional perfusion, and cardiopulmonary bypass procedures." These are procedures performed on a living patient, not on samples of biological material outside the body.
- Device Description: The description details a pump for moving fluids (blood) within a system connected to a patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Sarns 9000 is a medical device used in a surgical/procedural setting to manage blood flow during specific medical interventions.
N/A
Intended Use / Indications for Use
The Sarns 9000 Universal Roller Pump is indicated for use in extracorporeal circulation of blood for arterial regional perfusion, and cardiopulmonary bypass procedures only, when used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The Sarns 9000 Universal Roller Pump is a microprocessor controlled 2-roller peristaltic pump with adjustable occlusion. The pump is capable of flows up to 9.99 L/min (depending on pump head tubing used) at pump speeds up to 250 RPM. The Sarns 9000 Universal Roller Pump is dependent on the Sarns 9000 Perfusion System to provide power.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified perfusionist
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Nonclinical tests were performed on the device to determine substantial equivalence. Electromagnetic Compatibility (EMC) tests were also performed to ensure equivalent or better results.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.4370 Roller-type cardiopulmonary bypass blood pump.
(a)
Identification. A roller-type cardiopulmonary bypass blood pump is a device that uses a revolving roller mechanism to pump the blood through the cardiopulmonary bypass circuit during bypass surgery.(b)
Classification. Class II (performance standards).
0
Section 2 - Summary & Certification
2.1 510(k) Summary
A 510(k) Summary of Safety and Effectiveness is on the next page.
APR 1 9 1996
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Page 5 of 541
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3M Health Care Sarns™ and CDPM Products 6200 Jackson Road PO Box 1247 Ann Arbor, MI 48106-1247 118A 800 521 2818 161 313 663 4145 Tel 313 663 7981 Fax
Image /page/1/Picture/2 description: The image shows the logo for 3M. The logo is in black and white and features the number 3 followed by the letter M. The font is bold and slightly distressed, giving it a textured appearance.
1
K53904
August 9, 1995
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. The assigned 510(k) number is _ 1 : ' :