K Number

Device Name

SARNS 800 ROLLER PUMP

Manufacturer

3M HEALTH CARE, SARNS

Date Cleared

1996-04-19

(245 days)

Product Code

DWB

Regulation Number

870.4370

Intended Use

The Sarns 8000 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.

Device Description

The Sarns 8000 Roller Pump consists of a Universal Roller Pump, which is a microprocessor controlled 2-roller peristaltic pump with adjustable occlusion, and a power supply. 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 8000 Roller Pump can be used as a stand-alone device or it is compatible with the Sarns 8000 Modular Perfusion System.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K915183

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description mentions a "microprocessor controlled" pump, which indicates digital control, but there is no mention of AI, ML, or any learning or adaptive capabilities. The device description and performance studies focus on basic pump function and safety, not advanced algorithms.

Therapeutic

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 a patient's condition.

Diagnostic

No
Explanation: The device is described as a roller pump used for extracorporeal circulation of blood during medical procedures, such as cardiopulmonary bypass. Its function is to facilitate blood flow, not to diagnose a condition or disease.

SaMD (Software as a Medical Device)

The device description explicitly states it consists of a "Universal Roller Pump" and a "power supply," which are hardware components.

IVD (In Vitro Diagnostic)

Based on the provided information, the Sarns 8000 Roller Pump is not an In Vitro Diagnostic (IVD) 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." This involves circulating blood outside the body during medical procedures, not for testing or analyzing samples in vitro (in a lab setting).
Device Description: The description details a "microprocessor controlled 2-roller peristaltic pump." This is a mechanical device designed to move fluids, not to perform diagnostic tests on biological samples.
Lack of IVD Characteristics: The document does not mention any features related to analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory tests.

IVD devices are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Sarns 8000 Roller Pump's function is purely mechanical and related to supporting physiological processes during surgery.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

Not Found

Device Description

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 who is experienced in the operation of Sarns or similar equipment.

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

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Nonclinical tests were performed on the device to determine substantial equivalence. Electromagnetic Compatibility (EMC) tests were also performed to ensure equivalent or better results.

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.

K915183

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

Regulation Number and Section

§ 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).

Summary

Section 2 - Summary & Certification

2.1 510(k) Summary

ﮯ :: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :

and and the state of the comments of

A 510(k) Summary of Safety and Effectiveness is on the next page.

Image /page/0/Picture/3 description: The image shows a handwritten string of characters. The characters appear to be 'K953901'. The handwriting is in black ink and is on a white background. The characters are connected and have a cursive style.

APR 1 9 1996

3M Confidential

Page 5 of 668

3M Health Care Sarns™ and CDI™ Products

6200 Jackson Road PO Box 1247 Ann Arbor, MI 48106-1247 USA 800 521 2818 Tel 313 663 4145 Tel 313 663 7981 Frix

Image /page/1/Picture/2 description: The image shows the 3M logo. The logo is in black and consists of the number 3 followed by the letter M. The logo is simple and recognizable.

Kts 370/

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 K953 yt

This 510(k) is for the Sarns 8000 Roller Pump, a "Roller-type cardiopulmonary bypass blood pump" and "Cardiopulmonary bypass pump speed control". The new Sarns 8000 Roller Pump is substantially equivalent to the existing Sarns 8000 Roller Pump (K915183).

The Sarns 8000 Roller Pump has different technological characteristics from the predicate device. The design and the manufacturing process have been changed. The modified roller pump is manufactured using some Surface Mount Technology (SMT) components and processes to produce the circuit boards which contain the pump electronics. The electronic packaging of some of the components on these circuit boards is SMT instead of Through-Hole Technology (THT). Also, the software has undergone minor changes to remap the I/O addresses.

The Sarns 8000 Roller Pump has the same performance as the predicate device. Nonclinical tests were performed on the device to determine substantial equivalence. Electromagnetic Compatibility (EMC) tests were also performed to ensure equivalent or better results.

Cheryl Rosenberg
Cheryl Rosenberg

(313) 663-4145 Phone (313) 663-5062 Fax

Page 6 of 668

2.2 Safety Literature Search

()

ﻤﺴﺘﻌ

l certify that I have conducted a reasonable search of all information known or otherwise available to me about the types and causes of safety and/or effectiveness problems that have been reported for blood roller pumps. I further certify that I am aware of the types of problems to which blood roller pumps are susceptible and that the following list of safety and/or effectiveness problems about blood roller pumps is complete and accurate:

1.) Air Emboli
2.) Hemolysis
3.) Loss of speed control
Random pump stops 4.)

Below is a bibliography of the materials upon which the above summary is based:

1.) Customer Field Input Log, various dates, Sarns, 3M Health Care
2.) Intermittent Failure of a Stockert/Shiley Multiflow Roller Pump Module, The Journal of Extra-Corporeal Technology, Volume 25, Number 3, 1993
3.) Medical Device Report M566956, M186992, M186044, M138277, various dates, Sarns, 3M Health Care
4.) Medical Device Report M494536, filed 4/21/94, Sarns, 3M Health Care
5.) Medical Device Report M444060, M123912, M111730, M101274, various dates, Sams, 3M Health Care
6.) Medical Device Report M435457, M242746, M225052, M184140, M138914, M174191, various dates, Sarns, 3M Health Care
7.) Medical Device Report M377761, filed 2/26/93, Sarns, 3M Health Care
8.) Medical Device Report M125141, received 6/24/86, Cobe Labs, Inc.
Medical Device Report M269021, M244886, M244883, M225527, M210562, 9.) M210551, M210545, M129763, various dates, Shiley, Inc.
10.) Medical Device Report M266724, M245762, M243742, M221182, various dates, Shiley, Inc.
11.) Medical Device Report M253241, M250682, M225194, M221859, various dates, Shiley, Inc.
12.) Medical Device Report M235614, M233235, various dates, Shiley, Inc.
13.) Medical Device Report M220822, M212362, M212346, M210217, M166630, M164988, M137248, various dates, Shiley, Inc.
14.) Medical Device Report M210544, received 8/17/90, Shiley, Inc.
15.) Medical Device Report M218408, received 12/10/90, Shiley, Inc.
16.) Medical Device Report M218946, received 12/17/90, Shiley, Inc.
17.) Medical Device Report M162834, received 1/5/89, Shiley, Inc.
18.) Medical Device Report M162828, M162829, M162830, M162831, M162832, M162833, M162836, M162838, M162839, M162840, M162841, M164234, M164858, M164860, M164850, M164934, M169675, various dates, Shiley, Inc.
19.) Medical Device Report M151200, received 2/26/88, Shiley, Inc.
20.) Medical Device Report M113582, received 11/5/92, Shiley, Inc.

3M Confidential

. . . . . .

Bibliography (continued)

21.) Medical Device Report M149951, M154495, M158908, M162837, M166744, M169035, M181659, M183581, M183582, M201061, M203578, M204035, M204038, M204528, M206003, M206119, M206314, M206208, M209511, M214496, M218406, M218555, M218949, M218952, M218954, M220245, M220248, M220824, M221189, M221190, M222866, M225528, M225533, M232442, M231336, M231337, M231338, M235611, M235947, M238231, M248275, M243327, M244887, M245205, M245936, M245940, M247740, M247741, M249816, M249823, M252531, M262466, M268638, M269022, M269713, M272031, various dates, Shiley, Inc.
22.) Medical Device Report M364517, M311533, M310489, M308281, M306710, M306708, M306205, M283826, M282507, M273690, various dates, Sorin Biomedical, Inc.
23.) Medical Device Report M345060, M317126, various dates, Sorin Biomedical, Inc.
24.) Medical Device Report M344176, received 9/2/92, Sorin Biomedical, Inc.
25.) Medical Device Report M324153, received 9/30/92, Sorin Biomedical, Inc.
26.) Medical Device Report M321079, received 8/13/92, Sorin Biomedical, Inc.
27.) Medical Device Report M285491, received 4/29/92, Sorin Biomedical, Inc.
28.) Medical Device Report M283413, received 4/15/92, Sorin Biomedical, Inc.

Printed name of person required to submit 510(k):	Cheryl Rosenberg
Signature of person required to submit 510(k):	Cheryl Rosenberg
Title of person submitting 510(k):	Advanced Regulatory Affairs Coordinator
Name of Company:	3M Health Care
Date:	August 9, 1995

3M Confidential

randes

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