SARNS 9000 UNIVERSAL ROLLER PUMP
Device Facts
| Record ID | K953904 |
|---|---|
| Device Name | SARNS 9000 UNIVERSAL ROLLER PUMP |
| Applicant | 3M Health Care, Ltd. |
| Product Code | DWB · Cardiovascular |
| Decision Date | Apr 19, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.4370 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
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.
Device Story
Microprocessor-controlled 2-roller peristaltic pump; provides extracorporeal blood circulation for cardiopulmonary bypass and arterial regional perfusion. Input: electrical power from Sarns 9000 Perfusion System; mechanical rotation of rollers. Operation: adjustable occlusion; flows up to 9.99 L/min; speeds up to 250 RPM. Output: controlled blood flow. Used in clinical settings (e.g., OR) by qualified perfusionists. Healthcare providers monitor pump speed/flow to manage patient circulation during bypass. Benefits: enables life-sustaining blood circulation during cardiac/vascular procedures.
Clinical Evidence
Bench testing only. No clinical data provided. Performance equivalence established through nonclinical testing and EMC evaluation.
Technological Characteristics
Microprocessor-controlled 2-roller peristaltic pump. Circuit boards utilize Surface Mount Technology (SMT) components. Powered by Sarns 9000 Perfusion System. Adjustable occlusion mechanism. Flow capacity up to 9.99 L/min; max speed 250 RPM.
Indications for Use
Indicated for patients requiring extracorporeal circulation of blood for arterial regional perfusion and cardiopulmonary bypass procedures. Intended for use by qualified, experienced perfusionists.
Regulatory Classification
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.
Predicate Devices
- Sarns 9000 Universal Roller Pump (K871131)
Reference Devices
- Stockert/Shiley Multiflow Roller Pump Module
- Cobe Labs, Inc. roller pumps
- Shiley, Inc. roller pumps
- Sorin Biomedical, Inc. roller pumps
Submission Summary (Full Text)
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# Section 2 - Summary & Certification
## 2.1 510(k) Summary
A 510(k) Summary of Safety and Effectiveness is on the next page.
K953904
APR 19 1996
3M Confidential
Page 5 of 541
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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 Fax
3M
K353904
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 K353904.
This 510(k) is for the Sarns 9000 Universal Roller Pump, a "Roller-type cardiopulmonary bypass blood pump" and "Cardiopulmonary bypass pump speed control". The new Sarns 9000 Universal Roller Pump is substantially equivalent to the existing Sarns 9000 Universal Roller Pump (K871131).
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.
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.
The Sarns 9000 Universal 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 9000 Universal 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
(313) 663-4145 Phone
(313) 663-5062 Fax
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3M Confidential
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## 2.2 Safety Literature Search
I 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
4.) Random pump stops
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, Sarns, 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.
9.) Medical Device Report M269021, M244886, M244883, M225527, M210562, 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.
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# Bibliography (continued)
21.) **Medical Device Report** M149951, M154495, M158908, M162835, 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
Page 8 of 541
