BETATRANS I AND II

K951592 · Duxbury Scientific, Inc. · CAC · Mar 4, 1996 · Anesthesiology

Device Facts

• Record ID: K951592
• Device Name: BETATRANS I AND II
• Applicant: Duxbury Scientific, Inc.
• Product Code: CAC · Anesthesiology
• Decision Date: Mar 4, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5830
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

To collect and infuse blood lost by a patient due to orthopaedic surgery.

Device Story

Beta/rans™ Orthopaedic Autotransfusion System collects and reinfuses shed blood during orthopaedic surgery. System components include stainless steel trocar, PVC wound drain, PVC blood collection line, 800ml PETG blood collection chamber with 260 micron gross clot pre-filter, and sterile 800ml blood bags. Patented 'Duxbury Connector' with integral valves allows sterile connection/disconnection between chamber and bags. Vacuum tube assembly with 0.45 micron bacterial air filter and one-way valves manages chamber venting during blood collection and transfer. Device operates via vacuum/pressure to facilitate blood recovery. Healthcare providers use the system to recover patient blood for autologous transfusion, potentially reducing need for allogeneic blood products.

Clinical Evidence

Bench testing only. Studies included biocompatibility (USP Class VI, cytotoxicity, systemic toxicity, Ames mutagenicity, sensitization), hemocompatibility (comparison of blood parameters pre- and post-collection vs. predicate), and physical performance (pressure/vacuum leak tests, particulate testing per AAMI AT6). Results demonstrated no significant toxicity, no mutagenicity, and blood parameter equivalence to predicates.

Technological Characteristics

Materials: Stainless steel, PVC, PETG (Eastman 6763), Plastisol, K-Resin, Polyester, Nylon, ABS, Polycarbonate, Elastomeric/Acrylic. Sensing/Actuation: Mechanical vacuum/pressure-driven fluid collection. Connectivity: None. Sterilization: Gamma irradiation per AAMI 'Guide to Industrial Sterilization' (1991). Form factor: 800ml collection chamber with integrated 260 micron filter and proprietary valved connector system.

Indications for Use

Indicated for patients undergoing orthopaedic surgery requiring collection and reinfusion of shed blood.

Regulatory Classification

Identification

An autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma.

Predicate Devices

• Stryker® ConstaVac™ Blood Conservation System
• Solcotrans® Plus (Davol®, a division of C.R. Bard, Inc.)
• Gish Medical Blood Recovery/Autotransfusion system
• Gish Medical Orthofusor
• Boeringer Laboratories AutoVac

Submission Summary (Full Text)

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k951592

510(k) Summary of Safety and Effectiveness

## General Information

Manufacturer:
Duxbury Scientific, Inc.
183 Whiting Street
Hingham, MA 02043

Contact Person:
Robert M. Engler
Telephone number [phone]

## Device Name

Proprietary Name:
Beta/rans™ Orthopaedic Autotransfusion System

Classification Name:
Autotransfusion Apparatus

## Predicate Devices

Stryker® ConstaVac™ Blood Conservation System
Solcotrans® Plus (Davol®, a division of C.R. Bard, Inc.)
Gish Medical Blood Recovery/Autotransfusion system
Gish Medical Orthofusor
Boeringer Laboratories AutoVac

## Product Description

The Beta/rans™ Orthopaedic Autotransfusion System consists of a stainless steel trocar and PVC wound drain available in 1/8", 3/16 and 1/4" ID sizes the line is connected to a PVC blood collection line with a universal Y connector and pinch clamp which connects to a 800ml PETG blood collection chamber with integral 260 micron gross clot pre-filter and either one or two female halves of a patented "Duxbury Connector" bonded to the bottom of the chamber. one or two preconnected sterile 800ml blood bag.

A bag contains at it's top a male "Duxbury Connector" and a transfusion port. A safety cap covers the transfusion port and is available for use as a cover for the male connector once separated from the collection chamber. The bags male and female connector are shipped in a locked position. In this position a valve is

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located in each half of the connector remains closed, preventing fluid or air to pass in either direction.

A vacuum tube assembly consisting of a 0.45 micron bacterial air filter, one way outflow valve, pinch clamp, and a five in one suction connector for venting of the chamber, as air is displaced by incoming blood. A vent cap assembly with a tethered screw on cap, one way inflow valve and a 0.45 micron filter to allow venting of the chamber during transfer of blood to the blood bag(s).

## Substantial Equivalence

The Betatrons™ Orthopaedic Autotransfusion System is substantially equivalent to the Stryker® ConstaVac™ Blood Collection System, Davol®'s Solcotrans® Plus, Gish Medical Orthofusor and Boehringer Laboratories AutoVac in that they are designed with the same design principles, made of the same or similar materials, and have the same indication and contraindications for use.

## Indications for Use

To collect and infuse blood lost by a patient due to orthopaedic surgery.

## Summary of Studies

Performance testing results confirm the subject device conformance to the ANSI/AAMI Standard AT6-199 and FDA modified ISO 10993-1:1992(E) biocompatibility matrix. The product labeling conforms to 15th Edition AABB Standard. Sterilization was performed using AAMI's "Guide to Industrial Sterilization", 1991:Method 3. and gamma irradiation. Studies using aged, sterile units included pressure and vacuum challenges, biocompatibility testing, helium leak test, microbial challenge to the product and connector, and function hemocompatibility testing. Hemocompatibility studies compared a series of blood and blood cell parameters using aged, pooled human blood versus values samples obtained prior to collection and predicate devices. The testing indicates the BetaTrans product meets applicable standards, is biocompatible, equal to or better than the predicate device, and performs according to design specifications.

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BetaTrans Biocompatibility Summary Test
Special Immersion Test- Duxbury Valve

Bacterial EndoToxin Testing

MEM Elution L929 Cytotoxicity Test

U.S.P. Intracutaneous Test

U.S.P. Systemic Injection Test

Ames Mutagenicity Test

Guinea Pig Maximization (Kligman) Test

U.S.P. Subchronic Toxicity Test

Hemocompatibility (Performance Test)

Results
No growth of challenge organism in connector

Less than 0.03 EU/ml or less than 1.2 EU/Device found

No reaction greater than grade 2

Meets the requirement of the test. No mean skin reactions greater than a difference of 1.0 from the blank.

Meets the requirement of the test. No significant difference from the test group to the control group.

The BetaTrans Unit was not mutagenic against any of the tester strains either directly or following metabolic activation with S9(M+)

Skin Reactions were not observed in the guinea pigs treated with the BetaTrans Unit

The BetaTrans Unit did not show any discernable toxicity in the systemic portion of the study after 33 days.

All blood and blood cell parameters pretest were equivalent post test and to the predicate device

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# Betatrans Component Biocompatibility Summary

| Component | Material | Test | Results |
| --- | --- | --- | --- |
| Y-Connector | Plastisol | USP Class VI | Negative |
| Blood Line | Polyvinyl Chloride | USP Class VI | Negative |
| Blood Chamber | Eastman PETG 6763 | Performed as part of Unit | |
| Gross Blood Filter | K-Resin & Polyester | USP Class VI | Negative |
| Adjustable Strap | Nylon | N/A | No Patient or Blood Contact |
| Vernay Duckbill | Elastomeric & Acrylic | USP VI
L929 cytotoxicity
USP Physiochemical
Hemolysis | Negative
Negative
Negative
Negative |
| Duxbury Connector | ABS & Polycarbonate | USP Class VI | Negative |
| Blood Bags | PVC Film | USP Class VI | Negative |

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Performance Testing Physical

| Test | Results |
| --- | --- |
| Leak Test- 200mmHg Pressure | No Leaks were observed |
| Leak Test- 100mmHg Vacuum | No Leaks were observed |
| Particulates | Meets AAMI AT6 Standard |

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