(333 days)
Not Found
No
The device description focuses on mechanical components and fluid handling, with no mention of AI/ML terms or functionalities. The performance studies also focus on traditional medical device testing like biocompatibility and hemocompatibility.
Yes
The device is used to collect and infuse blood lost by a patient due to orthopedic surgery, which directly impacts the patient's physiological state and recovery.
No
The device description indicates its purpose is to collect and infuse blood lost during orthopedic surgery, not to diagnose medical conditions or analyze biological samples for diagnostic purposes.
No
The device description details numerous physical components made of materials like stainless steel, PVC, and PETG, including a trocar, drain, collection line, collection chamber, blood bag, vacuum tube assembly, and vent cap assembly. This clearly indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "collect and infuse blood lost by a patient due to orthopaedic surgery." This describes a system for managing blood within the patient's body (autotransfusion), not for analyzing samples in vitro (outside the body) to diagnose a condition.
- Device Description: The description details components for collecting, filtering, and storing blood for reinfusion. It does not mention any reagents, assays, or analytical components typically found in IVD devices.
- Lack of IVD-related information: The document does not include information about diagnostic parameters, analytical performance, or clinical validation for diagnostic purposes, which are standard for IVD submissions.
- Predicate Devices: The listed predicate devices are all autotransfusion systems, which are not IVD devices.
Therefore, the Betatrans Orthopaedic Autotransfusion System is a medical device used for blood management during surgery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
To collect and infuse blood lost by a patient due to orthopaedic surgery ..
Product codes
Not Found
Device Description
The Betatrans™ 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 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).
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
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance 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 biocompatibile, equal to or better than the predicate device, and performs according to design specifications.
Key Metrics
Not Found
Predicate Device(s)
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
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
95/592
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 (617) 740-3100 | |
| Device Name | |
| Proprietary Name: | Betatrans TM 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 Betatrans™ 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
| 1
1
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 biocompatibile, equal to or better than the predicate device, and performs according to design specifications.
2
| 13 | |
|---|---|
| BetaTrans Biocompatibility Summary | |
| Test | |
| Special Immersion Test- Duxbury Valve | Results |
| No growth of challenge | |
| organism in connector | |
| Bacterial EndoToxin Testing | Less than 0.03 EU/ml or less |
| than 1.2 EU/Device found | |
| MEM Elution L929 Cytotoxicity Test | No reaction greater than |
| grade 2 | |
| U.S.P. Intracutaneous Test | Meets the requirement of the |
| test. No mean skin reactions | |
| greater than a difference of | |
| 1.0 from the blank. | |
| U.S.P. Systemic Injection Test | Meets the requirement of the |
| test. No significant difference | |
| from the test group to the | |
| control group. | |
| Ames Mutagenicity Test | The BetaTrans Unit was not |
| mutagenic against any of the | |
| tester strains either directly or | |
| following metabolic activation | |
| with S9(M+) | |
| Guinea Pig Maximization (Kligman) Test | Skin Reactions were not |
| observed in the guinea pigs | |
| treated with the BetaTrans | |
| Unit | |
| U.S.P. Subchronic Toxicity Test | The BetaTrans Unit did not |
| show any discernable toxicity | |
| in the systemic portion of the | |
| study after 33 days. | |
| Hemocompatibility (Performance Test) | All blood and blood cell |
| parameters pretest were | |
| equivalent post test and to the | |
| predicate device |
3
Betatrans Component Biocompatibility Summary
| Component | Material | Tes | 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 |
4
Performance Testing Physical
Test
Leak Test- 200mmHg Pressure
Leak Test- 100mmHg Vacuum
Particulates
Results
No Leaks were observed
No Leaks were observed
Meets AAMI AT6 Standard