(193 days)
No
The device description and performance studies focus on the mechanical function of diverting blood and the resulting reduction in contamination. There is no mention of AI, ML, image processing, or any data-driven decision-making within the device itself.
No.
The primary intended use of the device is for blood collection for in vitro diagnostic testing, specifically to reduce blood culture contamination. While it mentions components can be used for short-term infusion after sample collection, its main therapeutic action is not described as treating or curing a disease.
No
The device is a blood collection system designed to prevent contamination of blood samples for in vitro diagnostic testing, but it does not perform the diagnostic testing itself.
No
The device description explicitly states it is a "single use, sterile, mechanical device" made of "injection molded, medical grade plastics" and includes "Off-the-Shelf (OTS) components" for interfacing with the patient and collection. This clearly indicates a hardware-based medical device, not a software-only one.
Based on the provided text, the Steripath® Gen2 Blood Collection System is not an IVD (In Vitro Diagnostic) device itself.
Here's why:
- Intended Use: The intended use states it's a "system to draw blood for in vitro diagnostic testing." This indicates it's a tool used in preparation for IVD testing, not the test itself.
- Device Description: The description focuses on the mechanical function of diverting and sequestering blood. It doesn't describe any reagents, assays, or analytical processes that would be characteristic of an IVD.
- Function: The primary function is to improve the quality of the blood sample collected for subsequent testing by reducing contamination. It doesn't perform any diagnostic analysis on the blood.
- Performance Studies: The performance studies focus on the reduction of blood culture contamination, which is a measure of the device's effectiveness in sample collection, not its diagnostic accuracy.
While the device is used in conjunction with IVD testing (specifically blood cultures), it is a blood collection system, which is a separate category of medical device.
N/A
Intended Use / Indications for Use
The Steripath® Gen2 Blood Collection System is a system to draw blood for in vitro diagnostic testing.
The Steripath® Gen2 Blood Collection is indicated for use as a blood collection system that diverts and sequesters the initial specimen prior to collection of a subsequent test sample to requency of blood culture contamination when contaminants are present in the initial blood sample compared to blood cultures drawn with standard procedure without manual diversion.
Additionally, components of the system may be used for infusion following sample collection after disconnection of the Initial Specimen Diversion Device® (ISDD®). Venipuncture needles are indicated for short term infusion (less than 2 hours).
Product codes (comma separated list FDA assigned to the subject device)
JKA, FPA
Device Description
The Steripath® Gen2 Blood Collection System diverts and sequesters the initial portion of the blood specimen (potentially contaminated blood) in the diversion reservoir. When diversion is complete, a subsequent blood sample flows through a second pathway within the device. The subsequent blood sample is collected either directly into a culture bottle (not provided by Magnolia Medical Technologies), or into a syringe that is used to inoculate culture bottles. Upon removal of the ISDD®, components of the system can be used for infusion per the included manufacturer's instructions for use (note: infusion with butterfly needles is limited to less than 2hrs). The subject device incorporates multiple configurations that include various inlet and outlet accessories that are previously cleared as referenced below.
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
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)
The Steripath® Gen2 Blood Collection System has been found to conform to its System, Labeling, Controls, Interfaces, Accessory, Functional, Physical, Biological Safety and Packaging requirements. It has also been found to conform to FDA consensus, medical device safety and international harmonized standards. Conformity to key medical device safety requirements include:
Sterilization – The system is sterilized using validated Ethylene Oxide (EO) processes in conformance with ANSI/AAMI/ISO 11135:2014 "Sterilization of Health Care Products-Ethylene Oxide- Requirements for development, validation, and routine control of sterilization process for medical devices".
Aging/Shelf Life Test – The system is validated to achieve a real-time 1-year shelf-life. Prior to distribution, Accelerated Aging is performed in conformity with ASTM F1980-16 "Standards Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices"
Biological Safety (Biocompatibility Tests) – The system meets the requirements of ANSI/AAMI/ISO 10993-1:2009/(R)2013 "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process", for a short duration (
§ 862.1675 Blood specimen collection device.
(a)
Identification. A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.(b)
Classification. Class II.
0
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February 28, 2020
Magnolia Medical Technologies, Inc. John Ray Director of Operations 200 West Mercer Street Suite 500 Seattle, Washington 98119
Re: K192247
Trade/Device Name: Steripath Gen2 Blood Collection System Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: Class II Product Code: JKA, FPA Dated: January 28, 2020 Received: January 28, 2020
Dear John Ray:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Geeta Pamidimukkala Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices. and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K192247
Device Name Steripath® Gen2 Blood Collection System
Indications for Use (Describe) The Steripath® Gen2 Blood Collection System is a system to draw blood for in vitro diagnostic testing.
The Steripath® Gen2 Blood Collection is indicated for use as a blood collection system that diverts and sequesters the initial specimen prior to collection of a subsequent test sample to requency of blood culture contamination when contaminants are present in the initial blood sample compared to blood cultures drawn with standard procedure without manual diversion.
Additionally, components of the system may be used for infusion following sample collection after disconnection of the Initial Specimen Diversion Device® (ISDD®). Venipuncture needles are indicated for short term infusion (less than 2 hours).
| Type of Use (Select one or both, as applicable) | |
|---|---|
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(K) Summary
In accordance with 21 CFR 807.92(c) the following summary information is provided:
| 510(k) Number | K192247 |
|---|---|
| Date Prepared: | February 28, 2020 |
| Submitter: | Magnolia Medical Technologies, Inc. |
| 200 West Mercer Street | |
| Suite 500 | |
| Seattle WA 98119 | |
| Registration number: 3009976527 | |
| Contact Person: | John Ray |
| Director of Operations | |
| Phone: 425-985-8061 | |
| john.ray@magnolia-medical.com | |
| Trade Name: | Steripath® Gen2 Blood Collection System |
| Common Name: | Blood Collection System |
| Classification Name: | Blood specimen collection device |
| Regulation Number: | 862.1675 |
| Regulatory Class: | Class II |
| Product Code: | JKA and FPA |
| Predicate Device: | BD Vacutainer® Push Button Blood Collection Set (K030573) |
| Device Description: | The Steripath® Gen2 Blood Collection System diverts and sequesters the |
| initial portion of the blood specimen (potentially contaminated blood) in the | |
| diversion reservoir. When diversion is complete, a subsequent blood sample | |
| flows through a second pathway within the device. The subsequent blood | |
| sample is collected either directly into a culture bottle (not provided by | |
| Magnolia Medical Technologies), or into a syringe that is used to inoculate | |
| culture bottles. Upon removal of the ISDD®, components of the system can | |
| be used for infusion per the included manufacturer's instructions for use | |
| (note: infusion with butterfly needles is limited to less than 2hrs). | |
| The subject device incorporates multiple configurations that include various | |
| inlet and outlet accessories that are previously cleared as referenced below. |
4
The following configurations of the Steripath® Gen2 Blood Collection System are available:
| Steripath®
Kit Model
| Number | ISDD® | Inlet Accessory | Outlet Accessory |
|---|---|---|---|
| 2700-EN | P00133 | Luer Extension, 9" | |
| ICU Medical, Inc. | |||
| Model B1798-NS | |||
| K964435 | Transfer Adapter | ||
| Smith's Medical | |||
| Model 96004 | |||
| K081229 | |||
| 2700-21-EN | P00133 | Blood Collection Set, 21G | |
| Becton Dickinson | |||
| Model 367326 | |||
| K030573 | Transfer Adapter | ||
| Smith's Medical | |||
| Model 96004 | |||
| K081229 | |||
| 2700-23-EN | P00133 | Blood Collection Set, 23G | |
| Becton Dickinson | |||
| Model 367324 | |||
| K030573 | Transfer Adapter | ||
| Smith's Medical | |||
| Model 96004 | |||
| K081229 | |||
| 27BD-EN | P00133 | Luer Extension, 9" | |
| ICU Medical, Inc. | |||
| Model B1798-NS | |||
| K964435 | Becton Dickinson | ||
| Model 364902 | |||
| K991088 | |||
| 27BD-21-EN | P00133 | Blood Collection Set, 21G | |
| Becton Dickinson | |||
| Model 367326 | |||
| K030573 | Becton Dickinson | ||
| Model 364902 | |||
| K991088 | |||
| 27BD-23-EN | P00133 | Blood Collection Set, 23G | |
| Becton Dickinson | |||
| Model 367324 | |||
| K030573 | Becton Dickinson | ||
| Model 364902 | |||
| K991088 | |||
| 27TS-EN | P00133 | Luer Extension, 9" | |
| ICU Medical, Inc. | |||
| Model B1798-NS | |||
| K964435 | Transfer Adapter | ||
| Smith's Medical | |||
| Model 96000S | |||
| K081229 | |||
| 27TS-21-EN | P00133 | Blood Collection Set, 21G | |
| Becton Dickinson | |||
| Model 367326 | |||
| K030573 | Transfer Adapter | ||
| Smith's Medical | |||
| Model 96000S | |||
| K081229 | |||
| 27TS-23-EN | P00133 | Blood Collection Set, 23G | |
| Becton Dickinson | |||
| Model 367324 | |||
| K030573 | Transfer Adapter | ||
| Smith's Medical | |||
| Model 96000S | |||
| K081229 | |||
| 2710-EN | P00133 | Luer Extension, 9" | |
| ICU Medical, Inc. | |||
| Model B1798-NS | |||
| K964435 | Syringe, 10ml | ||
| Becton Dickinson | |||
| Model 301029 | |||
| K980987 | |||
| Steripath® | |||
| Kit Model | |||
| Number | ISDD® | Inlet Accessory | Outlet Accessory |
| 2720-EN | P00133 | Luer Extension, 9" | |
| ICU Medical | |||
| Model B1798-NS | |||
| K964435 | Syringe, 20ml | ||
| Becton Dickinson | |||
| Model 301031 | |||
| K980987 | |||
| 2710-21-EN | P00133 | Blood Collection Set, 21G | |
| Becton Dickinson | |||
| Model 367326 | |||
| K030573 | Syringe, 10ml | ||
| Becton Dickinson | |||
| Model 301029 | |||
| K980987 | |||
| 2720-21-EN | P00133 | Blood Collection Set, 21G | |
| Becton Dickinson | |||
| Model 367326 | |||
| K030573 | Syringe, 20ml | ||
| Becton Dickinson | |||
| Model 301031 | |||
| K980987 | |||
| 2710-23-EN | P00133 | Blood Collection Set, 23G | |
| Becton Dickinson | |||
| Model 367324 | |||
| K030573 | Syringe, 10ml | ||
| Becton Dickinson | |||
| Model 301029 | |||
| K980987 | |||
| 2720-23-EN | P00133 | Blood Collection Set, 23G | |
| Becton Dickinson | |||
| Model 367324 | |||
| K030573 | Syringe, 20ml | ||
| Becton Dickinson | |||
| Model 301031 | |||
| K980987 |
5
Table 5-1 Steripath Configurations
6
| Intended Use /
| Indications for Use | Intended Use/Indications for Use: |
|---|---|
| The Steripath® Gen2 Blood Collection System is a system to draw blood for | |
| in vitro diagnostic testing. |
The Steripath® Gen2 Blood Collection System is indicated for use as a blood |
s a blood collection system that diverts and sequesters the initial specimen prior to collection of a subsequent test sample to reduce the frequency of blood culture contamination when contaminants are present in the initial blood sample compared to blood cultures drawn with standard procedure without manual diversion.
Additionally, components of the system may be used for infusion following sample collection after disconnection of the Initial Specimen Diversion Device® (ISDD®). Venipuncture needles are indicated for short term infusion (less than 2 hours).
Differences in Intended Use/Indications for Use
The predicate device is the same component used in the configurations of the Steripath® Gen2 Blood Collection System. Both the subject device and predicate are intended to draw blood for in vitro diagnostic testing.
Both the Steripath® Gen2 Blood Collection System and the predicate device facilitate the collection of blood samples for a variety of in vitro diagnostic tests including collection of blood culture samples. Diversion and sequestration of 1.5mL to 2.0mL of the initial sample does not alter this intended use or the indications for use as compared to the predicate.
Diversion and sequestration of 1.5mL to 2.0mL of the initial sample does not raise new questions of safety or effectiveness in the indication of blood collection.
7
The Steripath® Gen2 Blood Collection System is a single use, sterile, Technology: mechanical device that diverts and sequesters the initial 1.5mL to 2.0mL of blood from the patient. The system consists of an Initial Specimen Diversion Device® (ISDD®) made of injection molded, medical grade plastics. Off-the-Shelf (OTS) components provide the interface to the patient vasculature, and to the culture bottle or syringe for subsequent sample collection. Upon removal of the ISDD®, components of the system can be used for infusion per the included manufacturer's instructions for use (note: infusion with butterfly needles is limited to less than 2hrs).
The predicate device is also a single use, sterile, mechanical device for collecting blood specimens and is indicated for infusion. The Steripath® Gen2 Blood Collection System includes specimen diversion technology, while the predicate device does not. Inclusion of this technology does not raise new questions of safety or effectiveness.
Differences between the Steripath Gen2 Blood Collection System and the Predicate Device are noted in Table 5-2 below.
| Item | Steripath® Gen2 Blood Collection System | Predicate Device, BD Vacutainer® Push Button Blood Collection Set (K030573) | Difference between Steripath® Gen2 Blood Collection System and Predicate Device |
|---|---|---|---|
| FR Number(s) | 862.1675 | 862.1675 | Same |
| Product Code | JKA and FPA | JKA and FPA | Same |
| Classification Name | Tubes, Vials, Systems, Serum Separators, Blood Collection | Tubes, Vials, Systems, Serum Separators, Blood Collection | Same |
| Common Name | Blood collection set | Blood collection set | Same |
| Regulatory Class | Class II | Class II | Same |
| Classification Panel | Clinical Chemistry and Clinical Toxicology Panel, Division of Chemistry and Toxicology Devices, Office of In Vitro Diagnostics and Radiological Health | Clinical Chemistry and Clinical Toxicology Panel, Division of Chemistry and Toxicology Devices, Office of In Vitro Diagnostics and Radiological Health | Same |
| Intended Use | The Steripath® Gen2 Blood Collection System is a system to draw blood for in vitro diagnostic testing. | The BD Vacutainer® Push Button Blood Collection Set is intended for blood collection. | The predicate device is the same component used in the configurations of the Steripath® Gen2 Blood Collection System. |
| Item | Steripath® Gen2 Blood | ||
| Collection System | Predicate Device, BD | ||
| Vacutainer® Push Button | |||
| Blood Collection Set | |||
| (K030573) | Difference between | ||
| Steripath® Gen2 | |||
| Blood Collection | |||
| System and | |||
| Predicate Device | |||
| Configurations. | |||
| Both are intended | |||
| to draw blood for in | |||
| vitro diagnostic | |||
| testing. | |||
| Indications for Use | The Steripath® Gen2 | ||
| Blood Collection System is | |||
| indicated for use as a | |||
| blood collection system | |||
| that diverts and | |||
| sequesters the initial | |||
| specimen prior to | |||
| collection of a subsequent | |||
| test sample to reduce the | |||
| frequency of blood culture | |||
| contamination when | |||
| contaminants are present | |||
| in the initial blood sample | |||
| compared to blood | |||
| cultures drawn with | |||
| standard procedure | |||
| without manual diversion. | |||
| Additionally, components | |||
| of the system may be | |||
| used for infusion following | |||
| sample collection after | |||
| disconnection of the Initial | |||
| Specimen Diversion | |||
| Device®. Venipuncture | |||
| needles are indicated for | |||
| short term infusion (less | |||
| than 2 hours). | The BD Vacutainer® Push | ||
| Button Blood Collection Set | |||
| is a sterile, multiple sample, | |||
| single use winged blood | |||
| collection set intended for | |||
| venipuncture to obtain | |||
| blood specimens from | |||
| patients. | |||
| The BD Vacutainer® Push | |||
| Button Blood Collection Set | |||
| is also indicated for the | |||
| intravenous administration | |||
| of fluids as indicated in 21 | |||
| CFR 820.5440. It may be | |||
| used for any patient | |||
| population with | |||
| consideration given to | |||
| patient size and | |||
| appropriateness for the | |||
| solution being infused and | |||
| duration of therapy. | |||
| The recommended use of | |||
| the device is to activate the | |||
| needle prior to removal | |||
| from the venipuncture site. | |||
| The retraction of the | |||
| intravenous (IV) end of the | |||
| needle aids in the | |||
| prevention of accidental | |||
| needlestick injury. | The predicate | ||
| device is the same | |||
| component used in | |||
| the configurations | |||
| of the Steripath® | |||
| Gen2 Blood | |||
| Collection System. | |||
| Configurations. | |||
| Both are intended | |||
| to draw blood for in | |||
| vitro diagnostic | |||
| testing. |
The fact that the
predicate device
indications for use
do not include
diversion
technology does
not raise new
questions of safety
or effectiveness
given that:
Both the SteripathⓇ
Gen2 Blood
Collection System
and the predicate
device facilitate the
collection of blood
samples for a
variety of in vitro
diagnostic tests
including collection
of blood culture |
| Item | Steripath® Gen2 Blood
Collection System | Predicate Device, BD
Vacutainer® Push Button
Blood Collection Set
(K030573) | Difference between
Steripath® Gen2
Blood Collection
System and
Predicate Device |
| | | | samples. Diversion
and sequestration
of 1.5mL to 2.0mL
of the initial sample
does not alter this
intended use or
indications for use
as compared to the
predicate. |
| | | | Diversion and
sequestration of
1.5mL to 2.0mL of
the initial sample
does not raise new
questions of safety
or effectiveness in
the indication of
blood collection. |
| Contraindications | None | None | Same |
| Prescription Status | Prescription Use Only | Prescription Use Only | Same |
| Initial Specimen
Diversion Device
(ISDD®) | P00133 Base Assembly,
Gen2 | None | The Steripath®
Gen2 Blood
Collection System
includes the Initial
Specimen Diversion
Device® to divert
and sequester the
initial blood sample
to reduce frequency
of blood culture
contamination.
The predicate
device does not
include diversion
technology |
| Packaging | Chevron Pouch, 12" x 6" | PETG Co-polyester tray with | The Steripath® |
| Item | Steripath® Gen2 Blood Collection System | Predicate Device, BD Vacutainer® Push Button Blood Collection Set (K030573) | Difference between Steripath® Gen2 Blood Collection System and Predicate Device |
| | | | Collection System uses a medical grade pouch for the sterile packaging instead of a tray system.
Having passed testing per FDA recognized consensus standards for packaging, these differences raise no new questions of safety or effectiveness. |
| Sterilization Method | Ethylene Oxide
Steris, Temecula CA | Gamma Radiation
Site unknown | The Steripath® Gen2 Blood Collection System uses a different method of sterilization than the predicate device.
Because the Sterility Assurance Level (SAL) is unchanged (10-6), and the process is validated per FDA recognized consensus standards, the sterilization method change raises no new questions of safety or effectiveness. |
| Item | Steripath® Gen2 Blood
Collection System | Predicate Device, BD
Vacutainer® Push Button
Blood Collection Set
(K030573) | Difference between
Steripath® Gen2
Blood Collection
System and
Predicate Device |
| Non-pyrogenic | Yes | Yes | Same |
| Shelf Life | 1 year | 2 years | The Steripath®
Gen2 Blood
Collection System
has a shorter shelf-
life than the
predicate device.
Because the
Steripath® Gen2
Blood Collection
System meets its
requirements
following real-time
aging test, this
difference raises no
new questions of
safety or
effectiveness. |
| Materials | Medical grade materials
(stainless steel, pvc
tubing, medical grade
adhesives polycarbonate) | Medical grade materials
(stainless steel needles, pvc
tubing, medical grade
adhesives) | The Steripath®
Gen2 Blood
Collection System
has the additional
medical grade
materials,
(thermoplastics,
and elastomers)
contained in the
Initial Specimen
Diversion Device®
(ISDD®).
Having completed
appropriate
biocompatibility
testing per FDA
recognized
consensus
standards, the
addition of the
ISDD® materials |
| Item | Steripath® Gen2 Blood
Collection System | Predicate Device, BD
Vacutainer® Push Button
Blood Collection Set
(K030573) | Difference between
Steripath® Gen2
Blood Collection
System and
Predicate Device |
| | | | raises no new
questions of safety
or effectiveness. |
| Biocompatibility
Testing | ISO 10993-1
ISO 10993-4
ISO 10993-5
ISO 10993-10
ISO 10993-11 | ISO 10993-1 | The Steripath®
Gen2 Blood
Collection System
was tested in
accordance with
FDA recognized
consensus
biocompatibility
standards for short
duration, blood
contacting devices.
Having completed
appropriate
biocompatibility
testing per FDA
recognized
consensus
standards, the
addition of the
ISDD® materials
raises no new
questions of safety
or effectiveness. |
| Transport
Environment | ASTM D4169-09
distribution cycle 13,
assurance level II | Unknown | The Steripath®
Gen2 Blood
Collection System
was tested for
transport
environment as
noted.
Having passed
testing per FDA
recognized
consensus
standards for
transportation |
| Item | Steripath® Gen2 Blood
Collection System | Predicate Device, BD
Vacutainer® Push Button
Blood Collection Set
(K030573) | Difference between
Steripath® Gen2
Blood Collection
System and
Predicate Device |
| | | | environment, the
test differences
raise no new
questions of safety
or effectiveness. |
8
9
10
11
12
13
Table 5-2 Predicate Device Comparison Table
14
PASS
| Summary of
Performance Testing: | The Steripath® Gen2 Blood Collection System has been found to conform to
its System, Labeling, Controls, Interfaces, Accessory, Functional, Physical,
Biological Safety and Packaging requirements. It has also been found to
conform to FDA consensus, medical device safety and international
harmonized standards. Conformity to key medical device safety
requirements include:
Sterilization – The system is sterilized using validated Ethylene Oxide (EO)
processes in conformance with ANSI/AAMI/ISO 11135:2014 "Sterilization of
Health Care Products-Ethylene Oxide- Requirements for development,
validation, and routine control of sterilization process for medical devices".
Aging/Shelf Life Test – The system is validated to achieve a real-time 1-year
shelf-life. Prior to distribution, Accelerated Aging is performed in conformity
with ASTM F1980-16 "Standards Guide for Accelerated Aging of Sterile
Barrier Systems for Medical Devices"
Biological Safety (Biocompatibility Tests) – The system meets the
requirements of ANSI/AAMI/ISO 10993-1:2009/(R)2013 "Biological
evaluation of medical devices – Part 1: Evaluation and testing within a risk
management process", for a short duration (1 Rupp ME, et al., Reduction in Blood Culture Contamination Through Use of Initial Specimen Diversion Device®, Clinical Infection Diseases, July 2017.
2 Bell M, et al., Effectiveness Of A Novel Specimen Collection System In Reducing Blood Culture Contamination Rates, J Emergency Nursing, November 2018.