(210 days)
No
The device description and performance studies focus on mechanical and physical properties related to blood collection and diversion, with no mention of AI or ML.
No
The device is described as a "blood collection system" intended for collecting blood for "in vitro diagnostic testing" and to "reduce the frequency of blood culture contamination." It is also mentioned that components may be used for infusion "after disconnection of the Initial Specimen Diversion Device®." While it involves blood collection and potentially infusion, its primary stated purpose is for diagnostic sample collection and contamination reduction, not for treating a disease or health condition.
No.
The device is a blood collection system intended to reduce contamination for in vitro diagnostic testing, not a diagnostic device itself.
No
The device description clearly outlines physical components (ISDD, syringes, luer extension) and the performance testing focuses on physical and functional aspects of these hardware components (sequestration, vacuum performance, volume, pressure, sterilization, aging, biocompatibility, packaging). There is no mention of software as a component or its function.
Based on the provided text, the Steripath® Micro 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 mechanism of diverting and collecting blood samples. It describes the physical components and how they function to obtain a sample.
- Performance Studies: The performance studies listed focus on the device's ability to sequester blood, maintain vacuum, handle pressure, and meet sterilization, aging, and biocompatibility standards. These are characteristics of a medical device used for sample collection, not the analytical performance of an IVD test.
- Lack of IVD Specific Information: There is no mention of analyzing the blood sample, detecting specific analytes, or providing diagnostic information. The key metrics and performance studies are related to the sample collection process, not the diagnostic outcome.
The device is a blood collection system designed to improve the quality of samples used for IVD testing by reducing contamination. It's a pre-analytical device that supports IVD procedures.
N/A
Intended Use / Indications for Use
The Steripath® Micro Blood Collection System is a system to draw blood for in vitro diagnostic testing.
The Steripath® Micro 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® (ISDD®).
Product codes (comma separated list FDA assigned to the subject device)
JKA, FPA
Device Description
The Steripath® Micro 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 into a syringe that is used to inoculate culture bottles. Upon removal of the Initial Specimen Diversion Device®, ISDD®, components of the system can be used for infusion per the included manufacturer's instructions for use.
The subject device incorporates multiple syringe oulet accessory configurations that include and three sizes of syringes that are previously cleared as referenced below. The Steripath® Micro Blood Collection System are available:
| Steripath® Micro Kit Model Number | ISDD® | Inlet Accessory | Outlet Accessory |
|---|---|---|---|
| 4005-EN | P00353 | Luer Extension, 7" ICU Medical, Inc. Model B1754-NS K964435 | Syringe, 5ml Becton Dickinson Model 301027 K980987 |
| 4010-EN | P00353 | Luer Extension, 7" ICU Medical, Inc. Model B1754-NS K964435 | Syringe, 10ml Becton Dickinson Model 301029 K980987 |
| 4020-EN | P00353 | Luer Extension, 7" ICU Medical, Inc. Model B1754-NS K964435 | Syringe, 20ml Becton Dickinson Model 301031 K980987 |
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® Micro Blood Collection System has been found to its System, Labeling, Controls, Interfaces, Accessory, Functional, Physical, Biological Safety and Packaging required by the risk analysis, all design verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met. It has also been found to FDA consensus, medical device safety and international harmonized standards. Conformity to key medical device safety requirements include:
Sterilization – The system is sterilized using validation processes in conformance with ISO 11137-1 "Sterilization of health care products – Radiation Part 1: Requirement, validation, and routine control of a sterilization process for medical devices".
Aging/Shelf Life Test – The system is validated to achieve an accelerated 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 ISO 10993-1:2018 "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process", for a short duration (
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
0
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October 8, 2020
Magnolia Medical Technologies Inc. Gregory J. Bullington CEO 200 West Mercer Street, Suite 500 Seattle, Washington 98119
Re: K200661
Trade/Device Name: Steripath® Micro Blood Collection System Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: Class II Product Code: JKA. FPA Dated: September 10, 2020 Received: September 10, 2020
Dear Gregory J. Bullington:
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.
1
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 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 (OS) 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 medical devices and radiation-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 Payal Patel 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) K200661
Device Name Steripath® Micro Blood Collection System
Indications for Use (Describe) The Steripath® Micro Blood Collection System is a system to draw blood for in vitro diagnostic testing.
The Steripath® Micro 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® (ISDD®).
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
K200661 510(k) Summary
In accordance with 21 CFR 807.92(c) the following summary information is provided:
510(k) Number: K200661
Date Prepared: September 10, 2020
Submitter:
Magnolia Medical Technologies, Inc. 200 West Mercer Street Suite 500 Seattle WA 98119 Registration number: 3009976527
Contact Person:
Greg Bullington CEO Phone: (888) 617-3420 regulatory@magnolia-medical.com
Trade Name: Steripath® Micro Blood Collection System
Common Name: Blood collection set
Regulation Name: Blood Specimen Collection Device
Regulation Number: 862.1675
Regulatory Class: Class II
Product Code: JKA and FPA
Predicate Device: K192247-Steripath® Gen2 Blood Collection System K192247, Product codes JKA & FPA, Class II
Device Description:
The Steripath® Micro 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 into a syringe that is used to inoculate culture bottles. Upon removal of the Initial Specimen Diversion Device®, ISDD®, components of the system can be used for infusion per the included manufacturer's instructions for use.
The subject device incorporates multiple syringe oulet accessory configurations that include and three sizes of syringes that are previously cleared as referenced below. The Steripath® Micro Blood Collection System are available:
| Steripath®
Micro Kit
Model
| Number | ISDD® | Inlet Accessory | Outlet Accessory |
|---|---|---|---|
| 4005-EN | P00353 | Luer Extension, 7" | |
| ICU Medical, Inc. | |||
| Model B1754-NS | |||
| K964435 | Syringe, 5ml | ||
| Becton Dickinson | |||
| Model 301027 | |||
| K980987 | |||
| 4010-EN | P00353 | Luer Extension, 7" | |
| ICU Medical, Inc. | |||
| Model B1754-NS | |||
| K964435 | Syringe, 10ml | ||
| Becton Dickinson | |||
| Model 301029 | |||
| K980987 | |||
| 4020-EN | P00353 | Luer Extension, 7" | |
| ICU Medical, Inc. | |||
| Model B1754-NS | |||
| K964435 | Syringe, 20ml | ||
| Becton Dickinson | |||
| Model 301031 | |||
| K980987 |
Table 1: Steripath® Micro Configurations Available
Intended Use/Indications for Use:
The Steripath® Micro 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 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®).
4
Differences in Intended Use/Indications for Use
The Intended Use / Indications for use are the predicate device except that the Micro device removes the venipuncture needles and associated 2 hour limitation on infusion.
Technology:
The Steripath® Micro Blood Collection System is a single use, sterile, mechanical device that initial 0.6mL to 0.9mL of blood from the patient. The Steripath® Micro is designed for patients where maximum allowable total blood draw volume is limited or for patients with difficult venous access. The system consists of an Initial Specimen Diversion Device® (ISDD®) made of injection molded, medical grade plastics. Off-the-Shelf (OTS) components provide interface to the patient vasculature (via a peripheral IV start not provided by Magnolia) and sample collection is achieve by a syringe. Upon removal of the ISDD®, components of the system can be used for infusion per the included manufacturer's instructions for use.
Differences between the Steripath® Micro Blood Collection System and the Predicate Steripath® Gen2 Blood Collection System are noted in Table 2 below.
| ltem | Steripath® Micro
Blood Collection
System
K200661 | Predicate Device,
Steripath® Gen2
Blood Collection
System (K192247) | Difference between
Steripath® Micro
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 | Blood Specimen
Collection Device | Blood Specimen
Collection Device | Same |
| Common Name | Blood collection set | Blood collection set | Same |
| Regulatory Class | Class II | Class II | Same |
| Intended Use | The Steripath® Micro
Blood Collection
System is a system to
draw blood for in vitro
diagnostic testing. | The Steripath® Micro
Blood Collection
System is a system to
draw blood for in vitro
diagnostic testing. | Same |
| Indications for Use | The Steripath® Micro
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®. | 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). | Indications for use
changed slightly due
to removal of
venipuncture needles.
The changes raise no
new questions of
safety or
effectiveness. |
| Contraindications | None | None | Same |
| Prescription Status | Prescription Use Only | Prescription Use Only | Same |
| | | | |
| Item | Steripath® Micro
Blood Collection
System | Predicate Device,
Steripath® Gen2
Blood Collection
System (K192247) | Difference between
Steripath® Micro
Blood Collection
System and
Predicate Device |
| Patient Interface
(ISDD® Inlet
Accessories) | Luer Extension, 7"
ICU Medical, Inc.
Model B1754-NS
K964435 | Blood Collection Set,
21G
Becton Dickinson
Model 367326
(K030573)
Blood Collection Set,
23G
Becton Dickinson
Model 367324
(K030573)
Luer Extension, 9"
ICU Medical, Inc.
Model B1798-NS
(K964435) | Micro adds a 7" Luer
extension and
removes venipuncture
needle patient
interfaces. The
changes raise no new
questions of safety or
effectiveness. |
| Culture
Bottle/
Syringe
Interface
(ISDD® Outlet
Accessories) | Syringe, 10ml
Becton Dickinson
Model 301029
(K980987)
Syringe, 20ml
Becton Dickinson
Model 301031
(K980987)
Syringe, 5ml
Becton Dickinson
Model 301027
K980987 | Transfer Adapter,
BD Luer-Lok Access
Device
Model 364902
(K991088)
BD Bottle Interface
Transfer Adapter,
Saf-T Holder Blood
Culture Device with
Male Luer Adapter
Smiths Medical
Model 96004 &
Model 96000S
(K081229)
BioMerieux® and
ThermoFisher® Bottle
interfaces
Syringe, 10ml
Becton Dickinson
Model 301029
(K980987)
Syringe, 20ml
Becton Dickinson
Model 301031
(K980987) | Micro adds a 5mL
syringe and removes
Transfer Adapter
bottle interfaces. The
changes raise no new
questions of safety or
effectiveness. |
| Initial Specimen
Diversion Device®
(ISDD®) | P00353 Base
Assembly, Steripath®
Micro | P00133 Base
Assembly, Gen2 | Average Micro
diversion volume =
0.75mL. Average
Gen2 diversion
volume = 1.75mL.
Based on these
averages, a 1mL
reduction in diversion
volume raises no new
questions of safety or
effectiveness.
Literature supporting
Micro diversion
volume is referenced
in Patton et al.1 |
| Packaging | Chevron Pouch, 12" x
6"
TPT-0270 to TPF-
0524a | Chevron Pouch, 12" x
6"
TPT-0270 to TPF-
0524a | Same |
| Sterilization Method | Gamma Radiation
Steris, Ontario CA | Ethylene Oxide
Steris, Temecula CA | The Steripath® Micro
gamma radiation
sterilization process is
validated to FDA
recognized consensus
standards to the same
sterility assurance
level as the predicate
device (10-6).
Therefore this change
raises no new |
| ltem | Steripath® Micro
Blood Collection
System | Predicate Device,
Steripath® Gen2
Blood Collection
System (K192247) | Difference between
Steripath® Micro
Blood Collection
System and
Predicate Device |
| | | | questions of safety or
effectiveness. |
| SAL Level | 10-6 | 10-6 | Same |
| Non-pyrogenic | Yes | Yes | Same |
| Shelf Life | 1 year | 1 year | Same |
| Materials | Medical grade
materials (pvc tubing,
medical grade
adhesives,
polycarbonate,
silicone, TPE) | Medical grade
materials (stainless
steel, pvc tubing,
medical grade
adhesives,
polycarbonate) | The Steripath® Micro
Blood Collection
System has slightly
different medical
grade materials,
(thermoplastics, and
elastomers) than
Steripath® Gen2.
Having completed
appropriate
biocompatibility testing
per FDA recognized
consensus standards,
the changes in
materials of the
Steripath® Micro of
the raise 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
ISO 10993-4
ISO 10993-5
ISO 10993-10
ISO 10993-11 | The Steripath® Gen2
Blood Collection
System was tested in
accordance with FDA
recognized consensus
biocompatibility
standards for short
duration, blood
contacting devices. |
| Transport
Environment | ASTM D4169-09
distribution cycle 13,
assurance level II | ASTM D4169-09
distribution cycle 13,
assurance level II | Same |
5
6
Table 2: Substantial Equivalence Table
² Patton RG, Schmitt T. (2010) "Innovation for reducing blood culture contamination: initial specimen diversion technique". J. Clin. Microbio; 48:4501-3
Summary of Performance Testing:
The Steripath® Micro Blood Collection System has been found to its System, Labeling, Controls, Interfaces, Accessory, Functional, Physical, Biological Safety and Packaging required by the risk analysis, all design verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met. It has also been found to FDA consensus, medical device safety and international harmonized standards. Conformity to key medical device safety requirements include:
Sterilization – The system is sterilized using validation processes in conformance with ISO 11137-1 "Sterilization of health care products – Radiation Part 1: Requirement, validation, and routine control of a sterilization process for medical devices".
Aging/Shelf Life Test – The system is validated to achieve an accelerated 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 ISO 10993-1:2018 "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process", for a short duration (