(121 days)
No
The device description and performance studies focus on mechanical diversion and sequestration of blood, with no mention of AI or ML technologies.
No.
The device is described as a "blood collection system for in vitro diagnostic testing" and its primary function is to reduce blood culture contamination. While it has a secondary use for infusion, its main purpose is diagnostic blood collection, not therapeutic treatment or prevention of disease.
No
Explanation: The device is a blood collection system designed to reduce contamination during blood draws for in vitro diagnostic testing. It does not perform the diagnostic testing itself; rather, it prepares the sample for such testing by diverting initial potentially contaminated blood.
No
The device description clearly outlines a physical blood collection system with components like needles, diversion chambers, and pathways for blood flow. The performance studies also focus on physical characteristics and biological safety, not software validation.
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 text explicitly states the system is used "to draw blood for in vitro diagnostic testing." This indicates the system is a tool for collecting the sample that will then be used in an IVD test, but it doesn't perform the diagnostic test itself.
- Device Description: The description focuses on the mechanism of blood collection, diversion, and sequestration. It describes how the blood is handled before it reaches the culture bottle or syringe for testing.
- Lack of Diagnostic Function: There is no mention of the device analyzing the blood sample, providing a diagnosis, or interacting with reagents or instruments that perform a diagnostic test.
- Performance Studies: The performance studies listed focus on the physical and functional aspects of the blood collection system (sterilization, shelf-life, biocompatibility, packaging integrity, and functional performance), not on the accuracy or reliability of a diagnostic result.
- Predicate and Reference Devices: The predicate and reference devices are also blood collection sets and syringes, which are not typically classified as IVDs.
In summary, the Steripath® Micro Blood Collection System is a device used in the process of obtaining a sample for IVD testing, but it is not an IVD device itself.
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 cultures drawn with standard procedure without manual diversion.
Additionally, components of the system may be used for infusion following sample collection after discomection of the Initial Specimen Diversion Device® (ISDD®).
Product codes
JKA, FPA
Device Description
The device, Steripath® Micro Blood Collection System, is a system to draw blood for in vitro diagnostic testing. The purpose of this submission is to expand the product line to include inlet components with the BD Venipuncture® UltraTouch™ Push Button Needle, outlet components with a transfer adapter, and universal models with no inlet component.
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.
The device sequesters and diverts 0.5 - 1.0 mL of the initial specimen of blood (potentially contaminated) into a diversion chamber. Once diversion is complete, a subsequent blood sample flows through a second pathway within the device and 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. Additionally, components of the system may be used for infusion after disconnection of the Initial Specimen Diversion Device® (ISDD®).
The Steripath® Micro Blood Collection System, needle configurations, for the subject device are manufactured using non-sterile BD UltraTouch® needles, which are equivalent to the commercially available BD UltraTouch® Push Button™ Blood Collection Set (K212724), except for the sterilization step. The Steripath® Micro Blood Collection System and UltraTouch® needles have the same intended use. Incorporation of the needle with the ISDD® functions on the same technological characteristics and principles of operation with the difference that the subject device leverages the Initial Specimen Diversion Technology® (ISDT) and mechanically sequesters the initial specimen of blood. Inclusion of this technology does not raise any added questions of safety or effectiveness.
The different configurations of the Steripath® Micro Blood Collection System are made available by using different combinations of the inlet and outlet accessories. Proposed configurations are listed in Table 5.1.
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 conforms to its System, Labeling, Controls, Interfaces, Accessory, Functional, Physical, Biological Safety and Packaging requirements. As required by the risk analysis, all design verification and validation activities were performed, and the results demonstrated that the predetermined acceptance criteria were met.
- a) Sterilization -ISO 11137-1:2006/AMD 2018 "Sterilization of health care products -Radiation Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices."
- Bacteriostasis/Fungistasis (B/F Test)
- Bioburden
- . Sterility
The system complies with the gamma radiation process validated per the VDmax® 25kGy dose and an SAL of 10-6.
- b) Aging/Shelf-Life Test –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."
- Diversion volume
- Functional (needle insertion, blood collection, and needle retraction)
- Functional (hub attachment, blood collection, and removal)
- Functional (culture bottle septum puncture, blood collection, and removal)
- Pressure rating
- Protection from harm ●
The system is validated to a twelve (12) months shelf-life.
- Biocompatibility testing –ISO 10993-1:2018 "Biological evaluation of medical devices c) Part 1: Evaluation and testing within a risk management process. The battery of testing included the following tests:
- Cytotoxicity
- Sensitization
- Irritation (intracutaneous reactivity)
- Acute System Toxicity
- Pyrogenicity (LAL)
- Subacute Toxicity
- Hemolysis.
The system meets the requirements for a limited contact duration (24 h to 30 d) depending on the device part/component, blood path indirect, contacting device.
- d) Packaging Integrity Testing / Shipping Tests -ASTM D4169-16, "Standard Practice for Performance Testing of Shipping Containers and Systems", Distribution Cycle 13, Assurance Level II.
- Seal Strength ●
- Package leaks ●
- Drop tests
The system meets the requirements of the standard.
Performance Testing - The Steripath® Micro Blood Collection System successfully meets all functional and performance requirements for safe and effective performance, as noted below. Results of this testing demonstrate that the Steripath® Micro Blood Collection System and its components meet all requirements for its intended use. The performance testing is summarized in Table 5.3.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Steripath Micro Blood Collection System (K200661)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
November 30, 2022
Magnolia Medical Technologies Donna Matuizek Senior Director, Ouality and Regulatory 200 West Mercer Street, Suite 500 Seattle, Washington 98119
Re: K222299
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: October 28, 2022 Received: October 31, 2022
Dear Donna Matuizek:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 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,
Danil Walloschek, Jr.
David Wolloscheck, Ph.D. For Joyce M. Whang, Ph.D. Acting 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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K22299
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 cultures drawn with standard procedure without manual diversion.
Additionally, components of the system may be used for infusion following sample collection after discomection of the Initial Specimen Diversion Device® (ISDD®).
| 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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Steripath Micro Blood Collection System 510(k) Premarket Notification 510(k) Summary
K22299 510(k) Summary
| Date Prepared: | November 16, 2022 |
|---|---|
| Submitter: | Magnolia Medical Technologies, Inc. |
| 200 West Mercer Street | |
| Suite 500 | |
| Seattle WA 98119 | |
| Phone: 888-617-3420 | |
| Registration number: 3009976527 | |
| Contact Person: | Donna Matuizek |
| Sr. Director of Quality and Regulatory | |
| Magnolia Medical Technologies Inc. | |
| Phone: 1 206-558-4760 | |
| Fax: 206-673-2895 | |
| donna.matuizek@magnolia-medical.com | |
| Trade Name: | Steripath® Micro Blood Collection System |
| Common Name: | Blood Collection Tubes, Vials, Systems, Serum Separators |
| Regulation Name: | Blood Specimen Collection Device |
| Regulation | |
| Number: | 21 CFR 862.1675 |
| Regulatory Class: | Class II |
| Product Code: | JKA and FPA |
| Primary Predicate: | Steripath Micro Blood Collection System (K200661) |
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Image /page/4/Picture/0 description: The image shows the logo for Magnolia Medical Technologies. The word "MAGNOLIA" is in large, bold, blue letters, with a check mark incorporated into the "M". Below that, "MEDICAL TECHNOLOGIES" is written in smaller, gray letters. The logo is simple and professional, conveying a sense of trust and reliability.
5.1. Device Description:
The device, Steripath® Micro Blood Collection System, is a system to draw blood for in vitro diagnostic testing. The purpose of this submission is to expand the product line to include inlet components with the BD Venipuncture® UltraTouch™ Push Button Needle, outlet components with a transfer adapter, and universal models with no inlet component.
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.
The device sequesters and diverts 0.5 - 1.0 mL of the initial specimen of blood (potentially contaminated) into a diversion chamber. Once diversion is complete, a subsequent blood sample flows through a second pathway within the device and 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. Additionally, components of the system may be used for infusion after disconnection of the Initial Specimen Diversion Device® (ISDD®).
The Steripath® Micro Blood Collection System, needle configurations, for the subject device are manufactured using non-sterile BD UltraTouch® needles, which are equivalent to the commercially available BD UltraTouch® Push Button™ Blood Collection Set (K212724), except for the sterilization step. The Steripath® Micro Blood Collection System and UltraTouch® needles have the same intended use. Incorporation of the needle with the ISDD® functions on the same technological characteristics and principles of operation with the difference that the subject device leverages the Initial Specimen Diversion Technology® (ISDT) and mechanically sequesters the initial specimen of blood. Inclusion of this technology does not raise any added questions of safety or effectiveness.
The different configurations of the Steripath® Micro Blood Collection System are made available by using different combinations of the inlet and outlet accessories. Proposed configurations are listed in Table 5.1.
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Image /page/5/Picture/0 description: The image shows the logo for Magnolia Medical Technologies. The word "MAGNOLIA" is written in large, bold, blue letters. A blue checkmark is to the left of the word. Below the word "MAGNOLIA" is the phrase "MEDICAL TECHNOLOGIES" in smaller, gray letters.
| Table 5.1 Steripath Micro Blood Collection System Configurations | ||
|---|---|---|
| -- | ------------------------------------------------------------------ | -- |
| Model No. | Base Assembly | Description | Inlet | Outlet |
|---|---|---|---|---|
| 4000-EN | P00818-001 | Steripath Micro | ||
| Blood Collection | ||||
| System - 9in Luer, | ||||
| Wide Neck | ||||
| Transfer Adapter | ||||
| (TA) | Luer Extension, | |||
| ICU Medical, 9" | ||||
| Length | Wide Neck | |||
| Transfer | ||||
| Adapter | ||||
| Assembly | ||||
| 4000-21UT-EN | P00818-001 | Steripath Micro | ||
| Blood Collection | ||||
| System - 21G | ||||
| UltraTouch, Wide | ||||
| Neck TA | Blood | |||
| Collection Set, | ||||
| Push Button, | ||||
| UltraTouch, | ||||
| 21G, BD, Non- | ||||
| Sterile | Wide Neck | |||
| Transfer | ||||
| Adapter | ||||
| Assembly | ||||
| 4000-23UT-EN | P00818-001 | Steripath Micro | ||
| Blood Collection | ||||
| System - 23G | ||||
| UltraTouch, Wide | ||||
| Neck TA | Blood | |||
| Collection Set, | ||||
| Push Button, | ||||
| UltraTouch, | ||||
| 23G, BD, | ||||
| Non-Sterile | Wide Neck | |||
| Transfer | ||||
| Adapter | ||||
| Assembly | ||||
| 4000-UN-EN | P00818-001 | Steripath Micro | ||
| Blood Collection | ||||
| System - | ||||
| Universal, Wide | ||||
| Neck TA | No inlet | Wide Neck | ||
| Transfer | ||||
| Adapter | ||||
| Assembly | ||||
| 40BD-EN | P00818-001 | Steripath Micro | ||
| Blood Collection | ||||
| System - 9in Luer, | ||||
| Long Neck TA | Luer Extension, | |||
| ICU Medical, 9" | ||||
| Length | Long Neck | |||
| Transfer | ||||
| Adapter | ||||
| Assembly | ||||
| 40BD-21UT-EN | P00818-001 | Steripath Micro | ||
| Blood Collection | ||||
| System - 21G | ||||
| UltraTouch, Long | ||||
| Neck TA | Blood | |||
| Collection Set, | ||||
| Push Button, | ||||
| UltraTouch, | ||||
| 21G, BD, | ||||
| Non-Sterile | Long Neck | |||
| Transfer | ||||
| Adapter | ||||
| Assembly | ||||
| Model No. | Base Assembly | Description | Inlet | Outlet |
| 40BD-23UT-EN | P00818-001 | Steripath Micro | ||
| Blood Collection | ||||
| System - 23G | ||||
| UltraTouch, Long | ||||
| Neck TA | Blood | |||
| Collection Set, | ||||
| Push Button, | ||||
| UltraTouch, | ||||
| 23G, BD, | ||||
| Non-Sterile | Long Neck | |||
| Transfer | ||||
| Adapter | ||||
| Assembly | ||||
| 40BD-UN-EN | P00818-001 | Steripath Micro | ||
| Blood Collection | ||||
| System - | ||||
| Universal, Long | ||||
| Neck TA | No inlet | Long Neck | ||
| Transfer | ||||
| Adapter | ||||
| Assembly | ||||
| 4005-EN | P00818-001 | Steripath Micro | ||
| Blood Collection | ||||
| System - 7in Luer, | ||||
| 5mL Syringe | Luer Extension, | |||
| ICU Medical, 7" | ||||
| Length | Syringe, 5mL, | |||
| Polypropylene | ||||
| 4005-21UT-EN | P00818-001 | Steripath Micro | ||
| Blood Collection | ||||
| System - 21G | ||||
| UltraTouch, 5mL | ||||
| Syringe | Blood | |||
| Collection Set, | ||||
| Push Button, | ||||
| Ultra-Touch, | ||||
| 21G, BD, | ||||
| Non-Sterile | Syringe, 5mL, | |||
| Polypropylene | ||||
| 4005-23UT-EN | P00818-001 | Steripath Micro | ||
| Blood Collection | ||||
| System - 23G | ||||
| UltraTouch, 5mL | ||||
| Syringe | Blood | |||
| Collection Set, | ||||
| Push Button, | ||||
| Ultra-Touch, | ||||
| 23G, BD, | ||||
| Non-Sterile | Syringe, 5mL, | |||
| Polypropylene | ||||
| 4005-UN-EN | P00818-001 | Steripath Micro | ||
| Blood Collection | ||||
| System - | ||||
| Universal, 5mL | ||||
| Syringe | No inlet | Syringe, 5mL, | ||
| Polypropylene | ||||
| 4010-EN | P00818-001 | Steripath Micro | ||
| Blood Collection | ||||
| System - 7in Luer, | ||||
| 10mL Syringe | Luer Extension, | |||
| ICU Medical, 7" | ||||
| Length | Syringe, 10mL, | |||
| Polypropylene | ||||
| Model No. | Base Assembly | Description | Inlet | Outlet |
| 4010-21UT-EN | P00818-001 | Steripath Micro | ||
| Blood Collection | ||||
| System - 21G | ||||
| UltraTouch, 10mL | ||||
| Syringe | Blood | |||
| Collection Set, | ||||
| Push Button, | ||||
| Ultra-Touch, | ||||
| 21G, BD, | ||||
| Non-Sterile | Syringe, 10mL, | |||
| Polypropylene | ||||
| 4010-23UT-EN | P00818-001 | Steripath Micro | ||
| Blood Collection | ||||
| System - 23G | ||||
| UltraTouch, 10mL | ||||
| Syringe | Blood | |||
| Collection Set, | ||||
| Push Button, | ||||
| Ultra-Touch, | ||||
| 23G, BD, | ||||
| Non-Sterile | Syringe, 10mL, | |||
| Polypropylene | ||||
| 4010-UN-EN | P00818-001 | Steripath Micro | ||
| Blood Collection | ||||
| System - | ||||
| Universal, 10mL | ||||
| Syringe | No inlet | Syringe, 10mL, | ||
| Polypropylene | ||||
| 4020-EN | P00818-001 | Steripath Micro | ||
| Blood Collection | ||||
| System - 7in Luer, | ||||
| 20mL Syringe | Luer Extension, | |||
| ICU Medical, 7" | ||||
| Length | Syringe, 20mL, | |||
| Polypropylene | ||||
| 4020-21UT-EN | P00818-001 | Steripath Micro | ||
| Blood Collection | ||||
| System - 21G | ||||
| UltraTouch, 20mL | ||||
| Syringe | Blood | |||
| Collection Set, | ||||
| Push Button, | ||||
| Ultra-Touch, | ||||
| 21G, BD, | ||||
| Non-Sterile | Syringe, 20mL, | |||
| Polypropylene | ||||
| 4020-UN-EN | P00818-001 | Steripath Micro | ||
| Blood Collection | ||||
| System - | ||||
| Universal, 20mL | ||||
| Syringe | No inlet | Syringe, 20mL, | ||
| Polypropylene |
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Image /page/6/Picture/0 description: The image shows the logo for Magnolia Medical Technologies. The word "MAGNOLIA" is written in large, bold, blue letters. A blue checkmark is placed above the letter "M". Below the word "MAGNOLIA", the words "MEDICAL TECHNOLOGIES" are written in smaller, gray letters.
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Image /page/7/Picture/0 description: The image shows the logo for Magnolia Medical Technologies. The word "MAGNOLIA" is written in large, bold, blue letters. A blue checkmark is placed above the "M" in Magnolia. Below "MAGNOLIA" the words "MEDICAL TECHNOLOGIES" are written in smaller, gray letters.
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Image /page/8/Picture/0 description: The image shows the logo for Magnolia Medical Technologies. The word "MAGNOLIA" is written in large, bold, blue letters, with a blue checkmark above the "M". Below "MAGNOLIA", the words "MEDICAL TECHNOLOGIES" are written in smaller, gray letters. The logo is simple and professional, and it conveys a sense of trust and reliability.
Intended Use/ Indication for Use: 5.2.
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®).
Technological characteristics 5.3.
The Steripath® Micro Blood Collection System is a pre-assembled single use, sterile, mechanical device that diverts and sequesters the initial 0.5mL to 1.0mL of blood from the patient. The device consists of the proprietary Initial Specimen Diversion Device® (ISDD®) made of injection molded, medical grade plastics, an inlet component, and an outlet component. The inlet components include needles and Luer extensions for interfacing with patients while the outlet components include syringes and transfer adapters for interfacing to blood culture bottles. The device family also includes no-inlet configurations which requires a compatible inlet to be attached prior to use.
Venous blood access is obtained by venipuncture or connecting to the peripheral IV catheter hub using the standard blood collection procedure. The negative pressure created by actuating the syringe plunger or by connecting the culture bottle to the transfer adapter, causes blood to flow into the C-shaped diversion chamber. When the C-shaped chamber is filled with blood, the button on the side of the diversion chamber is depressed to isolate the initial specimen and a new sterile pathway opens to collect a subsequent specimen for blood culture or other analysis.
The predicate device – the three (3) previously cleared models (4005-EN, 4020-EN) of Steripath® Micro Blood Collection System (K200661) – utilizes the same technology and principle of operation as the subject device. A comparison of the technological characteristics is listed in Table 5.2.
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Image /page/9/Picture/0 description: The image shows the logo for Magnolia Medical Technologies. The word "MAGNOLIA" is in large, blue, sans-serif font, with a checkmark symbol in the upper left corner. Below the word "MAGNOLIA" is the phrase "MEDICAL TECHNOLOGIES" in a smaller, gray, sans-serif font.
Steripath Micro Blood Collection System
510(k) Premarket Notification 510(k) Summary
| Device
Characteristics | Subject Device | Predicate Device | Comparison of subject
and Predicate |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 |
| Indication 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. | 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. | Same |
| | Additionally, components of
the system may be used for
infusion following sample
collection after
disconnection of the Initial
Specimen Diversion Device
(ISDD®). | Additionally, components of
the system may be used for
infusion following sample
collection after
disconnection of the Initial
Specimen Diversion Device
(ISDD®). | |
| Materials | Medical grade materials
(stainless steel, pvc tubing,
medical grade adhesives,
polycarbonate, silicone, TPE) | Medical grade materials
(stainless steel, pvc tubing,
medical grade adhesives,
polycarbonate, silicone, TPE) | Same |
| Inlet
Components,
User Interface | BD Vacutainer® UltraTouch™
Push Button Blood
Collection Set
21G
Becton Dickinson
Model 367365
(K212724)
BD Vacutainer® UltraTouch™
Push Button Blood
Collection Set
23G | Luer Extension, 7"
ICU Medical, Inc.
Model B1754-NS
(K964435) | The subject device adds a
9" Luer extension as well
as the existing 7" Luer
extension. Both Luer
extensions are
manufactured by ICU
Medical and received
clearance under K964435.
The Patient Interface
Components are identical
to the predicate device
and does not raise new or |
| Device
Characteristics | Subject Device | Predicate Device | Comparison of subject
and Predicate |
| | Becton Dickinson
Model 367364
(K212724) | | different questions of
safety or effectiveness. |
| | Luer Extension, 9"
ICU Medical, Inc.
Model B1798-NS
(K964435) | | The predicate device,
Steripath® Micro Blood
Collection System
(K200661), has no needle
inlet configurations. The
needle configurations for
the subject device are
manufactured using non-
sterile BD UltraTouch®
needles, which are
equivalent to the
commercially available BD
UltraTouch® Push Button™
Blood Collection Set
(K212724), except for the
sterilization step. The
Steripath® Micro Blood
Collection System is
validated to SAL6, with a
25kGy MAX dose and the
BD UltraTouch needles
(K212724) undergo a
single ~25kGy gamma
sterilization cycle. This
change does not raise new
or different questions of
safety or effectiveness. |
| | Luer Extension, 7"
ICU Medical, Inc.
Model B1754-NS
(K964435) | | |
| | None
(Device provided without
inlet component) | | The subject device
includes no-inlet
configurations for
compatibility with user
supplied venipuncture
needles and IV catheters
with integrated J-Loops,
which are commonly used
for blood collection in
standard practice. This
does not raise new
questions of safety or
effectiveness. |
| Outlet
Components | Syringe, 10ml
Becton Dickinson | Syringe, 10ml
Becton Dickinson | The only difference is the
subject device adds |
| Device
Characteristics | Subject Device | Predicate Device | Comparison of subject
and Predicate |
| Culture Bottle
Interface | Model 301029
(K980987) | Model 301029
(K980987) | configurations including
transfer adapter outlet
components. The Maveric
Medical Transfer Adapters
(TAs) are off-the-shelf
components and interact
with existing blood culture
bottle interface
technologies. The changes
do not raise any new or
different questions of
safety or effectiveness. |
| | Syringe, 20ml
Becton Dickinson
Model 301031
(K980987) | Syringe, 20ml
Becton Dickinson
Model 301031
(K980987) | |
| | Syringe, 5ml
Becton Dickinson
Model 301027
(K980987) | Syringe, 5ml
Becton Dickinson
Model 301027
(K980987) | |
| | Transfer Adapter, Maveric
Medical Long Neck
PN P01045-001
BD Bottle Interface | | |
| | Transfer Adapter, Maveric
Medical Wide Neck
PN P01042-001
BioMerieux® and
Thermo Fisher® Bottle
interfaces | | |
| | Diversion Volume | 0.5mL to 1.0mL | |
| | | Mechanism of
Diversion | |
| | | Mechanism of
Sequestering
Diversion Sample | |
| Device
Characteristics | Subject Device | Predicate Device | Comparison of subject
and Predicate |
| | | | |
| User Workflow | + Access vein
- Draw with syringe or
bottle - Push button to switch path
- Continue to draw with
syringe or bottle | + Access vein - Draw with syringe
- Push button to switch path
- Continue to draw with
syringe | The only difference is the
subject device also uses
configurations with a
transfer adapter outlet,
allowing the user to
complete blood draw with
a culture bottle. This
technique is commonly
used for blood collection
in standard practice and
does not raise new or
different questions of
safety or effectiveness. |
| Diversion Device
Form Factor | 4cm Long x 2cm Wide x 4cm
High | 4cm Long x 2cm Wide x 4cm
High | Same |
| Sterile Packaging | Chevron Pouch, 12" x 6"
TPT-0270 to TPF-0524a | Chevron Pouch, 12" x 6"
TPT-0270 to TPF-0524a | Same |
| Shelf Box | E flute Material
15"x5.5"x4.5"
15"x5.5"x7" | E flute Material
15"x5.5"x4.5" | A larger Shelf Box is used
for bulkier configurations
which incorporate the
Wide Neck Transfer
Adapters. This larger Shelf
Box is made of the same
materials as the predicate
device Shelf Box and has
completed appropriate
transportation and
conditioning testing per
recognized FDA consensus
standards. This change
does not raise new or
different questions of
safety or effectiveness |
Magnolia Medical Technologies® | 200 W Mercer St. STE 500, Seattle, WA 98119 | 1-888-617-3420 | magnolia-medical.com Page 5-7 of 5-13
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Steripath Micro Blood Collection System 510(k) Premarket Notification 510(k) Summary
1 J Clin Microbiol 2010 Dec;48(12):4501-3 doi: 10.1128/JCM.00910-10. Epub 2010 Oct 13
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| Device
Characteristics | Subject Device | Predicate Device | Comparison of subject
and Predicate |
|---------------------------|---------------------------------------------------------------------------------------------------------|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Transport Box | Corrugated Kraft material
27.75"x15.25"x14.25"
Corrugated Kraft material
28.75"x15.625"x9.625" | Corrugated Kraft material
27.75"x15.25"x14.25" | A larger Transport Box is
used for bulkier
configurations which
incorporate the Wide
Neck Transfer Adapters.
This larger Transport Box
is made of the same
materials as the predicate
device Transport Box and
has completed
appropriate
transportation and
conditioning testing per
recognized FDA consensus
standards. This change
does not raise new or
different questions of
safety or effectiveness. |
Summary of Performed Testing 5.4.
The Steripath® Micro Blood Collection System conforms to its System, Labeling, Controls, Interfaces, Accessory, Functional, Physical, Biological Safety and Packaging requirements. As required by the risk analysis, all design verification and validation activities were performed, and the results demonstrated that the predetermined acceptance criteria were met.
- a) Sterilization -ISO 11137-1:2006/AMD 2018 "Sterilization of health care products -Radiation Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices."
- Bacteriostasis/Fungistasis (B/F Test)
- Bioburden
- . Sterility
The system complies with the gamma radiation process validated per the VDmax® 25kGy dose and an SAL of 10-6.
- b) Aging/Shelf-Life Test –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."
- Diversion volume
- Functional (needle insertion, blood collection, and needle retraction)
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Sterinath Micro Blood Collection System 10(k) Premarket Notification 510(k) Summarv
- Functional (hub attachment, blood collection, and removal)
- Functional (culture bottle septum puncture, blood collection, and removal)
- Pressure rating
- Protection from harm ●
The system is validated to a twelve (12) months shelf-life.
- Biocompatibility testing –ISO 10993-1:2018 "Biological evaluation of medical devices c) Part 1: Evaluation and testing within a risk management process. The battery of testing included the following tests:
- Cytotoxicity
- Sensitization
- Irritation (intracutaneous reactivity)
- Acute System Toxicity
- Pyrogenicity (LAL)
- Subacute Toxicity
- Hemolysis.
The system meets the requirements for a limited contact duration (24 h to 30 d) depending on the device part/component, blood path indirect, contacting device.
- d) Packaging Integrity Testing / Shipping Tests -ASTM D4169-16, "Standard Practice for Performance Testing of Shipping Containers and Systems", Distribution Cycle 13, Assurance Level II.
- Seal Strength ●
- Package leaks ●
- Drop tests
The system meets the requirements of the standard.
Performance Testing - The Steripath® Micro Blood Collection System successfully meets all functional and performance requirements for safe and effective performance, as noted below. Results of this testing demonstrate that the Steripath® Micro Blood Collection System and its components meet all requirements for its intended use. The performance testing is summarized in Table 5.3.
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Table 5.3 Requirements for Safe and Effective Use
| Requirement | Description | Verification
Test Result |
|--------------------------------|---------------------------------------------------------------------------------------------------|-----------------------------|
| Sequestration | The ISDD® shall sequester the diversion volume. | PASS |
| Minimum Vacuum
performance. | The ISDD® shall meet its performance
requirements under minimum vacuum conditions. | PASS |
| Maximum Vacuum
performance. | The ISDD® shall meet its performance
requirements under maximum vacuum conditions. | PASS |
| Diversion Volume. | The ISDD® shall meet the minimum and maximum
diversion volume requirements | PASS |
| Positive Pressure
Maximum | The ISDD® shall remain functionally intact and safe
under maximum positive pressure conditions | PASS |
Conclusions 5.5.
The Steripath® Micro Blood Collection System is substantially equivalent to the predicate device - the Steripath® Micro Blood Collection System (K200661) - as it has the same intended use/indications for use. The subject and predicate device function using the same technological characteristics and principles of operation. While there are some differences between the subject and predicate device has been tested appropriately and these differences do not raise new or different questions of safety or effectiveness and the subject device is substantially equivalent to the predicate device.