Steripath Micro Blood Collection System

K222299 · Magnolia Medical Technologies · JKA · Nov 30, 2022 · Clinical Chemistry

Device Facts

• Record ID: K222299
• Device Name: Steripath Micro Blood Collection System
• Applicant: Magnolia Medical Technologies
• Product Code: JKA · Clinical Chemistry
• Decision Date: Nov 30, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1675
• Device Class: Class 2

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 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 disconnection of the Initial Specimen Diversion Device® (ISDD®).

Device Story

Steripath® Micro Blood Collection System is a sterile, single-use mechanical device for blood collection. It diverts and sequesters 0.5-1.0 mL of initial blood (potentially contaminated) into a C-shaped chamber. Once filled, a button is depressed to isolate the initial specimen and open a new sterile pathway for subsequent sample collection into a culture bottle or syringe. Used in clinical settings by healthcare providers during venipuncture or via peripheral IV catheter hubs. The device includes various inlet (needles, Luer extensions) and outlet (syringes, transfer adapters) configurations. By reducing initial specimen contamination, the device helps improve the accuracy of blood culture results, potentially reducing false-positive diagnoses of bloodstream infections and unnecessary antibiotic use. Components can be used for infusion after the diversion device is disconnected.

Clinical Evidence

Bench testing only. Testing included sterilization validation (ISO 11137-1), accelerated aging (ASTM F1980-16), biocompatibility (ISO 10993-1), packaging/shipping integrity (ASTM D4169-16), and functional performance (sequestration volume, vacuum performance, pressure testing). All predetermined acceptance criteria were met.

Technological Characteristics

Single-use, sterile, mechanical device. Materials: stainless steel, PVC, polycarbonate, silicone, TPE, medical-grade adhesives. Principle: mechanical diversion of initial blood volume via C-shaped chamber. Connectivity: none. Sterilization: gamma radiation (25kGy, SAL 10^-6). Form factor: various inlet/outlet configurations (needles, Luer extensions, syringes, transfer adapters).

Indications for Use

Indicated for use as a blood collection system to divert and sequester the initial 0.5-1.0 mL of blood prior to collecting a subsequent test sample to reduce blood culture contamination. Components may be used for infusion after ISDD® disconnection.

Regulatory Classification

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.

Predicate Devices

• Steripath Micro Blood Collection System (K200661)

Reference Devices

• BD UltraTouch® Push Button™ Blood Collection Set (K212724)
• ICU Medical Luer Extension (K964435)
• Becton Dickinson Syringe (K980987)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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# 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.<br>200 West Mercer Street<br>Suite 500<br>Seattle WA 98119<br>Phone: [phone]<br>Registration number: 3009976527 |
| Contact Person: | Donna Matuizek<br>Sr. Director of Quality and Regulatory<br>Magnolia Medical Technologies Inc.<br>Phone: [phone]<br>Fax: [phone]<br>[e-mail] |
| Trade Name: | Steripath® Micro Blood Collection System |
| Common Name: | Blood Collection Tubes, Vials, Systems, Serum Separators |
| Regulation Name: | Blood Specimen Collection Device |
| Regulation<br>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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| | Table 5.1 Steripath Micro Blood Collection System Configurations | |
|--|------------------------------------------------------------------|--|
|--|------------------------------------------------------------------|--|

| Model No. | Base Assembly | Description | Inlet | Outlet |
|--------------|---------------|----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|----------------------------------------------|
| 4000-EN | P00818-001 | Steripath Micro<br>Blood Collection<br>System - 9in Luer,<br>Wide Neck<br>Transfer Adapter<br>(TA) | Luer Extension,<br>ICU Medical, 9"<br>Length | Wide Neck<br>Transfer<br>Adapter<br>Assembly |
| 4000-21UT-EN | P00818-001 | Steripath Micro<br>Blood Collection<br>System - 21G<br>UltraTouch, Wide<br>Neck TA | Blood<br>Collection Set,<br>Push Button,<br>UltraTouch,<br>21G, BD, Non-<br>Sterile | Wide Neck<br>Transfer<br>Adapter<br>Assembly |
| 4000-23UT-EN | P00818-001 | Steripath Micro<br>Blood Collection<br>System - 23G<br>UltraTouch, Wide<br>Neck TA | Blood<br>Collection Set,<br>Push Button,<br>UltraTouch,<br>23G, BD,<br>Non-Sterile | Wide Neck<br>Transfer<br>Adapter<br>Assembly |
| 4000-UN-EN | P00818-001 | Steripath Micro<br>Blood Collection<br>System -<br>Universal, Wide<br>Neck TA | No inlet | Wide Neck<br>Transfer<br>Adapter<br>Assembly |
| 40BD-EN | P00818-001 | Steripath Micro<br>Blood Collection<br>System - 9in Luer,<br>Long Neck TA | Luer Extension,<br>ICU Medical, 9"<br>Length | Long Neck<br>Transfer<br>Adapter<br>Assembly |
| 40BD-21UT-EN | P00818-001 | Steripath Micro<br>Blood Collection<br>System - 21G<br>UltraTouch, Long<br>Neck TA | Blood<br>Collection Set,<br>Push Button,<br>UltraTouch,<br>21G, BD,<br>Non-Sterile | Long Neck<br>Transfer<br>Adapter<br>Assembly |
| Model No. | Base Assembly | Description | Inlet | Outlet |
| 40BD-23UT-EN | P00818-001 | Steripath Micro<br>Blood Collection<br>System - 23G<br>UltraTouch, Long<br>Neck TA | Blood<br>Collection Set,<br>Push Button,<br>UltraTouch,<br>23G, BD,<br>Non-Sterile | Long Neck<br>Transfer<br>Adapter<br>Assembly |
| 40BD-UN-EN | P00818-001 | Steripath Micro<br>Blood Collection<br>System -<br>Universal, Long<br>Neck TA | No inlet | Long Neck<br>Transfer<br>Adapter<br>Assembly |
| 4005-EN | P00818-001 | Steripath Micro<br>Blood Collection<br>System - 7in Luer,<br>5mL Syringe | Luer Extension,<br>ICU Medical, 7"<br>Length | Syringe, 5mL,<br>Polypropylene |
| 4005-21UT-EN | P00818-001 | Steripath Micro<br>Blood Collection<br>System - 21G<br>UltraTouch, 5mL<br>Syringe | Blood<br>Collection Set,<br>Push Button,<br>Ultra-Touch,<br>21G, BD,<br>Non-Sterile | Syringe, 5mL,<br>Polypropylene |
| 4005-23UT-EN | P00818-001 | Steripath Micro<br>Blood Collection<br>System - 23G<br>UltraTouch, 5mL<br>Syringe | Blood<br>Collection Set,<br>Push Button,<br>Ultra-Touch,<br>23G, BD,<br>Non-Sterile | Syringe, 5mL,<br>Polypropylene |
| 4005-UN-EN | P00818-001 | Steripath Micro<br>Blood Collection<br>System -<br>Universal, 5mL<br>Syringe | No inlet | Syringe, 5mL,<br>Polypropylene |
| 4010-EN | P00818-001 | Steripath Micro<br>Blood Collection<br>System - 7in Luer,<br>10mL Syringe | Luer Extension,<br>ICU Medical, 7"<br>Length | Syringe, 10mL,<br>Polypropylene |
| Model No. | Base Assembly | Description | Inlet | Outlet |
| 4010-21UT-EN | P00818-001 | Steripath Micro<br>Blood Collection<br>System - 21G<br>UltraTouch, 10mL<br>Syringe | Blood<br>Collection Set,<br>Push Button,<br>Ultra-Touch,<br>21G, BD,<br>Non-Sterile | Syringe, 10mL,<br>Polypropylene |
| 4010-23UT-EN | P00818-001 | Steripath Micro<br>Blood Collection<br>System - 23G<br>UltraTouch, 10mL<br>Syringe | Blood<br>Collection Set,<br>Push Button,<br>Ultra-Touch,<br>23G, BD,<br>Non-Sterile | Syringe, 10mL,<br>Polypropylene |
| 4010-UN-EN | P00818-001 | Steripath Micro<br>Blood Collection<br>System -<br>Universal, 10mL<br>Syringe | No inlet | Syringe, 10mL,<br>Polypropylene |
| 4020-EN | P00818-001 | Steripath Micro<br>Blood Collection<br>System - 7in Luer,<br>20mL Syringe | Luer Extension,<br>ICU Medical, 7"<br>Length | Syringe, 20mL,<br>Polypropylene |
| 4020-21UT-EN | P00818-001 | Steripath Micro<br>Blood Collection<br>System - 21G<br>UltraTouch, 20mL<br>Syringe | Blood<br>Collection Set,<br>Push Button,<br>Ultra-Touch,<br>21G, BD,<br>Non-Sterile | Syringe, 20mL,<br>Polypropylene |
| 4020-UN-EN | P00818-001 | Steripath Micro<br>Blood Collection<br>System -<br>Universal, 20mL<br>Syringe | No inlet | Syringe, 20mL,<br>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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Steripath Micro Blood Collection System
510(k) Premarket Notification 510(k) Summary

| Device<br>Characteristics | Subject Device | Predicate Device | Comparison of subject<br>and Predicate |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Steripath® Micro Blood<br>Collection System is a<br>system to draw blood for <i>in vitro</i> diagnostic testing. | The Steripath® Micro Blood<br>Collection System is a<br>system to draw blood for <i>in vitro</i> diagnostic testing. | Same |
| Indication for Use | The Steripath® Micro Blood<br>Collection System is<br>indicated for use as a blood<br>collection system that<br>diverts and sequesters the<br>initial specimen prior to<br>collection of a subsequent<br>test sample to reduce the<br>frequency of blood culture<br>contamination when<br>contaminants are present in<br>the initial blood sample<br>compared to blood cultures<br>drawn with standard<br>procedure without manual<br>diversion. | The Steripath® Micro Blood<br>Collection System is<br>indicated for use as a blood<br>collection system that<br>diverts and sequesters the<br>initial specimen prior to<br>collection of a subsequent<br>test sample to reduce the<br>frequency of blood culture<br>contamination when<br>contaminants are present in<br>the initial blood sample<br>compared to blood cultures<br>drawn with standard<br>procedure without manual<br>diversion. | Same |
| | Additionally, components of<br>the system may be used for<br>infusion following sample<br>collection after<br>disconnection of the Initial<br>Specimen Diversion Device<br>(ISDD®). | Additionally, components of<br>the system may be used for<br>infusion following sample<br>collection after<br>disconnection of the Initial<br>Specimen Diversion Device<br>(ISDD®). | |
| Materials | Medical grade materials<br>(stainless steel, pvc tubing,<br>medical grade adhesives,<br>polycarbonate, silicone, TPE) | Medical grade materials<br>(stainless steel, pvc tubing,<br>medical grade adhesives,<br>polycarbonate, silicone, TPE) | Same |
| Inlet<br>Components,<br>User Interface | BD Vacutainer® UltraTouch™<br>Push Button Blood<br>Collection Set<br>21G<br>Becton Dickinson<br>Model 367365<br>(K212724)<br><br>BD Vacutainer® UltraTouch™<br>Push Button Blood<br>Collection Set<br>23G | Luer Extension, 7"<br>ICU Medical, Inc.<br>Model B1754-NS<br>(K964435) | The subject device adds a<br>9" Luer extension as well<br>as the existing 7" Luer<br>extension. Both Luer<br>extensions are<br>manufactured by ICU<br>Medical and received<br>clearance under K964435.<br>The Patient Interface<br>Components are identical<br>to the predicate device<br>and does not raise new or |
| Device<br>Characteristics | Subject Device | Predicate Device | Comparison of subject<br>and Predicate |
| | Becton Dickinson<br>Model 367364<br>(K212724) | | different questions of<br>safety or effectiveness. |
| | Luer Extension, 9"<br>ICU Medical, Inc.<br>Model B1798-NS<br>(K964435) | | The predicate device,<br>Steripath® Micro Blood<br>Collection System<br>(K200661), has no needle<br>inlet configurations. The<br>needle configurations for<br>the subject device are<br>manufactured using non-<br>sterile BD UltraTouch®<br>needles, which are<br>equivalent to the<br>commercially available BD<br>UltraTouch® Push Button™<br>Blood Collection Set<br>(K212724), except for the<br>sterilization step. The<br>Steripath® Micro Blood<br>Collection System is<br>validated to SAL6, with a<br>25kGy MAX dose and the<br>BD UltraTouch needles<br>(K212724) undergo a<br>single ~25kGy gamma<br>sterilization cycle. This<br>change does not raise new<br>or different questions of<br>safety or effectiveness. |
| | Luer Extension, 7"<br>ICU Medical, Inc.<br>Model B1754-NS<br>(K964435) | | |
| | None<br>(Device provided without<br>inlet component) | | The subject device<br>includes no-inlet<br>configurations for<br>compatibility with user<br>supplied venipuncture<br>needles and IV catheters<br>with integrated J-Loops,<br>which are commonly used<br>for blood collection in<br>standard practice. This<br>does not raise new<br>questions of safety or<br>effectiveness. |
| Outlet<br>Components | Syringe, 10ml<br>Becton Dickinson | Syringe, 10ml<br>Becton Dickinson | The only difference is the<br>subject device adds |
| Device<br>Characteristics | Subject Device | Predicate Device | Comparison of subject<br>and Predicate |
| Culture Bottle<br>Interface | Model 301029<br>(K980987) | Model 301029<br>(K980987) | configurations including<br>transfer adapter outlet<br>components. The Maveric<br>Medical Transfer Adapters<br>(TAs) are off-the-shelf<br>components and interact<br>with existing blood culture<br>bottle interface<br>technologies. The changes<br>do not raise any new or<br>different questions of<br>safety or effectiveness. |
| | Syringe, 20ml<br>Becton Dickinson<br>Model 301031<br>(K980987) | Syringe, 20ml<br>Becton Dickinson<br>Model 301031<br>(K980987) | |
| | Syringe, 5ml<br>Becton Dickinson<br>Model 301027<br>(K980987) | Syringe, 5ml<br>Becton Dickinson<br>Model 301027<br>(K980987) | |
| | Transfer Adapter, Maveric<br>Medical Long Neck<br>PN P01045-001<br>BD Bottle Interface | | |
| | Transfer Adapter, Maveric<br>Medical Wide Neck<br>PN P01042-001<br>BioMerieux® and<br>Thermo Fisher® Bottle<br>interfaces | | |
| | Diversion Volume | 0.5mL to 1.0mL | |
| | | Mechanism of<br>Diversion | |
| | | Mechanism of<br>Sequestering<br>Diversion Sample | |
| Device<br>Characteristics | Subject Device | Predicate Device | Comparison of subject<br>and Predicate |
| | | | |
| User Workflow | + Access vein<br>+ Draw with syringe or<br>bottle<br>+ Push button to switch path<br>+ Continue to draw with<br>syringe or bottle | + Access vein<br>+ Draw with syringe<br>+ Push button to switch path<br>+ Continue to draw with<br>syringe | The only difference is the<br>subject device also uses<br>configurations with a<br>transfer adapter outlet,<br>allowing the user to<br>complete blood draw with<br>a culture bottle. This<br>technique is commonly<br>used for blood collection<br>in standard practice and<br>does not raise new or<br>different questions of<br>safety or effectiveness. |
| Diversion Device<br>Form Factor | 4cm Long x 2cm Wide x 4cm<br>High | 4cm Long x 2cm Wide x 4cm<br>High | Same |
| Sterile Packaging | Chevron Pouch, 12" x 6"<br>TPT-0270 to TPF-0524a | Chevron Pouch, 12" x 6"<br>TPT-0270 to TPF-0524a | Same |
| Shelf Box | E flute Material<br>15"x5.5"x4.5"<br>15"x5.5"x7" | E flute Material<br>15"x5.5"x4.5" | A larger Shelf Box is used<br>for bulkier configurations<br>which incorporate the<br>Wide Neck Transfer<br>Adapters. This larger Shelf<br>Box is made of the same<br>materials as the predicate<br>device Shelf Box and has<br>completed appropriate<br>transportation and<br>conditioning testing per<br>recognized FDA consensus<br>standards. This change<br>does not raise new or<br>different questions of<br>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<br>Characteristics | Subject Device | Predicate Device | Comparison of subject<br>and Predicate |
|---------------------------|---------------------------------------------------------------------------------------------------------|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Transport Box | Corrugated Kraft material<br>27.75"x15.25"x14.25"<br>Corrugated Kraft material<br>28.75"x15.625"x9.625" | Corrugated Kraft material<br>27.75"x15.25"x14.25" | A larger Transport Box is<br>used for bulkier<br>configurations which<br>incorporate the Wide<br>Neck Transfer Adapters.<br>This larger Transport Box<br>is made of the same<br>materials as the predicate<br>device Transport Box and<br>has completed<br>appropriate<br>transportation and<br>conditioning testing per<br>recognized FDA consensus<br>standards. This change<br>does not raise new or<br>different questions of<br>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) on prolonged 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<br>Test Result |
|--------------------------------|---------------------------------------------------------------------------------------------------|-----------------------------|
| Sequestration | The ISDD® shall sequester the diversion volume. | PASS |
| Minimum Vacuum<br>performance. | The ISDD® shall meet its performance<br>requirements under minimum vacuum conditions. | PASS |
| Maximum Vacuum<br>performance. | The ISDD® shall meet its performance<br>requirements under maximum vacuum conditions. | PASS |
| Diversion Volume. | The ISDD® shall meet the minimum and maximum<br>diversion volume requirements | PASS |
| Positive Pressure<br>Maximum | The ISDD® shall remain functionally intact and safe<br>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.