Steripath Gen2 Blood Collection System

K192247 · Magnolia Medical Technologies, Inc. · JKA · Feb 28, 2020 · Clinical Chemistry

Device Facts

• Record ID: K192247
• Device Name: Steripath Gen2 Blood Collection System
• Applicant: Magnolia Medical Technologies, Inc.
• Product Code: JKA · Clinical Chemistry
• Decision Date: Feb 28, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1675
• Device Class: Class 2

Intended Use

The Steripath® Gen2 Blood Collection System is a system to draw blood for in vitro diagnostic testing. The Steripath® Gen2 Blood Collection System is indicated for use as a blood collection system that diverts and sequesters the initial specimen prior to collection of a subsequent test sample to reduce the frequency of blood culture contamination when contaminants are present in the initial blood sample compared to blood cultures drawn with standard procedure without manual diversion. Additionally, components of the system may be used for infusion following sample collection after disconnection of the Initial Specimen Diversion Device® (ISDD®). Venipuncture needles are indicated for short term infusion (less than 2 hours).

Device Story

Steripath Gen2 is a sterile, single-use mechanical blood collection system designed to reduce blood culture contamination. It utilizes an Initial Specimen Diversion Device (ISDD) to divert and sequester the first 1.5mL to 2.0mL of blood, which typically contains skin contaminants, before allowing the subsequent sample to flow into a culture bottle or syringe. The device is operated by clinicians during venipuncture. After the diversion phase, the ISDD is disconnected, and the remaining system components can be used for short-term IV infusion. By isolating the initial blood volume, the device improves the accuracy of blood culture results, potentially reducing false-positive diagnoses of bloodstream infections and unnecessary antibiotic use.

Clinical Evidence

Clinical evidence includes two studies comparing Steripath to standard blood culture collection procedures. A company-sponsored study (Rupp et al., 2017) at UNMC (n=1,808 total samples; 904 Steripath) showed an 87.6% reduction in contamination. A second study (Bell et al., 2018) at Lee Health (n=41,685 total samples; 6,293 Steripath) showed an 82.8% reduction in contamination.

Technological Characteristics

Mechanical, single-use device composed of medical-grade plastics (polycarbonate), PVC tubing, and stainless steel needles. Features an ISDD for blood diversion. Sterilized via Ethylene Oxide (ANSI/AAMI/ISO 11135:2014). Biocompatibility tested per ISO 10993-1. Packaging validated per ASTM D4169-16. No software or electronic components.

Indications for Use

Indicated for use as a blood collection system for patients requiring blood culture collection to reduce contamination frequency. Components may be used for short-term (less than 2 hours) intravenous 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

• BD Vacutainer® Push Button Blood Collection Set (K030573)

Submission Summary (Full Text)

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February 28, 2020

Magnolia Medical Technologies, Inc. John Ray Director of Operations 200 West Mercer Street Suite 500 Seattle, Washington 98119

Re: K192247

Trade/Device Name: Steripath Gen2 Blood Collection System Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: Class II Product Code: JKA, FPA Dated: January 28, 2020 Received: January 28, 2020

Dear John Ray:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for Geeta Pamidimukkala Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices. and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K192247

Device Name Steripath® Gen2 Blood Collection System

#### Indications for Use (Describe) The Steripath® Gen2 Blood Collection System is a system to draw blood for in vitro diagnostic testing.

The Steripath® Gen2 Blood Collection is indicated for use as a blood collection system that diverts and sequesters the initial specimen prior to collection of a subsequent test sample to requency of blood culture contamination when contaminants are present in the initial blood sample compared to blood cultures drawn with standard procedure without manual diversion.

Additionally, components of the system may be used for infusion following sample collection after disconnection of the Initial Specimen Diversion Device® (ISDD®). Venipuncture needles are indicated for short term infusion (less than 2 hours).

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
| | |

X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(K) Summary

In accordance with 21 CFR 807.92(c) the following summary information is provided:

| 510(k) Number | K192247 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | February 28, 2020 |
| Submitter: | Magnolia Medical Technologies, Inc.<br>200 West Mercer Street<br>Suite 500<br>Seattle WA 98119<br>Registration number: 3009976527 |
| Contact Person: | John Ray<br>Director of Operations<br>Phone: [phone]<br>[e-mail] |
| Trade Name: | Steripath® Gen2 Blood Collection System |
| Common Name: | Blood Collection System |
| Classification Name: | Blood specimen collection device |
| Regulation Number: | 862.1675 |
| Regulatory Class: | Class II |
| Product Code: | JKA and FPA |
| Predicate Device: | BD Vacutainer® Push Button Blood Collection Set (K030573) |
| Device Description: | The Steripath® Gen2 Blood Collection System diverts and sequesters the<br>initial portion of the blood specimen (potentially contaminated blood) in the<br>diversion reservoir. When diversion is complete, a subsequent blood sample<br>flows through a second pathway within the device. The subsequent blood<br>sample is collected either directly into a culture bottle (not provided by<br>Magnolia Medical Technologies), or into a syringe that is used to inoculate<br>culture bottles. Upon removal of the ISDD®, components of the system can<br>be used for infusion per the included manufacturer's instructions for use<br>(note: infusion with butterfly needles is limited to less than 2hrs).<br>The subject device incorporates multiple configurations that include various<br>inlet and outlet accessories that are previously cleared as referenced below. |

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The following configurations of the Steripath® Gen2 Blood Collection System are available:

| Steripath®<br>Kit Model<br>Number | ISDD® | Inlet Accessory | Outlet Accessory |
|-----------------------------------|--------|--------------------------------------------------------------------------|----------------------------------------------------------------|
| 2700-EN | P00133 | Luer Extension, 9"<br>ICU Medical, Inc.<br>Model B1798-NS<br>K964435 | Transfer Adapter<br>Smith's Medical<br>Model 96004<br>K081229 |
| 2700-21-EN | P00133 | Blood Collection Set, 21G<br>Becton Dickinson<br>Model 367326<br>K030573 | Transfer Adapter<br>Smith's Medical<br>Model 96004<br>K081229 |
| 2700-23-EN | P00133 | Blood Collection Set, 23G<br>Becton Dickinson<br>Model 367324<br>K030573 | Transfer Adapter<br>Smith's Medical<br>Model 96004<br>K081229 |
| 27BD-EN | P00133 | Luer Extension, 9"<br>ICU Medical, Inc.<br>Model B1798-NS<br>K964435 | Becton Dickinson<br>Model 364902<br>K991088 |
| 27BD-21-EN | P00133 | Blood Collection Set, 21G<br>Becton Dickinson<br>Model 367326<br>K030573 | Becton Dickinson<br>Model 364902<br>K991088 |
| 27BD-23-EN | P00133 | Blood Collection Set, 23G<br>Becton Dickinson<br>Model 367324<br>K030573 | Becton Dickinson<br>Model 364902<br>K991088 |
| 27TS-EN | P00133 | Luer Extension, 9"<br>ICU Medical, Inc.<br>Model B1798-NS<br>K964435 | Transfer Adapter<br>Smith's Medical<br>Model 96000S<br>K081229 |
| 27TS-21-EN | P00133 | Blood Collection Set, 21G<br>Becton Dickinson<br>Model 367326<br>K030573 | Transfer Adapter<br>Smith's Medical<br>Model 96000S<br>K081229 |
| 27TS-23-EN | P00133 | Blood Collection Set, 23G<br>Becton Dickinson<br>Model 367324<br>K030573 | Transfer Adapter<br>Smith's Medical<br>Model 96000S<br>K081229 |
| 2710-EN | P00133 | Luer Extension, 9"<br>ICU Medical, Inc.<br>Model B1798-NS<br>K964435 | Syringe, 10ml<br>Becton Dickinson<br>Model 301029<br>K980987 |
| Steripath®<br>Kit Model<br>Number | ISDD® | Inlet Accessory | Outlet Accessory |
| 2720-EN | P00133 | Luer Extension, 9"<br>ICU Medical<br>Model B1798-NS<br>K964435 | Syringe, 20ml<br>Becton Dickinson<br>Model 301031<br>K980987 |
| 2710-21-EN | P00133 | Blood Collection Set, 21G<br>Becton Dickinson<br>Model 367326<br>K030573 | Syringe, 10ml<br>Becton Dickinson<br>Model 301029<br>K980987 |
| 2720-21-EN | P00133 | Blood Collection Set, 21G<br>Becton Dickinson<br>Model 367326<br>K030573 | Syringe, 20ml<br>Becton Dickinson<br>Model 301031<br>K980987 |
| 2710-23-EN | P00133 | Blood Collection Set, 23G<br>Becton Dickinson<br>Model 367324<br>K030573 | Syringe, 10ml<br>Becton Dickinson<br>Model 301029<br>K980987 |
| 2720-23-EN | P00133 | Blood Collection Set, 23G<br>Becton Dickinson<br>Model 367324<br>K030573 | Syringe, 20ml<br>Becton Dickinson<br>Model 301031<br>K980987 |

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Table 5-1 Steripath Configurations

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| Intended Use /<br>Indications for Use | Intended Use/Indications for Use: |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The Steripath® Gen2 Blood Collection System is a system to draw blood for<br><i>in vitro</i> diagnostic testing.<br><br>The Steripath® Gen2 Blood Collection System is indicated for use as a blood |

s a blood collection system that diverts and sequesters the initial specimen prior to collection of a subsequent test sample to reduce the frequency of blood culture contamination when contaminants are present in the initial blood sample compared to blood cultures drawn with standard procedure without manual diversion.

Additionally, components of the system may be used for infusion following sample collection after disconnection of the Initial Specimen Diversion Device® (ISDD®). Venipuncture needles are indicated for short term infusion (less than 2 hours).

## Differences in Intended Use/Indications for Use

The predicate device is the same component used in the configurations of the Steripath® Gen2 Blood Collection System. Both the subject device and predicate are intended to draw blood for in vitro diagnostic testing.

Both the Steripath® Gen2 Blood Collection System and the predicate device facilitate the collection of blood samples for a variety of in vitro diagnostic tests including collection of blood culture samples. Diversion and sequestration of 1.5mL to 2.0mL of the initial sample does not alter this intended use or the indications for use as compared to the predicate.

Diversion and sequestration of 1.5mL to 2.0mL of the initial sample does not raise new questions of safety or effectiveness in the indication of blood collection.

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### The Steripath® Gen2 Blood Collection System is a single use, sterile, Technology: mechanical device that diverts and sequesters the initial 1.5mL to 2.0mL of blood from the patient. The system consists of an Initial Specimen Diversion Device® (ISDD®) made of injection molded, medical grade plastics. Off-the-Shelf (OTS) components provide the interface to the patient vasculature, and to the culture bottle or syringe for subsequent sample collection. Upon removal of the ISDD®, components of the system can be used for infusion per the included manufacturer's instructions for use (note: infusion with butterfly needles is limited to less than 2hrs).

The predicate device is also a single use, sterile, mechanical device for collecting blood specimens and is indicated for infusion. The Steripath® Gen2 Blood Collection System includes specimen diversion technology, while the predicate device does not. Inclusion of this technology does not raise new questions of safety or effectiveness.

Differences between the Steripath Gen2 Blood Collection System and the Predicate Device are noted in Table 5-2 below.

| Item | Steripath® Gen2 Blood Collection System | Predicate Device, BD Vacutainer® Push Button Blood Collection Set (K030573) | Difference between Steripath® Gen2 Blood Collection System and Predicate Device |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FR Number(s) | 862.1675 | 862.1675 | Same |
| Product Code | JKA and FPA | JKA and FPA | Same |
| Classification Name | Tubes, Vials, Systems, Serum Separators, Blood Collection | Tubes, Vials, Systems, Serum Separators, Blood Collection | Same |
| Common Name | Blood collection set | Blood collection set | Same |
| Regulatory Class | Class II | Class II | Same |
| Classification Panel | Clinical Chemistry and Clinical Toxicology Panel, Division of Chemistry and Toxicology Devices, Office of In Vitro Diagnostics and Radiological Health | Clinical Chemistry and Clinical Toxicology Panel, Division of Chemistry and Toxicology Devices, Office of In Vitro Diagnostics and Radiological Health | Same |
| Intended Use | The Steripath® Gen2 Blood Collection System is a system to draw blood for in vitro diagnostic testing. | The BD Vacutainer® Push Button Blood Collection Set is intended for blood collection. | The predicate device is the same component used in the configurations of the Steripath® Gen2 Blood Collection System. |
| Item | Steripath® Gen2 Blood<br>Collection System | Predicate Device, BD<br>Vacutainer® Push Button<br>Blood Collection Set<br>(K030573) | Difference between<br>Steripath® Gen2<br>Blood Collection<br>System and<br>Predicate Device |
| | | | Configurations.<br>Both are intended<br>to draw blood for <i>in</i><br><i>vitro</i> diagnostic<br>testing. |
| Indications for Use | The Steripath® Gen2<br>Blood Collection System is<br>indicated for use as a<br>blood collection system<br>that diverts and<br>sequesters the initial<br>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<br>in the initial blood sample<br>compared to blood<br>cultures drawn with<br>standard procedure<br>without manual diversion.<br>Additionally, components<br>of the system may be<br>used for infusion following<br>sample collection after<br>disconnection of the Initial<br>Specimen Diversion<br>Device®. Venipuncture<br>needles are indicated for<br>short term infusion (less<br>than 2 hours). | The BD Vacutainer® Push<br>Button Blood Collection Set<br>is a sterile, multiple sample,<br>single use winged blood<br>collection set intended for<br>venipuncture to obtain<br>blood specimens from<br>patients.<br>The BD Vacutainer® Push<br>Button Blood Collection Set<br>is also indicated for the<br>intravenous administration<br>of fluids as indicated in 21<br>CFR 820.5440. It may be<br>used for any patient<br>population with<br>consideration given to<br>patient size and<br>appropriateness for the<br>solution being infused and<br>duration of therapy.<br>The recommended use of<br>the device is to activate the<br>needle prior to removal<br>from the venipuncture site.<br>The retraction of the<br>intravenous (IV) end of the<br>needle aids in the<br>prevention of accidental<br>needlestick injury. | The predicate<br>device is the same<br>component used in<br>the configurations<br>of the Steripath®<br>Gen2 Blood<br>Collection System.<br>Configurations.<br>Both are intended<br>to draw blood for <i>in</i><br><i>vitro</i> diagnostic<br>testing.<br><br>The fact that the<br>predicate device<br>indications for use<br>do not include<br>diversion<br>technology does<br>not raise new<br>questions of safety<br>or effectiveness<br>given that:<br><br>Both the SteripathⓇ<br>Gen2 Blood<br>Collection System<br>and the predicate<br>device facilitate the<br>collection of blood<br>samples for a<br>variety of <i>in vitro</i><br>diagnostic tests<br>including collection<br>of blood culture |
| Item | Steripath® Gen2 Blood<br>Collection System | Predicate Device, BD<br>Vacutainer® Push Button<br>Blood Collection Set<br>(K030573) | Difference between<br>Steripath® Gen2<br>Blood Collection<br>System and<br>Predicate Device |
| | | | samples. Diversion<br>and sequestration<br>of 1.5mL to 2.0mL<br>of the initial sample<br>does not alter this<br>intended use or<br>indications for use<br>as compared to the<br>predicate. |
| | | | Diversion and<br>sequestration of<br>1.5mL to 2.0mL of<br>the initial sample<br>does not raise new<br>questions of safety<br>or effectiveness in<br>the indication of<br>blood collection. |
| Contraindications | None | None | Same |
| Prescription Status | Prescription Use Only | Prescription Use Only | Same |
| Initial Specimen<br>Diversion Device<br>(ISDD®) | P00133 Base Assembly,<br>Gen2 | None | The Steripath®<br>Gen2 Blood<br>Collection System<br>includes the Initial<br>Specimen Diversion<br>Device® to divert<br>and sequester the<br>initial blood sample<br>to reduce frequency<br>of blood culture<br>contamination.<br><br>The predicate<br>device does not<br>include diversion<br>technology |
| Packaging | Chevron Pouch, 12" x 6" | PETG Co-polyester tray with | The Steripath® |
| Item | Steripath® Gen2 Blood Collection System | Predicate Device, BD Vacutainer® Push Button Blood Collection Set (K030573) | Difference between Steripath® Gen2 Blood Collection System and Predicate Device |
| | | | Collection System uses a medical grade pouch for the sterile packaging instead of a tray system.<br><br>Having passed testing per FDA recognized consensus standards for packaging, these differences raise no new questions of safety or effectiveness. |
| Sterilization Method | Ethylene Oxide<br>Steris, Temecula CA | Gamma Radiation<br>Site unknown | The Steripath® Gen2 Blood Collection System uses a different method of sterilization than the predicate device.<br><br>Because the Sterility Assurance Level (SAL) is unchanged (10-6), and the process is validated per FDA recognized consensus standards, the sterilization method change raises no new questions of safety or effectiveness. |
| Item | Steripath® Gen2 Blood<br>Collection System | Predicate Device, BD<br>Vacutainer® Push Button<br>Blood Collection Set<br>(K030573) | Difference between<br>Steripath® Gen2<br>Blood Collection<br>System and<br>Predicate Device |
| Non-pyrogenic | Yes | Yes | Same |
| Shelf Life | 1 year…