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®).

Device Description

The Steripath® Micro Blood Collection System diverts and sequesters the initial portion of the blood specimen (potentially contaminated blood) in the diversion reservoir. When diversion is complete, a subsequent blood sample flows through a second pathway within the device. The subsequent blood sample is collected into a syringe that is used to inoculate culture bottles. Upon removal of the Initial Specimen Diversion Device®, ISDD®, components of the system can be used for infusion per the included manufacturer's instructions for use.

The subject device incorporates multiple syringe oulet accessory configurations that include and three sizes of syringes that are previously cleared as referenced below. The Steripath® Micro Blood Collection System are available:

Steripath®Micro KitModelNumber	ISDD®	Inlet Accessory	Outlet Accessory
4005-EN	P00353	Luer Extension, 7"ICU Medical, Inc.Model B1754-NSK964435	Syringe, 5mlBecton DickinsonModel 301027K980987
4010-EN	P00353	Luer Extension, 7"ICU Medical, Inc.Model B1754-NSK964435	Syringe, 10mlBecton DickinsonModel 301029K980987
4020-EN	P00353	Luer Extension, 7"ICU Medical, Inc.Model B1754-NSK964435	Syringe, 20mlBecton DickinsonModel 301031K980987

AI/ML Overview

The provided document is a 510(k) summary for the Steripath® Micro Blood Collection System (K200661). It details the device's indications for use, technology, comparison to a predicate device, and performance testing. However, it does not contain specific acceptance criteria, reported device performance metrics (e.g., sensitivity, specificity, accuracy, or contamination rates), sample sizes for test sets, data provenance, information about expert ground truth, adjudication methods, MRMC study details, or standalone performance metrics for the aspects related to the "acceptance criteria and study that proves the device meets the acceptance criteria" as requested in the prompt.

The "Summary of Performance Testing" section lists some requirements and states "PASS" for each, but this is a high-level summary and doesn't provide the detailed numbers, methodologies, or study specifics that would typically characterize a study proving device performance against acceptance criteria. It primarily focuses on comparing the new device to its predicate and ensuring it meets safety and functionality standards.

Therefore, many aspects of your request cannot be fulfilled by the provided document.

Here's a breakdown of what can and cannot be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions several requirements and functional tests:

Sequestration
Minimum Vacuum performance
Maximum Vacuum performance
Diversion Volume
Positive Pressure Maximum

For each of these, the "Verification Test Result" is reported as "PASS". However, the actual acceptance criteria (e.g., minimum percentage of sequestration, specific vacuum pressure ranges, specific diversion volume ranges) are not detailed in this document. The "PASS" result indicates the device met unstated criteria.

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified for the listed performance tests.
Data Provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable/Not provided. The performance tests described (e.g., sequestration, vacuum performance) are technical/engineering tests, not clinical evaluations requiring expert interpretation of ground truth in the context of diagnostic accuracy.

4. Adjudication method for the test set:

Not applicable/Not provided. These are technical tests, not diagnostic interpretations.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a blood collection system, not an AI diagnostic device that assists human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a mechanical blood collection system, not an algorithm.

7. The type of ground truth used:

For the listed performance tests (Sequestration, Vacuum performance, Diversion Volume, Positive Pressure Maximum), the "ground truth" would be established by the physical and functional specifications of the device, measured by engineering testing methods. It is not expert consensus, pathology, or outcomes data in a clinical diagnostic sense. The document states "all design verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met."

8. The sample size for the training set:

Not applicable. This is a mechanical device, not an AI/machine learning model that requires a training set.

9. How the ground truth for the training set was established:

Not applicable.

In summary, the provided document focuses on substantiating equivalency to a predicate device through general functional and safety testing, rather than presenting detailed clinical performance study results against specific, quantitatively defined acceptance criteria for diagnostic accuracy or contamination rates with detailed study methodologies. The "PASS" results for functional requirements confirm the device meets its design specifications but lacks the granular data requested in your prompt.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 8, 2020

Magnolia Medical Technologies Inc. Gregory J. Bullington CEO 200 West Mercer Street, Suite 500 Seattle, Washington 98119

Re: K200661

Trade/Device Name: Steripath® Micro Blood Collection System Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: Class II Product Code: JKA. FPA Dated: September 10, 2020 Received: September 10, 2020

Dear Gregory J. Bullington:

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

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

{1}------------------------------------------------

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

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

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

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

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K200661

Device Name Steripath® Micro Blood Collection System

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

Additionally, components of the system may be used for infusion following sample collection after disconnection of the Initial Specimen Diversion Device® (ISDD®).

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

K200661 510(k) Summary

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

510(k) Number: K200661

Date Prepared: September 10, 2020

Submitter:

Magnolia Medical Technologies, Inc. 200 West Mercer Street Suite 500 Seattle WA 98119 Registration number: 3009976527

Contact Person:

Greg Bullington CEO Phone: (888) 617-3420 regulatory@magnolia-medical.com

Trade Name: Steripath® Micro Blood Collection System

Common Name: Blood collection set

Regulation Name: Blood Specimen Collection Device

Regulation Number: 862.1675

Regulatory Class: Class II

Product Code: JKA and FPA

Predicate Device: K192247-Steripath® Gen2 Blood Collection System K192247, Product codes JKA & FPA, Class II

Device Description:

Steripath®Micro KitModelNumber	ISDD®	Inlet Accessory	Outlet Accessory
4005-EN	P00353	Luer Extension, 7"ICU Medical, Inc.Model B1754-NSK964435	Syringe, 5mlBecton DickinsonModel 301027K980987
4010-EN	P00353	Luer Extension, 7"ICU Medical, Inc.Model B1754-NSK964435	Syringe, 10mlBecton DickinsonModel 301029K980987
4020-EN	P00353	Luer Extension, 7"ICU Medical, Inc.Model B1754-NSK964435	Syringe, 20mlBecton DickinsonModel 301031K980987

Table 1: Steripath® Micro Configurations Available

Intended Use/Indications for Use:

The Steripath® Micro Blood Collection System is a system to draw blood for in vitro diagnostic testing.

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

Additionally, components of the system may be used for infusion following sample collection after disconnection of the Initial Specimen Diversion Device® (ISDD®).

{4}------------------------------------------------

Differences in Intended Use/Indications for Use

The Intended Use / Indications for use are the predicate device except that the Micro device removes the venipuncture needles and associated 2 hour limitation on infusion.

Technology:

The Steripath® Micro Blood Collection System is a single use, sterile, mechanical device that initial 0.6mL to 0.9mL of blood from the patient. The Steripath® Micro is designed for patients where maximum allowable total blood draw volume is limited or for patients with difficult venous access. The system consists of an Initial Specimen Diversion Device® (ISDD®) made of injection molded, medical grade plastics. Off-the-Shelf (OTS) components provide interface to the patient vasculature (via a peripheral IV start not provided by Magnolia) and sample collection is achieve by a syringe. Upon removal of the ISDD®, components of the system can be used for infusion per the included manufacturer's instructions for use.

Differences between the Steripath® Micro Blood Collection System and the Predicate Steripath® Gen2 Blood Collection System are noted in Table 2 below.

ltem	Steripath® MicroBlood CollectionSystemK200661	Predicate Device,Steripath® Gen2Blood CollectionSystem (K192247)	Difference betweenSteripath® MicroBlood CollectionSystem andPredicate Device
FR Number(s)	862.1675	862.1675	Same
Product Code	JKA and FPA	JKA and FPA	Same
Classification Name	Blood SpecimenCollection Device	Blood SpecimenCollection Device	Same
Common Name	Blood collection set	Blood collection set	Same
Regulatory Class	Class II	Class II	Same
Intended Use	The Steripath® MicroBlood CollectionSystem is a system todraw blood for in vitrodiagnostic testing.	The Steripath® MicroBlood CollectionSystem is a system todraw blood for in vitrodiagnostic testing.	Same
Indications for Use	The Steripath® MicroBlood CollectionSystem is indicated foruse as a bloodcollection system thatdiverts and sequestersthe initial specimenprior to collection of asubsequent testsample to reduce thefrequency of bloodculture contaminationwhen contaminantsare present in theinitial blood samplecompared to bloodcultures drawn withstandard procedurewithout manualdiversion.Additionally,components of thesystem may be usedfor infusion followingsample collection afterdisconnection of theInitial SpecimenDiversion Device®.	The Steripath® Gen2Blood CollectionSystem is indicated foruse as a bloodcollection system thatdiverts and sequestersthe initial specimenprior to collection of asubsequent testsample to reduce thefrequency of bloodculture contaminationwhen contaminantsare present in theinitial blood samplecompared to bloodcultures drawn withstandard procedurewithout manualdiversion.Additionally,components of thesystem may be usedfor infusion followingsample collection afterdisconnection of theInitial SpecimenDiversion Device®.Venipuncture needlesare indicated for shortterm infusion (lessthan 2 hours).	Indications for usechanged slightly dueto removal ofvenipuncture needles.The changes raise nonew questions ofsafety oreffectiveness.
Contraindications	None	None	Same
Prescription Status	Prescription Use Only	Prescription Use Only	Same

Item	Steripath® MicroBlood CollectionSystem	Predicate Device,Steripath® Gen2Blood CollectionSystem (K192247)	Difference betweenSteripath® MicroBlood CollectionSystem andPredicate Device
Patient Interface(ISDD® InletAccessories)	Luer Extension, 7"ICU Medical, Inc.Model B1754-NSK964435	Blood Collection Set,21GBecton DickinsonModel 367326(K030573)Blood Collection Set,23GBecton DickinsonModel 367324(K030573)Luer Extension, 9"ICU Medical, Inc.Model B1798-NS(K964435)	Micro adds a 7" Luerextension andremoves venipunctureneedle patientinterfaces. Thechanges raise no newquestions of safety oreffectiveness.
CultureBottle/SyringeInterface(ISDD® OutletAccessories)	Syringe, 10mlBecton DickinsonModel 301029(K980987)Syringe, 20mlBecton DickinsonModel 301031(K980987)Syringe, 5mlBecton DickinsonModel 301027K980987	Transfer Adapter,BD Luer-Lok AccessDeviceModel 364902(K991088)BD Bottle InterfaceTransfer Adapter,Saf-T Holder BloodCulture Device withMale Luer AdapterSmiths MedicalModel 96004 &Model 96000S(K081229)BioMerieux® andThermoFisher® BottleinterfacesSyringe, 10mlBecton DickinsonModel 301029(K980987)Syringe, 20mlBecton DickinsonModel 301031(K980987)	Micro adds a 5mLsyringe and removesTransfer Adapterbottle interfaces. Thechanges raise no newquestions of safety oreffectiveness.
Initial SpecimenDiversion Device®(ISDD®)	P00353 BaseAssembly, Steripath®Micro	P00133 BaseAssembly, Gen2	Average Microdiversion volume =0.75mL. AverageGen2 diversionvolume = 1.75mL.Based on theseaverages, a 1mLreduction in diversionvolume raises no newquestions of safety oreffectiveness.Literature supportingMicro diversionvolume is referencedin Patton et al.1
Packaging	Chevron Pouch, 12" x6"TPT-0270 to TPF-0524a	Chevron Pouch, 12" x6"TPT-0270 to TPF-0524a	Same
Sterilization Method	Gamma RadiationSteris, Ontario CA	Ethylene OxideSteris, Temecula CA	The Steripath® Microgamma radiationsterilization process isvalidated to FDArecognized consensusstandards to the samesterility assurancelevel as the predicatedevice (10-6).Therefore this changeraises no new
ltem	Steripath® MicroBlood CollectionSystem	Predicate Device,Steripath® Gen2Blood CollectionSystem (K192247)	Difference betweenSteripath® MicroBlood CollectionSystem andPredicate Device
			questions of safety oreffectiveness.
SAL Level	10-6	10-6	Same
Non-pyrogenic	Yes	Yes	Same
Shelf Life	1 year	1 year	Same
Materials	Medical gradematerials (pvc tubing,medical gradeadhesives,polycarbonate,silicone, TPE)	Medical gradematerials (stainlesssteel, pvc tubing,medical gradeadhesives,polycarbonate)	The Steripath® MicroBlood CollectionSystem has slightlydifferent medicalgrade materials,(thermoplastics, andelastomers) thanSteripath® Gen2.Having completedappropriatebiocompatibility testingper FDA recognizedconsensus standards,the changes inmaterials of theSteripath® Micro ofthe raise no newquestions of safety oreffectiveness.
BiocompatibilityTesting	ISO 10993-1ISO 10993-4ISO 10993-5ISO 10993-10ISO 10993-11	ISO 10993-1ISO 10993-4ISO 10993-5ISO 10993-10ISO 10993-11	The Steripath® Gen2Blood CollectionSystem was tested inaccordance with FDArecognized consensusbiocompatibilitystandards for shortduration, bloodcontacting devices.
TransportEnvironment	ASTM D4169-09distribution cycle 13,assurance level II	ASTM D4169-09distribution cycle 13,assurance level II	Same

{5}------------------------------------------------

{6}------------------------------------------------

Table 2: Substantial Equivalence Table

² Patton RG, Schmitt T. (2010) "Innovation for reducing blood culture contamination: initial specimen diversion technique". J. Clin. Microbio; 48:4501-3

Summary of Performance Testing:

The Steripath® Micro Blood Collection System has been found to its System, Labeling, Controls, Interfaces, Accessory, Functional, Physical, Biological Safety and Packaging required by the risk analysis, all design verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met. It has also been found to FDA consensus, medical device safety and international harmonized standards. Conformity to key medical device safety requirements include:

Sterilization – The system is sterilized using validation processes in conformance with ISO 11137-1 "Sterilization of health care products – Radiation Part 1: Requirement, validation, and routine control of a sterilization process for medical devices".

Aging/Shelf Life Test – The system is validated to achieve an accelerated 1-year shelf-life. Prior to distribution, Accelerated Aging is performed in conformity with ASTM F1980-16 "Standards Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices"

Biological Safety (Biocompatibility Tests) – The system meets the requirements of ISO 10993-1:2018 "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process", for a short duration (<24hrs.), blood path indirect, contacting device. Testing included Cytotoxicity, Sensitization (intracutaneous reactivity), Acute System Toxicity, Pyrogenicity, and Hemocompatibility.

Packaging Integrity Testing / Shipping Tests – The system meets the requirements of ASTM D4169-16, "Standard Practice for Performance Testing of Shipping Containers and Systems", Distribution Cycle 13, Assurance Level II.

Functional and Performance Testing – The system meets its functional requirements for safe and effective performance as noted below.

{7}------------------------------------------------

Requirement	Description	VerificationTest 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: Through performance testing the Sterion System has demonstrated substantial equivalence to the predicate device, the Steripath® Gen2 Blood Collection System (K192247)

Regulation Number and Section

§ 880.5440 Intravascular administration set.

(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.