(121 days)
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®).
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.
The provided text describes a medical device, the Steripath® Micro Blood Collection System, and its 510(k) premarket notification for substantial equivalence to a predicate device. The information details the device's characteristics and various types of testing performed to demonstrate its safety and effectiveness.
Here's an analysis of the acceptance criteria and the study information as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Requirement | Description | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Sequestration | The ISDD® shall sequester the diversion volume. | Effective sequestration of the diversion volume. | PASS |
| Minimum Vacuum performance. | The ISDD® shall meet its performance requirements under minimum vacuum conditions. | Performance within specifications under minimum vacuum. | PASS |
| Maximum Vacuum performance. | The ISDD® shall meet its performance requirements under maximum vacuum conditions. | Performance within specifications under maximum vacuum. | PASS |
| Diversion Volume. | The ISDD® shall meet the minimum and maximum diversion volume requirements. | Diversion volume between 0.5mL and 1.0mL. | PASS |
| Positive Pressure Maximum | The ISDD® shall remain functionally intact and safe under maximum positive pressure conditions. | Remaining functionally intact and safe under maximum positive pressure. | PASS |
| Sterilization | Compliance with gamma radiation process. | Sterility Assurance Level (SAL) of 10^-6 at 25kGy dose. | Complies |
| Aging/Shelf-Life (12 months) | Maintenance of functional properties over time. | Functional (needle insertion, blood collection, needle retraction, hub attachment, culture bottle septum puncture, blood collection, removal), diversion volume, and pressure rating maintained. | Validated to 12 months |
| Biocompatibility | Meets requirements for biological evaluation. | Compliance with ISO 10993-1 for indicated contact duration. | Meets requirements |
| Packaging Integrity / Shipping | Packaging maintain integrity during transport. | Compliance with ASTM D4169-16, Distribution Cycle 13, Assurance Level II; seal strength, package leaks, drop tests met. | Meets requirements |
| Functional (General) | Meets all functional and performance requirements for safe and effective performance. | Safe and effective performance for intended use. | Successfully meets all |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not explicitly state the sample sizes used for the individual performance tests (sequestration, vacuum, diversion volume, etc.). It describes the types of tests performed (e.g., Sterilization, Aging/Shelf-Life, Biocompatibility, Packaging Integrity, and Performance Testing) and states that "all design verification and validation activities were performed."
The data provenance is not specified in terms of country of origin or whether it was retrospective or prospective data. The testing appears to be primarily laboratory-based engineering and performance verification testing rather than large-scale clinical studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the text. The type of testing described (e.g., sterilization, biocompatibility, mechanical performance) typically relies on established standards and laboratory protocols rather than human expert interpretation for "ground truth" in the way a diagnostic imaging study would.
4. Adjudication Method for the Test Set
This information is not applicable or not provided. Since the testing focuses on objective mechanical and biological properties against established standards, an adjudication method for conflicting expert opinions is not relevant in the context of the described tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done based on the provided text. The submission focuses on device characteristics and performance verification for substantial equivalence, not comparative effectiveness of human readers with or without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, this device is a physical medical device (blood collection system), not an AI algorithm. Therefore, "standalone" algorithm performance is not applicable.
7. The Type of Ground Truth Used
The ground truth used for the device's performance is based on established industry standards and engineering specifications for medical devices. For example:
- Sterilization: Standards like ISO 11137-1.
- Aging/Shelf-Life: Standards like ASTM F1980-16.
- Biocompatibility: Standards like ISO 10993-1.
- Packaging: Standards like ASTM D4169-16.
- Functional requirements (e.g., diversion volume, vacuum performance) are based on the device's design specifications.
8. The Sample Size for the Training Set
This device is not an AI/ML algorithm that requires a training set. Therefore, this information is not applicable.
9. How the Ground Truth for the Training Set Was Established
This device is not an AI/ML algorithm. Therefore, this information is not applicable.
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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 (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
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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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Image /page/3/Picture/0 description: The image contains the logo for Magnolia Medical Technologies. The logo features the word "MAGNOLIA" in a bold, blue font, with a checkmark symbol integrated into the letter "M". Below the word "MAGNOLIA", the words "MEDICAL TECHNOLOGIES" are written in a smaller, gray font.
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 StreetSuite 500Seattle WA 98119Phone: 888-617-3420Registration number: 3009976527 |
| Contact Person: | Donna MatuizekSr. Director of Quality and RegulatoryMagnolia Medical Technologies Inc.Phone: 1 206-558-4760Fax: 206-673-2895donna.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 |
| RegulationNumber: | 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 MicroBlood CollectionSystem - 9in Luer,Wide NeckTransfer Adapter(TA) | Luer Extension,ICU Medical, 9"Length | Wide NeckTransferAdapterAssembly |
| 4000-21UT-EN | P00818-001 | Steripath MicroBlood CollectionSystem - 21GUltraTouch, WideNeck TA | BloodCollection Set,Push Button,UltraTouch,21G, BD, Non-Sterile | Wide NeckTransferAdapterAssembly |
| 4000-23UT-EN | P00818-001 | Steripath MicroBlood CollectionSystem - 23GUltraTouch, WideNeck TA | BloodCollection Set,Push Button,UltraTouch,23G, BD,Non-Sterile | Wide NeckTransferAdapterAssembly |
| 4000-UN-EN | P00818-001 | Steripath MicroBlood CollectionSystem -Universal, WideNeck TA | No inlet | Wide NeckTransferAdapterAssembly |
| 40BD-EN | P00818-001 | Steripath MicroBlood CollectionSystem - 9in Luer,Long Neck TA | Luer Extension,ICU Medical, 9"Length | Long NeckTransferAdapterAssembly |
| 40BD-21UT-EN | P00818-001 | Steripath MicroBlood CollectionSystem - 21GUltraTouch, LongNeck TA | BloodCollection Set,Push Button,UltraTouch,21G, BD,Non-Sterile | Long NeckTransferAdapterAssembly |
| Model No. | Base Assembly | Description | Inlet | Outlet |
| 40BD-23UT-EN | P00818-001 | Steripath MicroBlood CollectionSystem - 23GUltraTouch, LongNeck TA | BloodCollection Set,Push Button,UltraTouch,23G, BD,Non-Sterile | Long NeckTransferAdapterAssembly |
| 40BD-UN-EN | P00818-001 | Steripath MicroBlood CollectionSystem -Universal, LongNeck TA | No inlet | Long NeckTransferAdapterAssembly |
| 4005-EN | P00818-001 | Steripath MicroBlood CollectionSystem - 7in Luer,5mL Syringe | Luer Extension,ICU Medical, 7"Length | Syringe, 5mL,Polypropylene |
| 4005-21UT-EN | P00818-001 | Steripath MicroBlood CollectionSystem - 21GUltraTouch, 5mLSyringe | BloodCollection Set,Push Button,Ultra-Touch,21G, BD,Non-Sterile | Syringe, 5mL,Polypropylene |
| 4005-23UT-EN | P00818-001 | Steripath MicroBlood CollectionSystem - 23GUltraTouch, 5mLSyringe | BloodCollection Set,Push Button,Ultra-Touch,23G, BD,Non-Sterile | Syringe, 5mL,Polypropylene |
| 4005-UN-EN | P00818-001 | Steripath MicroBlood CollectionSystem -Universal, 5mLSyringe | No inlet | Syringe, 5mL,Polypropylene |
| 4010-EN | P00818-001 | Steripath MicroBlood CollectionSystem - 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 MicroBlood CollectionSystem - 21GUltraTouch, 10mLSyringe | BloodCollection Set,Push Button,Ultra-Touch,21G, BD,Non-Sterile | Syringe, 10mL,Polypropylene |
| 4010-23UT-EN | P00818-001 | Steripath MicroBlood CollectionSystem - 23GUltraTouch, 10mLSyringe | BloodCollection Set,Push Button,Ultra-Touch,23G, BD,Non-Sterile | Syringe, 10mL,Polypropylene |
| 4010-UN-EN | P00818-001 | Steripath MicroBlood CollectionSystem -Universal, 10mLSyringe | No inlet | Syringe, 10mL,Polypropylene |
| 4020-EN | P00818-001 | Steripath MicroBlood CollectionSystem - 7in Luer,20mL Syringe | Luer Extension,ICU Medical, 7"Length | Syringe, 20mL,Polypropylene |
| 4020-21UT-EN | P00818-001 | Steripath MicroBlood CollectionSystem - 21GUltraTouch, 20mLSyringe | BloodCollection Set,Push Button,Ultra-Touch,21G, BD,Non-Sterile | Syringe, 20mL,Polypropylene |
| 4020-UN-EN | P00818-001 | Steripath MicroBlood CollectionSystem -Universal, 20mLSyringe | 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
| DeviceCharacteristics | Subject Device | Predicate Device | Comparison of subjectand Predicate |
|---|---|---|---|
| Intended Use | The Steripath® Micro BloodCollection System is asystem to draw blood for in vitro diagnostic testing. | The Steripath® Micro BloodCollection System is asystem to draw blood for in vitro diagnostic testing. | Same |
| Indication for Use | The Steripath® Micro BloodCollection System isindicated for use as a bloodcollection system thatdiverts and sequesters theinitial specimen prior tocollection of a subsequenttest sample to reduce thefrequency of blood culturecontamination whencontaminants are present inthe initial blood samplecompared to blood culturesdrawn with standardprocedure without manualdiversion. | The Steripath® Micro BloodCollection System isindicated for use as a bloodcollection system thatdiverts and sequesters theinitial specimen prior tocollection of a subsequenttest sample to reduce thefrequency of blood culturecontamination whencontaminants are present inthe initial blood samplecompared to blood culturesdrawn with standardprocedure without manualdiversion. | Same |
| Additionally, components ofthe system may be used forinfusion following samplecollection afterdisconnection of the InitialSpecimen Diversion Device(ISDD®). | Additionally, components ofthe system may be used forinfusion following samplecollection afterdisconnection of the InitialSpecimen 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 |
| InletComponents,User Interface | BD Vacutainer® UltraTouch™Push Button BloodCollection Set21GBecton DickinsonModel 367365(K212724)BD Vacutainer® UltraTouch™Push Button BloodCollection Set23G | Luer Extension, 7"ICU Medical, Inc.Model B1754-NS(K964435) | The subject device adds a9" Luer extension as wellas the existing 7" Luerextension. Both Luerextensions aremanufactured by ICUMedical and receivedclearance under K964435.The Patient InterfaceComponents are identicalto the predicate deviceand does not raise new or |
| DeviceCharacteristics | Subject Device | Predicate Device | Comparison of subjectand Predicate |
| Becton DickinsonModel 367364(K212724) | different questions ofsafety or effectiveness. | ||
| Luer Extension, 9"ICU Medical, Inc.Model B1798-NS(K964435) | The predicate device,Steripath® Micro BloodCollection System(K200661), has no needleinlet configurations. Theneedle configurations forthe subject device aremanufactured using non-sterile BD UltraTouch®needles, which areequivalent to thecommercially available BDUltraTouch® Push Button™Blood Collection Set(K212724), except for thesterilization step. TheSteripath® Micro BloodCollection System isvalidated to SAL6, with a25kGy MAX dose and theBD UltraTouch needles(K212724) undergo asingle ~25kGy gammasterilization cycle. Thischange does not raise newor different questions ofsafety or effectiveness. | ||
| Luer Extension, 7"ICU Medical, Inc.Model B1754-NS(K964435) | |||
| None(Device provided withoutinlet component) | The subject deviceincludes no-inletconfigurations forcompatibility with usersupplied venipunctureneedles and IV catheterswith integrated J-Loops,which are commonly usedfor blood collection instandard practice. Thisdoes not raise newquestions of safety oreffectiveness. | ||
| OutletComponents | Syringe, 10mlBecton Dickinson | Syringe, 10mlBecton Dickinson | The only difference is thesubject device adds |
| DeviceCharacteristics | Subject Device | Predicate Device | Comparison of subjectand Predicate |
| Culture BottleInterface | Model 301029(K980987) | Model 301029(K980987) | configurations includingtransfer adapter outletcomponents. The MavericMedical Transfer Adapters(TAs) are off-the-shelfcomponents and interactwith existing blood culturebottle interfacetechnologies. The changesdo not raise any new ordifferent questions ofsafety or effectiveness. |
| Syringe, 20mlBecton DickinsonModel 301031(K980987) | Syringe, 20mlBecton DickinsonModel 301031(K980987) | ||
| Syringe, 5mlBecton DickinsonModel 301027(K980987) | Syringe, 5mlBecton DickinsonModel 301027(K980987) | ||
| Transfer Adapter, MavericMedical Long NeckPN P01045-001BD Bottle Interface | |||
| Transfer Adapter, MavericMedical Wide NeckPN P01042-001BioMerieux® andThermo Fisher® Bottleinterfaces | |||
| Diversion Volume | 0.5mL to 1.0mL | ||
| Mechanism ofDiversion | |||
| Mechanism ofSequesteringDiversion Sample | |||
| DeviceCharacteristics | Subject Device | Predicate Device | Comparison of subjectand Predicate |
| User Workflow | + Access vein+ Draw with syringe orbottle+ Push button to switch path+ Continue to draw withsyringe or bottle | + Access vein+ Draw with syringe+ Push button to switch path+ Continue to draw withsyringe | The only difference is thesubject device also usesconfigurations with atransfer adapter outlet,allowing the user tocomplete blood draw witha culture bottle. Thistechnique is commonlyused for blood collectionin standard practice anddoes not raise new ordifferent questions ofsafety or effectiveness. |
| Diversion DeviceForm Factor | 4cm Long x 2cm Wide x 4cmHigh | 4cm Long x 2cm Wide x 4cmHigh | 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 Material15"x5.5"x4.5"15"x5.5"x7" | E flute Material15"x5.5"x4.5" | A larger Shelf Box is usedfor bulkier configurationswhich incorporate theWide Neck TransferAdapters. This larger ShelfBox is made of the samematerials as the predicatedevice Shelf Box and hascompleted appropriatetransportation andconditioning testing perrecognized FDA consensusstandards. This changedoes not raise new ordifferent questions ofsafety 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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Image /page/10/Picture/0 description: The image shows the logo for Magnolia Medical Technologies. The word "MAGNOLIA" is in large, bold, blue letters, with a checkmark symbol to the left of the word. Below "MAGNOLIA" in smaller, gray letters are the words "MEDICAL TECHNOLOGIES."
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Image /page/11/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 "MAGNOLIA" the words "MEDICAL TECHNOLOGIES" are written in smaller, gray letters.
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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| DeviceCharacteristics | Subject Device | Predicate Device | Comparison of subjectand Predicate |
|---|---|---|---|
| Transport Box | Corrugated Kraft material27.75"x15.25"x14.25"Corrugated Kraft material28.75"x15.625"x9.625" | Corrugated Kraft material27.75"x15.25"x14.25" | A larger Transport Box isused for bulkierconfigurations whichincorporate the WideNeck Transfer Adapters.This larger Transport Boxis made of the samematerials as the predicatedevice Transport Box andhas completedappropriatetransportation andconditioning testing perrecognized FDA consensusstandards. This changedoes not raise new ordifferent questions ofsafety 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 | VerificationTest Result |
|---|---|---|
| Sequestration | The ISDD® shall sequester the diversion volume. | PASS |
| Minimum Vacuumperformance. | The ISDD® shall meet its performancerequirements under minimum vacuum conditions. | PASS |
| Maximum Vacuumperformance. | The ISDD® shall meet its performancerequirements under maximum vacuum conditions. | PASS |
| Diversion Volume. | The ISDD® shall meet the minimum and maximumdiversion volume requirements | PASS |
| Positive PressureMaximum | The ISDD® shall remain functionally intact and safeunder 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.
§ 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.