(193 days)
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).
The Steripath® Gen2 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 either directly into a culture bottle (not provided by Magnolia Medical Technologies), or into a syringe that is used to inoculate culture bottles. 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 subject device incorporates multiple configurations that include various inlet and outlet accessories that are previously cleared as referenced below.
The Steripath® Gen2 Blood Collection System is a single use, sterile, 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).
Here's an analysis of the provided text to extract information about the acceptance criteria and the study proving the device's performance, structured as requested.
The provided document describes a 510(k) premarket notification for the "Steripath® Gen2 Blood Collection System." This type of submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving enhanced effectiveness through a primary clinical endpoint study as might be required for a PMA. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are geared towards showing functional equivalence, safety, and a reasonable expectation of effectiveness, rather than a direct clinical performance study against a defined clinical endpoint for de novo approval.
The primary claim of effectiveness for the Steripath® Gen2 is its ability to reduce the frequency of blood culture contamination. While clinical studies are summarized, the core of the FDA's acceptance for a 510(k) clearance hinges on functional and performance testing, and the demonstration that the new feature (initial specimen diversion) does not raise new questions of safety or effectiveness.
Acceptance Criteria and Reported Device Performance
The "acceptance criteria" for the device are largely derived from its functional requirements and safety standards. The reported device performance indicates that the device passed all these verification tests.
1. Table of Acceptance Criteria and the Reported Device Performance:
| Acceptance Criteria (Requirement) | Description | Reported Device Performance (Verification Test Result) |
|---|---|---|
| Unidirectional movement | Operation of the ISDD® actuator shall result in unidirectional movement. | PASS |
| Diversion state negative pressure | In the diversion state, the ISDD® shall generate negative pressure in the diversion chamber and inlet flow path. | PASS |
| Minimum diversion volume | The ISDD® shall meet the minimum diversion volume requirement. | PASS |
| Diversion compliance | The ISDD shall sequester the diversion volume prior to opening the second sample path. | PASS |
| Fully actuated blood collection | When fully actuated the ISDD shall allow flow through the second sample path. | PASS |
| Actuation Lock | When fully actuated, the ISDD® shall lock-out travel of the actuator. | PASS |
| Actuation force, maximum | The ISDD® shall require less than the maximum force to actuate. | PASS |
| Actuation, blocked inlet | With the inlet blocked, the ISDD® shall remain safe during operation. | PASS |
| Winged needle accessory | The Steripath® Gen2 Blood Collection System shall be supplied with commercially available, sharps-safe, winged, hypodermic needle assembly. | PASS |
| Backflow prevention | The ISDD® shall not be operable in a manner that allows blood towards patient. | PASS |
| Sterilization | The system is sterilized using validated Ethylene Oxide (EO) processes in conformance with ANSI/AAMI/ISO 11135:2014. | Conforms (validated) |
| Aging/Shelf Life Test | The system is validated to achieve a real-time 1-year shelf-life, with Accelerated Aging performed in conformity with ASTM F1980-16. | Conforms (validated, 1-year shelf-life) |
| Biological Safety (Biocompatibility Tests) | The system meets the requirements of ANSI/AAMI/ISO 10993-1:2009/(R)2013 for a short duration (<24hrs), blood path indirect, contacting device. Testing included Cytotoxicity, Sensitization, Irritation (intracutaneous reactivity), Acute System Toxicity, and Hemocompatibility. | Conforms (passed tests) |
| Packaging Integrity Testing / Shipping Tests | The system meets the requirements of ASTM D4169-16, Distribution Cycle 13, Assurance Level II. | Conforms (passed tests) |
Study Proving the Device Meets Acceptance Criteria:
The document describes "Functional and Performance Testing" which includes the "Key Functional and Performance Requirements" listed in the table above. It states: "The system meets its functional requirements for safe and effective performance as noted below." All listed verification test results are "PASS."
Additionally, the submission references clinical testing to support the device's efficacy claim regarding contamination reduction, although the document does not explicitly state these clinical results as "acceptance criteria" for the 510(k) clearance itself, but rather as supportive evidence for the indication for use related to contamination reduction. These are presented as summaries of human studies:
| Study | Institution | Total Samples Collected | Samples Collected Using Steripath® | Reduction in Contamination % Using Steripath® |
|---|---|---|---|---|
| Rupp | U. of Nebraska Medical Center (UNMC) | 1,808 | 904 | 87.6% |
| Bell | Lee Health | 41,685 | 6,293 | 82.8% |
No details are given on specific statistical acceptance criteria for these clinical studies within this summary document (e.g., minimum percentage reduction or hypothesis testing results), as the primary focus for a 510(k) is often substantial equivalence based on safety and functional performance.
Additional Information for the Study
The request includes several points typically associated with AI/ML model validation studies. The provided document concerns a mechanical blood collection device and not an AI/ML system. Therefore, many of these points are not applicable or directly addressed in the provided FDA 510(k) summary for a non-AI device. I will address them to the extent possible, noting when a point is not applicable.
2. Sample size used for the test set and the data provenance:
- Functional/Performance Testing (Test Set): The document states "The Steripath® Gen2 Blood Collection System has been found to conform to its System, Labeling, Controls, Interfaces, Accessory, Functional, Physical, Biological Safety and Packaging requirements." and "functional requirements for safe and effective performance." The specific number of devices tested for each functional requirement (e.g., for "Unidirectional movement" or "Actuation force") is not specified in this summary document.
- Clinical Testing (Test Set):
- Rupp Study: 1,808 total samples, 904 collected using Steripath®.
- Bell Study: 41,685 total samples, 6,293 collected using Steripath®.
- Data Provenance:
- Functional/Performance: Implied to be internal testing by Magnolia Medical Technologies, Inc.
- Clinical: Retrospective or prospective status is not explicitly stated in this summary, but the studies were conducted at U. of Nebraska Medical Center (UNMC) and Lee Health (USA, implicitly, as it's an FDA submission). The Rupp study is identified as a "company sponsored study."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable (N/A) for this device. This pertains typically to AI/ML image analysis, where ground truth often requires expert annotation. For a mechanical blood collection device, "ground truth" for contamination would typically be laboratory culture results, not expert consensus on images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. Again, this is typically for AI/ML studies involving human reader review. The clinical studies here involve laboratory results (blood culture contamination rates), which inherently establish their 'truth' through a standardized, objective process.
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:
- No, an MRMC study was not done. This is a mechanical device, not an AI assistance tool for human readers. The clinical studies compared the device's performance against standard procedure without manual diversion, effectively comparing a new collection method to an older one, not human reader performance with or without AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This device does not have an "algorithm only" mode; it is a physical medical device used for blood collection.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the functional/performance requirements, the "ground truth" is adherence to engineering specifications and relevant standards.
- For the clinical studies, the "ground truth" for contamination reduction would be laboratory blood culture results (positive for contaminants vs. negative), which constitutes clinical outcome data relevant to the device's intended use.
8. The sample size for the training set:
- N/A. As a physical device, there is no "training set" in the context of machine learning. The device design and manufacturing process are developed through engineering and design controls, not data training.
9. How the ground truth for the training set was established:
- N/A. Same reason as above.
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Image /page/0/Picture/0 description: The image contains 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.
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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.200 West Mercer StreetSuite 500Seattle WA 98119Registration number: 3009976527 |
| Contact Person: | John RayDirector of OperationsPhone: 425-985-8061john.ray@magnolia-medical.com |
| 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 theinitial portion of the blood specimen (potentially contaminated blood) in thediversion reservoir. When diversion is complete, a subsequent blood sampleflows through a second pathway within the device. The subsequent bloodsample is collected either directly into a culture bottle (not provided byMagnolia Medical Technologies), or into a syringe that is used to inoculateculture bottles. Upon removal of the ISDD®, components of the system canbe used for infusion per the included manufacturer's instructions for use(note: infusion with butterfly needles is limited to less than 2hrs).The subject device incorporates multiple configurations that include variousinlet 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®Kit ModelNumber | ISDD® | Inlet Accessory | Outlet Accessory |
|---|---|---|---|
| 2700-EN | P00133 | Luer Extension, 9"ICU Medical, Inc.Model B1798-NSK964435 | Transfer AdapterSmith's MedicalModel 96004K081229 |
| 2700-21-EN | P00133 | Blood Collection Set, 21GBecton DickinsonModel 367326K030573 | Transfer AdapterSmith's MedicalModel 96004K081229 |
| 2700-23-EN | P00133 | Blood Collection Set, 23GBecton DickinsonModel 367324K030573 | Transfer AdapterSmith's MedicalModel 96004K081229 |
| 27BD-EN | P00133 | Luer Extension, 9"ICU Medical, Inc.Model B1798-NSK964435 | Becton DickinsonModel 364902K991088 |
| 27BD-21-EN | P00133 | Blood Collection Set, 21GBecton DickinsonModel 367326K030573 | Becton DickinsonModel 364902K991088 |
| 27BD-23-EN | P00133 | Blood Collection Set, 23GBecton DickinsonModel 367324K030573 | Becton DickinsonModel 364902K991088 |
| 27TS-EN | P00133 | Luer Extension, 9"ICU Medical, Inc.Model B1798-NSK964435 | Transfer AdapterSmith's MedicalModel 96000SK081229 |
| 27TS-21-EN | P00133 | Blood Collection Set, 21GBecton DickinsonModel 367326K030573 | Transfer AdapterSmith's MedicalModel 96000SK081229 |
| 27TS-23-EN | P00133 | Blood Collection Set, 23GBecton DickinsonModel 367324K030573 | Transfer AdapterSmith's MedicalModel 96000SK081229 |
| 2710-EN | P00133 | Luer Extension, 9"ICU Medical, Inc.Model B1798-NSK964435 | Syringe, 10mlBecton DickinsonModel 301029K980987 |
| Steripath®Kit ModelNumber | ISDD® | Inlet Accessory | Outlet Accessory |
| 2720-EN | P00133 | Luer Extension, 9"ICU MedicalModel B1798-NSK964435 | Syringe, 20mlBecton DickinsonModel 301031K980987 |
| 2710-21-EN | P00133 | Blood Collection Set, 21GBecton DickinsonModel 367326K030573 | Syringe, 10mlBecton DickinsonModel 301029K980987 |
| 2720-21-EN | P00133 | Blood Collection Set, 21GBecton DickinsonModel 367326K030573 | Syringe, 20mlBecton DickinsonModel 301031K980987 |
| 2710-23-EN | P00133 | Blood Collection Set, 23GBecton DickinsonModel 367324K030573 | Syringe, 10mlBecton DickinsonModel 301029K980987 |
| 2720-23-EN | P00133 | Blood Collection Set, 23GBecton DickinsonModel 367324K030573 | Syringe, 20mlBecton DickinsonModel 301031K980987 |
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Table 5-1 Steripath Configurations
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| Intended Use /Indications for Use | Intended Use/Indications for Use: |
|---|---|
| The Steripath® Gen2 Blood Collection System is a system to draw blood forin vitro diagnostic testing.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 BloodCollection System | Predicate Device, BDVacutainer® Push ButtonBlood Collection Set(K030573) | Difference betweenSteripath® Gen2Blood CollectionSystem andPredicate Device |
| Configurations.Both are intendedto draw blood for invitro diagnostictesting. | |||
| Indications for Use | The Steripath® Gen2Blood Collection System isindicated for use as ablood collection systemthat diverts andsequesters the initialspecimen prior tocollection of a subsequenttest sample to reduce thefrequency of blood culturecontamination whencontaminants are presentin the initial blood samplecompared to bloodcultures drawn withstandard procedurewithout manual diversion.Additionally, componentsof the system may beused for infusion followingsample collection afterdisconnection of the InitialSpecimen DiversionDevice®. Venipunctureneedles are indicated forshort term infusion (lessthan 2 hours). | The BD Vacutainer® PushButton Blood Collection Setis a sterile, multiple sample,single use winged bloodcollection set intended forvenipuncture to obtainblood specimens frompatients.The BD Vacutainer® PushButton Blood Collection Setis also indicated for theintravenous administrationof fluids as indicated in 21CFR 820.5440. It may beused for any patientpopulation withconsideration given topatient size andappropriateness for thesolution being infused andduration of therapy.The recommended use ofthe device is to activate theneedle prior to removalfrom the venipuncture site.The retraction of theintravenous (IV) end of theneedle aids in theprevention of accidentalneedlestick injury. | The predicatedevice is the samecomponent used inthe configurationsof the Steripath®Gen2 BloodCollection System.Configurations.Both are intendedto draw blood for invitro diagnostictesting.The fact that thepredicate deviceindications for usedo not includediversiontechnology doesnot raise newquestions of safetyor effectivenessgiven that:Both the SteripathⓇGen2 BloodCollection Systemand the predicatedevice facilitate thecollection of bloodsamples for avariety of in vitrodiagnostic testsincluding collectionof blood culture |
| Item | Steripath® Gen2 BloodCollection System | Predicate Device, BDVacutainer® Push ButtonBlood Collection Set(K030573) | Difference betweenSteripath® Gen2Blood CollectionSystem andPredicate Device |
| samples. Diversionand sequestrationof 1.5mL to 2.0mLof the initial sampledoes not alter thisintended use orindications for useas compared to thepredicate. | |||
| Diversion andsequestration of1.5mL to 2.0mL ofthe initial sampledoes not raise newquestions of safetyor effectiveness inthe indication ofblood collection. | |||
| Contraindications | None | None | Same |
| Prescription Status | Prescription Use Only | Prescription Use Only | Same |
| Initial SpecimenDiversion Device(ISDD®) | P00133 Base Assembly,Gen2 | None | The Steripath®Gen2 BloodCollection Systemincludes the InitialSpecimen DiversionDevice® to divertand sequester theinitial blood sampleto reduce frequencyof blood culturecontamination.The predicatedevice does notinclude diversiontechnology |
| 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.Having passed testing per FDA recognized consensus standards for packaging, these differences raise no new questions of safety or effectiveness. | |||
| Sterilization Method | Ethylene OxideSteris, Temecula CA | Gamma RadiationSite unknown | The Steripath® Gen2 Blood Collection System uses a different method of sterilization than the predicate device.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 BloodCollection System | Predicate Device, BDVacutainer® Push ButtonBlood Collection Set(K030573) | Difference betweenSteripath® Gen2Blood CollectionSystem andPredicate Device |
| Non-pyrogenic | Yes | Yes | Same |
| Shelf Life | 1 year | 2 years | The Steripath®Gen2 BloodCollection Systemhas a shorter shelf-life than thepredicate device.Because theSteripath® Gen2Blood CollectionSystem meets itsrequirementsfollowing real-timeaging test, thisdifference raises nonew questions ofsafety oreffectiveness. |
| Materials | Medical grade materials(stainless steel, pvctubing, medical gradeadhesives polycarbonate) | Medical grade materials(stainless steel needles, pvctubing, medical gradeadhesives) | The Steripath®Gen2 BloodCollection Systemhas the additionalmedical gradematerials,(thermoplastics,and elastomers)contained in theInitial SpecimenDiversion Device®(ISDD®).Having completedappropriatebiocompatibilitytesting per FDArecognizedconsensusstandards, theaddition of theISDD® materials |
| Item | Steripath® Gen2 BloodCollection System | Predicate Device, BDVacutainer® Push ButtonBlood Collection Set(K030573) | Difference betweenSteripath® Gen2Blood CollectionSystem andPredicate Device |
| raises no newquestions of safetyor effectiveness. | |||
| BiocompatibilityTesting | ISO 10993-1ISO 10993-4ISO 10993-5ISO 10993-10ISO 10993-11 | ISO 10993-1 | The Steripath®Gen2 BloodCollection Systemwas tested inaccordance withFDA recognizedconsensusbiocompatibilitystandards for shortduration, bloodcontacting devices.Having completedappropriatebiocompatibilitytesting per FDArecognizedconsensusstandards, theaddition of theISDD® materialsraises no newquestions of safetyor effectiveness. |
| TransportEnvironment | ASTM D4169-09distribution cycle 13,assurance level II | Unknown | The Steripath®Gen2 BloodCollection Systemwas tested fortransportenvironment asnoted.Having passedtesting per FDArecognizedconsensusstandards fortransportation |
| Item | Steripath® Gen2 BloodCollection System | Predicate Device, BDVacutainer® Push ButtonBlood Collection Set(K030573) | Difference betweenSteripath® Gen2Blood CollectionSystem andPredicate Device |
| environment, thetest differencesraise no newquestions of safetyor effectiveness. |
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Table 5-2 Predicate Device Comparison Table
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PASS
| Summary ofPerformance Testing: | The Steripath® Gen2 Blood Collection System has been found to conform toits System, Labeling, Controls, Interfaces, Accessory, Functional, Physical,Biological Safety and Packaging requirements. It has also been found toconform to FDA consensus, medical device safety and internationalharmonized standards. Conformity to key medical device safetyrequirements include:Sterilization – The system is sterilized using validated Ethylene Oxide (EO)processes in conformance with ANSI/AAMI/ISO 11135:2014 "Sterilization ofHealth Care Products-Ethylene Oxide- Requirements for development,validation, and routine control of sterilization process for medical devices".Aging/Shelf Life Test – The system is validated to achieve a real-time 1-yearshelf-life. Prior to distribution, Accelerated Aging is performed in conformitywith ASTM F1980-16 "Standards Guide for Accelerated Aging of SterileBarrier Systems for Medical Devices"Biological Safety (Biocompatibility Tests) – The system meets therequirements of ANSI/AAMI/ISO 10993-1:2009/(R)2013 "Biologicalevaluation of medical devices – Part 1: Evaluation and testing within a riskmanagement process", for a short duration (<24hrs), blood path indirect,contacting device. Testing included Cytotoxicity, Sensitization, Irritation(intracutaneous reactivity), Acute System Toxicity, and Hemocompatibility.Packaging Integrity Testing / Shipping Tests – The system meets therequirements of ASTM D4169-16, "Standard Practice for PerformanceTesting of Shipping Containers and Systems", Distribution Cycle 13,Assurance Level II.Functional and Performance Testing – The system meets its functionalrequirements for safe and effective performance as noted below.Because the commercially available predicate device is an accessory to theSteripath® Gen2 Blood Collection System, it was included in tests that weredetermined to have potential for impact on the predicate device's ability tosafely meets its cleared intended use as a blood collection device. | ||
|---|---|---|---|
| Requirement | Description | Verification TestResult | |
| Unidirectionalmovement | Operation of the ISDD® actuator shallresult in unidirectional movement. | PASS | |
| Requirement | Description | Verification TestResult | |
| Diversion statenegative pressure | In the diversion state, the ISDD® shallgenerate negative pressure in thediversion chamber and inlet flow path | PASS | |
| Minimumdiversion volume | The ISDD® shall meet the minimumdiversion volume requirement. | PASS | |
| Diversioncompliance | The ISDD shall sequester the diversionvolume prior to opening the secondsample path. | PASS | |
| Fully actuatedblood collection | When fully actuated the ISDD shall allowflow through the second sample path. | PASS | |
| Actuation Lock | When fully actuated, the ISDD® shalllock-out travel of the actuator. | PASS | |
| Actuation force,maximum | The ISDD® shall require less than themaximum force to actuate. | PASS | |
| Actuation,blocked inlet | With the inlet blocked, the ISDD® shallremain safe during operation. | PASS | |
| Winged needleaccessory | The Steripath® Gen2 Blood CollectionSystem shall be supplied withcommercially available, sharps-safe,winged, hypodermic needle assembly. | PASS |
Backflow
prevention
The ISDD® shall not be operable in a
manner that allows blood towards
patient.
{15}------------------------------------------------
Table 5- 3 Key Functional and Performance Requirements
{16}------------------------------------------------
Summary of Clinical Testing
Human studies of the use of the Steripath® Blood Collection System are summarized below. Steripath® results are compared to blood cultures collected using standard procedure without manual diversion.
| TotalSamplesCollected | SamplesCollectedUsingSteripath® | Reduction inContamination% UsingSteripath® | ||
|---|---|---|---|---|
| Investigator | Institution | |||
| Steripath® Studies Comparing Steripath® to standard blood culture proceduredraws (without manual diversion) | ||||
| Rupp1(companysponsoredstudy) | U. of Nebraska MedicalCenter (UNMC) | 1,808 | 904 | 87.6% |
| Bell2 | Lee Health | 41,685 | 6,293 | 82.8% |
Table 5- 4 Clinical Testing
Conclusions: The Steripath® Gen2 Blood Collection System is substantially equivalent to the predicate device, the BD Vacutainer® Push Button Blood Collection Set (K030573).
1 Rupp ME, et al., Reduction in Blood Culture Contamination Through Use of Initial Specimen Diversion Device®, Clinical Infection Diseases, July 2017.
2 Bell M, et al., Effectiveness Of A Novel Specimen Collection System In Reducing Blood Culture Contamination Rates, J Emergency Nursing, November 2018.
§ 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.