(279 days)
The SOL-GUARD™ Safety Pull-Button Blood Collection Set is a sterile, multi-sample, single-use fixed winged blood collection set intended for venipuncture to obtain blood specimens . When used without the male Luer adapter, the device allows the clinician to obtain blood sampling to the female hub with a syringe, if necessary, or can be used for short-term (up to 2 hours), single infusions with consideration given to patient size and appropriateness for the solution being infused. The device is not to be left in place and remain under the direct supervision of a clinician.
The recommended use of the device is to activate the needle safety feature prior to removal the venipuncture site.
The retraction of the intravenous (IV) end of the needle aids in the prevention of accidental needlestick injury.
SOL-GUARD™ Safety Pull-Button Blood Collection Set, is a single-use, sterile, winged blood collection needle that can be used for blood collection and/or the short-term (up to 2 hours) infusion of intravenous fluids. The device is offered with butterfly needle set which has either 21-, 23- or 25-gauge needle with integral butterfly wings, offered in two different flexible tubing lengths of 178mm and 305mm, and a safety tube with tubing leading to a female luer connector. The female luer connector is optionally attached to a luer adapter, or luer adapter plus a tube holder.
The device is designed with spring retractable needle technology that allows needle retraction after use to prevent needle stick injury and blood exposure. When the Button on the body of the butterfly is pulled back, the spring is released, and the needle is retracted into the clear plastic safety tube. In the activated position, the needle is completely enclosed within the clear plastic safety tube which guards against accidental needlesticks during normal handling and disposal.
Acceptance Criteria and Device Performance for SOL-GUARD™ Safety Pull-Button Blood Collection Set (K213718)
This document describes the acceptance criteria and study proving the SOL-GUARD™ Safety Pull-Button Blood Collection Set meets those criteria, based on the provided FDA 510(k) summary.
It's important to note that the provided text is a 510(k) summary for a Sharps Injury Protection Device, specifically a blood collection set. The regulatory pathway for this type of device primarily focuses on demonstrating substantial equivalence to a predicate device, rather than a full-scale clinical study that establishes performance against strict, quantifiable clinical acceptance criteria (like sensitivity/specificity for a diagnostic AI). Therefore, the "acceptance criteria" here are largely related to bench testing, biocompatibility, and usability demonstrating equivalent safety and effectiveness to the predicate, particularly regarding the safety mechanism.
The documentation focuses on comparing the subject device to a predicate device (BD Vacutainer® UltraTouch™ Push Button Blood Collection Set, K153309) and demonstrating that any differences do not raise new questions of safety or effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are largely derived from recognized international standards and a demonstration of equivalence to the predicate device. The performance data presented are primarily from bench testing, biocompatibility testing, and simulated usability studies.
| Acceptance Criteria Category | Specific Acceptance Criteria (based on standards/equivalence to predicate) | Reported Device Performance (from studies/tests) |
|---|---|---|
| Safety Mechanism Activation & Effectiveness | Activation: Mechanism for withdrawing the needle must function reliably. Needlestick Prevention: Must adequately prevent accidental needlestick injuries post-use. Jammed Retraction: Resistance to jammed retraction. Unlocking Resistance: Safety shield must resist unintentional unlocking. | All tests (Forces for Activation, Simulated "in-Vein" Needle Retraction, Simulated Jammed Retraction, and Safety Shield Unlocking Resistance) and a Simulated Usability Study demonstrated that the "Pull" motion activates the safety mechanism effectively and provides the same protection as the predicate device. |
| Material Biocompatibility | No adverse biological reactions (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, hemocompatibility). | Passed all biocompatibility tests per ISO 10993 (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Pyrogenicity, Acute systemic toxicity, Hemocompatibility). |
| Sterilization & Sterility Assurance | Sterility Assurance Level (SAL) of 10^-6; acceptable residuals (EO/ECH); non-pyrogenic. | Sterilization validated per ISO 11135, achieving an SAL of 10^-6. Met applicable acceptance criteria for EO and ECH residuals per ISO 10993-7 and pyrogenicity per USP <151>. Bacterial endotoxin testing conducted on every lot in manufacturing to meet 20EU/device. |
| Physical and Performance Characteristics | Adherence to relevant ISO standards for needles, tubing, connectors (e.g., dimensions, flow rates, connector integrity). Acceptable particulate matter levels. | Conformance with ISO 7864, ISO 6009, ISO 8536-4, ISO 9626, ISO 80369-7, ISO 80369-20, ISO 20696, ISO 23908. Particulate matter testing met USP <788> acceptance criteria. |
| Shelf-Life | Device maintains safety and effectiveness over its claimed shelf-life. | Real-time and accelerated shelf-life testing per ASTM F1980-16 demonstrated no impact on safety or effectiveness for a 3-year shelf-life. |
| Packaging Integrity | Maintains sterile barrier. | Sterile Barrier Packaging testing (Peeling force per ASTM F88/F88M, Clean Peel per ISO 11607-1, and ASTM F1929 for Dye Penetration Test) performed. |
| Shipping Integrity | Device and packaging integrity maintained during shipping. | Simulated Shipping per ISTA 3A conducted. |
2. Sample Size Used for the Test Set and Data Provenance
Given the nature of a 510(k) submission for a sharps injury protection device, formal "test sets" of patient data (as one would see for an AI/diagnostic device) are not typically used. The "test set" here refers to:
- Physical device samples used for bench testing (e.g., for force measurements, retraction tests, flow rates). The exact number of samples for each test is not specified in the summary but would be detailed in the full test reports.
- Physical device samples used for biocompatibility testing (extracted materials).
- Volunteer participants for the "Simulated Usability Study." The number of participants is not specified.
Data Provenance: The studies are prospective bench and usability studies conducted by the manufacturer (Sol-Millennium Medical, Inc.). The country of origin for the data is implicitly the location where the manufacturer's testing facilities are based.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
For this type of device, "ground truth" is not established by clinical experts in the sense of diagnosing a condition. Instead, the "ground truth" or "objective criteria" are defined by:
- International standards (ISO, ASTM, USP): These standards define measurable physical and chemical properties and performance benchmarks.
- Engineering specifications and regulatory requirements: Defining what constitutes "safe" and "effective" operation of the device's mechanisms.
- Predicate device performance: Used as a benchmark for equivalence.
Therefore, there wasn't a panel of "experts" (e.g., radiologists) used to establish a clinical ground truth for a test set. Rather, the "ground truth" is based on established engineering principles, validated test methods, and regulatory precedents. Individuals involved would include:
- Engineers and Quality Control personnel: Qualified to design, execute, and interpret bench tests in accordance with relevant standards.
- Toxicologists/Biocompatibility Specialists: Qualified to interpret biocompatibility test results.
- Regulatory Affairs Specialists: Qualified to interpret regulatory requirements and predicate device information.
4. Adjudication Method for the Test Set
Adjudication methods like "2+1" or "3+1" are relevant for subjective interpretations by multiple human readers (e.g., in medical image analysis). For this device, where "ground truth" is based on objective measurements and adherence to standards, such a medical adjudication method is not applicable.
The "adjudication" is inherent in the validation of the test methods themselves (e.g., ensuring they are robust and reproducible) and the interpretation of results against pre-defined acceptance criteria derived from standards or engineering specifications. Any discrepancies in test results would be handled through and internal quality system's investigation and retesting procedures.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was conducted or is applicable for this type of device.
MRMC studies are typically performed for AI-assisted diagnostic devices to assess how AI impacts the diagnostic performance (e.g., accuracy, sensitivity, specificity) of human readers or to compare reader performance with and without AI assistance. This device is a blood collection set with a safety mechanism, not a diagnostic tool requiring human interpretation of complex medical data.
The "human factor" component was addressed through a "Simulated Usability Study" to ensure the safety mechanism is intuitive and effective for users, but this is distinct from an MRMC study.
6. Standalone (Algorithm Only) Performance
Not applicable. This device is a physical medical device, not a software algorithm. Therefore, there is no "standalone" algorithm-only performance to evaluate. The "standalone" performance for this device is its physical and mechanical performance as evaluated through bench testing.
7. Type of Ground Truth Used
The "ground truth" for this device's evaluation is primarily based on:
- Objective physical measurements: Forces, dimensions, flow rates, particulate counts, sterility (measured via biological indicators/analytical tests).
- Adherence to recognized industry standards: ISO, ASTM, USP, which define performance benchmarks and test methodologies.
- Biocompatibility test results: Based on standardized biological assays.
- Simulated use studies: Observing user interaction with the device under controlled, non-clinical conditions.
It does not involve expert consensus on clinical diagnoses, pathology, or patient outcomes data directly for determining the device's classification or performance in the 510(k) context. The device's safety mechanism aims to prevent adverse outcomes (needlestick injuries), and its effectiveness is demonstrated through mechanical reliability, not by analyzing patient outcome data from a clinical trial.
8. Sample Size for the Training Set
Not applicable. As this is a physical medical device and not an AI/machine learning algorithm, there is no "training set" of data in the computational sense. The device's design is based on engineering principles and iterative development, not on training a model with data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set. The design and manufacturing processes for the device are governed by quality management systems (e.g., 21 CFR Part 820 Quality System Regulation). Performance characteristics are verified through design validation and verification activities, not machine learning training.
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August 30, 2022
Sol-Millennium Medical, Inc. PJ Pasia Director, Regulatory Affair 315 Shawnee North Drive Suite 100. Suwanee, Georgia 30024
Re: K213718
Trade/Device Name: SOL-GUARD Safety Pull Button Collection Set Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: Class II Product Code: JKA, FPA Dated: August 1, 2022 Received: August 2, 2022
Dear PJ Pasia:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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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,
David Wolloscheck, Ph.D. For Payal Patel 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) K213718
Device Name
SOL-GUARD™ Safety Pull-Button Blood Collection Set
Indications for Use (Describe)
The SOL-GUARD™ Safety Pull-Button Blood Collection Set is a sterile, multi-sample, single-use fixed winged blood collection set intended for venipuncture to obtain blood specimens . When used without the male Luer adapter, the device allows the clinician to obtain blood sampling to the female hub with a syringe, if necessary, or can be used for short-term (up to 2 hours), single infusions with consideration given to patient size and appropriateness for the solution being infused. The device is not to be left in place and remain under the direct supervision of a clinician.
The recommended use of the device is to activate the needle safety feature prior to removal the venipuncture site.
The retraction of the intravenous (IV) end of the needle aids in the prevention of accidental needlestick injury.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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K213718. 510(k) Summary
August 30, 2022 Date Prepared:
Submitter Information A.
Sol-Millennium Medical, Inc. 315 Shawnee North Drive, Suite 100 Suwanee, GA 30024 Contact Person: PJ Pasia Phone Number: 847-363-1264
B. Device Information
| Trade/Proprietary Name: | SOL-GUARD™ Safety Pull-Button BloodCollection Set |
|---|---|
| Common name of device: | Tubes, Vials, Systems, Serum Separators,Blood Collection |
| Product Code: | JKA, FPA |
| Regulatory Class: | II |
| Regulation Number: | 862.1675 |
| Regulation Name: | Blood Specimen Collection Device |
| Review Panel | Clinical Chemistry |
C. Predicate Device
| K153309 | BD Vacutainer® UltraTouch™ Push | |
|---|---|---|
| Button Blood Collection Set |
D. Device Description
SOL-GUARD™ Safety Pull-Button Blood Collection Set, is a single-use, sterile, winged blood collection needle that can be used for blood collection and/or the short-term (up to 2 hours) infusion of intravenous fluids. The device is offered with butterfly needle set which has either 21-, 23- or 25-gauge needle with integral butterfly wings, offered in two different flexible tubing lengths of 178mm and 305mm, and a safety tube with tubing leading to a female luer connector. The female luer connector is optionally attached to a luer adapter, or luer adapter plus a tube holder.
The device is designed with spring retractable needle technology that allows needle retraction after use to prevent needle stick injury and blood exposure. When the Button on the body of the butterfly is pulled back, the spring is released, and the needle is retracted into the clear plastic safety tube. In the activated position, the needle is completely enclosed within the clear plastic safety tube which guards against accidental needlesticks during normal handling and disposal.
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The SOL-GUARD™ Safety Pull-Button Blood Collection Set is comprised of 3 different configurations as shown below.
| Model Name | Attachments |
|---|---|
| SOL-GUARD™ Safety Pull-Button Blood Collection Setwith Pre-attached Holder | Provided with pre-assembledLuer adapter and Tube holder |
| SOL-GUARD™ Safety Pull-Button Blood Collection Setwith Luer Adapter | Provided with Luer adapter only |
| SOL-GUARD™ Safety Pull-Button IV Infusion Set | No attachment provided |
E. Indications for Use
| Characteristic | Subject DeviceSOL-GUARD™ Safety Pull-ButtonBlood Collection SetK213718 | Predicate DeviceBD Vacutainer UltraTouch PushButton Blood Collection SetK153309 |
|---|---|---|
| Indicationsfor Use | The SOL-GUARD™ Safety Pull-Button Blood Collection Set is asterile, multi-sample, single-use fixedwinged blood collection set intendedfor venipuncture to obtain bloodspecimens from patients. When usedwithout the male Luer adapter, thedevice allows the clinician to obtainblood sampling to the female hubwith a syringe, if necessary, or can beused for short-term (up to 2 hours),single infusions with considerationgiven to patient size andappropriateness for the solution beinginfused. The device is not to be left inplace and remain under the directsupervision of a clinician.The recommended use of the deviceis to activate the needle safety featureprior to removal the venipuncturesite.The retraction of the intravenous (IV)end of the needle aids in theprevention of accidental needlesticksinjury. | The BD Vacutainer UltraTouch PushButton Blood Collection Set is asterile, multi-sample, single-usefixed winged blood collection setintended for venipuncture to obtainblood specimens from patients.When used without the male lueradapter, the device allows theclinician to obtain blood sampling tothe female hub with a syringe, ifnecessary, or can be used for short-term, single infusions withconsideration given to patient sizeand appropriateness for the solutionbeing infused. The device is not tobe left in place and remain under thedirect supervision of a clinician.The recommended use of the deviceis to activate the needle safetyfeature prior to removal from thevenipuncture site.The retraction of the intravenous(IV) end of the needle aids in theprevention of accidental needlestickinjury. |
| PrescriptionOnly or Overthe Counter | Prescription Only | Prescription Only |
There is minor difference to the Indications for Use Statement between the predicate and the subject device. The duration of usage in the Indication for Use statement, "up to 2
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hours" versus "short term" is not an actual difference. The predicate device's maximum time for infusion is also up to 2 hours, according to predicate's IFU, except not stated in their Indication for Use statement. Specifying the duration of use provides clarity and does not affect safety or effectiveness or raise different questions of safety and effectiveness.
F. Comparison of Technological Characteristics
Information was submitted to demonstrate that there are no significant differences in technological characteristics between the SOL-GUARD™ Safety Pull-button Blood Collection Set and the BD Vacutainer® UltraTouch Push Button Blood Collection Set. The following comparison chart and discussions show that the subject device and the predicate device are substantially equivalent.
| Specification | Subject Device | Predicate Device | Comments |
|---|---|---|---|
| SOL-GUARD SafetyPull-Button BloodCollection SetK213718 | BD VacutainerUltratech Push ButtonBlood Collection SetK153309 | (Same or Different) | |
| Indicated for infusion | Yes | Yes | Same |
| Single use | Yes | Yes | Same |
| Activation of safety mechanism | Pull Button | Push Button | Different /See comment #1 |
| Components: | |||
| Needle Gauge Sizes | 21G, 23G, 25G | 21G, 23G, 25G | Same |
| Needle Diameter ID | Thin Wall | Ultra-Thin Wall | Different /See comment #2 |
| Tubing Length | 7" and 12" | 7" and 12" | Same |
| Needle Length | 0.75" | 0.75" | Same |
| Needle Point | 3-bevel | 5-bevel | Different /See comment #3 |
| Performance: | |||
| Sterilization Method | Ethylene Oxide | Gamma | Different /See comment #4 |
| Sterility Assurance Level (SAL) | 10-6 | 10-6 | Same |
| Non-pyrogenic | Yes | Yes | Same |
| Shelf life | 3 years | 2 years | Different /See comment #5 |
| Materials: | |||
| Needle | Stainless Steel | Stainless Steel | Different /See comment #6 |
| Needle/Hub Glue | Epoxy Glue | UV cure adhesive | |
| Spring | Stainless Steel | Stainless Steel |
SIDE BY SIDE COMPARISON TABLE
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| Specification | Subject DeviceSOL-GUARD SafetyPull-Button BloodCollection SetK213718 | Predicate DeviceBD VacutainerUltratech Push ButtonBlood Collection SetK153309 | Comments(Same or Different) |
|---|---|---|---|
| Needle Hub | Low DensityPolyethylene | Polypropylene | |
| Sliding Button | Polycarbonate | Polypropylene | |
| Needle Protector | Low DensityPolyethylene | Polyethylene | |
| Wings | Polyvinyl Chloride | Polyolefin | |
| Housing A | Polycarbonate | Polypropylene | |
| Housing B | Polycarbonate | Acrylic | |
| Tubing | Polyvinyl Chloride | Polyvinyl Chloride | |
| Female Luer LockConnector | Polyvinyl Chloride | Acrylonitrile-butadiene-styrene | |
| Luer Adapter | Luer Adapter Hub:PolypropyleneNeedle Cap: LowDensity PolyethyleneNeedle: Stainless SteelRubber Sleeve:Polyisoprene Rubber | Luer Adapter hub:PolypropyleneNeedle Cap: PolypropyleneNeedle: Stainless SteelRubber Sleeve: SyntheticIsoprene Rubber | |
| Holder | Polypropylene | unknown |
Discussions of Differences in Technological Characteristics
Comment 1: Activation of safety mechanism
For the subject device, to activate the safety mechanism, the button on the body of the butterfly is pulled back, while the predicate device requires to push the button. Both (pull and push) actions allow the release of the internal spring that withdraws the needle from the patient's arm into the safety tube of the blood collection device. Both bench testing (Forces for Activation, Simulated "in-Vein" Needle Retraction, Simulated Jammed Retraction, and Safety Shield Unlocking Resistance) and Simulated Usability Study demonstrated that the "Pull" motion can activate the safety mechanism and provide the same protection for needlestick injury as the predicate device. This difference does not affect safety or effectiveness or raise different questions of safety and effectiveness.
Comment 2: Needle Diameter Wall
Although the predicate has an Ultra-Thin wall, its original version was a thin-walled needle covered under K030573 (predicate of BD Vacutainer UltraTouch Push Button Blood Collection Set). The difference in needle wall thickness does not raise any questions of safety and effectiveness.
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Comment 3: Needle Point
Although the predicate has a 5-bevel needle point, its original version was a 3-bevel needle point covered under K030573 (predicate of BD Vacutainer UltraTouch Push Button Blood Collection Set). The difference in bevel type does not raise any questions of safety and effectiveness.
Comment 4: Sterilization Method
The sterilization validation per ISO 11135 shows that the subject device can reach the same sterilization assurance level as predicate device and there is no impact to safety and effectiveness caused by using Ethylene Oxide sterilization.
Comment 5: Shelf life
The real time and accelerated shelf-life testing per ASTM F1980-16 were conducted on subject device, demonstrating no safety and effectiveness were impacted by the prolonged shelf life.
Comment 6: Materials
The biocompatibility per ISO 10993 and performance testing showed that differences in materials of construction do not raise any questions of safety or effectiveness.
G. Performance Testing
The SOL-GUARD Safety Pull-Button Blood Collection Set described in this summary were tested and demonstrated to be in conformance with the following FDA recognized standards:
- . ISO 7864:2016: Sterile hypodermic needles for single use - Requirements and test methods
- ISO 6009:2016: Hypodermic needles for single use - Colour coding for identification
- ISO 8536-4:2019: Infusion equipment for medical use Part 4: Infusion sets for ● single use, gravity feed
- ISO 9626:2016: Stainless steel needle tubing for the manufacture of medical ● devices - Requirements and test methods
- . ISO 80369-7:2021: Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
- ISO 80369-20:2015: Small-bore connectors for liguids and gases in healthcare . applications - Part 20: Common test methods
- ISO 20696:2018: Sterile urethral catheters for single use
- ISO 23908:2011: Sharps injury protection Requirements and test methods -. Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
Biocompatibility
In accordance with ISO 10993-1, the needle is classified as: Externally Communicating Device, Blood Path Indirect, Limited Contact (<24 hours). The following testing were conducted:
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- Cytotoxicity
- Sensitization
- Intracutaneous Reactivity ●
- Pyrogenicity
- Acute systemic toxicity ●
- Hemocompatibility
Particulate Matter
Particulate matter testing was conducted in accordance with USP <788> Particulate Matter in Injections and met the USP acceptance criteria.
Sterility, Pyrogen, Shelf-life, Bacterial Endotoxin, and Shipping
The subject device is intended to be sterilized with Ethylene Oxide procedures validated per ISO 11135. The subject device met applicable acceptance criteria for EO and ECH residuals per ISO 10993-7 and pyrogenicity per USP <151>. The following additional tests were conducted:
- Sterile Barrier Packaging testing (Peeling force per ASTM F88/F88M, Clean Peel per ISO 11607-1, and ASTM F1929 for Dye Penetration Test).
- 3-year shelf-life test per ASTM F1980-16 Standard Guide for Accelerated Aging ● of Sterile Barrier Systems for Medical Devices.
- Bacterial Endotoxin testing per European pharmacopoeia 10.2.6.14.
- Simulated Shipping per ISTA 3A Packaged-Product for Parcel Delivery System ● Shipments 70kg (150lb) or Less.
In addition, bacterial endotoxin testing is conducted on every lot during manufacturing to meet pyrogen limit specification 20EU/device.
H. Conclusion
The differences between the subject and the predicate devices do not raise any new or different questions of safety and effectiveness. Based on the information provided in this submission, the subject devices, have been determined to be substantially equivalent to the predicate device, BD Vacutainer® UltraTouch™ Push Button Blood Collection Set.
§ 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.