(124 days)
The Monarch Safety Blood Collection Set is a sterile, multi-sample, single use fixed winged blood collection set. The device is indicated for general medical use in Healthcare Facilities by medical professionals with the patient population to include both adolescent and adult patients. The Monarch Blood Collection Set is intended to be used with evacuated blood collection tubes and/or blood culture bottles. The Monarch Blood Collection device is to remain under direct supervision of a medical professional during use.
The Monarch Blood Collection set includes a safety feature to prevent accidental needlestick injury during normal handling and disposal. The safety feature is initiated by full manual retraction of the needle from the venipuncture site to prevent accidental needlesticks during handling and disposal. The Monarch Blood Collection set is not intended for infusion, IV administration, or transfusion.
The Monarch Blood Collection Set is a sterile, single-use, winged needle with tubing and luer connector. Each Monarch Blood Collection device is individually wrapped in a blister pouch. Monarch Blood collection sets include configurations for three (3) needle gauges (21, 23, 25) each with a tubing length of 12 inches. All the models are included with the back-end needle and a vacutainer holder.
A blood collection assembly, comprises of a needle assembly fixedly coupled to a fingeractivated actuator and tubing, the needle assembly comprising a needle; a hub including a channel in a top surface of the hub, a proximal end and a distal end, the distal end defining a cavity and a distal passageway, the channel slidably engaging the fingeractivated actuator such that when the finger-activated actuator is moved from a first position at a distal end of the hub to a second position toward a proximal end of the hub; an active closure assembly including a door and a biasing mechanism positioned within the cavity such that when the finger-activated actuator is in the second position, the biasing mechanism operates to move the door along the cavity to contact the needle; and a support wall positioned adjacent the cavity such that, when the finger-activated actuator is in the second position, the needle contacts the support wall.
Nature of contact duration for the device is limited exposure ≤ 24 h. Nature of body contact is external communicating device: Circulating blood.
This is a medical device 510(k) summary, not a study evaluating an AI algorithm, therefore, information regarding acceptance criteria, device performance, sample size for test/training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable.
The document describes the Monarch Blood Collection Set and compares it to a predicate device (SOL-GUARD™ Safety Pull-Button Blood Collection Set, K213718) to demonstrate substantial equivalence.
Here's the relevant information from the provided text:
1. A table of acceptance criteria and the reported device performance
This document does not provide a table of acceptance criteria and reported device performance in the context of an AI algorithm study. Instead, it compares the technological characteristics and performance specifications of the Monarch Blood Collection Set to those of a predicate device. The performance aspects listed for the subject device include:
- Sterilization Method: Ethylene Oxide
- Sterility Assurance Level (SAL): 10^-6
- Non-pyrogenic: Yes
- Shelf life: 5 years (demonstrated with performance testing after 5 years of aging)
These are compared against the predicate device's characteristics to show substantial equivalence.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a medical device submission, not an AI algorithm study. There is no "test set" in the context of an AI study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is a medical device submission, not an AI algorithm study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a medical device submission, not an AI algorithm study.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a medical device submission, not an AI algorithm study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device submission, not an AI algorithm study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. This is a medical device submission, not an AI algorithm study. The "ground truth" equivalent would be established by validated test methods and standards for medical devices (e.g., ISO, ASTM standards for sterilization, biocompatibility, needle safety, etc.).
8. The sample size for the training set
Not applicable. This is a medical device submission, not an AI algorithm study.
9. How the ground truth for the training set was established
Not applicable. This is a medical device submission, not an AI algorithm study.
General Device Information from the Document:
The provided document (a 510(k) summary) states that Monarch Blood Collection Set is substantially equivalent to a predicate device (SOL-GUARD Safety Pull-Button Blood Collection Set, K213718).
Study for Device Performance (Non-Clinical Testing):
The document references a comprehensive list of recognized standards and guidance documents under "8. Testing Summary for the Non-Clinical testing" (pages 9-10). These standards cover various aspects of the device's performance, safety, and manufacturing, including:
- Packaging: ISO 11607-1, ISTA-3A, ASTM F1980-21, ASTM F1886/F1886M-16, ASTM F2096-11R19, ASTM F88/F88M-21, ASTM F1929-15
- Sterilization: ISO 11135, ISO 11737-2, ISO 10993-7
- Needle Properties: ISO 7864, ISO 9626
- Small-bore connectors: ISO 80369-7, ISO 80369-20
- Sharps Injury Protection: ISO 23908 (This standard specifically addresses the safety feature to prevent accidental needlestick injuries, which is a key feature of the Monarch Blood Collection Set).
- Biocompatibility (ISO 10993 series):
- Acute Systemic Toxicity
- Complete Blood Count and Leukocyte study
- Cytotoxicity Study
- Genotoxicity Studies (Bacterial reverse mutation, In-Vitro mammalian chromosomal Aberration)
- Hemolysis Study
- Intracutaneous reactivity study
- Material mediated Pyrogenicity Study
- Skin sensitization Study
- Thrombosis Study (Platelet Count and Morphology by SEM image)
- ISO 10993-3 (genotoxicity, carcinogenicity, reproductive toxicity)
- ISO 10993-33 (guidance on genotoxicity)
- ISO 10993-4 (interactions with blood)
- ISO 10993-5 (in vitro cytotoxicity)
- ISO 10993-10 (skin sensitization)
- ISO 10993-11 (systemic toxicity)
- ISO 10993-23 (irritation)
- ISO 10993-17 (leachable substances)
- Other: ANSI AAMI ST72:2019 / USP <Chapter 161> (Bacterial endotoxins), USP Chapter 788 (Particulate matter in Injection)
The statement "Clinical studies are not required to demonstrate substantial equivalence to the predicate device" (page 12) indicates that the non-clinical testing performed in accordance with these recognized standards was deemed sufficient by the FDA to demonstrate the safety and effectiveness of the device.
The study proving the device meets acceptance criteria is implied to be the battery of non-clinical tests performed according to the listed international and national standards. These tests assess various attributes such as sterility, biocompatibility, physical integrity, and the effectiveness of the safety mechanism. The results of these tests, conducted according to the specified methodologies, collectively form the evidence that the device meets the safety and performance requirements for its intended use and is substantially equivalent to the predicate device.
For example, the compliance with ISO 23908 demonstrates that the sharps injury protection feature meets the required standards. Biocompatibility testing per ISO 10993 series ensures the materials used are safe for bodily contact. Shelf-life testing after 5 years of aging, as mentioned in the comparison table, demonstrates the device's performance over its stated shelf life.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 4, 2023
The Monarch Company Pooja Kannam Director of Quality and Regulatory affairs 4000 Eagle Point Corporate Drive Birmingham, Alabama 35242
Re: K232308
Trade/Device Name: Monarch Blood Collection Set Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: Class II Product Code: JKA Dated: November 2, 2023 Received: November 2, 2023
Dear Pooja Kannam:
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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrb/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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/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,
Daniel Walloschek
David Wolloscheck, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices
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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) K232308
Device Name Monarch Blood Collection Set
Indications for Use (Describe)
The Monarch Safety Blood Collection Set is a sterile, multi-sample, single use fixed winged blood collection set. The device is indicated for general medical use in Healthcare Facilities by medical professionals with the patient population to include both adolescent and adult patients. The Monarch Blood Collection Set is intended blood collection tubes and/or blood culture bottles. The Monarch Blood Collection device is to remain under direct supervision of a medical professional during use.
The Monarch Blood Collection set includes a safety feature to prevent accidental needlestick injury during normal handling and disposal. The safety feature is initiated by full manual retraction of the needle from the venipuncture site to prevent accidental needlesticks during handling and disposal. The Monarch Blood Collection set is not intended for infusion, IV administration, or transfusion.
| 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/4/Picture/0 description: The image shows the logo for Monarch blood collection sets. The logo features a blue butterfly on the left, followed by the word "monarch" in blue, bold letters. Below "monarch" is the phrase "blood collection sets" in a smaller, lighter blue font. The "TM" symbol is located to the right of the word "monarch".
K232308: 510K summary For Monarch Blood Collection set
1. Submission date
12/01/2023
2. Submitter Information
The Monarch Company, LLC
4000 Eagle point Corporate Drive
Birmingham, AL, 35242-1900
Contact Information Phone Number Email Address
3. Device Information
Trade/Proprietary name Common Name of device
Product Code Regulatory Class Regulation Number Regulation name Review Panel
Pooja Priyanka Kannam 901-598-1429 poojak@hmg-distribution.com
Monarch Blood Collection Set Blood Collection Set
JKA II 862.1675 Blood Specimen Collection Device Clinical Chemistry
4. Predicate Device
SOL-GUARD™ Safety Pull-Button Blood Collection Set
5. Device Description
The Monarch Blood Collection Set is a sterile, single-use, winged needle with tubing and luer connector. Each Monarch Blood Collection device is individually wrapped in a blister pouch. Monarch Blood collection sets include configurations for three (3) needle gauges (21, 23, 25) each with a tubing length of 12 inches. All the models are included with the back-end needle and a vacutainer holder.
A blood collection assembly, comprises of a needle assembly fixedly coupled to a fingeractivated actuator and tubing, the needle assembly comprising a needle; a hub including a channel in a top surface of the hub, a proximal end and a distal end, the distal end
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Image /page/5/Picture/0 description: The image shows the logo for Monarch blood collection sets. The logo features a blue butterfly on the left, followed by the word "monarch" in blue, block letters. Below "monarch" is the phrase "blood collection sets" in a smaller, blue font. The "TM" symbol is located to the right of the word "monarch".
defining a cavity and a distal passageway, the channel slidably engaging the fingeractivated actuator such that when the finger-activated actuator is moved from a first position at a distal end of the hub to a second position toward a proximal end of the hub; an active closure assembly including a door and a biasing mechanism positioned within the cavity such that when the finger-activated actuator is in the second position, the biasing mechanism operates to move the door along the cavity to contact the needle; and a support wall positioned adjacent the cavity such that, when the finger-activated actuator is in the second position, the needle contacts the support wall.
Nature of contact duration for the device is limited exposure ≤ 24 h. Nature of body contact is external communicating device: Circulating blood.
| Model Name | Configuration |
|---|---|
| M2112 | 21g, 3/4" Needle, 12" tubing, without luer adapter |
| M2312 | 23g, 3/4" Needle, 12" tubing, without luer adapter |
| M2512 | 25g, 3/4" Needle, 12" tubing, without luer adapter |
The Monarch Blood Collection set is available in the following models,
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Image /page/6/Picture/0 description: The image is a logo for "monarch blood collection sets". The word "monarch" is in a large, sans-serif font, and the words "blood collection sets" are in a smaller, sans-serif font below the word "monarch". To the left of the word "monarch" is a stylized butterfly. The letters and butterfly are all in blue.
6. Indications For Use
| Characteristic | Subject DeviceMonarch Safety blood Collection Set | Predicate DeviceSOL-GUARDTM Safety Pull-Button BloodCollection SetK213718 | |
|---|---|---|---|
| Indications forUse | The Monarch Safety Blood Collection Set isa sterile, multi-sample, single use fixedwinged blood collection set. The device isindicated for general medical use inHealthcare Facilities by medicalprofessionals with the patient population toinclude both adolescent and adult patients.The Monarch Blood Collection Set isintended to be used with evacuated bloodcollection tubes and/or blood culture bottles.The Monarch Blood Collection device is toremain under direct supervision of a medicalprofessional during use.The Monarch Blood Collection set includesa safety feature to prevent accidentalneedlestick injury during normal handlingand disposal. The safety feature is initiatedby full manual retraction of the needle fromthe venipuncture site to prevent accidentalneedlesticks during handling and disposal.The Monarch Blood Collection set is notintended for infusion, IV administration, ortransfusion. | The SOL-GUARDTM Safety Pull- Button BloodCollection Set is a sterile, multi-sample, single-use fixed winged blood collection set intendedfor venipuncture to obtain blood specimens fronpatients. When used without the male Lueradapter, the device allows the clinician to obtainblood sampling to the female hub with a syringe,if necessary, or can be used for short-term (up to2 hours), single infusions with considerationgiven to patient size and appropriateness for thesolution being infused. The device is not to beleft in place and remain under the directsupervision of a clinician.The recommended use of the device is toactivate the needle safety feature prior toremoval the venipuncture site.The retraction of the intravenous (IV) end of theneedle aids in the prevention of accidentalneedlesticksinjury. | |
| PrescriptionOnly or Overthe Counter | Prescription Only | Prescription Only | |
| Specification | Subject DeviceMonarch Safety bloodCollection Set | Predicate DeviceSOL-GUARD™ SafetyPull-Button BloodCollection SetK213718 | Comments (Same orDifferent) |
| Indicated forinfusion | No | Yes | Different. Subject device shouldnot be used for infusion. Thesubject device is intended for asubset of the predicate deviceintended use. The difference doesnot raise new or different questionsof safety and effectiveness. |
| Single use | Yes | Yes | Same |
| Activation ofsafety mechanism | Finger Tab That pulls back(Slide actuated) | Pull Button | Subject device has a differentmechanism to retract the needle.The needle safety feature wastested in accordance withISO23908:2011. This differencedoes not impact the safety andeffectiveness of the subjectdevice. |
| Components: | |||
| Needle Gauge Sizes | 21G, 23G, 25G | 21G, 23G, 25G | Same |
| Needle Diameter ID | Thin Wall | Thin Wall | Same |
| Tubing Length | 12" | 7" and 12" | Different. Only one size of tubingis provided by Monarch. Thedevice was adequately tested inaccordance with ISO 80369-7:2021. This difference does notimpact the safety andeffectiveness of the subjectdevice. |
| Needle Length | 0.75" | 0.75" | Same |
| Needle Point | 3-bevel | 3-bevel | Same |
| Performance: | |||
| Sterilization Method | Ethylene Oxide | Ethylene Oxide | Same |
| Sterility AssuranceLevel (SAL) | $10^{-6}$ | $10^{-6}$ | Same |
| Non-pyrogenic | Yes | Yes | Same |
| Shelf life | 5 years | 3 years | Shelf life of the subject device is5 years. Device performance wasconducted after 5 years of agingto demonstrate the deviceperformed to specification overthe 5-year shelf life. Thedifference does not raise any newor different questions of safety |
| Subject Device | Predicate Device | Comments (Same or | |
| Specification | Monarch Safety bloodCollection Set | SOL-GUARD™ SafetyPull-Button BloodCollection Set | Different) |
| K213718 | and effectiveness. | ||
| Materials: | |||
| Needle | Stainless Steel | Stainless Steel | Same |
| Needle/Hub Glue | UV cure Adhesive | Epoxy Glue | The needle was tested inaccordance with ISO 7864:2016and ISO9626:2016.This difference does not impactthe safety and effectiveness of thesubject device. |
| Spring | Stainless Steel | Stainless Steel | Same |
| Needle Hub | MethylMethacrylonitrileButadiene Styrene | Low Density Polyethylene | Different material: however,ISO10993-1 testing demonstratesbiocompatibility of the device.There is no impact to safety andeffectiveness caused by thesubject device |
| Sliding Button | Polypropylene | Polycarbonate | Different material: however,ISO10993-1 testing demonstratesbiocompatibility of the device.There is no impact on the safetyand effective caused by thedifferent type of material used bythe subject device. |
| Door | Polyoxymethylene | N/A | Different. Predicate device doesnot have a door; however, deviceperformance and biocompatibilitytesting demonstrate this differencedoes not impact the safety andeffectiveness of the subjectdevice. |
| Needle Protector | Polypropylene | Low Density Polyethylene | Slightly different for the densityof the material; however, deviceperformance and biocompatibilitytesting demonstrate there is noimpact on the safety andeffectiveness of the subject due tothe density difference of thematerial. |
| Wings | EthylVinyl Acetate | Polyvinyl Chloride | Different material: however,ISO10993-1 testing demonstratesbiocompatibility of the device.This difference does not impactthe safety and effectiveness of thesubject device. |
| Housing A | Acrylonitrile ButadieneStyrene | Polycarbonate | Different material: howeverISO10993-1 testing demonstratesbiocompatibility of the device.This difference does not impact. |
| Specification | Subject DeviceMonarch Safety bloodCollection Set | Predicate DeviceSOL-GUARD™ SafetyPull-Button BloodCollection SetK213718 | Comments (Same orDifferent) |
| Housing B | N/A | Polycarbonate | the safety and effectiveness of thesubject device.Subject device does not havehousing B. This does not impactthe safety or effectiveness of theSubject device. |
| Tubing | Polyvinyl Chloride | Polyvinyl Chloride | Same |
| Female Luer LockConnector | MethylMethacrylonitrileButadiene Styrene | Polyvinyl Chloride | Different material; howeverISO10993-1 testing demonstratesbiocompatibility of the device.This difference does not impactthe safety and effectiveness of thesubject device. |
| Luer Adapter | MethylMethacrylonitrileButadiene Styrene | Luer Adapter Hub:Polypropylene Needle Cap:Low Density PolyethyleneNeedle: Stainless Steel RubberSleeve: Polyisoprene Rubber | Different material; howeverISO10993-1 testing demonstratesbiocompatibility of the device.This difference does not impactthe safety and effectiveness of thesubject device. |
| Holder | CLEARBLEND 165 (animpact modified styrene acryliccopolymer blend) | Polypropylene | Different material; howeverISO10993-1 testing demonstratesbiocompatibility of the device..This difference does not impactthe safety and effectiveness of thesubject device. |
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Image /page/7/Picture/0 description: The image shows the logo for Monarch blood collection sets. The logo features a blue butterfly on the left, followed by the word "monarch" in blue, with "TM" in a smaller font size in the upper right corner. Below "monarch" is the phrase "blood collection sets" in a smaller, blue font.
7. Comparison Table for Technological Characteristics
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Image /page/8/Picture/0 description: The image shows the logo for Monarch blood collection sets. The logo features a blue butterfly on the left, followed by the word "monarch" in blue, bold letters. Below the word "monarch" is the phrase "blood collection sets" in smaller, blue letters. The "TM" symbol is located to the right of the word "monarch".
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Image /page/9/Picture/0 description: The image shows the logo for Monarch blood collection sets. The logo features a blue butterfly on the left, followed by the word "monarch" in blue, bold letters. Below "monarch" is the phrase "blood collection sets" in a smaller, lighter blue font. The "TM" symbol is located to the right of the word "monarch".
8. Testing Summary for the Non-Clinical testing
| Standard or a guidance reference | Description of the standard or guidance | |
|---|---|---|
| ISO 11607-1 Second Edition2019-02 | Packaging for terminally sterilizedmedical devices - Part 1: Requirementsfor materials, sterile barrier systemsand packaging systems | |
| ISO 11135 Second Edition2014-07-15Amendment 1 2018-10 | Sterilization of health-care products –Ethylene oxide — Requirements forthe development, validation androutine control of a sterilizationprocess for medical devices –Amendment 1: Revision of Annex E,Single batch release | |
| ISO 7864 Fourth edition 2016-08-01 | Sterile hypodermic needles for singleuse - Requirements and test methods | |
| Standard or a guidancereference | Description of the standard orguidance | |
| ISO 80369-7 Second edition2021-05 | Small-bore connectors for liquids andgases in healthcare applications - Part7: Connectors for intravascular orhypodermic applications | a. Acute SystemicToxicityb. Complete BloodCount andLeukocyte studyc. Cytotoxicity Studyd. Genotoxicity Study:Bacterial reversemutation |
| ISO 80369-20 First edition2015-05-15 | Small-bore connectors for liquids andgases in healthcare applications - Part20: Common test methods | |
| ISO 23908 First edition 2011-06-11 | Sharps injury protection -Requirements and test methods -Sharps protection features for single-use hypodermic needles, introducersfor catheters and needles used forblood sampling | e. Genotoxicity Study:In-Vitro mammalianchromosomalAberration |
| ISO 9626 Second edition 2016-08-01 | Stainless steel needle tubing for themanufacture of medical devices -Requirements and test methods | f. Hemolysis Studyg. Intracutaneousreactivity studyh. Material mediatedPyrogenicity Studyi. Skin sensitizationStudy |
| ANSI AAMI ST72:2019 /USP <Chapter 161> | Bacterial endotoxins – Test methods,routine monitoring, and alternatives tobatch testing | j. Thrombosis Study(Platelet Count andMorphology bySEM image) |
| ISO 11737-2 Third Edition2019-12 / USP <Chapter 71> | Microbiological methods - Part 2:Tests of sterility performed in thedefinition, validation and maintenanceof a sterilization process | |
| USP Chapter 788 | Particulate matter in Injection | |
| ISO 10993-3 Third Edition2014-10 | Biological evaluation of medicaldevices - Part 3: Tests forgenotoxicity, carcinogenicity andreproductive toxicity | |
| ISO 10993-33 First Edition2015-03 | Biological evaluation of medicaldevices - Part 33: Guidance on teststo evaluate genotoxicity –Supplement to ISO 10993-3 | |
| ISO 10993-4 Third Edition2017-04 | Biological evaluation of medicaldevices--Part 4: Selection of tests forinteractions with blood | |
| ISO 10993-5 Third edition2009-06-01 | Biological evaluation of medicaldevices - Part 5: Tests for in vitrocytotoxicity | |
| Standard or a guidancereference | Description of the standard orguidance | |
| ISO 10993-10 Fourth edition2021-11 | Biological evaluation of medicaldevices - Part 10: Tests for skinsensitization | |
| ISO 10993-11 Third edition2017-09 | Biological evaluation of medicaldevices - Part 11: Tests for systemictoxicity | |
| ISO 10993-23 First Edition2021-01 | Biological evaluation of medicaldevices — Part 23: Tests for irritation | |
| ISO 10993-17 First Edition2002-12-01 | Biological evaluation of medicaldevices —Part 17: Establishment of allowablelimits for leachable substances | |
| ISO 10993-7 Second Edition2008-10-15 Amendment 12019-12 | Biological evaluation of medicaldevices — Part 7: Ethylene oxidesterilization residuals — Amendment1: Applicability of allowable limits forneonates and infants | |
| ASTM F1980-21 | Standard Guide for Accelerated Agingof Sterile Barrier Systems and MedicalDevices | |
| ASTM F1886/F1886M-16 | Standard Test Method for DeterminingIntegrity of Seals for FlexiblePackaging by Visual Inspection | |
| ASTM F2096-11R19 | Standard Test Method for DetectingGross Leaks in Packaging by InternalPressurization (Bubble Test) | |
| ASTM F88/F88M-21 | Standard Test Method for SealStrength of Flexible Barrier Materials | |
| ASTM F1929-15 | Standard Test Method for DetectingSeal Leaks in Porous MedicalPackaging by Dye Penetration | |
| Packaged-Products for Parcel DeliverySystem Shipment 70 kg (150 lb) orless | ||
| ISTA-3A 2018 | Note: Post-Transportation testing wasalso performed on the packaging forVisual Inspection, Seal Strength(tensile) test, and Die Penetrationtesting. |
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Image /page/10/Picture/0 description: The image shows the logo for Monarch blood collection sets. The logo features a blue butterfly on the left side. To the right of the butterfly is the word "monarch" in blue, block letters with the letters getting smaller from left to right. Below the word "monarch" are the words "blood collection sets" in a smaller font.
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Image /page/11/Picture/0 description: The image contains the logo for Monarch blood collection sets. The logo features a blue butterfly on the left side. To the right of the butterfly is the word "monarch" in blue, with the letters in a bold, sans-serif font. Below the word "monarch" are the words "blood collection sets" in a smaller, sans-serif font, also in blue.
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Image /page/12/Picture/0 description: The image shows the logo for Monarch blood collection sets. The logo features a blue butterfly on the left side. To the right of the butterfly is the word "monarch" in blue, block letters, with the letters slightly overlapping each other. Below the word "monarch" are the words "blood collection sets" in a smaller, blue font.
9. Clinical Testing
Clinical studies are not required to demonstrate substantial equivalence to the predicate device.
10. Conclusion
The differences between the predicate device and the subject device do not raise new or different questions of safety or effectiveness. The Monarch Blood Collection Set is substantially equivalent to the SOL-GUARD Safety Pull Button Collection Set, K213718 with respect to indications for use, and technological characteristics.
§ 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.