(124 days)
Not Found
No
The description focuses on the mechanical design and safety features of a blood collection set, with no mention of AI or ML.
No
The device is described as a blood collection set, intended for drawing blood samples, not for treating a disease or condition. The "Intended Use" explicitly states it's "not intended for infusion, IV administration, or transfusion," which would typically be therapeutic applications.
No.
The device is a blood collection set used to draw blood samples, not to perform a diagnostic test itself. The blood collected with this device would then be sent to a lab for diagnostic testing.
No
The device description clearly details a physical blood collection set with needles, tubing, and a safety mechanism, indicating it is a hardware device, not software-only.
Based on the provided text, the Monarch Safety Blood Collection Set is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the collection of blood samples. It does not describe any diagnostic testing or analysis of the collected blood.
- Device Description: The device is a blood collection set, consisting of a needle, tubing, and connector. Its function is to facilitate the withdrawal of blood from a patient.
- Lack of Diagnostic Function: There is no mention of any components or processes within the device that perform diagnostic testing on the blood sample.
- Clinical Studies: The document states that clinical studies were not required, which is often the case for devices that are solely for sample collection and not for diagnostic purposes.
IVD devices are specifically designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Monarch Safety Blood Collection Set's function is limited to the collection of the sample itself.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
JKA
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 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 : Bacterial endotoxins – Test methods, routine monitoring, and alternatives to batch testing
- ISO 11737-2 Third Edition 2019-12 / USP : Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
- USP Chapter 788: Particulate matter in Injection
- ISO 10993-3 Third Edition 2014-10: Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
- ISO 10993-33 First Edition 2015-03: Biological evaluation of medical devices - Part 33: Guidance on tests to evaluate genotoxicity – Supplement to ISO 10993-3
- ISO 10993-4 Third Edition 2017-04: Biological evaluation of medical devices--Part 4: Selection of tests for interactions with blood
- ISO 10993-5 Third edition 2009-06-01: Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10 Fourth edition 2021-11: Biological evaluation of medical devices - Part 10: Tests for skin sensitization
- ISO 10993-11 Third edition 2017-09: Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
- ISO 10993-23 First Edition 2021-01: Biological evaluation of medical devices — Part 23: Tests for irritation
- ISO 10993-17 First Edition 2002-12-01: Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
- ISO 10993-7 Second Edition 2008-10-15 Amendment 1 2019-12: Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals — Amendment 1: Applicability of allowable limits for neonates and infants
- ASTM F1980-21: Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices
- ASTM F1886/F1886M-16: Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
- ASTM F2096-11R19: Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
- ASTM F88/F88M-21: Standard Test Method for Seal Strength of Flexible Barrier Materials
- ASTM F1929-15: Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
- ISTA-3A 2018: Packaged-Products for Parcel Delivery System Shipment 70 kg (150 lb) or less (Note: Post-Transportation testing was also performed on the packaging for Visual Inspection, Seal Strength (tensile) test, and Die Penetration testing.)
Biological evaluation tests conducted include:
a. Acute Systemic Toxicity
b. Complete Blood Count and Leukocyte study
c. Cytotoxicity Study
d. Genotoxicity Study: Bacterial reverse mutation
e. Genotoxicity Study: In-Vitro mammalian chromosomal Aberration
f. Hemolysis Study
g. Intracutaneous reactivity study
h. Material mediated Pyrogenicity Study
i. Skin sensitization Study
j. Thrombosis Study (Platelet Count and Morphology by SEM image)
Clinical studies are not required to demonstrate substantial equivalence to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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).
1
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
2
Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
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
5
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 Device
Monarch Safety blood Collection Set | Predicate Device
SOL-GUARDTM Safety Pull-Button Blood
Collection Set
K213718 | |
|---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | 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 SOL-GUARDTM 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 fron
patients. 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
needlesticks
injury. | |
| Prescription
Only or Over
the Counter | Prescription Only | Prescription Only | |
| Specification | Subject Device
Monarch Safety blood
Collection Set | Predicate Device
SOL-GUARD™ Safety
Pull-Button Blood
Collection Set
K213718 | Comments (Same or
Different) |
| Indicated for
infusion | No | Yes | Different. Subject device should
not be used for infusion. The
subject device is intended for a
subset of the predicate device
intended use. The difference does
not raise new or different questions
of safety and effectiveness. |
| Single use | Yes | Yes | Same |
| Activation of
safety mechanism | Finger Tab That pulls back
(Slide actuated) | Pull Button | Subject device has a different
mechanism to retract the needle.
The needle safety feature was
tested in accordance with
ISO23908:2011. This difference
does not impact the safety and
effectiveness of the subject
device. |
| 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 tubing
is provided by Monarch. The
device was adequately tested in
accordance with ISO 80369-7
:2021. This difference does not
impact the safety and
effectiveness of the subject
device. |
| Needle Length | 0.75" | 0.75" | Same |
| Needle Point | 3-bevel | 3-bevel | Same |
| Performance: | | | |
| Sterilization Method | Ethylene Oxide | Ethylene Oxide | Same |
| Sterility Assurance
Level (SAL) | $10^{-6}$ | $10^{-6}$ | Same |
| Non-pyrogenic | Yes | Yes | Same |
| Shelf life | 5 years | 3 years | Shelf life of the subject device is
5 years. Device performance was
conducted after 5 years of aging
to demonstrate the device
performed to specification over
the 5-year shelf life. The
difference does not raise any new
or different questions of safety |
| | Subject Device | Predicate Device | Comments (Same or |
| Specification | Monarch Safety blood
Collection Set | SOL-GUARD™ Safety
Pull-Button Blood
Collection Set | Different) |
| | | K213718 | and effectiveness. |
| Materials: | | | |
| Needle | Stainless Steel | Stainless Steel | Same |
| Needle/Hub Glue | UV cure Adhesive | Epoxy Glue | The needle was tested in
accordance with ISO 7864:2016
and ISO9626:2016.
This difference does not impact
the safety and effectiveness of the
subject device. |
| Spring | Stainless Steel | Stainless Steel | Same |
| Needle Hub | MethylMethacrylonitrile
Butadiene Styrene | Low Density Polyethylene | Different material: however,
ISO10993-1 testing demonstrates
biocompatibility of the device.
There is no impact to safety and
effectiveness caused by the
subject device |
| Sliding Button | Polypropylene | Polycarbonate | Different material: however,
ISO10993-1 testing demonstrates
biocompatibility of the device.
There is no impact on the safety
and effective caused by the
different type of material used by
the subject device. |
| Door | Polyoxymethylene | N/A | Different. Predicate device does
not have a door; however, device
performance and biocompatibility
testing demonstrate this difference
does not impact the safety and
effectiveness of the subject
device. |
| Needle Protector | Polypropylene | Low Density Polyethylene | Slightly different for the density
of the material; however, device
performance and biocompatibility
testing demonstrate there is no
impact on the safety and
effectiveness of the subject due to
the density difference of the
material. |
| Wings | EthylVinyl Acetate | Polyvinyl Chloride | Different material: however,
ISO10993-1 testing demonstrates
biocompatibility of the device.
This difference does not impact
the safety and effectiveness of the
subject device. |
| Housing A | Acrylonitrile Butadiene
Styrene | Polycarbonate | Different material: however
ISO10993-1 testing demonstrates
biocompatibility of the device.
This difference does not impact. |
| Specification | Subject Device
Monarch Safety blood
Collection Set | Predicate Device
SOL-GUARD™ Safety
Pull-Button Blood
Collection Set
K213718 | Comments (Same or
Different) |
| Housing B | N/A | Polycarbonate | the safety and effectiveness of the
subject device.
Subject device does not have
housing B. This does not impact
the safety or effectiveness of the
Subject device. |
| Tubing | Polyvinyl Chloride | Polyvinyl Chloride | Same |
| Female Luer Lock
Connector | MethylMethacrylonitrile
Butadiene Styrene | Polyvinyl Chloride | Different material; however
ISO10993-1 testing demonstrates
biocompatibility of the device.
This difference does not impact
the safety and effectiveness of the
subject device. |
| Luer Adapter | MethylMethacrylonitrile
Butadiene Styrene | Luer Adapter Hub:
Polypropylene Needle Cap:
Low Density Polyethylene
Needle: Stainless Steel Rubber
Sleeve: Polyisoprene Rubber | Different material; however
ISO10993-1 testing demonstrates
biocompatibility of the device.
This difference does not impact
the safety and effectiveness of the
subject device. |
| Holder | CLEARBLEND 165 (an
impact modified styrene acrylic
copolymer blend) | Polypropylene | Different material; however
ISO10993-1 testing demonstrates
biocompatibility of the device..
This difference does not impact
the safety and effectiveness of the
subject 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".
9
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 Edition | ||
| 2019-02 | Packaging for terminally sterilized | |
| medical devices - Part 1: Requirements | ||
| for materials, sterile barrier systems | ||
| and packaging systems | ||
| ISO 11135 Second Edition | ||
| 2014-07-15 | ||
| Amendment 1 2018-10 | Sterilization of health-care products – | |
| Ethylene oxide — Requirements for | ||
| the development, validation and | ||
| routine control of a sterilization | ||
| process for medical devices – | ||
| Amendment 1: Revision of Annex E, | ||
| Single batch release | ||
| ISO 7864 Fourth edition 2016- | ||
| 08-01 | Sterile hypodermic needles for single | |
| use - Requirements and test methods | ||
| Standard or a guidance | ||
| reference | Description of the standard or | |
| guidance | ||
| ISO 80369-7 Second edition | ||
| 2021-05 | Small-bore connectors for liquids and | |
| gases in healthcare applications - Part | ||
| 7: Connectors for intravascular or | ||
| hypodermic applications | a. Acute Systemic | |
| Toxicity | ||
| b. Complete Blood | ||
| Count and | ||
| Leukocyte study | ||
| c. Cytotoxicity Study | ||
| d. Genotoxicity Study: | ||
| Bacterial reverse | ||
| mutation | ||
| ISO 80369-20 First edition | ||
| 2015-05-15 | Small-bore connectors for liquids and | |
| gases in healthcare applications - Part | ||
| 20: 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, introducers | ||
| for catheters and needles used for | ||
| blood sampling | e. Genotoxicity Study: | |
| In-Vitro mammalian | ||
| chromosomal | ||
| Aberration | ||
| ISO 9626 Second edition 2016- | ||
| 08-01 | Stainless steel needle tubing for the | |
| manufacture of medical devices - | ||
| Requirements and test methods | f. Hemolysis Study | |
| g. Intracutaneous | ||
| reactivity study | ||
| h. Material mediated | ||
| Pyrogenicity Study | ||
| i. Skin sensitization | ||
| Study | ||
| ANSI AAMI ST72:2019 / | ||
| USP | Bacterial endotoxins – Test methods, | |
| routine monitoring, and alternatives to | ||
| batch testing | j. Thrombosis Study | |
| (Platelet Count and | ||
| Morphology by | ||
| SEM image) | ||
| ISO 11737-2 Third Edition | ||
| 2019-12 / USP | Microbiological methods - Part 2: | |
| Tests of sterility performed in the | ||
| definition, validation and maintenance | ||
| of a sterilization process | ||
| USP Chapter 788 | Particulate matter in Injection | |
| ISO 10993-3 Third Edition | ||
| 2014-10 | Biological evaluation of medical | |
| devices - Part 3: Tests for | ||
| genotoxicity, carcinogenicity and | ||
| reproductive toxicity | ||
| ISO 10993-33 First Edition | ||
| 2015-03 | Biological evaluation of medical | |
| devices - Part 33: Guidance on tests | ||
| to evaluate genotoxicity – | ||
| Supplement to ISO 10993-3 | ||
| ISO 10993-4 Third Edition | ||
| 2017-04 | Biological evaluation of medical | |
| devices--Part 4: Selection of tests for | ||
| interactions with blood | ||
| ISO 10993-5 Third edition | ||
| 2009-06-01 | Biological evaluation of medical | |
| devices - Part 5: Tests for in vitro | ||
| cytotoxicity | ||
| Standard or a guidance | ||
| reference | Description of the standard or | |
| guidance | ||
| ISO 10993-10 Fourth edition | ||
| 2021-11 | Biological evaluation of medical | |
| devices - Part 10: Tests for skin | ||
| sensitization | ||
| ISO 10993-11 Third edition | ||
| 2017-09 | Biological evaluation of medical | |
| devices - Part 11: Tests for systemic | ||
| toxicity | ||
| ISO 10993-23 First Edition | ||
| 2021-01 | Biological evaluation of medical | |
| devices — Part 23: Tests for irritation | ||
| ISO 10993-17 First Edition | ||
| 2002-12-01 | Biological evaluation of medical | |
| devices — | ||
| Part 17: Establishment of allowable | ||
| limits for leachable substances | ||
| ISO 10993-7 Second Edition | ||
| 2008-10-15 Amendment 1 | ||
| 2019-12 | Biological evaluation of medical | |
| devices — Part 7: Ethylene oxide | ||
| sterilization residuals — Amendment | ||
| 1: Applicability of allowable limits for | ||
| neonates and infants | ||
| ASTM F1980-21 | Standard Guide for Accelerated Aging | |
| of Sterile Barrier Systems and Medical | ||
| Devices | ||
| ASTM F1886/F1886M-16 | Standard Test Method for Determining | |
| Integrity of Seals for Flexible | ||
| Packaging by Visual Inspection | ||
| ASTM F2096-11R19 | Standard Test Method for Detecting | |
| Gross Leaks in Packaging by Internal | ||
| Pressurization (Bubble Test) | ||
| ASTM F88/F88M-21 | Standard Test Method for Seal | |
| Strength of Flexible Barrier Materials | ||
| ASTM F1929-15 | Standard Test Method for Detecting | |
| Seal Leaks in Porous Medical | ||
| Packaging by Dye Penetration | ||
| Packaged-Products for Parcel Delivery | ||
| System Shipment 70 kg (150 lb) or | ||
| less | ||
| ISTA-3A 2018 | Note: Post-Transportation testing was | |
| also performed on the packaging for | ||
| Visual Inspection, Seal Strength | ||
| (tensile) test, and Die Penetration | ||
| testing. |
10
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.