Who is the manufacturer of Monarch Blood Collection Set?

The Monarch Company filed the 510(k) submission for Monarch Blood Collection Set (K232308).

What is the FDA product code for Monarch Blood Collection Set?

JKA. It is classified under 21 CFR 862.1675 as a Class 2 device in the Clinical Chemistry panel.

What is the regulatory pathway for Monarch Blood Collection Set?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Monarch Blood Collection Set?

SOL-GUARD™ Safety Pull-Button Blood Collection Set (K213718).

Who can help prepare an FDA 510(k) submission like Monarch Blood Collection Set?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Monarch Blood Collection Set

K232308 · The Monarch Company · JKA · Dec 4, 2023 · Clinical Chemistry

Device Facts

Record ID	K232308
Device Name	Monarch Blood Collection Set
Applicant	The Monarch Company
Product Code	JKA · Clinical Chemistry
Decision Date	Dec 4, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1675
Device Class	Class 2

Intended 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.

Device Story

Sterile, single-use, winged needle blood collection set; includes tubing and vacutainer holder. Operates via manual venipuncture; features finger-activated slide mechanism for needle retraction into a protective housing to prevent needlestick injuries. Used in healthcare facilities by medical professionals; device remains under direct supervision during use. Provides safe blood specimen collection into evacuated tubes or culture bottles. Benefits patient and clinician by reducing risk of accidental sharps injury during handling and disposal.

Clinical Evidence

Bench testing only. No clinical data required for substantial equivalence.

Technological Characteristics

Materials: Stainless steel needle/spring; MethylMethacrylonitrile Butadiene Styrene hub/luer; Polypropylene sliding button/protector; Polyoxymethylene door; EthylVinyl Acetate wings; PVC tubing; CLEARBLEND 165 holder. Standards: ISO 7864, ISO 9626, ISO 80369-7/20, ISO 23908, ISO 10993 series, ISO 11135, ISO 11607-1. Sterilization: Ethylene Oxide (SAL 10^-6). Form factor: Winged needle with 12-inch tubing.

Indications for Use

Indicated for general medical use in healthcare facilities by medical professionals for adolescent and adult patients; intended for blood collection using evacuated tubes or blood culture bottles; not for infusion, IV administration, or transfusion.

Regulatory Classification

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.

Predicate Devices

SOL-GUARD™ Safety Pull-Button Blood Collection Set (K213718)

Related Devices

K022875 — MODIFICATION TO BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET · Becton, Dickinson & CO · Sep 11, 2002
K202188 — Safety Blood Collection Sets for Single Use · Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. · Feb 19, 2021
K230408 — K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM) · Sb-Kawasumi Laboratories, Inc. · Jun 1, 2023
K211293 — Safety Winged Blood Collection Sets · Promisemed Hangzhou Meditech Co., Ltd. · Jun 25, 2021
K243806 — Safety Winged Blood Collection Sets · Promisemed Hangzhou Meditech Co., Ltd. · Jan 10, 2025

Submission Summary (Full Text)

{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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ 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 K213718 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, {6}------------------------------------------------ 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…