The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter

Q: Who is the manufacturer of The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter?

Medsource International, LLC filed the 510(k) submission for The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter (K223788).

Q: What is the FDA product code for The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter?

FOZ. It is classified under 21 CFR 880.5200 as a Class 2 device in the General Hospital panel.

Q: What is the regulatory pathway for The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter?

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

Q: Who can help prepare an FDA 510(k) submission like The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter?

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.

K223788 · Medsource International, LLC · FOZ · Sep 15, 2023 · General Hospital

Device Facts

Record ID	K223788
Device Name	The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter
Applicant	Medsource International, LLC
Product Code	FOZ · General Hospital
Decision Date	Sep 15, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.5200
Device Class	Class 2
Attributes	Therapeutic, Pediatric

Indications for Use

The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter are indicated to sample blood or administer fluids intravenously. The MedSource TrueSafe Blood Control I.V. Safety Catheter and the MedSource ClearSafe Blood Control I.V. Safety Catheter may be used for any patient population with consideration given to adequacy for the vascular anatomy, appropriateness for the solution being administered and duration of the therapy.

Device Story

Device is a short-term (less than 30 days) intravascular safety catheter for fluid delivery or blood sampling. Input: vascular access via needle insertion. Operation: needle inserted to gain access; blood fills flashback chamber; needle retracted into catheter body upon placement. Safety mechanism: TrueSafe uses push-button; ClearSafe uses slide mechanism; both encapsulate needle to prevent accidental sticks. Blood control valve in catheter hub restricts fluid flow until male Luer is inserted. Used by healthcare personnel in clinical settings. Output: established vascular access. Benefit: provides safe, controlled intravenous access while protecting clinicians from sharps injuries.

Clinical Evidence

Bench testing only. No clinical data. Performance validated via simulated clinical use studies and testing to ISO 10555-1/5, ISO 594-1/2, and ISO 23908. Biocompatibility verified per ISO 10993 standards and ASTM hemocompatibility protocols.

Technological Characteristics

Materials: Polyurethane/PTFE (catheter), Polypropylene/K-Resin/MABS-T (hubs), Polyacetal (holder), Stainless Steel (needle). Features: Active manual safety mechanism (push-button or slide), blood control valve (PP/Silicon/POM), hydrophobic filter (PE). Dimensions: 14G-24G. Sterilization: Ethylene Oxide (EtO). Connectivity: None.

Indications for Use

Indicated for any patient population requiring intravenous fluid administration or blood sampling, subject to vascular anatomy, solution appropriateness, and therapy duration.

Regulatory Classification

Identification

An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.

Predicate Devices

MedSource TrueSafe Safety IV Catheter and MedSource TrueSafe Comfort Safety IV Catheter (K161779)

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. September 15, 2023 MedSource International LLC Emilie Andrews Quality and Regulatory Compliance Engineer 8600 Shelby Court, Suite 100 Chanhassen, Minnesota 55317 #### Re: K223788 Trade/Device Name: The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: FOZ Dated: August 15, 2023 Received: August 16, 2023 Dear Emilie Andrews: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ 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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, David 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 Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K223788 #### Device Name The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter #### Indications for Use (Describe) The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter are indicated to sample blood or administer fluids intravenously. The MedSource TrueSafe Blood Control I.V. Safety Catheter and the MedSource ClearSafe Blood Control I.V. Safety Catheter may be used for any patient population with consideration given to adequacy for the vascular anatomy, appropriateness for the solution being administered and duration of the therapy. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------|---------------------------------------------------------------------------------| | <div> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### 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." {3}------------------------------------------------ # MEDSOURCELABS #### K223788 - 510(k) Summary Date of Prepared: September 15, 2023 A. Submitter: MedSource International, LLC 8600 Shelby Court Chanhassen, MN 55317 #### B. Contact Person: Emilie Andrews, Regulatory and Quality Compliance Engineer 8600 Shelby Court Chanhassen, MN 55317 Phone: 952-220-8875 ### C. Proposed Device: Product Code: FOZ Trade Name: The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter Common Name: Short-Term Less Than 30 Days, Therapeutic, Intravascular Catheter Classification Name: Intravascular catheter Regulatory Reference: 21 CFR §880.5200 Review Panel: General Hospital Classification: Class II {4}------------------------------------------------ Image /page/4/Picture/2 description: The image shows the logo for MEDSOURCELABS. The text is in a bold, sans-serif font and is black. To the right of the text is a cluster of colorful hexagons. #### D. Predicate: 510(K): K161779 Product Code: FOZ Trade Name: MedSource TrueSafe Safety IV Catheter and MedSource TrueSafe Comfort Safety IV Catheter Common Name: Short-Term Less Than 30 Days, Therapeutic, Intravascular Catheter Classification Name: Intravascular catheter Regulatory Reference: 21 CFR §880.5200 Review Panel: General Hospital Classification: Class II #### E. Indications for Use: The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter are indicated to sample blood or administer fluids intravenously. The MedSource TrueSafe Blood Control I.V. Safety Catheter and the MedSource ClearSafe Blood Control I.V. Safety Catheter may be used for any patient population with consideration given to adequacy for the vascular anatomy, appropriateness for the solution being administered and duration of the therapy. #### F. Device Description: The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheters are a safety medical device used for inserting a catheter into a patient's body for the delivery of fluids or drainage of fluids from a patient's body. This device is engineered to protect healthcare workers using it against accidental needle stick injury. In addition, this device also secures the needle (used to insert the catheter) within the catheter body with either a push button or slide safety mechanism, thus protecting healthcare and other personnel from accidental needle sticks. {5}------------------------------------------------ Image /page/5/Picture/2 description: The image shows the logo for MEDSOURCELABS. The text is in a bold, sans-serif font and is black. To the right of the text is a cluster of colorful hexagons. The MedSource TrueSafe Blood Control I.V. Safety Catheter is comprised of a sharp needle attached to a needle hub with a catheter attached to a catheter hub. In the catheter hub there is a valve that, when activated, allows for the movement of fluids. In the 'inactivated' state prior to insertion of a male Luer, the movement of fluids is restricted. When the needle is retracted with the push button from the catheter the needle retracts into the body of the catheter and the needle is fully encapsulated. The MedSource ClearSafe Blood Control I.V. Safety Catheter blood control mechanism is identical to the MedSource TrueSafe Blood Control I.V. Safety Catheter. The only difference in design features is the ClearSafe Blood Control has a slide safety mechanism that retracts the needle into the catheter body. The needle is also fully encapsulated to prevent accidental needlesticks. There is no difference in clinical use between the two models and the use of one over the other depends on user preference. The MedSource TrueSafe and ClearSafe Blood Control Safety I.V. Catheter gauges are color coded for positive identification and range from 14G to 24G | Orange = 14G | Grey = 16G | Green = 18G | Pink = 20G | |--------------|------------|--------------|------------| | | Blue = 22G | Yellow = 24G | | #### G. SUMMARY OF COMPARISON TABLE OF PROPOSED DEVICE and PREDICATE The proposed device is substantially equivalent to the predicate device the MedSource TrueSafe Safety I.V. Catheter (K161779). The MedSource IV Safety Catheter is also used as a reference device. | Comparison Point | Submission Device | Predicate Device | Discussion n | Comments | |----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe | The MedSource Truesafe Safety I.V. Catheter and the MedSource TrueSafe | | | | | Blood Control I.V. Safety Catheter | Comfort Safety I.V. Catheter (K161779) | | | | Indications for Use | The MedSource TrueSafe Safety IV Catheter and the MedSource TrueSafe Comfort Safety IV Catheter is indicated to sample blood or administer fluids intravenously. The MedSource TrueSafe Safety IV Catheter and the MedSource TrueSafe Comfort Safety IV Catheter may be used for any patient population with consideration given to adequacy for the vascular anatomy appropriateness for the solution being administered and duration of the therapy. | The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter are indicated to sample blood or administer fluids intravenously. The MedSource TrueSafe Blood Control I.V. Safety Catheter and the MedSource ClearSafe Blood Control I.V. Safety Catheter may be used for any patient population with consideration given to adequacy for the vascular anatomy, appropriateness for the solution being administered and duration of the therapy | Same | | | Principles of Operations | The needle is inserted to gain vascular access. Then blood will fill the flashback chamber. After the needle is placed it will be removed from | The needle is inserted to gain vascular access. Then blood will fill the flashback chamber. After the needle is placed it will be removed from | Same | | | | the catheter leaving the catheter behind to allow for vascular access. As the needle is removed the needle is encapsulated inside the catheter body. | the catheter leaving the catheter behind to allow for vascular access. As the needle is removed the needle is encapsulated inside the catheter body. | | | | | | | | | | Catheter Outer Dimensions (O.D.) in mm | 24G - 0.7 22G - 0.9 20G - 1.1 18G - 1.3 16G – 1.8 14G - 2.1 | 24G - 0.7 22G - 0.9 20G - 1.1 18G - 1.3 16G - 1.7 14G – 2.1 | Same | | | Catheter Effective Length in mm | Gauge Length 24G 19 22G 25 20G - TrueSafe 30 20G - ClearSafe 32 18G - TrueSafe 30 18G - ClearSafe 32 16G - TrueSafe 30 16G - ClearSafe 32 14G - TrueSafe 45 | Gauge Length 24G 19 22G 25 20G 25 18G 25 16G 30 14G 45 | Differen t | Clinical simulated use was conducted to validate the addition of the blood control valve did not change the effectiveness of the device. Performance testing was done to ISO 10555-5 and ISO 10555-1 to verify there was no change to the effectiveness of the device Based on the testing done the catheter | | Number of Lumen(s) | Single Lumen | Single Lumen | Same | between the two IV Catheters does not affect the safety anddevice. | | Shape of Lumen(s) | Catheter hub – cylindrical with a taper down to the catheter | Catheter hub – cylindrical with a taper down to the catheter | Same | | | Flow Rate for Each Lumen(s) in mL/min | Gauge Flow Rate 24G – TrueSafe 18 24G – ClearSafe 20 22G – TrueSafe 33 22G – ClearSafe 36 20G – TrueSafe 55 20G – ClearSafe 61 18G – TrueSafe 85 18G – ClearSafe 94 16G 200 14G 270 | Gauge Flow Rate 24G 20 22G 36 20G 61 18G 92 16G 220 14G 297 | Different | Flow rate variance between the two IV Catheters is within the allowance in ISO 10555-1 ANNEX -E This does not raise new or different questions of safety or effectiveness. | | Proximal End configuration | Cupper | Cupper | Same | | | Distal End configuration | Beveled | Beveled | Same | | | Location of outlets or side ports | No ports | No ports | Same | | | Diameter of outlets or side ports | Not applicable no ports present | Not applicable no ports present | Same | | | Needle Stick Prevention Feature | Active - Manual safety mechanism Slide-ClearSafe and Push button-TrueSafe | Active - Manual safety mechanism Push button | Same Differen t | Clinical simulated use was conducted to validate the addition of the blood control valve did not change the effectiveness of the device. Performance testing was done to ISO 23908:2011 Based on the results of the testing this difference does not raise new or different questions of safety or effectiveness. | | Sterilization | Terminal Ethylene Oxide (EtO gas) | Terminal Ethylene Oxide (EtO gas) | Same | | | Catheter | Polyurethane (PUR) / (PTFE) Polytetrafluoroethyle ne | Polyurethane (PUR) / (PTFE) Polytetrafluoroethyle ne | Same | | | Needle | Stainless Steal | Stainless Steel | Same | | | Catheter Body | Polypropylene (PP) | K-Resin | Different | Clinical simulated use was conducted to validate the addition of the blood control valve did not change the effectiveness of the device. Performance testing was done to ISO 10555-5 ISO 10555-1, ISO 594-1 and ISO 594-2 to verify there was not change to the effectiveness of the device See the biocompatibility in Section H below for the list of biocompatibility testing done to verify there was no change in safety Based on the results of the testing this difference does not raise new or different questions of safety or effectiveness. | | Catheter Holder | Polyacetal (POM) | Polyacetal (POM) | Same | | | Needle Hub | K-Resin / MABS-T | K-Resin | Different | Clinical simulated use was conducted to validate the addition of the blood control valve did not change the effectiveness of the device. | | | | | | 10555-5, ISO 10555-1, ISO 594-1, ISO 594-2 to verify there was not change to the effectiveness of the device | | | | | | See the biocompatibility in Section H below for the list of biocompatibility testing done to verify there was no change in safety | | | | | | Based on the results of the testing this difference does not raise new or different questions of safety or effectiveness. | | Blood Control Valve | Polypropylene (PP) / Silicon / POM | Absent | Different | This valve is located inside the catheter hub. This is not present in the TrueSafe Safety IV models. This was added as an additional feature to help control possible blood flow out of the catheter hub | | | | | | Performance testing was done following ISO 594-1 and ISO 594-2 to verify | | | | | | to the effectiveness of the device | | | | | | Clinical simulated use was conducted to validate the addition of the blood control valve did not change the effectiveness of the device. | | | | | | See the biocompatibility in Section H below for the list of biocompatibility testing done to verify there was no change in safety | | | | | | Based on the results of the testing this difference does not raise new or different questions of safety or effectiveness. | | Flashback Chamber | Polypropylene (PP) / Polycarbonate (PC) | ABS | Different | Performance and biocompatibility evaluation demonstrates that the addition of Polytetrafluoroethyle ne does not raise additional questions of safety and effectiveness. | | | | | | Clinical simulated use was conducted to validate the addition | | | | | | of the blood control valve did not change the effectiveness of the device. Performance testing was done to ISO 10555-5: and ISO 10555-1 to verify there was no change to the effectiveness of the device | | | | | | See the biocompatibility in Section H below for the list of biocompatibility testing done to verify there was no change in safety | | | | | | Based on the results of the testing this difference does not raise new or different questions of safety or effectiveness.…

The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter

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Technological Characteristics

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Predicate Devices

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The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

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