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K Number
K221827
Device Name
Mais Central Venous Catheter
Manufacturer
Saudi Mais Co. for Medical Products
Date Cleared
2023-06-23

(365 days)

Product Code
FOZ
Regulation Number
880.5200
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Mais central venous catheters are indicated to provide short-term access (<30 days) to the central venous system. They are designed for administering I.V. fluids, blood products, drugs and parenteral nutrition solutions, as well as blood withdrawal and central venous pressure monitoring.
Device Description
Mais Central Venous Catheter is a radio opaque catheter, which is placed mainly in the subclavian, or jugular veins down to the right auricle as a short-term channeling access to the central venous system for central administration of drugs and central infusion of fluids and transfusion of blood. The device provides pre-operative access to infuse anesthesia drugs and quick central access in emergencies as cardiac standstill, shock, etc. Measuring the central venous pressure can be achieved by connecting the central lumen to the measuring device tube. Central venous (CV) catheters can be used in anesthesia, critical care, and emergency medicine. The correct positioning of the central venous catheter is of key significance for therapeutic success. For most applications, placement in the superior vena cava approximately 2cm before the opening into the right atrium is viewed as the optimal position for the catheter tip. The CV Catheter is needle punctured and surgically inserted into the superior vena cava (a large vein) of a patient. It can be planted inside for one-month maximum. Mais Catheters are made from soft polyurethane material and have double, triple or quadruple lumens, and the length is variable. The Mais catheter consists of a white radio opaque multi lumen tube which is tipped with a soft polyurethane material and has many side holes relevant to each lumen. There are markings along the effective length to indicate each centimeter. There is a connector which connects the catheter lumen(s) to a lumen of a transparent polyurethane extension tube so each catheter lumen is connected to a specific extension line. The connector is polyurethane and nearly triangular shaped. Each extension tube is marked to indicate which catheter lumen is attached to it. Distal lumen is used for the CVP monitoring. A flat clamp is put over each extension tube. The flat clamp is colored differently for a given multi lumen catheter.
More Information

K190855

Not Found

No
The 510(k) summary describes a standard central venous catheter and its physical properties and performance testing. There is no mention of any software, algorithms, or AI/ML capabilities.

Yes.
It is used for administering fluids, blood products, drugs, and parenteral nutrition solutions, as well as for blood withdrawal and central venous pressure monitoring, which are all therapeutic interventions or support therapeutic monitoring.

No

Explanation: The device is a central venous catheter used for administering fluids, withdrawing blood, and monitoring central venous pressure, which are therapeutic and monitoring functions, not diagnostic. While it can be used for "central venous pressure monitoring," this is a measurement or monitoring function, not a diagnostic one that identifies a disease or condition.

No

The device description clearly details a physical catheter made of polyurethane with multiple lumens, extension tubes, and clamps. It is surgically inserted into a patient's vein. This is a hardware medical device, not software only.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
  • Device Function: The Mais Central Venous Catheter is a medical device designed for accessing the central venous system for administering fluids, medications, and blood products, as well as for blood withdrawal and pressure monitoring. It is a physical device inserted into the body.
  • Intended Use: The intended use clearly describes its function as a means of accessing the central venous system, not for performing diagnostic tests on samples.
  • Device Description: The description focuses on the physical characteristics of the catheter and its placement within the body.
  • Performance Studies: The performance studies listed are related to the physical and functional integrity of the catheter (leak testing, flow rate, tensile strength, biocompatibility, sterilization, etc.), not the accuracy or performance of a diagnostic test.

The device is a therapeutic and monitoring tool, not a diagnostic one that analyzes samples outside the body.

N/A

Intended Use / Indications for Use

Mais central venous catheters are indicated to provide short-term access (24hr to 30days). The following testing was conducted:

  • Cytotoxicity
  • Sensitization ●
  • Irritation/Intracutaneous ●
  • Acute Systemic Toxicity
  • Subchronic Toxicity
  • Bacterial Reverse mutation assay
  • . Hemolysis
  • Implantation ●
    Particulate matter testing was conducted in accordance with USP Particulate Matter in Injections and met the USP acceptance criteria.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Breaking Load (Tensile Force) Test: Force required ≥ 15N as per ISO 10555-1:2013
Particulate matter testing: met the USP acceptance criteria.

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.

K190855

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

§ 880.5200 Intravascular catheter.

(a)
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.(b)
Classification. Class II (performance standards).

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.

June 23, 2023

Saudi Mais Co. for Medical Products % Vaibhav Rajal Official Correspondent for Saudi Mais Co. for Medical Products mdi Consultants Inc 55 Northern Blvd. Suite 200 Great Neck, New York 11021

Re: K221827

Trade/Device Name: Mais Central Venous Catheter Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: FOZ Dated: Mav 24, 2023 Received: May 24, 2023

Dear Vaibhav Rajal:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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,

Porsche Bennett

For 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

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Indications for Use

510(k) Number (if known) K221827

Device Name Mais Central Venous Catheter

Indications for Use (Describe)

Mais central venous catheters are indicated to provide short-term access ( 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."

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Saudi
mais Co.

Image /page/3/Picture/1 description: The image shows a stylized logo in black and white. The logo appears to be in Arabic script, with rounded, interconnected lines forming the letters. Below the main text, there are two small circles, positioned side by side.

C.R. 1010112398 A Limited Liability Capital S.R. (34,500,000) Fully Paid VAT No .: 3000 5661 72000 03

Image /page/3/Picture/3 description: The image shows a logo with the letters "SMMP" in bold, black font inside a red oval. Below the logo, there is Arabic text that includes the number 55358. The logo appears to be for an organization or company, with the Arabic text possibly indicating a membership or registration number.

ست ۱۰۱۰۱۱۲۳۹۸ شركة ذات مسؤولية محدودة

رأس المال المدفوع ( ٣٤.٥٠٠.٠٠٠) ريال مدفوع بالكامل

الرقم الضريبي : ۰۳ ۳۰۰۰۵۶۶۱۷۲۰۰۰

K221827- 510(k) SUMMARY

Date Summary Prepared: June 23, 2023

1. Submitter's Identification:

Saudi Mais Co. for Medical Products Alkharj Road, 3rd Industrial Area, Street No.256, P.O. Box: 3900 - Riyadh 14335-7599, Saudi Arabia Tel: + 966 11 2650184 Fax: + 966 11 2650139 Email: medical@mais.com.sa

2. Contact Person:

Mr. Salman Rashid Saudi Mais Co. for Medical Products Alkharj Road, 3rd Industrial Area, Street No.256, P.O. Box: 3900 - Riyadh 14335-7599, Saudi Arabia Tel: + 966 11 2650184 Email: qa@mais.com.sa

Official Correspondent: Mr. Vaibhav Arvind Rajal, Official Correspondent for Saudi Mais Co. for Medical Products, mdi Consultants, Inc., 55 Northern Blvd., Suite 200, Great Neck, 11021 Cell: (201) 887-3180 or (516) 482-9001 email: vaibhav@mdiconsultants.com

3. Subject Device:

Trade/Device Name: Mais Central Venous Catheter Common Name: Short-Term Less Than 30 Days Therapeutic Intravascular Catheter Regulation Description: Intravascular catheter Regulation Number: 21 CFR 880.5200 Regulatory Classification: Class II Product Code: FOZ

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4. Predicate Device

510(k) Number: K190855 Trade/Device Name: BD Acute Central Line Regulation Number: 21 CFR 880.5200 Requlation Name: Intravascular catheter Regulatory Classification: Class II Product Code: FOZ

5. Indications for Use Statement:

Mais central venous catheters are indicated to provide short-term access (24hr to 30days). The following testing was conducted:

  • Cytotoxicity

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  • Sensitization ●
  • Irritation/Intracutaneous ●
  • Acute Systemic Toxicity
  • Subchronic Toxicity
  • Bacterial Reverse mutation assay
  • . Hemolysis
  • Implantation ●

Particulate matter testing was conducted in accordance with USP Particulate Matter in Injections and met the USP acceptance criteria.

9. Sterilization and Stability Information

The subject device complies with sterilization requirements of ISO 11135:2014, Sterilization of Health Care Products -Ethylene Oxide - Part 1: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices.

  • . Package integrity: We evaluated the device for simulated shipping by testing for all its applicable performance and package testing in compliance with ISO 11607, ASTM F1886, ASTM F1929 and ASTM F88 standards after passing through different transportation medium and found to be free from any kind of change in physical, chemical, microbiological and the package status of the device.
    • ං ISO 11607-1:2006 +A1:2014 Packaging For Terminally Sterilized Medical Devices - Part 1: Requirements For Materials, Sterile Barrier Systems And Packaging Systems [Including: Amendment 1 (2014)]
  • The subject device, Mais Central Venous Catheter is provided in a sterile package. The ● proposed subject device. Mais Central Venous Catheter is in compliance with the following standards:
    • Visual Inspection ASTM F1886 o
    • Dye Migration Test ASTM F1929 o
    • Seal Peel Test ASTM F88/EN868-5 O
    • 11135 Second Edition 2014-07-15 Sterilization Of Health-Care Products - O Ethylene Oxide - Requirements For The Development, Validation And Routine Control Of A Sterilization Process For Medical Devices [Including: Amendment 1 (2018)]
    • 11737-1 Third Edition 2018-01 Sterilization Of Health Care Products о Microbiological Methods - Part 1: Determination Of A Population Of Microorganisms On Product
    • 11737-2 Second Edition 2009-11-15 Sterilization Of Medical Devices o Microbiological Methods - Part 2: Tests Of Sterility Performed In The Definition, Validation And Maintenance Of A Sterilization Process
  • The Shelf Life of 4 years based on the validation documentation of real aging from Study start date of 09-14-2014 to Study Completion date of 07-30-2018.

Conclusions:

The differences between the Mais Central Venous Catheter and the predicate device do not raise any new or different questions of safety or effectiveness. The subject device, Mais Central Venous Catheter is substantially equivalent to the predicate device, BD Acute Central Line, cleared under K190855.