ACENT™ Central Venous Catheter is an intravascular catheter, designed for infusion of fluid to the central venous system and/or for pressure measurements.

for short-term (less than 30 days) infusion therapy or parenteral nutrition
for continuous or intermittent monitoring of the central venous pressure,
for blood sampling.

Device Description

ACENT™ catheters are polyurethane, radiopaque single, double, or triple lumen catheters. The catheter is available in sizes that vary from 4 French through 8 French and lengths 8 cm through 20 cm. Each lumen extends from the vicinity of the distal tip to the main (bifurcation or junction) hub, where it branches via the connector into dedicated extension tubes for infusion of fluids. Each of the extension line has a slide clamp and are labeled to provide identification of the lumen size and location. The catheter body has depth markings, measured in cm from the catheter tips. The extension line marked "distal" is used for device placement with a compatible guide wire. The distal tip is soft to minimize patient trauma during insertion. The device is radiopaque to allow verification of location in the patient. Central venous catheters are inserted into a large vein and threaded into the central venous system.

AI/ML Overview

The ACENT™ Central Venous Catheter is a medical device designed for infusion of fluids to the central venous system, pressure measurements, short-term infusion therapy or parenteral nutrition (less than 30 days), continuous or intermittent monitoring of central venous pressure, and blood sampling.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria/Standard	Reported Device Performance
Bench Performance	ISO 10555-1	Adhered to
	ISO 10555-3	Adhered to
	ISO 594-1	Adhered to
	ISO 594-2	Adhered to
	ISO 14971	Adhered to
	USP <788>	Met requirement for particulate testing
Biocompatibility	ISO 10993-1	Tests conducted: Cytotoxicity, Sensitization, Irritation/Intracutaneous reactivity, Acute Systemic Toxicity, Sub Chronic Toxicity Study, Genotoxicity, Implantation study, Hemocompatibility, Pyrogenicity (Material and Bacterial)
Sterilization	AAMI/ANSI/ISO 11135	Validated to a Sterility Assurance Level (SAL) of 10^-6
	ISO 10993-7 (ETO residuals)	Met requirements
Packaging & Shelf Life	ISO 11607-1	Packaging validated. Shelf life established for 2 years.
	ASTM 1980	Shelf life validated.
Substantial Equivalence	All technical characteristics, intended use, and performance	The device is considered substantially equivalent to the predicate device (Able Central Venous Catheter, K070451), presenting no new questions of safety or effectiveness.

2. Sample Size Used for the Test Set and Data Provenance:

The provided document describes bench performance testing, biocompatibility testing, sterilization validation, and packaging & shelf life studies. It does not specify a "test set" in the context of clinical data with human subjects or a comparison to expert ground truth.

For bench performance tests, the document states "sterilized production lot" was used, but the specific number of units tested is not provided.
For biocompatibility tests, the document lists various tests performed, which would involve in vitro and in vivo (animal) models, but does not specify sample sizes for these tests.
For sterilization validation and packaging/shelf life studies, standard industrial validation protocols were followed, which involve specific sample sizes per the respective standards. However, the exact sample sizes are not explicitly stated in this summary.

Data Provenance: The studies are described as bench performance, biocompatibility, sterilization, and packaging & shelf life studies, which are laboratory-based and generally not associated with country of origin in the same way as human clinical data. They are not retrospective or prospective clinical studies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

This information is not applicable to the provided document. The studies described are technical performance tests, biocompatibility assessments, and sterilization validations, which rely on established scientific and engineering standards and validated methods, rather than expert consensus on clinical diagnoses or interpretations of images/data for a "test set" in the context of AI or advanced diagnostic devices.

4. Adjudication Method for the Test Set:

This information is not applicable as there is no "test set" requiring adjudication by experts in the context of this device's performance data. The studies performed are based on predefined standards and objective measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically conducted for diagnostic imaging devices or AI-assisted diagnostic tools to evaluate how a device impacts human reader performance. The ACENT™ Central Venous Catheter is a hardware device for infusion and measurement, not a diagnostic tool requiring human interpretation of output.

6. If a Standalone (i.e., algorithm-only without human-in-the-loop performance) Was Done:

No, a standalone (algorithm-only) performance study was not done. This type of study is relevant for AI or algorithmic devices. The ACENT™ Central Venous Catheter is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for the performance of the ACENT™ Central Venous Catheter is based on adherence to international and national standards (e.g., ISO, USP, ASTM, AAMI/ANSI) for medical devices. This includes:

Engineering specifications and standards for physical performance (e.g., strength, flow rates, connection integrity).
Biological evaluation standards for biocompatibility (e.g., absence of cytotoxicity, irritation, systemic toxicity).
Sterilization validation standards to ensure a specified sterility assurance level.
Packaging integrity standards to maintain sterility and function over the shelf life.

This is distinct from clinical "expert consensus," "pathology," or "outcomes data" which would be used for diagnostic devices or clinical trials.

8. The Sample Size for the Training Set:

This information is not applicable. The ACENT™ Central Venous Catheter is a hardware medical device, not an AI or machine learning algorithm, and therefore does not have a "training set."

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable, as there is no training set for this device.

Summary

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November 24, 2020

Global Medikit Limited % Atonu Dutta, CEO Meditech Consulting 102, Platinum Avenue, Vikram Society, Gotri Road Vadodara, Gujarat India 390021

Re: K193158

Trade/Device Name: ACENT™ Central Venous Catheter Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: FOZ Dated: October 17, 2020 Received: October 30, 2020

Dear Atonu Dutta:

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,

for Payal Patel

Acting 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) K193158

Device Name ACENTTM Central Venous Catheter

Indications for Use (Describe)

ACENT™ Central Venous Catheter is an intravascular catheter, designed for infusion of fluid to the central venous system and/or for pressure measurements.

for short-term (less than 30 days) infusion therapy or parenteral nutrition
for continuous or intermittent monitoring of the central venous pressure,
for blood sampling.

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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510(K) Summary

K193158

l. Submitter

M/s. Global Medikit Limited

Khasra No. 323 (MI) Camp Road, Selaqui Deharadun, Uttrakhand, India

Tel. No: +91 11 27667889.

E-mail : regulatory@globalmedikit.in

Web site: www.globalmedikit.in

Contact Person: Mr. Mahendra Singh

Date of Prepare: 24th November 2020

Application Correspondent:

C/o: Atonu Dutta, CEO

Meditech Consulting

102 Platinum Avenue, Vikram Society, Gotri Road, Vadodara, Gujarat INDIA 390021

Tel: (91) 990-5805571

E-mail: medtect.requlatory@gmail.com

II. Device

Trade Name	ACENT™ Central Venous Catheter
Common Name	Catheter, Intravascular, Therapeutic, Short-term(less than 30 days)
Device Class	II
Review Panel	General Hospital
Product Code	FOZ
Regulation Number	21 CFR 880.5200
Regulation Name	Intravascular Catheter

III. Predicate Device

Trade Name	:	Able Central Venous Catheter
Manufacture	:	Foshan Nanhai Bai He Medical Technology Co., Ltd.
510(K) No.	:	K070451

IV. Device Description

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guide wire.

The distal tip is soft to minimize patient trauma during insertion. The device is radiopaque to allow verification of location in the patient. Central venous catheters are inserted into a large vein and threaded into the central venous system.

V. Indications for Use

ACENT™ Central Venous Catheter is an intravascular catheter, designed for infusion of fluid to the central venous system and/or for pressure measurements.

for short-term (less than 30 days) infusion therapy or parenteral nutrition
for continuous or intermittent monitoring of the central venous pressure,
for blood sampling.

VI. Substantial Equivalence

The ACENT™ Central Venous Catheter is substantially equivalent to marketed predicate devices with respect to intended use and technological characteristics. The ACENT™ Central Venous Catheter operates on the same principle as predicate device. Comparison Chart of ACENT™ Central Venous Catheter System and Predicate devices is provided below:

Characteristics	Subject Device	Predicate Device	Change
Device Name	ACENT™Central VenousCatheter	Able Central VenousCatheter	-
510 (K)	K193158	K070451	-
Manufacturer	Global Medikit Ltd.	Foshan Nanhai Bai HeMedical Technology Co.,Ltd	-
Common Name	Central VenousCatheter	Central Venous Catheter	No Change
RegulationName	Intravascular Catheter	Intravascular Catheter	No Change
Class	II	II	No Change
Product Code	FOZ	FOZ	No Change
RegulationNumber	21 CFR 880.5200	21 CFR 880.5200	No Change
Use duration	Short Term(Less than 30days)	Short Term (Lessthan 30 days)	No Change
Single PatientUse	Yes	Yes	No Change
PatientContact	External communicating devicecirculating blood contactprolonged use (Short term)	External communicatingdevice circulating bloodcontact prolonged use(Short term)	No Change
Indications forUse	ACENT™ Central VenousCatheter is an intravascularcatheter, designed for infusionof fluid to the central venoussystem and/or for pressuremeasurements.for short-term (less than30 days) infusion therapyor parenteral nutrition for continuous orintermittent monitoring ofthe central venouspressure, for blood sampling.	The Central Venous Catheters Indications areincluding:14G, 16G, 18G, and 20G insingle-lumen catheters;4F, 5F, 7F, and 8F in double-lumen catheters;are intended for vascularaccess infusionand withdrawal of blood,blood products, and fluids,plasma pheresis,hyperalimentation, centralvenous blood sampling andcontinuous and intermittentdrug infusion.	same.In subject deviceindication is forgeneral infusiontherapy andparenteralnutritionwhereas thepredicateincludes plasmapheresis, andinfusion of bloodand bloodproducts. Theintended use ofthe subjectdevice is withinthe scope of theintended use ofthe predicate.
CatheterPlacementmethod	Percutaneous via Seldingertechnique	Percutaneous via Seldingertechnique	No Change
Number ofCatheter Lumens	1 to 3	1 to 3	No Change
Catheter size
Single Lumen	4fr, 5fr, 6fr, 7fr (14G,16G,18G)	3fr,4fr,5fr,6fr,7fr(14G,16G,18G,20G)	Sizes are similarexcept that thePredicate has anadditional 3fr(20G) size.Sizes of subjectdevice are withinthe range of thepredicate. Thedifference willnot affect safetyandeffectiveness ofthe subjectdeviceperformancetesting isconducted onworst case

Double Lumen	5fr, 5.5fr, 7fr, 7.5fr	4fr,5fr,7fr,8fr	The subjectdevice hasadditional sizes(5Fr and 7.5 Fr)that are withinthe range of thepredicate devicesizes (4fr and8fr). Theadditional sizeswill not affectsafety andeffectiveness ofthe subjectdevice becauseperformancetesting isconducted onworst casesizes.
Triple Lumen	5fr, 5.5fr, 7fr, 7.5fr, 8fr	5.5fr,7fr	The subjectdevice hasadditional sizes,5fr,7.5fr, &8fr.The additionalsizes will notaffect safety andeffectiveness ofthe subjectdevice becauseperformancetesting isconducted onworst case sizes.
Catheter Length
Single Lumen	15,16 & 20 cm	15,16 & 20 cm	No Change
Double Lumen	15,16 & 20 cm	15,16 & 20 cm	No Change
Triple Lumen	8,12,13, 15,16 & 20cm	8,12,13, 15,16 & 20cm	No Change
CatheterTip Targetanatomy	SVC-RA junction	SVC-RA junction	No Change
Catheter TipLocationConfirmationMethod	X-Ray	X-Ray	No Change
Catheter DistalEndConfiguration	Straight and tapered	Straight and tapered	No Change
Catheter InkMarkings	yes	yes	No Change
Catheter ShaftMaterial	Polyurethane	Polyurethane	No Change
Catheter Tip &Shaft Material	Polyurethane	Polyurethane	No Change
Lumen Shape	Round, Crescent	Round, Crescent	No Change
Packaging	Plastic Tray with Tyvek Lid stock	Plastic Tray with Tyvek Lid stock	No Change
Sterility AssuranceLevel (SAL)	$10^{-6}$	$10^{-6}$	No Change
Sterilization	Ethylene Oxide	Ethylene Oxide	No Change

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VII. Performance Data

The following performance data were provided in support of the substantial equivalence determination.

Bench Performance

The performance testing of ACENT™ Central Venous Catheter is carried out on sterilized production lot and per the following standard:

ISO 10555 -1, "Intravascular catheters Sterile and single-use catheters Part 1: . General requirements"
ISO 10555-3, "Intravascular catheters Sterile and single-use catheters Part 3: . Central venous catheters"
ISO 594-1, "Conical fittings with a 6% (Luer) taper for syringes, needles and certain . other medical equipment - Part 1: General requirements"
ISO 594-2, Conical fittings with a 6% (Luer) taper for syringes, needles and certain . other medical equipment - Part 2: Lock fittings"
ISO 14971, "Medical devices Applications of risk management to medical devices" .
Particulate testing per USP <788> ●

Biocompatibility

The biocompatibility evaluation for ACENT™ Central Venous Catheter was conducted in accordance with the guidance document "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" and ISO 10993-1, "Biological evaluation of Medical Devices Part 1: Evaluation and testing within a risk management process" as recognized by FDA.

As per ISO 10993-1, ACENT™ Central Venous catheter is an external communicating device with prolonged circulating blood contact. Accordingly, the following biological evaluation tests were conducted:

Cytotoxicity
Sensitization
Irritation / Intracutaneous reactivity ●
Acute Systemic Toxicity
Sub Chronic Toxicity Study
Genotoxicity
Implantation study
Hemocompatibility
Pyrogenicity (Material and Bacterial)

Sterilization

The sterilization process has been validated per AAMI/ANSI/ISO 11135, ", Sterilization of Health-Care Products - Ethylene Oxide - Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices" and demonstrated a sterility assurance level of 10°. Ethylene oxide residuals were tested and met ISO 10993-7, "Biological

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Evaluation Of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals" requirements.

Packaging & Shelf life

Following packaging and shelf life study was conducted to ensure package integrity throughout the shelf life. The shelf life is established for 2 years.

· Packaging validation as per ISO 11607-1, "Packaging for terminally Sterilized Medical Devices - Part 1: Packaging For Terminally Sterilized Medical Devices - Part 1: Requirements for Materials, Sterile Barrier Systems And Packaging Systems"
Shelf life validation as per ASTM 1980, "Standard guide for Accelerated Aging of Sterile . Barrier Systems for Medical Devices" & ISO 11607-1, "Packaging for terminally Sterilized Medical Devices - Part 1: Packaging For Terminally Sterilized Medical Devices - Part 1: Requirements for Materials, Sterile Barrier Systems And Packaging Systems"

VIII. Conclusion

ACENT™ Central Venous Catheter is substantially equivalent to the predicate device and presents no new questions of safety or effectiveness when compared in design, technological characteristics, performance testing, and intended use to the predicate device.

Regulation Number and Section

§ 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).