K Number

Device Name

ACENT Central Venous Catheter

Manufacturer

Global Medikit Limited

Date Cleared

2020-11-24

(376 days)

Product Code

FOZ

Regulation Number

880.5200

Intended 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.

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K070451

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a physical medical device (catheter) and its materials, dimensions, and performance testing based on established standards. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.

Therapeutic

No.
This device is designed for infusion of fluids, pressure measurements, and blood sampling, which are diagnostic or supportive functions rather than direct therapeutic actions to treat a disease or condition.

Diagnostic

Yes

Explanation: The device is described as being able to perform "continuous or intermittent monitoring of the central venous pressure," which is a diagnostic function.

SaMD (Software as a Medical Device)

The device description clearly indicates it is a physical catheter made of polyurethane with multiple lumens and physical characteristics like size, length, and depth markings. It also mentions bench performance testing related to physical standards (ISO 10555, etc.) and biocompatibility, which are relevant to hardware devices. There is no mention of software as the primary component or function.

IVD (In Vitro Diagnostic)

Based on the provided information, the ACENT™ Central Venous Catheter is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use clearly describes a device used within the patient's body for infusion, pressure measurement, and blood sampling. These are all in vivo procedures.
Device Description: The description details a physical catheter designed for insertion into the central venous system. This is a medical device used directly on or in a patient.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens outside the body (in vitro) to provide information about a physiological state, health, or disease.

IVD devices are typically used to test samples like blood, urine, or tissue in a laboratory setting. The ACENT™ Central Venous Catheter is a therapeutic and monitoring device used directly on the patient.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

FOZ

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Central Venous System

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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 ●

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 10-6. Ethylene oxide residuals were tested and met ISO 10993-7, "Biological 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"

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.

K070451

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

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).

Summary

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and 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.

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

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

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

guide wire.

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 Venous
Catheter	Able Central Venous
Catheter	-
510 (K)	K193158	K070451	-
Manufacturer	Global Medikit Ltd.	Foshan Nanhai Bai He
Medical Technology Co.,
Ltd	-
Common Name	Central Venous
Catheter	Central Venous Catheter	No Change
Regulation
Name	Intravascular Catheter	Intravascular Catheter	No Change
Class	II	II	No Change
Product Code	FOZ	FOZ	No Change
Regulation
Number	21 CFR 880.5200	21 CFR 880.5200	No Change
Use duration	Short Term
(Less than 30
days)	Short Term (Less
than 30 days)	No Change
Single Patient
Use	Yes	Yes	No Change
Patient
Contact	External communicating device
circulating blood contact
prolonged use (Short term)	External communicating
device circulating blood
contact prolonged use
(Short term)	No Change
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.	The Central Venous Catheters Indications are
including:
14G, 16G, 18G, and 20G in
single-lumen catheters;
4F, 5F, 7F, and 8F in double-
lumen catheters;
are intended for vascular
access infusion
and withdrawal of blood,
blood products, and fluids,
plasma pheresis,
hyperalimentation, central
venous blood sampling and
continuous and intermittent
drug infusion.	same.
In subject device
indication is for
general infusion
therapy and
parenteral
nutrition
whereas the
predicate
includes plasma
pheresis, and
infusion of blood
and blood
products. The
intended use of
the subject
device is within
the scope of the
intended use of
the predicate.
Catheter
Placement
method	Percutaneous via Seldinger
technique	Percutaneous via Seldinger
technique	No Change
Number of
Catheter 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 similar
except that the
Predicate has an
additional 3fr
(20G) size.
Sizes of subject
device are within
the range of the
predicate. The
difference will
not affect safety
and
effectiveness of
the subject
device
performance
testing is
conducted on
worst case

Double Lumen	5fr, 5.5fr, 7fr, 7.5fr	4fr,5fr,7fr,8fr	The subject
device has
additional sizes
(5Fr and 7.5 Fr)
that are within
the range of the
predicate device
sizes (4fr and
8fr). The
additional sizes
will not affect
safety and
effectiveness of
the subject
device because
performance
testing is
conducted on
worst case
sizes.
Triple Lumen	5fr, 5.5fr, 7fr, 7.5fr, 8fr	5.5fr,7fr	The subject
device has
additional sizes,
5fr,7.5fr, &8fr.
The additional
sizes will not
affect safety and
effectiveness of
the subject
device because
performance
testing is
conducted on
worst 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
Catheter
Tip Target
anatomy	SVC-RA junction	SVC-RA junction	No Change
Catheter Tip
Location
Confirmation
Method	X-Ray	X-Ray	No Change
Catheter Distal
End
Configuration	Straight and tapered	Straight and tapered	No Change
Catheter Ink
Markings	yes	yes	No Change
Catheter Shaft
Material	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 Assurance
Level (SAL)	$10^{-6}$	$10^{-6}$	No Change
Sterilization	Ethylene Oxide	Ethylene Oxide	No Change

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 ●

Biocompatibility

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

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.