ACENT™ Central Venous Catheter

K193158 · Global Medikit Limited · FOZ · Nov 24, 2020 · General Hospital

Device Facts

• Record ID: K193158
• Device Name: ACENT™ Central Venous Catheter
• Applicant: Global Medikit Limited
• Product Code: FOZ · General Hospital
• Decision Date: Nov 24, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic

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 Story

ACENT™ Central Venous Catheter is a polyurethane, radiopaque, single/double/triple-lumen catheter used for central venous access. Inserted percutaneously via Seldinger technique into a large vein and threaded to the SVC-RA junction. Used in clinical settings for short-term infusion therapy, parenteral nutrition, central venous pressure monitoring, and blood sampling. Features depth markings and soft distal tip to minimize trauma. Radiopacity allows for X-ray verification of placement. Output is fluid delivery or pressure data for clinical monitoring. Benefits include reliable vascular access for critical care and nutrition.

Clinical Evidence

No clinical data. Bench testing only. Testing included ISO 10555-1/3 (catheter requirements), ISO 594-1/2 (luer fittings), USP <788> (particulate), and comprehensive biocompatibility (ISO 10993-1) including cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, implantation, hemocompatibility, and pyrogenicity. Sterilization validated per ISO 11135; packaging/shelf-life validated per ISO 11607-1 and ASTM 1980.

Technological Characteristics

Polyurethane construction; radiopaque; single, double, or triple lumen configurations (4F-8F). Percutaneous insertion via Seldinger technique. Ethylene oxide sterilization (SAL 10^-6). Complies with ISO 10555-1/3, ISO 594-1/2, ISO 10993-1, ISO 11135, ISO 11607-1, and ASTM 1980.

Indications for Use

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

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

• Able Central Venous Catheter (K070451)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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) |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-size: 12px;"> <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
| <span style="font-size: 12px;"> <span> <span style="border: 1px solid black; display: inline-block; width: 13px; height: 13px; vertical-align: middle;"></span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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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: [phone].

E-mail : [e-mail]

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: [phone]

E-mail: [e-mail]

#### II. Device

| Trade Name | ACENT™ Central Venous Catheter |
|-------------------|-------------------------------------------------------------------------|
| Common Name | Catheter, Intravascular, Therapeutic, Short-term<br>(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

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

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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™<br>Central Venous<br>Catheter | Able Central Venous<br>Catheter | - |
| 510 (K) | K193158 | K070451 | - |
| Manufacturer | Global Medikit Ltd. | Foshan Nanhai Bai He<br>Medical Technology Co.,<br>Ltd | - |
| Common Name | Central Venous<br>Catheter | Central Venous Catheter | No Change |
| Regulation<br>Name | Intravascular Catheter | Intravascular Catheter | No Change |
| Class | II | II | No Change |
| Product Code | FOZ | FOZ | No Change |
| Regulation<br>Number | 21 CFR 880.5200 | 21 CFR 880.5200 | No Change |
| Use duration | Short Term<br>(Less than 30<br>days) | Short Term (Less<br>than 30 days) | No Change |
| Single Patient<br>Use | Yes | Yes | No Change |
| Patient<br>Contact | External communicating device<br>circulating blood contact<br>prolonged use (Short term) | External communicating<br>device circulating blood<br>contact prolonged use<br>(Short term) | No Change |
| Indications for<br>Use | ACENT™ Central Venous<br>Catheter is an intravascular<br>catheter, designed for infusion<br>of fluid to the central venous<br>system and/or for pressure<br>measurements.<br>for short-term (less than<br>30 days) infusion therapy<br>or parenteral nutrition for continuous or<br>intermittent monitoring of<br>the central venous<br>pressure, for blood sampling. | The Central Venous Catheters Indications are<br>including:<br>14G, 16G, 18G, and 20G in<br>single-lumen catheters;<br>4F, 5F, 7F, and 8F in double-<br>lumen catheters;<br>are intended for vascular<br>access infusion<br>and withdrawal of blood,<br>blood products, and fluids,<br>plasma pheresis,<br>hyperalimentation, central<br>venous blood sampling and<br>continuous and intermittent<br>drug infusion. | same.<br>In subject device<br>indication is for<br>general infusion<br>therapy and<br>parenteral<br>nutrition<br>whereas the<br>predicate<br>includes plasma<br>pheresis, and<br>infusion of blood<br>and blood<br>products. The<br>intended use of<br>the subject<br>device is within<br>the scope of the<br>intended use of<br>the predicate. |
| Catheter<br>Placement<br>method | Percutaneous via Seldinger<br>technique | Percutaneous via Seldinger<br>technique | No Change |
| Number of<br>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<br>(14G,16G,18G,20G) | Sizes are similar<br>except that the<br>Predicate has an<br>additional 3fr<br>(20G) size.<br>Sizes of subject<br>device are within<br>the range of the<br>predicate. The<br>difference will<br>not affect safety<br>and<br>effectiveness of<br>the subject<br>device<br>performance<br>testing is<br>conducted on<br>worst case |
| | | | |
| Double Lumen | 5fr, 5.5fr, 7fr, 7.5fr | 4fr,5fr,7fr,8fr | The subject<br>device has<br>additional sizes<br>(5Fr and 7.5 Fr)<br>that are within<br>the range of the<br>predicate device<br>sizes (4fr and<br>8fr). The<br>additional sizes<br>will not affect<br>safety and<br>effectiveness of<br>the subject<br>device because<br>performance<br>testing is<br>conducted on<br>worst case<br>sizes. |
| Triple Lumen | 5fr, 5.5fr, 7fr, 7.5fr, 8fr | 5.5fr,7fr | The subject<br>device has<br>additional sizes,<br>5fr,7.5fr, &8fr.<br>The additional<br>sizes will not<br>affect safety and<br>effectiveness of<br>the subject<br>device because<br>performance<br>testing is<br>conducted on<br>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<br>Tip Target<br>anatomy | SVC-RA junction | SVC-RA junction | No Change |
| Catheter Tip<br>Location<br>Confirmation<br>Method | X-Ray | X-Ray | No Change |
| Catheter Distal<br>End<br>Configuration | Straight and tapered | Straight and tapered | No Change |
| Catheter Ink<br>Markings | yes | yes | No Change |
| Catheter Shaft<br>Material | Polyurethane | Polyurethane | No Change |
| Catheter Tip &<br>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<br>Level (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.