Pluski Safe 1 Safety IV Catheter is Passive anti-needle stick device for venous or arterial access for the infusion of fluids, drugs, and/or blood components. 14-22 gauge catheters may be used with power injectors for which the maximum pressure setting is 300 psi.

Device Description

Pluski Safe 1 Safety I.V. Catheter is a medical device used for inserting a catient's body for purpose of delivery of fluids or drainage of fluids from the patient's body. The device is equipped with a safety feature intended to prevent needle stick injuries. This device is engineered to protect healthcare workers using it against accidental needle stick injury and exposure to parts of the device that have come in contact with patient's blood or other body fluids and have hence been potentially contaminated with infectious agents.

The device contains different parts like Needle cover, Catheter holder, body, Cross clip safety & filterHub cover. Devices are available in winged and non-winged version.

These devices are sold in sterile form & are single use devices.

AI/ML Overview

This document is a 510(k) premarket notification for the Pluski Safe 1 Safety IV Catheter. It focuses on demonstrating substantial equivalence to a predicate device, not on presenting a clinical study proving specified acceptance criteria for algorithm performance. Therefore, most of the requested information regarding an AI model's performance study is not available in this document.

However, I can extract information related to the device's overall performance and safety standards, which are a form of acceptance criteria for medical devices.

Acceptance Criteria and Reported Device Performance (General Device Performance, not AI-specific):

The device performance of the Pluski Safe 1 Safety I.V. Catheter was demonstrated against a set of applicable international standards. These standards define the "acceptance criteria" for the device's physical, mechanical, and biological properties.

Acceptance Criteria (Standard)	Reported Device Performance
ISO 10555-1: Intravascular catheters - Part 1: General Requirements	Device demonstrated compliance with general requirements.
ISO 10555-5: Intravascular catheters - Part 5: Over-needle peripheral catheters	Device demonstrated compliance with over-needle peripheral catheter requirements.
ISO 80369-7: Small-bore connectors for intravascular or Hypodermic Applications (Luer taper)	Device demonstrated compliance with Luer taper specifications.
ISO 80369-20: Common test methods for small-bore connectors	Device utilized these common test methods.
ISO 23908:2011: Sharps injury protection - Features for single-use hypodermic needles, introducers for catheters	Device demonstrated sharps injury protection features.
ISO 10993-1: Biocompatibility evaluation for short-term intravascular catheter (Externally Communicating Device, Circulating Blood, Prolonged Contact)	Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Subchronic/Chronic Systemic Toxicity, Hemocompatibility, Complement Activation, Prothrombin time/Activated partial thromboplastin time, Pyrogenicity, Particulate matter testing conducted and passed.
Shelf life (ASTM F1980-16)	5 years validated.
Package Integrity (ASTM D4169/ISTA 2A)	Testing, conditioning, and simulated shipping performed.
Sterile Barrier Package Testing (ASTM F88/F88M:15, ASTM F1929-15, ASTM F1886-F1886M-16)	Peel testing, Dye Penetration, Visual Inspection performed.

Regarding AI-specific questions, the document does not contain this information as it pertains to a physical medical device, not an AI algorithm:

Sample size used for the test set and the data provenance: Not applicable.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of AI. For the physical device, ground truth is based on engineering standards, material science, and biological safety testing protocols.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary

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March 25, 2022

Mediplus (India) Limited Alka Goel Director Marketing 1261-1262. M.I.E. Part B. Bahadurgarh-124507 Harvana (India) Bahadurgarh, Haryana 124507 India

Re: K210037

Trade/Device Name: Pluski Safe 1 Safety IV Catheter Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: FOZ Dated: February 21, 2022 Received: February 23, 2022

Dear Alka Goel:

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

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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,

Gang Peng for Payal Patel 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) K210037

Device Name Pluski Safe 1 Safety I.V. Catheter

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 201.5 and Part
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Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

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K210037 510k Summary

Preparation Date: March 25, 2022

Submitter's Name: Mediplus (India) Limited .
Address: Plot No-1261-1262, M.I.E. Part B, Bahadurgarh-124507 Haryana (India) .
• Contact Person Name: Mrs. Alka Goel
Title: Director Marketing
• Phone Number: +91-9818269055

Proprietary Name:	Pluski Safe 1 Safety I.V. Catheter
Common or Usual Name:	Safety I.V Cannula
Classification Name:	Catheter, Intravascular, Therapeutic, Short-TermLess Than 30 Days
Product Code:	FOZ
Device Class:	II
Review Pane:	General Hospital
Regulation Number:	21 CFR 880.5200

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Predicate Device:

Mediplus Device	Predicate Device
Pluski Safe 1 Safety IV Catheter (K 210037)	Introcan Safety IV Catheter(K020785)

Device Description:

The device contains different parts like Needle cover, Catheter holder, body, Cross clip safety & filterHub cover. Devices are available in winged and non-winged version.

These devices are sold in sterile form & are single use devices.

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Sr. No	Gauge Size	Length ofCatheter (mm)	Catheter OD (mm)	Color
1	14G	32	2.10	Orange
2	16G	32	1.80	Medium Grey
4	18G	45	1.30	Deep Green
5	20G	32	1.10	Pink
6	22G	25	0.90	Deep Blue
7	24G	19	0.70	Yellow

Device is available in below mentioned sizes

Indications for Use:

Pluski Safe 1 Safety IV Catheter is Passive anti-needle stick device for venous or arterial access for the infusion of fluid, drugs, and/or blood components. 14-22 gauge catheters may be used with power injectors for which the maximum pressure setting is300 psi.

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MEDIPLUS (INDIA) LIMITED

S. No.	TechnologicalCharacteristics	Proposed Device (Mediplus IndiaLimited)	Predicate Device (B. BraunMedical)K020785	Remarks
1	Product Code	FOZ	FOZ	Same as predicatedevice
2	Regulation Number	21 CFR 880.5200	21 CFR 880.5200	Same as predicatedevice
3	Device Class	Class II	Class II	Same as predicatedevice
4	Indications For Use	Pluski Safe 1 Safety IV Catheter is Passiveanti-stick device for venous or arterialaccess for the infusion of fluids, drugs,and/or blood products. 14-22 gaugecatheters may be used with powerinjectors which the maximum pressuresetting is 300 psi.	Passive anti-stick devices forvenous or arterial access for theinfusion of fluids, drugs, and/orblood components. 14-22gauge catheters may be usedfor power injections for whichthe maximum pressure settingis 300 psi.	Same as predicatedevice
5	Catheter Gauges	14G-24G	14G-24G	Same as predicatedevice
6	Needle SafetyFeature	YES	YES	Same as predicatedevice

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7	Sterilization	By EO (ethylene oxide gas sterilization)	By EO (ethylene oxide gas sterilization)	Same as predicate device
8	Shelf Life	5 Years	5 Years	Same as predicate device
9	Device Use	Single use	Single use	Same as predicate device
10	Radio detectable	Yes	Yes	Same as predicate device
11	Material	Polypropylene, Stainless Steel, P.U.R,Poly Oxy Methylene, Polypropylene, Resin	Stainless Steel, P.U.R	DifferentComment #1
12	Packaging	Form/Fill/Seal Blister Pack	Form/Fill/Seal Blister Pack	Same as predicate device

Difference #1 Materials

The materials of construction for subject and predicate device are different. Biocompatibility testing has been conducted with the subject device that demonstrate that there is no biological risk. This difference does not raiferent questions of safety or effectiveness.

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Image /page/8/Picture/0 description: The image shows the logo for MEDIPLUS (INDIA) LIMITED. The logo consists of a cube-like shape made up of black and white squares. Below the logo, the text "MEDIPLUS (INDIA) LIMITED" is written in bold, followed by "Performance Standards:" on the next line.

The device performance of Pluski Safe 1 Safety I.V. Catheter has been demonstrated against the following applicable standards:

ISO 10555-1 Intravascular catheters Sterile and single-use catheters Part 1: General Requirements .
ISO 10555-5 Intravascular catheters Sterile and single-use catheters Part 5: Over-needle peripheral catheters
ISO 80369-7: Small-bore connectors for liquid and gases in healthcare applications- Part 7 Connectors for . intravascular or Hypodermic Applications Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical Equipment — Part 1: General requirements
· ISO 80369-20: Small-bore connectors for liquids and gases in healthcare applications Part 20: Common test methods
· ISO 23908:2011: Sharps injury protection-Features for single-use hypodermic needles, introducers for catheters, and needles used for blood sampling

Biocompatibility Standards

In accordance with ISO 10993-1, the short-term intravascular catheter is classified as: Externally Communicating Device, Circulating Blood, Prolonged Contact (>24 hours to 30 days). The following testing was conducted:

Cytotoxicity
. Sensitization
· Irritation
Acute Systemic Toxicity

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MEDIPLUS (INDIA) LIMITED

Subchronic/Chronic Systemic Toxicity
Hemocompatibility (hemolysis direct/indirect)
Complement Activation testing .
Prothrombin time/Activated partial thromboplastin time testing .
· Pyrogenicity
Particulate matter testing ●

Sterility, Shipping and Shelf-life

Shelf life 5 years validated per ASTM F1980-16 .
Package Integrity testing, conditioning, and simulated shipping per ASTM D4169/ISTA 2A ●
Sterile Barrier Package Testing performed on the subject device: .
- Peel testing ASTM F88/F88M:15
- Dye Penetration ASTM F1929-15 .
- Visual Inspection ASTM F1886-F1886M-16 ●

Conclusion:

The differences between the predicate device and the subject device do not raise any new or different ● questions of safety or effectiveness. The Pluski Safety 1 Safety IV Catheter is substantially equivalent to Introcan Safety IV Catheter with respect to indications for use, target population, treatment methods and technological characteristics.

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).