Pluski Safe 1 Safety IV Catheter

{0}------------------------------------------------ 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: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters. 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K210037 Device Name Pluski Safe 1 Safety I.V. Catheter #### Indications for Use (Describe) 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. Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 201.5 and Part | |----------------------------------------------| |----------------------------------------------| > Prescription Use (Part 21 CFR 801 Subpart D) __ Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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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-Term<br>Less Than 30 Days | | Product Code: | FOZ | | Device Class: | II | | Review Pane: | General Hospital | | Regulation Number: | 21 CFR 880.5200 | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for MEDIPLUS (INDIA) LIMITED. The logo consists of a cube-like shape made up of white crosses and black squares. Below the logo, the text "MEDIPLUS (INDIA) LIMITED" is written in a bold, sans-serif font. ### Predicate Device: | Mediplus Device | Predicate Device | |---------------------------------------------|--------------------------------------| | Pluski Safe 1 Safety IV Catheter (K 210037) | Introcan Safety IV Catheter(K020785) | ### 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. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for MEDIPLUS (INDIA) LIMITED. The logo consists of a geometric shape resembling a cube constructed from black and white plus signs. Below the geometric shape, the text "MEDIPLUS (INDIA) LIMITED" is written in a bold, sans-serif font. The text is centered below the geometric shape. | Sr. No | Gauge Size | Length of<br>Catheter (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. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows a cube with a pattern of black and white crosses. The crosses are arranged in a repeating pattern on each face of the cube. The black crosses are surrounded by white crosses, and vice versa. The cube is shown in a perspective view, with three faces visible. MEDIPLUS (INDIA) LIMITED | S. No. | Technological<br>Characteristics | Proposed Device (Mediplus India<br>Limited) | Predicate Device (B. Braun<br>Medical)<br>K020785 | Remarks | |--------|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------| | 1 | Product Code | FOZ | FOZ | Same as predicate<br>device | | 2 | Regulation Number | 21 CFR 880.5200 | 21 CFR 880.5200 | Same as predicate<br>device | | 3 | Device Class | Class II | Class II | Same as predicate<br>device | | 4 | Indications For Use | Pluski Safe 1 Safety IV Catheter is Passive<br>anti-stick device for venous or arterial<br>access for the infusion of fluids, drugs,<br>and/or blood products. 14-22 gauge<br>catheters may be used with power<br>injectors which the maximum pressure<br>setting is 300 psi. | Passive anti-stick devices for<br>venous or arterial access for the<br>infusion of fluids, drugs, and/or<br>blood components. 14-22<br>gauge catheters may be used<br>for power injections for which<br>the maximum pressure setting<br>is 300 psi. | Same as predicate<br>device | | 5 | Catheter Gauges | 14G-24G | 14G-24G | Same as predicate<br>device | | 6 | Needle Safety<br>Feature | YES | YES | Same as predicate<br>device | {7}------------------------------------------------ Image /page/7/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 plus signs. The text "MEDIPLUS (INDIA) LIMITED" is written in bold, all-caps letters below the cube. | 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,<br>Poly Oxy Methylene, Polypropylene, Resin | Stainless Steel, P.U.R | Different<br>Comment #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. {8}------------------------------------------------ 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 {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows a black and white logo. The logo is a cube made up of smaller cubes. The smaller cubes are arranged in a pattern of black and white crosses. ### 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.