Revital Cady

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text on the right. The symbol is a stylized representation of a caduceus, a traditional symbol of medicine, with intertwined snakes and wings. To the right of the symbol is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue, with "FDA" in a larger font size than the rest of the text. November 6, 2023 Revital Healthcare (EPZ) Limited % Atonu Dutta CEO Alceon Medtech Consulting 1008, 10th Floor, "OCEAN", Sarabhai Compound Near Centre Square mall, Dr. V.S. Marg Vadodara, Gujarat 390007 India Re: K231519 Trade/Device Name: Revital Cady Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF, FMF, FMI Dated: October 4, 2023 Received: October 10, 2023 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" {1}------------------------------------------------ (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). Change to an Existing Device" (https://www.fda.gov/media/99785/download). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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. # Juliane C. Lessard -S Juliane C. Lessard, Ph.D. Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors {2}------------------------------------------------ OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K231519 Device Name REVITAL CADY Indications for Use (Describe) Auto-Disable Syringe is used to administer intramuscular / intravenous medicines or fixed dose immunization. | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <div> <span> <svg class="bi bi-check-square-fill" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M2 0a2 2 0 0 0-2 2v12a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V2a2 2 0 0 0-2-2H2zm10.03 4.97a.75.75 0 0 0-1.08.022L7.477 9.417 5.384 7.323a.75.75 0 0 0-1.06 1.06L6.97 11.03a.75.75 0 0 0 1.079-.02l3.992-4.99a.75.75 0 0 0-.01-1.05z" fill-rule="evenodd"></path> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> <svg class="bi bi-square" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M14 1H2a1 1 0 0 0-1 1v12a1 1 0 0 0 1 1h12a1 1 0 0 0 1-1V2a1 1 0 0 0-1-1zM2 0a2 2 0 0 0-2 2v12a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V2a2 2 0 0 0-2-2H2z" fill-rule="evenodd"></path> </svg> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### 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. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ # K231519 510(K) Summary ## 1. Submission Sponsor #### Ankur Vora (Director Operations/MR) Revital Healthcare (EPZ) Limited LR No. 5025/1239 Takaungu P.O. Box 80713-80100 Mombasa, Kenya Phone: +254 711443366; +254 790 412900 Email: ankur@rhcare-epz.com; quality@rhcare-epz.com # 2. Primary Correspondent Mr. Atonu Dutta (CEO, Alceon Medtech Consulting) 1008, 10th Floor, "OCEAN", Sarabhai Compound, Near Centre Square mall, Dr. V.S. Marg, Vadodara, Gujarat-390023, India. Phone: (+91) 9925023428 Email: regulatory@alceonconsulting.com # 3. Date of preparing the summary 11/4/2023 #### 4. Device Details Table 1: Device details | Device name (Generic): | Hypodermic Auto Disable Syringe with Needle | |----------------------------|---------------------------------------------| | Device name (Trade Name): | Revital Cady | | Classification Regulation: | 21 CFR 880.5860, 21 CFR880.5570 | | Device Class: | Class II | | Product Code: | FMF, FMI | | Panel: | General hospital | {5}------------------------------------------------ # 5. Predicate Device Table 2: Predicate Device | Subject Device<br>Manufacturer | Subject Device | Primary Predicate<br>Device 510K | Secondary<br>Predicate<br>Device510K | |----------------------------------------|--------------------------------------------------------------------|----------------------------------|--------------------------------------| | Revital<br>Healthcare (EPZ)<br>Limited | Auto Disable Syringe with<br>Needle for Fixed Dose<br>Immunization | K210464 | K211214<br>(For Needle) | # 6. Device Description The Revital Cady is an Auto Disable Fixed Dose Immunization Syringe. It is a three-piece Syringe having male 6% luer slip connection. The Syringe is supplied sterile with nonintegrated Needle having female 6% luer slip connection. The device is sterilized by ETO gas. lt is a disposable, single use and non-pyrogenic device. The Syringe is available in volume of 0.5ml and packed with a needle of 23G size. It is individually packed in blister pouch. The Syringe has an early activation auto disable feature. When the plunger is pulled back, it is connected to a stainless-steel clip inside the barrel and the auto-disable feature is activated at the start of dose administration. After completion of administration, the plunger is detached from the gasket by pulling back. The Syringe consist of four components i.e. - 1. Barrel - 2. Plunger - 3. Gasket - 4. S.S Clip The barrel is made of Polypropylene (PP) with graduated scale printed on its outer wall. The barrel has a nozzle with 6% male luer slip connector that facilitates the connection with the female luer slip connection of the needle. The graduated scale on barrel is indicated in millimetres. {6}------------------------------------------------ The plunger is a solid rod made of Polypropylene. It is used to draw fluid in and out of the barrel by pulling and pushing. The plunger has small rectangular holes on which a clip is fitted. The clip is made up of stainless steel and it is use to activate the auto disable feature. The gasket is made up of PTFE and fitted on top of the plunger. The Syringe is supplied with a Hypodermic Needle is made of three components i.e. - 1. Needle tube - 2. Needle hub - 3. Needle cap The Needle is made up of stainless steel and bonded to the Needle hub by epoxy and UV glue. The hub and cap of the Needle is made of Polypropylene. The cap is used to protect the needle tip from damage as well as injury. ## Raw Materials: ## Table 3: Raw Materials | Components | Material | Grade | CAS No. | Type of Body Contact | |-------------|-------------------------|---------|----------------|----------------------------------| | Syringe | | | | | | Barrel | Polypropylene | RG568MO | 9003-07-0 | Indirect contact with blood path | | Plunger | Polypropylene | RG568MO | 9002-88-4 | Indirect contact with blood path | | Gasket | Thermoplastic elastomer | 3250-01 | 66070-58-4 | Indirect contact with blood path | | Clip | Stainless Steel | SS304 | - | No Contact | | Needle | | | | | | Needle tube | Stainless steel | SS304 | Not applicable | Direct contact with blood path | | Needle cap | Polypropylene | RG568MO | - | No contact | | Needle hub | Polypropylene | RG568MO | - | No contact | {7}------------------------------------------------ # • Indication for use: Auto – Disable Syringe is used to administer intramuscular / intravenous medicines or for fixed dose immunization. # 7. Comparison to a predicate device # 1. Comparison of Auto Disable Syringe to Predicate device | Description | Subject Device<br>(K231519) | Primary Predicate Device<br>(K210464) | Comparison | |-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------| | Product | Auto Disable Syringe with<br>Needle | Auto Disable Syringe | Same | | Product code | FMF | FMF | Same | | Regulation<br>Number | 21 CFR 880.5860 | 21 CFR 880.5860 | Same | | Class | II | II | Same | | Indication for<br>Use | Auto - Disable Syringe is<br>used to administer<br>intramuscular /<br>intravenous medicines or<br>for fixed dose<br>immunization. | The AUTO DISABLE<br>SYRINGE is intended<br>for use in the suction and<br>injection of vaccine for<br>medical purposes.<br>Additionally, after injection<br>to the body, the plunger<br>can be automatically<br>locked by the triggered<br>mechanism to prevent the<br>re-use of this syringe. | Same | | Technological Characteristics | | | | | Configuration | Barrel<br>Plunger<br>Gasket<br>Clip | Barrel<br>Plunger<br>Gasket<br>Clip | Same | | Materials | Barrel - Polypropylene<br>Plunger - Polypropylene<br>Gasket- Thermoplastic<br>Elastomer<br>Clip- Stainless Steel | Barrel - Polypropylene<br>Plunger - Polypropylene<br>Gasket- Polyisoprene<br>Rubber<br>Clip- Stainless Steel | Different 1 | | Reuse<br>Prevention<br>(Safety) Feature | Auto - Disable, prevents<br>syringe re-use | Auto - Disable, prevents<br>syringe re-use | Same | | Auto disable<br>feature<br>activation | Automatically Activate | Automatically Activate | | | Type of Needle | Non-integrated | Integrated | Different 2 | | Description | Subject Device<br>(K231519) | Primary Predicate Device<br>(K210464) | Comparison | | Dose Setting /<br>Volumes | Fixed dose: 0.5 ml | 0.05ml, 0.10ml, 0.20ml,<br>0.25ml, 0.30ml, 0.40ml,<br>0.50ml, 1.0ml | Same<br>(Predicate<br>device have<br>some<br>additional<br>volume sizes<br>syringes) | | Barrel<br>transparency | Transparent & Clear | Transparent & Clear | Same | | Lubricant | Silicon Oil | Silicon Oil | Same | | Biocompatibility | 1. Cytotoxicity<br>2. Sensitization<br>3. Irritation or<br>Intracutaneous<br>reactivity<br>4. Acute systemic<br>toxicity<br>5. Material mediated<br>pyrogenicity<br>6. Hemocompatibility | 1. Cytotoxicity<br>2. Sensitization<br>3. Irritation or<br>Intracutaneous<br>reactivity<br>4. Acute systemic<br>toxicity<br>5. Material mediated<br>pyrogenicity<br>6. Hemocompatibility | Same | | Syringe<br>Performance | Complied with ISO 7886-3,<br>ISO 7886-1, ISO 9626, ISO<br>80369-7, ISO 7864 | Complied with ISO 7886-3,<br>ISO 7886-1, ISO 9626, ISO<br>7864 | Same | | Sterilization<br>Method | EO Sterilized | EO Sterilized | Same | | Single Use | Yes | Yes | Same | | Shelf Life | 5 years | 5 years | Same | | Labeling | Complies with 21 CFR Part<br>801 | Complies with 21 CFR Part<br>801 | Same | {8}------------------------------------------------ # 2. Comparison of Needle to Predicate Device | Description | Subject Device<br>(K231519) | Secondary Predicate<br>Device<br>(211214) | Comparison | |-----------------------------|--------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------| | Class | Class II | Class II | Same | | Indication for Use | Auto - Disable<br>Syringe is used to<br>administer<br>intramuscular /<br>intravenous | The sterile hypodermic<br>needles for single use<br>are intended to used<br>with a luer lock or luer<br>slip syringe and | Different | | Description | Subject Device<br>(K231519) | Secondary Predicate<br>Device<br>(211214) | Comparison | | | medicines or for<br>fixed dose<br>immunization. | injection devices for<br>general purpose fluid<br>injection/aspiration | | | Regulatory number | 21 CFR Part 880.5570 | 21 CFR Part 880.5570 | Same | | Product code | FMI | FMI | Same | | Configuration | Needle Hub<br>Needle Cap<br>(Protective cover)<br>Needle | Needle Hub<br>Protective cover<br>Needle | Same | | Materials | | | | | Needle Hub | Polypropylene | Polypropylene | Different 4 | | Needle | Stainless steel | Stainless steel | | | Needle Cover | Polypropylene | Polypropylene | | | Technical specification | | | | | Needle gauge | 23 G | 30G, 27G, 26G, 25G,<br>24G, 23G,<br>22G, 21G, 20G, 19G,<br>18G | Same- (Predicate<br>device have some<br>additional gauge<br>sizes) | | Nozzle type | Luer-Slip | Luer-lock/ Luer-Slip | Same- (Predicate<br>device has<br>additional nozzle<br>type) | | Needle hub color | Deep Blue (Color<br>coded as per ISO<br>6009) | Color coded as per ISO<br>6009 | Same | | Hub/needle bond<br>strength | Complies as per ISO<br>7864:2016 | Complies as per ISO<br>7864:2016 | Same | | Needle performance | ISO 9626, ISO 80369-<br>7, ISO 7864 | ISO 9626, ISO 80369-7,<br>ISO 7864 | Same | {9}------------------------------------------------ ## Substantial Equivalence Discussion: #### Different 1: Thermoplastic Elastomer has a property of elasticity, low Young's modulus and high yield strain. They are permeable and at ambient temperature relatively soft and deformable. Their primary uses are for seals, adhesives, and molded flexible parts¹. However, the device is tested in accordance with ISO 7886-3:2020, ISO 7886-1:2017, ISO 80369-7:2016, ISO {10}------------------------------------------------ 7864:2016, ISO 9626:2016 standards and results were found satisfactory. The device has also cleared all biocompatibility testing. Considering these factors, the difference of material does not create any safety issue and would perform as intended. Hence, the difference can be considered acceptable. ## Different 2: The Hypodermic Auto Disable Syringe comes with integrated and non-integrated type of Needle. The performance of both type of Needle should comply to ISO 7886-3:2020 clause 12. The auto disable syringe manufactured by Revital Healthcare (EPZ) limited comes with non- integrated Needle. The non-integrated needle is tested according to ISO 7886-3:2020 clause 12, and results were found satisfactory. The device has also cleared other performance test required as per ISO 7886-3:2020, ISO 7886-1:2017, ISO 80369-7:2016, ISO 7864:2016, ISO 9626:2016 standards and results were found satisfactory. Considering these factors, the difference of type of Needle does not create any safety issue and would perform as intended. Hence, the difference can be considered acceptable. ## Different 3: The predicate device has an integrated needle, and the subject device has a non-integrated needle. To prove substantial equivalence of the subject device's non-integrated needle, the secondary predicate is selected. However, the subject device needle intends to be used with the subject device syringe only; therefore, the indications for use are considered the same for both the syringe and the needle. Additionally, the non-integrated needle was tested as per ISO 7886-3:2020, ISO 7864:2016, ISO 9626:2016, ISO 80369-7:2021 standard requirements, and the results met the acceptance criteria. Considering the difference of type of Needle does not create any safety issue and would perform as intended. Hence, the difference can be considered acceptable. #### Different 4: The material grade for the predicate device is unknown; therefore, it is considered different in comparison to Table 2. However, the subject device materials were tested for biocompatibility, and the results were acceptable. Considering these factors, the material difference creates no safety issue and the device would perform as intended. Hence, the difference can be considered acceptable. # 8. Summary of non-clinical performance data Non-clinical tests were conducted to verify that the proposed device met all design specifications, and is Substantially Equivalent (SE) to the predicate device and reference device. | STANDARDS | TEST PARAMETERS | |-----------|-----------------| |-----------|-----------------| {11}------------------------------------------------ | ISO 7886-1:2017 | ISO 7886-1 Second edition 2017-05 - Sterile hypodermic syringes for<br>single use - Part 1: Syringes for manual use | |------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | ISO 7886-3:2020 | ISO 7886-3 Second edition 2020-05 - Sterile hypodermic syringes for<br>single use - Part 3: Auto-disabled syringes for fixed-dose immunization | | ISO 9626:2016 | ISO 9626 Second edition 2016-08-01 - Stainless steel needle tubing for<br>the manufacture of medical devices - Requirements and test methods | | ISO 80369-7:2021 | ISO 80369-7 Second edition 2021-05 - Small-bore connectors for<br>liquids and gases in healthcare applications - Part 7: Connectors for<br>intravascular or hypodermic applications | | ISO 7864:2016 | ISO 7864 Fourth edition 2016-08-01 - Sterile hypodermic needles for<br>single use - Requirements and test methods | | USP <71> | Sterility tests | | USP <85> | Bacterial endotoxin test | | USP <788> | Particulate contamination test | ## Biocompatibility Test: - Cytotoxicity, ISO 10993-5:2009 - Acute Systematic Toxicity, ISO 10993-11:2017 - Skin Sensitization, ISO 10993-10:2021 ● - Intracutaneous Reactivity, ISO 10993-23:2021 ● - Hemolysis (Direct & Indirect), ISO 10993-4:2017 & ASTM F756-17 0 - 0 Material Mediated Pyrogenicity #### Packaging & Transits Study: ISO 11607-1:2019 2nd edition - Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems, and packaging systems ISO 11607-2:2019 2nd edition -Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing, and assembly processes ASTM D4169-16 - Standard Practice for Performance Testing of Shipping Containers and Systems #### Sterilization Test: ISO 11135:2014/AMD 1:2018 2nd edition - Sterilization of health care products - Ethylene oxide - Requirements for development, validation, and routine control of a sterilization process for medical devices. ## EO Residual Test: ISO 10993-7:2008/Amd 1:2019 2nd edition- Biological evaluation of medical devices - Part 7: {12}------------------------------------------------ Ethylene oxide sterilization residuals, and it meets the requirements of the standard. ## Bacterial Endotoxin Test: The Bacterial endotoxin testing of subject devices was performed by the "Gel-Clot Method" and meets the requirement of USP <85>. # 9. Summary of clinical performance data No clinical study is included in this submission. # 10. Conclusion The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.