(165 days)
Auto-Disable Syringe is used to administer intramuscular / intravenous medicines or fixed dose immunization.
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. 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.
The provided text describes the Revital Cady Auto-Disable Syringe, a Class II medical device, and its substantial equivalence to predicate devices, K210464 and K211214 (for the needle). The submission focuses on non-clinical performance data to demonstrate that the device meets acceptance criteria.
Here's an organized breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The Revital Cady device, including both the syringe and the needle, was tested against various ISO standards and USP tests. The reported performance uniformly states that the results were "satisfactory" or "complied with" the respective standards, indicating that the device met the acceptance criteria defined by these standards.
| Test Parameter / Standard | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Syringe Performance | ||
| ISO 7886-1:2017 | Compliance with standard | Complied / Satisfactory |
| ISO 7886-3:2020 | Compliance with standard | Complied / Satisfactory |
| ISO 80369-7:2021 | Compliance with standard | Complied / Satisfactory |
| Needle Performance | ||
| ISO 9626:2016 | Compliance with standard | Complied / Satisfactory |
| ISO 7864:2016 | Compliance with standard | Complied / Satisfactory |
| Sterility & Biocompatibility | ||
| USP <71> (Sterility) | Sterility | Met requirement |
| USP <85> (Bacterial Endotoxin) | Compliance with USP <85> | Met requirement |
| USP <788> (Particulate Contamination) | Compliance with standard (implied) | Complied / Satisfactory |
| Cytotoxicity (ISO 10993-5:2009) | Acceptable toxicity levels | Acceptable |
| Acute Systemic Toxicity (ISO 10993-11:2017) | Acceptable toxicity levels | Acceptable |
| Skin Sensitization (ISO 10993-10:2021) | Acceptable sensitization levels | Acceptable |
| Intracutaneous Reactivity (ISO 10993-23:2021) | Acceptable reactivity levels | Acceptable |
| Hemolysis (ISO 10993-4:2017 & ASTM F756-17) | Acceptable hemolysis | Acceptable |
| Material Mediated Pyrogenicity | No pyrogenicity | Acceptable |
| Packaging & Transit Study | ||
| ISO 11607-1:2019 | Compliance with standard | Complied |
| ISO 11607-2:2019 | Compliance with standard | Complied |
| ASTM D4169-16 | Compliance with standard | Complied |
| Sterilization Test | ||
| ISO 11135:2014/AMD 1:2018 | Compliance with standard | Complied |
| EO Residual Test | ||
| ISO 10993-7:2008/Amd 1:2019 | Meets requirements of standard | Meets requirement |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for each non-clinical test. It only states that tests were "conducted" and "results were found satisfactory" or "met the requirement of the standard."
The data provenance is not explicitly mentioned in terms of country of origin or whether it was retrospective or prospective. However, safety and performance testing for Substantial Equivalence are typically conducted prospectively in a controlled laboratory environment by the manufacturer or a contracted lab. Given the manufacturer is Revital Healthcare (EPZ) Limited in Kenya and the primary correspondent is in India, the testing was likely conducted in one of these locations or by an international lab.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable. The study involves non-clinical performance and biocompatibility testing against established international standards (ISO, USP, ASTM). Ground truth in this context is determined by the objective results of these tests and their comparison to the defined acceptance criteria within the standards, not by expert consensus on subjective evaluations.
4. Adjudication Method for the Test Set
Not applicable. As described above, the evaluation is based on objective measurements against established technical standards, not on human adjudication of subjective assessments.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document explicitly states: "No clinical study is included in this submission." Therefore, an MRMC comparative effectiveness study was not performed. The submission relies solely on non-clinical performance data to demonstrate substantial equivalence.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. The device is a physical medical device (an auto-disable syringe), not an algorithm or software. Therefore, the concept of "standalone algorithm performance" is not relevant.
7. The Type of Ground Truth Used
The ground truth for device performance is defined by adherence to the quantitative and qualitative requirements outlined in the referenced international standards (e.g., ISO 7886-1, ISO 9626, ISO 10993 series, USP monographs). This includes:
- Quantitative measurements: For aspects like dose volume accuracy (implied by syringe standards), needle dimensions, bond strength, residual EO levels, particulate contamination.
- Qualitative assessment: For sterility, biocompatibility (e.g., absence of cytotoxicity, irritation), and functional performance demonstrating the auto-disable mechanism works as intended.
Essentially, the "ground truth" is compliance with these universally accepted specifications for medical devices of this type.
8. The Sample Size for the Training Set
Not applicable. This device is a physical auto-disable syringe, not an AI/ML algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a physical device.
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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"
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(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
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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) 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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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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 |
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5. Predicate Device
Table 2: Predicate Device
| Subject DeviceManufacturer | Subject Device | Primary PredicateDevice 510K | SecondaryPredicateDevice510K |
|---|---|---|---|
| RevitalHealthcare (EPZ)Limited | Auto Disable Syringe withNeedle for Fixed DoseImmunization | K210464 | K211214(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.
-
- Barrel
-
- Plunger
-
- Gasket
-
- 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.
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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.
-
- Needle tube
-
- Needle hub
-
- 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 |
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• 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(K231519) | Primary Predicate Device(K210464) | Comparison |
|---|---|---|---|
| Product | Auto Disable Syringe withNeedle | Auto Disable Syringe | Same |
| Product code | FMF | FMF | Same |
| RegulationNumber | 21 CFR 880.5860 | 21 CFR 880.5860 | Same |
| Class | II | II | Same |
| Indication forUse | Auto - Disable Syringe isused to administerintramuscular /intravenous medicines orfor fixed doseimmunization. | The AUTO DISABLESYRINGE is intendedfor use in the suction andinjection of vaccine formedical purposes.Additionally, after injectionto the body, the plungercan be automaticallylocked by the triggeredmechanism to prevent there-use of this syringe. | Same |
| Technological Characteristics | |||
| Configuration | BarrelPlungerGasketClip | BarrelPlungerGasketClip | Same |
| Materials | Barrel - PolypropylenePlunger - PolypropyleneGasket- ThermoplasticElastomerClip- Stainless Steel | Barrel - PolypropylenePlunger - PolypropyleneGasket- PolyisopreneRubberClip- Stainless Steel | Different 1 |
| ReusePrevention(Safety) Feature | Auto - Disable, preventssyringe re-use | Auto - Disable, preventssyringe re-use | Same |
| Auto disablefeatureactivation | Automatically Activate | Automatically Activate | |
| Type of Needle | Non-integrated | Integrated | Different 2 |
| Description | Subject Device(K231519) | Primary Predicate Device(K210464) | Comparison |
| Dose Setting /Volumes | Fixed dose: 0.5 ml | 0.05ml, 0.10ml, 0.20ml,0.25ml, 0.30ml, 0.40ml,0.50ml, 1.0ml | Same(Predicatedevice havesomeadditionalvolume sizessyringes) |
| Barreltransparency | Transparent & Clear | Transparent & Clear | Same |
| Lubricant | Silicon Oil | Silicon Oil | Same |
| Biocompatibility | 1. Cytotoxicity2. Sensitization3. Irritation orIntracutaneousreactivity4. Acute systemictoxicity5. Material mediatedpyrogenicity6. Hemocompatibility | 1. Cytotoxicity2. Sensitization3. Irritation orIntracutaneousreactivity4. Acute systemictoxicity5. Material mediatedpyrogenicity6. Hemocompatibility | Same |
| SyringePerformance | Complied with ISO 7886-3,ISO 7886-1, ISO 9626, ISO80369-7, ISO 7864 | Complied with ISO 7886-3,ISO 7886-1, ISO 9626, ISO7864 | Same |
| SterilizationMethod | EO Sterilized | EO Sterilized | Same |
| Single Use | Yes | Yes | Same |
| Shelf Life | 5 years | 5 years | Same |
| Labeling | Complies with 21 CFR Part801 | Complies with 21 CFR Part801 | Same |
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2. Comparison of Needle to Predicate Device
| Description | Subject Device(K231519) | Secondary PredicateDevice(211214) | Comparison |
|---|---|---|---|
| Class | Class II | Class II | Same |
| Indication for Use | Auto - DisableSyringe is used toadministerintramuscular /intravenous | The sterile hypodermicneedles for single useare intended to usedwith a luer lock or luerslip syringe and | Different |
| Description | Subject Device(K231519) | Secondary PredicateDevice(211214) | Comparison |
| medicines or forfixed doseimmunization. | injection devices forgeneral purpose fluidinjection/aspiration | ||
| Regulatory number | 21 CFR Part 880.5570 | 21 CFR Part 880.5570 | Same |
| Product code | FMI | FMI | Same |
| Configuration | Needle HubNeedle Cap(Protective cover)Needle | Needle HubProtective coverNeedle | 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,24G, 23G,22G, 21G, 20G, 19G,18G | Same- (Predicatedevice have someadditional gaugesizes) |
| Nozzle type | Luer-Slip | Luer-lock/ Luer-Slip | Same- (Predicatedevice hasadditional nozzletype) |
| Needle hub color | Deep Blue (Colorcoded as per ISO6009) | Color coded as per ISO6009 | Same |
| Hub/needle bondstrength | Complies as per ISO7864:2016 | Complies as per ISO7864:2016 | Same |
| Needle performance | ISO 9626, ISO 80369-7, ISO 7864 | ISO 9626, ISO 80369-7,ISO 7864 | Same |
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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
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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 |
|---|---|
| ----------- | ----------------- |
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| ISO 7886-1:2017 | ISO 7886-1 Second edition 2017-05 - Sterile hypodermic syringes forsingle use - Part 1: Syringes for manual use |
|---|---|
| ISO 7886-3:2020 | ISO 7886-3 Second edition 2020-05 - Sterile hypodermic syringes forsingle use - Part 3: Auto-disabled syringes for fixed-dose immunization |
| ISO 9626:2016 | ISO 9626 Second edition 2016-08-01 - Stainless steel needle tubing forthe manufacture of medical devices - Requirements and test methods |
| ISO 80369-7:2021 | ISO 80369-7 Second edition 2021-05 - Small-bore connectors forliquids and gases in healthcare applications - Part 7: Connectors forintravascular or hypodermic applications |
| ISO 7864:2016 | ISO 7864 Fourth edition 2016-08-01 - Sterile hypodermic needles forsingle 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:
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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.
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).