(165 days)
The Safety Syringe with permanently attached needle is intended for use by health care professionals for general purpose aspiration of fluid from vials, ampoules and liquid injection below the skin. The Safety sheath of Syringe is designed to aid in the prevention of needle stick injuries and reduce the potential of syringe reuse.
The Disposable Syringe with permanently attached needle is intended for use by health care professionals for general purpose aspiration of fluid from vials, ampoules and liquid injection below the surface of the skin.
The proposed Syringes include Disposable Syringe with permanently attached needle and a Safety Syringe with permanently attached needle. The Disposable Syringe with permanently attached needle have one kind of product configuration, and the Safety Syringe with permanently attached needle has two kinds of product configurations. The proposed syringes are available in different combination of syringe volumes and/or needle sizes, and the syringe is sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied sterile in packaging to maintain the sterility of the device during the shelf life of three years.
This is a 510(k) premarket notification for a medical device (Safety Syringe with permanently attached needle; Disposable Syringe with permanently attached needle), not an AI/ML powered device. Therefore, the common acceptance criteria and study designs applicable to AI/ML devices, such as those involving human readers, effect sizes, specific ground truth methods, and training/test set sample sizes for AI model development, are not relevant to this document.
The document describes performance testing for substantial equivalence to predicate devices, which focuses on various engineering and biocompatibility standards.
Here's the relevant information about the acceptance criteria and study (non-clinical) that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present acceptance criteria and performance in a direct "acceptance criteria vs. reported performance" table for all aspects. Instead, it refers to compliance with established international standards for medical devices. The "reported device performance" is implicitly that the device complies with these standards where listed.
| Acceptance Criteria (Standard Compliance) | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| ISO 10993-5: 2009 (Cytotoxicity) | Performed, conforms |
| ISO 10993-10: 2010 (Skin sensitization, Intracutaneous reactivity) | Performed, conforms |
| ISO 10993-4: 2017 (Hemolysis) | Performed, conforms |
| ISO 10993-11: 2017 (Acute systemic toxicity, Pyrogenicity) | Performed, conforms |
| USP <788> (Particulate matter) | Performed, conforms |
| Sterilization & Shelf Life: | |
| ISO 11135 (EO Sterilization) | Validated |
| USP42-NF37 <85> (Bacteria Endotoxin Limit) | Carried out |
| ISO 10993-7:2008 (EO residue, ECH residue) | Performed, conforms |
| ASTM F1980-16 (Aging Test for Shelf Life) | Performed, determines 3-year shelf life |
| ASTM F88/F88M-15 (Seal strength) | Performed, packaging acceptable |
| ASTM F 1929-2015 (Blue Dye Penetration) | Performed, packaging acceptable |
| ASTM F 1886/ F 1886M-16 (Seal Integrity Visual Inspection) | Performed, packaging acceptable |
| Performance Testing: | |
| ISO 7886-1: 2017 (Sterile hypodermic syringes for manual use) | Performed, conforms |
| ISO 7886-4: 2018 (Syringes with re-use prevention feature) | Performed, conforms |
| ISO 7864: 2016 (Sterile hypodermic needles) | Performed, conforms |
| ISO 9626:2016 (Stainless Steel Needle Tubing) | Performed, conforms |
| ISO 23908: 2011 (Sharps injury protection) | Performed, conforms |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the exact sample sizes for each of the non-clinical tests mentioned. The "tests" are laboratory-based and generally involve a specified number of samples needed to demonstrate compliance with the relevant ISO or ASTM standards. Data provenance is not described in terms of country of origin as it's not clinical data, but rather laboratory test results. All tests are non-clinical (laboratory-based).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
Not applicable. These are non-clinical, laboratory-based tests for physical and material properties, not clinical evaluations requiring expert interpretation for ground truth.
4. Adjudication Method for the Test Set:
Not applicable for non-clinical laboratory testing. Results are typically objectively measured against standard specifications.
5. 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. This device is a manual medical device, not an AI-powered system that would involve human readers or AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a manual medical device, not an AI algorithm.
7. The type of ground truth used:
For this device, "ground truth" is defined by the objective specifications and acceptance criteria outlined in the referenced international standards (ISO, ASTM, USP). For example:
- Biocompatibility: The "ground truth" is the acceptable range of biological response according to ISO 10993 standards.
- Sterilization: The "ground truth" is a Sterility Assurance Level (SAL) of 10^-6, verified by methods validated to ISO 11135.
- Physical Performance: The "ground truth" is the specific functional and dimensional requirements set forth in standards like ISO 7886-1 or ISO 9626.
There is no "expert consensus" or "pathology" in the traditional sense for these types of mechanical and material tests.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device; there is no training set.
9. How the ground truth for the training set was established:
Not applicable. There is no training set for this type of device.
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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: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
October 17, 2022
Jiangxi Maidikang Medical Devices Co., Ltd Wu Huansheng Management Room 308, floor 3, building 1, Jiangxi pharmaceutical co., Ltd, No 999, kelun Avenue, pharmaceutical industrial park Yichun, Jiangxi China
Re: K221308
Trade/Device Name: Safety Syringe with permanently attached needle; Disposable Syringe with permanently attached needle Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF, MEG Dated: September 8, 2022 Received: September 14, 2022
Dear Wu Huansheng:
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
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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 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,
CAPT Alan M. Stevens 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) K221308
Device Name
Safety Syringe with permanently attached needle Disposable Syringe with permanently attached needle
Indications for Use (Describe)
The Safety Syringe with permanently attached needle is intended for use by health care professionals for general purpose aspiration of fluid from vials, ampoules and liquid injection below the skin. The Safety sheath of Syringe is designed to aid in the prevention of needle stick injuries and reduce the potential of syringe reuse.
The Disposable Syringe with permanently attached needle is intended for use by health care professionals for general purpose aspiration of fluid from vials, ampoules and liquid injection below the surface of the skin.
| 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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510(k) summary
l Submitter
Device submitter: Jiangxi Maidikang Medical Devices Co., Ltd.
Room 308, floor 3, building 1, jiangxi pharmaceutical co., Ltd, No 999, kelun Avenue, pharmaceutical industrial park, Yuanzhou District, Yichun City, Jiangxi province
Contract manufacturer: Anhui Tiankang Medical Technology Co., Ltd.
No.228, Weiyi Road, Economic Development Zone, Tianchang City, Anhui, China.
510(k) Number: K221308
Contact person: Name: Wu Huansheng Title: Management Phone: +86-13617915949 E-mail: 3487486481 @qq.com
Preparation Date: May 6th, 2022
II Device
Trade Name of Device: Safety Syringe with permanently attached needle Disposable Syringe with permanently attached needle Common Name: Piston syringe Regulation Number: 21CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: II Product code: FMF, MEG Review Panel: General Hospital III Predicate Devices
| Trade name: | 1ml Luer Slip or Luer Lock Syringe |
|---|---|
| Syringe with permanently attached needle (used as Predicate Device) | |
| Safety Syringe with permanently attached needle (used as Predicate Device) | |
| Common name: | Piston Syringe and antistick syringe |
| Classification: | Class II, 21 CFR 880.5860 |
| Product Code: | FMF, MEG |
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Premarket Notification: K192551 Manufacturer: Jiangsu Caina Medical Co., Ltd.
IV Device description
The proposed Syringes include Disposable Syringe with permanently attached needle and a Safety Syringe with permanently attached needle. The Disposable Syringe with permanently attached needle have one kind of product configuration, and the Safety Syringe with permanently attached needle has two kinds of product configurations. The proposed syringes are available in different combination of syringe volumes and/or needle sizes, and the syringe is sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied sterile in packaging to maintain the sterility of the device during the shelf life of three years.
| Model | SyringeVolume | Needle Length | NeedleGauge | Walltype | NeedleBevel |
|---|---|---|---|---|---|
| Disposable Syringewith permanentlyattached needle-TKSPN01 | 0.5ml; 1ml | 3/8" (10mm);1/2" (13mm);5/8" (16mm); | 23G | TW | LB |
| 3/4" (20mm);7/8" (22mm);1" (25mm); | 24G | RW | LB | ||
| 25G | RW | LB | |||
| 3/8" (10mm);1/2" (13mm);5/8" (16mm); | 26G | RW | LB | ||
| 3/4" (20mm); | 27G | RW | LB | ||
| 3/8" (10mm);1/2" (13mm);5/8" (16mm); | 28G | RW | LB | ||
| 3/10" (8mm); | 29G | RW | LB | ||
| 3/8" (10mm);1/2" (13mm); | 30G | RW | LB | ||
| 5/8" (16mm); | 31G | RW | LB | ||
| Safety Syringe withpermanently attachedneedle -TKSSPN01 | 0.3ml | 3/8" (10mm);1/2" (13mm);5/8" (16mm); | 27G | RW | LB |
| 28G | RW | LB | |||
| 3/10" (8mm); | 29G | RW | LB | ||
| 3/8" (10mm);1/2" (13mm); | 30G | RW | LB | ||
| 5/8" (16mm); | 31G | RW | LB |
Table 1 specification of proposed device
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| 0.5ml; 1ml | 3/8" (10mm);1/2" (13mm);5/8" (16mm); | 25G | RW | LB | |
|---|---|---|---|---|---|
| 26G | RW | LB | |||
| 27G | RW | LB | |||
| 28G | RW | LB | |||
| 3/10" (8mm);3/8" (10mm);1/2" (13mm); | 29G | RW | LB | ||
| 30G | RW | LB | |||
| 5/8" (16mm); | 31G | RW | LB | ||
| Safety Syringe withpermanently attachedneedle-TKSSPN02 | 1ml | 3/4" (20mm); | 21G | TW | LB |
| 7/8" (22mm); | 22G | TW | LB | ||
| 1" (25mm); | 23G | TW | LB | ||
| 1 1/4" (32mm); | 24G | RW | LB | ||
| 1 1/2" (38mm); | 25G | RW | LB | ||
| 3/4" (20mm) | 26G | RW | LB | ||
| 3/4" (20mm) | 27G | RW | LB |
V Indications for use
Disposable Syringe with permanently attached needle
The Disposable Syringe with permanently attached needle is intended for use by health care professionals for general purpose aspiration of fluid from vials, ampoules and liquid injection below the surface of the skin.
Safety Syringe with permanently attached needle
The Safety Syringe with permanently attached needle is intended for use by health care professionals for general purpose aspiration of fluid from vials, ampoules and liquid injection below the surface of the skin. The Safety sheath of Syringe is designed to aid in the prevention of needle stick injuries and reduce the potential of syringe reuse.
VI Comparison of technological characteristics with the predicate devices
The Disposable Syringe with permanently attached needle and Safety Syringe with permanently attached needle have the same intended use, technology, design and performance specifications to the legally marketed predicate device. The main differences between subject devices and predicate devices are the specification of syringe volume, needle gauge and needle length. This difference does not affect indication for use. The difference between the subject device and the predicate does not affect the safety and effectiveness of the subject device T
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| Devicefeature | Subject Device | Predicate Device K192551 | Comment |
|---|---|---|---|
| Product | Disposable Syringe withpermanently attachedneedle | Syringe with permanentlyattached needle | / |
| Syringe type | Piston syringe | Piston syringe | Same |
| Indicationsfor use | The Disposable Syringewith permanently attachedneedle is intended for useby health care professionalsfor general purposeaspiration of fluid from vials,ampoules and liquidinjection below the surfaceof the skin. | The Syringe withpermanently attachedneedle is intended for useby health care professionalsfor general purposeaspiration of fluid from vials,ampoules and liquidinjection below the surfaceof the skin. | Same |
| Product code | FMF | FMF | Same |
| Regulationnumber | 21 CFR 880.5860 | 21 CFR 880.5860 | Same |
| Class | II | II | Same |
| Principle ofoperation | For Manual Use Only, ForSingle Use Only | For Manual Use Only, ForSingle Use Only | Same |
| ConnectorType | Attached needle | Attached needle | Same |
| Needlegauge | 23G, 24G, 25G, 26G, 27G,28G, 29G, 30G, 31G | 21G, 23G, 25G, 26G, 27G,28G, 29G, 30G, 31G | Difference1 |
| NeedleLength | 8mm, 10mm, 13mm, 16mm,20mm, 22mm, 25mm | 8mm, 10mm, 13mm, 16mm,20mm, 25mm | |
| Needle walltype | RW, TW | RW, TW | |
| Needle bevel | 11°±2° | 11°±2°, 15°±2° | |
| SyringeVolume | 0.5ml, 1ml | 0.3ml, 0.5ml, 1ml | |
| Devicefeature | Subject Device | Predicate Device K192551 | Comment |
| Mainstructure andmaterials | (1) Needle cap (PP)(2) Needle (Stainless Steel304)(3) Piston (Polyisoprene)(4) Plunger (PP)(5) Barrel (PP) | Syringe with permanentlyattached needle-type A(1) needle cap (PP or PE)(2) needle (Stainless Steel304)(3) piston (Polyisoprene)(4) plunger (PP)(5) barrel (PP)(6) end cap (PP or PE)Syringe with permanentlyattached needle-type B(1) needle cap (PP or PE)(2) needle (Stainless Steel304)(3) piston (Polyisoprene)(4) plunger (PP or ABS)(5) barrel (PP) | Difference2 |
| Performancespecifications | Complies with ISO 7886-1;ISO 9626 and ISO 7864 | Complies with ISO 7886-1;ISO 9626 and ISO 7864 | Same |
| Single Use | Yes | Yes | Same |
| Sterilization | EO Sterilization | EO Sterilization | Same |
| SAL | 10-6 | 10-6 | Same |
| Biocompatibility | Contact level: blood path,indirect, limited contact (<24hours).Conforms to therequirement of ISO 10993series Standards | Contact level: blood path,indirect, limited contact (<24hours).Conforms to therequirement of ISO 10993series Standards | Same |
| Labeling | Complied with 21 CFR part801 | Complied with 21 CFR part801 | Same |
Table 6-1 Substantial equivalence discussion for Disposable Syringe with permanently attached needle
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Difference 1
The needle bevel of subject device (11°±2°) is smaller than the predicate device's bevel range of 11°±2ând 15° £°. The subject device's 0.5ml and 1ml syringe volume is smaller than the predicated device's syringe volume range of 0.3ml, 0.5ml and 1ml. And the needle gauge and length of subject devices are similar to the predicate device. This difference does not affect intended use. In addition, differences were addressed through ISO 7886-1, ISO 7864 and ISO 9626. The differences
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on syringe volume, needle bevel, needle gauge and length do not raise different question of safety and effectiveness.
Difference 2
The configuration of subject device is same as type B of predicate device, and compared with type A, the difference is that the subject device does not have an end cap. but the syringe with attached needle is widely used in the clinical. Whether there is an end cap or not will not affect the indication for use of the equipment itself. This difference does not raise new questions about safety and effectiveness.
The materials of subject device are similar to the predicated device. The proposed syringes' biocompatibility can be demonstrated by the biocompatibility tests. The differences on configuration and materials do not raise new questions about safety and effectiveness.
| Devicefeature | Subject Device | Predicate Device K192551 | Comment |
|---|---|---|---|
| Product | Safety Syringe withpermanently attachedneedle | Safety Syringe withpermanently attachedneedle | / |
| Syringe type | Piston syringe | Piston syringe | Same |
| Indicationsfor use | The Safety Syringe withpermanently attachedneedle is intended for useby health care professionalsfor general purposeaspiration of fluid from vials,ampoules and liquidinjection below the surfaceof the skin. The Safetysheath of Syringe isdesigned to aid in theprevention of needle stickinjuries and reduce thepotential or syringe reuse. | The Safety Syringe withpermanently attachedneedle is intended for useby health care professionalsfor general purposeaspiration of fluid from vials,ampoules and liquidinjection below the surfaceof the skin. The Safetysheath of Syringe isdesigned to aid in theprevention of needle stickinjuries and reduce thepotential or syringe reuse. | Same |
| Product code | MEG | MEG | Same |
| Regulationnumber | 21 CFR 880.5860 | 21 CFR 880.5860 | Same |
| Class | II | II | Same |
| Devicefeature | Subject Device | Predicate Device K192551 | Comment |
| Principle of operation | For Manual Use Only, ForSingle Use Only | For Manual Use Only, ForSingle Use Only | Same |
| ConnectorType | Attached needle | Attached needle | Same |
| Needlegauge | 21G, 22G, 23G, 24G, 25G,26G, 27G, 28G, 29G, 30G,31G | 21G, 23G, 25G, 26G, 27G,28G, 29G, 30G, 31G | Difference3 |
| NeedleLength | 8mm, 10mm, 13mm, 16mm,20mm, 22mm, 25mm,32mm, 38mm | 8mm, 10mm, 13mm, 16mm,20mm, 25mm | |
| Needle walltype | RW, TW | RW, TW | |
| Needle bevel | 11°±2° | 11°±2°, 15°±2° | |
| SyringeVolume | 0.3ml, 0.5ml, 1ml | 0.3ml, 0.5ml, 1ml | Same |
| Mainstructure andmaterials | (1) Protecitve cap (PP)(2) Needle (Stainless Steel304)(3) Safety mechanism-Connector base (PC)(4) Piston (Polyisoprene)(5) Safety mechanism-Sliding sleeve (PP)(6) Plunger (PP)(7) Barrel (PP) | (1) needle cap (PP or PE)(2) needle (Stainless Steel304)(3) safety mechanism (PC)(4) piston (Polyisoprene)(5) safety mechanism (PP)(6) plunger (PP)(7) barrel (PP) | Same |
| Performancespecifications | Complies with ISO 7886-1;ISO 9626 and ISO 7864 | Complies with ISO 7886-1;ISO 9626 and ISO 7864 | Same |
| Single Use | Yes | Yes | Same |
| Sterilization | EO Sterilization | EO Sterilization | Same |
| SAL | 10-6 | 10-6 | Same |
| Biocompatibility | Contact level: blood path,indirect, limited contact (<24hours).Conforms to therequirement of ISO 10993series Standards | Contact level: blood path,indirect, limited contact (<24hours).Conforms to therequirement of ISO 10993series Standards | Same |
| Labeling | Complied with 21 CFR part801 | Complied with 21 CFR part801 | Same |
Table 6-2 Substantial equivalence discussion for Safety Syringe with permanently attached needle
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Difference 3
The needle bevel of subject device (11°±2°) is smaller than the predicate device's bevel range of 11°±2'and 15°±2°. And the needle gauge and length of subject devices are similar to the predicate device, the difference is just in dimension. This difference does not affect intended use. In addition, differences were addressed through ISO 7864 and ISO 9626. The differences on syringe volume, needle bevel, needle gauge and length do not raise different question of safety and effectiveness.
VII Performance data
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
Biocompatibility of the Disposable Syringe with permanently attached needle and Safety Syringe with permanently attached needle were evaluated in accordance with ISO 10993-1:2018 for the body contact category of "External communication device - Blood path indirect" with a contact duration of "Limited (< 24 hours)". The following tests were performed, as recommended:
| Cytotoxicity | ISO 10993-5: 2009 |
|---|---|
| Skin sensitization | ISO 10993-10: 2010 |
| Hemolysis | ISO 10993-4: 2017 |
| Intracutaneous reactivity | ISO 10993-10: 2010 |
| Acute systemic toxicity | ISO 10993-11: 2017 |
| Pyrogenicity | ISO 10993-11: 2017 |
| Particulate matter | USP <788> |
Sterilization and shelf life testing
The sterilization method has been validated to ISO11135, which has thereby determined the routine control and monitoring parameters. Bacteria Endotoxin Limit is carried out according to USP42-NF37 <85> Bacterial Endotoxins Test.
The testing is performed according to the following standards:
| EO residue | ISO 10993-7:2008 |
|---|---|
| ECH residue | ISO 10993-7:2008 |
| Bacteria Endotoxin | USP42-NF37 <85> |
The shelf life of 3 year is determined based on stability studies which include ageing test according to FDA recognized standard ASTM F1980-16.
Package integrity testing was conducted on the final, packaged, and sterile devices after environmental conditioning and simulated transportation. All packaging deemed acceptable for protection of product and sterility maintenance.
The testing is performed according to the following standards:
Seal strength
ASTM F88/F88M-15
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Blue Dye Penetration Seal Integrity (Visual Inspection)
ASTM F 1929-2015 ASTM F 1886/ F 1886M-16
Performance testing
Performance testing is performed according to the following standards:
- ISO 7886-1: 2017, Sterile hypodermic syringes for single use- Part 1: Syringes for A manual use.
-
ISO 7886-4: 2018, Sterile hypodermic syringes for single use- Part 4: Syringes with re-use prevention feature
-
ISO 7864: 2016, ISO 9626:2016, Stainless Steel Needle Tubing For The Manufacture of Medical Devices.
-
ISO 9626:2016, Stainless Steel Needle Tubing for The Manufacture of Medical Devices.
-
ISO 23908: 2011 Sharps injury protection - Requirements and test methods -Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling.
VIII Clinical Test Conclusion
No clinical study is included in this submission.
IX Conclusion
The Disposable Syringe with permanently attached needle and Safety Syringe with permanently attached needle are substantially equivalent to its predicate devices. The non-clinical testing demonstrates that the device is as safe, as effective and performs as well as the legally marketed device.
§ 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).