(120 days)
Not Found
No
The device description and performance studies focus on mechanical safety features and standard biocompatibility/performance testing, with no mention of AI/ML components or data processing.
Yes
The device is described as "injecting fluids into or withdrawing fluids from the body" and mentions "delivery of Tuberculin" and "preparation/mixing of allergenic extracts/ prescribed substances," which are all therapeutic actions.
No
Explanation: The device is described as a syringe used for injecting or withdrawing fluids, with a safety feature to prevent needle sticks. Its intended uses (general injection, allergy, Tuberculin) are all therapeutic or for sample collection (withdrawal of fluids), not for diagnosing a condition.
No
The device description clearly outlines physical components like a piston, barrel, needle cap, etc., and describes sterilization and packaging, indicating it is a physical medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device for injecting or withdrawing fluids from the body and for the preparation/mixing of substances for injection. These are procedures performed on a patient, not on a sample from a patient to diagnose a condition.
- Device Description: The description details the physical components of a syringe and needle, designed for delivering or withdrawing substances from the body.
- Performance Studies: The performance studies focus on biocompatibility, sterility, and the functionality of the safety feature for preventing needle sticks during patient use. There are no studies related to analyzing biological samples for diagnostic purposes.
IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or treatment. This device's function is directly related to administering or withdrawing substances from the body, which falls outside the scope of an IVD.
N/A
Intended Use / Indications for Use
The Ret retractable Safety Syringe works like a conventional hypodermic syringe except for its ability to retract the contaminated needle inside of the syringe immediately after patient injection is activated by the syringe user. Because the contaminated needle is automatically withdrawn into the syringe user is protected from accidental needle sticks. These accidental needle sticks would occur between removing the needle from the patient and disposing of the syringe in a sharps disposable container.
For general injection use: The function of Retractable Safety Syringe is to provide a safe and reliable method of injecting fluids into or withdrawing fluids from the body. The Retractable Safety Syringe is designed to aid in the prevention of needle stick injuries and reduce the potential or syringe contains various capacity, such as 1ml, 2.5ml, 3ml, 5ml and 10ml.
For allergy use: The 1ml Retractable Safety Allergy Syringe is intended for the preparation/mixing of allergenic extracts/ prescribed substances, the manual aspiration of fluids, and for the injection of fluids into parts of the body below the surface of the skin. The Retractable Safety Syringe is designed to aid in the prevention of needle stick injuries and reduce the potential or syringe reuse.
For Tuberculin use: The 1ml Retractable Safety Tuberculin Syringe is intended for the delivery of Tuberculin. The Retractable Safety Syringe is designed to aid in the prevention of needle stick injuries and reduce the potential or syringe reuse.
Product codes (comma separated list FDA assigned to the subject device)
MEG
Device Description
The proposed devices are available in various specifications, including 1ml, 2.5ml, 3ml, 5ml and 10ml. The applications of Retractable Safety Syringe include general injection, allergy and Tuberculin. General injection use is for 1ml, 2.5ml, 3ml, 5ml and 10ml, while allergy and Tuberculin uses are only for 1ml.
The proposed device consists of eleven components: (1) piston, (3) barrel, (4) needle cap, (5) sealing plug, (6) slide bushing, (7) needle tube, (8) spring, (9) plunger lid, (10) barrel barb, (11) hub.
The proposed devices are provided sterile. The product is sterilized by Ethylene Oxide Gas to achieve a SAL of 10 · and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of five years.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospital
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility tests were conducted according to ISO 10993-5:2009, ISO 10993-10:20101, ISO 10993-11, ASTM F756-17, and ISO 10993-4:2017 to verify that the proposed devices are not adverse to human tissue.
Other non-clinical tests conducted include:
- ISO 10993-7:2008 Biological evaluation of medical devices- Part 7: Ethylene Oxide Sterilization Residuals
- USP Pyrogen Test
- ASTM F1929-15 Standard test method for detecting seal leaks in porous medical packaging by dye penetration.
- ASTM F88/F88M-15 standard method for seal strength of flexible barrier materials
- ASTM F1886 / F1886M-16, Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
- USP 39-NF34 Bacterial Endotoxins Test
- ISO 7864:2016 Sterile hypodermic needles for single use-requirements and test method.
- ISO 9626:2016 Stainless steel needle tubing for the manufacture of the medical devices-requirements and test method
- ISO 7886-1:2017 Sterile hypodermic syringe for single use- Part 1: Syringes for manual use
- 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
- USP 39-NF34 Particulate Matter in Injection.
A simulated clinical use study was conducted on the subject device (Retractable Safety Syringe for general use) to evaluate the effect of the safety feature per FDA Guidance "Medical Devices with Sharps Injury Prevention Features" issued on August 9, 2005. The test results demonstrated that the subject device complies with the requirements.
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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October 3, 2019
Jiangsu Caina Medical Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120, China
Re: K191490
Trade/Device Name: Retractable Safety Syringe, Retractable Safety Tuberculin Syringe, Retractable Safety Allergy Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: MEG Dated: August 19, 2019 Received: August 28, 2019
Dear Diana Hong:
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.
1
Page 2
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 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 (OS) 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 medical devices and radiation-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.
For Alan 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
2
Indications for Use
510(k) Number (if known) K191490
Device Name Retractable Safety Syringe Retractable Safety Tuberculin Syringe Retractable Safety Allergy Syringe
Indications for Use (Describe)
The Retractable Safety Syringe works like a conventional hypodermic syringe except for its ability to retract the contaminated needle inside of the syringe immediately after patient injection is activated by the syringe user. Because the contaminated needle is automatically withdrawn into the syringe user is protected from accidental needle sticks. These accidental needle sticks would occur between removing the needle from the patient and disposing of the syringe in a sharps disposable container.
For general injection use: The function of Retractable Safety Syringe is to provide a safe and reliable method of injecting fluids into or withdrawing fluids from the body. The Retractable Safety Syringe is designed to aid in the prevention of needle stick injuries and reduce the potential or syringe contains various capacity, such as 1ml, 2.5ml, 3ml, 5ml and 10ml.
For allergy use: The 1ml Retractable Safety Allergy Syringe is intended for the preparation/mixing of allergenic extracts/ prescribed substances, the manual aspiration of fluids, and for the injection of fluids into parts of the body below the surface of the skin. The Retractable Safety Syringe is designed to aid in the prevention of needle stick injuries and reduce the potential or syringe reuse.
For Tuberculin use: The 1ml Retractable Safety Tuberculin Syringe is intended for the delivery of Tuberculin. The Retractable Safety Syringe is designed to aid in the prevention of needle stick injuries and reduce the potential or syringe reuse.
| 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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3
510(k) Summary: K191490
-
- Submitter Information
Jiangsu Caine Medical Co., Ltd.
Submitter Name: Xinyan Ruan Submitter Address: No.23, Huanxi Road, Zhutang Town, Jiangsu, 214425, China Position: Quality Engineer Tel: +86-510-86205183 Fax: +86-510-86215183 Email: sherry.ruan@cainamed.com
Mid-Link Consulting Co., Ltd
Contact Person: Ms. Diana Hong (Primary Contact Person) Ms. Jing Cheng (Alternative Contact Person) Contact Address: P.O. Box 120-119, Shanghai, 200120, China Tel: +86-21-22815850, Fax: 001-3609253199 Email: info@mid-link.net
Date of Preparation: 10/3/2019
-
- Identification of Predicate Device
Predicate Device 1 510(k) Number: K980069 Product Name: Automated Retractable VanishPoint Syringe
- Identification of Predicate Device
Predicate Device 2 510(k) Number: K031594 Product Name: Bak'snap Duopro Safety Syring (Duopross) Safety'tray Allergy Safety Syringe Tray
Predicate Device 3 510(k) Number: K132681 Product Name: Sol-Guard Insulin and Tuberculin Safety Syringes
-
- Identification of Subject Device
Trade Name: Retractable Safety Syringe Retractable Safety Tuberculin Syringe
- Identification of Subject Device
4
Retractable Safety Allergy Syringe
Models: 1ml, 2.5ml, 3ml, 5ml and 10ml (for Retractable Safety Syringe) 1ml (for Retractable Safety Tuberculin Syringe and Retractable Safety Allergy Syringe)
Regulatory Information Regulation Name: Piston syringe Regulation Number: 21 CFR 880.5860 Classification: II Product Code: MEG Common Name: Syringe, Antistick
Device Description 4.
The proposed devices are available in various specifications, including 1ml, 2.5ml, 3ml, 5ml and 10ml. The applications of Retractable Safety Syringe include general injection, allergy and Tuberculin. General injection use is for 1ml, 2.5ml, 3ml, 5ml and 10ml, while allergy and Tuberculin uses are only for 1ml. The combinations of syringe and needle are listed in the below table.
| Syringe | Syringe volume | Matched needle | |||
|---|---|---|---|---|---|
| Needle gauge | Needle length | Needle wall | Bevel | ||
| Retractable | |||||
| Safety Syringe | 1ml | 31G | 8mm/10mm/13mm | Regular Wall | 11±2° |
| 30G | 8mm/10mm/13mm/16mm | Regular Wall | 11±2° | ||
| 29G | 8mm/10mm/13mm/16mm | Regular Wall | 11±2° | ||
| 28G | 8mm/10mm/13mm/16mm | Regular Wall | 11±2° | ||
| 27G | 10mm/13mm/16mm/20mm | Regular Wall | 11±2° | ||
| 26G | 13mm/16mm/20mm/25mm | Regular Wall | 11±2° | ||
| 25G | 13mm/16mm/20mm/25mm | Regular Wall | 11±2° | ||
| 24G | 16mm/20mm/25mm | Regular Wall | 11±2° | ||
| 2.5ml/3ml | 27G | 10mm/13mm/16mm/20mm | Regular Wall | 11±2° | |
| 26G | 13mm/16mm/20mm/25mm | Regular Wall | 11±2° | ||
| 25G | 13mm/16mm/20mm/25mm | Regular Wall | 11±2° | ||
| 24G | 16mm/20mm/25mm | Regular Wall | 11±2° | ||
| 23G | 20mm/25mm/32mm | Thin Wall | 11±2° | ||
| 22G | 20mm/25mm/32mm | Thin Wall | 11±2° | ||
| 5ml/10ml | 25G | 13mm/16mm/20mm/25mm | Regular Wall | 11±2° | |
| 24G | 16mm/20mm/25mm | Regular Wall | 11±2° | ||
| 23G | 20mm/25mm/32mm | Thin Wall | 11±2° | ||
| 22G | 20mm/25mm/32mm | Thin Wall | 11±2° |
Table 1 Combination of syringe and needle
5
| 21G | 20mm/25mm/32mm | Thin Wall | 11 $\pm$ 2° | ||
|---|---|---|---|---|---|
| 20G | 20mm/25mm/32mm | Thin Wall | 11 $\pm$ 2° | ||
| Retractable | |||||
| Safety | |||||
| Tuberculin | |||||
| Syringe/ | |||||
| Retractable | |||||
| Safety Allergy | |||||
| Syringe | 1ml | 31G | 8mm/10mm/13mm | Regular Wall | 11 $\pm$ 2° |
| 30G | 8mm/10mm/13mm/16mm | Regular Wall | 11 $\pm$ 2° | ||
| 29G | 8mm/10mm/13mm/16mm | Regular Wall | 11 $\pm$ 2° | ||
| 28G | 8mm/10mm/13mm/16mm | Regular Wall | 11 $\pm$ 2° | ||
| 27G | 10mm/13mm/16mm/20mm | Regular Wall | 11 $\pm$ 2° | ||
| 26G | 13mm/16mm/20mm/25mm | Regular Wall | 11 $\pm$ 2° | ||
| 25G | 13mm/16mm/20mm/25mm | Regular Wall | 11 $\pm$ 2° | ||
| 24G | 16mm/20mm/25mm | Regular Wall | 11 $\pm$ 2° |
The proposed device consists of eleven components: (1) piston, (3) barrel, (4) needle cap, (5) sealing plug, (6) slide bushing, (7) needle tube, (8) spring, (9) plunger lid, (10) barrel barb, (11) hub.
The proposed devices are provided sterile. The product is sterilized by Ethylene Oxide Gas to achieve a SAL of 10 · and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of five years.
- રું. Indications for Use Statement
| Subject Device | Predicate Device | Predicate Device | Predicate Device | |
|---|---|---|---|---|
| Characteristic | Device Name | Device Name | Device Name | Device Name |
| K191490 | K980069 | K031594 | K132681 | |
| Indications for Use | The Retractable Safety | |||
| Syringe works like a | ||||
| conventional | ||||
| hypodermic syringe | ||||
| except for its ability to | ||||
| retract the | ||||
| contaminated needle | ||||
| inside of the syringe | ||||
| immediately after | ||||
| patient injection. | ||||
| Needle retraction is | ||||
| activated by the | ||||
| syringe user. Because | ||||
| the contaminated | ||||
| needle is automatically | ||||
| withdrawn into the | ||||
| syringe plunge, the | The function of | |||
| the VanshPoint | ||||
| Syringe is to | ||||
| provide a safe and | ||||
| reliable method of | ||||
| injecting | ||||
| medication into a | ||||
| patient or | ||||
| withdrawing | ||||
| blood from a | ||||
| patient. The | ||||
| VanishPoint | ||||
| Syringe works | ||||
| like a | ||||
| conventional | ||||
| hypodermic | ||||
| syringe except for | The 1 mL Bak'Snap | |||
| DuoProTM Safety | ||||
| Syringe | ||||
| (DuoProSSTM) is a | ||||
| sterile, single use, | ||||
| disposable and non- | ||||
| reusable, manual, | ||||
| retractable safety | ||||
| syringe which is | ||||
| intended for | ||||
| injection of fluids | ||||
| into the body, while | ||||
| reducing the risk of | ||||
| sharps injuries and | ||||
| the potential for | ||||
| syringe reuse. | The Sol-Guard | |||
| Tuberculin (TB) | ||||
| Safety Syringe is | ||||
| intended for the | ||||
| delivery of | ||||
| Tuberculin. | ||||
| The Sol-Guard | ||||
| TB Safety | ||||
| Syringe Safety | ||||
| Sleeve covers the | ||||
| needle when | ||||
| activated. In the | ||||
| activated | ||||
| position, the | ||||
| Safety Shield | ||||
| guards against | ||||
| accidental needle |
| Table 2 Indications for Use Statement List | ||||
|---|---|---|---|---|
| -------------------------------------------- | -- | -- | -- | -- |
6
| syringe user is | its ability to | stick. |
|---|---|---|
| protected from | retract the | |
| accidental needle | contaminated | |
| sticks. These | needle inside of | |
| accidental needle | the syringe | |
| sticks would occur | immediately after | |
| between removing the | patient injection. | |
| needle from the patient | Needle retraction | |
| and disposing of the | is activated by the | |
| syringe in a sharps | syringe user. | |
| disposable container. | Because the | |
| For general injection | contaminated | |
| use: The function of | needle is | |
| Retractable Safety | automatically | |
| Syringe is to provide a | withdrawn into | |
| safe and reliable | the syringe | |
| method of injecting | plunge, the | |
| fluids into or | syringe user is | |
| withdrawing fluids | protected from | |
| from the body. The | accidental needle | |
| Retractable Safety | sticks. These | |
| Syringe is designed to | accidental needle | |
| aid in the prevention | sticks would | |
| of needle stick injuries | occur between | |
| and reduce the | removing the | |
| potential or syringe | needle from the | |
| reuse. The syringe | patient and | |
| contains various | disposing of the | |
| capacity, such as 1ml, | syringe in a | |
| 2.5ml, 3ml, 5ml and | sharps disposable | |
| 10ml. | container. | |
| For allergy use: The | ||
| 1ml Retractable Safety | ||
| Allergy Syringe is | ||
| intended for the | ||
| preparation/mixing of | ||
| allergenic | ||
| extracts/prescribed | ||
| substances, the manual | ||
| aspiration of fluids, | ||
| and for the injection of |
7
| fluids into parts of the | ||||
|---|---|---|---|---|
| body below the | ||||
| surface of the skin. | ||||
| The Retractable Safety | ||||
| Syringe is designed to | ||||
| aid in the prevention | ||||
| of needle stick injuries | ||||
| and reduce the | ||||
| potential or syringe | ||||
| reuse. | ||||
| For Tuberculin use: | ||||
| The 1ml Retractable | ||||
| Safety Tuberculin | ||||
| Syringe is intended for | ||||
| the delivery of | ||||
| Tuberculin. The | ||||
| Retractable Safety | ||||
| Syringe is designed to | ||||
| aid in the prevention | ||||
| of needle stick injuries | ||||
| and reduce the | ||||
| potential or syringe | ||||
| reuse. | ||||
| Prescription Only or | ||||
| Over the Counter | Prescription | Prescription | Prescription | Prescription |
Discussion of differences in Indications for use statement
The differences in Indications for use statement for general injection use:
The indications for use of subject device (Retractable Safety Syringe) are substantially equivalent to that of the predicate device (K980069). Both work like a conventional hypodermic syringe and have the safety feature to aid in the prevention of needle stick injuries and reduce the potential or syringe reuse. The indications for use of the subject device include the syringe volumes and the predicate device doesn't include this information. But this difference will not affect the subject device's safety and effectiveness.
The differences in Indications for use statement for allergy use:
Although the indications for use of the predicate device (K031594) doesn't state the predicate device is an allergy syringe, its 510(k) Summary shows it is for allergy use. Additionally, the subject device and the predicate device have the safety feature to aid in the prevention of needle stick injuries and reduce the potential or syringe reuse.
The differences in Indications for use statement for tuberculin use:
8
Both the subject device and predicate device (K132681) are for tuberculin use, and they the safety feature to aid in the prevention of needle stick injuries and reduce the potential or syringe reuse. The indications for use of the subject device include the syringe volumes and the predicate device doesn't include this information. But this difference will not affect the subject device's safety and effectiveness.
- Summary of technological characteristics 6.
| Table 1 General Comparison with K980069 – for General Injection Use | |||
|---|---|---|---|
| ITEM | Subject Device | Predicate Device | Comments |
| Product code | K191490 | ||
| MEG | K980069 | ||
| MEG | Same | ||
| Regulation No. | 21 CFR 880.5860 | 21 CFR 880.5860 | Same |
| Class | II | II | Same |
| Configuration | Piston | ||
| Plunger | |||
| Barrel (graduated) | |||
| Safety feature | Piston | ||
| Plunger | |||
| Barrel (graduated) | |||
| Safety feature | Same | ||
| Sterility condition | EO Sterilized | EO Sterilized | Same |
| Environment of use | Hospital | Hospital | Same |
| Safety feature principle | Spring retraction | Spring retraction | Same |
| Volume | 1ml, 2.5ml, 3ml, 5ml and 10ml. | 1ml, 3ml, 5ml and 10ml | See Comment #1 |
| Needle gauge | 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G, 28G, 29G, 30G and 31G | 20-25G | See Comment #2 |
| Needle length | 8mm, 10mm, 13mm, 16mm, 20mm, 25mm and 32mm | 32mm~16mm | See Comment #2 |
| Needle Wall | Regular Wall | ||
| Thin Wall | Unknown | See Comment #2 | |
| Bevel | $11\pm2^\circ$ | Unknown | See Comment #2 |
| Single use | Yes | Yes | Same |
| Operation mode | For Manual Use Only, For Single Use only | For Manual Use Only, For Single Use only | Same |
| Label/labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Same |
| Materials | Plunger/Barrel/Needle cap/Plunger lid/ | ||
| Barrel barb: PP | |||
| Piston: Polyisoprene, | |||
| Sealing plug: TPE+PP | Unknown | See Comment #3 |
- משמעות משמעות המועד המועד המועד המועד המועד המועד המועד המועד המועד המועד המועד המועד המועד המועד המועד המועד המועד המועד המועד המועד המועד המועד המועד המועד המועד המועד המו
9
| Needle tube/Spring: Stainless Steel, | |
|---|---|
| Hub: MABS | |
| Lubricant: Polydimethysiloxane |
Discussion of Technological Characteristics
The following differences do not raise different questions of safety and effectiveness.
Comment 1
Differences in syringe volume between the predicate and subject device were addressed through ISO 7886-1 syringe performance testing.
Comment 2
Differences in needle gauge, length, wall and between the predicate and subject device were addressed through ISO 7864 and ISO 9626 needle performance testing.
Comment 3
Differences in materials between the predicate and subject device were addressed through ISO 10993 Biocompatibility testing.
| ITEM | Subject Device | Predicate Device | Comment |
|---|---|---|---|
| K191490 | K031594 | ||
| Product code | MEG | MEG | Same |
| Regulation No. | 21 CFR 880.5860 | 21 CFR 880.5860 | Same |
| Class | II | II | Same |
| Configuration | Piston | ||
| Plunger | |||
| Barrel (graduated) | |||
| Safety feature | Piston | ||
| Plunger | |||
| Barrel (graduated) | |||
| Safety feature | Same | ||
| Sterility | |||
| condition | EO Sterilized | EO Sterilized | Same |
| Environment of | |||
| use | Hospital | Hospital | Same |
| Safety feature | |||
| principle | Spring retraction | Spring retraction | Same |
| Volume | 1ml | 1ml | Same |
| Needle gauge | 24G, 25G, 26G, 27G, 28G, 29G, 30G | ||
| and 31G | Unknown | See Comment 4 | |
| Needle length | 8mm, 10mm, 13mm, 16mm, 20mm, | ||
| 25mm | Unknown | See Comment 5 |
Table 2 SE Comparison with K031594 - for allergy use
10
| Needle wall | Regular Wall | Unknown | See Comment 5 |
|---|---|---|---|
| Bevel | $11\pm2^\circ$ | Unknown | See Comment 5 |
| Single use | Yes | Yes | Same |
| Operation mode | For Manual Use Only, For Single Use | For Manual Use Only, | |
| For Single Use only | Same | ||
| only | |||
| Label/labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Same |
| Materials | Plunger/Barrel/Needle cap/Plunger lid/ | ||
| Barrel barb: PP | |||
| Piston: Polyisoprene, | |||
| Sealing plug: TPE+PP, | |||
| Needle tube/Spring: Stainless Steel, | |||
| Hub: MABS | |||
| Lubricant: Polydimethysiloxane | Unknown | See Comment 6 |
Discussion of Technological Characteristics
The following differences do not raise different questions of safety and effectiveness.
Comment 4
Differences in syringe volume between the predicate and subject device were addressed through ISO 7886-1 syringe performance testing.
Comment 5
Differences in needle gauge, length, wall and between the predicate and subject device were addressed through ISO 7864 and ISO 9626 needle performance testing.
Comment 6
Differences in materials between the predicate and subject device were addressed through ISO 10993 Biocompatibility testing.
| ITEM | Subject Device | Predicate Device | Comment |
|---|---|---|---|
| Product code | MEG | MEG | Same |
| Regulation No. | 21 CFR 880.5860 | 21 CFR 880.5860 | Same |
| Class | II | II | Same |
| Configuration | Piston | Piston | Same |
| Plunger | Plunger | Same | |
| Barrel (graduated) | Barrel (graduated) | Same | |
| Safety feature | Safety feature | Same | |
| Sterility | EO Sterilized | EO Sterilized | Same |
| K191490 | K132681 |
Table 3 SE Comparison with K132681 - for tuberculin use
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| condition | |||
|---|---|---|---|
| Environment of | |||
| use | Hospital | Hospital | Same |
| Safety feature | |||
| principle | Spring retraction | Spring retraction | Same |
| Volume | 1ml | 1ml | Same |
| Needle gauge | 24G, 25G, 26G, 27G, 28G, 29G, 30G | ||
| and 31G | Unknown | See Comment 7 | |
| Needle length | 8mm, 10mm, 13mm, 16mm, 20mm, | ||
| 25mm | Unknown | See Comment 8 | |
| Needle wall | Regular Wall | Unknown | See Comment 8 |
| Bevel | 11±2° | Unknown | See Comment 8 |
| Single use | Yes | Yes | Same |
| Operation mode | For Manual Use Only, For Single Use | ||
| only | For Manual Use Only, | ||
| For Single Use only | Same | ||
| Label/labeling | Complied with 21 CFR part 801 | Complied with 21 CFR | |
| part 801 | Same | ||
| Materials | Plunger/Barrel/Needle cap/Plunger lid/ | ||
| Barrel barb: PP | |||
| Piston: Polyisoprene, | |||
| Sealing plug: TPE+PP, | |||
| Needle tube/Spring: Stainless Steel, | |||
| Hub: MABS | |||
| Lubricant: Polydimethysiloxane | Unknown | See Comment 9 |
Discussion of Technological Characteristics
The following differences do not raise different questions of safety and effectiveness.
Comment 7
Differences in syringe volume between the predicate and subject device were addressed through ISO 7886-1 syringe performance testing.
Comment 8
Differences in needle gauge, length, wall and between the predicate and subject device were addressed through ISO 7864 and ISO 9626 needle performance testing.
Comment 9
Differences in materials between the predicate and subject device were addressed through ISO 10993 Biocompatibility testing.
-
- Non-Clinical Performance Testing
12
Biocompatibility
The proposed device is external communicating device, blood path indirect, contact duration is prolonged ( ISO 10993-5:2009 Biological evaluation of medical devices- Part 5: Test for in vitro cytotoxicity
- A ISO 10993-10:20101Biological evaluation of medical devices- Part 10: Test for irritation and delayed-type hypersensitivity
-
ISO 10993-11 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity
- A ASTM F756-17 Standard Practice for Assessment of Hemolytic Properties of Materials
- A ISO 10993-4:2017 Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood
Other non-clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
-
ISO 10993-7:2008 Biological evaluation of medical devices- Part 7: Ethylene Oxide Sterilization Residuals
- A USP Pyrogen Test
-
ASTM F1929-15 Standard test method for detecting seal leaks in porous medical packaging by dye penetration.
-
ASTM F88/F88M-15 standard method for seal strength of flexible barrier materials
- A ASTM F1886 / F1886M-16, Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
-
USP 39-NF34 Bacterial Endotoxins Test
-
ISO 7864:2016 Sterile hypodermic needles for single use-requirements and test method.
- A ISO 9626:2016 Stainless steel needle tubing for the manufacture of the medical devices-requirements and test method
- A ISO 7886-1:2017 Sterile hypodermic syringe for single use- Part 1: Syringes for manual use
-
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
- A USP 39-NF34 Particulate Matter in Injection.
In addition, a simulated clinical use study was conducted on the subject device (Retractable Safety Syringe for general use) to evaluate the effect of safety feature per FDA Guidance "Medical Devices with Sharps Injury Prevention Features" issued on August 9, 2005. The test results demonstrated that the subject device complies with the requirements.
13
-
Clinical Test Conclusion 8.
No clinical study is included in this submission. -
Substantially Equivalent (SE) Conclusion 9.
Based on the comparison with predicate device, the proposed device is determined to be Substantially Equivalent (SE) in safety and effectiveness to the legally marketed predicate device.