(165 days)
Not Found
No
The document describes a mechanical syringe with a safety feature and does not mention any computational or data-driven components.
No.
The device is intended for fluid aspiration and injection, and needle-stick injury prevention, not for treating specific diseases or conditions.
No
The device is a syringe for general purpose aspiration and injection, with a focus on preventing needle stick injuries and reuse. Its function is to administer or withdraw substances, not to provide information about the diagnosis, cure, mitigation, treatment, or prevention of disease.
No
The device description clearly describes physical syringes with attached needles, which are hardware components, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "general purpose aspiration of fluid from vials, ampoules and liquid injection below the skin." This describes a procedure performed on a patient, not a test performed on a sample taken from a patient to diagnose a condition.
- Device Description: The description focuses on the physical characteristics of the syringe and needle, sterilization, and packaging. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information.
IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This syringe is a tool for administering substances or withdrawing fluids directly from the body, which falls outside the scope of IVD.
N/A
Intended Use / Indications for Use
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.
Product codes
FMF, MEG
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
below the surface of the skin.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care professionals
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)
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 (
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 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
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
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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
1
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
2
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) |
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."
3
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 |
4
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 | Syringe
Volume | Needle Length | Needle
Gauge | Wall
type | Needle
Bevel |
|-----------------------------------------------------------------------|-------------------|----------------------------------------------|-----------------|--------------|-----------------|
| Disposable Syringe
with permanently
attached 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 with
permanently attached
needle -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
5
| 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 with
permanently attached
needle-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
6
| Device
| feature | Subject Device | Predicate Device K192551 | Comment |
|---|---|---|---|
| Product | Disposable Syringe with | ||
| permanently attached | |||
| needle | Syringe with permanently | ||
| attached needle | / | ||
| Syringe type | Piston syringe | Piston syringe | Same |
| Indications | |||
| for use | 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 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. | Same | ||
| Product code | FMF | FMF | Same |
| Regulation | |||
| number | 21 CFR 880.5860 | 21 CFR 880.5860 | Same |
| Class | II | II | Same |
| Principle of | |||
| operation | For Manual Use Only, For | ||
| Single Use Only | For Manual Use Only, For | ||
| Single Use Only | Same | ||
| Connector | |||
| Type | Attached needle | Attached needle | Same |
| Needle | |||
| gauge | 23G, 24G, 25G, 26G, 27G, | ||
| 28G, 29G, 30G, 31G | 21G, 23G, 25G, 26G, 27G, | ||
| 28G, 29G, 30G, 31G | Difference | ||
| 1 | |||
| Needle | |||
| Length | 8mm, 10mm, 13mm, 16mm, | ||
| 20mm, 22mm, 25mm | 8mm, 10mm, 13mm, 16mm, | ||
| 20mm, 25mm | |||
| Needle wall | |||
| type | RW, TW | RW, TW | |
| Needle bevel | 11°±2° | 11°±2°, 15°±2° | |
| Syringe | |||
| Volume | 0.5ml, 1ml | 0.3ml, 0.5ml, 1ml | |
| Device | |||
| feature | Subject Device | Predicate Device K192551 | Comment |
| Main | |||
| structure and | |||
| materials | (1) Needle cap (PP) | ||
| (2) Needle (Stainless Steel |
(3) Piston (Polyisoprene)
(4) Plunger (PP)
(5) Barrel (PP) | Syringe with permanently
attached needle-type A
(1) needle cap (PP or PE)
(2) needle (Stainless Steel
304)
(3) piston (Polyisoprene)
(4) plunger (PP)
(5) barrel (PP)
(6) end cap (PP or PE)
Syringe with permanently
attached needle-type B
(1) needle cap (PP or PE)
(2) needle (Stainless Steel
304)
(3) piston (Polyisoprene)
(4) plunger (PP or ABS)
(5) barrel (PP) | Difference
2 |
| Performance
specifications | 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 ( |
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 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 |
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
11
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.