(170 days)
Not Found
No
The device description and intended use are for a standard syringe and needle, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
This device is for aspiration and injection of fluids, not for treating a disease or condition.
No
Explanation: The device is described as a syringe with an attached needle for aspiration and injection of fluids, not for diagnostic purposes.
No
The device description clearly outlines physical components (syringe, needle, safety sheath) and mentions sterilization and shelf life, indicating a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "general purpose aspiration of fluid from vials, ampoules and liquid injection below the surface of the skin." This describes a device used for administering substances into the body or withdrawing substances from the body, which are clinical procedures performed on a patient.
- IVD Definition: In vitro diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. They are used outside the body (in vitro).
- Device Description: The description of syringes and needles aligns with devices used for injection and aspiration directly on a patient, not for testing specimens in a lab.
- Anatomical Site: "below the surface of the skin" indicates a direct interaction with the patient's body.
Therefore, this device falls under the category of a medical device used for direct patient care, not an in vitro diagnostic device.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
FMF, MEG
Device Description
The proposed Syringes include Disposable Syringe with permanently attached needle and Safety Syringe with permanently attached needle. The Disposable Syringe with permanently attached needle have one kind of product configuration (TKSPN01) and the Safety Syringe with permanently attached needle has two kinds of product configurations (TKSSPN01 and TKSSPN02).
The proposed syringes are available in different combination of syringe volumes and/or needle sizes. The syringe is sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6. The proposed device has a 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)
Biocompatibility testing:
- 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 )
Sterilization and shelf life testing:
- EO/ECH residue (ISO 10993-7:2008)
- Bacteria Endotoxin (USP42-NF37 )
- Shelf life (3 years) determined by aging test (ASTM F1980-16)
- Package integrity testing (after environmental conditioning and simulated transportation)
Performance testing:
- ISO 7886-1: 2017, Sterile hypodermic syringes for single use- Part 1: Syringes for manual use.
- ISO 7864: 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 6009:2016, Hypodermic needles for single use – Colour coding identification
- 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): 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
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: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
Anhui Tiankang Medical Technology Co., Ltd. Zhang Yong Management No.228,Weiyi Road, Economic Development Zone,Tianchang City, Anhui. China. Tianchang, Anhui 239300 China
Re: K220204
Trade/Device Name: Disposable Syringe with permanently attached needle, Safety Syringe with permanently attached needle Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF, MEG Dated: June 10, 2022 Received: June 21, 2022
Dear Zhang Yong:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 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,
For CAPT 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) K220204
Device Name
Disposable Syringe with permanently attached needle; Safety Syringe with permanently attached needle
Indications for Use (Describe)
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 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CER 801 Subpart D) | ☐ Over-The-Counter Use (21 CER 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
K220204
I Submitter
Device submitter: Anhui Tiankang Medical Technology Co., Ltd.
No.228, Weiyi Road, Economic Development Zone, Tianchang City, Anhui, China.
Establishment Registration Number 3007590959
Contact person: Name: Zhang Yong Title: Management representative Phone: +86-13705505106 Fax: +86-550-7309158 E-mail: zy@tkmedical.com
Preparation Date: July 13, 2022
II Device
Trade Name of Device: Disposable Syringe with permanently attached needle Safety 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 Safety Syringe with permanently attached needle. The Disposable Syringe with permanently attached needle have one kind of product configuration (TKSPN01) and the Safety Syringe with permanently attached needle has two kinds of product configurations (TKSSPN01 and TKSSPN02).
The proposed syringes are available in different combination of syringe volumes and/or needle sizes. The syringe is sterilized by Ethylene Oxide Gas to achieve a SAL of 10f . The proposed device has a 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); | 24G | RW | LB |
| | | 7/8" (22mm);
1" (25mm); | 25G | RW | LB |
| | | 3/8" (10mm);
1/2" (13mm);
5/8" (16mm);
3/4" (20mm); | 26G | RW | LB |
| | | 3/8" (10mm);
1/2" (13mm);
5/8" (16mm); | 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 |
| | | 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 |
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);
5/8" (16mm); | 29G | RW | LB |
| | | | 30G | RW | LB |
| | | | 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 are either identical or substantially equivalent to existing legally marketed predicate devices. The main differences between subject devices and predicate devices are the specification of syringe volume, needle gauge and needle length. The differences between the subject device and the predicate do not affect the safety and effectiveness of the subject device because evaluation is conducted using industry consensus standards and based on the performance requirements of the device. Therefore, these differences do not impact its safety and effectiveness.
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. | 1ml Luer Slip or Luer Lock | ||
| Syringe | |||
| 1ml Luer Slip or Luer Lock | |||
| Syringe is intended to be | |||
| connected with the luer slip | |||
| or luer lock needle and | |||
| 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. | |||
| Syringe with permanently | |||
| attached needle | |||
| 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. | |||
| Safety Syringe with | |||
| permanently attached | |||
| needle | |||
| The Safety Syringe with | |||
| permanently attached | Similar, | ||
| Comment 1 | |||
| Device | |||
| feature | Subject Device | Predicate Device K192551 | Comment |
| 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 or syringe reuse. | |||
| 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 | Different | ||
| Comment 2 | |||
| 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) | Different
Comment 3 |
| 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/ECH residue | ISO 10993-7:2008 |
|---|---|
| ---------------- | ------------------ |
| Bacteria Endotoxin | USP42-NF37 |
|---|---|
| -------------------- | ----------------- |
The shelf life of 3 year is determined based on stability studies which include aqeing 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:
13
| Seal strength | ASTM F88/F88M-15 |
|---|---|
| Blue Dye Penetration | ASTM F 1929-2015 |
| Seal Integrity (Visual Inspection) | 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 manual use.
- A 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 6009:2016, Hypodermic needles for single use – Colour coding identification
-
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, effective and performs as well as the legally marketed device.