(357 days)
Not Found
No
The document describes a standard hypodermic syringe and needle, with no mention of AI, ML, or any computational processing beyond basic device function.
No.
The device is intended for the aspiration and injection of fluids for medical purposes, which are diagnostic or procedural rather than therapeutic.
No
The device, a sterile hypodermic syringe and needle, is primarily intended for the aspiration and injection of fluids, which are therapeutic or procedural actions, not diagnostic ones. Diagnostic devices are used to detect or monitor diseases or conditions.
No
The device description clearly outlines physical components made of materials like stainless steel, PP, and rubber, and the performance studies focus on physical characteristics like biocompatibility, sterility, and mechanical performance. There is no mention of software as a component or function of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for the "aspiration of fluids for medical purposes" and "aspiration and injection of fluids for medical purposes." This describes a device used to physically move fluids within or from the body, not to perform tests on samples taken from the body.
- Device Description: The description details the physical components of a syringe and needle, materials used, and configurations (gauge, length, volume). This aligns with a device used for fluid handling, not for diagnostic testing.
- Lack of IVD Language: There is no mention of analyzing samples, detecting substances, diagnosing conditions, or any other language typically associated with in vitro diagnostics.
- Performance Studies: The performance studies focus on physical characteristics, biocompatibility, sterility, and shelf life, which are relevant to a medical device used for fluid handling, not an IVD.
IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is to aspirate or inject fluids, which is a procedural action, not a diagnostic test.
N/A
Intended Use / Indications for Use
Sterile Hypodermic Syringe for Single Use, with/without needle:
The sterile hypodermic syringe for single use, with/without needle is intended for use in the aspiration of fluids for medical purposes.
Sterile Hypodermic Needle for Single use:
The sterile hypodermic needle for single use is intended for use with syringes in the aspiration of fluids for medical purposes.
Product codes (comma separated list FDA assigned to the subject device)
FMF, FMF, FMI
Device Description
Sterile Hypodermic Syringe for Single Use, with/without needle:
The sterile hypodermic syringe for single use, with/without needle is intended for used in the aspiration and injection of fluids for medical purposes.
Sterile Hypodermic Needle for Single use:
The sterile hypodermic needle for single use is intended for use with syringes in the aspiration and injection of fluids for medical purposes.
The device is delivered in the following configurations:
Needle Gauge: 18,19,20,21,22,23,24,25,26,27,28,29,30G
Needle Length: 1/6"-1 1/2"
Syringe Volume: 1,2,3,5,10,20,30,50,60,100 ml
Materials:
Needle cap: PP
Needle tube: Stainless Steel
Needle hub: PP
Barrel: PP
Plunger stopper: Isoprene rubber
Plunger: PP
Ink: Black
Lubricant: Silicone oil
Adhesive: Epoxy resin
Colorant: PP masterbatch
The contact level of the subject device is blood path, indirect, and the contact duration is limited contact (
§ 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).
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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".
August 30, 2022
Jiangsu Jichun Medical Devices Co., Ltd. % Charles Mack Principal Engineer Irc 2950 E Lindrick Drive Chandler, Arizona 85249
Re: K212846
Trade/Device Name: Sterile Hypodermic Syringe for Single Use, with/without Needle, Sterile Hypodermic Needle for Single Use Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF, FMF, FMI Dated: July 27, 2022 Received: August 2, 2022
Dear Charles Mack:
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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
Sterile Hypodermic Syringe for Single Use, with/without needle Sterile Hypodermic Needle for Single use
Indications for Use (Describe)
Sterile Hypodermic Syringe for Single Use, with/without needle:
The sterile hypodermic syringe for single use, with/without needle is intended for use in the aspiration of fluids for medical purposes.
Sterile Hypodermic Needle for Single use:
The sterile hypodermic needle for single use is intended for use with syringes in the aspiration of fluids for medical purposes.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for Jichun Medical Devices. The logo features the text "Jichun Medical Devices" in a light gray font. To the right of the text is the acronym "JJMD" in a bold, blue font.
510(k) Summary (21 CFR §807.92)
Date of Preparation: July 29, 2022
Submitter Information: l.
| Submitter Name: | Jiangsu Jichun Medical Devices Co., Ltd. |
|---|---|
| Address: | NO.98, Baiyang Bridge, Zhenglu Town, Tianning, Changzhou, Jiangsu, China 213111 |
| Contact Person: | Zhu Pingnan/Head of Firm |
US Agent and Correspondent
Mr. Charles Mack Principal Engineer IRC 2950 E Lindrick Drive, Chandler, Arizona 85249 USA Tel: 931-625-4938 Email: charliemack@irc-us.com
II. Device
| Trade Name: | Sterile Hypodermic Syringe for Single Use, with/without needle |
|---|---|
| Common Name: | syringe, piston |
| Regulation Number: | 21 CFR §880.5860 |
| Regulation Name: | Piston syringe |
| Regulatory Class: | II |
| Product Code: | FMF |
| Classification Panel: | General Hospital |
Sterile Hypodermic Needle for Single Use Trade Name: Common Name: needle, hypodermic, single lumen Regulation Number:21 CFR §880.5570 Regulation Name: Hypodermic single lumen needle Regulatory Class: ll FMI Product Code: Classification Panel: General Hospital
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III. Predicate Device Information
| Manufacturer | Predicate Device | 510(k)
Number | Submitted Device |
|------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|------------------|--------------------------------------------------------------------------------------------------------------------------|
| Shanghai Kohope
Medical Devices
Co., Ltd | Sterile Hypodermic
Syringe for Single use,
with/without needle
Sterile Hypodermic
needle for Single use | K190002 | Sterile Hypodermic
Syringe for Single Use,
with/without needle,
and Sterile Hypodermic
Needle for Single Use |
IV. Device Description:
Sterile Hypodermic Syringe for Single Use, with/without needle:
The sterile hypodermic syringe for single use, with/without needle is intended for used in the aspiration and injection of fluids for medical purposes.
Sterile Hypodermic Needle for Single use:
The sterile hypodermic needle for single use is intended for use with syringes in the aspiration and injection of fluids for medical purposes.
The device is delivered in the following configurations:
| Needle Gauge | 18,19,20,21,22,23,24,25,26,27,28,29,30G |
|---|---|
| Needle Length | 1/6"-1 1/2" |
| Syringe Volume | 1,2,3,5,10,20,30,50,60,100 ml |
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| Needle Gauge | Compatible Needle Length | Compatible Syringe Volume | Compatible Wall Type |
|---|---|---|---|
| 18G | 1", 1 1/2" | 50 ml, 60 ml, 100 ml | RW, TW |
| 19G | 1", 1 1/2" | 50 ml, 60 ml, 100 ml | RW, TW |
| 20G | 1", 1 1/2" | 10ml, 20ml, 30ml, 50 ml | RW, TW |
| 21G | 1", 1 1/4", 1 1/2" | 5ml, 10ml, 20ml, 30ml | RW, TW |
| 22G | 1", 1 3/16", 1 1/4", 1 1/2" | 3ml, 5ml, 10ml, 20ml | RW, TW |
| 23G | 1", 1 1/8", 1 1/4", 1 1/2" | 3ml, 5ml, 10ml | RW, TW |
| 24G | 3/4", 1" | 1ml, 2ml, 3ml, 5ml | RW, TW |
| 25G | 5/8", 1", 1 1/2" | 1ml, 2ml, 3ml | RW, TW |
| 26G | 1/2", 1" | 1ml, 2ml | RW, TW |
| 27G | 1/2", 3/4", 1", 1 1/2" | 1ml | RW, TW |
| 28G | 1/3", 1/2" | 1ml | RW, TW |
| 29G | 1/4", 1/2" | 1ml | RW, TW |
| 30G | 1/6", 1/2" | 1ml | RW, TW |
The specifications noted below are available for the subject devices:
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Sterile Hypodermic Syringe for Single Use, with/without needle and Sterile Hypodermic Needle for Single use materials are as noted in the table below:
| Name | Material |
|---|---|
| Needle cap | PP |
| Needle tube | Stainless Steel |
| Needle hub | PP |
| Barrel | PP |
| Plunger stopper | Isoprene rubber |
| Plunger | PP |
| Ink | Black |
| Lubricant | Silicone oil |
| Adhesive | Epoxy resin |
| Colorant | PP masterbatch |
The contact level of the subject device is blood path, indirect, and the contact duration is limited contact (