(357 days)
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.
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
Sterile Hypodermic Syringe for Single Use, with/without needle and Sterile Hypodermic Needle for Single use materials are as noted in the table below:
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 (<24 hours).
I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the format you specified.
The document is a 510(k) premarket notification for "Sterile Hypodermic Syringe for Single Use, with/without Needle, Sterile Hypodermic Needle for Single Use." It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific performance acceptance criteria.
Here's what is missing from the text to fulfill your request:
- A table of acceptance criteria and the reported device performance: While the document mentions compliance with various ISO standards (e.g., ISO 80369-7, ISO 7886-1), it does not explicitly list the specific acceptance criteria for each parameter within these standards, nor does it present the reported device performance against those criteria in a tabular format. It only states that "All of the pre-determined acceptance criteria were met."
- Sample size used for the test set and the data provenance: The document indicates that "bench testing" was performed for performance and that "verification test" was done for biocompatibility and sterility, but it does not specify the sample sizes used for these tests or the data provenance (e.g., country of origin, retrospective/prospective).
- Number of experts used to establish the ground truth... and the qualifications: This information is typically relevant for studies involving human interpretation or subjective assessment, such as image analysis devices. For a physical medical device like a syringe or needle, "ground truth" would be established by objective measurements and standardized tests, not expert consensus. Therefore, this question is not applicable in this context.
- Adjudication method: Similar to the point above, adjudication methods like 2+1 or 3+1 are used for resolving disagreements among experts in subjective assessments. This is not applicable to the performance testing of a syringe or needle.
- If a multi reader multi case (MRMC) comparative effectiveness study was done...: This type of study is for evaluating diagnostic devices where human readers interpret data. It is not relevant to the described medical device.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: This is relevant for AI/ML-driven devices and is not applicable here.
- The type of ground truth used: As mentioned, for this type of device, ground truth is established through adherence to international standards and objective measurement, not expert consensus, pathology, or outcomes data in the usual sense.
- The sample size for the training set: This refers to the development of AI/ML models, which is not applicable to this device.
- How the ground truth for the training set was established: Not applicable.
The document primarily provides a list of ISO standards that the device complies with, stating general compliance rather than detailed performance results against quantifiable acceptance criteria for each specific test. It explicitly states, "No clinical testing was performed" and "No clinical study is included in this submission," further indicating the absence of human-centric studies.
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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
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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
CAPT Alan M. Stevens Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and 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 KohopeMedical DevicesCo., Ltd | Sterile HypodermicSyringe for Single use,with/without needleSterile Hypodermicneedle for Single use | K190002 | Sterile HypodermicSyringe for Single Use,with/without needle,and Sterile HypodermicNeedle 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 (<24 hours).
V. 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 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.
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VI. Comparison of Technological Characteristics with the Predicate Device Table 1 - Sterile Hypodermic Syringe for Single Use, with/without needle
| Features &Description | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| 510(k) Numbers | K212846 | K190002 | - |
| Device Name | Sterile Hypodermic Syringe forSingle Use, with/without Needle | Sterile Hypodermic Syringe forSingle Use, with/without needle | - |
| Product Code | FMF | FMF | Identical |
| 21CFR Regulation | 880.5860 | 880.5860 | Identical |
| Class | 2 | 2 | Identical |
| Indication for Use | The sterile hypodermic syringefor single use, with/withoutneedle is intended for use in theaspiration and injection of fluidsfor medical purposes. | The sterile hypodermic syringefor single use, with/withoutneedle is intended to be used formedical purposes to inject fluidinto or withdraw fluid from body. | Identical |
| Configuration | PistonPlungerBarrel | PistonPlungerBarrel | Identical |
| Operation mode | For Manual Use Only, For SingleUse only | For Manual Use Only, For SingleUse only | Identical |
| Syringe Volume | 1ml, 2ml, 3ml, 5ml, 10ml, 20ml,30ml, 50ml, 60ml and 100ml | 1ml, 3ml, 5ml, 6ml, 10ml, 20ml,30ml, 35ml, 50ml and 60ml | The difference does not raise newquestions of safety and effectivenessof the proposed device. The subjectdevices' syringe volume is differentfrom the predicate device but stillconforms to the same applicableperformance standards as predicatedevice. |
| Needle Gauge | 18G,19G,20G,21G,22G,23G,24G,25G,26G,27G,28G,29G,30G | 18G,19G,20G,21G,22G,23G,24G,25G,26G,27G,28G,29G,30G | Identical |
| Needle Length | 4~38 mm (1/6" ~ 1 1/2") | 4~38 mm | Identical |
| Features &Description | Subject Device | Predicate Device | Comparison |
| Material: | |||
| Barrel | PP | PP | Identical |
| Needle | PP, SUS304 | PP, SUS304 | Identical |
| Plunger | PP | PP | Identical |
| Plunger stopper | Isoprene Rubber | Isoprene Rubber | Identical |
| Performance | ISO 7886-1ISO 7864ISO 9626ISO 80369-7ISO 80369-20 | ISO 7886-1ISO 7864ISO 9626 | Identical |
| Biocompatibility | ISO10993-1 | ISO10993-1 | Identical |
| Sterilization | EO | EO | Identical |
| SAL | 10-6 | 10-6 | Identical |
| Label/labeling | 21 CFR Part 801 | 21 CFR Part 801 | Identical |
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| Features &Description | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| 510(k) Numbers | K212846 | K190002 | - |
| Device Name | Sterile Hypodermic Needle for Single Use | Sterile Hypodermic Needle for Single Use | - |
| Product Code | FMI | FMI | Identical |
| 21CFR Regulation | 880.5570 | 880.5570 | Identical |
| Class | 2 | 2 | Identical |
| Indication for Use | The sterile hypodermic needle for single use is intended for use with syringes in the aspiration and injection of fluids for medical purpose. | The sterile hypodermic needle for single use is intended for use with syringes and injection devices for general purpose fluid injection/aspiration. | Identical |
| Configuration | Protective capNeedle tubeAdhesivesNeedle hub | Protective capNeedle tubeAdhesivesNeedle hub | Identical |
| Operation mode | For Manual Use Only, For Single Use only | For Manual Use Only, For Single Use only | Identical |
| Needle Gauge | 18G,19G,20G,21G,22G,23G,24G,25G,26G,27G,28G,29G,30G | 18G,19G,20G,21G,22G,23G,24G,25G,26G,27G,28G,29G,30G | Identical |
| Needle Length | 4~38 mm (1/6" ~ 1 1/2") | 4~38 mm | Identical |
| Material: | |||
| Protective cap | PP | PP | Identical |
| Needle tube | Stainless steel (SUS304) | Stainless steel (SUS304) | Identical |
| Needle hub | PP | PP | Identical |
| Adhesives | Epoxy Resin | Epoxy Resin | Identical |
| Performance | ISO 7864ISO 9626ISO 80369-7ISO 80369-20 | ISO 7864ISO 9626 | Identical |
| Biocompatibility | ISO10993-1 | ISO10993-1 | Identical |
| Features &Description | Subject Device | Predicate Device | Comparison |
| Sterilization | EO | EO | Identical |
| SAL | 10-6 | 10-6 | Identical |
| Label/labeling | 21 CFR Part 801 | 21 CFR Part 801 | Identical |
Table 2 - Sterile Hypodermic Needle for Single use
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VII. Performance Data
Performance testing was provided in support of the substantial equivalence determination and to validate and verify that the Sterile Hypodermic Syringe for Single Use, with/without needle and Sterile Hypodermic Needle for Single use met all requirements of related international standards, including biocompatibility, sterility, and product specifications. Results of these tests demonstrate compliance with the requirements of the consensus standards noted below.
Non-clinical Testing
Performance Testing
Performance Testing The subject device meets all performance standards for Sterile Hypodermic Needle: ISO 80369-7, Second edition 2020-12 ISO 80369-20, First edition 2015-05-15 ISO 7886-1 Second edition 2017-05 ISO 7864, Fourth edition 2016-08-01 ISO 9626, Second edition 2016-08-01
For the finished device, it meets the defined performance requirements through bench testing.
Clinical Study
No clinical testing was performed.
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Biocompatibility
The new device complies with the biocompatibility requirement defined in ISO10993-1. Patient contact classification: The contact level of the subject device is blood path, indirect, and the contact duration is limited contact (<24 hours). The verification test shows that the new devices comply with the biocompatibility requirement defined in ISO10993-1, the same as the predicate device.
- In Vitro Cytotoxicity Test (ISO10993-5: 2009) -
- Skin Sensitization Test (ISO10993-10: 2010) -
- -Intradermal Reactivity Test (ISO10993-10: 2010)
- Coaqulation test (ISO10993-4: 2002Amd1:2006(E) -
- Complement activity Test (ISO10993-4: 2002 Amd1: 2006(E) -
- Hemolytic Properties Test (ASTM F756-13) -
- Pyrogen Test (ISO 10993-11:2006) -
- USP 788 Particulate Matter in Injections
All of the pre-determined acceptance criteria were met.
Sterility Information
The devices are EO sterilized. The sterilization conducted according to below standards:
- ISO11135
- ISO11737-1 -
- ISO11737-2 -
- -ISO 10993-7
- -ANSI/AAMI ST72
All of the pre-determined acceptance criteria were met.
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Package and Shelf Life:
We conducted the package and shelf life verification testing noted below to support the shelf life claim:
- AAMI/ANSI/ISO 11137-1:2006/(R) 2010
- AAMI/ANSI/ISO 11737-2:2009 -
- AAMI/ANSI/ISO 11607-1:2006/(R) 2010 -
- ASTM F1929-98 (2004) -
- ASTM D4169-16 -
- ASTM F1980-07 -
- ASTM D3078-02 (2008) -
- ASTM F88/F88M-09 -
The testing was conducted as noted below:
- Product Performance Inspection (Chemical performance and Physical performance) -
- -Sterile Test
- Vacuum Leak Test -
- Dye penetration test -
- Agar Contact-Attack Test -
- -Tensile Seal Strength Test
- -Accelerated Aging Test
The test result supports the 5 years shelf life claim for the subject device from the sterilization date.
All of the pre-determined acceptance criteria were met.
Clinical Test:
No clinical study is included in this submission.
VIII. Conclusions:
Based on the information defined above, we conclude that the subject device is substantially equivalent to the marketed predicate device. Any difference between them does not pose a new question of safety and performance.
§ 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).