(430 days)
Not Found
No
The device description and performance studies focus on the physical properties, sterilization, and biocompatibility of a standard syringe, with no mention of AI or ML.
No.
The device is a syringe, which is used to inject or withdraw fluids, not to directly treat a disease or condition.
No
The device is a syringe, intended to inject or withdraw fluids, not to diagnose a condition.
No
The device description clearly outlines physical components (polycarbonate barrels, plungers, rubber tips) and manufacturing processes (sterilization, molding), indicating it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to inject fluids into or withdraw fluids from the body." This describes a direct interaction with the patient's body for therapeutic or diagnostic purposes within the body, not for testing samples outside the body.
- Device Description: The description details a syringe, which is a tool for administering or collecting substances from the body. It doesn't mention any components or functions related to analyzing biological samples.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances in samples
- Providing information for diagnosis, monitoring, or treatment based on sample analysis
- Reagents or test kits
The device described is a standard medical syringe used for procedures like injections or aspirations, which are not considered in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Medwell Technology Polycarbonate Syringes are intended to inject fluids into or withdraw fluids from the body.
Product codes (comma separated list FDA assigned to the subject device)
FMF
Device Description
The Medwell Technology PC Syringes are provided sterile or in bulk non-sterile for further processing (e.g. sterilization). They are single use devices consisting of rigid polycarbonate barrels with luer slip or luer lock tips and various colored plungers with a synthetic rubber tip (stopper). The syringe barrels are printed with graduated markings in cc (1- 30 milliliters) indicating the volume of liquid inside the various size syringe barrels.
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
Not Found
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 performance of the subject Medwell Technology PC Syringes is identical to the predicate devices as no material, manufacturing or technological changes have occurred.
Testing per ISO 7886-1, ISO 80369-7, and ISO 10993-1 were conducted to demonstrate conformance to the recognized standards and substantial equivalence with the predicate device.
Biocompatibility Testing:
In accordance with ISO 10993-1, the syringe complies with the standards for patient contact profile > 24 hrs
§ 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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November 4, 2022
Medwell Technology Ltd Jonathan Gilbert Regulatory/Clinical Affairs Consultant to Medwell Technology Ltd 1641 Jeurissen Lane Chanhassen, Minnesota 55317
Re: K212764
Trade/Device Name: Medwell Technology Polycarbonate Syringes Regulation Number: 21 CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: Class II Product Code: FMF Dated: October 11, 2022 Received: October 12, 2022
Dear Jonathan Gilbert:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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,
Alan M.
Stevens
-S3
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) K212764
Device Name
Medwell Technology Polycarbonate Syringes
Indications for Use (Describe)
The Medwell Technology Polycarbonate Syringes are intended to inject thuids into or withdraw fluids from the body.
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
K212764 510(k) Summary
| 1. Sponsor: | Medwell Technology Ltd
8th Building, Pujing, Fumin Industry Zone, DaLang Town
Dongguan City, Guandong 523770 China |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Jon Gilbert, Consultant
906.361.3237
jgilb.raca@gmail.com |
| 2. Preparation Date: | November 1, 2022 |
| 3. Subject Device
Common Name: | Piston Syringes |
| Trade Name: | Medwell Technology Polycarbonate Syringes |
| Regulation Number: | 21 CFR 880.5860 |
| Regulation Name: | Piston syringe |
| Classification Panel: | General Hospital |
| Regulatory Class: | Class II |
| Product Code: | FMF |
| 4. Predicate Device | MHC Standard and NRFit Tip Syringes
K171131, cleared November 8, 2017 |
| 5. Device Description: | The Medwell Technology PC Syringes are provided
sterile or in bulk non-sterile for further processing (e.g.
sterilization). They are single use devices consisting of
rigid polycarbonate barrels with luer slip or luer lock tips
and various colored plungers with a synthetic rubber tip
(stopper). The syringe barrels are printed with graduated
markings in cc (1- 30 milliliters) indicating the volume of
liquid inside the various size syringe barrels. |
| 6. Indication for Use: | The Medwell Technology Polycarbonate Syringes are
intended to inject fluids into or withdraw fluids from the body. |
4
| 7. Substantially Equivalent (SE) Comparison: | |||
|---|---|---|---|
| Table 2. Technological Characteristics & Substantial Equivalence Table | |||
| Item | Propose Device | ||
| K212764 | Predicate Device | ||
| K171131 | Comparison* | ||
| Product name | Sterile and Non-sterile | ||
| Hypodermic Syringes for | |||
| Single Use | Sterile and Non-sterile | ||
| Hypodermic Syringes for | |||
| Single Use | Same | ||
| Product Code | FMF | FMF | Same |
| Regulation No. | 21 CFR 880.5860 | 21 CFR 880.5860 | Same |
| Class | CLASS II | CLASS II | Same |
| Syringe Volume | 1cc - 30cc | 1cc - 30cc | Same |
| Nozzle Type | Luer slip; Luer lock | Luer slip; Luer lock | Same |
| Configuration and | |||
| material | Barrel Polycarbonate | Barrel Polycarbonate | Same |
| Plunger ABS polymer | Plunger ABS Polymer | ||
| Plunger Tip Elastomer | Plunger Tip Elastomer | ||
| Silicone Oil Medical Grade | Silicone Oil Medical Grade | Same | |
| Operation Mode | Manual Use | Manual Use | Same |
| Syringe | |||
| Performance | Complies with ISO | ||
| 7886-1:2017 | Complies with ISO 7886-1:2017 | Same | |
| Biocompatibility | Complies with ISO | ||
| 10993 series standards | |||
| for patient contact | |||
| profile > 24 hrs 24 hrs 24 hrs |