(234 days)
Not Found
No
The device description and performance studies focus on the physical characteristics, sterilization, and functional performance of a syringe, with no mention of AI or ML.
No
The device, a syringe, is used to administer a therapeutic substance (Dysport®), but it is not therapeutic itself. Its function is to deliver the drug, not to treat the condition.
No
Explanation: The device description states it is a piston syringe with a needle, intended for intramuscular administration of Dysport. It is a delivery device for a drug, not a device used to diagnose a medical condition.
No
The device description clearly describes a physical syringe with a needle, barrel, plunger, and gasket, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the intramuscular administration of a drug (Dysport®) for a therapeutic purpose (improving glabellar lines). This is a direct treatment, not a diagnostic test performed on a sample from the body.
- Device Description: The device is a syringe with a needle, designed for injecting a substance into the body. This is a delivery device, not a device used to analyze biological samples for diagnostic information.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to administer a treatment, which falls outside the scope of an IVD.
N/A
Intended Use / Indications for Use
The aboNT Syringe is indicated for intramuscular administration of Dysport® for the temporary improvement of moderate to severe glabellar lines in adults Particulate Matter in Injections .
Key results: Internal verification and validation testing confirms the subject device specifications are met, and the testing results support the claims for biocompatibility, shelf life, sterilization, and functional testing according to Recognized standards. The testing results of non-clinical testing and comparison of technological characteristics with the predicate device demonstrate that the aboNT Syringe performs equivalent to the predicate device when used as intended.
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).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
4/15/2022
Nipro Medical Corporation Jessica Oswald-Mcleod Director QARA 3150 NW 107th Ave Doral, Florida 33172
Re: K212677
Trade/Device Name: aboNT SYRINGE Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF, FMF, FMI Dated: March 16. 2022 Received: March 18, 2022
Dear Jessica Oswald-Mcleod:
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) K212677
Device Name aboNT SYRINGE
Indications for Use (Describe)
| Indicated for intramuscular administration of Dysport® for the temporary improvement of moderate to severe glabellar lines in adults one or both , as applicable) |
|---|
| ---------------------------------------------------------------- |
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 contains the logo for Nipro Corporation. The logo consists of a blue abstract symbol on the left and the word "NIPRO" in blue block letters on the right. The abstract symbol appears to be two interlocking shapes, possibly representing the letter 'N'.
510(K) Summary: K212677 aboNT Syringe
This 510(k) Summary is in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The content is provided in conformance with 21 CFR §807.92.
| 1. | 807.92(a)(1) Submitter Identification | |
|---|---|---|
| Applicant Name: | Nipro Medical Corporation | |
| Applicant Address: | 3150 NW 107th Ave. Doral FL 33172 USA | |
| Phone: | +1 305-432-6699 | |
| Establishment Registration: | 1056186 | |
| Contact Person: | Jessica Oswald-McLeod | |
| Director, Quality Assurance and Regulatory Affairs | ||
| Email: | JessicaO@nipromed.com | |
| Preparation Date: | April 15, 2022 |
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- 807.92(a)(2) Device Identification Trade Name: aboNT Syringe Common Name: Disposable syringe with Needle Classification Name: piston syringe Requlation Number: 880.5860, 880.5570 Panel: General Hospital (80) Product Code: FMF, FMI Regulatory Class: Class 2
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- 807.92(a)(3) Predicate Identification Legally marketed substantial equivalent device: K123710, UniTox® Syringe
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- 807.92(a)(4) Device Description
The aboNT Syringe is a piston syringe with needle consisting of graduated barrel, plunger rod, and gasket. It is provided with a permanently attached hypodermic needle that is 31G x 5/16″. The syringe barrel is 0.3 mL in volume, with a graduated scale labeled in both volumetric (mL) and corresponding unit dosing for Dysport® (60 units/0.3mL). The syringe is sterile, single use only, non-toxic, non-pyrogenic and sterilized by E-beam radiation. The shelf-life has been determined to be 5 years.
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- 807.92(a)(5) Indications for Use
The aboNT Syringe is indicated for intramuscular administration of Dysport® for treatment of glabellar lines in adults Particulate Matter in Injections .
- 807.92(a)(5) Indications for Use
-
- 807.92(b)(2) Summary of Clinical Testing
This submission does not warrant any clinical testing, therefore no clinical testing performed for or provided in this submission.
-
- 807.92(b)(3) Conclusions drawn from non-clinical and clinical tests.
The aboNT Syringe is identical to the predicate in intended use, device operation, and functional capabilities. Due to the difference in specific drug, minor differences exist in the indications for use, and model configuration. These differences do not pose any new risks to the safety and effectiveness of the device.
- 807.92(b)(3) Conclusions drawn from non-clinical and clinical tests.
Internal verification and validation testing confirms the subject device specifications are met, and the testing results support the claims for biocompatibility, shelf life, sterilization, and functional testing according to Recognized standards.
The testing results of non-clinical testing and comparison of technological characteristics with the predicate device demonstrate that the aboNT Syringe performs equivalent to the predicate device when used as intended.