aboNT SYRINGE

K212677 · Nipro Medical Corporation · FMF · Apr 15, 2022 · General Hospital

Device Facts

• Record ID: K212677
• Device Name: aboNT SYRINGE
• Applicant: Nipro Medical Corporation
• Product Code: FMF · General Hospital
• Decision Date: Apr 15, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The aboNT Syringe is indicated for intramuscular administration of Dysport® for treatment of glabellar lines in adults <65 years of age.

Device Story

The aboNT Syringe is a manual, single-use, sterile piston syringe with a permanently attached 31G x 5/16" hypodermic needle. It features a 0.3 mL barrel with specific graduation markings for Dysport® dosing (60 units/0.3mL). The device is used by healthcare professionals to administer Dysport® via intramuscular injection to treat glabellar lines. The low-dead space design ensures accurate delivery of the neurotoxic protein. The device is sterilized via E-beam radiation and has a 5-year shelf life. It functions as a standard manual syringe, with its specific volume and markings tailored to the requirements of the drug being administered.

Clinical Evidence

No clinical testing was performed or provided for this submission; substantial equivalence is supported by bench testing only.

Technological Characteristics

Piston syringe with permanently attached 31G x 5/16" needle; 0.3 mL volume; graduated scale for Dysport® units. Materials comply with ISO 10993-1. Sterilization via E-beam radiation (ISO 11137). Performance testing per ISO 7886-1, ISO 7864, ISO 8537, and ISO 11608-1. Packaging/shelf-life testing per ASTM F1980, ASTM D4169, ASTM F1929, and ASTM F88/F88M. No software or electronic components.

Indications for Use

Indicated for intramuscular administration of Dysport® for the temporary improvement of moderate to severe glabellar lines in adults <65 years of age.

Regulatory Classification

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.

Predicate Devices

• UniTox® Syringe (K123710)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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# 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 <65 years of age.

| Type of Use (Select <i>one</i> or <i>both</i> , 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: | [phone] |
| | Establishment Registration: | 1056186 |
| | Contact Person: | Jessica Oswald-McLeod |
| | | Director, Quality Assurance and Regulatory Affairs |
| | Email: | [e-mail] |
| | Preparation Date: | April 15, 2022 |

- 2. 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
- 3. 807.92(a)(3) Predicate Identification Legally marketed substantial equivalent device: K123710, UniTox® Syringe
- 4. 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.

- 5. 807.92(a)(5) Indications for Use
The aboNT Syringe is indicated for intramuscular administration of Dysport® for treatment of glabellar lines in adults <65 years of age.

- 6. 807.92(a)(6) Comparison of the technological characteristics The syringe is substantially equivalent to the predicate device in the following technological characteristics:

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| | Element of<br>Comparison | Subject Device | Predicate | Discussion of<br>Differences |
|----|-------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| A) | Product Description | | | |
| 1. | Intended Use | Injection of Dysport | Injection of Botox | Similar - both<br>syringes are<br>intended to be<br>used for<br>administration of<br>botulinum toxin |
| 2. | Indications for<br>Use | The aboNT Syringe is<br>indicated for<br>intramuscular<br>administration of<br>Dysport® for<br>treatment of glabellar<br>lines in adults <65<br>years of age. | UniTox Syringe is single<br>use, sterile, intended<br>use for the<br>subcutaneous injection<br>of Botox® Cosmetic into<br>parts of body below the<br>surface of skin. | Similar - both<br>syringes are<br>intended to be<br>used for<br>administration of<br>botulinum toxin |
| 3. | Syringe type | Piston syringe with<br>attached needle | Piston syringe with<br>attached needle | Same |
| 4. | Specific drug use | Dysport® | Botox Cosmetic | Similar - both<br>drugs are a<br>neurotoxic protein<br>used to diminish<br>wrinkles. |
| 5. | Design<br>consideration | Permanently attached<br>needle, low-dead space<br>syringe, with specific toxin<br>dose graduation markings | Permanently attached<br>needle, low-dead space<br>syringe, with specific<br>toxin dose graduation<br>markings | Same |
| 6. | Operational<br>Principles | Manual | Manual | Same |
| B) | Physical Characteristics | | | |
| 1. | volume | 0.3mL / 60 units of<br>Dysport | 0.5mL / 20 units of<br>Botox | Similar - volume<br>is based on<br>needed treatment. |
| 2. | needle length | 5/16 | | |
| | Element of<br>Comparison | Subject Device | Predicate | Discussion of<br>Differences |
| 6. | needle cover<br>color | Natural | yellow | Similar – does not<br>raise any new<br>issues of safety or<br>effectiveness |
| C) | Dimensional Characteristics (results of testing provided in Exhibit DD) | | | |
| 1. | Length of barrel<br>(mm) | 67.55 ± 0.50 | Min: 82.675<br>Max: 82.723 | Differences in<br>dimensional<br>characteristics<br>due to volume of<br>syringe.<br>The subject device<br>volume is 0.3mL,<br>compared to the<br>predicate volume<br>of 0.5mL. |
| 2. | inner diameter of<br>barrel (mm) | 3.00 ±0.05 | Min: 3.491<br>Max: 3.585 | |
| 3. | outer diameter of<br>barrel (mm) | 5.18 ± 0.2 | Min: 5.393<br>Max: 5.454 | |
| 4. | Gasket - Outer<br>diameter of 1st<br>seal (mm) | 3.36 ± 0.05 | Min: 3.792<br>Max: 3.810 | |
| 5. | Gasket - Outer<br>diameter of 2nd<br>seal (mm) | 3.36 ± 0.05 | Min: 3.703<br>Max: 3.724 | |
| D) | Biocompatibility | | | |
| 1. | Category | Complaint to ISO 10993-1 | Complaint to ISO<br>10993-1 | Same |
| E) | Mechanical and Performance Specifications | | | |
| 1. | barrel<br>transparency - | No particle and<br>extraneous matter | No particle and<br>extraneous matter | Same |
| 2. | delivery accuracy | Less than half nominal<br>capacity :<br>Min: 0.0968 mL<br>Max: 0.1024 mL<br>Equal to or greater than<br>half nominal capacity:<br>Min: 0.269 mL<br>Max: 0.300 mL | Less than half nominal<br>capacity :<br>Min: 0.0957 mL<br>Max: 0.1008 mL<br>Equal to or greater than<br>half nominal capacity:<br>Min: 0.485 mL<br>Max: 0.496 mL | Both devices<br>within<br>specification |
| 3. | reuse durability | NA – single use only | NA - single use only | Same |
| 4. | needle cover<br>strength | Min: 0.32 kgf<br>Max: 0.51 kgf | Min: 0.52 kgf<br>Max: 1.57 kgf | Both devices<br>within<br>specification |
| 5. | hub/needle bond<br>strength | Min: 44.72 N | Min: 42.65 N | Both devices<br>within<br>specification |
| F) | Sterilization | | | |
| | Element of<br>Comparison | Subject Device | Predicate | Discussion of<br>Differences |
| 1. | Method | E-Beam | EtO | Similar – no new<br>issues of safety<br>and effectiveness |
| 2. | Shelf-life | 5 years | 5 years | Same |

# Table 1: Technological Characteristics Comparison

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El Co 1.

2.

# 7. 807.92(a)(6) Substantial Equivalence

The subject device is substantially equivalent in fundamental design, function, device materials, operating principle, intended use and technology as the legally marketed predicate device. The differences between the devices are due to the administration of a similar specific drug; this drug determines the requirements of the syringe graduation scale markings, syringe volume, and needle gauge.

Testing confirms that these differences do not raise any issues of safety and effectiveness. The aboNT Syringe meets specifications equivalent in design and technological characteristics to the predicate device.

The subject device complies with all applicable voluntary consensus standards for performance, biocompatibility, packaging, transportation, and sterilization. This testing supports the claims of substantial equivalence to the predicate device.

## 8. 807.92(b)(1) Summary of Non-clinical tests

Non-clinical tests performed are outlined below. All tests were performed within the specifications of the standards listed.

- a. Visual Inspection
- ISO 7886-1 Second edition 2017-05 Sterile hypodermic syringes for single use -. Part 1: Syringes for manual use
- . ISO 7864 Fourth edition 2016-08-01 Sterile hypodermic needles for single use -Requirements and test methods)
- b. Dimensional Specifications
- ISO 7886-1 Second edition 2017-05 Sterile hypodermic syringes for single use -. Part 1: Syringes for manual use
- c. Mechanical and Performance Characteristic
- ISO 7886-1 Second edition 2017-05 Sterile hypodermic syringes for single use -Part 1: Syringes for manual use
- . ISO 7864 Fourth edition 2016-08-01 Sterile hypodermic needles for single use -Requirements and test methods
- ISO 8537 Third edition 2016-03-15 Sterile single-use syringes, with or without needle, for insulin.
- ISO 11608-1 Third edition 2014-12-15 Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems
- d. Chemical and biological characteristic
- ISO 7886-1 Second edition 2017-05 Sterile hypodermic syringes for single use -● Part 1: Syringes for manual use
- . ISO 8537 Third edition 2016-03-15 Sterile single-use syringes, with or without needle, for insulin.
- e. Sterilization validation
- ISO 11137-1 First edition 2006-04-15 Sterilization of health care products -. Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices [Including: Amendment 1 (2013) and Amendment 2 (2018)]

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- ISO 11137-2 Third edition 2013-06-01 Sterilization of health care products -. Radiation - Part 2: Establishing the sterilization dose
- . ISO 11137-3 Second edition 2017-06 Sterilization of health care products -Radiation - Part 3: Guidance on dosimetric aspects of development, validation, and routine control
- f. Shelf-life testing
- ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for . Medical Devices Transportation tests
- ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers . and Systems
- g. Dye Penetration and Seal Strength testing
- ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical . Packaging by Dye Penetration
- ASTM F88/F88M-1 Standard Test Method for Seal Strength of Flexible Barrier . Materials
- h. Biocompatibility and Chemical Characterization
- . ISO 10993-1 Fifth edition 2018-08 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- 1. Cytotoxicity: MEM Elution
- 2. Sensitization: Kligman Maximization
- 3. Intracutaneous Irritation
- 4. USP Rabbit Pyrogen Study, Material Mediated
- 5. Extractables and Leachables
- i. Particulate Matter
- USP <788> Particulate Matter in Injections .
- 9. 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.

- 10. 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.

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.