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

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.

AI/ML Overview

The provided text describes the submission of a medical device (aboNT Syringe) for FDA clearance (K212677) and details its non-clinical testing for substantial equivalence to a predicate device. It explicitly states that no clinical testing was performed or provided, and therefore, a multi-reader multi-case (MRMC) comparative effectiveness study with human readers assisted by AI was not conducted, and a standalone algorithm performance study was not conducted.

Here's an analysis of the provided information regarding acceptance criteria and studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding "reported device performance" in the format one might expect for a study evaluating an AI algorithm's diagnostic performance. Instead, it compares the subject device (aboNT Syringe) to a predicate device (UniTox® Syringe) across various technological characteristics. The "performance" in this context refers to meeting established standards for syringe manufacturing and function, rather than diagnostic accuracy.

However, we can extract some "acceptance criteria" based on the comparisons and testing outlined. The "reported device performance" is implicitly that the subject device meets these standards and is "within specification."

Acceptance Criteria (Derived from Standards/Predicate Comparison)	Reported Device Performance (Subject Device)
Intended Use: Injection of botulinum toxin (Dysport®)	Meets (Indicated for intramuscular administration of Dysport®)
Syringe Type: Piston syringe with attached needle	Meets (Piston syringe with attached needle)
Design: Permanently attached needle, low-dead space, specific toxin dose graduation markings	Meets (Permanently attached needle, low-dead space, specific toxin dose graduation markings)
Operational Principles: Manual	Meets (Manual)
Biocompatibility: Compliant to ISO 10993-1	Compliant to ISO 10993-1
Barrel Transparency: No particle and extraneous matter	No particle and extraneous matter
Delivery Accuracy (Less than half nominal cap.): Within specified range (Predicate: Min: 0.0957 mL, Max: 0.1008 mL)	Min: 0.0968 mL, Max: 0.1024 mL (Within specification)
Delivery Accuracy (Equal to or greater than half nominal cap.): Within specified range (Predicate: Min: 0.485 mL, Max: 0.496 mL)	Min: 0.269 mL, Max: 0.300 mL (Within specification, noting volume difference)
Reuse Durability: NA – single use only	NA – single use only
Needle Cover Strength: Within specified range (Predicate: Min: 0.52 kgf, Max: 1.57 kgf)	Min: 0.32 kgf, Max: 0.51 kgf (Within specification)
Hub/Needle Bond Strength: Within specified range (Predicate: Min: 42.65 N)	Min: 44.72 N (Within specification)
Sterilization Method: E-Beam or equivalent	E-Beam (Similar, no new issues)
Shelf-life: 5 years	5 years
Visual Inspection: Meets ISO 7886-1, ISO 7864	Meets standards
Dimensional Specifications: Meets ISO 7886-1	Meets standards
Mechanical & Performance Characteristics: Meets ISO 7886-1, ISO 7864, ISO 8537, ISO 11608-1	Meets standards
Chemical & Biological Characteristics: Meets ISO 7886-1, ISO 8537	Meets standards
Sterilization Validation: Meets ISO 11137-1, -2, -3	Meets standards
Shelf-life Testing: Meets ASTM F1980-16, ASTM D4169-16	Meets standards
Dye Penetration & Seal Strength: Meets ASTM F1929-15, ASTM F88/F88M-1	Meets standards
Biocompatibility: Meets ISO 10993-1 methods (Cytotoxicity, Sensitization, Intracutaneous Irritation, Pyrogen, Extractables/Leachables)	Meets standards
Particulate Matter: Meets USP <788>	Meets standard

2. Sample size used for the test set and the data provenance

The document does not specify a distinct "test set" in the context of an AI algorithm evaluation with sample sizes. The testing conducted is primarily non-clinical, involving material and performance assessments according to established standards. For these physical and chemical tests, sample sizes would typically be defined by the specific standard, but are not detailed in this summary. The data provenance is internal to the manufacturer's testing processes as required for regulatory submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is a non-clinical evaluation of a medical device (syringe), not an AI algorithm requiring expert ground truth for diagnostic accuracy.

4. Adjudication method for the test set

Not applicable. This is a non-clinical evaluation of a medical device (syringe), not an AI algorithm requiring expert adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not conducted. The document explicitly states: "This submission does not warrant any clinical testing, therefore no clinical testing performed for or provided in this submission." This device is a syringe, not an AI-powered diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

No, a standalone algorithm performance study was not done. The device is a syringe, not an AI algorithm.

7. The type of ground truth used

For the non-clinical tests, the "ground truth" is defined by the specifications and acceptable ranges established by recognized international and national standards (e.g., ISO 7886-1, ISO 7864, ASTM F1980-16, USP <788>, etc.). The device's performance is compared against these scientifically established benchmarks.

8. The sample size for the training set

Not applicable. This is a non-clinical evaluation of a syringe; there is no "training set" in the context of machine learning.

9. How the ground truth for the training set was established

Not applicable. There is no "training set" or corresponding ground truth establishment for an AI algorithm in this submission.

Summary

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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

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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 (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

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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 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

1. 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
1. 807.92(a)(3) Predicate Identification Legally marketed substantial equivalent device: K123710, UniTox® Syringe
1. 807.92(a)(4) Device Description

1. 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.
1. 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 ofComparison	Subject Device	Predicate	Discussion ofDifferences
A)	Product Description
1.	Intended Use	Injection of Dysport	Injection of Botox	Similar - bothsyringes areintended to beused foradministration ofbotulinum toxin
2.	Indications forUse	The aboNT Syringe isindicated forintramuscularadministration ofDysport® fortreatment of glabellarlines in adults <65years of age.	UniTox Syringe is singleuse, sterile, intendeduse for thesubcutaneous injectionof Botox® Cosmetic intoparts of body below thesurface of skin.	Similar - bothsyringes areintended to beused foradministration ofbotulinum toxin
3.	Syringe type	Piston syringe withattached needle	Piston syringe withattached needle	Same
4.	Specific drug use	Dysport®	Botox Cosmetic	Similar - bothdrugs are aneurotoxic proteinused to diminishwrinkles.
5.	Designconsideration	Permanently attachedneedle, low-dead spacesyringe, with specific toxindose graduation markings	Permanently attachedneedle, low-dead spacesyringe, with specifictoxin dose graduationmarkings	Same
6.	OperationalPrinciples	Manual	Manual	Same
B)	Physical Characteristics
1.	volume	0.3mL / 60 units ofDysport	0.5mL / 20 units ofBotox	Similar - volumeis based onneeded treatment.
2.	needle length	5/16
	Element ofComparison	Subject Device	Predicate	Discussion ofDifferences
6.	needle covercolor	Natural	yellow	Similar – does notraise any newissues of safety oreffectiveness
C)	Dimensional Characteristics (results of testing provided in Exhibit DD)
1.	Length of barrel(mm)	67.55 ± 0.50	Min: 82.675Max: 82.723	Differences indimensionalcharacteristicsdue to volume ofsyringe.The subject devicevolume is 0.3mL,compared to thepredicate volumeof 0.5mL.
2.	inner diameter ofbarrel (mm)	3.00 ±0.05	Min: 3.491Max: 3.585
3.	outer diameter ofbarrel (mm)	5.18 ± 0.2	Min: 5.393Max: 5.454
4.	Gasket - Outerdiameter of 1stseal (mm)	3.36 ± 0.05	Min: 3.792Max: 3.810
5.	Gasket - Outerdiameter of 2ndseal (mm)	3.36 ± 0.05	Min: 3.703Max: 3.724
D)	Biocompatibility
1.	Category	Complaint to ISO 10993-1	Complaint to ISO10993-1	Same
E)	Mechanical and Performance Specifications
1.	barreltransparency -	No particle andextraneous matter	No particle andextraneous matter	Same
2.	delivery accuracy	Less than half nominalcapacity :Min: 0.0968 mLMax: 0.1024 mLEqual to or greater thanhalf nominal capacity:Min: 0.269 mLMax: 0.300 mL	Less than half nominalcapacity :Min: 0.0957 mLMax: 0.1008 mLEqual to or greater thanhalf nominal capacity:Min: 0.485 mLMax: 0.496 mL	Both deviceswithinspecification
3.	reuse durability	NA – single use only	NA - single use only	Same
4.	needle coverstrength	Min: 0.32 kgfMax: 0.51 kgf	Min: 0.52 kgfMax: 1.57 kgf	Both deviceswithinspecification
5.	hub/needle bondstrength	Min: 44.72 N	Min: 42.65 N	Both deviceswithinspecification
F)	Sterilization
	Element ofComparison	Subject Device	Predicate	Discussion ofDifferences
1.	Method	E-Beam	EtO	Similar – no newissues of safetyand effectiveness
2.	Shelf-life	5 years	5 years	Same

Table 1: Technological Characteristics Comparison

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El Co 1.

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
    - 1. Sensitization: Kligman Maximization
    - 1. Intracutaneous Irritation
    - 1. USP Rabbit Pyrogen Study, Material Mediated
    - 1. Extractables and Leachables
- i. Particulate Matter
  - USP <788> Particulate Matter in Injections .
1. 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.

1. 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.

Regulation Number and Section

§ 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).