The MicroDose Injector is designed for low volume ophthalmic injection into the subretinal space. It consists of one (1)1mL syringe and one (1) connector, which is joined to VFC tubing that is attached to a pneumatic air source, enabling a surgeon control for administering subretinal injections. The device is supplied sterile and intended for single-use only and cannot be reused or resterilized.

AI/ML Overview

This document is a 510(k) summary for the MedOne Surgical, Inc. MicroDose™ Injector. As such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in terms of clinical performance or diagnostic accuracy.

Therefore, many of the requested sections (sample size for test/training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types) are not applicable or cannot be extracted from this type of regulatory submission, as they pertain to studies involving performance metrics like sensitivity, specificity, or reader agreement, which are not the subject of this 510(k). This submission primarily covers technical, safety, and functionality aspects to establish equivalence.

Here's an analysis of the available information:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria in the typical sense of numerical performance targets (e.g., sensitivity > X%, specificity > Y%). Instead, it establishes equivalence based on meeting various technical, safety, and functional testing requirements.

Acceptance Criteria (Implicit from testing)	Reported Device Performance
Biocompatibility (ISO 10993-1)	Meets ISO 10993-1 (Cytotoxicity, Sensitization, Irritation, Systemic toxicity, Pyrogenicity)
Sterilization Assurance Level (SAL)	Achieves SAL of 10^-6 (ISO 11137-1 and ISO 11137-2)
Shelf-life	Established 5-year expiration date
Package Integrity & Functionality	All tests passed post-shipping
Intended Use	Same as predicate device (low volume ophthalmic injection into the subretinal space)
Technological Characteristics	Substantially equivalent to predicate device (K200325) in terms of materials, mode of operation (pneumatic), volume (1mL)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable/available from the 510(k) summary. The "tests" performed are engineering and laboratory tests (biocompatibility, sterilization, shelf-life, package testing), not clinical or diagnostic performance studies with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable/available. Ground truth as understood in AI/diagnostic studies (e.g., expert consensus on medical images) is not relevant to the types of tests conducted for this device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/available. Adjudication methods are typically used in clinical studies involving human interpretation or consensus, which are not presented here.

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

This information is not applicable/available. The MicroDose™ Injector is a physical medical device (syringe system), not an AI-powered diagnostic or assistive tool.

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

This information is not applicable/available. The device is not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for the tests performed can be characterized as follows:

Biocompatibility: Established standards and validated laboratory methodologies (e.g., cell viability assays for cytotoxicity, skin reaction assessment for sensitization, animal models for systemic toxicity).
Sterilization: Microbiological methods to confirm the absence of viable microorganisms to the specified SAL.
Shelf-life: Real-time or accelerated aging studies with functional testing at intervals to determine the point at which the device no longer meets specifications.
Package integrity: Physical testing (e.g., burst strength, seal integrity) according to recognized standards.
Functionality: Direct measurement against engineering specifications (e.g., flow rate, volume delivery accuracy).

8. The sample size for the training set

This information is not applicable/available. There is no "training set" as this device is not an AI/machine learning algorithm.

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

This information is not applicable/available. As there is no training set for an AI algorithm, there is no associated ground truth in that context.

Summary

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April 26, 2021

Image /page/0/Picture/1 description: The image contains 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

MedOne Surgical, Inc. % Darla Elkin President Elkin RC, LLC 42 North Chantsong Circle The Woodlands, Texas 77382

Re: K203264

Trade/Device Name: MicroDose Injector Regulation Number: 21 CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: Class II Product Code: FMF Dated: March 15, 2021 Received: March 17, 2021

Dear Ms. Elkin:

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 FD A 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 (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,

Elvin Ng Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental 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) K203264

Device Name MicroDose™ Injector

Indications for Use (Describe)

The MicroDose Injector is indicated for low volume ophthalmic injections into the subretinal space.

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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Image /page/3/Picture/1 description: The image shows the logo for MedOne Surgical Inc. The logo consists of a blue circle with a lowercase "m" inside, followed by the text "MedOne" in a combination of green and blue. Below the logo, the text "MedOne Surgical Inc. MicroDose™ Injector" is displayed in a smaller font size.

510(k) SUMMARY MedOne Surgical, Inc. MicroDose™ Injector

This 510(k) Summary is submitted in accordance with 21 CFR Part 807, section 807.92

Sponsor's Name and Address:	MedOne Surgical, Incorporated670 Tallevast DriveSarasota, Florida 34243
Contact Person:	Darla J. ElkinElkin RC, LLC42 North Chantsong CircleThe Woodlands, Texas 77382Telephone: 281.450.8163Facsimile: 941.359.1708delkin@elkinrc.com
Date Summary Prepared	November 4, 2020
Device Trade Name:	MicroDose™ Injector
Common Name:	Syringe, Piston
Product Code:	FMF
Device Classification:	Class II
Predicate Devices:	K200325Orbit Subretinal Delivery System

Device Description:

Indications for Use:

The MicroDose is indicated for low volume ophthalmic injection into the subretinal space.

Technological Characteristics and Substantial Equivalence

The technical features of the MicroDose Injector are substantially equivalent to the predicate device (K200325) intended use/indication for use, materials, technological characteristics, and labelling.

Table 1 on the following page provides the comparison between the MedOne MicroDose Injector and the predicate device.

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Image /page/4/Picture/1 description: The image shows the logo for MedOne. The logo consists of a green circle with a lowercase "m" inside, followed by the word "MedOne" in green and blue. Below the logo, the text "MedOne Surgical Inc. MicroDose" is written in a smaller font.

Feature	MicroDose™ InjectorProposed Device	Orbit Subretinal Delivery SystemPredicate Device
K#	K203264	K200325
Device Classification/Code	Class IIFMF, Syringe, Piston21 CFR 880.5860	Class IIFMF, Syringe, Piston21 CFR 880.5860
Secondary ProductClassification/Code	N/A	Class IHMX, Ophthalmic Cannula21 CFR 886.4350
Indication for Use	The MicroDose is indicated forlow volume ophthalmicinjection into the subretinalspace.	The Orbit Subretinal DeliverySystem is indicated formicroinjection into the subretinalspace.
How Supplied	Sterile, single use only.	Sterile, single-use only.
Configuration	1mL Syringe (syringe barreland piston - plunger removed)and Connector	1mL Syringe (syringe barrel,plunger and piston), cannula,tubing set, CPC adapter, magneticpad, ophthalmic marker
Mode of Operation	Pneumatic	Pneumatic or Manual
Volume	1mL	1mL
Fluid Delivery	Cannula supplied separately	Cannula supplied with device
Biocompatibility	Meets ISO 10993-1	Meets ISO 10993-1

Table 1. Comparison of the Technological Characteristics of the New Device and Predicate Device:

The MicroDose shares the same intended use, the same or similar device operation, and overall technical and functional capabilities to the predicate device and meets applicable standards. Therefore, the MicroDose is substantially equivalent to the predicate device, as outlined in Table 1. Any difference between the MicroDose and the predicate device has no significant influence on safety or effectiveness of the MicroDose Injector.

The primary similarities and differences for the predicate device include:

. Syringe configuration - The syringe component of the MicroDose shares the same components (1mL syringe barrel, and piston (plunger rod removed) as the Orbit syringe (1mL syringe barrel, plunger rod and piston). The primary technological difference is the MicroDose does not require use of a plunger rod and is removed during manufacture while the Orbit device has a removable plunger rod if the user wishes to operate the syringe pneumatically.
. Both devices use an injection cannula for fluid delivery. The cannula is supplied with the predicate device; the cannula is supplied separately from the MicroDose.
. Syringe operating principle - Both devices are used with a pneumatic air source. A technological difference is that the predicate device can also be used manually.
The Orbit device has a magnet encased within the SID housing to provide stability. Use of a magnet is not required for the MicroDose.

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Image /page/5/Picture/0 description: The image displays the logo for MedOne Surgical Inc. The logo features a stylized "m" inside a circle, followed by the text "MedOne" in a combination of green and blue colors. Below the logo, the text "MedOne Surgical Inc. MicroDose™ Injector" is present, indicating the company's name and a specific product they offer.

Performance Data

The following tests were successfully performed with the device to establish substantial equivalence to the predicate devices:

. Biocompatibility testing in accordance with ISO 10993-1 including Cytotoxicity (ISO 10993-5), Sensitization (ISO 10993-10), Irritation, Intracutaneous (ISO 10993-10), Irritation, Ocular (ISO 10993-10), Systemic toxicity (ISO 10993-11) and Pyrogenicity (ISO 10993-11).
. Sterilization validation in accordance with ISO 11137-1 and ISO 11137-2 to provide a Sterility Assurance Level of 10-6.
9 Shelf-life testing was conducted for the sterile device to establish a 5 year expiration date.
. Package and performance testing was performed post shipping to ensure package integrity and functionality of the device. All tests passed.

Conclusion

The MicroDose™ Injector was found to be substantially equivalent to the predicate device as it shares the same intended use and key technological characteristics as the predicate device. Therefore, the device has been shown to be substantially equivalent to the predicate device.

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).