(172 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI/ML terms or data-driven performance metrics.
Yes.
The device is used for low volume ophthalmic injections into the subretinal space, which is a medical intervention intended to treat or manage a condition.
No
The device is an injector designed for administering subretinal injections, not for diagnosing medical conditions.
No
The device description explicitly details physical components like a syringe, connector, tubing, and a pneumatic air source, indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The MicroDose Injector is used to deliver a substance (presumably a medication or therapeutic agent) into the subretinal space within the eye. This is a direct intervention on the body, not a test performed on a specimen.
- Intended Use: The intended use clearly states "for low volume ophthalmic injections into the subretinal space." This describes a therapeutic or procedural use, not a diagnostic test.
The device is a surgical instrument used for administering treatment, not for diagnosing a condition by analyzing a sample.
N/A
Intended Use / Indications for Use
The MicroDose Injector is indicated for low volume ophthalmic injections into the subretinal space.
Product codes
FMF
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subretinal space (ophthalmic)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon
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
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.
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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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
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 (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, Incorporated
670 Tallevast Drive
Sarasota, Florida 34243 |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Darla J. Elkin
Elkin RC, LLC
42 North Chantsong Circle
The Woodlands, Texas 77382
Telephone: 281.450.8163
Facsimile: 941.359.1708
delkin@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: | K200325
Orbit Subretinal Delivery System |
Device Description:
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.
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™ Injector
Proposed Device | Orbit Subretinal Delivery System
Predicate Device |
|------------------------------------------|----------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| K# | K203264 | K200325 |
| Device Classification/Code | Class II
FMF, Syringe, Piston
21 CFR 880.5860 | Class II
FMF, Syringe, Piston
21 CFR 880.5860 |
| Secondary Product
Classification/Code | N/A | Class I
HMX, Ophthalmic Cannula
21 CFR 886.4350 |
| Indication for Use | The MicroDose is indicated for
low volume ophthalmic
injection into the subretinal
space. | The Orbit Subretinal Delivery
System is indicated for
microinjection into the subretinal
space. |
| How Supplied | Sterile, single use only. | Sterile, single-use only. |
| Configuration | 1mL Syringe (syringe barrel
and piston - plunger removed)
and Connector | 1mL Syringe (syringe barrel,
plunger and piston), cannula,
tubing set, CPC adapter, magnetic
pad, 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.