K Number

Device Name

Eclipse DermaFlex Cannula

Manufacturer

Eclipse MedCorp, LLC

Date Cleared

2020-11-05

(307 days)

Product Code

FMI

Regulation Number

880.5570

Intended Use

The Eclipse DermaFlex Cannula is intended to inject fluids intradermally.

Device Description

The Eclipse DermaFlex Cannula is provided as a single-use, sterile device. It is comprised of a needle. hub and cap. This device comes in a variety of needle gauges and lengths. The Eclipse DermaFlex Cannula offers AN type and B Type. The AN type is a hypodermic single lumen needle intended to prepare the site for injection. The tip of this pilot needle is sharpened at one end, while the other end is joined to a hub. The B type has a metal tube with the tip, which is closed and blunt, while the cannula has an opening laterally at a lower point under the tip. On the other end, the device is joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or secondary medication sets to prepare and administer fluids/ medications/ drugs to a patient.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K110606

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical characteristics and standard performance testing of a cannula, with no mention of AI or ML.

Therapeutic

No
The device is described as a cannula intended to inject fluids intradermally, and one type is for preparing the site for injection, while the other administers fluids/medications/drugs. This indicates it is a delivery device for substances, not a device that therapeutically treats a condition itself.

Diagnostic

The document states that the device is "intended to inject fluids intradermally" and to "prepare and administer fluids/ medications/ drugs to a patient," which are therapeutic or administrative functions, not diagnostic ones.

SaMD (Software as a Medical Device)

The device description clearly states it is comprised of a needle, hub, and cap, which are physical hardware components. The performance studies also focus on hardware-related testing like sterilization, shelf life, and biocompatibility.

IVD (In Vitro Diagnostic)

Based on the provided information, the Eclipse DermaFlex Cannula is not an IVD (In Vitro Diagnostic) device.

Here's why:

Intended Use: The intended use is "to inject fluids intradermally." This describes a procedure performed on the patient, not a test performed on a sample taken from the patient.
Device Description: The description details a needle/cannula designed for injection, which is consistent with a device used for administering substances directly into the body.
Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide diagnostic information based on such analysis.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The Eclipse DermaFlex Cannula's function is to deliver substances into the body, which is a therapeutic or procedural function, not a diagnostic one.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Eclipse DermaFlex Cannula is intended to inject fluids intradermally.

Product codes (comma separated list FDA assigned to the subject device)

FMI

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Performance testing for the DermaFlex Cannula was conducted in accordance with the following standards.

Sterlization Validation Test in accordance with ISO 11135, ISO 11138-1, ISO 11138-2, ISO 11737-1, ISO . 10993-7, and AAMI TIR28
. Shelf Life Validation Test in accordance with ISO 11608-2, ASTM F1929, and ISO 11737-2
Biocompatibility testing in accordance with ISO 10993-1. ISO 10993-10, ISO 10993-10, ISO ● 10993-4
Performance Tests in accordance with ISO 9626:2016, ISO 7864: 2016, ISO 80369-7
ISO 6009: 2016–Hypodermic needles for single use Colour coding for identification ●

The results of the performance testing for the device meets the device meets the established characteristics and performance requirements needed to perform its intended function. Substantial equivalence is established as these are the same standards established for the predicate device as well. As the Eclipse meets the required criteria of the standards, its performance may be considered to support substantial equivalence.

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.

K110606

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

Regulation Number and Section

§ 880.5570 Hypodermic single lumen needle.

(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).

Summary

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, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in large, bold, blue letters, and the word "ADMINISTRATION" in smaller, blue letters below.

November 5, 2020

Eclipse MedCorp, LLC Julie Summerville Senior Director of Product Management 5916 Stone Creek Drive Suite#120 The Colony, Texas 75056

Re: K200017

Trade/Device Name: Eclipse DermaFlex Cannula Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: October 1, 2020 Received: October 5, 2020

Dear Julie Summerville:

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 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-reporting-

combination-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 medical devices and radiation-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

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K200017

Device Name Eclipse DermaFlex Cannula

Indications for Use (Describe)

The Eclipse DermaFlex Cannula is intended to inject fluids intradermally.

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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FORM FDA 3881 (7/17)

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Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(K) Summary-K200017 Prepared: June 30, 2020

1. 510k Submitter

Eclipse MedCorp, LLC. 5916 Stone Creek Dr. Suite #120 The Colony, TX 75056 U.S.A. Tel: (972) 380-2911 Fax: (866) 558-0415

2. Contact Person

Julie Summerville Sr. Dir. of Product Management Eclipse MedCorp, LLC 972.380.2911 x2405 jsummerville@eclipsemed.com

3. Device Name:

· Trade Name : Eclipse DermaFlex Cannula
· Requlation Description: Hypodermic single lumen needle
· Device Class: Class II
Product Code: FMI
· Requlation Number: 21 CFR Part 880.5570
· Review Panel: General Hospital

4. Predicate Device:

MV INTRADERMIC NEEDLES; MAGIC NEEDLE (K110606) by M.V. S.R.L.

5. Device Description:

Indication: 6.

The Eclipse DermaFlex Cannula is intended to inject fluids intradermally.

7. Technological Characteristics:

The subject device has the same indications for use, principle of operation and structure. The subject device is comprised of the same materials as the predicate, offers the same range of needle gauges and has the same syringe connection type. The needle tube length of the subject device, DermaFlex Cannula is within the size range of the predicate device. The subject device is marketed with a blunt tip needle and pilot needle. The predicate device is marketed with blunt tip needle and with or without a hypodermic needle (pilot needle).; however, both perform the same intended use. Additionally, there are slight differences in the design of the needle and cannula tips between the subject and predicate devices. The inclusion of the hypodermic needle and the slight differences in design are not considered to raise new questions of safety and effectiveness. Further, successful testing of the subject device to appropriate performance testing has been performed and these differences does not raise new questions with regard to safety and effectiveness.

Table of Technological Characteristics
	Subject Device	Predicate Device	Comments
Device Name	Eclipse DermaFlex Cannula	MV INTRADERMIC NEEDLES; MAGIC NEEDLE; MAGIC NEEDLE	NA
510k Applicant	Eclipse MedCorp, LLC.	M.V. S.R.L.	NA
Product Code	FMI	FMI	Same
510k Number	K200017	K110606	NA
Indications for Use	The Eclipse DermaFlex
Cannula is intended to inject
fluids intradermally.	The MV intradermic needles
are intended to inject fluids
intradermally.	Same
Structure	Hub, Needle, Protective Cap	Hub, Needle, Protective Cap	Same
Principle of Operation	This device is used in conjunction
with a piston syringe to deliver fluids/
medications/drugs into the body.
The device consists of a metal tube
(needle), joined to a female
connector (hub). This device comes
in a variety of needle gauges and
lengths.	This device is used in conjunction
with a piston syringe to deliver
fluids/ medications/drugs into the
body. This device consists of metal
tube (needle), joined to a female
connector (hub). This device comes
in a variety of needle gauges and
lengths.	Same
Tip Configuration	Sharpened tip (pilot needle) Closed
blunt tip, lateral opening
(Intradermic needle)	Sharpened tip (pilot needle
Closed blunt tip, lateral opening
(Intradermic needle)	Same
Needle Gauge	21, 22, 23, 25, 26, 27, 30	21, 22, 23, 25, 26, 27, 30	Same
Needle Tube
Length	25, 38, 40, 50, 60, 70mm	13, 25, 27, 35, 37, 40, 50, 57,
70mm	Equivalent: Needle
lengths within
predicate's range
Needle Tube
Material	Stainless Steel 304	Stainless Steel 304	Same
Connection to
Syringe	Luer taper	Luer taper	Same
Needle Hub
Material	Polypropylene	Polypropylene	Same
Needle Cap
Material	Polypropylene	Polypropylene	NA
Lubricant
Composition	Silicone	Silicone	Same
Sterilization
method	Ethylene Oxide Gas	Ethylene Oxide Gas	Same

Performance Testing

Performance testing for the DermaFlex Cannula was conducted in accordance with the following standards.

Sterlization Validation Test in accordance with ISO 11135, ISO 11138-1, ISO 11138-2, ISO 11737-1, ISO . 10993-7, and AAMI TIR28
. Shelf Life Validation Test in accordance with ISO 11608-2, ASTM F1929, and ISO 11737-2
Biocompatibility testing in accordance with ISO 10993-1. ISO 10993-10, ISO 10993-10, ISO ● 10993-4
Performance Tests in accordance with ISO 9626:2016, ISO 7864: 2016, ISO 80369-7
ISO 6009: 2016–Hypodermic needles for single use Colour coding for identification ●

Conclusion

Based on the information provided in this premarket notification, Eclipse MedCorp, LLC concludes that the Eclipse DermaFlex Cannula is substantially equivalent to predicate device.