Eclipse DermaFlex Cannula

K200017 · Eclipse Medcorp, LLC · FMI · Nov 5, 2020 · General Hospital

Device Facts

• Record ID: K200017
• Device Name: Eclipse DermaFlex Cannula
• Applicant: Eclipse Medcorp, LLC
• Product Code: FMI · General Hospital
• Decision Date: Nov 5, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Eclipse DermaFlex Cannula is intended to inject fluids intradermally.

Device Story

Eclipse DermaFlex Cannula is a single-use, sterile hypodermic single lumen needle system. Device consists of a needle, hub, and cap; available in various gauges and lengths. Two types: AN type (sharpened pilot needle for site preparation) and B type (blunt tip with lateral opening for fluid administration). Device connects to a piston syringe via a female luer hub. Used by clinicians to administer fluids, medications, or drugs intradermally. System facilitates precise delivery of injectables; blunt tip design minimizes tissue trauma during administration.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing included sterilization validation (ISO 11135, ISO 11138, ISO 11737, ISO 10993-7, AAMI TIR28), shelf life validation (ISO 11608-2, ASTM F1929, ISO 11737-2), biocompatibility (ISO 10993-1, -4, -10), and mechanical performance (ISO 9626:2016, ISO 7864:2016, ISO 80369-7, ISO 6009:2016).

Technological Characteristics

Single lumen hypodermic needle; stainless steel 304 tube; polypropylene hub and cap; silicone lubricant. Luer taper connection. Sterilized via Ethylene Oxide gas. Gauges: 21, 22, 23, 25, 26, 27, 30. Lengths: 25-70mm. Complies with ISO 9626, ISO 7864, ISO 80369-7, and ISO 6009.

Indications for Use

Indicated for patients requiring intradermal fluid injection.

Regulatory Classification

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.

Predicate Devices

• MV INTRADERMIC NEEDLES; MAGIC NEEDLE (K110606)

Submission Summary (Full Text)

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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.

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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 ([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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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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#### 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: [phone] Fax: [phone]

# 2. Contact Person

Julie Summerville Sr. Dir. of Product Management Eclipse MedCorp, LLC 972.380.2911 x2405 [e-mail]

## 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:

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.

#### 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.

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| 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<br>Cannula is intended to inject<br>fluids intradermally. | The MV intradermic needles<br>are intended to inject fluids<br>intradermally. | Same |
| Structure | Hub, Needle, Protective Cap | Hub, Needle, Protective Cap | Same |
| Principle of Operation | This device is used in conjunction<br>with a piston syringe to deliver fluids/<br>medications/drugs into the body.<br>The device consists of a metal tube<br>(needle), joined to a female<br>connector (hub). This device comes<br>in a variety of needle gauges and<br>lengths. | This device is used in conjunction<br>with a piston syringe to deliver<br>fluids/ medications/drugs into the<br>body. This device consists of metal<br>tube (needle), joined to a female<br>connector (hub). This device comes<br>in a variety of needle gauges and<br>lengths. | Same |
| Tip Configuration | Sharpened tip (pilot needle) Closed<br>blunt tip, lateral opening<br>(Intradermic needle) | Sharpened tip (pilot needle<br>Closed blunt tip, lateral opening<br>(Intradermic needle) | Same |
| Needle Gauge | 21, 22, 23, 25, 26, 27, 30 | 21, 22, 23, 25, 26, 27, 30 | Same |
| Needle Tube<br>Length | 25, 38, 40, 50, 60, 70mm | 13, 25, 27, 35, 37, 40, 50, 57,<br>70mm | Equivalent: Needle<br>lengths within<br>predicate's range |
| Needle Tube<br>Material | Stainless Steel 304 | Stainless Steel 304 | Same |
| Connection to<br>Syringe | Luer taper | Luer taper | Same |
| Needle Hub<br>Material | Polypropylene | Polypropylene | Same |
| Needle Cap<br>Material | Polypropylene | Polypropylene | NA |
| Lubricant<br>Composition | Silicone | Silicone | Same |
| Sterilization<br>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 ●

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.

#### 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.