Mini Stick ENVI Non-Vascular Introducer Kit

K170775 · AngioDynamics, Inc. · DYB · Jul 19, 2017 · Cardiovascular

Device Facts

• Record ID: K170775
• Device Name: Mini Stick ENVI Non-Vascular Introducer Kit
• Applicant: AngioDynamics, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Jul 19, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The Mini Stick ENVI Non-Vascular Introducer Kit is utilized to facilitate the introduction and placement of a 0.035 in (0.89 mm) or 0.038 in (0.97 mm) diameter guidewire for non-vascular procedures.

Device Story

The Mini Stick ENVI Non-Vascular Introducer Kit is a procedural tool used to facilitate guidewire placement in non-vascular clinical settings. The kit includes a triaxial sheath/dilator assembly with a stiffening cannula, an 18G or 21G needle with stylet, and guidewires (0.018 in floppy tip; 0.035 in or 0.038 in heavy duty). The device is operated by a clinician to gain access to a target site. The sheath features a radiopaque marker to assist the clinician in visualizing placement under imaging guidance. By providing a stable pathway for guidewire insertion, the device enables subsequent therapeutic or diagnostic interventions. It is intended for single-use and is provided sterile.

Clinical Evidence

Bench testing only. Testing performed in accordance with ISO 11070 (Sterile, Single-Use Intravascular, Introducers, Dilators and Guidewires) and ISO 594-2 (Conical Fittings 6% Luer Taper). Evaluations included tensile testing, leak testing, radiopacity, dimensional verification, compatibility, luer performance, corrosion resistance, and biocompatibility per ISO 10993-1.

Technological Characteristics

Triaxial sheath/dilator assembly (6F/4F), 18G/21G needles, and guidewires. Features radiopaque marker tips. Complies with ISO 11070 and ISO 594-2 standards. Sterile, single-use, non-powered mechanical device.

Indications for Use

Indicated for patients requiring non-vascular procedures where the introduction and placement of a 0.035 in or 0.038 in diameter guidewire is necessary.

Regulatory Classification

Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Predicate Devices

• Boston Scientific AccuStick Introducer System (K952828)

Reference Devices

• Cook Neff Percutaneous Access Set (K895044)
• Cook Percutaneous Trocar Needle
• Cook Skinny Needle with Chiba Tip (K851957)

Submission Summary (Full Text)

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July 19, 2017

AngioDynamics, Inc. Hans Kjolhede Specialist 1. Global Regulatory Affairs 26 Forest Street Marlborough, MA 01752

Re: K170775

Trade/Device Name: Mini Stick ENVI Non-Vascular Introducer Kit Regulation Number: 21 CFR§ 870.1340 Regulation Name: Catheter Introducer Regulatory Class: II Product Code: DYB, GBX, GAA Dated: June 16, 2017 Received: June 19, 2017

Dear Hans Kjolhede:

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. 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.

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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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

# Charles Viviano -S

Benjamin R. Fisher, Ph.D. For Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known)

K170775

Device Name Mini Stick ENVI Non-Vascular Introducer Kit

Indications for Use (Describe)

The Mini Stick ENVI Non-Vascular Introducer Kit is utilized to facilitate the introduction and placement of a 0.035 in (0.89 mm) or 0.038 in (0.97 mm) diameter guidewire for non-vascular procedures.

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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Traditional Premarket Notification 510(k) Mini Stick ENVI Non-Vascular Introducer Kit

#### 510(k) Summary for the Mini Stick ENVI Non-Vascular Introducer Kit

Date prepared: July 19, 2017

#### A. Sponsor

AngioDynamics, Inc 26 Forest Street Marlborough, MA 01752

#### B. Contact

Hans Kjolhede Global Regulatory Affairs [phone]

#### C. Device Name

Trade Name: Common/Usual Name: Classification:

Classification Name:

#### Wanda Carpinella Director, Regulatory Affairs [phone]

Boston Scientific Corporation

AccuStick Introducer System

Class II, 21 CFR §870.1340-ProCode: DYB Class I, 21 CFR §878.4200-ProCode: GBX

Introduction/Drainage Catheter and Accessories

K952828

Catheter Introducer

Mini Stick ENVI Non-Vascular Introducer Kit Non-Vascular Introducer Kit Class II, 21 CFR §870.1340-ProCode: DYB Class I, 21 CFR §878.4200-ProCode: GBX Class I, 21 CFR §878.4800-ProCode: GAA Biliary Catheter and Accessories (Gastroenterology and Urology Panel) Introduction/Drainage Catheter and Accessories (General and Plastic Surgery Panel) Needle, Aspiration and Injection, Disposable (General and Plastic Surgery Panel)

#### D. Predicate Device(s)

Manufacturer: Predicate Name: Predicate 510(k): Classification:

Classification Name:

#### E. Reference Devices

| Cook Neff Percutaneous Access Set | K895044 |
|-----------------------------------|-----------------------------------|
| Cook Percutaneous Trocar Needle | Exempt per 878.4800 |
| Cook Skinny Needle with Chiba Tip | K851957 (Now exempt per 878.4800) |

#### F. Device Description

The Mini Stick ENVI Non-Vascular Introducer Kit contains one or more of the following components. Reference unit label for specific devices: Triaxial Sheath/Dilator assembly with stiffening cannula; 18G (1.4 mm) or 21G (0.9 mm) needle with stylet; 0.018 in (0.46 mm) floppy tip guidewire; 0.035 in (0.89 mm) or 0.038 in (0.97 mm) heavy duty guidewire. For user convenience, all kit components are also available in multiple kit configurations as sterile, standalone devices.

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Traditional Premarket Notification 510(k) Mini Stick ENVI Non-Vascular Introducer Kit

#### G. Intended Use/Indications for Use

The Mini Stick ENVI Non-Vascular Introducer Kit configurations are indicated as follows:

- . The Mini Stick ENVI Non-Vascular Introducer Kit is utilized to facilitate the introduction and placement of a 0.035 in (0.89 mm) or 0.038 in (0.97 mm) diameter guidewire for non-vascular procedures.
#### H. Technological Characteristics

The proposed device has similar materials, design and components and technological characteristics as predicate and referenced devices.

| Predicate Comparison Table | | |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| | Proposed Mini Stick ENVI Kit | Boston Scientific AccuStick Introducer<br>System (K952828) |
| Indications for Use | The Mini Stick ENVI Non-Vascular<br>Introducer Kit is utilized to facilitate<br>the introduction and placement of a<br>0.035 in (0.89 mm) or 0.038 in (0.97<br>mm) diameter guidewire for non-<br>vascular procedures. | The AccuStick™ II Introducer System<br>with radiopaque marker facilitates<br>introduction and placement of a<br>guidewire. |
| Intended Use | Placement of guidewire in non-<br>vascular procedures. | Placement of guidewire in non-vascular<br>procedures. |
| Sheath Introducer<br>OD/Dilator ID | 6F/4F | 6F/4F |
| Triaxial Sheath<br>Length | 20cm | 20cm |
| Stiffening Cannula<br>Option | Yes | Yes |
| Sheath Radiopaque<br>Marker | Yes | Yes |
| RO Marker | Radiopaque Marker Tip | Radiopaque Marker Tip |
| Introducer Needle<br>Sizes* | 18G & 21G | 21G |
| Guidewire Sizes | 0.018 in.<br>0.035 in.<br>0.038 in. | 0.018 in.<br>0.038 in. |

*The reference devices are being cited to support substantial equivalence pertaining to needle configurations.

#### I. Performance Data

The proposed Mini Stick ENVI Non-Vascular Introducer Kit is substantially equivalent to the specified predicate device based on a comparison of technological characteristics and the results of non-clinical test performed in accordance with ISO 11070: Sterile, Single-Use Intravascular, Introducers, Dilators and Guidewires: 2014 and ISO 594-2: Conical Fittings 6% (Luer) Taper for Syringes, Needles, Certain Medical Equipment - Part 2 (1998), which included:

- Tensile Testing
- Leak Testing
- Radiopacity Testing .
- Dimensional verification
- Compatibility Testing .

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Traditional Premarket Notification 510(k) Mini Stick ENVI Non-Vascular Introducer Kit

- Luer performance ●
- Corrosion Resistance ●
- Biocompatibility per ISO 10993-1 .

### J. Conclusion

The results of the non-clinical testing and a comparison of similarities and differences demonstrate that the proposed and predicate devices are substantially equivalent