(127 days)
No
The device description and performance studies focus on physical characteristics and standard medical device testing, with no mention of AI or ML.
No.
The device facilitates guidewire placement for non-vascular procedures, but it does not directly treat or diagnose a disease or condition; it is a tool used in a medical procedure.
No
The device is an introducer kit and associated components used to facilitate the introduction and placement of guidewires for non-vascular procedures, not to diagnose a condition.
No
The device description explicitly lists physical components such as a sheath/dilator assembly, needles, and guidewires, and the performance studies involve testing of these physical characteristics.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is 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." This describes a device used in vivo (within the body) for a procedural purpose (introducing a guidewire).
- Device Description: The components listed (sheath/dilator, needles, guidewires) are all instruments used for accessing and navigating within the body during a medical procedure.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the body, not to be inserted into the body for procedural purposes.
N/A
Intended Use / Indications for 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.
Product codes
DYB, GBX, GAA
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.
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
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
- Luer performance
- Corrosion Resistance
- Biocompatibility per ISO 10993-1.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).
0
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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1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)
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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3
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 (508) 658-7944
C. Device Name
Trade Name: Common/Usual Name: Classification:
Classification Name:
Wanda Carpinella Director, Regulatory Affairs (508) 658-7990
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
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.
4
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 | |
| System (K952828) | ||
| Indications for 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. | The AccuStick™ II Introducer System | |
| with radiopaque marker facilitates | ||
| introduction and placement of a | ||
| guidewire. | ||
| Intended Use | Placement of guidewire in non- | |
| vascular procedures. | Placement of guidewire in non-vascular | |
| procedures. | ||
| Sheath Introducer | ||
| OD/Dilator ID | 6F/4F | 6F/4F |
| Triaxial Sheath | ||
| Length | 20cm | 20cm |
| Stiffening Cannula | ||
| Option | Yes | Yes |
| Sheath Radiopaque | ||
| Marker | Yes | Yes |
| RO Marker | Radiopaque Marker Tip | Radiopaque Marker Tip |
| Introducer Needle | ||
| Sizes* | 18G & 21G | 21G |
| Guidewire Sizes | 0.018 in. | |
| 0.035 in. | ||
| 0.038 in. | 0.018 in. | |
| 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 .
5
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