(127 days)
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 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.
The provided document is a 510(k) Premarket Notification for a medical device called the "Mini Stick ENVI Non-Vascular Introducer Kit." This document focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and non-clinical performance data.
Therefore, the concepts of acceptance criteria for diagnostic performance, a test set, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information are not applicable to this type of submission. This device is an introducer kit, and the evaluation is primarily focused on its physical and functional characteristics, not on diagnostic accuracy of an AI or image-based system.
Here's an analysis based on the information provided, explaining why certain sections of your request are not relevant:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the context of diagnostic performance metrics like sensitivity, specificity, accuracy, etc., because it's a physical medical device, not a diagnostic algorithm. However, it lists performance tests conducted to demonstrate the device's functional integrity and safety. We can infer the "acceptance criteria" were successful completion of these tests in accordance with the cited ISO standards.
| Test Category | Reported Device Performance (Implied Acceptance Criteria: Met standards) |
|---|---|
| Tensile Testing | Performed in accordance with ISO 11070:2014 |
| Leak Testing | Performed in accordance with ISO 11070:2014 |
| Radiopacity Testing | Performed in accordance with ISO 11070:2014 |
| Dimensional verification | Performed in accordance with ISO 11070:2014 |
| Compatibility Testing | Performed in accordance with ISO 11070:2014 |
| Luer performance | Performed in accordance with ISO 594-2:1998 |
| Corrosion Resistance | Performed in accordance with an unspecified standard (likely ISO) |
| Biocompatibility | Performed per ISO 10993-1 |
2. Sample size used for the test set and the data provenance
Not applicable. This device is not a diagnostic tool or algorithm that uses a "test set" of patient data. The "tests" mentioned are non-clinical engineering and material tests, which would involve specific numbers of device components or assemblies, not patient samples or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth, in the context of diagnostic performance, is not relevant here. The "truth" in this context is whether the device physically meets its intended specifications and safety standards, determined by engineering and scientific testing, not expert interpretation of diagnostic images or clinical data.
4. Adjudication method for the test set
Not applicable for the same reasons as above. Adjudication methods are used to establish a consensus ground truth from multiple expert interpretations, which is not relevant for the functional testing of a physical introducer kit.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. MRMC studies are for evaluating the performance of diagnostic systems (often AI-assisted) with human readers. This device is an introducer kit, not a diagnostic system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. There is no algorithm associated with this device.
7. The type of ground truth used
Not applicable in the diagnostic sense. The "ground truth" for this device's performance is established by its manufacturing specifications and compliance with international standards for medical devices (e.g., ISO 11070, ISO 594-2, ISO 10993-1) as demonstrated through physical and chemical testing.
8. The sample size for the training set
Not applicable. This is not an AI/ML device; there is no "training set."
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an AI/ML model, there is no ground truth to be established for it.
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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 (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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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.
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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 IntroducerSystem (K952828) | |
| Indications for Use | The Mini Stick ENVI Non-VascularIntroducer Kit is utilized to facilitatethe introduction and placement of a0.035 in (0.89 mm) or 0.038 in (0.97mm) diameter guidewire for non-vascular procedures. | The AccuStick™ II Introducer Systemwith radiopaque marker facilitatesintroduction and placement of aguidewire. |
| Intended Use | Placement of guidewire in non-vascular procedures. | Placement of guidewire in non-vascularprocedures. |
| Sheath IntroducerOD/Dilator ID | 6F/4F | 6F/4F |
| Triaxial SheathLength | 20cm | 20cm |
| Stiffening CannulaOption | Yes | Yes |
| Sheath RadiopaqueMarker | Yes | Yes |
| RO Marker | Radiopaque Marker Tip | Radiopaque Marker Tip |
| Introducer NeedleSizes* | 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 .
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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
§ 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).