(246 days)
No
The description focuses on the mechanical properties and delivery system of a stent, with no mention of AI or ML capabilities.
Yes
The device is intended for maintaining esophageal luminal patency in esophageal strictures and occluding concurrent esophageal fistulas, which are therapeutic interventions.
No
Explanation: The device, an esophageal stent system, is intended for maintaining luminal patency and occluding fistulas, which are therapeutic functions, not diagnostic ones. It is used for treatment, not for identifying a disease or condition.
No
The device description clearly details a physical medical device (stent and delivery system) and its components, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to maintain esophageal luminal patency and occlude fistulas in patients with malignant tumors. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is a self-expanding stent and a delivery system for placing the stent within the esophagus. This is a medical device used for treatment, not for analyzing samples from the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, tissue, etc.) or the use of reagents or assays to provide diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Agile Esophageal Stent System is a therapeutic device used to treat a physical condition within the body.
N/A
Intended Use / Indications for Use
The Agile™ Esophageal Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas.
Product codes
ESW
Device Description
The Agile™ Esophageal Stent System is intended for the endoscopic placement of the selfexpanding nitinol stent for maintaining luminal patency in esophageal strictures. The flexible Agile Stent and through-the scope Delivery System allow for stent placement through direct visualization. The Agile™ Esophageal Stent System is supplied sterile.
The Agile™ Stent is a flexible. MR conditional, self-expanding, braided nitinol stent. The proximal and distal ends of the stent have a flare which is larger in diameter than the stent body. The stent wires at each end of the flare are looped. A suture is threaded within the looped ends of both the proximal and distal stent flares to aid in repositioning during initial placement. The proposed Agile Stent is both fully and partially covered in a silicone covering.
The Agile™ Stent comes preloaded and constrained in the delivery system. The delivery system consists of two coaxial shafts compatible with a minimum 3.7mm working channel of a therapeutic gastroscope. The exterior tube is used to constrain the stent before deployment and to reconstrain the stent after partial deployment. The delivery system has radiopaque and visual markers to aid the user in accurate stent placement. There are three visual markers on the delivery system handle to aid in the placement of the stent under endoscopic visualization and four radiopaque markers on the interior of the delivery system to aid in placement of the stent under fluoroscopic visualization.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
esophageal
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 Agile™ Esophageal Stent System successfully passed all pre-defined product specifications for the tests performed.
Bench Tests and Results:
- Guidewire Passage - Pass
- Trackability/Pushability - Pass
- Deployment and Reconstrainment - Pass
- Delivery System Removal - Pass
- Immediate Stent Opening - Pass
- Delivery System Withdrawal - Pass
- Stent Hoop Expansion and Compression Force - Pass
- Delivery System Working Length - Pass
- Delivery System Outer Diameter - Pass
- Visual Transition Zone Length - Pass
- Stent Foreshortening - Pass
- Final Unconstrained Stent Length - Pass
- Stent Flare Length - Pass
- Non-Covered Length (Partially Covered Codes Only) - Pass
- Stent Covering Length (Partially Covered Codes Only) - Pass
- Stent Diameter - Pass
- Flare Diameter - Pass
- Tip to Inner Member Bond Tensile - Pass
- Inner Jacket to Handle Assembly Tensile - Pass
- Reconstrainment Band to Inner Jacket Tensile - Pass
- Exterior Tube to Handle Bond Tensile - Pass
- Inner Jacket to Inner Member Bond Tensile - Pass
- Exterior Tube Transition Zone Tensile - Pass
- Suture Pull Strength Test - Pass
- Corrosion Testing - Pass
- Fatigue Testing - Pass
- Deployment Accuracy - Pass
- Magnetic Resonance Testing - Pass
Comparative Bench Testing:
29. Stent Hoop Expansion & Compression Force: Comparative bench testing was conducted on the Agile Esophageal Stent System and its substantially equivalent predicate device. The comparative testing demonstrated that the Stent Hoop Expansion and Compression Force of the Agile Esophageal Stents falls within the range of the currently marketed predicates for the propose stent diameters.
Key Metrics
Not Found
Predicate Device(s)
K091510/ K073266, K123205, K080838
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.3610 Esophageal prosthesis.
(a)
Identification. An esophageal prosthesis is a rigid, flexible, or expandable tubular device made of a plastic, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the esophagus. The metal esophageal prosthesis may be uncovered or covered with a polymeric material. This device may also include a device delivery system.(b)
Classification. Class II. The special control for this device is FDA's “Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses.”
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
September 21, 2018
Boston Scientific Corporation Kayla Mackey Regulatory Affairs Specialist II 100 Boston Scientific Way Marlborough, Massachusetts 01752
Re: K180144
Trade/Device Name: Agile Esophageal Stent System Regulation Number: 21 CFR 878.3610 Regulation Name: Esophageal Prosthesis Regulatory Class: Class II Product Code: ESW Dated: August 22, 2018 Received: August 23, 2018
Dear Kayla Mackey:
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
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/7 description: The image shows the FDA logo on the left side. On the right side of the image, there is text that says "Jeffrey W" followed by "2018.09" and then "-04'00'". The FDA logo is a stylized version of the letters FDA.
Jeffrey W. Cooper -S 2018.09.21 15:47:15
for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| Form Approved: OMB No. 0910-0120 | |
|---|---|
| Expiration Date: 06/30/2020 | |
| See PRA Statement below. |
| 510(k) Number (if known) | Unknown K180144 |
|---|---|
| Device Name | Agile Esophageal Stent System |
| Indications for Use (Describe) | The Agile Esophageal Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas. |
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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FORM FDA 3881 (7/17)
Page 1 of 1
19
3
SECTION 5: 510(K) SUMMARY
1. Submitter:
Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752
Kayla Mackey Regulatory Affairs Specialist II Telephone: 508-683-4534 Fax: 508-683-5939
Date Prepared: January 16, 2018
2. Device:
| Trade Name: | Agile™ Esophageal Stent System |
|---|---|
| Classification Name: | Esophageal Prosthesis |
| Regulation Number: | 21 CFR 878.3610 |
| Product Code: | ESW |
| Classification: | Class II |
3. Predicate Device(s):
| Trade Name: | Wallflex Esophageal Fully &
Partially Covered Stent System |
|----------------------|---------------------------------------------------------------|
| 510(k) Number: | K091510/ K073266 |
| Classification Name: | Esophageal Prosthesis |
| Regulation Number: | 21 CFR 878.3610 |
| Product Code: | ESW |
| Classification: | Class II |
| Trade Name: | Taewoong Niti-S Esophageal TTS
Stent |
| 510(k) Number: | K123205 |
| Classification Name: | Esophageal Prosthesis |
| Regulation Number: | 21 CFR 878.3610 |
| Product Code: | ESW |
| Classification: | Class II |
| Trade Name: | Merit Alimaxx-ES Esophageal
Stent |
| 510(k) Number: | K080838 |
4
Classification Name: Regulation Number: Product Code: Classification:
Esophageal Prosthesis 21 CFR 878.3610 ESW Class II
Reference Device:
Trade Name: 510(k) Number: Classification Name: Regulation Number: Product Code: Classification:
Ultraflex Esophageal NG Stent System K091816 Esophageal Prosthesis 21 CFR 878.3610 ESW Class II
4. Device Description:
The Agile™ Esophageal Stent System is intended for the endoscopic placement of the selfexpanding nitinol stent for maintaining luminal patency in esophageal strictures. The flexible Agile Stent and through-the scope Delivery System allow for stent placement through direct visualization. The Agile™ Esophageal Stent System is supplied sterile.
The Agile™ Stent is a flexible. MR conditional, self-expanding, braided nitinol stent. The proximal and distal ends of the stent have a flare which is larger in diameter than the stent body. The stent wires at each end of the flare are looped. A suture is threaded within the looped ends of both the proximal and distal stent flares to aid in repositioning during initial placement. The proposed Agile Stent is both fully and partially covered in a silicone covering.
The Agile™ Stent comes preloaded and constrained in the delivery system. The delivery system consists of two coaxial shafts compatible with a minimum 3.7mm working channel of a therapeutic gastroscope. The exterior tube is used to constrain the stent before deployment and to reconstrain the stent after partial deployment. The delivery system has radiopaque and visual markers to aid the user in accurate stent placement. There are three visual markers on the delivery system handle to aid in the placement of the stent under endoscopic visualization and four radiopaque markers on the interior of the delivery system to aid in placement of the stent under fluoroscopic visualization.
| Table 5-1: Agile Partially Covered Stent Sizes | |||
|---|---|---|---|
| UPN | Stent Size | ||
| Stent Diameter | Stent Length | Flare Diameter | |
| M00517200 | 14mm | 62 mm | 19mm |
| M00517210 | 14mm | 102 mm | 19mm |
| M00517220 | 14mm | 119 mm | 19mm |
| M00517230 | 14mm | 148 mm | 19mm |
| M00517240 | 18mm | 59 mm | 23mm |
| M00517250 | 18mm | 97 mm | 23mm |
| M00517260 | 18mm | 119 mm | 23mm |
| M00517270 | 18mm | 149 mm | 23mm |
Proposed Model Configurations:
5
| Table 5-1: Agile Partially Covered Stent Sizes | |||
|---|---|---|---|
| UPN | Stent Size | ||
| Stent Diameter | Stent Length | Flare Diameter | |
| M00517280 | 23mm | 62 mm | 28mm |
| M00517290 | 23mm | 101 mm | 28mm |
| M00517300 | 23mm | 120 mm | 28mm |
| M00517310 | 23mm | 150 mm | 28mm |
| Table 5-2: Agile Fully Covered Stent Sizes | |||
|---|---|---|---|
| UPN | Stent Size | ||
| Stent Diameter | Stent Length | Flare Diameter | |
| M00517400 | 14mm | 62 mm | 19mm |
| M00517410 | 14mm | 102 mm | 19mm |
| M00517420 | 14mm | 119 mm | 19mm |
| M00517430 | 14mm | 148 mm | 19mm |
| M00517440 | 18mm | 59 mm | 23mm |
| M00517450 | 18mm | 97 mm | 23mm |
| M00517460 | 18mm | 119 mm | 23mm |
| M00517470 | 18mm | 149 mm | 23mm |
| M00517480 | 23mm | 62 mm | 28mm |
| M00517490 | 23mm | 101 mm | 28mm |
| M00517500 | 23mm | 120mm | 28mm |
| M00517510 | 23mm | 150mm | 28mm |
5. Indications for Use:
The Agile™ Esophageal Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas.
6. Technological Characteristics
The intended use of the proposed Agile™ Esophageal Stent System is identical to the predicate Wallflex Esophageal Fully and Partially Covered Stent System. Taewoong Niti-S TTS Esophageal Stent, and Merit Alimaxx-ES Esophageal Stent.
The proposed Agile™ Esophageal Stent Delivery system is similiar to the predicate Taewoong Niti-S TTS Esophageal delivery system in overall length and working length, outer diameter, method of placement, and guidewire compatibility.
The proposed Agile™ Esophageal Stent is similar to the predicate Wallflex Esophageal Fully and Partially Covered Stents, Taewoong Niti-S TTS Esophageal Stents, and Merit Alimaxx-ES Esophageal Stents in terms of performance, stent diameter, and stent length. The
6
stent materials are similar between the proposed Agile Esophageal Stent System and the predicate Wallflex Esophageal Fully and Partially Covered Stents.
7. Biocompatibility Analysis
The following biocompatibility tests have been completed for the proposed Agile Esophageal Fully Covered Stent System.
| Table 5-3 Summary of Agile Esophageal Fully Covered Stent Biocompatibility Testing | |||
|---|---|---|---|
| Test | Results | ||
| MEM Elution Cytotoxicity/Part 5 | Pass | ||
| Sub-acute (Subchronic)/Part 11/ Intravenous Toxicity | Pass | ||
| Guinea Pig Maximization Sensitization/Part 10 | Pass | ||
| Intracutaneous Reactivity/Part 10 | Pass | ||
| Sub-acute (Subchronic)/Part 11/ Intraperitoneal Toxicity | Pass | ||
| Materials Mediated Rabbit Pyrogen/Part 11 | Pass | ||
| Ames Mutagenicity/ Part 3 | Pass | ||
| Acute Systemic Injection/Part 11 | Pass | ||
| Mouse Lymphoma / Part 3 | Pass | ||
| Analytical Testing/ Part 18 (NVR; GCMS; LC-MS; ICPMS; | |||
| HS-GC-MS) | Pass | ||
| Implantation (Intramuscular)/ Part 6 | |||
| (4weeks) | Pass | ||
| Implantation (Intramuscular)/ Part 6 | |||
| (13 weeks) | Pass |
| Test | Results |
|---|---|
| MEM Elution Cytotoxicity/Part 5 | Pass |
| Intracutaneous Reactivity/Part 10 | Pass |
| Guinea Pig Maximization Sensitization/Part 10 | Pass |
| Analytical testing | Pass |
7
Ultraflex Esophageal NG Stent System (K091816) was used as a reference device to support the biocompatibility of the Agile Esophageal Partially Covered Stent. The following biocompatibility tests have been leveraged from Ultraflex Esophgeal NG Stent System (K091816).
| Table 5-5 Summary of Ultraflex Esophageal NG Stent System Biocompatibility Testing | ||
|---|---|---|
| Test | Results | |
| Cytotoxicity | Pass | |
| Sensitization | Pass | |
| Intracutaneous Reactivity | Pass | |
| Systemic Toxicity- Acute Systemic Toxicity | Pass | |
| Subacute Toxicity- Intravenous | Pass | |
| Subacute Toxicity- Intraperitoneal | Pass | |
| Genotoxicity- Ames Assay | Pass | |
| Mouse Lymphoma | Pass | |
| Mouse Lymphoma / Part 3 | Pass | |
| Implantation (12 weeks) | Pass | |
| USP Physiochemical | Pass |
8. Performance Data
The proposed Agile™ Esophageal Stent System successfully passed all pre-defined product specifications for the tests performed. Below is a summary of the tests performed on the Agile Esophageal Stent System:
| Table 5-6 Summary of Bench Tests and Results | ||
|---|---|---|
| No. | Test | Results |
| (Pass/Fail) | ||
| 1 | Guidewire Passage | Pass |
| 2 | Trackability/Pushability | Pass |
| 3 | Deployment and Reconstrainment | Pass |
| 4 | Delivery System Removal | Pass |
| 5 | Immediate Stent Opening | Pass |
| 6 | Delivery System Withdrawal | Pass |
| 7 | Stent Hoop Expansion and Compression Force | Pass |
| 8 | Delivery System Working Length | Pass |
| 9 | Delivery System Outer Diameter | Pass |
| 10 | Visual Transition Zone Length | Pass |
| 11 | Stent Foreshortening | Pass |
| 12 | Final Unconstrained Stent Length | Pass |
| 13 | Stent Flare Length | Pass |
8
| 14 | Non-Covered Length (Partially Covered Codes Only) | Pass |
|---|---|---|
| 15 | Stent Covering Length (Partially Covered Codes Only) | Pass |
| 16 | Stent Diameter | Pass |
| 17 | Flare Diameter | Pass |
| 18 | Tip to Inner Member Bond Tensile | Pass |
| 19 | Inner Jacket to Handle Assembly Tensile | Pass |
| 20 | Reconstrainment Band to Inner Jacket Tensile | Pass |
| 21 | Exterior Tube to Handle Bond Tensile | Pass |
| 22 | Inner Jacket to Inner Member Bond Tensile | Pass |
| 23 | Exterior Tube Transition Zone Tensile | Pass |
| 24 | Suture Pull Strength Test | Pass |
| 25 | Corrosion Testing | Pass |
| 26 | Fatigue Testing | Pass |
| 27 | Deployment Accuracy | Pass |
| 28 | Magnetic Resonance Testing | Pass |
| Table 5-7 Summary of the Comparative Bench Tests | |
|---|---|
| No. | Test |
| 29 | Stent Hoop Expansion & Compression Force |
9. Comparative Bench Testing
Comparative bench testing was conducted on the Agile Esophageal Stent System and its substantially equivalent predicate device. The comparative testing demonstrated that the Stent Hoop Expansion and Compression Force of the Agile Esophageal Stents falls within the range of the currently marketed predicates for the propose stent diameters.
Conclusion:
The information Boston Scientific provided in this submission demonstrates that the proposed Agile Esophageal Stent System is substantially equivalent to the currently cleared predicate devices thru the design and performance characteristics and indication for use.