(257 days)
The ARCHIMEDES biodegradable pancreatic stent is intended to drain pancreatic ducts in patients indicated for pancreatic duct stenting.
The ARCHIMEDES Biodegradable Pancreatic Stent is intended to be delivered through the working channel of a therapeutic endoscope using a guidewire with a maximum outer diameter of 0.035 inches and a pushing catheter of between 5 to 10 French.
The ARCHIMEDES™ Biodegradable Pancreatic Stent is a single use, sterile, biodegradable stent implant intended for use in the pancreatic duct. The device is intended to be delivered endoscopically through the working channel of a duodenoscope.
The ARCHIMEDES™ has a fluted cross-sectional profile and provides three drainage channels, two of which spiral in a double helical pattern down the length of the stent and one of which is the hollow inner lumen of the device tube. This unique design permits fluids to flow both around and through the stent. It has a curved form design to fit the natural curvature of the pancreatic duct, and contains flap and split-end features to minimize spontaneous migration of the stent while in situ. The tips of the stent are tapered to facilitate atraumatic insertion through the papilla. The stent is visible under fluoroscopy. The 8F and 10F stent design contains flaps on each end. The 6F stent design has a flap on one end and a split-end feature on the other end.
The stent is offered in outer diameters of 2.0mm (6F), 2.6mm (8F), or 3.4mm (10F), and in various lengths to accommodate variations in pancreatic anatomy across individuals (40, 60, 80, 100, 125, 150, 175, 200, and 225 mm). The ARCHIMEDES™ is designed to be an alternative to plastic stents that maintains the same clinical purpose. In particular, it is used in a manner similar to current FDA-cleared plastic pancreatic stents. The primary difference is that the ARCHIMEDES™ biodegrades in-situ rather than requiring an additional procedure for removal needed of plastic stents.
The Minimal Strength Retention (MSR) time for the material - i.e., the minimum amount of time for which the device retains at least 10% of an initial strength parameter and remains intact with no breaks is 12 days. Full-degradation or no stent presence is reached within <95 days.
The provided FDA 510(k) clearance letter and summary for the ARCHIMEDES™ Biodegradable Pancreatic Stent do not contain the specific acceptance criteria and detailed performance results for the device. While it states that "All tests met required acceptance criteria," the actual criteria and reported numerical performance are not explicitly listed.
Furthermore, the document alludes to "eight clinical studies" but provides no details whatsoever about their methodology, sample sizes, data provenance, expert qualifications, adjudication methods, or specific outcomes. It's a high-level statement without any actionable data.
Therefore, many of your requested fields cannot be filled from the provided text.
Here's a breakdown of what can be extracted and what cannot, based on the input:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Non-clinical Performance | |
| Visual Inspection | Met required acceptance criteria (no specific details provided) |
| Outer diameter, Length | Met required acceptance criteria (no specific details provided) |
| Stent Swelling Characterization | Met required acceptance criteria (no specific details provided) |
| Flow Rate | Met required acceptance criteria (no specific details provided) |
| Inherent Viscosity | Met required acceptance criteria (no specific details provided) |
| Guidewire Compatibility | Met required acceptance criteria (no specific details provided) |
| Endoscope Compatibility | Met required acceptance criteria (no specific details provided) |
| Introducer Sleeve Compatibility | Met required acceptance criteria (no specific details provided) |
| Simulated Use | Met required acceptance criteria (no specific details provided) |
| Trackability | Met required acceptance criteria (no specific details provided) |
| Pushability | Met required acceptance criteria (no specific details provided) |
| Flexibility/Kink Resistance | Met required acceptance criteria (no specific details provided) |
| Retraction Force | Met required acceptance criteria (no specific details provided) |
| Tensile Strength | Met required acceptance criteria (no specific details provided) |
| Fluoroscopic Visibility | Met required acceptance criteria (no specific details provided) |
| Degradation | Met required acceptance criteria (no specific details provided) |
| Biocompatibility (per ISO 10993-1:2009) | |
| MEM Elution Cytotoxicity | Met required acceptance criteria (no specific details provided) |
| Implantation | Met required acceptance criteria (no specific details provided) |
| Guinea Pig Maximization Sensitization | Met required acceptance criteria (no specific details provided) |
| 28 Day Dual Route IV/IP Systemic Toxicity | Met required acceptance criteria (no specific details provided) |
| Acute Systemic Injection | Met required acceptance criteria (no specific details provided) |
| Intracutaneous Reactivity | Met required acceptance criteria (no specific details provided) |
| Material Mediated Pyrogen | Met required acceptance criteria (no specific details provided) |
| Chemical Extractables Studies & Toxicological Risk Assessment | Met FDA's Guidance document (no specific details provided) |
| Sterilization (per ISO 11135-1) | Met Sterilization requirements (no specific details provided) |
| Ethylene Oxide Sterilization Residuals (per ISO 10993-7) | Met Ethylene Oxide Sterilization Residuals requirements (no specific details provided) |
| Minimal Strength Retention (MSR) | The device retains at least 10% of an initial strength parameter and remains intact with no breaks for 12 days. |
| Full Degradation | Full-degradation or no stent presence is reached within <95 days. |
| Clinical Performance (Safety, Efficacy, Clinical Performance, Degradation Profile, Technical Success) | Supported by eight clinical studies (no specific details provided) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for any of the eight clinical studies mentioned.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective is only generally mentioned as "various settings, including single-center and multicenter, prospective and retrospective, randomized and non-randomized designs" for the collection of 8 studies, but not for any specific study or a "test set").
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not specified. The document only mentions "eight clinical studies" but no details on expert involvement for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified.
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. This device is a physical medical stent, not an AI or imaging diagnostic device. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study regarding human readers and AI assistance is irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable, as this is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the non-clinical tests, the ground truth is based on the specified acceptance criteria for each test (e.g., ISO standards, FDA guidance documents).
- For the clinical studies, the document vaguely states they evaluated "safety, efficacy, clinical performance, degradation profile, and technical success," implying outcomes data would be the primary ground truth. However, no specifics are provided.
8. The sample size for the training set
- Not applicable. This is a physical medical device, not a machine learning model that requires a training set. If the question implicitly refers to pre-clinical testing or animal studies that might inform design, no specific "training set" size is provided in the document.
9. How the ground truth for the training set was established
- Not applicable, as there is no "training set" in the context of this device.
FDA 510(k) Clearance Letter - ARCHIMEDES Biodegradable Pancreatic Stent
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.00
July 16, 2025
Q3 Medical USA, LLC (c/o Q3 Medical Devices Ltd.)
℅ John J. Smith
Partner
Hogan Lovells US LLP
Columbia Square
555 Thirteenth Street, NW
Washington, D.C., District of Columbia 20004
Re: K243412
Trade/Device Name: ARCHIMEDES Biodegradable Pancreatic Stent
Regulation Number: 21 CFR 876.5010
Regulation Name: Biliary catheter and accessories
Regulatory Class: Class II
Product Code: FGE
Dated: November 1, 2024
Received: June 27, 2025
Dear John J. Smith:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
Page 2
K243412 - John J. Smith Page 2
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Page 3
K243412 - John J. Smith Page 3
Sincerely,
STEPHANIE COLE -S
for Anthony C. Lee, Ph.D., M.B.A
Acting Assistant Director
DHT3A: Division of Renal, Gastrointestinal,
Obesity, and Transplant Devices
OHT3: Office of Gastrorenal, ObGyn,
General Hospital, and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Indications for Use
Submission Number (if known)
K243412
Device Name
ARCHIMEDES Biodegradable Pancreatic Stent
Indications for Use (Describe)
The ARCHIMEDES biodegradable pancreatic stent is intended to drain pancreatic ducts in patients indicated for pancreatic duct stenting.
The ARCHIMEDES Biodegradable Pancreatic Stent is intended to be delivered through the working channel of a therapeutic endoscope using a guidewire with a maximum outer diameter of 0.035 inches and a pushing catheter of between 5 to 10 French.
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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
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:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Page 5
510(k) Summary
1. Submitter
Company Name: Q3 Medical USA, LLC
Company Address: 1800 Camden Rd., Suite 107
Charlotte, NC 28203
Contact: Eric K. Mangiardi, MSc.
President and CEO
(704) 712-1331
emangiardi@q3medical.com
Date Prepared: July 15, 2025
2. Device
Trade Name: ARCHIMEDES™ Biodegradable Pancreatic Stent
Common Name: Pancreatic Stent
Product Code: FGE
Device Class: Class II
Device Panel: Gastroenterology / Urology
Classification Regulation: 21 CRF 876.5010, Biliary catheter and accessories
3. Predicate Device
Trade Name: Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers
Clearance number: K133700
Common Name: Stents, Drains, and Dilators for the Biliary Ducts
Product Code: FGE
Device Class: Class II
Device Panel: Gastroenterology / Urology
Classification Regulation: 21 CRF 876.5010, Biliary catheter and accessories
K243412 - Page 1/9
Page 6
4. Reference Device
Trade Name: Microvasive Temporary Ureteral Drainage Stent
Clearance number: K013784
Common Name: Ureteral Stent, Indwelling Ureteral Catheter
Product Code: FAD
Device Class: Class II
Device Panel: Gastroenterology / Urology
Classification Regulation: 21 CFR 876.4620 – Stent, Ureteral
K243412 - Page 2/9
Page 7
5. Device Description and Technological Characteristics
The ARCHIMEDES™ Biodegradable Pancreatic Stent is a single use, sterile, biodegradable stent implant intended for use in the pancreatic duct. The device is intended to be delivered endoscopically through the working channel of a duodenoscope.
The ARCHIMEDES™ has a fluted cross-sectional profile and provides three drainage channels, two of which spiral in a double helical pattern down the length of the stent and one of which is the hollow inner lumen of the device tube. This unique design permits fluids to flow both around and through the stent. It has a curved form design to fit the natural curvature of the pancreatic duct, and contains flap and split-end features to minimize spontaneous migration of the stent while in situ. The tips of the stent are tapered to facilitate atraumatic insertion through the papilla. The stent is visible under fluoroscopy. The 8F and 10F stent design contains flaps on each end. The 6F stent design has a flap on one end and a split-end feature on the other end.
The stent is offered in outer diameters of 2.0mm (6F), 2.6mm (8F), or 3.4mm (10F), and in various lengths to accommodate variations in pancreatic anatomy across individuals (40, 60, 80, 100, 125, 150, 175, 200, and 225 mm). The ARCHIMEDES™ is designed to be an alternative to plastic stents that maintains the same clinical purpose. In particular, it is used in a manner similar to current FDA-cleared plastic pancreatic stents. The primary difference is that the ARCHIMEDES™ biodegrades in-situ rather than requiring an additional procedure for removal needed of plastic stents.
The Minimal Strength Retention (MSR) time for the material - i.e., the minimum amount of time for which the device retains at least 10% of an initial strength parameter and remains intact with no breaks is 12 days. Full-degradation or no stent presence is reached within <95 days.
6. Indications for Use
The ARCHIMEDES™ biodegradable pancreatic stent is intended to drain pancreatic ducts in patients indicated for pancreatic duct stenting.
The ARCHIMEDES™ Biodegradable Pancreatic Stent is intended to be delivered through the working channel of a therapeutic endoscope using a guidewire with a maximum outer diameter of 0.035 inches and a pushing catheter of between 5 to 10 French.
K243412 - Page 3/9
Page 8
7. Comparison to the Predicate Device
Primary Predicate Device
The ARCHIMEDES™ Biodegradable pancreatic stent is substantially equivalent to the currently marketed Advanix™ Pancreatic Stent and NaviFlex™ RX Pancreatic Delivery System and NaviFlex Pushers (K133700) as follows: same intended use and principles of operations, same packaging and sterilization methods; and similar technological characteristics.
Reference Device
The Microvasive Temporary Ureteral Drainage Stent (K013784) is an appropriate reference device, as it has the same general principles of operation in facilitating short-term drainage of fluid and it is a biodegradable stent that was cleared on the basis of demonstrating substantial equivalence to a nonabsorbable stent predicate device.
The ARCHIMEDES fast-degrading pancreatic stent shares key technological characteristics with the proposed predicate device in that they are both implantable stents intended to drain pancreatic ducts. The stents are offered in various lengths to accommodate different patients' anatomies.
The main technological difference between the ARCHIMEDES and the proposed predicate device is the stent material. The ARCHIMEDES stent is made of a bioresorbable polymer that degrades in the patient's body over time, and thus does not require removal. The Advanix stent is also made of a polymer, but it is not biodegradable, and therefore must be removed. However, this difference does not raise new questions of safety or effectiveness. The ARCHIMEDES stent operates in the same manner as existing non-biodegradable pancreatic stents for which the risks are well-understood and adequately mitigated through general and special controls.
| Device Properties | ARCHIMEDES Biodegradable Pancreatic Stent (Subject Device) | AdvaniX™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers (Primary Predicate) K133700 | Microvasive Temporary Ureteral Drainage Stent (Reference Device) K013784 |
|---|---|---|---|
| Intended Use/Indications for Use | The ARCHIMEDES biodegradable pancreatic stent is intended to drain pancreatic ducts in patients | The Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) | The device is intended to facilitate the passage of |
K243412 - Page 4/9
Page 9
| Device Properties | ARCHIMEDES Biodegradable Pancreatic Stent (Subject Device) | AdvaniX™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers (Primary Predicate) K133700 | Microvasive Temporary Ureteral Drainage Stent (Reference Device) K013784 |
|---|---|---|---|
| indicated for pancreatic duct stenting. The ARCHIMEDES Biodegradable Pancreatic Stent is intended to be delivered through the working channel of a therapeutic endoscope using a guidewire with a maximum outer diameter of 0.035 inches and a pushing catheter of between 5 to 10 French. | Pancreatic Delivery System and Pushers is intended for delivery of the stent to the pancreatic duct (PD): Used to drain pancreatic ducts | urine from the kidney to the bladder. | |
| Classification/Regulation | Class II 21 CFR 876.5010 | Class II 21 CFR 876.5010 | Class II 21 CFR 876.4620 |
| Product Code | FGE | FGE | FAD |
| Device Description Summary | The "ARCHIMEDES Fast Biodegradable Pancreatic Stent" device is a single use, synthetic, biodegradable, polymeric implant, composed of polymers used extensively in implantable and absorbable medical devices. | The Advanix™ Pancreatic Stents are provided in straight or single pigtail shape. The straight shape stents have trailing barbs and/or leading barbs depending on application, a rounded or tapered leading end tip to facilitate access through the papilla, and a rounded trailing end to abut the push catheter portion of the delivery system or stent pusher. The single pigtail stent may or may not have leading end barbs depending on | The Microvasive Temporary Ureteral Drainage Stent is 6 Fr x 26.5 cm, with an open-ended coil at each end. The stent is an extruded polymeric tube made of a reversible cross-linked alginate polymer with an incorporated radiopacifier. The device is placed, using standard ureteral stent placement techniques that can be placed transurethrally, percutaneously or via open surgery using |
K243412 - Page 5/9
Page 10
| Device Properties | ARCHIMEDES Biodegradable Pancreatic Stent (Subject Device) | AdvaniX™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers (Primary Predicate) K133700 | Microvasive Temporary Ureteral Drainage Stent (Reference Device) K013784 |
|---|---|---|---|
| indicated for pancreatic duct stenting. The ARCHIMEDES Biodegradable Pancreatic Stent is intended to be delivered through the working channel of a therapeutic endoscope using a guidewire with a maximum outer diameter of 0.035 inches and a pushing catheter of between 5 to 10 French. | Pancreatic Delivery System and Pushers is intended for delivery of the stent to the pancreatic duct (PD): Used to drain pancreatic ducts | urine from the kidney to the bladder. | |
| Classification/Regulation | Class II 21 CFR 876.5010 | Class II 21 CFR 876.5010 | Class II 21 CFR 876.4620 |
| Product Code | FGE | FGE | FAD |
| Device Description Summary | The "ARCHIMEDES Fast Biodegradable Pancreatic Stent" device is a single use, synthetic, biodegradable, polymeric implant, composed of polymers used extensively in implantable and absorbable medical devices. | The Advanix™ Pancreatic Stents are provided in straight or single pigtail shape. The straight shape stents have trailing barbs and/or leading barbs depending on application, a rounded or tapered leading end tip to facilitate access through the papilla, and a rounded trailing end to abut the push catheter portion of the delivery system or stent pusher. The single pigtail stent may or may not have leading end barbs depending on application, a rounded or tapered leading end tip to facilitate access through the papilla, and a rounded trailing end to abut the push catheter portion of the delivery system or stent pusher. The single pigtail stent may or may not have leading end barbs depending on | The Microvasive Temporary Ureteral Drainage Stent is 6 Fr x 26.5 cm, with an open-ended coil at each end. The stent is an extruded polymeric tube made of a reversible cross-linked alginate polymer with an incorporated radiopacifier. The device is placed, using standard ureteral stent placement techniques that can be placed transurethrally, percutaneously or via open surgery using endoscopic and/or radiographic techniques. |
K243412 - Page 5/9
Page 11
| Device Properties | ARCHIMEDES Biodegradable Pancreatic Stent (Subject Device) | AdvaniX™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers (Primary Predicate) K133700 | Microvasive Temporary Ureteral Drainage Stent (Reference Device) K013784 |
|---|---|---|---|
| application. Some stents have lateral drainage holes in the pigtails. a tapered or rounded leading end tip. and a rounded trailing end. All stents have either an endoscopic marker, fluoroscopic marker, or both on the trailing or leading end of the stent to assist with depth of placement in the pancreatic duct. The location and presence of an endoscopic or fluoroscopic marker is dependent on the length and diameter size of the stent. Some codes have side port holes in the body of the stent. | |||
| Accessories | The following accessories are required for use of the ARCHIMEDES stent. Of the accessories listed below, only the introducer sleeve is supplied with the ARCHIMEDES stent. • Introducer sleeve (supplied with ARCHIMEDES) • Therapeutic duodenoscope with a 4.2mm working channel | Stent is used with appropriate delivery system or stent pushers. |
K243412 - Page 6/9
Page 12
| Device Properties | ARCHIMEDES Biodegradable Pancreatic Stent (Subject Device) | AdvaniX™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers (Primary Predicate) K133700 | Microvasive Temporary Ureteral Drainage Stent (Reference Device) K013784 |
|---|---|---|---|
| • Guidewire: up to 0.035" • Pushing catheter: size dependent on physician's preference | |||
| Dimensions | The stent is offered in outer diameters of 2.0mm, 2.6mm, or 3.4 mm, and in various lengths to accommodate variations in pancreatic anatomy across individuals (40, 60, 80, 100, 125, 150, 175, 200, and 225 mm). | 3F, 4F, 5F, 7F, 10F | 6 Fr x 26.5 cm |
| Biocompatibility | Stent is contact with tissue/bone for a permanent duration (>30 days). Accordingly, the device has been tested per GLP for biocompatibility endpoints in accordance with ISO 10993-1: 2009. | The proposed Boston Scientific Advanix Pancreatic Stent and NaviFlex Rapid Exchange (RX) Pancreatic Delivery System and Pushers were evaluated in accordance with EN ISO 10993-1:2009- Evaluation and Testing within a risk management system. The following tests were performed on the stent: Cytotoxicity, Irritation, Sensitization, Acute Systemic Toxicity, Subchronic Toxicity, Genotoxicity, Implant, USP Physicochemical, and Latex. | The device meets the biocompatibility requirements of ISO 10993 for its intended use. |
| Sterilization | Sterile, EtOH | Not Specified | Not Specified |
| Single Use/Reuse | Single use only | Single use only | Single use only |
K243412 - Page 7/9
Page 13
8. Performance Data
Non-clinical performance
The proposed device meets the requirements of ISO 10993 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a risk management process", ISO 11135-1 "Sterilization of Health Care products - Ethylene Oxide - Part 1: Requirements for Development, Validation, and Routine Control of Sterilization processes for Medical Devices", and ISO 10993-7 "Biological evaluation of medical devices - Part 7: ethylene oxide sterilization residuals".
The following Biocompatibility tests were performed on the ARCHIMEDES™ Biodegradable Pancreatic Stent: MEM Elution Cytotoxicity; Implantation; Guinea Pig Maximization Sensitization; 28 Day Dual Route IV/IP Systemic Toxicity; Acute Systemic Injection; Intracutaneous Reactivity; and Material Mediated Pyrogen. In addition, the results of chemical extractable studies and Toxicological Risk Assessment are provided which meet FDA's Guidance document, entitled, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process."
The proposed device bench testing is in alignment with FDA guidance document, "Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions". The following bench tests were performed on the ARCHIMEDES™ Biodegradable Pancreatic Stent: Visual Inspection; Outer diameter, Length; Stent Swelling Characterization; Flow Rate; Inherent Viscosity; Guidewire Compatibility; Endoscope Compatibility; Introducer Sleeve Compatibility; Simulated Use; Trackability; Pushability; Flexibility/Kink Resistance; Retraction Force; Tensile Strength; Fluoroscopic Visibility; and Degradation.
All tests met required acceptance criteria, therefore supporting the finding of substantial equivalence.
Clinical studies
The safety and efficacy of ARCHIMEDES™ Biodegradable Pancreatic Stent is also supported by eight clinical studies. The studies were conducted in various settings, including single-center and multicenter, prospective and retrospective, randomized and non-randomized designs. They included a diverse range of patients with different indications for stent placement and a variety of pancreatic conditions. The studies collectively evaluated various aspects of the ARCHIMEDES Fast stent, including its safety, efficacy, clinical performance, degradation profile, and technical success.
9. Conclusion
Q3 Medical LLC has demonstrated through its bench and clinical studies that the proposed ARCHIMEDES™ Biodegradable Pancreatic Stent is substantially equivalent to the legally marketed predicate device Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers (K133700).
K243412 - Page 9/9
§ 876.5010 Biliary catheter and accessories.
(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.