ARCHIMEDES Biodegradable Pancreatic Stent

K243412 · Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) · FGE · Jul 16, 2025 · Gastroenterology, Urology

Device Facts

• Record ID: K243412
• Device Name: ARCHIMEDES Biodegradable Pancreatic Stent
• Applicant: Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.)
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: Jul 16, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Single-use, sterile, biodegradable pancreatic stent; delivered endoscopically via duodenoscope working channel using guidewire and pushing catheter. Fluted cross-sectional profile with three drainage channels (two spiral, one hollow lumen) to facilitate fluid flow around and through device. Curved design fits pancreatic duct anatomy; includes flaps and split-ends to minimize migration. Tapered tips facilitate atraumatic insertion. Visible under fluoroscopy. Biodegrades in-situ, eliminating need for secondary removal procedure. Minimal strength retention (MSR) time is 12 days; full degradation occurs within <95 days. Used by physicians in clinical settings to manage pancreatic duct drainage, providing an alternative to non-absorbable plastic stents.

Clinical Evidence

Supported by eight clinical studies (single/multicenter, prospective/retrospective, randomized/non-randomized). Studies evaluated safety, efficacy, clinical performance, degradation profile, and technical success across diverse patient populations with various pancreatic conditions.

Technological Characteristics

Synthetic, biodegradable polymeric implant. Fluted profile; 2.0mm (6F), 2.6mm (8F), 3.4mm (10F) diameters; lengths 40-225mm. Sterilized via Ethylene Oxide (EtOH). Biocompatibility per ISO 10993-1. Mechanical features: flaps/split-ends for migration resistance, tapered tips, fluoroscopic visibility.

Indications for Use

Indicated for patients requiring pancreatic duct stenting for drainage of pancreatic ducts.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Advanix TM Pancreatic Stent and NaviFlex TM Rapid Exchange (RX) Pancreatic Delivery System and Pushers (K133700)

Reference Devices

• Microvasive Temporary Ureteral Drainage Stent (K013784)

Submission Summary (Full Text)

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FDA U.S. FOOD &amp; DRUG ADMINISTRATION

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"

U.S. Food &amp; Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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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 ([e-mail]) or phone [phone] or 301-796-7100).

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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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

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.

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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

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K243412 - Page 1/9

# 510(k) Summary
K243412

## 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
[phone]
[e-mail]

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 TM Pancreatic Stent and NaviFlex TM 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

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## 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

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# 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 &lt;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.

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## 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 NaviFlexQm 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 |

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| Device Properties | ARCHIMEDES
Biodegradable Pancreatic
Stent
(Subject Device) | AdvaniX™ Pancreatic
Stent and NaviFlexQm
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 |

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| Device Properties | ARCHIMEDES
Biodegradable Pancreatic
Stent
(Subject Device) | AdvaniX™ Pancreatic
Stent and NaviFlexQm
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. | endoscopic and/or
radiographic techniques. |
| 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. | |

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| Device Properties | ARCHIMEDES
Biodegradable Pancreatic
Stent
(Subject Device) | AdvaniX™ Pancreatic
Stent and NaviFlexQm
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 |

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| Device Properties | ARCHIMEDES Biodegradable Pancreatic Stent (Subject Device) | AdvaniXTM Pancreatic Stent and NaviFlexQm Rapid Exchange (RX) Pancreatic Delivery System and Pushers (Primary Predicate) K133700 | Microvasive Temporary Ureteral Drainage Stent (Reference Device) K013784 |
| --- | --- | --- | --- |
| Single Use/Reuse | Single use only | Single use only | Single use only |

# 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.

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## 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).