(64 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a balloon catheter, with no mention of AI or ML.
Yes
Explanation: The device is used for the endoscopic removal of stones in the biliary system. This is a therapeutic intervention designed to treat a medical condition.
No
Explanation: The device is described as a "Biliary Stone Removal Device" used for "endoscopic removal of stones." This indicates a therapeutic, interventional function rather than a diagnostic one. While it can be used for "contrast injection while occluding the duct," this is a supporting function for the primary therapeutic purpose, not a standalone diagnostic capability.
No
The device description clearly outlines a physical catheter system with a balloon, lumens, and a syringe for inflation. The performance studies focus on the physical properties and functionality of this hardware. There is no mention of software components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "endoscopic removal of stones in the biliary system or for contrast injection while occluding the duct." This is a therapeutic or interventional procedure performed directly on the patient's body.
- Device Description: The device is a physical catheter system with a balloon and lumens for inflation and injection. It is used to physically interact with and manipulate structures within the biliary system.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform any analysis of specimens in vitro (outside the body).
The RSH Biliary Stone Removal Device is a medical device used for a therapeutic procedure, not an IVD.
N/A
Intended Use / Indications for Use
The RSH Biliary Stone Removal Device is used for endoscopic removal of stones in the biliary system or for contrast injection while occluding the duct.
Product codes (comma separated list FDA assigned to the subject device)
LQR, FGE
Device Description
The RSH Biliary Stone Removal Device is a single-use quad lumen polyurethane balloon catheter system which can be placed with or without the need of a guide-wire. The balloon is inflated using saline with the supplied 10ml syringe. The device is equipped with two flush ports, proximal and distal to the balloon, for contrast injection. The device is provided sterile.
The device is similar to the predicate device, except the balloon is polyurethane rather than latex, the fill is saline rather than air, and 4 lumens are used rather than
§ 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.
0
RSH LLC
5121 Feagan St
Houston, TX 77007
Phone: (713) 679-8657
| 510(k) Number | |
|---|---|
| Contact Person: | Amy Springs |
| Manager of RSH LLC | |
| 5121 Feagan St | |
| Houston, TX 77007 | |
| Phone: (713) 679-8657 |
AUG 07 2013
| Summary Date: | June 3, 2013 |
|---|---|
| Product Trade Name: | RSH Biliary Stone Removal Device |
| Common Name: | Dislodger, stone, biliary (LQR) |
| Catheter, biliary, diagnostic (FGE) | |
| Classification Name: | Biliary catheter and accessories (21 CFR 876.5010, Class 2) |
| Predicate(s): | K102082/K041606 Extractor™ Retrieval Balloon catheters |
| Intended Use: | The RSH Biliary Stone Removal Device is used for endoscopic |
| removal of stones in the biliary system or for contrast injection | |
| while occluding the duct. | |
| Device Description: | The RSH Biliary Stone Removal Device is a single-use quad |
| lumen polyurethane balloon catheter system which can be placed | |
| with or without the need of a guide-wire. The balloon is inflated | |
| using saline with the supplied 10ml syringe. The device is | |
| equipped with two flush ports, proximal and distal to the balloon, | |
| for contrast injection. The device is provided sterile. | |
| The device is similar to the predicate device, except the balloon is | |
| polyurethane rather than latex, the fill is saline rather than air, and | |
| 4 lumens are used rather than ≤ 3 lumens. With more lumens, a | |
| somewhat larger balloon diameter range, 9 -25 mm, is achieved in | |
| one size rather than three sizes. |
Safety & Performance:
| | Equivalency was demonstrated through comparison to the
predicate device, biocompatibility, and bench testing. |
|------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Biocompatibility testing consisted of cytotoxicity, sensitization
and irritation, all of which yielded passing results. |
| | Bench testing conducted is listed below along with conclusions: |
| Balloon - Sizing/
Compliance. Multiple
Inflation. Burst and Leak | All catheters performed through a range of 9mm - 25
mm without failure, leak, or rupture; inflated multiple
times without failure, and inflated to 25mm without
leakage. The working range was demonstrated. |
| Flush Volume | All catheters flushed lumens at or above the specified
minimum flow rate demonstrating acceptable flushing
capability. |
1
RSH LLC
5121 Feagan St Houston, TX 77007 Phone: (713) 679-8657
K131642 pg 2 of 2
| Manifold – Leak | All catheters held the minimum pressure at all three
ports demonstrating acceptable leak resistance. |
|---------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Balloon – Inflation/
Deflation | All catheters inflated and deflated as required
demonstrating acceptable balloon performance.. |
| Manifold – Tensile
Strength | All catheters met the minimum bond strength with
95% Confidence/ 95% Reliability demonstrating
acceptable break resistance. |
| Model / Wire Loading.
Endoscope Compatibility,
Kink Resistance
(flexibility) | All catheters loaded and advanced over a .035" guide
wire, were delivered through the endoscope channel.
endured a 90° deflection without kinking or breaking.
and endured minimum tensile load without bursting
when pulled back against endoscope. Acceptable
handling characteristics were demonstrated.
All catheters and the predicated devices tested
dislodged the stone without balloon rupture. The
catheter demonstrated comparable effectiveness to the
predicate device. |
Based on the results of comparison, biocompatibility testing and bench testing summarized above, the RSH Biliary Stone Removal Device has been demonstrated to be acceptable for the intended use and substantially equivalent to the predicate device in safety, effectiveness and performance.
Conclusion:
1 This document uses the term "substantial equivalent" as intended in 21 CFR 807.87 and not as defined in Title 36 of the U.S. Code.
2
Image /page/2/Picture/0 description: The image shows the seal for the Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 7, 2013
RSH LLC % Amy Springs Manager 5121 Feagan Street HOUSTON TX 77007
Re: K131642
Trade/Device Name: RSH Biliary Stone Removal Device Regulation Number: 21 CFR 876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: Class II Product Code: LQR, FGE Dated: June 3, 2013 Received: June 4, 2013
Dear Amy Springs,
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. You must
3
Page 2 - Amy Springs
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 Small Manufacturers, International and Consumer Assistance 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" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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 yours,
Herbert P. Lerner -S
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
4
Indications for Use
510(k) Number (if known): K131642
Device Name: RSH Biliary Stone Removal Device
Indications for Use:
The RSH Biliary Stone Removal Device is used for endoscopic removal of stones in the biliary system or for contrast injection while occluding the duct.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Herbert P. Lerner -S
(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K131642 510(k) Number _
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