(103 days)
Not Found
No
The device description and performance studies focus on the physical properties and clinical efficacy of a polymeric plug, with no mention of AI or ML technologies.
Yes
The device aids in a medical procedure to improve its effectiveness by preventing stone migration, which directly contributes to the treatment of renal calculi.
No
Explanation: The device is intended to prevent migration of renal calculi during intracorporeal lithotripsy procedures, which is a therapeutic function, not a diagnostic one. It does not identify a disease, condition, or health status.
No
The device description clearly states it is a "self-forming polymeric plug" with physical properties that change with temperature, indicating it is a physical medical device, not 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 "prevent migration of renal calculi during intracorporeal lithotripsy procedures." This is a therapeutic and procedural use, not a diagnostic one.
- Device Description: The device is a physical plug with specific material properties designed to block the ureter. It does not involve testing samples from the human body to provide diagnostic information.
- Lack of Diagnostic Activity: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status or disease.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
BackStop is intended for use in the ureter to prevent migration of renal calculi during intracorporeal lithotripsy procedures.
Product codes
FFL, ONJ
Device Description
BackStop™ is a self-forming polymeric plug with reverse thermosensitive properties. At room temperature it is viscous but injectable. When the temperature of the plug increases , its viscosity increases and it forms a plug that is intended for use in the ureter to prevent migration of renal calculi during intracorporeal lithotripsy procedures. The material is water soluble and is removed by irrigating the plug with saline.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ureter
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
BackStop™ was evaluated in a prospective, randomized, single-blind, controlled multi-site clinical study. A total of sixty-eight (68) subjects with a single stone in the proximal ureter and an indication for ureteroscopic lithotripsy were enrolled and each subject was randomly assigned to either the experimental group (BackStop™, n=34) or the control group (standard of care, no anti-retropulsion device, n=34). Measured endpoints included the presence of retropulsion, the need for subsequent procedures, stone-free rate at follow-up, the occurrence of adverse events and the ability to dissolve BackStop™ and reverse the ureteral plug at the completion of lithotripsy. Results: There were no adverse events, nor any incidents of an occluded ureter postlithotripsy in the BackStop™ group. The test of the primary study hypothesis revealed a statistically significant lower rate of retropulsion {p=0.0002} in the BackStop™ group {8.8%, n = 3) compared to the control group (52.9%, n = 18). There were no significant differences between the two groups with respect to the secondary efficacy endpoints of stone-free rate at follow-up or need for additional procedures. The investigators concluded that BackStop™ is a novel and easy to use method of preventing stone fragment retropulsion during lithotripsy for the management of ureteral stones. Pluromed feels the study supports the conclusion that BackStop™ is a safe and effective method of preventing retropulsion during lithotripsy. BackStop™ prevents retropulsion of all size fragments and is easily removed after the procedure.
Key Metrics
p=0.0002 (comparing retropulsion rates between groups)
Predicate Device(s)
K863081, K970121, K013784, K924608
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.4680 Ureteral stone dislodger.
(a)
Identification. A ureteral stone dislodger is a device that consists of a bougie or a catheter with an expandable wire basket near the tip, a special flexible tip, or other special construction. It is inserted through a cystoscope and used to entrap and remove stones from the ureter. This generic type of device includes the metal basket and the flexible ureteral stone dislodger.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.
0
510(k) Summary
JUN - 2 2009
Safety and Effectiveness Data Summary
Prepared By:
Telephone Number: Fax Number:
Contact Person:
Proprietary Name:
Classification Name: Common Name:
Classification: Regulation Number: Product Code:
Performance Standards:
Predicates:
Description of Device:
Pluromed, Inc. 25-H Olympia Avenue Woburn; MA 01801 781.932.0574 419.828.6350
James Wilkie
BackStop™ and BackStop™ Injector (accessory to BackStop) Ureteral Stone Dislodger Urological stone entrapment device
Class II 21 CFR 876.4680 FFL
No Performance Standards have been established for the device described in this Premarket Notification under section 514 of the FD&C Act.
-
- Cook Urological N-Trap™ (K863081)
-
- Boston Scientific Stone Cone™ (K970121)
-
- Boston Scientific Temporary Indwelling Ureteral Catheter / Ureteral Stent (K013784)
-
- Boston Scientific Temp-Tip Drainage Catheter (K924608)
BackStop™ is a self-forming polymeric plug with reverse thermosensitive properties. At room temperature it is viscous but injectable. When the temperature of the plug increases , its viscosity increases and it forms a plug that is intended for use in the ureter to prevent migration of renal calculi during intracorporeal lithotripsy procedures. The material is water soluble and is removed by irrigating the plug with saline.
Substantial Equivalence:
Below is a comparison of predicate devices to BackStop™ .
1
| | Pluromed
BackStop
current 510k | Cook Urological
N-Trap
510(k)
K863081 | Boston Scientific
Stone Cone
510(k)
K970121 | Boston Scientific
Temporary Indwelling
Ureteral Stent
510(k) K013784 | Boston Scientific
Temp-Tip drainage
catheter
510(k) K924608 |
|----------------|-----------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|----------------------------------------------------------------------|
| Intended Use | BackStop is intended
for use in the ureter to
prevent migration of
renal calculi during
intracorporeal
lithotripsy procedures. | To prevent retrograde
migration of stone
fragments during
lithotripsy | To entrap stone
fragments during
lithotripsy | To facilitate the
passage of urine from
the kidney to the
bladder. | To facilitate drainage from
the kidney to the bladder. |
| Mode of Action | Mechanically occludes
the ureter. Stones or
fragments are trapped
by the plug. | Mechanically occludes
the ureter. Stones or
fragments are trapped
in basket. | Mechanically occludes
the ureter. Stones or
fragments are trapped
in cone. | Facilitates ureteral
drainage | Facilitates ureteral
drainage |
| Removal | Dissolved with saline,
excreted | Manually removed | Manually removed | Dissolution and
excretion in urine | Dissolution of PVA distal
tip and excretion in urine |
| Application | Manual insertion into
the ureter | Manual insertion into
ureter | Manual insertion into
ureter | Manual insertion into
the ureter | Manual insertion into the
ureter |
| Materials | Rapid Transition
Polymer, saline | Nitinol | Nitinol | Reversible cross linked
alginate polymer with
incorporated
radiopacifier | PVA distal tip |
| Shape | Gel plug takes the
shape of the ureter | Round mesh basket
with tether for removal
from ureter | Conical tipped basket
with tether for removal
from ureter | Extended polymeric
tube with open ended
coil at each end | Pigtail shape |
| Stone Removal | Conventional stone
removal | Physically captured in
mesh basket and
manually withdrawn | Physically captured in
conical basket and
manually withdrawn | N/A | N/A |
| How Supplied | Sterile package | Sterile package | Sterile package | Sterile package | Sterile package |
| Use | Single Use | Single Use | Single Use | Single Use | Single Use |
| Sterility | Sterile | Sterile | Sterile | Sterile | Sterile |
·
. :
:
: 上一篇:
.
: 上一篇:
:
1
K096430 Page 2/3
1
.
. .
:
·
100 - 100 -
. .
: 上一篇:
. :
2
Clinical Summary:
BackStop™ was evaluated in a prospective, randomized, single-blind, controlled multi-site clinical study. A total of sixty-eight (68) subjects with a single stone in the proximal ureter and an indication for ureteroscopic lithotripsy were enrolled and each subject was randomly assigned to either the experimental group (BackStop™, n=34) or the control group (standard of care, no anti-retropulsion device, n=34). Measured endpoints included the presence of retropulsion, the need for subsequent procedures, stone-free rate at follow-up, the occurrence of adverse events and the ability to dissolve BackStop™ and reverse the ureteral plug at the completion of lithotripsy. Results: There were no adverse events, nor any incidents of an occluded ureter postlithotripsy in the BackStop™ group. The test of the primary study hypothesis revealed a statistically significant lower rate of retropulsion {p=0.0002} in the BackStop™ group {8.8%, n = 3) compared to the control group (52.9%, n = 18). There were no significant differences between the two groups with respect to the secondary efficacy endpoints of stone-free rate at follow-up or need for additional procedures. The investigators concluded that BackStop™ is a novel and easy to use method of preventing stone fragment retropulsion during lithotripsy for the management of ureteral stones. Pluromed feels the study supports the conclusion that BackStop™ is a safe and effective method of preventing retropulsion during lithotripsy. BackStop™ prevents retropulsion of all size fragments and is easily removed after the procedure.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The eagle is positioned to the right of a circular emblem that contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the circumference of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 2 2009
Mr. James Wilkie Vice President, Operations Pluromed. Inc. · 25-H Olympia Avenue WOBURN MA 01801
Re: K090430
Trade/Device Name: BackStop™M Regulation Number: 21 CFR 876.4680 Regulation Name: Ureteral stone dislodger Regulatory Class: II Product Code: ONJ Dated: May 7, 2009 Received: May 11, 2009
Dear Mr. Wilkie:
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 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 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.
4
Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
21 CFR 876.xxx (Gastroenterology/Renal/Urology) (240) 276-0115 21 CFR 884.xxx (Obstetrics/Gynecology) (240) 276-0115 21 CFR 892.xxx (Radiology) (240) 276-0120 Other (240) 276-0100
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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Irine M. Morris
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K090430
Device Name:
BackStop
Indications For Use:
BackStop is intended for use in the ureter to prevent migration of renal calculi during intracorporeal lithotripsy procedures.
Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hogu M. Whang
(Division Sigh-Off)
Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number
Page 1 of