(46 days)
Not Found
No
The summary describes a standard ureteroscope with mechanical and optical functions, and there is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is described as capable of performing therapeutic procedures such as "extract[ing] or fragment[ing] stones" using various accessories.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is designed for "endoscopic observation and diagnosis within both the urinary tract... and biliary tract".
No
The device description clearly describes a physical ureteroscope, an instrument used for examining the inside of the urinary and biliary tracts, and mentions physical components like a distal tip and channels for accessories. The performance studies also focus on physical characteristics and standards related to optical instruments and biocompatibility, not software validation.
Based on the provided information, the EndoCure Model EUR078A is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for endoscopic observation and diagnosis within the urinary and biliary tracts, and for therapeutic endoscopic procedures within these organs. This involves directly visualizing and interacting with internal body structures.
- Device Description: The device is described as a ureteroscope, an instrument used to examine the inside of the urinary tract. It facilitates direct visualization and allows for the insertion of tools for therapeutic procedures.
- Nature of IVD Devices: IVD devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. They do not involve direct interaction with internal body structures in the way an endoscope does.
The EndoCure Model EUR078A is a medical device used for in vivo (within the living body) procedures, not in vitro (in glass/outside the body) diagnostics.
N/A
Intended Use / Indications for Use
The EndoCure Model EUR078A has been designed for endoscopic observation and diagnosis within both the urinary tract (ureter, renal pelvis, and renal calyx) and biliary tract (common bile duct and hepatic duct). Therapeutic endoscopic procedures using various kinds of accessories are also possible, and include the ability to extract or fragment stones within these organs.
Product codes (comma separated list FDA assigned to the subject device)
FBN
Device Description
EndoCure Model EUR078A is used during the examination / procedure as an ureteroscope. The ureteroscope is an instrument for examining the inside of the urinary tract. The ureteroscope is used to see beyond the bladder into the ureters, the tubes that carry urine from the kidneys to the bladder. Through the ureteroscope, the doctor can see a stone in the ureter and then remove it with a small basket at the end of a wire inserted through an extra channel in the ureteroscope. Another way to treat a stone through an ureteroscope is to extend a flexible fiber through the scope up to the stone and then, with a laser beam projected through the fiber, break the stone into smaller pieces that can then pass out of the body in the urine. The EndoCure Model EUR078A ureteroscope is not designed for or intended to be used with electro-surgical (cautery) devices due to the metal distal tip.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urinary tract (ureter, renal pelvis, and renal calyx) and biliary tract (common bile duct and hepatic duct)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical Testing:
Safety Testing:
- ISO 10993-5 Biological Evaluation of Medical Devices Part 5: Tests for In Vitro . Cytotoxicity (ISO MEM Elution Assay with L-929 Mouse Fibroblast Cells)
- ISO 10993-10 Biological Evaluation of Medical Devices Part 10: Tests for . Irritation and Skin Sensitization (Intracutaneous Reactivity Test) (ISO Guinea Pig Maximization Sensitization Test)
- ISO 10993-10 Biological Evaluation of Medical Devices Part 10: Tests for . Irritation and Skin Sensitization (Acute Systemic Injection Test)
- . ISO 10993-11: Biological Evaluation of Medical devices – Part 11: Test for Systemic Toxicity
- IEC 60601-1:2005 + CORR. 1 (2006) + CORR. 2 (2007) + AM1 (2012) 0r IEC 60601-. 1: 2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
- . IEC 60601-1-2:2007 Third Edition, Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility – Requirements and tests
- IEC 60601-2-18 Medical electrical equipment Part 2: Particular requirements for the basic safety and essential performance of endoscopic equipment
Performance testing:
- . FTIR and SEM Analysis
- . Angulation Flex Bench test
- . ISO 8600-3 Optics and Optical Instruments – Medical endoscopes and endoscopic accessories – Part 3: Determination of field of view and direction of view of endoscopes with optics.
- ISO 8600-4 Optics and Optical Instruments Medical endoscopes and . endoscopic accessories – Part 4: Determination of maximum width of insertion portion.
Key Results: "The EndoCure Model EUR078A is substantially equivalent to the predicate device in intended use, materials and design. Safety and performance testing to ISO 8600-3 and ISO 8600-4 and biocompatibility testing to ISO 10993 Standards concluded that the device does not introduce significant questions of safety and efficacy and is substantially equivalent to the predicate."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 7, 2016
EndoCure Technologies, Inc. % E.J. Smith Consultant Smith Associates 1468 Harwell Avenue Crofton, MD 21114
Re: K161147
Trade/Device Name: EndoCure Model EUR078A Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FBN Dated: April 20, 2016 Received: April 22, 2016
Dear E.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 (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 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
1
Page 2 - E.J. Smith
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 Industry and Consumer Education 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" (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 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 Industry and Consumer Education 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,
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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
Indications for Use
510(k) Number (if known) K161147
Device Name EndoCure Model EUR078A
Indications for Use (Describe)
The EndoCure Model EUR078A has been designed for endoscopic observation and diagnosis within both the urinary tract (ureter, renal pelvis, and renal calyx) and biliary tract (common bile duct and hepatic duct). Therapeutic endoscopic procedures using various kinds of accessories are also possible, and include the ability to extract or fragment stones within these organs.
| 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) |
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31
510(k) Summary 807.92C
SPONSOR
807.92(a)(1)
| Company name: | EndoCure Technologies, Inc. |
|---|---|
| Company Address: | 5801 Ammendale Road, Suite |
| Beltsville, MD 20705 | |
| Telephone Number: | 301-937-8848 |
| Contact Person: | Charles J. Neff (Vice President |
| Summary Preparation Date: | Operations) April 19, 2016 |
DEVICE NAME
807.92(A)(2)
| Trade Name: | EndoCure Model EUR078A |
|---|---|
| Common/Usual Name: | Flexible Endoscope |
| Classification Name: | Endoscopes and Accessories |
| Regulation Number: | 21 CFR 876.1500 |
| Product Code: | FBN |
| Device Class: | Class II |
PREDICATE DEVICE
807.92(a)(3)
| Company | Product | 510(k) Number |
|---|---|---|
| Olympus, Inc. | Ureterorenofiberscope/Choledochofiberscope | K912120 |
DEVICE DESCRIPTION
807.92(a)(4)
EndoCure Model EUR078A is used during the examination / procedure as an ureteroscope. The ureteroscope is an instrument for examining the inside of the urinary tract. The ureteroscope is used to see beyond the bladder into the ureters, the tubes that carry urine from the kidneys to the bladder. Through the ureteroscope, the doctor can see a stone in the ureter and then remove it with a small basket at the end of a wire inserted through an extra channel in the
4
ureteroscope. Another way to treat a stone through an ureteroscope is to extend a flexible fiber through the scope up to the stone and then, with a laser beam projected through the fiber, break the stone into smaller pieces that can then pass out of the body in the urine. The EndoCure Model EUR078A ureteroscope is not designed for or intended to be used with electro-surgical (cautery) devices due to the metal distal tip.
DEVICE INDICATIONS FOR USE
The EndoCure Model EUR078A has been designed for endoscopic observation and diagnosis within both the urinary tract (ureter, renal pelvis, and renal calyx) and biliary tract (common bile duct and hepatic duct). Therapeutic endoscopic procedures using various kinds of accessories are also possible, and include the ability to extract or fragment stones within these organs.
COMPARISON OF TECHNICAL CHARACTERISTICS
807.92(A)(6)
807.92(A)(5)
| Parameters | EndoCure Model
EUR078A | Olympus Corporation
URF-P2
Ureterorenofiberscope/
Choledochofiberscope | Similarities and
Differences |
|------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|
| 510(k) Number | K141866 | K912120 | N/A |
| Intended Use | The EndoCure Model
EUR078A has been
designed for
endoscopic observation
and diagnosis within
both the urinary tract
(ureter, renal pelvis,
and renal calyx) and
biliary tract (common
bile duct and hepatic
duct). Therapeutic
endoscopic procedures
using various kinds of
accessories are also
possible, and include
the ability to extract or
fragment stones within
these organs. | The Olympus URF Type
P2 has been designed
for endoscopic
observation and
diagnosis within both
the urinary tract (ureter,
renal pelvis, and renal
calyx) and biliary tract
(common bile duct and
hepatic duct).
Therapeutic endoscopic
procedures using
various kinds of
accessories are also
possible, and include
the ability to extract or
fragment stones within
these organs. | Substantially
equivalent
indications for use |
| Field of View | 90 degree | 90 degree | Identical |
| Depth of View | 1-50mm | 1-50mm | Identical |
| Optical System | Fiberoptic Bundle | Fiberoptic Bundle | Identical |
| Distal End Outer | 7.3 French (2.43mm) | 9.3 French (3.1mm) | Difference in distal |
5
| Diameter | end outer diameter | ||
|---|---|---|---|
| Insertion Tube O.D. | 8.4 French (2.8mm) | 9.9 French (3.3mm) | Difference in insertion tube O.D. |
| Bending Angulation | Up:270/Down:270 | Up:180/Down:180 | Difference in bending angulation |
| Channel Inner Diameter | 1.2mm | 1.2mm | Identical |
| Working Length | 700mm | 700mm | Identical |
Nonclinical Testing
Safety Testing
- ISO 10993-5 Biological Evaluation of Medical Devices Part 5: Tests for In Vitro . Cytotoxicity (ISO MEM Elution Assay with L-929 Mouse Fibroblast Cells)
- ISO 10993-10 Biological Evaluation of Medical Devices Part 10: Tests for . Irritation and Skin Sensitization (Intracutaneous Reactivity Test) (ISO Guinea Pig Maximization Sensitization Test)
- ISO 10993-10 Biological Evaluation of Medical Devices Part 10: Tests for . Irritation and Skin Sensitization (Acute Systemic Injection Test)
- . ISO 10993-11: Biological Evaluation of Medical devices – Part 11: Test for Systemic Toxicity
- IEC 60601-1:2005 + CORR. 1 (2006) + CORR. 2 (2007) + AM1 (2012) 0r IEC 60601-. 1: 2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
- . IEC 60601-1-2:2007 Third Edition, Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility – Requirements and tests
- IEC 60601-2-18 Medical electrical equipment Part 2: Particular requirements for the basic safety and essential performance of endoscopic equipment
Performance testing
- . FTIR and SEM Analysis
- . Angulation Flex Bench test
- . ISO 8600-3 Optics and Optical Instruments – Medical endoscopes and endoscopic accessories – Part 3: Determination of field of view and direction of view of endoscopes with optics.
6
- ISO 8600-4 Optics and Optical Instruments Medical endoscopes and . endoscopic accessories – Part 4: Determination of maximum width of insertion portion.
CONCLUSION
807.92(B)(3)
The EndoCure Model EUR078A is substantially equivalent to the predicate device in intended use, materials and design. Safety and performance testing to ISO 8600-3 and ISO 8600-4 and biocompatibility testing to ISO 10993 Standards concluded that the device does not introduce significant questions of safety and efficacy and is substantially equivalent to the predicate.