(87 days)
1 pre-amend., K980302
Not Found
No
The document describes a set of mechanical and optical instruments for visualization and manipulation, with no mention of software, image processing, or AI/ML terms.
No.
The device is used for visualization, manipulation, grasping, cutting, dissecting, and removal of tissue and foreign bodies, and for coagulation of minor hemorrhages, which are all diagnostic or surgical interventions, not therapeutic treatments.
No
The device is primarily used for visualization, manipulation, and treatment (grasping, cutting, coagulation) within the bladder, urethra, and ureter. While visualization is a component of diagnosis, the listed "Intended Use / Indications for Use" does not explicitly state that the device is used for diagnosing a condition or disease, but rather for performing procedures.
No
The device description explicitly lists physical components such as Sheaths, Obturators, Inserts, Adapters, and Optical Forceps, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used to visualize and manipulate anatomical structures (bladder, urethra, ureter) within the body via natural passages. It also describes the use of instruments for grasping, cutting, and coagulation within the body.
- Device Description: The device components listed (Sheaths, Obturators, Inserts, Adapters, Optical Forceps) are all instruments used for direct interaction with internal anatomy.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, urine, tissue samples, etc.) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are specifically designed to perform tests on samples taken from the human body. This device is designed for direct intervention and visualization within the body.
N/A
Intended Use / Indications for Use
The Cysto-Urethroscopes 'E-Line' and Accessories are used to visualize and manipulate the bladder, urethra and ureter via natural passages.
The sheath is used to house the endoscope, inserts, and attachments. The sheath provides irrigation, water supply and drainage.
The obturator/vlewing obturator serves to insert the sheaths atraumatically. If a viewing obturator is used, the insertion can be observed.
The inserts are used to guide and angle flexible auxiliary instruments.
The attachments (adapters) serve to connect endoscope and sheath.
The forceps/optical forceps and scissors are used for endoscopically controlled grasping, manipulating, cutting, dissecting and removal of tissue, bladder stones and foreign bodies via natural and surgically created passages.
Optical forceps with unipolar HF connections are used for coagulation by means of high frequency currents to treat minor hemorrhages.
Product codes (comma separated list FDA assigned to the subject device)
FBO
Device Description
The Cysto-Urethroscopes "E-Line" submission consists of Sheaths, Obturators, Inserts, Adapters and Optical Forceps.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bladder, urethra and 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The submitted devices are in conformance with the relevant provisions of the Medical Device Directive 93/42/EEC. This are pending approval by a conformity assessment procedure according to Annex II and VII.
No clinical tests performed.
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.
1 pre-amend., K980302
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.
0
JUL 2 7 2015
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Richard Wolf Medical Instruments Corp. Robert L. Casarsa Quality Assurance Manager 353 Corporate Woods Parkway Vernon Hills, IL 60061
Re: K011496 Trade/Device Name: Cysto-Urethroscope "E-Line" and Accessories Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FBO Dated (Date on orig SE ltr): May 14, 2001 Received (Date on orig SE Itr): May 15, 2001
Dear Mr. Casarsa,
This letter corrects our substantially equivalent letter of August 10, 2001.
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
1
Page 2 -
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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/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 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,
Benjamin R. Fisher -S
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
PROTESFICIES 587
510(k) Number (if known): KO11496
Device Name: Cysto-Urethroscope 'E-Line' and Acessories
Intended Use: The Cysto-Urethroscopes 'E-Line' and Accessories are used to visualize and manipulate the bladder, urethra and ureter via natural passages.
The sheath is used to house the endoscope, inserts, and attachments. The sheath provides irrigation, water supply and drainage.
The obturator/vlewing obturator serves to insert the sheaths atraumatically. If a viewing obturator is used, the insertion can be observed.
The inserts are used to guide and angle flexible auxiliary instruments.
The attachments (adapters) serve to connect endoscope and sheath.
The forceps/optical forceps and scissors are used for endoscopically controlled grasping, manipulating, cutting, dissecting and removal of tissue, bladder stones and foreign bodies via natural and surgically created passages.
Optical forceps with unipolar HF connections are used for coagulation by means of high frequency currents to treat minor hemorrhages.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE)
Nancy C Broglin
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K011496
Prescription Use
Per 21 CFR 801.109
OR
Over-The Counter
5-1 Revised 8/1/01
3
AUG 1 0 2001
Image /page/3/Picture/2 description: The image shows the logo for Richard Wolf Medical Instruments Corporation. The logo features the words "RICHARD WOLF" in a bold, sans-serif font, with the word "WOLF" being significantly larger than "RICHARD". To the right of the text is a square graphic containing a stylized image of a wolf. Below the text is the phrase "Medical Instruments Corporation" in a smaller font.
353 Corporate Woods Parkway Vernon Hills, IL 60061 Phone: 847-913-1113 Customer Service: 800-323-WOLF www.richard-wolf.com
510(k) Summary of Safety and Effectiveness
| Company / Institution name: | Richard Wolf Medical Instruments Corp. |
|---|---|
| Division name (if applicable): | N.A. |
| Street address: | 353 Corporate Woods Parkway |
| City: | Vernon Hills |
| State/Province: | Illinois |
| Country: | USA |
| ZIP/Postal Code: | 60061 |
| Contact name: | Mr. Robert L. Casarsa |
| Contact title: | Quality Assurance Manager |
| Date of Preparation: | May 14, 2001 |
| FDA establishment regulation number: | 14 184 79 |
| Phone number (include area code): | (847) 913-1113 |
| FAX number (include area code): | (847) 913-0924 |
Product Information:
| Trade name: | Cysto-Urethroscopes "E-Line", existing of: Sheaths, Obturators, Inserts, Attachments, and Forceps |
|---|---|
| Model number: | 8650.xxx,8652.xxx, 8660.xxx.....see section 4: 'submitted devices' |
| Common name: | Cysto-Urethroscopes and accessories |
| Classification Name: | Cysto-Urethroscopes and accessories |
Information on devices to which substantial equivalence is claimed:
| 510(k) Number | Trade or proprietary or model name | Manufacturer |
|---|---|---|
| 1 pre-amend. | 1 Cysto-Urethroscopes | 1 Richard Wolf |
| 2 K980302 | 2 Resectoscopes, Instruments and Accessories E-Line | 2 Richard Wolf |
4
ਜ਼ਿੰ
1.0 Description
The Cysto-Urethroscopes "E-Line" submission consists of Sheaths, Obturators, Inserts, Adapters and Optical Forceps.
2.0 Intended Use
The Cysto-Urethroscopes "E-Line" and Accessories are used to visualize and manipulate bladder, urethra and ureter via natural passages.
The sheath is used to house the endoscope, inserts, and attachments. The sheath provides irrigation, water supply and drainage.
The obturator/viewing obturator serves to insert the sheaths atraumatically. If a viewing obturator is used, the insertion can be observed.
The Inserts are used to guide and angle flexible auxiliary instruments.
The attachments (adapters) serve to connect endoscope and sheath.
The forceps/optical forceps and scissors are used for endoscopically controlled grasping, manipulating, cutting, dissecting and removal of tissue, bladder stones and foreign bodies via natural and surgically created passages.
Optical forceps with unipolar HF connections are used for coagulation by means of high frequency currents to treat minor hemorrhages.
3.0 Technological Characteristics
The submitted Cysro-Urethroscopes " E-Line" are equivalent in function and intended use/indication to pre-amendment devices. They are optimized and improved in dimensions and material due to technical progress. They have a modern ergonomic design "E-Line" same a Resectoscope "E-Line", cleared in pre-market notification K980302.
Substantial Equivalence 4.0
The submitted devices pose the same type of questions about safety or effectiveness as the compared devices. The new technological characteristics have not diminished safety or effectiveness. The submitted devices are substantially equivalent to pre-amendment devices and to existing devices ( K980302 ) sold by Richard Wolf.
5.0 Performance Data
The submitted devices are in conformance with the relevant provisions of the Medical Device Directive 93/42/EEC. This are pending approval by a conformity assessment procedure according to Annex II and VII.
- 6.0 Clinical Tests
No clinical tests performed.
Conclusions Drawn 7.0
These devices are designed and tested to guarantee the safety and effectiveness when used according to . the instructions manual.
By. Robert L. Casassa
Robert L. Casarsa Quality Assurance Manager
Date: Aug 1, 2001
12-2 Revised 8/1/01