(159 days)
pre-enact.
Not Found
No
The device description and intended use focus on mechanical instruments for endoscopic procedures, with no mention of AI or ML capabilities.
Yes.
The device description and intended use explicitly state that various therapeutic procedures can be performed, and components like stone extractors, electrodes, and bougies are used for therapeutic interventions.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states "Various diagnostic and therapeutic procedures can be performed" and lists "biopsy for tumor diagnostics" and "The forceps are used for endoscopically controlled grasping and obtaining tissue specimens for diagnosis." It also mentions "The stone extractors are intended for minimally invasive, diagnostic and therapeutic interventions" and "The bougies are intended for minimally invasive, diagnostic and therapeutic interventions."
No
The device description explicitly lists physical instruments like forceps, stone extractors, electrodes, and bougies, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This testing is performed outside the body (in vitro).
- Device Function: The described auxiliary instruments are used directly within the patient's body during endoscopic procedures. They are used for tasks like grasping tissue for biopsy, extracting stones, controlling bleeding, and dilating organs.
- Intended Use: The intended use clearly describes procedures performed in vivo (within the living body) under endoscopic view. While some procedures involve obtaining tissue for subsequent diagnosis (which would be performed by an IVD device), the instruments themselves are not performing the in vitro diagnostic test.
Therefore, these instruments are considered surgical or endoscopic accessories used for diagnostic and therapeutic interventions within the body, not for in vitro diagnostic testing of specimens.
N/A
Intended Use / Indications for Use
The auxiliary instruments for ureteroscopes and uretero-renoscopes are used for preliminary procedures in the ureter and kidney, as well as for procedures in the urethra and bladder.
Flexible and rigid auxiliary instruments can be used in connection with single or double instrument ports.
Various diagnostic and therapeutic procedures can be performed, for example:
- transurethral extraction of uretero calculi
- biopsy for tumor diagnostics
- removal of foreign bodies, e.g. ureteral stents
The interventions are carried out by trained and experienced surgeons who consider the general condition and the anatomic specialties of the patient in their diagnosis.
Forceps: The forceps are used for endoscopically controlled grasping and obtaining tissue specimens for diagnosis. Both flexible and rigid forceps are available.
Stone Extractors: The stone extractors (graspers) are used to grasp stones or stone calculi and extract them out of urological tract. The stone extractor is also used to immobilize the calculus while disintegrating the stone.
The stone extractors are intended for minimally invasive, diagnostic and therapeutic interventions. They are used e.g. in conjunction with ureteroscopes and uretero-renoscopes.
Electrodes: Various electrodes are used for controlling bleeding and for removing or destruction of tissue by use of unipolar high-frequency current under endoscopic view.
Bougies (Dilators): The bougies are used for the atraumatic distention of tubular organs. The flexible hollow dilators can be inserted over a guide wire, for example into the renal pelvis.
The bougies are intended for minimally invasive, diagnostic and therapeutic interventions.
Product codes (comma separated list FDA assigned to the subject device)
78 FAS, FCL, KOG, FAX, and FFL
Device Description
The submitted auxiliary instruments for URS are accessories for the ureterrenoscopy. These are rigid or flexible biopsy, grasping, and foreign body forceps, stone extractors, unipolar electrodes for high frequency applications, and bougies.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ureter and kidney, as well as for procedures in the urethra and bladder.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained and experienced surgeons
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)
- Mechanical load test of the forceps and stone graspers show that there is no breakage of the jaw or other parts of the instrument if used normally.
- The steam sterilization in clinical use and tests performed by Richard Wolf show that the steam sterilization has no influence on the functional performance of the submitted instruments when using the fractional method.
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-enact.
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
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments 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 (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
K 971315 pg 1982
1
353 Corporate Woods Parkway Vernon I lills, Illinois 60061 Phone: 847.943.4443 Fax: $47,913,1488
SEP 1 5 1007
RICHARD WOL
MEDICAL INSTRUMENTS CORPORATION
| Submitter: | Date of Preparation: | |
|---|---|---|
| Company / Institution name: | March 14, 1997 | |
| RICHARD WOLF MEDICAL INSTRUMENTS CORP. | FDA establishment registration number: | |
| Division name (if applicable): | 14 184 79 | |
| N.A. | Phone number (include area code): | |
| Street address: | (847) 913-1113 | |
| 353 Corporate Woods Parkway | FAX number (include area code): | |
| City: | (847) 913-0924 | |
| Vernon Hills | State/Province: | |
| Contact name: | Illinois | |
| Mr. Robert L. Casarsa | Country: | |
| Contact title: | USA | |
| Quality Assurance Manager | ZIP / Postal Code: | |
| Product Information: | ||
| Trade name: | Model numbers: See section 1: 'Submitted Devices: Auxiliary Instruments for URS' | |
| Auxiliary Instruments for URS | Classification name: | |
| Common name: | Endoscope and accessories | |
| Rigid and flexible forceps, stone extractors, electrodes, bougies | ||
| Information on devices to which substantial equivalence is claimed: | ||
| 510(k) Number | Trade or proprietary or model name | Manufacturer |
| 1 pre-enact. | 1 various instruments for urological endoscopes, see equivalent devices | 1 Richard Wolf M.I.C. |
| 2 | 2 various instruments for urological endoscopes, see equivalent devices | 2 Circon |
| 3 | 3 various instruments for urological endoscopes, see equivalent devices | 3 Karl Storz |
| 4 | 4 | 4 |
1.0 Description
The submitted auxiliary instruments for URS are accessories for the ureterrenoscopy. These are rigid or flexible biopsy, grasping, and foreign body forceps, stone extractors, unipolar electrodes for high frequency applications, and bougies.
1
K 9-7, 3,15 Pg 2 of 2
SEP 1 5 1997
2.0 Intended Use
The auxillary instruments for ureteroscopes and uretero-renoscopes are used for preliminary procedures in the ureter and kidney, as well as for procedures in the urethra and bladder.
Flexible and rigid auxiliary instruments can be used in connection with single or double instrument ports.
Various diagnostic and therapeutic procedures can be performed, for example:
- transurethral extraction of uretero calculi .
- biopsy for tumor diagnostics .
- removal of foreign bodies, e.g. ureteral stents .
The interventions are carried out by trained and experienced surgeons who consider the general condition and the anatomic specialties of the patient in their diagnosis.
- · The forceps are used for endoscopically controlled grasping, and obtaining tissue specimens for diagnosis. Both flexible and rigid forceps are available.
- · The stone extractors (graspers) are used to grasp stone calculi and extract them out of urological tract. The stone extractor is also used to immobilize the calculus while disintegrating the stone.
- · Various electrodes are used for controlling bleedings and for removing or destruction of tissue by use of unipolar high-frequency current under endoscopic view.
- · The bougies (dilators) are used for the atraumatic distention of tubular organs. The flexible hollow dilators can be inserted over a guide wire, for example into the renal pelvis.
3.0 Technological Characteristics
The basic design of the submitted instruments is similar to the devices sold prior to 1976 and to competitor's products. The diameter of the submitted forceps is smaller, the mouth of the jaws is designed shorter to ensure the same stability.
The submitted forceps, stone extractors, and HF electrodes are adapted to the anatomy in ureterorenoscopy, the working length becomes smaller and longer.
Substantial Equivalence 4.0
These devices are substantially equivalent to existing pre-enactment devices sold by Richard Wolf and 510(k) devices sold by Storz and Circon.
5.0 Performance Data
- · Mechanical load test of the forceps and stone graspers show that there is no breakage of the jaw or other parts of the instrument if used normally.
- · The steam sterilization in clinical use and tests performed by Richard Wolf show that the steam sterilization has no influence on the functional performance of the submitted instruments when using the fractional method.
2
Image /page/2/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Robert L. Casarsa Richard Wolf Medical Instruments Corporation 353 Corporate Woods Parkway Vernon Hills, Illinois 60061
SFP 1 5 1997
Re: K971315
Auxiliary Instruments for Ureteroscopes and Uretero-Renoscope (URS) Dated: July 1, 1997 Received: July 2, 1997 Regulatory Class: II 21 CFR 8876.4300, 876.1075, 876.1500, 876.5520, and 876.4680 Product Code: 78 FAS, FCL, KOG, FAX, and FFL
Dear Mr. Casarsa:
We have reviewed vour Section 5100k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in interstated in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Ouality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours.
W. Lillian Yin, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATIONS FOR USE
510(k) Number (if known):
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications for Use:
- The auxiliary instruments for ureteroscopes and uretero-renoscopes are used for General: preliminary procedures in the ureter and kidney, as well as for procedures in the urethra and bladder.
Flexible and rigid auxiliary instruments can be used in connection with single or double instrument ports.
Various diagnostic and therapeutic procedures can be performed, for example:
- · transurethral extraction of uretero calculi
- · biopsy for tumor diagnostics
- · removal of foreign bodies, e.g. ureteral stents
The interventions are carried out by trained and experienced surgeons who consider the general condition and the anatomic specialties of the patient in their diagnosis.
The forceps are used for endoscopically controlled grasping and obtaining tissue specimens Forceps: for diagnosis. Both flexible and rigid forceps are available.
Stone Extractors: The stone extractors (graspers) are used to grasp stones or stone calculi and extract them out of urological tract. The stone extractor is also used to immobilize the calculus while disintegrating the stone.
The stone extractors are intended for minimally invasive, diagnostic and therapeutic interventions. Thev are used e.g. in conjunction with ureteroscopes and uretero-renoscopes.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Roler R. Sattling/
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K971315
Prescription Use
Per 21 CFR 801.109
OR
Over-The Counter
4
K 97/315 Pg 242
Various electrodes are used for controlling bleeding and for removing or Electrodes: destruction of tissue by use of unipolar high-frequency current under endoscopic view.
The bougies are used for the atraumatic distention of tubular organs. The Bougies (Dilators): flexible hollow dilators can be inserted over a guide wire, for example into the renal pelvis.
The bougies are intended for minimally invasive, diagnostic and therapeutic interventions.
Contraindications resulting from the general findings or described in the Contraindications: relevant literature must be observed.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE)
Ruler R. Rathling /
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K971315
Prescription Use Per 21 CFR 801.109
OR
Over-The Counter