(50 days)
Not Found
No
The device description and intended use clearly describe a manually operated mechanical device for tissue morcellation and grasping. There is no mention of any computational or algorithmic components, let alone AI or ML.
No
The device is used to shred and remove large pieces of tissue, which is a surgical tool function, not for treating a disease or condition itself.
No
The device is a surgical tool used to shred and remove tissue; it does not diagnose conditions.
No
The device description clearly details physical components like a rotary knife, protective sleeve, grasping forceps, and trocar sleeve, indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The RIWO CUT-Morcellator is a surgical instrument used to physically cut and remove tissue during a surgical procedure. It is not used to analyze samples outside the body.
- Intended Use: The intended use clearly states it's for "gynecologic and surgical laparoscopic procedures to shred large pieces of tissue and to remove myomata or other tissue." This describes a surgical intervention, not a diagnostic test.
- Device Description: The description details the mechanical components and how they are used to cut and grasp tissue within the body. There is no mention of analyzing biological samples.
Therefore, the RIWO CUT-Morcellator is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
RIWO CUT-Morcellator 8386.205:
The RIWO CUT-Morcellator is used in gynecologic and surgical laparoscopic procedures to shred large pieces of tissue and to remove myomata or other tissue by means of a manually operated tubular knife.
Severed tissue like myoma, uterus or cysts can be grasped by a forceps, morcella extracted.
Claw Grasping Forceps 8385.181:
- · The claw grasping forceps is used to grasp and hold organs and tissue (e.g. myomas) under laparoscopic view.
- · The forceps can be inserted into the abdomen via a 10 mm trocar sleeve.
- · The forceps can also be introduced via a 15/10 or 20/10 reducing sleeve with the corresponding trocar sleeves.
- · The forceps can be used in connection with the RIWO CUT-Morcellator 8386.205.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The RIWO CUT-Morcellator 8386.205 is a manually operated rotary knife with a sealed protective sleeve. Via the protective sleeve, a grasping forceps 8385.181 for grasping the tissue to be morcellated is introduced also under gas-tight conditions. In the case of proper use (operating instructions), the replaceable cutting knife can not be damaged. The preassembled unit (consisting of Cutting Sleeve, protection sleeve and grasping forceps) is inserted into the trocar sleeve 8943.011, which was previously inserted into the abdominal with the help of the dilator and guide sleeve 8943.911.
The Trocar Sleeve, 8943.011 (internal diameter of 15mm) may be used for insertion of morcellator.
The Claw Grasping Forceps, 8385.181 can be used for grasping the tissue.
RIWO CUT-Morcellator. A harded knife with corrugated edge is screwed on the outer sleeve with 15 mm diameter. Via a handle provided with recessed grips, the cutting sleeve is made rotate by hand. The handle is fitted with a replaceable sealing system. The protective sleeve also provided with a sealing cap is introduced via the cutting sleeve. A claw grasping forceps (opening with both jaws) can be brought to the operation field via the protective sleeve. If the tissue to be morcellated is grasped with the grasping forceps, the forceps must be withdrawn into the protective sleeve until the marking is visible. This will ensure that the sharp cutting edges of the knife are not damaged by the forceps branches.
The claw grasping forceps is a tube shaft instrument with axial handle and spring-mechanism. The jaws have sharp hooks which enter into the tissue.
The trocar sleeve is a tube with a trumpet valve which can be opened, when the morcellator is inserted. The dilation and guide sleeve is a tube with a screw-in tip.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
- · A 100% outgoing test ensures, that there is no permanently deformation of the forceps if normally used.
- · The steam stenlization tests performed by Richard Wolf shows, that the steam sterilization has no influence to the functional performance of the RIWO CUT-Morcellator or of the claw grasping forceps, 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., K942201
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
§ 884.1720 Gynecologic laparoscope and accessories.
(a)
Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. 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 § 884.9.
0
Richard Wolf Medical Instruments Corporation
MAR - 4 1997 K970105 fig 3
353 Corporate Woods Parkway Vernon Hills, Illinois 60061 Telephone: 847.913.1113 Fax: 847.913.1488
510(k) Summary of Safety and Effectiveness
| Submitter: | Date of Preparation: |
|---|---|
| Company / Institution name: | January 10, 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 | ZIP / Postal Code: |
| State/Province: | 60061 |
| Illinois | Country: |
| Contact name: | USA |
| Mr. Robert L. Casarsa | |
| Contact title: | |
| Quality Assurance Manager |
| Product Information: | |
|---|---|
| Trade name: | Model number: |
| RIWO CUT-Morcellator | 8386.205, 8385.181 |
| Common name: | Classification name: |
| Tissue Morcellator | Gynecologic laparoscope and accessories |
| Information on devices to which substantial equivalence is claimed: |
|---|
| --------------------------------------------------------------------- |
| 510(k) Number | Trade or proprietary or model name | Manufacturer |
|---|---|---|
| 1 pre-enact. | 1 Palmer grasping and biopsy forceps 8383.16 | 1 Richard Wolf |
| 2 | 2 Serrated Edged Macro-Morcellator-Set 15/5, type-no. 7674-1 | 2 Wisap |
| 3 | 3 STEINER Electromechanic Morcellator, type-no. 26712811 | 3 Karl Storz |
| 4 K942201 | 4 Trocar Sleeve System | 4 Richard Wolf |
1.0 Description
The RIWO CUT-Morcellator 8386.205 is a manually operated rotary knife with a sealed protective sleeve. Via the protective sleeve, a grasping forceps 8385.181 for grasping the tissue to be morcellated is introduced also under gas-tight conditions. In the case of proper use (operating instructions), the replaceable cutting knife can not be damaged. The preassembled unit (consisting of Cutting Sleeve, protection sleeve and grasping forceps) is inserted into the trocar sleeve 8943.011, which was previously inserted into the abdominal with the help of the dilator and guide sleeve 8943.911.
2.0 Intended Use
RIWO CUT-Morcellator 8386.205:
The RIWO CUT-Morcellator is used in gynecologic and surgical laparoscopic procedures to shred large pieces of tissue and to remove myomata or other tissue by means of a manually operated tubular knife.
Severed tissue like myoma, uterus or cysts can be grasped by a forceps, morcella extracted.
1
Richard Wolf Medical Instruments Corporation
1 970105 1207 7 353 Corporate Woods Parkway Vernon Hills, Illinois 60061 Telephone: 847.913.1113 Fax: 847.913.1488
The Trocar Sleeve, 8943.011 (internal diameter of 15mm) may be used for insertion of morcellator.
The Claw Grasping Forceps, 8385.181 can be used for grasping the tissue.
Claw Grasping Forceps 8385.181:
- · The claw grasping forceps is used to grasp and hold organs and tissue (e.g. myomas) under laparoscopic view.
- · The forceps can be inserted into the abdomen via a 10 mm trocar sleeve.
- · The forceps can also be introduced via a 15/10 or 20/10 reducing sleeve with the corresponding trocar sleeves.
- · The forceps can be used in connection with the RIWO CUT-Morcellator 8386.205.
Contraindications:
Observe contradindications for the patient which result findings and are described in the relevant literature, for example:
- · Use of a tissue bag for malignant or suspected malignant tissue.
- · Do not use in vascularized tissue, devascularize first.
- · Not for use as a dissecting tool.
- · Potential damage to healthy tissue with inappropriate contact.
- · User of instruments does not have appropriate training.
3.0 Technological Characteristics
RIWO CUT-Morcellator. A harded knife with corrugated edge is screwed on the outer sleeve with 15 mm diameter. Via a handle provided with recessed grips, the cutting sleeve is made rotate by hand. The handle is fitted with a replaceable sealing system. The protective sleeve also provided with a sealing cap is introduced via the cutting sleeve. A claw grasping forceps (opening with both jaws) can be brought to the operation field via the protective sleeve. If the tissue to be morcellated is grasped with the grasping forceps, the forceps must be withdrawn into the protective sleeve until the marking is visible. This will ensure that the sharp cutting edges of the knife are not damaged by the forceps branches.
The claw grasping forceps is a tube shaft instrument with axial handle and spring-mechanism. The jaws have sharp hooks which enter into the tissue.
The trocar sleeve is a tube with a trumpet valve which can be opened, when the morcellator is inserted. The dilation and guide sleeve is a tube with a screw-in tip.
4.0 Substantial Equivalence
These devices are substantially equivalent to existing pre-enactment devices and 510(k) devices sold by Richard Wolf and 510(k) devices sold by Karl Storz and Wisap.
-5.0 Performance Data
- · A 100% outgoing test ensures, that there is no permanently deformation of the forceps if normally used.
- · The steam stenlization tests performed by Richard Wolf shows, that the steam sterilization has no influence to the functional performance of the RIWO CUT-Morcellator or of the claw grasping forceps, when using the fractional method.
Image /page/1/Picture/29 description: The image shows the words "RICHARD WOLF" in a bold, sans-serif font. The words are stacked on top of each other, with "RICHARD" on top and "WOLF" on the bottom. To the right of the words is a logo that appears to be a stylized letter "A" inside of a rounded square. The logo is also in black and white.
2
.
Richard Wolf Medical Instruments Corporation
11970105 pany 353 Corporate Woods Parkway Vernon Hills, Illinois 60061 Telephone: 847.913.1113 Fax: 847.913.1488
6,0 Clinical Tests
No clinical tests performed.
7.0 Conclusions Drawn
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:
Image /page/2/Picture/13 description: The image shows the words "RICHARD WOLF" in a bold, sans-serif font. The word "RICHARD" is stacked on top of the word "WOLF". To the right of the words is a square box with a stylized letter "A" inside. The letter "A" is made up of thick lines and has a small circle in the lower right corner.