(393 days)
Not Found
Not Found
No
The description focuses on mechanical instruments for surgical manipulation and visualization, with no mention of computational analysis, algorithms, or learning processes.
No
The device is described as an instrument set used to support a surgical procedure (laparoscopically assisted vaginal hysterectomy), fix the uterus, and change or manipulate its position. It does not directly treat or diagnose a disease.
No
Explanation: The provided text describes surgical instruments used for hysterectomies (e.g., vaginal tube, mandrin, instrumentation insert, uterus manipulator). These devices are designed to support and facilitate the physical removal of the uterus, not to diagnose medical conditions or analyze patient health data.
No
The device description clearly outlines physical instruments (vaginal tube, mandrin, instrumentation insert, uterus manipulator, uterus probe) used in a surgical procedure. There is no mention of software as the primary or sole component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for supporting a surgical procedure (laparoscopically assisted vaginal hysterectomy) by providing visualization, guidance, support, and manipulation of the uterus and vaginal vault. This is a surgical instrument, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details mechanical instruments designed for surgical manipulation and access. There is no mention of reagents, calibrators, controls, or any components typically associated with in vitro diagnostic testing.
- Lack of IVD Characteristics: The text does not mention any analysis of biological samples (blood, urine, tissue, etc.), diagnostic information, or any of the typical characteristics of an IVD.
Therefore, this device falls under the category of a surgical instrument rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For laparoscopic assisted vaginal hysterectomy
The Endoscopic Hysterectony instrument set consisting of vaginal tube, mandrin and instrumentation insert is used to support LAVH (laparoscopically assisted vaginal hysterectomy).
- The tube is used for visualization of the cervical portio. . The distal section of the vaginal tube can be seen during laparoscopically assisted vaginal hysterectorny, and thus serves the surgeon as a guide and support during cutting. The tube allows pneumoperitoneum to be maintained during cutting and opening of the posterior vaginal vault.
- The mandrin supports the introduction of the vagina. Prior to introduction it is inserted into . the vaginal tube and locked in place.
- The instrumentation insert has two openings instrument ports through which surgical instruments are t inserted into the vaginal tube without loss of gas.
For the use of the uterus manipulator in endoscopic hysterectomy: Indication:
- Uterus myomatosis
- Abnormal uterine bleeding
The Uterus Manipulator set, consisting of uterus manipulator and uterus probe is used to support LAVH.
The uters manipulator is an instrument with a distally inclinable probe section. The part of the instrument which is inserted in the uterus serves to fix the uterus and change or manipulate its position.
Product codes (comma separated list FDA assigned to the subject device)
85 HEW, 85 HDP
Device Description
The Endoscopic Hysterectory instruments and Uterus manipulator are designed to remove the The Endoscopic Hysterectority instruments and Ocerae manifactures of the tube.
uterus through the vagina. The obturator can be introduced into the vagina through the tube. The vaginal tube is gas tight.
The changeable distal tip of the uterus manipulator is deflectible so that the uterus can be The changeable distan lip of the uteras numbuitible the cervic part on the moved in optimal operation position. The Jose invith the locking device (17). When the turned
manipulator and can be lockly alia dia resea in the docking device (17). When th manipulator and can be locked and released win the deflected angle. When the luer sealing
handle is moved clockwise, the used and right a nandle is moved the instrument can be cleaned by rinsing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Uterus, Vagina, Pelvic
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)
Mechanical stress test of the vaginal tube shows, that the bayonet locking system is tight affer 100,000 cycles of opening and closing.
Mechanical test of the uterus manipulator shows that the mechanical resistance of the hinch is strong enough for the manipulating of the uterus.
The steam sterilization in the clinical use and the tests performed by Richard Wolf shows, that the steam sterilization has no influence to the quality of the endoscopic hysterectomy instruments and uterus manipulator, when using the fractional method.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Not Found
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
§ 884.1640 Culdoscope and accessories.
(a)
Identification. A culdoscope is a device designed to permit direct viewing of the organs within the peritoneum by a telescopic system introduced into the pelvic cavity through the posterior vaginal fornix. 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 preheaters, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for culdoscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such culdoscope accessory instruments include: 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
K6126 1/5
| Richard Wolf Medical Instruments Corporation | |
|---|---|
| ---------------------------------------------- | -- |
NOV 2 5 1997
353 Corporate Woods Parkway Vernon Hills, Illinois 60061 Telephone: 847.913.1113
| 510(k) Summary of Safety and Effectiveness | |
|---|---|
| -------------------------------------------- | -- |
| Submitter: | |
|---|---|
| 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 |
| Contact name: | Mr. Robert L. Casarsa |
| Contact title: | Quality Assurance Manager |
| Date of Preparation: | October 25, 1996 |
|---|---|
| FDA establishment registration number: | 14 184 79 |
| Phone number (include area code): | (847) 913-1113 |
| FAX number (include area code): | (847) 913-0924 |
| ZIP / Postal Code: | 60061 |
| Trade name: | Endoscopic Hysterectomy and Uterus manipulator |
|---|---|
| Model number: | 8370.501/.511/.512 /.513, 8983.011 /.111 /.201 |
| Common name: | |
| Classification name: | Endoscope and accessories |
Information on devices to which substantial equivalence is claimed:
| 510(k) Number | Trade or proprietary or model name | Manufacturer |
|---|---|---|
| 1 | 1 valtchev manipulator | 1 European Patent Applicant 94103496.9 |
| 2 | 2 RUMI | 2 Cooper Surgical |
| 3 pre-enactment | 3 8370.00 | 3 Richard Wolf Medical Instruments |
| 4 | 4 26201A | 4 Storz |
| 5 | 5 24945A | 5 Storz |
| 6 pre-enactment | 6 8991.02 | 6 Richard Wolf Medical Instruments |
| 7 pre-enactment | 7 4837 C | 7 Richard Wolf Medical Instruments |
| 8 | 8 24945AO | 8 Storz |
| 9 | 9 24945E | 9 Storz |
1.0 Description
Description
The Endoscopic Hysterectory instruments and Uterus manipulator are designed to remove the The Endoscopic Hysterectority instruments and Ocerae manifactures of the tube.
uterus through the vagina. The obturator can be introduced into the vagina through the tube. The vaginal tube is gas tight.
The changeable distal tip of the uterus manipulator is deflectible so that the uterus can be The changeable distan lip of the uteras numbuitible the cervic part on the moved in optimal operation position. The Jose invith the locking device (17). When the turned
manipulator and can be lockly alia dia resea in the docking device (17). When th manipulator and can be locked and released win the deflected angle. When the luer sealing
handle is moved clockwise, the used and right a nandle is moved the instrument can be cleaned by rinsing.
Image /page/0/Picture/11 description: The image shows the words "RICHARD WOLF" in a stylized font. The word "RICHARD" is above the word "WOLF", and the letters in "WOLF" are larger and bolder. To the right of the words is a logo that appears to be a stylized letter "A" inside of a rounded square.
1
K9164276 2/3
353 Corporate Woods Parkway Vernon Hills. Illinois 60061 Telephone: 847.913.1113 Fax : 847.913.1488
2.0 Intended Use
The instrument set consisting of vaginal tube, obturator (mandrin) and instrumentation inserts in combination with the uterus manipulator and uterus probe is used to support LAVH (laparoscopically assisted vaginal hysterectomy).
2.1 Contraindication
Contraindications described in the relevant literature must be observed.
Diagnosis and treatment of a pelvic mass that is too large to fit intact into an impermeable sack (