(393 days)
For laparoscopic assisted vaginal hysterectomy
The Endoscopic Hysterectony instrument set consisting of vaginal tube, mandrin and instrumentation insert is used to support LAVH (lapa-roscopically 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 Endoscopic Hysterectory instruments and Uterus manipulator are designed to remove the 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 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.
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.
The provided text describes a 510(k) submission for an "Endoscopic Hysterectomy and Uterus Manipulator" and its acceptance criteria, along with the studies (or lack thereof) conducted to demonstrate its performance.
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Vaginal tube bayonet locking system tightness | Tested performance: "Mechanical stress test of the vaginal tube shows, that the bayonet locking system is tight after 100,000 cycles of opening and closing." |
| Uterus manipulator hinge mechanical resistance | Tested performance: "Mechanical test of the uterus manipulator shows that the mechanical resistance of the hinch is strong enough for the manipulating of the uterus." |
| Influence of steam sterilization on quality | Tested performance: "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." The implication is that the quality remains acceptable after sterilization. |
| Biocompatibility (Implicit for medical devices) | Not explicitly stated in the performance data, but implied by regulatory submission. The device is likely made of materials known to be biocompatible for its intended use. |
| Sterility (Implicit for surgical instruments) | Not explicitly stated as a test directly, but the steam sterilization method is mentioned. The implication is that the device can be effectively sterilized. |
| Gas Tightness (For specific components) | Mentioned as a "Technological Characteristic" ("gas tightness," "gas tight instrumental ports"). No specific performance data provided for demonstrating this, but assumed to be met. |
| Functionality for LAVH | Implicitly demonstrated through substantial equivalence to predicate devices and description of its intended use. No specific quantifiable functional performance metrics are provided. |
| Optimal operation position of uterus (deflectible) | Mentioned as a design feature ("changeable distal tip of the uterus manipulator is deflectible so that the uterus can be moved in optimal operation position"). No specific performance data provided for demonstrating this. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a "test set" in the context of clinical or diagnostic studies. The "sample sizes" for the mechanical stress tests are:
- Vaginal tube bayonet locking system: 1 device (tested for 100,000 cycles).
- Uterus manipulator hinge: 1 device (tested for its mechanical resistance).
- Sterilization: Not quantifiable as a "sample size" in this context, but implies multiple sterilization cycles were performed.
- Data Provenance: The mechanical and sterilization tests were performed by Richard Wolf Medical Instruments Corporation (the manufacturer). This is internal testing. The document refers to "clinical use" for steam sterilization but does not provide details of specific studies. This is retrospective/internal company data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not applicable. The tests performed were mechanical and sterilization tests, not diagnostic or clinical accuracy studies that require expert-established ground truth.
4. Adjudication Method for the Test Set
- Not applicable. No adjudication method was mentioned or required for the mechanical performance and sterilization tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. No MRMC comparative effectiveness study was mentioned. The device is a surgical instrument, not an AI or diagnostic tool where such studies would typically be performed to assess human reader improvement with AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
- No. This is not an AI or algorithmic device; it is a physical surgical instrument. Therefore, a standalone algorithm performance study is not applicable.
7. The Type of Ground Truth Used
- Engineering specifications and standards for mechanical integrity and sterilization efficacy. For the mechanical tests, the ground truth is the absence of failure (e.g., locking system remaining tight, hinge being strong enough). For sterilization, the ground truth is effective sterilization without adverse impact on the device.
8. The Sample Size for the Training Set
- Not applicable. This device is a surgical instrument and does not involve machine learning or AI, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set, this question is irrelevant.
Additional Notes from the Document:
- Clinical Tests: The document explicitly states: "No clinical tests performed." It references literature (Dr. Reich, "The Role of Laparoscopy in Hysterectomy," 1994) but this is for background or validation of the procedure (LAVH), not a clinical study on the safety and effectiveness of this specific device.
- Substantial Equivalence: The primary method for demonstrating safety and effectiveness is through substantial equivalence to legally marketed predicate devices. This means the new device is compared to existing devices concerning design, materials, intended use, and technological characteristics, arguing that it is as safe and effective as those already on the market.
- Device Type: This submission is for a traditional medical device (surgical instruments), not an advanced diagnostic or AI-driven system. The "acceptance criteria" discussed are primarily related to mechanical durability and material compatibility, typical for this class of device.
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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.
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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 (<8 x 5 in.).
Laparoscopic Hysterectomy is not indicated when vaginal hysterectomy is possible.
The medical status of the patient may prohibit surgery. Anemia, diabetes, lung disorders, cardiac disease, and bleeding diathesis must be evaluated before surgery. Age should rarely be a deterrent. Cesarean hysterectomy is an absolute contraindication. Placenta accreta, uterine atony, unspecified uterine bleeding, and uterine rupture are relative contraindications for peripartum hysterectorny at present. Another contraindication might be stage III ovarian cancer that requires a large abdominal incision.
Inexperience of the surgeon is a contraindication to the laparoscopic approach.
3.0 Technological Characteristics
- · autoclavable
- speziell shaped tubal tip .
- gas tightness .
- gas tight instrumental ports .
4.0 Substantial Equivalence
The basic design of the tube and obturator are equivalent to pre enactment devices from R. Wolf and equivalent to existing competitive devices. There are some modifications in dimension e.g. length, diameter; contour, function and working insert for its intended use in LAVH.
The manipulator is based on pre enactment devices from R.Wolf, but is changed in design and now used through the tube for its intended use in LAVH and is equivalent to competitive devices.
Image /page/1/Picture/19 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 rounded corners, inside of which is a stylized logo. The logo appears to be the letters "A" and "H" intertwined.
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K+L4276 3/3
Richard Wolf Medical Instruments Corporation
353 Corporate Woods Parkway Vernon Hills, Illinois 60061 Telephone: 847.913.1113 Fax: 847.913.1488
5.0 Performance Data
Merhanical 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.
6.0 Clinical Tests
No clinical tests performed.
(see literature Dr. Reich "The Role of Laparoscopy in Hysterectomy", Advances in Obstetrics and Gynecology, vol. 1 1994, Mosby-Year Book, Inc.).
7.0 Conclusions Drawn
These devices are designed and tested to guarantee the safety and effectiveness, when used according to the instruction manual.
By: Robert L. Casasa
Robert L. Casarsa Quality Assurance Manager
Date: Oct 22 96
Image /page/2/Picture/15 description: The image shows the logo for Richard Wolf. The words "RICHARD WOLF" are stacked on top of each other, with "RICHARD" on top and "WOLF" on the bottom. To the right of the words is a square with rounded corners, inside of which is a symbol that looks like a stylized letter "A" with some other shapes. The text and symbol are all in black and white.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged around the top half of the circle. Inside the circle is a stylized image of what appears to be a person embracing another person.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2 5 1997
Mr. Robert L. Casarsa Quality Assurance Manager Richard Wolf Medical Instruments Corporation 353 Corporate Woods Parkway Vernon Hills, Illinois 60061
Re: K964276
Endoscopic Hysterectomy and Uterus Manipulator (see attached list for model names and numbers) Dated: August 25, 1997 Received: August 29, 1997 Regulatory class: II 21 CFR §884.4160/Product code: 85 HEW 21 CFR §884.4530/Product code: 85 HDP
Dear Mr. Casarsa:
We have reviewed your Section 510(k) 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 the enclosure) to devices marketed 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, 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.
If your device is classified (see above) into either 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 Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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 affect any 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 question 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 vours.
William Yu
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
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510(k) Number (if known):
P192
Endoscopic Hysterectomy and Uterus Manipulator Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for 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 �
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE) P fert (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number . ()[{ ()ver-The-Counter Use_ Preseription Use 1 - 3 Per CFR 21 CFR 801 109
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Indications for Use:
Indications for Use:
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
Robert R. Sothing/
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K964276
OR
Over-The-Counter Use
Prescription Use
Per CFR 21 CFR 801.109
( )[Հ 1 - 4
TOTAL P.05
§ 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.