(73 days)
Not Found
No
The document describes a set of mechanical surgical instruments (trocars and sleeves) and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
No
The device is used for gaining access to body cavities and enlarging access for examination, diagnosis, and/or therapy when used in conjunction with endoscopic accessories, but it is not itself a therapeutic device. It facilitates therapeutic procedures rather than performing them directly.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is for "examination, diagnosis, and/or therapy when used in conjunction with endoscopic accessories". The "Device Description" also mentions its suitability for "diagnostics".
No
The device description explicitly details physical components (trocar sleeves, trocars, dilation set) made of biocompatible materials, indicating 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 states that the device is used to gain access to body cavities for examination, diagnosis, and/or therapy in conjunction with endoscopic accessories. This describes a surgical or interventional procedure, not a diagnostic test performed on samples outside the body.
- Device Description: The description details surgical instruments (trocar sleeves and trocars) used for minimally invasive laparoscopic surgery. This aligns with surgical tools, not diagnostic reagents or equipment used to analyze biological samples.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to facilitate access for visualization and intervention within the body.
N/A
Intended Use / Indications for Use
The trocar sleeves and trocars serve to provide artificial access to body cavities. Trocar sleeves of smaller diameters can be replaced with trocar sleeves of bigger diameters with the dilation set.
Product codes (comma separated list FDA assigned to the subject device)
85 HET, 78 FDE
Device Description
The trocar sleeves are part of the MICRO and MINI instrument set for laparoscopic microsurgery, particularily suitable for diagnostics, smaller interventions, outpatient, and pediatric laparoscopy. The instruments smaller diameter allows better cosmetic effects than the larger diameters because they are less invasive.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Body cavities
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 steam sterilization tests performed by Richard Wolf show that the steam sterilization has no influence on the functional performance of the submitted devices when using the fractional method. No clinical tests performed. These devices are designed and tested to guarantee the safety and effectiveness when used according to the instruction manual.
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., K932441, 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
Vernon 1 lills, Illinois 6006 1 Phone: 847.913.1143 Fax: 847.913.1488
MEDIC
510(k) Summary of Safety and Effectiveness
DEC 12 1997
| 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: | September 26, 1997 |
|---|---|
| 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: | Trocar sleeves and trocars,
Dilatation sleeve and guide rod |
|----------------------|----------------------------------------------------------------|
| Model number: | 8930.xxx,
8756.xxx,
8309.xxx,
8903.xxx |
| Common name: | Trocar sleeves and trocars |
| Classification Name: | Trocar |
Information on devices to which substantial equivalence is claimed:
| 510(k) Number | Trade or proprietary or model name | Manufacturer |
|---|---|---|
| 1 pre-enact. | 1 Trocar sleeve with trocar | 1 Richard Wolf |
| 2 K932441 | 2 Trocar system | 2 Richard Wolf |
| 3 K942201 | 3 Laparoscopy dilation system | 3 Richard Wolf |
| 4 | 4 Trocars and thread sleeve | 4 Karl Storz |
| 5 | 5 Trocars/ cannulas systems | 5 Jarit |
1.0 Description
The trocar sleeves are part of the MICRO and MINI instrument set for laparoscopic microsurgery, particularily suitable for diagnostics, smaller interventions, outpatient, and pediatric laparoscopy.
The instruments smaller diameter allows better cosmetic effects than the larger diameters because they are less invasive.
べアグ
1
Image /page/1/Picture/1 description: The image shows a close-up of a symbol or character, possibly from a non-Latin alphabet or a stylized font. The symbol is dark and appears to be stamped or printed onto a lighter background. The edges of the symbol are somewhat rough, suggesting it may be part of a larger text or design.
2.0 Intended Use
The trocar sleeves and trocars serve to provide artificial access to body cavities.
Trocar sleeves of smaller diameters can be replaced with trocar sleeves of bigger diameters with the dilation set.
Technological Characteristics 3.0
The trocar sleeves and trocars have comparable biocompatible device materials as previous R. Wolf devices. The dimensions are smaller to perform minimally invasive laparoscopy. Partly the trocar sleeves are without automatic valves as a result of minimizing the sealing housing.
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 Jarit.
5.0 Performance Data
The steam sterilization tests performed by Richard Wolf show that the steam sterilization has no influence on the functional performance of the submitted devices when using the fractional method.
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 instruction manual.
By: Robert J. Casassa
Robert L. Casarsa Quality Assurance Manager
Date: Sept 25, 97
8-2
2
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC | 2 |997
Mr. Robert L. Casarsa Quality Assurance Manager Richard Wolf Medical Instruments Corporation 353 Corporate Woods Parkway Vernon Hills, Illinois 60061
Re: K973737
MINI Trocar sleeve and trocars 3.5 mm; MICRO Trocar sleeve and trocars 2 mm; Dilatation sleeve and guide rod 2 - 3.5 mm Dated: September 26, 1997 Received: September 30, 1997 Regulatory class: II 21 CFR §884.1720/Product code: 85 HET 21 CFR §876.1500/Product code: 78 FDE
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, 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.
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 OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Pailure 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 (2) 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.Liau Yu
Lillian Yiu, 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
3
| Comments of Children Comers of | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| - | ||||||||||||||||||||||||
| : | ||||||||||||||||||||||||
| . | ||||||||||||||||||||||||
| Compound Collection of Confinition | ||||||||||||||||||||||||
| . Balland Annual Comments of the Career of Children Comments of Children | ||||||||||||||||||||||||
| . | ||||||||||||||||||||||||
Indications for Use
510(k) Number (if known):
Trocar sleeves, trocars and dilation sleeve
Intended Use:
Device Name:
The trocar sleeves and trocars serve to gain access to body cavities.
The dilation set is used for enlarging the access; trocar sleeves of smaller diameters can be replaced with trocar sleeves of larger diameters.
Indication and Scope of Application:
For examination, diagnosis, and/or therapy when used in conjunction with endoscopic accessories in the various medical specialties such as surgery, urology and, gynecology when used by suitably trained and qualified specialists.
Contraindications:
There are currently no known contraindications relating directly to the product. The physician should decide whether or not the planned application can be performed based on the of the patient's general condition.
Combinations:
The trocar sleeves and trocars are used in with insufflators, reducing sleeves, extraction sleeves, dilation sleeves, guide rods, threaded fixation sleeves, sliding cones and, endoscopes, as well as endoscopic accessories (e.g. forceps, electrodes).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Robert D. Ratliff
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices K 4 510(k) Number .
Prescription Use
Per 21 CFR 801.109
OR
Over-The Counter