(188 days)
K962799, 2, 3, 4
Not Found
No
The device description and performance studies focus on mechanical components and sterilization, with no mention of AI/ML or image processing.
No.
The device's intended use is for applying/maintaining pneumoperitoneum, and providing access/visualization for diagnostic and therapeutic procedures, but it does not directly perform a therapeutic action itself; it facilitates other therapeutic (and diagnostic) procedures.
No
Explanation: The device is described as providing access and visualization for both "diagnostic and therapeutic purposes," indicating it is not solely a diagnostic device. Since its functions extend beyond diagnosis to include therapy, it is not exclusively a diagnostic device.
No
The device description explicitly lists hardware components such as cannulas, tubes, and telescopes made of stainless steel, brass, glass, and plastic.
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 system is used for applying and maintaining pneumoperitoneum, and providing access and visualization for laparoscopic and hysteroscopic procedures. These are all procedures performed on the patient's body, not on samples taken from the patient's body.
- Device Description: The description details the physical components of the system (cannula, tubes, telescopes) which are used for surgical access and visualization. There is no mention of reagents, assays, or any components used to analyze biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes
- Providing diagnostic information based on laboratory testing
In summary, the Microendoscope system is a surgical instrument used for minimally invasive procedures, not a device for performing diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
The Microendoscope system is used to apply and maintain pneumoperitoneum for laparoscopic procedures and to provide access and visualization for diagnostic and therapeutic purposes for laparoscopic and hysteroscopic procedures.
Product codes (comma separated list FDA assigned to the subject device)
85 HIH, HET
Device Description
Cannula and tubes are made of medical grade stainless steel and chrome plated brass. Telescopes are made of medical grade stainless steel (sleeve), glass-lenses, glass-fibers, brass chrome plated (housing), and plastic (eyepiece).
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)
Instruments have been tested to assure the function of the spring loaded cannula and the possibility of steam autoclaving. No clinical tests performed.
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.
K962799, 2, 3, 4
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
§ 884.1690 Hysteroscope and accessories.
(a)
Identification. A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for hysteroscope 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 hysteroscope accessory instruments include: lens cleaning brush, cannula (without trocar or valves), clamp/hemostat/grasper, curette, instrument guide, forceps, dissector, mechanical (noninflatable), and scissors. 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
OCT 2 199
Telenhone: 847 Fax: 847,913,1488
| 510(k) Summary of Safety and Effectiveness | |||||
|---|---|---|---|---|---|
| Submitter: | Date of Preparation: | ||||
| April 16, 1997 | |||||
| Company / Institution name: | FDA establishment registration number: | ||||
| RICHARD WOLF MEDICAL INSTRUMENTS CORP. | 14 184 79 | ||||
| Division name (if applicable): | Phone number (include area code): | ||||
| N.A. | (847) 913-1113 | ||||
| Street address: | FAX number (include area code): | ||||
| 353 Corporate Woods Parkway | (847) 913-0924 | ||||
| City: | |||||
| Vernon Hills | State/Province: | ||||
| Illinois | Country: | ||||
| USA | ZIP / Postal Code: | ||||
| 60061 | |||||
| Contact name: | |||||
| Mr. Robert L. Casarsa | |||||
| Contact title: | |||||
| Quality Assurance Manager | |||||
| Product Information: | |||||
| Trade name: | |||||
| Mini Laparoscopes | Model number: | ||||
| 8755.xxx | |||||
| Common name: | Classification name: | ||||
| Veress Cannula Spring Loaded, Telescope | Set Laparoscopy | ||||
| Information on devices to which substantial equivalence is claimed: | |||||
| 510(k) | Trade or proprietary or model name | Manufacturer | |||
| Number | |||||
| 1 K962799 | 1 Mini Laparoscopes | 1 Richard Wolf M.I.C. | |||
| 2 | 2 Surgy Needle VN-1500 | 2 IMAGYN | |||
| 3 | 3 Veress Needle AN3MM | 3 Ethicon | |||
| 4 | 4 OMS-PNS Pixie Microendoscope | 4 Origin |
1.0 Description
Cannula and tubes are made of medical grade stainless steel and chrome plated brass.
Telescopes are made of medical grade stainless steel (sleeve), glass-lenses, glass-fibers, brass chrome plated (housing), and plastic (eyepiece).
2.0 Intended Use
The Microendoscope system is used to apply and maintain pneumoperitoneum for laparoscopic procedures and to provide access and visualization for diagnostic and therapeutic purposes for laparoscopic and hysteroscopic procedures.
Image /page/0/Figure/9 description: The image shows the logo for Richard Wolf. The text "RICHARD" is stacked on top of the text "WOLF". To the right of the text is a square with rounded corners that contains a stylized image. The image appears to be a drawing of a person.
1
Richard Wolf Medical Instruments Corporation
353 Corporate Woods Parkway Vernon Hills, Illinois 60061 Telephone: 847.913.1113 Fax: 847.913.1488
K971420
P2972
Technological Characteristics 3.0
As the intended use describes, the set is miniaturized in diameter and length for minimally invasive laparoscopy. The veress cannula and the tubes are larger in diameter and longer in working length. The telescopes are shorter in length and smaller in diameter.
Substantial Equivalence 4.0
The submitted devices are substantially equivalent to existing pre-enactment devices sold by Richard Wolf and 510(k) devices sold by Imagyn, Ethicon, and Origin.
Performance Data 5.0
Instruments have been tested to assure the function of the spring loaded cannula and the possibility of steam autoclaving.
6.0 Clinical Tests
No clinical tests performed.
Conclusions Drawn 7.0
The mentioned R. Wolf Mini Laparoscopy devices are substantially equivalent to existing devices on the market. They have been tested to allow safe usage with no significant changes during the standard lifetime when used according to instructions.
By: Robert J. Casassa
Date: APR 15, 97
Robert L. Casarsa Quality Assurance Manager
Image /page/1/Picture/16 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 square with rounded corners, inside of which is a stylized drawing of the letters "A" and "I".
2
Image /page/2/Picture/0 description: The image shows a seal for the Department of Health and Human Services. The seal is circular and contains an emblem in the center. The emblem consists of a stylized representation of an eagle or other bird with its wings spread. The words "DEPARTMENT OF HEALTH - HUMAN" are arranged around the top of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 22 1997
Mr. Robert L. Casarsa Quality Assurance Manager Richard Wolf Medical Instruments Corporation 353 Corporate Woods Parkway Vernon Hills, Illinois 60061
Re: K971420
Microendoscope System (Mini Lap) for OB/GYN Use Dated: July 31, 1997 Received: August 1, 1997 Regulatory Class: II 21 CFR §884.1690 & 884.1720 Product Code: 85 HIH & HET
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 Device Amendments, or to 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 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 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 questions 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,
h.T.Liau Yri
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
K971420 510(k) Number (if known): _
7
Microendoscope System (Mini Lap) for OB/GYN Use Device Name:_
Intended Use:
The Microendoscope system is used to apply and maintain pneumoperotoneum for laparoscopic procedures and to provide access and visualization for diagnostic and therapeutic purposes for laparoscopic and hysteroscopic procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE)
Robert R. Sather/
(Division Sign Off)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 1971420
510(k) Number K94 1142
Prescription Use Per 21 CFR 801.109 L
OR
Over-The Counter