(88 days)
For the coagulation of tubes, tissue coagulation and vascular coagulation to stop bleedings under endoscopic vision.
For therapy in connection with endoscopic accessories used in medical specialies such as urology, gynecology, surgery.
Not to be used for female sterilization (coagulation of fallopian tubes).
The modular hipolar forcep set provides precise grasping and axial holding placement of the jaws. performs thorough hygiene, and site irrigation can be achieved without using additional instruments
Here's a breakdown of the acceptance criteria and study information based on the provided document:
This document describes a 510(k) submission for Modular Bipolar Forceps. It's crucial to understand that for this type of device (bipolar forceps), the regulatory pathway at the time primarily relied on demonstrating substantial equivalence to a predicate device, rather than detailed clinical performance studies with specific statistical acceptance criteria as might be seen for novel, higher-risk devices or software.
Therefore, the "acceptance criteria" here are framed around compliance with relevant standards and demonstrating equivalence, not necessarily quantitative performance metrics for a specific function like "accuracy" or "sensitivity" as one might expect from a machine learning algorithm.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria / Standard | Reported Device Performance / Compliance |
|---|---|---|
| Material Biocompatibility | Assure biocompatibility of new material (for insulation) | Device materials tests were performed to assure biocompatibility of the new material. The tests indicated that no irritation would occur. |
| Electrical Safety & Performance | Meet appropriate sections of ANSI/AAMI standard on high frequency devices 11518 | The bipolar forceps were tested to meet the appropriate sections of ANSI/AAMI standard on high frequency devices 11518. |
| Electrical Safety & Performance | Meet appropriate sections of IEC 601-1 and IEC 601-2-2 | The bipolar forceps were tested to meet the appropriate sections of IEC 601-1 and IEC 601-2-2. |
| Safety and Effectiveness (General) | Designed and tested to guarantee safety and effectiveness | "These devices are designed and tested to guarantee the safety and effectiveness, when used according to the instructions manual." (Conclusion) |
| Substantial Equivalence | Device poses same type of questions about safety/effectiveness as predicate | "The submitted devices pose the same type of questions about safety or effectiveness as the compared devices." |
| Substantial Equivalence | New technological characteristics do not diminish safety/effectiveness | "The new technological characteristics have not diminished safety or effectiveness." (Changes noted: more durable coated insulation, added irrigation port). |
| Intended Use | Suitable for "coagulation of tubes, tissue coagulation, and vascular coagulation to stop bleedings under endoscopic vision." | The device is marketed for this intended use, implying it meets this criterion through its design and testing against standards. |
| Non-Interference (Irrigation Port) | No irrigation would occur (implying unintended irrigation) | Device materials tests indicated that no irrigation would occur (likely meaning no unintended fluid leakage or issues related to the new irrigation port when not being used for irrigation). This is ambiguous but suggests performance related to the new feature. |
Study Details:
Given the nature of the device (medical instrument, not an AI/software device) and the regulatory context (510(k) for substantial equivalence in 1998), many of the questions related to AI/ML device studies are not applicable (N/A) to this documentation.
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- N/A. This document describes engineering performance tests and biocompatibility tests for a physical medical instrument, not a study involving patient data or a "test set" in the context of AI/ML evaluation.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- N/A. No ground truth in the sense of expert annotation for a test set was established. The "ground truth" for this device's performance would be adherence to engineering standards and successful operation in simulated environments.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. No such adjudication method was used as there was no expert review of a test set in this context.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- N/A. This is a physical medical instrument, not an AI/ML system, so an MRMC study is irrelevant.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is a physical medical instrument; there is no algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" or verification mechanism for this device's performance was primarily through:
- Compliance with recognized industry standards: ANSI/AAMI 11518, IEC 601-1, IEC 601-2-2.
- Biocompatibility testing: Assuring no irritation from new materials.
- Demonstration of "Substantial Equivalence" to a legally marketed predicate device: This implies the predicate device's established safety and effectiveness forms the basis for the new device's acceptance.
- The "ground truth" or verification mechanism for this device's performance was primarily through:
-
The sample size for the training set:
- N/A. There is no "training set" in the context of an AI/ML algorithm for this device.
-
How the ground truth for the training set was established:
- N/A. There is no "training set" and therefore no ground truth establishment for it.
Summary of the Study:
The "study" described in this 510(k) summary is primarily a pre-market regulatory submission process focused on demonstrating substantial equivalence to previously marketed devices. It involves:
- Bench Testing: To meet electrical safety and performance standards (ANSI/AAMI, IEC).
- Material Biocompatibility Testing: For the new insulation material.
- Comparison to Predicate Devices: Analyzing technological characteristics to ensure no new questions of safety or effectiveness are raised and that safety/effectiveness are not diminished by changes.
- No clinical tests were performed, which is typical for 510(k) devices where substantial equivalence can be demonstrated through non-clinical means.
The document states: "These devices are designed and tested to guarantee the safety and effectiveness, when used according to the instructions manual." This constitutes the overall conclusion of their study.
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7 1998 JUL
8
RICHARD WOLF
MEDICAL INSTRUMENTS CORPORATION
981321
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 |
| ZIP / Postal Code: | 60061 |
| Contact name: | Mr. Robert L. Casarsa |
| Contact title: | Quality Assurance Manager |
| Date of Preparation: | April 8, 1998 |
|---|---|
| FDA establishment registration number: | 1418479 |
| Phone number (include area code): | (847) 913-1113 |
| FAX number (include area code): | (847) 913-0924 |
Product Information:
| Trade name: | Bipolar forceps set (modular) |
|---|---|
| Model number: | 8390.xxx, 8391.xxx, 8393.xxx, 8394.xxx |
| Common name: | Modular Bipolar forceps |
| Classification name: | Bipolar forceps |
Information on devices to which substantial equivalence is claimed:
| 510(k) Number | Trade or proprietary or model name | Manufacturer |
|---|---|---|
| 1 pre-enact. | Kleppinger bipolar forceps 8383.21, 8384.21 | Richard Wolf GmbH |
| 2 | 2 | 2 |
1.0 Description
The modular hipolar forcep set provides precise grasping and axial holding placement of the jaws. performs thorough hygiene, and site irrigation can be achieved without using additional instruments
Revised 6/19/98
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Image /page/1/Picture/3 description: The image shows a black square with a white symbol inside. The symbol appears to be a stylized letter or character, possibly from a non-Latin alphabet or a unique design. The symbol is composed of lines and curves, creating an abstract and somewhat angular shape. The overall impression is that of a logo or icon.
2.0 Intended Use
The bipolar forceps are used for coagulation of tubes, tissue coagulation, and vascular coagulation to stop bleedings under endoscopic vision.
Not to be used for female sterilization (coagulation of fallopian tubes).
3.0 Technological Characteristics
There are no significant technological characteristic changes to the new devices compared to the pre-enactment devices. The insulation of the electrodes is changed to a more durable coared material. An irrigation port is added.
Substantial Equivalence 4.0
The submitted devices pose the same type of questions about safety or effectiveness as the compared devices. The new technological characteristics have not diminished safety or effectiveness. The submitted devices are substantially equivalent to existing pre-enactment devices sold by Richard Wolf. In addition, the submitted devices are substantially equivalent to devices sold by various competitors.
ડ.0 Performance Data
No known FDA performance standard exists.
The bipolar forceps were tested to meet the appropriate sections of the ANSI/ AAMI standard on high frequency devices 11518 and IEC 601-1/ 1EC 601-2-2. Device materials tests were performed to assure biocompatibility of the new material. The tests indicated that no irrigation would occur.
6.0 Clinical Tests
No special 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: 6/1/98
Revised 6/19/98
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Image /page/2/Picture/11 description: The image shows a partial view of the Department of Health & Human Services logo. The text "DEPARTMENT OF HEALTH &" is visible vertically along the left side of the image. To the right of the text is the symbol of the Department of Health & Human Services, which is a stylized representation of people.
7 1998 JUL
Mr. Robert L. Casarsa ·Richard Wolf Medical Instruments Corporation 353 Corporate Woods Parkway Vernon Hills, Illinois 60061
Re: K981321 Trade Name: Modular Bipolar Forceps Regulatory Class: II Product Code: GEI Dated: April 8.1998 Received: April 10, 1998
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, 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 II (Special Controls) or 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 the Electronic Product 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.
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Page 2 - Mr. Robert Casarsa
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) 594-4595. 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,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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13:29 9661-67-471
RICHARD MULL
1 2 2 2 2 2 2 2 2 2 2 2 2 4 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 1 : 813
510(k) Number (if known): ______ K981321
Binolar Forceps Set (modular) Device Name:__________________________________________________________________________________________________________________________________________________________________
Intended Use:
For the coagulation of tubes, tissue coagulation and vascular coagulation to stop bleedings under endoscopic vision.
Indication and field of application:
For therapy in connection with endoscopic accessories used in medical specialies such as urology, gynecology, surgery.
Contraindications:
Not to be used for female sterilization (coagulation of fallopian tubes).
Contraindications are inflammations or bacterial contamination of wounds in the operation site. Contraindications directly related to the product are currently unknown. The attending physician must determine if the intended use is appropriate based on the yeneral condition of the patient. For further instructions, refer to the latest medical literature.
(17),EASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDHED)
Daodd
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K981321
Prescription Use
Per 21 CFR 801.109
( ))ર
Over-The-Counter__
Revised 6/19/98
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.