(26 days)
Electrosurgical cutting and coagulation, mechanical grasping and dissection of tissue Droving the performance of laparoscopic and general surgical procedures.
The device is a Class II medical device. The PK ZIP WING Cutting Dissecting forceps is a modification to the predicate devices cleared under K904993. The bipolar dissecting forceps is identical in construction (with the exception of shaft length) and in component materials when compared to the predicate device. The dissector jaws are electrically isolated from each other enabling one jaw to act as a return electrode, eliminating the need for a return pad. In addition a cutting electrode mounted in one of the jaws is electrically isolated from the dissector jaw enabling the jaw to act as a return electrode. The modification has not altered the fundamental technology of the predicate devices cleared under K904993. The intended use: Electrosurgical cutting and coagulation, grasping and dissection during surgical procedures is identical when compared to the predicate devices. The energy source, Bipolar Electrosurgical Energy, is the same energy type as used for the predicate devices.
The provided text describes a 510(k) submission for the "PK ZIP WING Cutting Dissector" and focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study with specific acceptance criteria and performance metrics typically seen in clinical trials for novel devices.
Therefore, many of the requested categories of information, such as detailed acceptance criteria, specific device performance numerical values, sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance studies, and training set information, are not present in this type of regulatory document.
However, based on the information provided, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Reported Device Performance (as stated or implied) |
|---|---|
| Intended Use | "Electrosurgical cutting and coagulation, grasping and dissection during surgical procedures is identical when compared to the predicate devices." (Implies it performs these functions adequately.) |
| Fundamental Technology | "The modification has not altered the fundamental technology of the predicate devices cleared under K904993." (Implies the core working principle is maintained.) |
| Construction | "The bipolar dissecting forceps is identical in construction (with the exception of shaft length) and in component materials when compared to the predicate device." (Implies mechanical integrity and material compatibility are maintained.) |
| Safety and Effectiveness | "no new issues of safety and effectiveness are raised." (Implies that its safety and effectiveness profiles are similar to the predicate device.) |
| Energy Source | "The energy source, Bipolar Electrosurgical Energy, is the same energy type as used for the predicate devices." (Implies electrical performance and safety are comparable.) |
Note: For 510(k) submissions, the "acceptance criteria" are generally demonstrating that the new device is "substantially equivalent" to a legally marketed predicate device. This often involves showing similar design, materials, intended use, energy source, and performance characteristics (even if not quantified in the same way as a full clinical study). The "performance" is primarily demonstrated through this comparison to the predicate.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The filing focuses on a technical comparison to a predicate device rather than a clinical study with a test set of patient data.
3. 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)
This information is not provided as there is no mention of a clinical study involving experts establishing ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided as there is no mention of a clinical study or test set requiring adjudication.
5. 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
An MRMC comparative effectiveness study was not conducted. This is an electrosurgical instrument, not an AI-assisted diagnostic device, so comparing human readers with/without AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study in the context of an algorithm or AI was not done, as this is an electrosurgical device. The performance is assessed through its mechanical and electrical function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The concept of "ground truth" as applied to diagnostic or AI devices is not directly applicable here. The assessment of this device is based on its functional equivalence to a predicate electrosurgical device, ensuring it performs its intended actions (cutting, coagulation, grasping, dissection) safely and effectively, similar to the already cleared device. This would likely involve engineering testing, material testing, and functional testing to confirm these aspects, rather than clinical ground truth as understood in diagnostic studies.
8. The sample size for the training set
This information is not provided. The device is an electrosurgical instrument, not a machine learning model, so the concept of a "training set" is not applicable.
9. How the ground truth for the training set was established
This information is not provided and is not applicable to this type of device.
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F: 510(k) Summary
October 16, 2002
NOV 1 3 2002
| Company: | Gyrus Medical, Inc. |
|---|---|
| 6655Wedgwood Road | |
| Maple Grove, MN | |
| Tel. No. (763) 416-3000 | |
| FAX. No. (763) 416-3070 | |
| Contact: | Frederick G. Mades |
| Regulatory Affairs Manager | |
| Common/Usual Name: | Electrosurgical Instruments |
| Classification Name: | Electrosurgical Cutting and Coagulation Device And Accessories(21 CFR 878.4400) |
| Proprietary Name: | PK ZIP WING Cutting Dissector |
The device is a Class II medical device. The PK ZIP WING Cutting Dissecting forceps is a modification to the predicate devices cleared under K904993. The bipolar dissecting forceps is identical in construction (with the exception of shaft length) and in component materials when compared to the predicate device. The dissector jaws are electrically isolated from each other enabling one jaw to act as a return electrode, eliminating the need for a return pad. In addition a cutting electrode mounted in one of the jaws is electrically isolated from the dissector jaw enabling the jaw to act as a return electrode. The modification has not altered the fundamental technology of the predicate devices cleared under K904993. The intended use: Electrosurgical cutting and coagulation, grasping and dissection during surgical procedures is identical when compared to the predicate devices. The energy source, Bipolar Electrosurgical Energy, is the same energy type as used for the predicate devices.
In conclusion, as the design, materials of construction, function and intended use of the PK ZIP Wing Cutting Dissector is similar to that of the predicate devices currently cleared. Gyrus Medical Inc. believes that no new issues of safety and effectiveness are raised and that the submitted device is substantially equivalent.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
t and Drug Administration Cornorate Boulevard kville MD: 20850
Gyrus Medical, Inc. Frederick G. Mades Regulatory Affairs Manager 6655 Wedgwood Road Maple Grove, Minnesota 55311
Re: K023493
Trade/Device Name: PK ZIP WING Cutting Dissector Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories; Regulatory Class: Class II Product Code: GEI Dated: October 16, 2002 Received: October 18, 2002
Dear Mr. Mades:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Frederick G. Mades
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Muriam C. Parret
كَ كَ Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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ી ર 0 234 510(k) Number (if known): PK ZIP WING Dissector Device Name:
Indications for Use:
Electrosurgical cutting and coagulation, mechanical grasping and dissection of tissue Droving the performance of laparoscopic and general surgical procedures.
Prescription Use
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurence of CDRH, Office of Device Evaulation (ODE) (Optional Format 3-10-98)
(Posted July 1, 1998)
Miriam C. Phoret
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K023493
§ 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.