(329 days)
Electrosurgical coagulation, mechanical grasping and dissection of tissue, and sealing of vessels up to 7mm, during the performance of open general surgical procedures.
The device consists of grasping jaws connected to a handle. The handle has finger loops integrated into it to allow the physician to easily manipulate the device for electrosurgical coagulation including the sealing of vessels. The overall length of the device is nine (9) inches. The device will be available in three distinct jaw configurations. The energy source, Bipolar Electrosurgical Energy, is the same energy type as used for the predicate devices. The forceps jaws are electrically isolated from each other enabling one jaw to act as a return electrode, eliminating the need for a return pad.
The provided text describes the 510(k) summary for the Gyrus OPEN FORCEPS, a Class II medical device. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed acceptance criteria and a study to prove meeting those criteria for a novel algorithm or AI device.
Therefore, most of the requested information regarding acceptance criteria, performance metrics, sample sizes, expert involvement, and ground truth establishment is not available in the provided document, as it pertains to a different type of device approval process.
Here's what can be extracted and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Specific quantitative acceptance criteria are not explicitly stated in the document. | The study indicates the device is "safe and effective and conforms to its Intended Use." |
| Substantial equivalence to predicate devices K000496, K981916, and K010010 in: | |
| - Design | "similar in construction" |
| - Component materials | "similar in component materials" |
| - Function | Not explicitly stated but implied by substantial equivalence |
| - Intended Use | "similar to the predicate devices" |
| Preclinical laboratory data and bench test data provide verification that the device is safe and effective. | Not specified in detail. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not mentioned. The document states "Preclinical laboratory data and bench test data," but does not provide specific sample sizes for these tests.
- Data Provenance: Not mentioned (e.g., country of origin, retrospective/prospective). These would typically be relevant for clinical data, which is not described.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable/not mentioned. The study referenced "Preclinical laboratory data and bench test data" for a physical device, not an AI or diagnostic algorithm requiring expert-established ground truth.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/not mentioned. This is not relevant for a device demonstrating substantial equivalence through bench and preclinical testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted interpretation devices, which the Gyrus OPEN FORCEPS is not.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Not applicable. The device is a physical electrosurgical instrument; there is no "algorithm only" performance to evaluate.
7. The Type of Ground Truth Used
- Type of Ground Truth: For the "Preclinical laboratory data and bench test data," the ground truth would likely be established by engineering specifications, physical measurements, and performance standards for electrosurgical devices (e.g., tissue impedance, temperature profiles, vessel seal integrity). Specific details are not provided.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. The device is a physical instrument, not an AI/ML model that undergoes a "training set" phase.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable. (See #8)
Summary of Device and Approval Process:
The K024286 submission for the Gyrus OPEN FORCEPS is for a physical electrosurgical instrument. The approval is based on demonstrating substantial equivalence to existing predicate devices (K000496, K981916, K010010). This means the device is considered safe and effective because its design, materials, function, and indications for use are similar to devices already on the market. The "study" mentioned consists of "Preclinical laboratory data and bench test data" to verify safety and effectiveness, but it is not detailed in the provided documents. The 510(k) process for such devices typically relies heavily on engineering and performance testing against established standards, rather than large-scale clinical trials or expert-adjudicated performance metrics common for AI/diagnostic tools.
{0}------------------------------------------------
NOV 1 7 2003
K024286
H: 510(k) Summary of Safety and Effectiveness
December 18, 2002
Page ① of
Page ①
Gyrus Medical, Inc. Company: 6655Wedgwood Road Maple Grove, MN Tel. No. (763) 416-3000 FAX. No. (763) 416-3070 Contact: Mark Jensen VP Regulatory Affairs / Quality Assurance Common/Usual Name: Electrosurgical Instruments Classification Name: Electrosurgical Cutting and Coagulation Device And Accessories (21 CFR 878.4400) Proprietary Name: Gyrus OPEN FORCEPS
The device is a Class II medical device. The Gyrus OPEN FORCEPS is a modification to the predicate device cleared under K000496. The Open Forceps is similar in construction and in component materials when compared to the predicate device. The indications for use are similar to the predicate devices cleared under K981916 and K010010. The device consists of grasping jaws connected to a handle. The handle has finger loops integrated into it to allow the physician to easily manipulate the device for electrosurgical coagulation including the sealing of vessels. The overall length of the device is nine (9) inches. The device will be available in three distinct jaw configurations. The intended use of the device is to electrosurgically coagulate tissue and the sealing of vessels up to 7mm during the performance of open general surgical procedures. The energy source, Bipolar Electrosurgical Energy, is the same energy type as used for the predicate devices. The forceps jaws are electrically isolated from each other enabling one jaw to act as a return electrode, eliminating the need for a return pad. Preclinical laboratory data and bench test data provide verification that the device is safe and effective and conforms to its Intended Use.
In conclusion, as the design, materials of construction, function and intended use of the Gyrus OPEN FORCEPS 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.
{1}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a black and white circular logo for the Department of Health & Human Services - USA. The logo features the department's name in a circular arrangement around a central emblem. The emblem is a stylized representation of a human figure, possibly meant to symbolize health and well-being.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 17 2003
Ms. Mercedes P. Bayani Director Regulatory and Clinical Affairs Gyrus Medical, Inc. 6655 Wedgwood Road, Suite 105 Maple Grove, Minnesota 55311-3602
Re: K024286
Trade/Device Name: Gyrus Open Forceps Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: September 19, 2003 Received: September 23, 2003
Dear Ms. Bayani:
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{2}------------------------------------------------
Page 2 - Ms. Mercedes P. Bayani
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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,
Miriam C. Provost
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
{3}------------------------------------------------
Page 1 of 1
510(k) Number (if known): _ K O 2 4 28 b Device Name: Gyrus Open Forceps
Indications for Use:
ﺮ
Electrosurgical coagulation, mechanical grasping and dissection of tissue, and sealing of vessels up to 7mm, during the performance of open general surgical procedures.
(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) | |
| Prescription Use | OR Over-the-Counter |
| (Per 21 CFR 801.109) |
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K024286
§ 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.