(167 days)
Used to permit direct viewing and access to the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures. As used with the Gynecare Versapoint System, the indications for use include: Excision of intrauterine myomas Excision of intrauterine polyps Lysis of intrauterine adhesions Incision of uterine septa
The Gyrus Hysteroscopic Resectoscope that we intend to market employs an electrode specific resectoscope-working element. All other sheaths etc., are standard COMEG components. A "Quick Connection" feature is used to attach the working element to the sheath. Endoscopic electrosurgical instruments and accessories are described under "Endoscope and Accessories" in 21 CFR 876.1500, and Hysteroscopes are described in 21 CFR 884.1690. The Hysteroscopic Resectoscope is intended to enable the viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures. The surgeon performs the examination through the cervical canal. The working elements are the devices that house and control various electrodes and lasers used to remove cut, coagulate, and transect tissue. The surgeon controls the back and forth movement of the electrode, using finger controls. The working elements also house a telescope for visualization. Current is transmitted to the electrode through a high frequency cable. These devices are composed of stainless steel, stainless steel chrome plated, plastic and brass chrome plated parts.
Here's an analysis of the provided text regarding the Gyrus Hysteroscopic Resectoscope's acceptance criteria and the study that proves it meets them:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided document, specific numerical acceptance criteria and detailed performance metrics are not explicitly stated in a quantifiable way. The document focuses on demonstrating substantial equivalence to predicate devices rather than quantitative performance against a predefined set of criteria.
| Acceptance Criteria (Inferred from "Performance Data" and "Technological Characteristics") | Reported Device Performance |
|---|---|
| Safety and Efficacy (General): Device is safe and effective for its intended use. | Pre-clinical and benchtop testing was performed to "verify that the product meets the performance requirements described" and "substantiates the efficacy of the resectoscope for the hysteroscopic usage." |
| Technological Equivalence: Same technological characteristics as predicate devices. | "The modified device has the same technological characteristics as the predicate devices. The form, fit and function is similar." |
| Intended Use Fulfillment: Enables viewing of cervical canal and uterine cavity for diagnostic/surgical procedures, including tissue cutting, removal, and dissection. | The device's "Intended Use" and "Indications Statement" align with these functions. |
| Substantial Equivalence: To legally marketed predicate devices. | "Based upon the 510(k) summaries and 510(k) statements (21 CFR 807) and the information provided herein, we conclude that the new device is substantially equivalent to the predicate devices under the Federal Food, Drug, Cosmetic Act." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a sample size for any test set.
- Data Provenance: The document states "Pre-clinical as well as bench top testing has been performed." This implies controlled laboratory settings. There is no mention of human subject data, country of origin, or whether the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not specified.
- Qualifications: Not specified.
4. Adjudication Method for the Test Set
- No adjudication method is mentioned, as the type of "test set" and the nature of the "ground truth" (see point 7) are not detailed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
-
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is more common for diagnostic imaging AI systems and not typically for a resectoscope device.
- Effect Size of Human Reader Improvement: Not applicable, as no MRMC study was conducted.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study Was Done
- No, a standalone (algorithm only) performance study was not done. This device is an instrument used by a human surgeon, not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this medical device's performance relies on engineering verification and validation. This includes:
- Confirmation that the device functions as designed (e.g., proper control of electrodes, effective cutting/coagulation).
- Compliance with material specifications and safety standards.
- Functional equivalence to predicate devices.
There is no mention of ground truth established by expert consensus, pathology, or outcomes data from patient studies.
8. The Sample Size for the Training Set
- Not applicable. This device is a physical instrument, not an AI algorithm that requires a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no "training set" for this device.
{0}------------------------------------------------
۱ ﻣﺴ
SECTION 7
| 510(k) Summary of Safety and Effectiveness | |
|---|---|
| Statement | Information supporting claims of substantial equivalence, as defined under the Federal Food, Drug, and Cosmetic Act, respecting safety and effectiveness is summarized below. For the convenience of the Reviewer, this summary is formatted in accordance with the Agency's final rule "...510(k) Summaries and 510(k) Statements..." (21 CFR 807) and can be used to provide a substantial equivalence summary to anyone requesting it from the Agency. |
| MODIFIED DEVICE NAME: Gyrus Hysteroscopic Resectoscope | |
| PREDICATE DEVICE NAME: COMEG Endoscopy Resectoscope and Karl Storz Hysteroscopic Resectoscope Models 27040/27050. | |
| Device Description | The Gyrus Hysteroscopic Resectoscope that we intend to market employs an electrode specific resectoscope-working element. All other sheaths etc., are standard COMEG components. A "Quick Connection" feature is used to attach the working element to the sheath. |
| Endoscopic electrosurgical instruments and accessories are described under "Endoscope and Accessories" in 21 CFR 876.1500, and Hysteroscopes are described in 21 CFR 884.1690. | |
| The Hysteroscopic Resectoscope is intended to enable the viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures. | |
| The surgeon performs the examination through the cervical canal. The working elements are the devices that house and control various electrodes and lasers used to remove cut, coagulate, and transect tissue. The surgeon controls the back and forth movement of the electrode, using finger controls. The working elements also house a telescope for visualization. Current is transmitted to the electrode through a high frequency cable. | |
| These devices are composed of stainless steel, stainless steel chrome plated, plastic and brass chrome plated parts. | |
Continued on next page
{1}------------------------------------------------
510(k) Summary of Safety and Effectiveness, Continued
| Intended Use | The Gyrus Hysteroscopic Resectoscope is intended to enable the viewing ofthe cervical canal and the uterine cavity for the purpose of performingdiagnostic and surgical procedures. The surgical applications include tissuecutting, removal, and dissection as required or encountered in gynecologichysteroscopic electrosurgical procedures for the treatment of intrauterinemyomas, polyps, adhesions, and septa. | |
|---|---|---|
| IndicationsStatement | The Gyrus Hysteroscopic Resectoscope is used to permit the direct viewing ofthe cervical canal and the uterine cavity for the purpose of performingdiagnostic and surgical procedures. | |
| Technologicalcharacteristics | The modified device has the same technological characteristics as the predicatedevices. The form, fit and function is similar. | |
| PerformanceData | Pre-clinical as well as bench top testing has been performed to verify that theproduct meets the performance requirements described. This substantiates theefficacy of the resectoscope for the hysteroscopic usage. | |
| Conclusion | Based upon the 510(k) summaries and 510(k) statements (21 CFR 807) andthe information provided herein, we conclude that the new device issubstantially equivalent to the predicate devices under the Federal Food, Drug,Cosmetic Act. | |
| Contact | David KayDirector of Regulatory Affairs and Quality AssuranceGyrus Medical Ltd.Fortran RoadSt. MellonsCardiff, CF3 0LTUnited Kingdom | |
| Date | August 4, 1998 |
{2}------------------------------------------------
Rockville MD 20850
Food and Drug Administration 9200 Corporate Boulevard
Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which consists of a stylized human figure with three wavy lines representing the head, body, and legs. The emblem is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
JAN 2 1 1999
David Kay Director, Regulatory Affairs & Quality Assurance Gyrus Medical Fortran Road St. Mellons Cardiff CF3 OLT UNITED KINGDOM
Re: K982771
Gyrus Axipoler™ Hysteroscopic Resectoscope Dated: November 23, 1998 Received: November 25, 1998 Regulatory Class: II 21 CFR 884.1690/Procode: 85 HIH
Dear Mr. Kay:
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 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). 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 verily 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.
If you desire specific advice for your device on our labeling requlation (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 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/dsma/dsmamain.html".
Sincerely yours,
Capt. Daniel G. Schultz, M.D.
Capt. Daniel G. Schultz. M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
INDICATIONS FOR USE
| 510(k) Number (if known): | K982771 |
|---|---|
| Device Name: | Gyrus Hysteroscopic Resectoscope |
| Indications for Use: | Used to permit direct viewing and access to the cervical canal andthe uterine cavity for the purpose of performing diagnostic andsurgical procedures. As used with the Gynecare VersapointSystem, the indications for use include:Excision of intrauterine myomasExcision of intrauterine polypsLysis of intrauterine adhesionsIncision of uterine septa |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
signature
Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devi CD I S10(k) Number
Prescription Use
OR
Over-The-Counter Use _
(Optional Format 1-2-96)
4
Gyrus Hysteroscopic Resectoscope Gyrus Medical, Ltd.
§ 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.