(87 days)
Not Found
Not Found
No
The document describes a manual surgical device and explicitly states "Not Found" for mentions of AI, DNN, or ML, and descriptions of training/test sets.
Yes
The device is used to perform surgical procedures for various gynecological conditions, which implies it is used for treatment.
No
The device is described as a "manual single-use sterile surgical device" used for "Ob/Gyn hysteroscopic surgical procedures" like resection and ablation. Its intended uses involve treatment rather than diagnosis.
No
The device description explicitly states it is a "manual single-use sterile surgical device" with physical components like stainless steel, tungsten, copper/nickel alloy, and insulation. This indicates a hardware device, not a software-only one.
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 these instruments are for use by qualified surgeons during Ob/Gyn hysteroscopic surgical procedures. This indicates a direct surgical intervention on the patient's body.
- Device Description: The device is described as a "manual single-use sterile surgical device" used for "Monopolar Vaporization." This is a surgical tool, not a device used to examine specimens in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVDs are typically used to detect, measure, or identify substances or characteristics in these samples to diagnose or monitor a medical condition.
Therefore, the KSEA Monopolar Vaporization Electrodes are surgical instruments used for treatment, not for in vitro diagnostic purposes.
N/A
Intended Use / Indications for Use
The KSEA Monopolar Vaporization Electrodes are indicated for use by qualified surgeons during Ob/Gyn hysteroscopic surgical procedures including:
- abnormal uterine bleeding,
- infertility, .
- transuterine resection of fibroids, ●
- endometrial ablation, .
- resectoscopic management of Mullerian fusion defects, ●
- resectoscopic management of intrauterine lesions, and
- resectoscopic management of intractable uterine bleeding.
Product codes
85HIH, 85KNF
Device Description
The KSEA Monopolar Vaporization Electrodes are manual single-use sterile surgical devices. The body contact materials are surgical grade stainless steel, tungsten, and a copper/nickel alloy. The Monopolar Vaporization Electrodes are insulated with commonly used materials.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intrauterine / Uterus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified surgeons
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image shows a logo with the word "TORZ" in a stylized font. Below the word "TORZ" is the phrase "Sports Endoscopy". The background of the image is grainy and textured, giving it a vintage or distressed look. The logo and text are in a contrasting color, making them stand out against the background.
ીવડી તે
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document is accurate and complete to the best of KSEA's knowledge.
| Applicant: | Karl Storz Endoscopy - America, Inc.
600 Corporate Pointe Drive
Culver City, CA 90230
(310) 558-1500 |
|------------------------|---------------------------------------------------------------------------------------------------------------|
| Contact: | Kevin Kennan
Regulatory Affairs Specialist |
| Device Identification: | Common Name:
Monopolar Electrodes |
| | Trade Name: (optional)
KSEA Monopolar Vaporization Electrodes |
Indication: The KSEA Monopolar Vaporization Electrodes are indicated for use by qualified surgeons during Ob/Gyn hysteroscopic surgical procedures including:
- abnormal uterine bleeding,
- infertility, .
- transuterine resection of fibroids, ●
- endometrial ablation, .
- resectoscopic management of Mullerian fusion defects, ●
- resectoscopic management of intrauterine lesions, and
- resectoscopic management of intractable uterine bleeding.
Device Description: The KSEA Monopolar Vaporization Electrodes are manual single-use sterile surgical devices. The body contact materials are surgical grade stainless steel, tungsten, and a copper/nickel alloy. The Monopolar Vaporization Electrodes are insulated with commonly used materials.
Substantial Equivalence: The KSEA Monopolar Vaporization Electrodes are substantially equivalent to the predicate devices since the basic features, design and intended uses are similar. The minor differences in design and dimensions between the KSEA Monopolar Vaporization Electrodes and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no effect on the performance, function or intended use of these devices.
Signed:
Kevin Keenan
Senior Regulatory Affairs Specialist
1
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings or feathers. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
1999 JAN
Kevin A. Kennan Senior Regulatory Affairs Specialist Karl Storz Endoscopy - America, Inc. 600 Corporate Pointe Culver City, CA 90230
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Re: K983569
Spike 5mm 27050 VG, Spike 3mm 27050 VK, Roller 5mm 27050 RG, Roller 3mm 27050 RK, Roller Cutting 27050 KG, VAPOR Cutting 27050 SG, VAPOR CUT 27050 WG Dated: October 7, 1998 Received: October 13, 1998 Regulatory Class: II 21 CFR 884.1690/Procode: 85HIH 21CFR 884.4160/Procode: 85KNF
Dear Mr. Kennan
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. You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls 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 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 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.
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 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. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Image /page/2/Picture/0 description: The image shows the logo for Karl Storz Endoscopy. The word "STORZ" is written in large, bold, white letters at the top of the logo. Below that, the words "Karl Storz Endoscopy" are written in a smaller font. The logo is set against a black background. The image has a grainy appearance.
510(k) Number (if known):
Device Name: Monopolar Vaporization Electrodes
Indications for Use: These instruments are intended for use by qualified surgeons during Ob/Gyn hysteroscopic surgical procedures including:
- abnormal uterine bleeding, ●
- . infertility,
- transuterine resection of fibroids, .
- . endometrial ablation,
- resectoscopic management of Mullerian fusion defects, .
- resectoscopic management of intrauterine lesions, and .
- resectoscopic management of intractable uterine bleeding. .
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David G. Seggerman
(Division Sign-Off) Division of Reproductive, Anominal, ENT and Radiological Devices 983469 510(k) Number .
Prescription Use: _ OR Over-The-Counter Use: _
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
Image /page/2/Picture/17 description: The image shows a sequence of numbers. The numbers are six zeros followed by a three. The zeros are all the same size and shape, and they are evenly spaced apart. The three is larger than the zeros, and it is located to the right of the zeros.