(90 days)
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Not Found
No
The device description explicitly states that all devices are manually operated, and there is no mention of AI, ML, or image processing capabilities.
Yes
The device is indicated for both diagnostic and therapeutic procedures, including operative procedures like transection of intrauterine septa and adhesions.
Yes
The "Intended Use / Indications for Use" section explicitly lists "Diagnostic" conditions for which the device is indicated, such as "infertility and pregnancy wastage," "abnormal uterine bleeding," and "evaluation of abnormalities of the endometrium."
No
The device description clearly states it is a "straight, graduated shaft endoscope with a remote eyepiece" and includes an "Alken Motion Control Device," indicating it is a physical, manually operated surgical device with hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body.
- Device Description: The description clearly states that the KSEA Semi-Rigid Hysteroscope and Accessories are used to "view the uterus" and "perform various diagnostic and therapeutic procedures" within the patient's body. The Alken Motion Control Device also guides instruments into the patient.
- Anatomical Site: The anatomical site is the uterus, which is an internal organ.
- Lack of IVD Characteristics: There is no mention of analyzing samples, using reagents, or performing tests on bodily fluids or tissues outside of the body.
This device is a surgical endoscope used for direct visualization and intervention within the uterus, which falls under the category of medical devices used in vivo (within a living organism).
N/A
Intended Use / Indications for Use
Indication: The KSEA Semi-Rigid Hysteroscope and Accessories are designed to view the uterus, and, using additional accessories, to perform various diagnostic and therapeutic procedures. The Alken Motion Control Device attaches to an instrument channel to precisely guide the introduction of small instrument into the patient.
Indications for Use: The Karl Storz Semi-Rigid Hysteroscope and Accessories are indicated in the following conditions:
- Diagnostic
infertility and pregnancy wastage abnormal uterine bleeding intrauterine foreign body pelvic pain monitoring of IUD status evaluation of abnormal hysterosalpingogram evaluation of abnormalities of the endometrium
Operative
directed biopsy transection of intrauterine septa transection of intrauterine adhesions
Product codes
85 HIH
Device Description
The KSEA Semi-Rigid Hysteroscope is a straight, graduated shaft endoscope with a remote eyepiece. The Alken Motion Control Device is an attachment to the instrument channel to control the introduction and movement of accessories. All devices are manually operated, reusable surgical devices. Body contact materials are stainless steel (chromium-plated Monel 400®).
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
uterus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Not Found
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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Image /page/0/Picture/0 description: The image shows the logo for Karl Storz Endoscopy. The logo is white text on a black background. The top line of the logo says "STORZ" in large, bold letters. The second line of the logo says "Karl Storz Endoscopy" in smaller letters.
K97 1578
JUL 2 4 1997
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 are accurate and complete to the best of KSEA's knowledge.
| Applicant: | Karl Storz Endoscopy - America, Inc.
600 Corporate Pointe
Culver City, CA 90230
(310) 558-1500 |
|------------------------|---------------------------------------------------------------------------------------------------------|
| Contact: | Marlena Allen Piercy, Ph.D.
Senior Clinical Affairs Specialist |
| Device Identification: | Common Name
Semi-Rigid Hysteroscope and Accessories
Trade Name |
KSEA Semi-Rigid Hysteroscope KSEA Alken Motion Control Device
Indication: The KSEA Semi-Rigid Hysteroscope and Accessories are designed to view the uterus, and, using additional accessories, to perform various diagnostic and therapeutic procedures. The Alken Motion Control Device attaches to an instrument channel to precisely guide the introduction of small instrument into the patient.
Device Description: The KSEA Semi-Rigid Hysteroscope is a straight, graduated shaft endoscope with a remote eyepiece. The Alken Motion Control Device is an attachment to the instrument channel to control the introduction and movement of accessories. All devices are manually operated, reusable surgical devices. Body contact materials are stainless steel (chromium-plated Monel 400®).
Substantial Equivalence: The KSEA Semi-Rigid Hysteroscope and Accessories are substantially equivalent to the predicate devices since the basic features, design, and intended uses are the same or similar. The minor differences in dimensions between the KSEA Semi-Rigid Hysteroscope and Accessories and the predicate devices raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function, or intended use of these devices,
Signed: Mhelina Allen Piercey
Mariana Allen Piercey, Ph.D.
Marlena Allen Piercy, Ph.D. Senior Clinical Affairs Specialist
1
Image /page/1/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal features an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are written around the eagle in a circular pattern. The eagle is a symbol of the United States, and the seal represents the department's mission to protect the health of all Americans.
Semi-Rigid Hysteroscope and Alken Motion
21 CFR §884.1690/Product code: 85 HIH
Control Device . ..........................
Dated: April 23, 1997
Regulatory class: II
Received: April 25, 1997
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Marlena Allen Piercy, Ph.D. Senior Clinical Affairs Specialist Karl Storz Endoscopy-America, Inc. . 600 Corporate Pointe Culver City, California 90230-7600
JUL 2 4 1997
Dear Dr. Piercy:
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 intenstated 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, 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.
Re: K971518
If your device is classified (see above) into either 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 (OS) 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 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 80) and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question 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.
h.7liau Yu
Lillian Yin, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Kan Storz Endoscopy-America, Inc.
600 Corporate Pointe Culver City, California 90230-7600 Phone 310 558 1500
Toll Free 800 421 0837 Fax 310 410 5527
510(k) Number (if known): Not yet assigned
Device Name: Semi-Rigid Hysteroscope with Accessories
Indications for Use: The Karl Storz Semi-Rigid Hysteroscope and Accessories are indicated in the following conditions:
- Diagnostic
infertility and pregnancy wastage abnormal uterine bleeding intrauterine foreign body pelvic pain monitoring of IUD status evaluation of abnormal hysterosalpingogram evaluation of abnormalities of the endometrium
Operative
directed biopsy transection of intrauterine septa transection of intrauterine adhesions
Absolute Contraindications for Use: acute PID
Relative Contraindications for Use:
inability to distend uterus cervical/vaginal infection known pregnancy uterine bleeding or menses invasive carcinoma of the cervix recent uterine perforation medical contraindication intolerance to anesthesia cervical stenosis
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Prescription Use: | ✓ |
| (Per 21 CFR 801.109) | OR Over-The-Counter Use: |
| (Optional Format 1-2-96) | |
| Rolera satting | |
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K971518 |
| 000003 |