(90 days)
Not Found
Not Found
No
The summary describes a manual, reusable surgical snare made of stainless steel, with no mention of software, image processing, or AI/ML terms.
Yes.
The device is intended for resection of uterine polyps and tumors, which constitutes a therapeutic intervention.
No
The device is described as a surgical tool for resection (removal) of uterine polyps and tumors, not for diagnosing them.
No
The device description explicitly states it is a "manual reusable surgical device" made of "surgical grade stainless steel," indicating it is a physical hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description: The KSEA HP-Snare is described as a "manual reusable surgical device" intended for "hysteroscopic use" for "resection of uterine polyps and tumors." This means it's a surgical tool used inside the body during a procedure.
The device is used for a surgical intervention, not for testing samples taken from the body.
N/A
Intended Use / Indications for Use
The KSEA HP-Snare is intended for hysteroscopic use by qualified surgeons or physicians for resection of uterine polyps and tumors.
These instruments are intended for hysteroscopic use by qualified surgeons or plysicians in the resection of uterine polyps and tumors.
Product codes (comma separated list FDA assigned to the subject device)
85 HIH
Device Description
The KSEA HF-Snare is a manual reusable surgical devices provided to the end-user in a non-sterile condition. The body contact materials are surgical grade stainless steel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
uterine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified surgeons or physicians
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
FEB 1 1999
Image /page/0/Picture/1 description: The image contains a sequence of alphanumeric characters. The characters are 'K983901'. The characters are written in a bold, handwritten style.
.
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 KSBA'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:
Snare |
| | Trade Name: (optional)
KSEA HF-Snare |
Indication: The KSEA HP-Snare is intended for hysteroscopic use by qualified surgeons or physicians for resection of uterine polyps and tumors.
Device Description: The KSEA HF-Snare is a manual reusable surgical devices provided to the end-user in a non-sterile condition. The body contact materials are surgical grade stainless steel.
Substantial Equivalence: The KSEA HF-Snare for the resection of uterine polyps and tumors 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 HF-Snare and the predicate devices raise no now issues of safety and effectiveness, as these design differences have no effect on the performance, function or intended use of these devices.
Signed:
Kuegg Stannert
Kevin Kennan 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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a symbol of three stylized human profiles facing to the right, arranged in a row.
FEB 1 1999
Mr. Kevin Kennan Senior Regulatory Affairs Specialist Karl Storz Endoscopy-America, Inc. 600 Corporate Pointe Culver City, CA 90230-7600
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Re: K983901 Bettocchi Polypectomy Snare (HF-Snare) Dated: October 30, 1998 Received: November 3, 1998 Regulatory Class: II 21 CFR 884.1690/Procode: 85 HIH
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 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 regulations 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 verify such assumptions. Failure to comply with the GMP regulation may result in requlatory 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 vour device and thus, permits your device to proceed to the market.
ff 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 requlation 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 vours.
Cant. Daniel C. Schultz, M.C.
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
510(k) Number (if known): K983901
Device Name: HF-Snare
Indications for Use: These instruments are intended for hysteroscopic use by qualified surgeons or plysicians in the resection of uterine polyps and tumors.
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(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) |
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
| 510(k) Number | K983901 |
|---|---|
| --------------- | --------- |