(88 days)
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Not Found
No
The description focuses on the physical components and intended uses of a standard endoscope, with no mention of AI, ML, image processing, or performance metrics typically associated with AI/ML devices.
Yes
The "Indications for Use" section explicitly states that the device is used to "perform various diagnostic and therapeutic procedures" and lists several conditions for which it can be used for "treatment."
Yes
The document explicitly states that the endoscope is used for various diagnostic procedures and lists several diagnostic uses under "Specific Indications for Use," such as "diagnosis and/or treatment of ectopic pregnancy" and "determination of the presence and extent of pelvic endometriosis."
No
The device description explicitly states it is comprised of a rigid tolescope made of surgical grade stainless steel, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used during surgical procedures for visualization, diagnosis, and treatment within the body (gynecologic laparoscopic procedures). IVDs are used to examine specimens outside the body (in vitro) to provide information about a patient's health.
- Device Description: The description details a rigid endoscope, which is a tool for direct visualization inside the body. This is consistent with a surgical instrument, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or laboratory procedures, which are hallmarks of IVDs.
Therefore, the KSEA DCI Endoscope is a surgical endoscope used for direct visualization and intervention within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The KSEA DCI Endoscope is indicated for use during gynecologic laparoscopic surgical procedures, and, using additional accessories, to perform various diagnostic and therapeutic procedures.
Specific Indications for Use
- unexplained pelvic pain (acute, chronic)
- infertility work-up
- . tubal sterilization
- unexplained primary or secondary amenorthea
- . diagnosis and/or treatment of ectopic pregnancy
- . evaluation, diagnosis and/or treatment of small pelvic tumors, including m vomata
- evaluation of congenital anomalies of the pelvic organs
- retrieval of foreign bodies .
- determination of the presence and extent of pelvic endometriosis .
- . determination of the presence and extent of pelvic inflammatory disease
- . laparoscopic assisted vaginal hysterectomy
- . visualization, diagnosis and/or treatment of perforate abdominal organs
Product codes (comma separated list FDA assigned to the subject device)
85 HET
Device Description
The KSEA DCI Endoscope is comprised of a rigid, panoramic tolescope which utilizes rod lens technology. The body contact portions of the KSEA DCI Endoscope are composed of surgical grade stainless steel, which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility for human use.
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
pelvic organs, abdominal organs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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
§ 884.1720 Gynecologic laparoscope and accessories.
(a)
Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. 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/1 description: The image shows a sequence of handwritten characters, which appear to be alphanumeric. The characters are 'K990004'. The characters are written in black ink on a white background. The handwriting is somewhat stylized, with some characters slightly overlapping or connected.
5100% 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:
Endoscope |
| | Trade Name: (optional)
Karl Storz Direct Coupled Interface (DCI) Endoscope |
Indication: The KSEA DCI Endoscope is indicated for use during gynecologic laparoscopic surgical procedures, and, using additional accessories, to perform various diagnostic and therapeutic procedures.
Specific Indications for Use
- unexplained pelvic pain (acute, chronic) ●
- infertility work-up ●
- . tubal sterilization
- unexplained primary or secondary amenorthea
- . diagnosis and/or treatment of ectopic pregnancy
- . evaluation, diagnosis and/or treatment of small pelvic tumors, including m vomata
- evaluation of congenital anomalies of the pelvic organs �
- retrieval of foreign bodies .
- determination of the presence and extent of pelvic endometriosis .
- . determination of the presence and extent of pelvic inflammatory disease
- . laparoscopic assisted vaginal hysterectomy
- . visualization, diagnosis and/or treatment of perforate abdominal organs
Device Description: The KSEA DCI Endoscope is comprised of a rigid, panoramic tolescope which utilizes rod lens technology. The body contact portions of the KSEA DCI Endoscope are composed of surgical grade stainless steel, which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility for human use.
1
Substantial Equivalence: The KSIEA DCI Endoscope is substantially equivalent to the predicate devices since the basic features, design and intended uses are the same. The minor differences between the KSEA DCI Endoscope and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no affect on the performance, function or intended use of the devices.
Signed:
Kevin Kennan
Senior Regulatory Affairs Specialist
Senior Regulatory Affairs Specialist
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the symbol.
Public Health Service
APR 2 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Re: K990004
Karl Storz Direct Coupled Interface (DCI) Endoscope (for Gynecologic Laparoscopy) Dated: September 23, 1998 Received: January 4, 1999 Regulatory Class: II 21 CFR 884.1720/Procode: 85 HET
Mr. Kevin A. Kennan Senior Regulatory Affairs Specialist Karl Storz Endoscopy - America, Inc. 600 Corporate Pointe Culver City, CA 90230-7600
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,
APT 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
510(k) Number (if known): K990004
Device Name: Karl Storz Direct Coupled Interface (DCI) Endoscope
Indications for Use: This instrument is indicated for use during gynecologic laparoscopic surgical procedures, and, using additional accessories, to perform various diagnostic and therapeutic procedures.
Specific Indications for Use
- unexplained pelvic pain (acute, chronic) .
- infertility work-up .
- . tubal sterilization
- unexplained primary or secondary amenorthea t
- diagnosis and/or treatment of ectopic pregnancy .
- evaluation, diagnosis and/or treatment of small pelvic turnors, including . myomata
- evaluation of congenital anomalies of the pelvic organs .
- retrieval of foreign bodies .
- determination of the presence and extent of pelvic endometriosis ●
- determination of the presence and extent of pelvic inflammatory disease ●
- laparoscopic assisted vaginal hysterectomy ●
- visualization, diagnosis and/or treatment of perforate abdominal organs .
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: ✓ OR Over-The-Counter Use: __
(Per 21 CFR 801.109) (Optional Format 1-2-96)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number. K990004