(96 days)
Not Found
Not Found
No
The description lists a combination of existing, legally marketed surgical devices and a control unit. There is no mention of any features or functionalities that would suggest the use of AI or ML, such as image analysis, predictive capabilities, or adaptive control algorithms. The control is described as touch screen or voice activation, which are standard user interfaces and do not inherently imply AI/ML.
Yes
The device is comprised of several components, many of which directly interact with the body or deliver therapeutic interventions (e.g., electrosurgical generator for cutting/coagulating tissue, gas insufflator for maintaining distention, suction/irrigation device for removing tissue).
Yes
The XENON 300 component of the OPserver LAP is explicitly stated to be "designed to supply light for endoscopic diagnostic and surgical procedures," and the THERMOFLATOR® is "designed for laparoscopic surgical and diagnostic procedures."
No
The device description explicitly states the OPserver LAP is comprised of multiple hardware components (XENON 300, Video Camera, THERMOFLATOR®, UNIDRIVE® II, AUTOCON® II 400, LAPAROMAT®, and QUADRO SWITCH). While it is controlled by software (Karl Storz SCB), it is an integral combination unit of hardware devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used during laparoscopic surgical procedures for tasks like providing light, capturing video, insufflating gas, controlling motorized instruments, electrosurgery, and suction/irrigation. These are all actions performed on the patient's body or within the surgical field.
- IVD Definition: In vitro diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of disease.
- Lack of Specimen Analysis: The description of the OPserver LAP and its components does not mention any analysis of biological specimens. Its function is to facilitate and perform actions within the surgical environment.
Therefore, the OPserver LAP is a surgical device used in vivo (within the living body), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The OPserver LAP is an integral combination unit comprised of the following legally marketed Karl Storz equipment intended for use in laparoscopic surgeries: XENON 300, Video Camera, THERMOFLATOR®, UNIDRIVE® II, AUTOCON® II 400, LAPAROMAT®, and QUADRO SWITCH.
The XENON 300 is a 300 watt short arc Xenon lamp light source designed to supply light for endoscopic diagnostic and surgical procedures.
The Video Camera is a camera system designed for use in laparoscopic surgeries. The TRICAM®/TELECAM® camera head is suitable for attachment to any rigid or flexible endoscope.
The THERMOFLATOR® is a gas insufflator designed for laparoscopic surgical and diagnostic procedures. The device is designed to carefully deliver large flow rates for rapid insufflation, and to monitor the amounts of CO2 gas needed to establish and maintain proper distention of the peritoneal cavity.
The UNIDRIVE® II is the control unit that operates the motorized handles during endoscopic surgical procedures.
The AUTOCON® II 400 is an electrosurgical generator that is intended for use by qualified surgeons to provide a high frequency (HF) electrical current for cutting and coagulating tissue during endoscopic surgeries.
The LAPAROMAT® is a high-capacity suction/irrigation device for use by qualified surgeons to infuse and aspirate sterile irrigation solutions into the peritoneal cavity to rinse or remove carbon deposits, blood clots, or excised tissue during laparoscopic and pelviscopic surgical procedures.
The QUADRO SWITCH, in conjunction with its associated handpiece or footswitch, functions as a suction/irrigation control switch device that controls the rinsing and removal of carbon deposits, blood clots, or excised tissue from operative sites during surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
FET, GCT
Device Description
The OPserver LAP is an integral combination unit comprised of the legally marketed Karl Storz equipment intended for use in laparoscopic surgeries.
The OPserver LAP is comprised of XENON 300, Video Camera, THERMOFLATOR®, UNIDRIVE® II, AUTOCON® II 400, LAPAROMAT®, and QUADRO SWITCH. It is controlled via the Karl Storz SCB either by touch screen or by voice activation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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): 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
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of a human figure in profile, with three overlapping faces suggesting a sense of community or interconnectedness. The figure is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Karl Storz Endoscopy-America, Inc. Ms. Suzie Chen Director of Regulatory Affairs 600 Corporate Pointe, 5th Floor Culver City, CA 90230-7600
JUL 2 7 2013
Re: K031895 Trade/Device Name: The KSEA OPserver LAP Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FET, GCT Dated (Date on orig SE ltr): July 5, 2003 Received (Date on orig SE Itr): July 22, 2003
Dear Ms. Chen,
This letter corrects our substantially equivalent letter of September 23, 2003.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be
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found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements. including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/0 description: The image shows a dark banner with the "STORZ Karl Storz Endoscopy" logo on the right side. The logo is white and features the word "STORZ" in a stylized font with concentric circles inside the letter "O". Below the word "STORZ" is the text "Karl Storz Endoscopy" in a smaller font. The rest of the banner is a dark, mottled texture.
510(k) Number (if known): Not yet assigned.
Device Name: Opserver LAP
Indications for Use: The OPserver LAP is an integral combination unit comprised of the following legally marketed Karl Storz equipment intended for use in laparoscopic surgeries: XENON 300, Video Camera, THERMOFLATOR®, UNIDRIVE® II, AUTOCON® II 400, LAPAROMAT®, and QUADRO SWITCH.
The XENON 300 is a 300 watt short arc Xenon lamp light source designed to supply light for endoscopic diagnostic and surgical procedures.
The Video Camera is a camera system designed for use in laparoscopic surgeries. The TRICAM®/TELECAM® camera head is suitable for attachment to any rigid or flexible endoscope.
The THERMOFLATOR® is a gas insufflator designed for laparoscopic surgical and diagnostic procedures. The device is designed to carefully deliver large flow rates for rapid insufflation, and to monitor the amounts of CO2 gas needed to establish and maintain proper distention of the peritoneal cavity.
(continued on next page)
(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)
Miriam C. Provost
(Division Sign-Off)
Division of General, Restorative and Neurological Devices
| 510(k) Number | K031895 |
|---|---|
| --------------- | --------- |
003
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The UNIDRIVE® II is the control unit that operates the motorized handles during endoscopic surgical procedures.
The AUTOCON® II 400 is an electrosurgical generator that is intended for use by qualified surgeons to provide a high frequency (HF) electrical current for cutting and coagulating tissue during endoscopic surgeries.
The LAPAROMAT® is a high-capacity suction/irrigation device for use by qualified surgeons to infuse and aspirate sterile irrigation solutions into the peritoneal cavity to rinse or remove carbon deposits, blood clots, or excised tissue during laparoscopic and pelviscopic surgical procedures.
The QUADRO SWITCH, in conjunction with its associated handpiece or footswitch, functions as a suction/irrigation control switch device that controls the rinsing and removal of carbon deposits, blood clots, or excised tissue from operative sites during surgical procedures.
(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)
Miriam L. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
004
510(k) Number K031895
4
Koslogg
SEP 2 3 2003 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.
Karl Storz Endoscopy - America, Inc. Applicant: 600 Corporate Pointe Drive Culver City, CA 90230 (310) 338-8100
Susie Chen Contact:
Common Name: Device Identification: Multi-component surgical equipment console
Trade Name: (optional) The KSEA OPserver LAP
Indication: The OPserver LAP is an integral combination unit comprised of the legally marketed Karl Storz equipment intended for use in laparoscopic surgeries.
Device Description: The OPserver LAP is comprised of XENON 300, Video Camera, THERMOFLATOR®, UNIDRIVE® II, AUTOCON® II 400, LAPAROMAT®, and QUADRO SWITCH. It is controlled via the Karl Storz SCB either by touch screen or by voice activation.
Substantial Equivalence: The KSEA OPserver LAP is substantially equivalent to the predicate devices since the performance specifications, safety features, and intended uses are identical. The minor differences between the KSEA OPserver LAP 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:
Susie Chen Director of Regulatory Affairs