(270 days)
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Not Found
No
The summary describes a gas insufflator, a mechanical device for delivering CO2. There is no mention of AI, ML, image processing, or any data-driven decision-making components.
No
The device is used for diagnostic and sterilization procedures, not for treating a disease or condition. It facilitates visualization and access during surgery but does not provide therapy itself.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the instrument provides gas insufflation "designed for diagnostic laparoscopic procedures".
No
The device description clearly states it is a "gas insufflator designed to deliver CO2 gas," indicating a physical hardware component.
Based on the provided information, the Karl Storz CO2 Endoflator is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for providing gas insufflation during laparoscopic procedures (diagnostic and sterilization). This is a surgical procedure performed in vivo (within the living body).
- Device Description: The device delivers CO2 gas to the abdominal cavity, which is also an in vivo action.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the living body) to provide information for diagnosis, monitoring, or screening. The description of the Karl Storz CO2 Endoflator does not involve the analysis of such specimens.
Therefore, the Karl Storz CO2 Endoflator is a surgical device used during in vivo procedures, not an IVD device.
N/A
Intended Use / Indications for Use
The Karl Storz CO2 Endoflator is designed for Ob/Gyn laparoscopic surgical and diagnostic procedures.
These instruments are intended for use by qualified surgeons and provide gas insufflation designed for
- diagnostic laparoscopic procedures, and
- laparoscopic sterilization procedures.
Product codes (comma separated list FDA assigned to the subject device)
85 HIF
Device Description
The Karl Storz CO2 Endoflator is a gas insufflator designed to deliver CO2 gas to the abdominal cavity to facilitate the use of endoscope and accessories.
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
abdominal cavity
Indicated Patient Age Range
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Intended User / Care Setting
qualified surgeons
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)
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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.
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).
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§ 884.1730 Laparoscopic insufflator.
(a)
Identification. A laparoscopic insufflator is a device used to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.(b)
Classification. (1) Class II (performance standards).(2) Class I for tubing and tubing/filter kits which include accessory instruments that are not used to effect intra-abdominal insufflation (pneumoperitoneum). 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 close-up of a handwritten inscription. The inscription appears to be the letters "KGL 343". The letters are written in a slightly rough, uneven style, suggesting they were written quickly or with a writing implement that didn't produce a perfectly smooth line.
MAY 27 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 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:
Gas Insufflator |
Trade Name: (optional) Karl Storz CO2 Endoflator
The Karl Storz CO2 Endoflator is designed for Ob/Gyn laparoscopic surgical and Indication: diagnostic procedures.
Device Description: The Karl Storz CO2 Endoflator is a gas insufflator designed to deliver CO2 gas to the abdominal cavity to facilitate the use of endoscope and accessories.
The Karl Storz CO2 Endoflator is substantially equivalent to the Substantial Equivalence: predicate devices since the basic features and intended uses are similar. The minor differences between the Karl Storz CO2 Endoflator 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:
Kevin Kennan Regulatory Affairs Specialist
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Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the logo is an abstract symbol that resembles a person with outstretched arms.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 27 1997
Mr. Kevin A. Kennan Regulatory Affairs Specialist -Karl Storz Endoscopy-America, Inc. 600 Corporate Pointe Culver City, California 90230-7600 Re: K963423
KSEA CO2 Endoflator ... Dated: April 22, 1997 Received: April 23, 1997 Regulatory class: II 21 CFR §884.1730/Product code: 85 HIF
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 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, 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 53 1 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) 594-4616. 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/dsmamain.html".
Sincerely yours,
Lillian Yin, Ph.D.
Lillian Vin, 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
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Image /page/2/Picture/0 description: The image shows the logo for Karl Storz Endoscopy. The logo features the word "STORZ" in large, bold letters, with a stylized "O" that resembles an eye. Below the word "STORZ" is the text "Karl Storz Endoscopy" in a smaller font.
210(k) Number (if known): 963423
Device Name: KSEA CO2 Endoflator
Indications for Use: These instruments are intended for use by qualified surgeons and provide gas insufflation designed for
- diagnostic laparoscopic procedures, and 印
- laparoscopic sterilization procedures. 程
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert R. Rathbun, Jr.
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number_1963423
Prescription Use:
OR Over-The-Counter Use: