(90 days)
These instruments are intended for use by qualified surgeons and provide gas insufflation designed for
- diagnostic laparoscopic procedures, and .
- laparoscopic sterilization procedures. .
The Karl Storz No Endoflator is a gas insufflator designed to deliver NoO gas to the abdominal cavity to facilitate the use of endoscope and accessories.
This document is a 510(k) summary for the Karl Storz N2O Endoflator, a gas insufflator for diagnostic laparoscopic and laparoscopic sterilization procedures. This type of device does not involve AI or algorithms, and therefore, most of the requested information, such as acceptance criteria, sample sizes for test and training sets, expert ground truth establishment, adjudication methods, multi-reader multi-case studies, and standalone algorithm performance, is not applicable.
Here's the relevant information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or detailed performance results in the format requested. The approval is based on "substantial equivalence" to predicate devices. The implicit acceptance criterion is that the device performs similarly to legally marketed predicate devices without raising new issues of safety and effectiveness.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a medical device (gas insufflator), not an AI/algorithm-based diagnostic tool. The submission focuses on device design and comparison to predicate devices, not clinical study data in the context of an algorithm's performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth establishment by experts is relevant for diagnostic algorithms.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for resolving discrepancies in expert interpretations for algorithmic ground truth.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a gas insufflator, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. For this device, the "ground truth" would be its ability to perform its intended function (delivering N2O gas to the abdominal cavity) safely and effectively, which is assessed through engineering principles, bench testing, and comparison to predicate devices rather than a diagnostic 'ground truth'.
8. The sample size for the training set
Not applicable. This device does not use a training set as it's not an AI/ML algorithm.
9. How the ground truth for the training set was established
Not applicable. This device does not have a training set or associated ground truth in the context of an algorithm.
Summary based on the provided text:
The Karl Storz N2O Endoflator received 510(k) clearance by demonstrating substantial equivalence to predicate devices. The claim is that "The minor differences between the Karl Storz N2O 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." This implies that the device meets existing safety and effectiveness standards, as demonstrated by the predicate devices, and that its performance is comparable. No specific performance metrics or clinical study data (in the context of an AI device) are presented in this summary document.
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Image /page/0/Picture/0 description: The image shows the logo for Karl Storz Endoscopy. The logo is in black and white, with the words "STORZ" in large, bold letters at the top. Below that, in smaller letters, are the words "Karl Storz Endoscopy". The logo also includes a circular design with a white dot in the center.
APR 1 5 1998
Pinl 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 DriveCulver City, CA 90230(310) 558-1500 |
|---|---|
| Contact: | Kevin KennanSenior Regulatory Affairs Specialist |
| Device Identification: | Common Name:Gas Insufflator |
Trade Name: (optional) Karl Storz N2O Endoflator
The Karl Storz N2O Endoflator is designed for diagnostic laparoscopic and Indication: laparoscopic sterilization procedures.
Device Description: The Karl Storz No Endoflator is a gas insufflator designed to deliver NoO gas to the abdominal cavity to facilitate the use of endoscope and accessories.
Substantial Equivalence: The Karl Storz N2O Endoflator is substantially equivalent to the predicate devices since the basic features and intended uses are similar. The minor differences between the Karl Storz N2O Endofiator 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 Senior Regulatory Affairs Specialist
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Image /page/1/Picture/0 description: The image shows a logo for the Department of Health. The logo features a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF" is visible, wrapping around the left side of the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 5 1998
Mr. Kevin A. Kennan Senior Regulatory Affairs Specialist Karl Storz Endoscopy - America, Inc. 600 Corporate Pointe Culver City, CA 90230-7600
Re: K980134
KSEA N20 Endoflator (Laparoscopic Insufflator) Dated: January 13, 1998 Received: January 15, 1998 Regulatory Class: II 21 CFR 884.1730/Procode: 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 (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/cdrb/dsmaldsmam.html".
Sincerely yours
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
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Image /page/2/Picture/0 description: The image shows the logo for Karl Storz Endoscopy. The logo consists of the word "STORZ" in large, stylized letters above the words "Karl Storz Endoscopy" in a smaller font. The "O" in STORZ is represented by a target symbol with concentric circles. The logo is in white against a black background.
510(k) Number (if known): Not Yet Assigned
Device Name: KSEA N2O Endoflator
Indications for Use: These instruments are intended for use by qualified surgeons and provide gas insufflation designed for
- diagnostic laparoscopic procedures, and .
- laparoscopic sterilization procedures. .
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert D Ratting/
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K981134
OR Over-The-Counter Use:
Prescription Use: سا (Per 21 CFR 801.109)
(Optional Format 1-2-96)
000003
§ 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.