K Number
K980134
Device Name
KSEA N2O ENDOFLATOR
Date Cleared
1998-04-15

(90 days)

Product Code
Regulation Number
884.1730
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
These instruments are intended for use by qualified surgeons and provide gas insufflation designed for - diagnostic laparoscopic procedures, and . - 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.
More Information

N/A

Not Found

No
The summary describes a gas insufflator with no mention of AI, ML, image processing, or data analysis that would typically indicate AI/ML functionality.

No
The device is described as a gas insufflator for diagnostic and sterilization procedures, which are interventional rather than therapeutic. While it facilitates procedures, it doesn't directly treat a disease or condition itself.

Yes

The "Intended Use / Indications for Use" section explicitly states that the instrument is intended for "diagnostic laparoscopic procedures."

No

The device description explicitly states it is a "gas insufflator designed to deliver NoO gas," which 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 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 gas to the abdominal cavity, which is an in vivo application.
  • Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the living body) to provide information about a person's health. The description of this device does not involve the analysis of any biological specimens.

Therefore, the Karl Storz No Endoflator is a surgical device used in vivo, not an IVD.

N/A

Intended Use / 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. .

Product codes

85 HIF

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

abdominal cavity

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)

Not Found

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.

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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.

K980134

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 Drive
Culver City, CA 90230
(310) 558-1500 |
|------------------------|---------------------------------------------------------------------------------------------------------------|
| Contact: | Kevin Kennan
Senior 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)

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