K Number
K080852
Device Name
KSEA ELECTRONIC CO2 ENDOFLATOR LC, MODEL 26430320-1
Date Cleared
2009-03-30

(369 days)

Product Code
Regulation Number
884.1730
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The KSEA Electronic CO2 ENDOFLATOR LC provides CO2 gas distention of the abdomen (pneumoperitoneum) for diagnostic or operative laparoscopy. See the instruction manual for your laparoscope for special indications for use.
Device Description
The KSEA Electronic CO2 ENDOFLATOR LC is an insufflation device for universal application in laparoscopic examinations and operations.
More Information

Not Found

No
The summary describes a standard insufflation device for laparoscopic procedures and contains no mention of AI, ML, or related concepts.

No
The device is used to create pneumoperitoneum for diagnostic or operative laparoscopy, which facilitates a procedure rather than directly treating a disease or condition.

Yes
The 'Intended Use / Indications for Use' section explicitly states that the device provides CO2 gas distention for "diagnostic or operative laparoscopy."

No

The device description explicitly states it is an "insufflation device" and provides "CO2 gas distention," indicating it is a hardware device that delivers gas, not a software-only product.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states the device provides CO2 gas distention of the abdomen for diagnostic or operative laparoscopy. This is a procedure performed in vivo (within the living body), not in vitro (outside the living body, typically on biological samples).
  • Device Description: The description reinforces its use in laparoscopic examinations and operations, which are surgical procedures performed on a living patient.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances in samples, or any other activity typically associated with in vitro diagnostics.

Therefore, the KSEA Electronic CO2 ENDOFLATOR LC is a surgical device used for insufflation during laparoscopic procedures, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

The KSEA Electronic CO2 ENDOFLATOR LC provides CO2 gas distention of the abdomen (pneumoperitoneum) for diagnostic or operative laparoscopy. See the instruction manual for your laparoscope for special indications for use.

Product codes

HIF

Device Description

The KSEA Electronic CO2 ENDOFLATOR LC is an insufflation device for universal application in laparoscopic examinations and operations.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

abdomen

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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)

K963423, K962863

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.

0

K08085z

mar 3 0 2009

Image /page/0/Picture/2 description: The image shows the logo for Karl Storz Endoscopy. The word "STORZ" is in large, bold, sans-serif font, with the "O" represented by a circle with a smaller circle inside. Below this, the words "KARL STORZ ENDOSCOPY" are printed in a smaller, sans-serif font. The logo is simple and professional, likely representing a medical or technological company.

510(k) SUMMARY

| Sponsor/Submitter: | Karl Storz Endoscopy-America, Inc.
600 Corporate Pointe
Culver City, CA 90230-7600
Phone: (310) 338-8100
Fax: (310) 410-5519 |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Crystal Dizol
Regulatory Affairs Specialist
Email: cdizol@ksea.com |
| Date of Submission: | March 25, 2008 |
| Device Trade Name: | KSEA Electronic CO2 ENDOFLATOR LC |
| Common Name: | Laparoscopic insufflator |
| Classification Name: | Laparoscopic insufflator |
| Regulation Number: | 21 CFR 884.1730 |
| Product Code: | HIF |
| Predicate Device(s): | KSEA CO2 ENDOFLATOR (K963423)
Karl Storz Model 264305-20 Electronic ENDOFLATOR (K962863) |
| Device Description: | The KSEA Electronic CO2 ENDOFLATOR LC is an insufflation device for
universal application in laparoscopic examinations and operations. |
| Indications for Use: | The KSEA Electronic CO2 ENDOFLATOR LC provides CO2 gas
distention of the abdomen for the diagnostic and/or operative
laparoscopy. See the instruction manual for your laparoscope for special
indications for use. |
| Technological
Characteristics: | The KSEA Electronic CO2 ENDOFLATOR LC is an electronic CO2 gas
insufflator. The device is intended to be used with a central gas supply
line to achieve pressures from 0-30 mmHg and flow rates of 0-30 L/min. |
| Summary of
Substantial
Equivalence: | The KSEA Electronic CO2 ENDOFLATOR LC is substantially equivalent
to the predicate devices since the basic features, design, and intended
uses are similar. The minor differences between the KSEA Electronic
CO2 ENDOFLATOR LC 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. For a
comparison between the KSEA Electronic CO2 ENDOFLATOR LC and
the predicate devices, refer to the attached substantial equivalence
chart |

:

:

1

STORE STORZENDOSCOPY

SUBSTANTIAL EQUIVALENCE TABLE FOR KSEA ELECTRONIC CO₂ ENDOFLATOR LC

:

080852

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 eagle with three stripes representing the department's mission. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 3 0 2009

Ms. Crystal K. Dizol Regulatory Affairs Specialist KARL STORZ Endoscopy-America, Inc. 2151 E. Grand Avenue EL SEGUNDO CA 90245

Re: K080852

Trade/Device Name: KSEA Electronic CO2 ENDOFLATOR LC Regulation Number: 21 CFR §884.1730 Regulation Name: Laparoscopic insufflator Regulatory Class: II Product Code: HIF Dated: March 6, 2009 Received: March 9, 2009

Dear Ms. Dizol:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register,

3

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; 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding os 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

21 CFR 876.xxx(Gastroenterology/Renal/Urology)(240) 276-0115
21 CFR 884.xxx(Obstetrics/Gynecology)(240) 276-0115
21 CFR 892.xxx(Radiology)(240) 276-0120
Other(240) 276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry.suppot/index.html.

Sincerely yours,

Laura B. Morris

anine M. M. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known): K080852

Device Name:

KSEA Electronic CO2 ENDOFLATOR LC

Indications for Use:

The KSEA Electronic CO2 ENDOFLATOR LC provides CO2 gas distention of the abdomen (pneumoperitoneum) for diagnostic or operative laparoscopy. See the instruction manual for your laparoscope for special indications for use.

Prescription Use: (21 CFR 801 Subpart D) AND/OR Over-The-Counter Use:

(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number.