STRYKER INFRAVISION ESOPHAGEAL KIT

K983220 · Stryker Endoscopy · FAT · Jun 4, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K983220
• Device Name: STRYKER INFRAVISION ESOPHAGEAL KIT
• Applicant: Stryker Endoscopy
• Product Code: FAT · Gastroenterology, Urology
• Decision Date: Jun 4, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5365
• Device Class: Class 2

Intended Use

The Stryker InfraVision™ Esophageal Kit is an esophageal transillumination device with a reusable fiberoptic light illumination source, and a combined disposable light, nasogastric, and balloon dilation system. It is intended to facilitate illumination of the esophagus during the fundoplication procedure as well as other thoracoscopic, laparoscopic, or open surgical procedures to help the surgeon identify organs and placement of medical devices and tissue.

Device Story

Stryker InfraVision Esophageal Kit provides esophageal transillumination during surgery. System consists of reusable fiberoptic light source and disposable light, nasogastric, and balloon dilation components. Used in OR by surgeons during fundoplication, thoracoscopic, laparoscopic, or open procedures. Device illuminates esophagus to assist surgeon in identifying anatomical structures and guiding placement of medical devices or tissue. Benefits include improved visualization of esophageal boundaries during minimally invasive or open surgery, aiding surgical precision.

Clinical Evidence

Bench testing only.

Technological Characteristics

System comprises reusable fiberoptic light source and disposable light/nasogastric/balloon dilation components. Materials and sterilization methods are consistent with currently marketed medical devices. Light source complies with 21 CFR 1040.10 performance standards for medical equipment.

Indications for Use

Indicated for use in patients undergoing fundoplication, thoracoscopic, laparoscopic, or open surgical procedures requiring esophageal transillumination to assist in organ identification and device/tissue placement.

Regulatory Classification

Identification

An esophageal dilator is a device that consists of a cylindrical instrument that may be hollow and weighted with mercury or a metal olive-shaped weight that slides on a guide, such as a string or wire and is used to dilate a stricture of the esophagus. This generic type of device includes esophageal or gastrointestinal bougies and the esophageal dilator (metal olive).

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

Predicate Devices

• Gabriel Infra Vision Esophageal Kit (K960173)
• Bard Balloon Dilatation System (K86343)
• Sherwood Argyle Salem Sump Tube (K810156)
• BioEnterics EndoLumina Illuminated (K944148)

Submission Summary (Full Text)

{0}------------------------------------------------

K983220

JUN 4 1998

## Y 2590 Walsh Ave. Santa Clara, CA 95051 SUMMARY SAFETY AND EFFICACY

| Device Name | Esophageal Dilator; 21 CFR 876.5365: Gastroenterology-Urology Device |
|---------------------------------|----------------------------------------------------------------------|
| Current Classification Name(s): | |
| Common and Usual Name: | Stryker Esophageal Kit or E-kit |
| Proprietary Name: | Stryker InfraVisionTM Esophageal Kit |

Device Sponsor

Stryker Endoscopy 2590 Walsh Ave. Santa Clara, CA 9505 l

This summary of 510(k) safety and effectiveness is being submitted in accordance with requirements of SMDA 1990.

The Stryker InfraVision™ Esophageal Kit illumintion source will comply with 21 CFR 1040.10 Performance The Stryker InfraVision™ Esophageal Kr Indimination Source Will Compy With U.S. Standard for Medical and Dental Equipment..

The Stryker InfraVision™ Esophageal Kit will be constructed of materials which are of the same manufacturing The Stryker InfraVision !" Esophagean and sterlization methods as currently marketed and approved medical
process, chemical composition, body contact and signings and purpose process, chemical composition, body connect in their intended purposes.
devices and are safe, effective, and durable for their intended purposes.

The Stryker InfraVision™ Esophageal Kit is equivalent in safety and effectives storently of devices currently The Stryker Infra Vision '''' Esophageal Kir - K960173; Bard Balloon Dilatation System - K86343; Sherwood
marketed (Gabriel Infra Vision™ Esophageal Kir - K960173; Bard Ballo marketed (Gabriel Infra Vision ''' Esophagean Kil - K500173, Bara Banow - 11-12-20148) which are used in
Argyle Salem Sump Tube - K810156; BioEnterics EndoLumina Illuminated the applications noted above.

this device does not raise new issues when compared to its predicate devices or uses. Therefore, it is considered substantially equivalent to those devices.

Stallin

Sean Cahill Design Engineer

{1}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/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 lines representing its wings and body. The eagle is enclosed in a circle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" surrounding the top half of the circle.

## JUN 4 1999

Mr. Sean Cahill Associate Project Engineer Stryker Endoscopy 2590 Walsh Avenue Santa Clara, California 95051

Re: K983220 Stryker InfraVision Esophageal Kit Regulatory Class: II 21 CFR §876.5365 Product Code: 78 FAT Dated: February 24, 1999 Received: March 8, 1999

Dear Mr. Cahill:

We have reviewed your Section 510(k) notification of intent to market the device We have reviewed your Section 5 U(K) notheation of intelsed to the first the fifte referenced above and we have december to legally marketed predicate devices marketed
indications for use stated in the enclosure) to legally marketed predical Device indications for use stated in the enclosure) (o legally marketd date of the Medical Device
in interstate commerce prior to May 28, 1976, the enactment with the provisions in interstate commerce prior to May 28, 1970, the chacin accorner with the provisions of
Amendments or to devices that have been reclassified in accorder the device Amendments or to devices that have been four and thereare, market the device,
the Federal Food, Drug, and Cosmetic Act (Act.). You may, thereore, market the device, the Federal Food, Drug, and Cosmetic Act (roo). " Tou may, "
subject to the general controls provisions of the Act. However, you are responsible to subject to the general controls provisions of the rich real, .
determine that the medical devices you use as component in the kit have either been determine that the medical devices you use as composents in the notification process (Section
determined as substantially equivalent under the May 28, 1976 the enactment day determined as substantially equivalent under the promation and 20, 1976, the enactment date
510(k) of the act), or were legally on the marks of your purchase your device 510(k) of the act), or were legally on the market profit on any of the stay our device of the Medical Device Amendments. Fiease noie: It you par sterilize) you must submit a
components in bulk (i.e., unfinished) and further process (c.g., sterilize) you must components in buik (1.6, unlimistica) and the provent ( ( - ) , )
new 510(k) before including these components in your reststation, listing of device new 510(k) before including these components for annual registration, listing of devices, good
provisions of the Act include requirements for annual registration and provisions of the Act metude requirements for allements of and one of the misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or If your device is classified (see above) increase additional controls. Existing
class III (Premarket Approval) it may be subject to such at Federal Regulation class III (Premarket Approval) it may be subject to sain the Code of Federal Regulations,
major regulations affecting your device can be found in assumes compliance major regulations affecting your device can occuration assumes compliance
Title 21, Parts 800 to 895. A substantially equivalent assumes one forth in the Quality Title 21, Parts 800 to 893. A Substantany equirements, as set forth in the Quality
with the Current Good Manufacturing Practice requirements, as set forth in the Cuality with the Current Good Manufacturing Practice Tractions (1 CFR Part 820) and
System Regulation (QS) for Medical Devices: General regulations Failure to System Regulation (QS) for Medical Devilles: "Gerifa such assumptions. Failure to
that, through periodic QS inspections, FDA will verselses assoc. In addition, the Fo that, through periodic QS inspections, IDA will regults action. In addition, the Food and
comply with the GMP regulation may in in regulation. In addition, the Food and comply with the GMP regulation may lesuit in regulatirs concerning your device in
Drug Administration (FDA) may publish further announcements notication submission Drug Administration (FDA) may publish turner almounters of the Boys of the Federal Register

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

{2}------------------------------------------------

Page 2 - Mr Sean Cahill

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 the labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D.

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nosc and Throat. and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

| Page | / |
|------|---|
| of | / |

510(k) Number (if known):

Stryker InfraVision™ Esophageal Kit Device Name:_

Indications For User

The Stryker InfraVision™ Esophageal Kit is an esophageal transillumination difation device with a reusable
s and ballon de la chain in the couliness ble fiberontic light qui illumination source, and a combined in the material that parent and comments on the noon and allion dilation
illumination of the A. Micro M. Faceboose it is invended to lamil illumination source, and a combined insposable thereport light, masques, and allat the esophagus during the the esophagus during the system. The Stryker Infra Vision™ Esopher and energic, or open surgical proceded on to be one of the once of the more of the more of the more of the may is one of the may fundoplication procedure as well as other thoracoscopic, lapacessors of open of the more of the may tissue.
intended to help the surgeon identify organs and placement of medi

(PLFASE 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

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
K98327

5100k) Number