ENDIUS SUCTION/IRRIGATION INSTRUMENT

K992535 · Endius, Inc. · OCX · Sep 1, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K992535
• Device Name: ENDIUS SUCTION/IRRIGATION INSTRUMENT
• Applicant: Endius, Inc.
• Product Code: OCX · Gastroenterology, Urology
• Decision Date: Sep 1, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Endius Suction Device is intended to be used to irrigate and aspirate fluid during Endoscopic and open spinal procedures

Device Story

Device consists of single-use disposable tubing set/trumpet valve attached to reusable suction/irrigation attachment. Used during endoscopic and open spinal procedures to irrigate and aspirate fluids, assisting in visualization. Operated by surgeons in clinical settings. Device facilitates fluid management to maintain clear surgical field.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and intended use comparison to predicate device.

Technological Characteristics

Materials: PVC, ABS, Delrin. Components: Single-use disposable tubing set/trumpet valve, reusable suction/irrigation attachment. Sterilization: Gamma irradiation. Packaging: Tyvek pouch.

Indications for Use

Indicated for irrigation and aspiration of fluids during endoscopic and open spinal surgical procedures.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Predicate Devices

• EndoSI™ Suction/Irrigation Trumpet Valve and Accessories

Submission Summary (Full Text)

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

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and head. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Endius, Inc. Ms. Susan Finneran Manager, Quality Assurance and Regulatory Affairs 23 West Bacon Street Plainville, MA 02762

JUL 2 7 2015

Re: K992535 Trade/Device Name: Endius Suction/Irrigation Device Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCX Dated (Date on orig SE ltr): July 28, 1999 Received (Date on orig SE ltr): July 29, 1999

Dear Ms. Finneran,

This letter corrects our substantially equivalent letter of September 1, 1999.

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be

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

Page 2 -

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.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

## Benjamin R. Fisher -S

Beniamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

## K992535

## 510(k) Number (if known):

Device Name: Endius Suction /Irrigation Device

Indications for Use: The Endius Suction Device is intended to be used to irrigate and aspirate fluid during Endoscopic and open spinal procedures

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

Concurence of CDRH, Office of Device Evaulation (ODE)

(Optional Format 3-10-98)

(Posted July 1, 1998)

ー

**Prescription Use**
**(Per 21 CFR 801.109)**

Bcotter

Restorative Devices

ી ર્વ

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

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

K992535

## Section 6 - 510(k) Summary of Safety and Effectiveness

| 6.1<br>Statement | This summary of 510(k) safety and effectiveness information is being submitted<br>in accordance with the requirements of SMDA 1990 and CFR 807.92 | | |
|----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| 6.2<br>Submitter | Endius, Inc.<br>23 West Bacon Street<br>Plainville, MA. 02762 | | |
| 6.3<br>Company<br>Contact | Susan Finneran<br>QA/ RA Manager<br>508-643-0983 | | |
| 6.4<br>Device Name | Proprietary Name: Endius Suction/Irrigation Instrument<br>Common Name: Endoscopic Suction/ Irrigation Device<br>Classification Name: Endoscope and Accessories | | |
| 6.5<br>Predicate<br>Legally<br>Marketed<br>Devices | EndoSITM Suction/Irrigation Trumpet Valve and Accessories | | |
| 6.6<br>Device<br>Description | The Endius Endoscopic Irrigation/ Suction Device is intended to be used to<br>irrigate and aspirate fluids during Endoscopic and open spinal Procedures and<br>therefore to assist in the visualization. The device consists of a single -use<br>disposable tubing set/trumpet valve which is intended to be attached to a re-<br>usable suction/irrigation attachment. | | |

33

{4}------------------------------------------------

| 6.7<br>Device<br>Indications and<br>Intended use | The Endius Suction /Irrigation Device is intended to be used to<br>irrigate/aspirate fluids during Endoscopic and open spinal surgical procedures. |
|--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
|--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|

| 6.8<br>Substantial<br>Equivalence | The Endius Endoscopic Spinal Access System is substantially equivalent to the<br>EndoSI™ Suction/Irrigation Trumpet Valve and Accessories |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|

| Device Name | EndoSIT™<br>Suction/Irrigation Device | Endius Suction/Irrigation Device |
|-----------------------|--------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| Intended use | Irrigation and Aspiration<br>of fluid during<br>laparoscopic procedures | Irrigation and Aspiration of fluid<br>during Endoscopic Spinal<br>procedures. |
| Materials | PVC, ABS | PVC, ABS, Delrin |
| Sterilization Methods | Sterile components<br>sterilized by gamma<br>irradiation | Sterile components sterilized by<br>gamma irradiation |
| Product<br>Labeling | Trumpet Valve: Sterile,<br>single use<br>Suction/Irrigation<br>attachment: Sterile,single<br>use | Trumpet Valve: Sterile, single use<br>Suction/Irrigation attachment:<br>Non-Sterile, re-usable |
| Packaging | Sterile components<br>packaged in Tyvek pouch | Sterile components packaged in<br>Tyvek pouch |

Applicant Susan Din

Date 7/27/99

34