ENDOSCOPIC STAPLE REMOVAL INSTRUMENT

K010620 · Onux Medical, Inc. · GCJ · May 17, 2001 · Gastroenterology, Urology

Device Facts

• Record ID: K010620
• Device Name: ENDOSCOPIC STAPLE REMOVAL INSTRUMENT
• Applicant: Onux Medical, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: May 17, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Salute staple removal instrument is a re-useable instrument intended for laparoscopic or open removal of Salute staples.

Device Story

Manual, re-useable surgical instrument for endoscopic or open removal of Salute staples. Device features trigger handle, actuation lever, and 5mm shaft. Operation: rod at distal end of shaft engages underside of staple; actuation of lever pulls staple into shaft for removal from surgical site; release of lever expels staple. Used by surgeons in OR settings. Benefits patient by facilitating safe, controlled removal of surgical staples.

Clinical Evidence

No clinical data provided; substantial equivalence based on descriptive comparison of technical characteristics and intended use.

Technological Characteristics

Manual, re-useable instrument. Features 5mm shaft, trigger handle, and actuation lever. Sterilization via steam autoclave.

Indications for Use

Indicated for laparoscopic or open removal of Salute staples in patients undergoing surgical procedures where such staples were previously placed.

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

• Ethicon Endopath™ ES Endoscopic Staple Extractor

Submission Summary (Full Text)

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Onux Medical, Inc. Mr. John Rice Vice President of Engineering 5 Merrill Drive Hampton, NH 03842

JUL 2 7 2015

Re: K010620 Trade/Device Name: Endoscopic Staple Removal Instrument Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated (Date on orig SE Itr): February 27, 2001 Received (Date on orig SE Itr): March 1, 2001

Dear Mr. Rice,

This letter corrects our substantially equivalent letter of May 17, 2001.

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

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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

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

Enclosure

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K010620

# Statement of Indications for Use

### INDICATIONS

The Salute staple removal instrument is a re-useable instrument intended for laparoscopic or open removal of Salute staples.

R. Mark N. Mellema
Division Sign Off

(Division Sign-Off) Division of General, Restorative and New of General, Resto

510(k) Number_________________________________________________________________________________________________________________________________________________________________ KO10620

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K010620

## 510(k) Summary

2/27/2001

Onux Medical, Inc., Contact Person: Trade or Proprietary Name: Common or Usual Name: Classification Name:

AY 1 7 2001

John Rice None established Endoscopic staple removal instrument Endoscope and/or Accessory

#### Devices to Which Equivalence is Claimed

The Salute staple removal instrument is substantially equivalent to the Ethicon Endopath™ ES Endoscopic Staple Extractor.

#### Description of Subject Device

The subject device is a manual instrument for endoscopic or open surgical procedures. It employs a trigger handle design with an actuation lever and 5mm shaft. A rod at the end of the shaft engages the underside of the staple and pulls it inside the shaft when the lever is actuated. When the lever is released, the staple is release from within the device. The instrument is re-useable and is sterilized by steam autoclave.

#### Intended Use of Subject Device

Both the Salute staple removal instrument and the Ethicon Endopath ES Endoscopic Staple Extractor are intended for laparoscopic or open removal of staples.

#### Comparison of Technical Aspects

Both the Salute staple removal instrument and the Endopath ES Staple Extractor are manual re-useable instruments for removing staples in either an open or laparoscopic surgical setting. They both engage the underside of the staple at the distal end of the device shaft. Both have levers that actuate of the staple. While the lever is kept closed, the extracted staple is held by the device for removal to outside the surgical area. Releasing the lever expels the staple from the device shaft.