INNERDYNE GENERIC RADIALLY EXPANDING DILATION, G-RED DEVICE

K990493 · Innerdyne, Inc. · GCJ · May 18, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K990493
• Device Name: INNERDYNE GENERIC RADIALLY EXPANDING DILATION, G-RED DEVICE
• Applicant: Innerdyne, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: May 18, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The InnerDyne, Inc., G-RED® device is intended to provide dilation access for the performance of laparoscopic procedures to establish a port of entry for diagnostic, therapeutic, and operative procedures. Percutaneous urological access, for typical procedures such as: Percutaneous nephroscopy. Percutaneous bladder access (suprapubic). Percutaneous laparoscopic access to primary body cavities (i.e., abdominal and thoracic), both primary and secondary punctures; and Percutaneous access into hollow body organs.

Device Story

G-RED® is a radially expanding dilator sheath assembly used in minimally invasive surgery. It is deployed via standard needle or catheter/guidewire (Seldinger) technique. The device consists of a blunt obturator and a dilator sheath; the sheath expands radially to accommodate the obturator, which in turn dilates surrounding tissue. Once the working channel is established, the obturator is removed, leaving the sheath in place to provide a sealed port for surgical instruments. The system allows for sequential dilation by swapping smaller cannulas for larger ones through the sheath. Used in clinical settings by physicians to facilitate access to abdominal/thoracic cavities and hollow organs. Benefits include reduced tissue trauma compared to traditional dilation methods and improved controllability during access.

Clinical Evidence

No clinical data. Substantial equivalence is based on design, material, and functional comparison to predicate devices.

Technological Characteristics

Medical-grade materials; components assembled via adhesives, welds, and mechanical interlocks. Radial dilation mechanism; available in various lengths and diameters. Disposable. No electronic components or software.

Indications for Use

Indicated for patients requiring minimally invasive surgical access to abdominal and thoracic cavities, or percutaneous access to hollow body organs (e.g., nephroscopy, suprapubic bladder access) for diagnostic, therapeutic, or operative 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

• InnerDyne, Inc., Step® device
• InnerDyne, Inc., R.E.D.® device

Submission Summary (Full Text)

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990493

## SUMMARY OF SAFETY & EFFECTIVENESS INFORMATION

- InnerDyne, Inc. Submitter: 5060 West Amelia Earhart Drive Salt Lake City, Utah 84116 [phone]
Date Prepared: 22 January 1999

- Rick Gaykowski Contact: Corporate Vice President, Regulatory Affairs and Quality Assurance
Classification Name: Dilator (Other) Glussmouthori Name: Percutaneous Dilator w/ Removable Sheath InnerDyne , Generic Radially Expanding Dilation "G-RED® " Trade/Proprietary Name: Device

The G-RED® device consists of an expandable dilator sheath assembly deployable via standard The O-Tice of needle or cather/guidewire (Seldinger or similar) placement technique. access (vercas typor noddio of outhers) is configured so as to be axially compressed to The tubular momber of the diserestion. Upon use, the dilator assembly reduce the outside than of the mandable sheath, penetrating the tissue into the target cavity (e.g., abdominal) or hollow organ.

For laparoscopic access to target cavities and hollow organs, the following instructions should I of loparoove After insufflation of the cavity, (if deemed necessary), the access needle is De differ the mountanda assembly, which consists of a blunt obturator and dilation removed. The unator our the lumen of the dilator sheath which expands radially to accommodate it. This process in turn, radially expands the walls of the surrounding tissue. accommodule in "This prirator is removed, leaving the expanding dilation sheath and dilator ronowing anation this cechnique allows the user to benefit from the unique safety features and controllability of radial dilation by going from a less traumatic initial stick, followed by radial controllability of facilities ) annel. Once the working channel is established, the diration to the dosire working onament of the patient, at the discretion of the expandable should the working cannula in place to provide a sealed port for passage of diagnostic, therapeutic, and/or surgical instruments.

This system configuration allows the user to initially place a small diameter dilator cannula for passage of small diagnostic instruments. The dilator cannula can then be removed from the lumen of the dilator sheath while leaving the sheath inserted through the tissues. A larger diameter dilation cannula can then be inserted through the dilator sheath to create a larger port for passage of the larger operative instruments.

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The device is assembled from medical grade materials under GMP conditions. Components are molded and machined by qualified suppliers. The components are assembled and secured by adhesives, welds, and mechanical interlocks. The G-RED® device is available in various lengths and working diameters to accommodate the selected size of indicated medical instruments. The subject product may be supplied in both disposable forms.

device is substantially equivalent to the predicate The subject InnerDyne, Inc., G-RED® InnerDyne, Inc., Step® device versions in basic design, product configuration, composition, utilized materials, function, deployment, warnings and precautions, contraindications, and intended use for access to abdominal/thoracic cavities, the InnerDyne, Inc., R.E.D. ® device versions for access to hollow body organs, and equivalent to a number of currently marketed products with the removable sheath design.

The subject G-RED® device is intended for use during minimally invasive surgery for temporary dilation access to the abdominal and thoracic cavities for passage of diagnostic, therapeutic and operative instruments into the abdominal and thoracic cavities, and for percutaneous access to hollow body organs. The device is configured to be used as either a primary or secondary stick.

From the foregoing, we conclude that the subject G-RED® device is as safe and effective as named predicates and currently marketed competitive devices for the stated indications.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 18

Mr. Rick Gaykowski Corporate Vice President, Regulatory Affairs and Quality Assurance InnerDyne, Inc. 5060 West Amelia Earhart Drive Salt Lake City, Utah 84116

K990493 Re:

Trade Name: InnerDyne, Inc., Generic Radically Expanding Dilation, "G-RED®" Device

Regulatory Class: II Product Code: GCJ Dated: February 16, 1999 Received: February 17, 1999

Dear Mr. Gaykowski:

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 (Special Controls) or class III (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 assumcs compliance with the current Good Manufacturing Practice requirement, 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.

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Page 2 -- Mr. Rick Gaykowski

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 [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/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

K990493

Device Name: InnerDyne, Inc., Generic Radially Expanding Dilation, G-RED®, Device.

Indications for Use: The InnerDyne, Inc., G-RED® device is intended to provide dilation access for the performance of laparoscopic procedures to establish a port of entry for diagnostic, therapeutic, and operative procedures.

- Percutaneous urological access, for typical procedures such as: .
- Percutaneous nephroscopy .
- Percutaneous bladder access (suprapubic) .
- Percutaneous laparoscopic access to primary body cavities (i.e., . abdominal and thoracic), both primary and secondary punctures; and
- Percutaneous access into hollow body organs. .

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

Concurrence of CDRH, Office of Device Evaluation (ODE) OR Over-the-Counter Use Prescription Use (Per 21 CFR 801.109) (Optional Format 1-2-96)

InnerDyne, Inc. G-RED® Device Premarket Notification

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