INNERDYNE RADIALLY EXPANDING DILATION, RED DEVICE by INNERDYNE, INC.

The InnerDyne, Inc., RED® device is intended for use during minimally invasive surgery to provide temporary dilation access to the abdominal/peritoneal cavity and to the lumen of specified internal organs to establish a port of entry for diagnostic, therapeutic, and operative instruments. Typical procedures for product use include:

Laparoscopic access to the abdominal/peritoneal cavity; .
Percutaneous gastrostomy; .
Percutaneous enterostomy; ●
Percutaneous cystostomy; .
. Percutaneous cholescystostomy; and
. Dilation of biliary and urethral strictures.

Device Description

The RED® device is an expandable dilator sheath assembly, consisting of a radially expanding sleeve, inflation syringe, cannula (with integral valve system), dilator, and insertion instrument (either an access needle or guidewire). The tubular member of the expandable sleeve is configured so as to be radially compressed to reduce the outside diameter of the device prior to insertion. Upon use, the dilator assembly is inserted through the radially expandable sleeve, penetrating the tissue into the target cavity (e.g., abdominal/peritoneal) or hollow organ.

AI/ML Overview

The provided text describes a medical device, the InnerDyne, Inc., Radially Expanding Dilation "RED®" Device, and its intended use. However, it does not contain any information regarding acceptance criteria or a study that proves the device meets those criteria.

This document is a Summary of Safety & Effectiveness Information (510(k) submission) to the FDA, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study results with specific acceptance criteria.

Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving their fulfillment based on this input. The document explicitly states:

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

This statement highlights that the submission is based on a claim of substantial equivalence to existing devices, meaning its safety and effectiveness are established by comparison to already approved devices, rather than through independent studies with explicit acceptance criteria provided in this document.

To answer your questions, I would need a different type of document, such as a clinical study report or a detailed device validation plan.

Summary

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SUMMARY OF SAFETY & EFFECTIVENESS INFORMATION

Submitter: InnerDyne, Inc. 5060 West Amelia Earhart Drive Salt Lake City, Utah 84116 (801) 350-3600

Date Prepared: 12 March 1999

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

For access to target cavities and hollow organs, the following instructions should be utilized. The needle and radially expanding sleeve should first be inserted into the target location. The needle removed, leaving the radially expanding sleeve in place. The dilator cannula assembly, which consists of a blunt dilation cannula, is then inserted through the lumen of the expandable sleeve which expands radially to accommodate it. This process in turn, radially expands the walls of the surrounding tissue. Following dilation the dilator is removed, leaving the radially expanding dilation sleeve and dilator cannula in place. This technique 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 dilation to the desire working channel.

Fill the provided syringe with 2.0 cc of liguid (A 50% concentration is recommended if using contrast). Attach the syringe to the reflux valve and draw a small vacuum to aspirate air. Tilt the syringe so that the air bubble floats away from the reflux valve. Inflate the balloon and remove the syringe. Once the working channel is established, the dilator be removed from the cannula leaving 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

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K99 0854 pg. 2 of 2

passage of small diagnostic instruments. The dilator cannula can then be removed from the lumen of the radially expanding sleeve while leaving the sleeve inserted through the tissues. A larger diameter dilation cannula can then be inserted through the expanding sleeve to create a larger port for passage of the larger operative instruments.

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 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.

The subject InnerDyne, Inc., RED® device is substantially equivalent to the predicate InnerDyne, Inc., R.E.D.® &, Step® device versions in basic design, product configuration, composition, utilized materials, function, deployment, warnings and precautions, contraindications, intended use for access to abdominal/thoracic cavities, and for access to hollow body organs.

The subject RED® device is intended for use during minimally invasive surgery for temporary dilation access to the abdominal/peritoneal 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 RED® device is as safe and effective as named predicates and currently marketed competitive devices for the stated indications. -

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes extending from its head, representing the department's services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is black and white.

AUG - 2 1999

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

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Re: K990854 InnerDyne, Inc., Radially Expanding Dilation, RED®, Device Dated: June 14, 1999 Received: June 16, 1999 Regulatory Class: Il 21 CFR §876.5010/Procode: 78 FGE 21 CFR §876.5090/Procode: 78 FFA 21 CFR §876.5980/Procode: 78 KGC 21 CFR §876.1500/Procode: 78 GCJ

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 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). 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 III (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 assumes compliance with the Current Good Manufacturing Practice requirements, 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.

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 cievices), piease contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation 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 (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours.

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

Enclosure

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Page 1 of 1

510(k) Number (if known):

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

Indications for Use: The InnerDyne, Inc., RED® device is intended for use during minimally invasive surgery to provide temporary dilation access to the abdominal/peritoneal cavity and to the lumen of specified internal organs to establish a port of entry for diagnostic, therapeutic, and operative instruments. Typical procedures for product use include:

Laparoscopic access to the abdominal/peritoneal cavity; .
Percutaneous gastrostomy; .
Percutaneous enterostomy; ●
Percutaneous cystostomy; .
. Percutaneous cholescystostomy; and
. Dilation of biliary and urethral strictures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Thmil La. Lagnm

Division of Reproductive, Abdominal, ENT and Radiological Devices 510(k) Number

Prescription Use (Per 21 CFR 801.109)

Over-the-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 876.5010 Biliary catheter and accessories.

(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.