The InnerDyne, Inc., Step® 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.

Laparoscopic access to the abdominal region, both primary and secondary punctures;
Thoracoscopic access to the thoracic cavity, both primary and secondary punctures; and
Percutaneous access into hollow body organs with typical use in such procedures as percutaneous gastrostomy, percutaneous enterostomy, cholecystostomy, and dilation of biliary and urethral strictures.

Device Description

The Step Trocar Expandable Port Step® device consists of an expandable dilator sheath assembly with an access (Veress-type) needle mounted within its lumen. The tubular member of the dilator sheath is configured so as to be axially compressed to reduce the outside diameter of the device prior to insertion. Upon use, the expanding dilator sheath/needle assembly is inserted through the abdominal/thoracic tissue into the target cavity or hollow organ.

For laparoscopic access to the abdominal/thoracic cavities, the following instructions should be utilized. After insufflation of the cavity, (if deemed necessary), the access needle is removed. The dilator cannula assembly, which consists of a blunt obturator, dilation cannula, and a pneumo valve, is inserted through the lumen of the dilator sheath which expands radially to accommodate it. This process in turn, radially expands the walls of the surrounding tissue. Following dilation the obturator is removed, leaving the expanding dilation sheath and dilator cannula in place to provide a sealed port for passage of diagnostic, therapeutic, and/or surgical instruments.

For access to hollow body organs (e.g., intragastric placement viewed as typical), the following instructions should be utilized. If endoscopic technique is utilized, an endoscope is advanced into the stomach using standard techniques, followed by stomach insufflation. An abdominal incision is made and the access needle/sheath assembly is inserted directly through the abdominal and stomach walls into the stomach. The access needle is removed and the cannula/dilator is advanced through the radially expanding sleeve. If laparoscopic technique is utilized, under laparoscopic vision the abdominal cavity is entered and the stomach site is selected for insertion of the access device. The sheath/needle assembly, is advanced into the stomach. The access needle is removed, leaving the expandable sheath in place. The dilator cannula assembly is inserted through the lumen of the dilator sheath which expands radially to accommodate it. Following dilation the dilator is removed, leaving the expandable sheath and dilator cannula in place to provide a sealed port for passage of the selected instruments. Once the desired instruments are placed, the access device cannula and expanding sheath are removed, allowing the stomach and abdominal wall to contract/relax. (Access to hollow organs other than the stomach, can be achieved following general laparoscopic technique and the access methodology described above.)

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.

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 Step® radially expanding access device is available in various lengths and working diameters to accommodate the selected size of indicated medical instruments. The subject product shall be available in both disposable and reusable forms.

AI/ML Overview

The provided text is a 510(k) premarket notification for the InnerDyne Step Trocar Expandable Port, "Step®". It focuses on establishing substantial equivalence to previously marketed devices rather than presenting a study with specific acceptance criteria and performance data in the typical sense of a diagnostic or AI-powered device.

Therefore, many of the requested elements for describing acceptance criteria and a study cannot be directly extracted or are not applicable to this type of submission.

Here's a breakdown of what can be inferred and what cannot:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Inferred from Substantial Equivalence Claim): The device is deemed acceptable if it is "substantially equivalent" to predicate devices in:
- Basic design
- Product configuration
- Composition
- Utilized materials
- Function
- Deployment
- Warnings and precautions
- Contraindications
- Intended use
- Safety and effectiveness for stated indications.
Reported Device Performance: The document explicitly states: "From the foregoing, we conclude that the subject Step® device is as safe and effective as named predicates and currently marketed competitive devices for the stated indications." This is a qualitative claim of equivalence, not a quantitative performance metric.

Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance
Safety: As safe as predicate devices	"as safe...as named predicates"
Effectiveness: As effective as predicate devices	"as effective as named predicates"
Design, materials, function, intended use equivalence	Met - No deviations from predicate described

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. This is a premarket notification based on substantial equivalence, not a clinical study with a test set of patient data. Performance is assessed by comparing technical characteristics and intended use to existing, legally marketed devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. No ground truth determination on patient data is described as part of this submission. The "ground truth" for this regulatory pathway is the established safety and effectiveness of the predicate devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. There is no test set or adjudication process described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This device is a surgical access port, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Implicit Ground Truth: The "ground truth" for this 510(k) submission is the established safety and effectiveness record of the predicate devices to which the new device is compared. This is derived from their historical marketing and regulatory clearance, which would have been based on appropriate evidence (e.g., clinical experience, scientific literature, prior studies for those predicates).

8. The sample size for the training set

Not Applicable. There is no "training set" in the context of this type of medical device submission.

9. How the ground truth for the training set was established

Not Applicable. See point 8.

Summary

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OCT 7 1998

SUMMARY OF SAFETY & EFFECTIVENESS INFORMATION

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

Date Prepared: 10 July 1998

Contact: Rick Gaykowski Corporate Vice President, Requiatory Affairs and Quality Assurance

Classification Name: Dilator (Other) Common/Usual Name: Percutaneous Dilator With Sheath Trade/Proprietary Name: InnerDyne Step Trocar Expandable Port, "Step® "

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accommodate it. Following dilation the dilator is removed, leaving the expandable sheath and dilator cannula in place to provide a sealed port for passage of the selected instruments. Once the desired instruments are placed, the access device cannula and expanding sheath are removed, allowing the stomach and abdominal wall to contract/relax. (Access to hollow organs other than the stomach, can be achieved following general laparoscopic technique and the access methodology described above.)

The subject InnerDyne, Inc., Step Trocar Expandable Port, Step® device is substantially equivalent to the predicate 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, and equivalent to the InnerDyne, Inc., R.E.D.® device versions for access to hollow body organs.

The subject Step® 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 with tvpical use in such procedures as percutaneous gastrostomy, percutaneous enterostomy, percutaneous cystostomy, percutaneous cholecystostomy, and dilation of biliary and urethral strictures. The device is configured to be used as either a primary or secondary stick.

From the foregoing, we conclude that the subject Step® 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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that form the wings and body of the bird.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 7 1998

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

Re: K982417 Trade Name: Innerdyne Step Trocar Expandable Port, "STEP" Regulatory Class: II Product Code: GCJ Dated: July 10, 1998 Received: July 13, 1998

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, labelinq, 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 assumes 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 requlations.

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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 (301) 594-4595. 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 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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). K982417

Device Name: InnerDyne, Inc., Step Trocar Expandable Port, Step ™

Indications for Use: The InnerDyne, Inc., Step® 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.

Laparoscopic access to the abdominal region, both primary and • secondary punctures;
. Thoracoscopic access to the thoracic cavity, both primary and secondary punctures; and
. Percutaneous access into hollow body organs with typical use in such procedures as percutaneous gastrostomy, percutaneous enterostomy, cholecystostomy, 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)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	1982417

Prescription Use(Per 21 CFR 801.109)	OR	Over-the-Counter Use(Optional Format 1-2-96)
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InnerDyne, Inc.Step® Device for Hollow Organs Premarket Notification

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Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
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.(b)
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.