The VersaStep* single use system is intended to provide dilation access to the abdominal and thoracic cavities for performing diagnostic and operative abdominal and thoracic procedures. The VersaStep* single use system is indicated for the following uses: - Laparoscopic access to the abdominal cavity, both primary and secondary punctures - Thoracoscopic access to the thoracic cavity, both primary and secondary punctures

Device Description

The VersaStep* single use system consists of a sterile insufflation and access needle, a radially expandable sleeve, and a dilator/ cannula. The cannula and dilators are available in 5 mm, 5 mm - 11 mm, and 5 mm - 12 mm diameters.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called VersaStep*, a single-use system intended for dilation access to abdominal and thoracic cavities. The document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed study proving the device meets specific acceptance criteria with performance metrics.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not present in the provided text. The document is for a 510(k) submission, which relies on demonstrating equivalence to existing, legally marketed devices, rather than proving novel performance against specific quantitative acceptance criteria through new clinical trials.

Based on the provided text, here's what can be extracted:

A table of acceptance criteria and the reported device performance
- Not present. The document does not specify quantitative acceptance criteria or report performance metrics in the format of a table. The review is based on "substantial equivalence" to predicate devices, focusing on intended use, technology, and safety aspects, rather than specific performance thresholds.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not present. There is no mention of a "test set" for performance evaluation in the context of a new study. The 510(k) process typically relies on demonstrating equivalence through comparison of design, materials, and intended use with predicate devices, and potentially non-clinical (e.g., bench) testing, without requiring large-scale clinical test sets like those used for efficacy studies.
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 present. As there's no mention of a "test set" for performance evaluation, there's no information about experts establishing ground truth for such a set.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not present. No test set or adjudication method is described.
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 present. This device is a surgical access system (dilator/trocar), not an AI-assisted diagnostic tool. Therefore, an MRMC study and AI performance improvement are not relevant or discussed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not present. This device is a physical medical instrument, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not present. No ground truth establishment is described in the context of a performance study. For a 510(k), "ground truth" relates more to the understanding of the predicate device's safety and effectiveness.
The sample size for the training set
- Not present. There is no mention of a training set for an algorithm or a new clinical study.
How the ground truth for the training set was established
- Not present. No training set is mentioned.

Summary of what is present:

The provided text is a 510(k) clearance letter and associated summary information for the VersaStep* device. It focuses on the following:

Device Name: VersaStep* single use system
Intended Use: To provide dilation access to the abdominal and thoracic cavities for performing diagnostic and operative abdominal and thoracic procedures (laparoscopic and thoracoscopic access).
Device Description: Consists of an insufflation and access needle, a radially expandable sleeve, and a dilator/cannula in various diameters.
Materials: Stated to be in accordance with ISO Standard # 10993-1.
Predicate Devices: InnerDyne Step Trocar Expandable Port, "One-Step*" (K961940) and Auto Suture* Modified Versaport* Trocar (K954108).
Regulatory Determination: The FDA determined the device is "substantially equivalent" to legally marketed predicate devices, allowing it to be marketed.

The core "proof" in this context is the demonstration of substantial equivalence to existing devices, meaning it has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness. This type of submission relies on comparison with predicate devices rather than new, extensive clinical studies with specified acceptance criteria and measured performance.

Summary

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SEP = 6 2001

Summary of Safety and Effectiveness IX.

SUBMITTER:

K 012539 United States Surgical A division of Tyco Healthcare Group, LP 150 Glover Avenue Norwalk, CT 06856

Chester McCoy CONTACT PERSON:

August 3, 2001 DATE PREPARED:

Dilator (Other) CLASSIFICATION NAME:

Percutaneous Dilator with Sheath COMMON NAME:

VersaStep* PROPRIETARY NAME:

InnerDyne Step Trocar Expandable Port, "One-Step*" PREDICATE DEVICES: (K961940) Auto Suture* Modified Versaport* Trocar (K954108)

DEVICE DESCRIPTION:

INTENDED USE:

The VersaStep* single use system consists of a sterile

5 mm, 5 mm - 11 mm, and 5 mm - 12 mm diameters.

insufflation and access needle, a radially expandable sleeve, and a dilator/ cannula. The cannula and dilators are available in

Laparoscopic access to the abdominal cavity, both 트 primary and secondary punctures
Thoracoscopic access to the thoracic cavity, both 그 primary and secondary punctures

All component materials of the VersaStep* single use MATERIALS: system are comprised of materials which are in accordance with ISO Standard # 10993-1.

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Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized image of three human profiles facing to the right, with wavy lines extending from the bottom of the profiles.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Chester McCoy Program Manager, Regulatory Affairs United States Surgical A Division of Tyco Healthcare Group, LP 150 Glover Avenue Norwalk, Connecticut 06856

Re: K012539

Trade/Device Name: VersaStep Regulation Number: 870.1390 Regulatory Class: II Product Code: GCJ Dated: August 6, 2001 Received: August 7, 2001

Dear Mr. McCoy:

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 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 requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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.

SEP = 6 2001

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Page 2 - Mr. Chester McCoy

This letter will allow you to begin marketing your device as described in your 510(k) premarket This letter will anon you of substantial equivalence of your device to a legally marketed notheation. The I Driving of succion 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 If you desire specific arriver diagnostic devices), please contact the Office of Compliance at additionally 607.10 for in This anglestions on the promotion and advertising of your device, (201) 594-1057. Traditionally, and (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small monifacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrb/dsma/dsmamain.html".

Sincerely yours,

Sus W.L. Ron

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

Enclosure

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V. Indications for Use

510(k) Number (if known): _ < ( 12539

Device Name: VersaStep*

Indications For Use:

Laparoscopic access to the abdominal cavity, both primary and secondary punctures 에
미 Thoracoscopic access to the thoracic cavity, both primary and secondary punctures

(Please do not write below this line - continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use: OR Over-The-Counter Use: (Per 21 CFR 801.109)

Sin Wall

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K012535

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.