STRYKER STILETTO ELECTROSURGICAL PROBE by Stryker Endoscopy

The Stryker Stiletto Electrosurgical Probe is indicated for use in laparoscopic surgical procedures, including laparoscopic general surgery, thoracic surgery, laparoscopic thoracic surgery, gynecological surgery, general surgery and urological surgery. The device allows for suction and irrigation of sterile irrigant solution, In addition, the device is intended to be used for electrosurqical cutting/coagulation during laparoscopic procedures.

Device Description

The Stryker Stiletto Electrosurgical Probe is a suction/irrigation probe with electrosurgical capability, composed of stainless steel, thermoplastic polymers (such as polyimide and PTFE) and thermoset polymers (like silicone rubber).

AI/ML Overview

The provided document is a 510(k) summary for the Stryker Stiletto Electrosurgical Probe. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with specific acceptance criteria and performance metrics for a new AI/software device. Therefore, much of the requested information regarding an "acceptance criteria and the study that proves the device meets the acceptance criteria" for an AI device cannot be directly extracted from this document.

However, I can extract the information relevant to the device's characteristics and the regulatory process, and explain why other requested details are not present.

Acceptance Criteria and Device Performance (as inferable from a 510(k) submission):

For a 510(k) submission like this, the "acceptance criteria" is typically centered around demonstrating substantial equivalence to a legally marketed predicate device. This means the new device is as safe and effective as the predicate. The "study" (or rather, the justification) involves showing that the new device does not raise new questions of safety or effectiveness and performs comparably to the predicate.

Given this context, here's what can be provided:

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Inferred from 510(k) Substantial Equivalence)	Reported Device Performance (as stated in 510(k))
Safety: Conforms to relevant safety standards for electrosurgical equipment and biological evaluation.	Conforms to: IEC 60601-2-2, ANSI/AAMI HF-18, ISO 10993, EN 552. No new safety questions raised compared to predicate.
Effectiveness/Performance: Operates as intended for electrosurgical cutting/coagulation and suction/irrigation, comparable to predicate.	Indicated for same laparoscopic surgical procedures (general, thoracic, gynecological, urological surgery). Allows for suction/irrigation and electrosurgical cutting/coagulation. No significant technological or performance differences from predicate.
Materials: Biocompatible and suitable for medical use.	Composed of stainless steel, thermoplastic polymers (polyimide, PTFE), and thermoset polymers (silicone rubber). Conforms to ISO 10993.
Intended Use: Similar indications for use as a legally marketed predicate device.	Identical Indications for Use to predicate (Stryker StrykeFlow Electrocautery Probes, K963765).

Sample size used for the test set and the data provenance: Not applicable. This document does not describe a clinical study with a "test set" in the context of an AI/software device. The demonstration of substantial equivalence relies on conformance to standards and comparison of device characteristics to a predicate, not performance on a dataset.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no mention of "ground truth" or expert review in this 510(k) submission, as it's not a study evaluating an AI/software device against expert interpretations.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. 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 applicable. This is for a manual surgical instrument, not an AI-assisted diagnostic or interpretative device.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is for a physical medical device, not a standalone algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. There is no ground truth data used in the context of evaluating an AI algorithm presented in this document. The "truth" for this device's regulatory pathway is its adherence to performance standards and its similarity to a predicate.
The sample size for the training set: Not applicable. The device is a physical electrosurgical probe, not a machine learning model, so there is no training set.
How the ground truth for the training set was established: Not applicable. There is no training set for this device.

Summary of Regulatory Finding:

The FDA determined that the Stryker Stiletto Electrosurgical Probe is substantially equivalent to the Strykeflow Electrocautery Probes (K963765). This determination is based on the new device having similar indications for use, technological characteristics, and conformance to recognized safety and performance standards, without raising new questions of safety or effectiveness.

Summary

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OCT 6 - 2005

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Endosconv

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Device Name	K052141
Proprietary Name:	Stryker Stiletto Electrosurgical Probe
Common and Usual Name:	Electrocautery Probe, Electrosurgical Probe
Classification Name:	Electrosurgical, Cutting & Coagulation Accessories

This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of the SMDA 1990.

The Stryker Stiletto Electrosurgical Probe is substantially equivalent in terms of safety and effectiveness to currently marketed devices, including the Strykeflow Electrocautery Probes (K963765).

The Stryker Stiletto Electrosurgical Probe is a new product developed by Stryker. The Stryker Stiletto Electrosurgical Probe is a suction/irrigation probe with electrosurgical capability, composed of stainless steel, thermoplastic polymers (such as polyimide and PTFE) and thermoset polymers (like silicone rubber).

The Stryker Stiletto Electrosurgical Probe is indicated for use in laparoscopic surgical procedures, including laparoscopic general surgery, thoracic surgery, laparoscopic thoracic surgery, gynecological surgery, general surgery and urological surgery. The device allows for suction of sterile irrigant solution. In addition, the device is intended to be used for electrosurgical cutting/coagulation during laparoscopic procedures.

The Stryker Stiletto Electrosurgical Probe conforms to the following voluntary safety and performance standards: IEC 60601-2-2 Particular Requirements for the Safety of High Frequency Surgical Equipment, ANSI/AAMI HF-18 Electrosurgical Devices, ISO 10993 Biological Evaluation of Medical Devices, EN 552 Sterilization of Medical Devices - Validation and Routine Control of Irradiation.

There are no significant technological or performance differences between the Stryker Stiletto Electrosurgical Probe and the identified predicate devices (Stryker StrykeFlow Electrocautery Probes, K963765), nor are there any new questions raised regarding safety or effectiveness, therefore, the Stryker Stiletto Electrosurgical Probe is substantially equivalent to the identified predicate devices and surgery systems.

Cuth Cay

・・.

ulatory Affairs Representative

8/5/05

Date:

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 6 - 2005

Crystal Ong Regulatory Affairs Representative Stryker Endoscopy 5900 Optical Court San Jose, California 95138

Re: K052141

Trade/Device Name: Stryker Stiletto Electrosurgical Probe Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: August 5, 2005 Received: August 9, 2005

Dear Ms. Ong:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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); 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.

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Page 2- Crystal Ong

This letter will allow you to begin marketing your device as described in your Section 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), please it you dealer eppenite an moliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Barbara Buellno

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number: K052141 Device Name: Stryker Stiletto Electrosurgical Probe

Indications for Use:

Contraindications:

The Stryker Stiletto Electrosurgical Probe is not indicated for use in hysteroscopic insufflation procedures. It is not to be used for intrauterine distention as it may result in an embolism.

Prescription Use_ (Part 21 CFR 801 Subpart D)

Over-The-Counter-Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Brown

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

510(k) Number
Stryker Stiletto Electrosurgical Probe 510(k) Submission
KOS2141

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Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.