(59 days)
NOT APPLICABLE
No
The summary describes a standard electrosurgical probe with suction and irrigation capabilities and makes no mention of AI or ML.
No.
The document indicates that the device is an electrosurgical probe intended for cutting and coagulation during surgical procedures, not for therapeutic treatment of a condition or disease.
No
Explanation: The device is an electrosurgical probe used for cutting and coagulation, as well as suction and irrigation during laparoscopic procedures. It is a therapeutic device, not a diagnostic one.
No
The device description explicitly states it is composed of physical materials like stainless steel and polymers, indicating it is a hardware device with electrosurgical capabilities, not software only.
Based on the provided information, the Stryker Stiletto Electrosurgical Probe is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for use in laparoscopic surgical procedures for cutting and coagulation, as well as suction and irrigation. This is a surgical device used directly on a patient during a procedure.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The Stryker Stiletto does not perform this function.
- Device Description: The description details the materials and function as a surgical probe, not a device for analyzing biological samples.
Therefore, the Stryker Stiletto Electrosurgical Probe falls under the category of a surgical instrument rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
GEI
Device Description
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Strykeflow Electrocautery Probes (K963765)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
2
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
3
510(k) Number: K052141 Device Name: Stryker Stiletto Electrosurgical Probe
Indications for Use:
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.
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)
OR
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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