(77 days)
Not Found
Not Found
No
The summary describes a manual surgical device that uses high-frequency electrical current for tissue manipulation. There is no mention of AI, ML, image processing, or any data-driven decision-making components.
No
The device is a surgical tool used to resect, ablate, or coagulate tissue, which are actions typically associated with treatment rather than diagnosis or therapy aimed at improving health. While part of a medical procedure, its function is not primarily therapeutic.
Yes
The "Intended Use / Indications for Use" section explicitly lists "bladder tumor diagnosis" as one of the procedures for which the device is intended.
No
The device description explicitly states it is a "manual surgical device, featuring a working element, a single-use cutting loop, and a high frequency cable," which are all hardware components.
Based on the provided information, the KSEA Bipolar Electrotome is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes a surgical device used in vivo (within the body) for resecting, ablating, or coagulating tissue during endoscopic urological procedures. IVD devices are used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description: The description details a manual surgical device with components like a cutting loop and cable, designed for direct interaction with tissue inside the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples, reagents, or providing diagnostic information based on laboratory testing.
Therefore, the KSEA Bipolar Electrotome is a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The KSEA Bipolar Electrotome is intended for use in combination with a resectoscope and a sheath by qualified surgeons to resect, ablate or coagulate tissue via a high frequency electrical current waveform during various endoscopic urological procedures. These procedures include bladder tumor diagnosis and resection, transurethral prostatic and bladder biopsy, transurethral prostatic resection, removal of urethral calculus, and treatment of vesical neck constriction.
Product codes
FAS
Device Description
The KSEA Bipolar Electrotome is a manual surgical device, featuring a working element, a single-use cutting loop, and a high frequency cable. It is designed to be used with a 4 mm resectoscope and a 24 or 26 Fr resectoscope sheath.
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
qualified surgeons
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo for Karl Storz Endoscopy. The logo is in white text on a dark background. The word "STORZ" is in large, bold letters, with a circle in the middle of the "O". Below the word "STORZ" is the phrase "KARL STORZ ENDOSCOPY" in smaller letters.
K06154/
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document is accurate and complete to the best of KSEA's knowledge.
| Applicant: | Karl Storz Endoscopy - America, Inc. |
|---|---|
| 600 Corporate Pointe Drive | |
| Culver City, CA 90230 | |
| (310) 338-8100 |
| AUG 2 1 2006 | |
|---|---|
| -- | -------------- |
Contact:
James A. Lee Senior Regulatory Affairs Specialist
Device Identification: Common Name: Bipolar Working Element/Cutting Loop/Cable
Trade Name: (optional) The KSEA Bipolar Electrotome
Indication: The KSEA Bipolar Electrotome is intended for use in combination with a resectoscope and a sheath by qualified surgeons to resect, ablate or coagulate tissue via a high frequency electrical current waveform during various endoscopic urological procedures. These procedures include bladder tumor diagnosis and resection, transurethral prostatic and bladder biopsy, transurethral prostatic resection, removal of urethral calculus, and treatment of vesical neck constriction.
Device Description: The KSEA Bipolar Electrotome is a manual surgical device, featuring a working element, a single-use cutting loop, and a high frequency cable. It is designed to be used with a 4 mm resectoscope and a 24 or 26 Fr resectoscope sheath.
Substantial Equivalence: The KSEA Bipolar Electrotome is substantially equivalent to the predicate devices since the basic features, dimensions, stainless steel, insulation materials and intended uses are similar. The minor differences between the KSEA Bipolar Electrotome and the predicate devices raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or intended use of these devices.
Signed:
A:
James A. Lee, Ph.D. Senior Regulatory Affairs Specialist
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
AUG 2 1 2006
James A. Lee, Ph.D. Senior Regulatory Affairs Specialist Karl Storz Endoscopy-America, Inc. 600 Corporate Pointe CULVER CITY CA 90230
Re: K061541
Trade/Device Name: KSEA Bipolar Electrotome Regulation Number: 21 CFR §876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: FAS Dated: August 3, 2006 Received: August 4, 2006
Dear Dr. Lee:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Bocton 9 rotty production is substantially equivalent (for the indications for reletect above and nave accemined arketed predicate devices marketed in interstate commerce use stated in the enotobare) to togally date of the Medical Device Amendments, or to devices that phot to May 20, 1970, and chances with the provisions of the Federal Food, Drug, and Cosmetic have bech recassified in accordance wif a premarket approval application (PMA). You may, Act (Act) that do flor roquire apple far the general controls provisions of the Act. The general therefore, mailier the device, saloject to an essent 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 IT your device is olassilled (500 a0010) within al controls. Existing major regulations affecting your Approval), it thay of subject to such adeitions, Title 21, Parts 800 to 898. In addition, FDA device can be found in the cements concerning your device in the Federal Register.
Image /page/1/Picture/10 description: The image shows a logo with the text "FDA Centennial 1906-2006". The logo is circular and contains the letters "FDA" in a stylized font. The text "Centennial" is written below the letters. The words "oling Public Health" are written in a decorative font below the logo.
2
Page 2 -
l,
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Prease be advised that I Dri- 3 issuates of a substition.
that FDA has made a determination that your device complies with other requirements of the Act that I DA has made a dolorimiation administered by other Federal agencies. You must of ally reach statutes and regaranents ancluding, but not limited to: registration and listing (21 Comply with an the Act 31equirements, morations, were and manufacturing practice requirements as set CFK Part 807), labeling (21 CFR Part 820); and if applicable, the electronic (200); and if applicable, the electronic (200 forth in the quality systems (QD) regarders (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) i his letter will anow you to begin manusing of substantial equivalence of your device to a legally premarket notification: "The PDA mialing of casion 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 desire specific advice for your he following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" Also, picase note the regulation other general information on your responsibilities under (21CFK Fall 607.77). Tod maj octain offer and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Image /page/3/Picture/0 description: The image shows the logo for Karl Storz Endoscopy. The logo consists of the word "STORZ" in large, bold letters, with a circular design in the middle of the word. Below the word "STORZ" is the text "KARL STORZ ENDOSCO". The logo is black and white.
510(k) Number (if known): K061541
Device Name: KSEA Bipolar Electrotome
Indications for Use: The KSEA Bipolar Electrotome is intended for use in combination with a resectoscope and a sheath by qualified surgeons to resect, ablate or coagulate tissue with a resercedope and a bitcher courtent waveform during various endoscopic urological via a nigh nequency ocedures include bladder tumor diagnosis and resection, procedures: These prossit and bladder biopsy, transurethral prostatic resection, removal of urethral calculus, and treatment of vesical neck constriction.
(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 Subpart D) (Per 21 CFR 801 Subpart C)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
| 510(k) Number | K061541 |
|---|---|
| --------------- | --------- |