(102 days)
Not Found
No
The description explicitly states the software "does not perform calculations" and "only relays Force FX functions and controls". There is no mention of AI, ML, or related concepts.
No
The device is described as an interface control box and connector to display and control electrosurgical generator parameters, but it does not directly perform any therapeutic function on a patient.
No
The device is an interface control box that displays and relays control parameters of an electrosurgical generator. It does not perform calculations or analyze data to diagnose a condition. Its purpose is to facilitate the surgeon's control of another device, not to provide diagnostic information.
No
The device description explicitly states it is an "interface control box" and a "connector box," indicating it includes hardware components in addition to software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is an "interface control box" that connects a computer to an electrosurgical generator. Its purpose is to display and control the generator's parameters for the surgeon.
- No Sample Analysis: There is no mention of the device analyzing any biological samples or performing any diagnostic tests on patient specimens.
- Focus on Control and Display: The primary function described is the relaying of "Force FX functions and controls" and displaying them on a monitor.
Therefore, the device's function is related to controlling and monitoring a surgical tool (electrosurgical generator) and does not involve in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Storz Communication Bus/ValleyLabs Force FX Control is an interface control box between the SCB computer and the electrosurgical generator. It contains software to display ValleyLab Force FX electrosurgical generator's control parameters on a SCB computer and screen. The Interface Unit serves as a connector box from the Force FX unit to the SCB compatible computer. The unit's software does not perform calculations. It only relays Force FX functions and controls on the SCB monitor for the surgeon's convenient control.
Product codes
78 KOG
Device Description
The Karl Storz SCB/ValleyLab Force FX Control connects a Storz Communication Bus computer to the ValleyLab Force FX electrosurgical generator. It enables the SCB computer to display and control the FX's functions.
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the text 'K041912' in a simple, handwritten style. The characters are clearly legible, with a mix of a letter and numbers. The text appears to be a code or identifier, possibly a serial number or a reference code.
1 25 2004 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) 558-1500 |
|------------------------|---------------------------------------------------------------------------------------------------------------|
| Contact: | Kam H. Leung, Ph.D.
(800) 421-0837 x 5386 |
| Device Identification: | Remote Control
SCB/ValleyLab Force FX Control |
Indication: The Storz Communication Bus/ValleyLabs Force FX Control is an interface control box between the SCB computer and the electrosurgical generator. It contains software to display ValleyLab Force FX electrosurgical generator's control parameters on a SCB computer and screen. The Interface Unit serves as a connector box from the Force FX unit to the SCB compatible computer. The unit's software does not perform calculations. It only relays Force FX functions and controls on the SCB monitor for the surgeon's convenient control.
Device Description: The Karl Storz SCB/ValleyLab Force FX Control connects a Storz Communication Bus computer to the ValleyLab Force FX electrosurgical generator. It enables the SCB computer to display and control the FX's functions.
Substantial Equivalence: The Karl Storz SCB/ValleyLab Force FX Interface Unit is substantially equivalent to the predicate device since the basic features and intended uses are the same. The minor differences between the Karl Storz SCB-ValleyLabs Force FX Interface Unit and the predicate device 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:
Kwan H. Lee, Ph.D.
Kam H. Leung, Ph.D. Senior Regulatory Specialist.
00.30 K041912
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features an eagle with its wings spread, and three lines extending from the eagle's head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
OCT 2 5 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Susie S. Chen Director, Regulatory Affairs Karl Storz Endoscopy - America, Inc. 600 Corporate Point 5th Floor CULVER CITY CA 90230-7600
Re: K041912
Trade/Device Name: SCB/ValleyLab FX Interface Unit Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: 78 KOG Dated: September 27, 2004 Received: September 30, 2004
Dear Ms. Chen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have and have determined the device is substantially equivalent (for the indications for use stated in above and have actering marketed predicate devices marketed in interstate commerce prior to the cholosate) to regardy manage of the Medical Device Amendments, or to devices that have been May 20, 1770, the classified in the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that recrassmed in accordantes approval application (PMA). You may, therefore, market the do not require approvisions 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 n your de roo is creen additional controls. Existing major regulations affecting your I ipproval), it 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 statues and regulations administered by other Federal agencies. You must comply with all the I oderal blaires and 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
This letter will allow you to begin marketing your device as described in your Section 510(k) Prins lotet notification. The FDA finding of substantial equivalence of your device to a legally promaticated 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 If you dobe of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Nancy C. brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATION FOR USE STATEMENT
510(k) Number (if known): K04 1912
Device Name: SCB/ValleyLabs Force FX Interface Unit
NON-STERILE REUSABLE COMPONENT
non-sterile, the interface unit must be covered with a sterile cover before use.
INTENDED USE: The Storz Communication Bus/ValleyLabs Force FX Control is an INTENDED USE. The Storz Commismourier and the electrosurgical generator. It contains software to display ValleyLab Force FX electrosurgical generator's control parameters on a SCB computer and screen. The Interface Unit serves as a connector box parameters on a SCB compater and seream. The unit's software does not from the Force T'A unit to the BD companse of the functions and controls on the SCB monitor for the surgeon's convenient control.
STORZ
Karl Storz Endoscopy
| Karl Storz | 600 Corporate Pointe | Phone 310 558 1500 |
|---|---|---|
| Endoscopy-America, Inc. | Culver City, CA 90230-7600 | Toll Free 800 421 0837 |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K041912 |
| Prescription Use | OR | Over-The-Counter Use | |
|---|---|---|---|
| ------------------ | ----------------------------------------------------------------------------------------------------------------------------------- | ---- | ---------------------- |
(Ontinnal Format 3-10-98)
(Per 21 C.F.R. 801.109)