(132 days)
Not Found
No
The summary describes a flexible endoscope with mechanical features and does not mention any AI/ML components or image processing capabilities.
Yes
The "Intended Use / Indications for Use" states it is intended for "performing diagnostic and therapeutic procedures."
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended for "examining the uning tract and the interior of the kidney, and, using additional accessories, performing diagnostic and therapeutic procedures." The term "examining" and "diagnostic procedures" clearly indicate its use in diagnosis.
No
The device description explicitly states it is a "flexible endoscope with active deflection capability," which is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used during minimally invasive urological procedures to examine the urinary tract and kidney and perform diagnostic and therapeutic procedures. This involves direct interaction with the patient's body.
- Device Description: The description confirms it's a flexible endoscope used for visualization and procedures within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health. IVDs are typically used in laboratories or point-of-care settings to analyze samples.
Therefore, the Stryker Flexible CystoNephroscope is a medical device used for in-vivo procedures, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Stryker Flexible CystoNephroscope is indicated for use during minimally invasive urological procedures through natural body offices or through percutaneous access, and is intended for but not limited to, examining the urinary tract and the interior of the kidney, and, using additional accessories, performing diagnostic and therapeutic procedures.
Product codes
78 FAJ, FGA
Device Description
The Stryker Flexible CystoNephroscope is a modification of the currently marketed Stryker Flexible Ureteroscope, with changes to labeling, performance, materials, and intended use. The Stryker Flexible CystoNephroscope is Substantially Equivalent to the currently marketed ACMI ACN-2 11001 DD Nephro-Fiberscope (K970427). The Stryker Flexible CystoNephroscope is a flexible endoscope with active deflection capability.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Urinary tract, interior of the kidney
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)
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
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
K0430yy
Device Name
| Proprietary Name: | Stryker Flexible CystoNephroscope |
|---|---|
| Common and Usual Name: | Endoscope, Cystoscope, Nephroscope |
| Classification Name: | Endoscope, Cystoscope, Nephroscope |
This 510(k) summary of safety and effectiveness is being submitted in accordance with requirements of the SMDA 1990.
The Stryker Flexible CystoNephroscope is substantially equivalent in terms of safety and The Stryker Flexible CystoNephroscope is Substantially Equivalin in Childer Collection Corporation of Corporation of Storz
effectiveness to the currently marketed ACMI ACN-2 11001 DD Nephro-Fiberscope (K970427).
The Stryker Flexible CystoNephroscope is a modification of the currently marketed Stryker The Stryker Flexible Cystolephroscope is a mounce, materials, and intended use. The Stryker
Flexible Ureteroscope, with changes to labeling, performance, mad intended use. Flexible Ureteroscope, with changes to abeling, peromance, ma interess and and of the country of the country of the more in interest of the first Plexible CyStoricphroooops of active deflection capability.
The Stryker Flexible CystoNephroscope is indicated for use during minimally invasive urological The Stryker Flexible Cystonephilosope is through perculaneous access, and is intended for but not
procedures through natural body offices or through perculaneous accessories, procedures through natural body offices of the intent of the kidney, and, using additional accessories,
limited to, examining the uning tract and the intenseduces illulled to, examining the and therapeutic procedures.
The Stryker Flexible CystoNephroscope conforms to the following voluntary safety of Endossanio The Stryker Flexible CystonesticsCope Connemis to the Stocking Comments for the Safety of Endoscopic Equipment, ISO 10993 Biological Evaluation of Medical Devices.
There are no significant technological or performance differences between the Stryter Flexible There are no significant technological of penomance there any new questions raised
CystoNephroscope and the identified predicale devices , nor are there any new substantially CystoNephroscope and the Identified predicate devices, nor and any any any and equivalent to the identified predicate devices.
Contact:
11/1/04
Date:
Christopher L. Cook
Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 Phone: 408-754-2288 408-754-2521 Fax: Email: chris.cook@stryker.com
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Image /page/1/Picture/2 description: The image shows a logo for the Department of Human Services. The logo features a stylized eagle with three lines representing its wings. The text "Department of Human Services" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 5 2005
Mr. Christopher L. Cook Regulatory Supervisor Stryker Endoscopy 5900 Optical Court SAN JOSE CA 95138
Re: K043022
Trade/Device Name: Stryker Flexible CystoNephroscope Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: 78 FAJ and FGA Dated: February 16, 2005 Received: February 17, 2005
Dear Mr. Cook:
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 (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 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
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter with anow you to ocgin maxing of substantial equivalence of your device to a legally premarket notification: "The PDA mianing of bassanian 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 desire specific advice for your de roo 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 the Also, please note the regulation entitled, formation on your responsibilities under the Act from the 807.77). " Ou may obtain other general 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/industry/support/index.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
Device Name: Stryker Fiexible CystoNephroscope
1 : 420 %
Indications for Use:
The Stryker Flexible CystoNephroscope is indicated for use during minimally invasive undigital The Stryker Flexible Cystonephosope is number on through percularies and is intended for procedures accessed through the united on the interior of the kidney, and, using additional
but not limited to, examining the unities and the interprogrammand but not limited to, examining the ennaly and therapeutic procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IE NEEDED) TE DELOW THOLE. Of CDRH, Office of Device Evaluation (ODE)
Kaila Lyons
(Division Sign-Off) Division of Reproductive, Abdominal and Badiological Devices 510(k; Number ________________________________________________________________________________________________________________________________________________________________
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter-Use_