(90 days)
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Not Found
No
The provided text describes a hardware system for endoscopic procedures and does not mention any AI or ML components or functionalities.
Yes
The device is described as providing "the means for endoscopic diagnostic and therapeutic surgical procedures" and lists examples of therapeutic procedures such as "ablation, biopsy, incision, and resection of tissue."
Yes
The "Intended Use / Indications for Use" and "Device Description" sections explicitly state that the system is intended for "endoscopic diagnostic and therapeutic surgical procedures" and provides "the user with the means for endoscopic diagnostic and therapeutic surgical procedures."
No
The device description explicitly states it is a "Hardware System" composed of physical components like endoscopes, sheaths, accessories, and applied parts. It does not mention any software as the primary or sole component.
Based on the provided information, 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. They are used outside of the body (in vitro).
- Device Description and Intended Use: The description clearly states the device is used for endoscopic diagnostic and therapeutic surgical procedures performed within the body (in vivo). It involves visualization, manipulation, ablation, biopsy, incision, and resection of tissue directly within the urological and gynecological anatomy.
- Lack of Mention of Samples: There is no mention of the device being used to analyze samples taken from the body.
The Stryker Urology and Gynecology Hardware System is a surgical device used for minimally invasive procedures performed directly on the patient's anatomy. This falls under the category of surgical instruments or systems, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Stryker Urology and Gynecology Hardware System is intended to provide the user with the means for endoscopic diagnostic and therapeutic surgical procedures. Examples of use of the product include the visualization and manipulation of anatomy, ablation, biopsy, incision, and resection of tissue, and/or as the surgeon deems appropriate. The system is intended for use in general urological and gynecological surgery through the minimally invasive approach, by utilizing natural orifices to access the surgical site. The system's use is intended for, but not limited to the following types of procedures:
Dilation of the urethra, and cold-slitting of urethral strictures
Trans-urethral incision and resection of the prostate
Trans-urethral removal of bladder tumors
Trans-cervical resection and ablation of the endometrium
Trans-cervical resection of fibroids
Product codes (comma separated list FDA assigned to the subject device)
78 KOG, FAJ, FAS, KQT
Device Description
The Stryker Urology and Gynecology Hardware System is composed of endoscopes, sheaths, accessories, and applied parts which provide the user with the means for endoscopic diagnostic and therapeutic surgical procedures.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Urethra, prostate, bladder, cervix, endometrium, uterus
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 884.1690 Hysteroscope and accessories.
(a)
Identification. A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for hysteroscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such hysteroscope accessory instruments include: lens cleaning brush, cannula (without trocar or valves), clamp/hemostat/grasper, curette, instrument guide, forceps, dissector, mechanical (noninflatable), and scissors. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.
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K040390
Page 1 of 2
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Device Name
| Proprietary Name: | Stryker Urology and Gynecology Hardware System |
|---|---|
| Common and Usual Name: | Scope, Obturator, Working Element, Sheath, Bridge, |
| Electrode, Albarran Deflector, Timberlake Obturator, | |
| Cutting Loop, Roller Ball, Cold Knives, | |
| Dilator/Sound/Bougie, Bladder Syringe, Ellik | |
| Evacuator, Forceps | |
| Classification Name: | Endoscope and accessories, Cystoscopes, |
| Hysteroscope, Resectoscope, Sheaths, Electrode, | |
| Urethrotome, Dilators, Evacuator, Non-Electric Biopsy | |
| Forceps, G-U, Surgical Instruments |
The Stryker Urology and Gynecology Hardware System is substantially equivalent in terms of safety and effectiveness to many currently marketed devices and surgery systems currently marketed by Henke Sass Wolf, Omnitech Systems, GIMMI, and ACMI.
The Stryker Urology and Gynecology Hardware System is an extension of the Hystero-Resectoscope and Accessories as currently marketed by Stryker and OEM suppliers Henke Sass Wolf and Omnitech Systems. The Stryker Urology and Gynecology Hardware System is composed of endoscopes, sheaths, accessories, and applied parts which provide the user with the means for endoscopic diagnostic and therapeutic surgical procedures.
The Stryker Urology and Gynecology Hardware System is intended to provide the user with the means for endoscopic diagnostic and therapeutic surgical procedures. Examples of use of the product include the visualization and manipulation of anatomy, ablation, biopsy, incision, and resection of tissue, and/or as the surgeon deems appropriate. The system is intended for use in general urological and gynecological surgery through the minimally invasive approach, by utilizing natural orifices to access the surgical site. The system's use is intended for, but not limited to the following types of procedures:
Dilation of the urethra, and cold-slitting of urethral strictures
Trans-urethral incision and resection of the prostate
Trans-urethral removal of bladder tumors
Trans-cervical resection and ablation of the endometrium
Trans-cervical resection of fibroids
Contraindications:
Acute Pelvic Inflammatory Disorder (PID) Hysteroscopy may be contraindicated by the following conditions, depending on their severity or extent:
Inability to distend the uterus Cervical stenosis Cervical/vaginal infection Uterine bleeding or menses Known pregnancy Invasive carcinoma of the cervix Recent uterine perforation
The Stryker Urology and Gynecology Hardware System conforms to the following performance standards: IEC 60601-1 safety and voluntary Medical Electrical Equipment - General Requirements for Safety, IEC 60601-2-2 Medical Electrical Equipment - General Requirements for Safety, Collateral Standard, Electromagnetic Compatibility, IEC 60601-2-18 Particular Requirements for the Safety of Endoscopic Equipment, ANSI/AAMI HF-18 Electrosurgical Devices, ISO 10993 Biological Evaluation of Medical Devices.
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K04039i
fuge 2f2
There are no significant technological or performance differences between the Stryker Urology and Gynecology Hardware System and the identified predicate devices and surgery Orology and "Gynoology" hardware ons raised regarding safety or effectiveness, therefore, the Stryker Urology and Gynecology Hardware System is substantially equivalent to the identified predicate devices and surgery systems.
Contact:
Christopher L. Cook
Date:
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/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 7 2004
Mr. Christopher L. Cook Quality Engineer Stryker Endoscopy 5900 Optical Court SAN JOSE CA 95138
Re: K040390 Trade/Device Name: Stryker Urology and Gynecology Hardware System Regulation Number: 21 CFR 884.1690 Regulation Name: Hysteroscope and accessories Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscope electrosurgical unit and accessories Regulation Number: 21 CFR 876.4370 Regulation Name: Gastroenterology-urology-urology evacuator Regulatory Class: II Regulatory Class HIH, and 78 KOG, FAJ, FAS, and KQT Dated: February 10, 2004 Received: February 17, 2004
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 (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 fisting (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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will and if you to organ and equivalence of your device of your device to a legally premaired 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 dosh bpooms at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx. Ixxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, to Compliance at (301) 594-4639. 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 may be obtained from the Division of Small miormation on your roopener 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
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Device Name: Stryker Urology and Gynecology Hardware System
Indications for Use:
The Stryker Urology and Gynecology Hardware System is intended to provide the user with the means for The Stryker Urology and Gylecology Hauware oyselling in the product include the product include the endoscopic diagnostic and therapeulic surgical procedures: cicision, and resea, andro as
visualization and manipulation of anatomy, aslation, and researchirel and gunecol visualization and manipulation of any and one in eneral underse and grecological and grecological and grecological and grecological site the surgeon deems appropriate. surgery through the minimally invasite up to following types of procedures:
The system's use is intended for, but not limited to the following the
Dilation of the urethra, and cold-slitting of urethral strictures
Trans-urethral incision and resection of the prostate
Trans-urethral removal of bladder tumors
Trans-cervical resection and ablation of the endometrium
Trans-cervical resection of fibroids
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
And of heym Over-The-Counter-Use_
(Division Sign-Off) (Division Sign-On)
Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number .