(106 days)
Not Found
No
The summary describes a mechanical scope holder and makes no mention of AI or ML.
No
The provided text describes an accessory used during surgical procedures to hold endoscopes; it does not describe a device that directly treats a disease or condition.
No
The device is described as an accessory to hold endoscopes steady and allow for rapid repositioning during surgical procedures. Its function is to assist in surgical procedures, not to diagnose conditions.
No
The device description explicitly states it is composed of physical materials (aluminum, stainless steel, PVC, PEEK), indicating it is a hardware device, not software-only.
Based on the provided information, the Stryker Scope Holder is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used to hold endoscopes steady during surgical procedures. This is a mechanical function performed on the patient during surgery, not a test performed on a sample taken from the patient to diagnose a condition.
- Device Description: The description details the materials and function of a mechanical holder.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other typical components or processes associated with in vitro diagnostics.
IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The Stryker Scope Holder does not perform this function.
N/A
Intended Use / Indications for Use
The Stryker Scope Holder is indicated for use in arthroscopic, nasal, abdominal and laparoscopic surgical procedures, including laparoscopic general surgery, thoracic surgery, and endoscopic surgery. The device is intended to hold endoscopes steady in a desired position during the previously mentioned procedures. In addition, the device allows for the rapid repositioning of these endoscopes, laparoscopes and accessories during these procedures.
Product codes
GCJ
Device Description
The Stryker Scope Holder is a new product developed by Stryker Scope Holder is an endoscopic accessory, composed of aluminum, stainless steel, PVC and PEEK.
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)
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
booss
5900 Optical Court San Jose, CA 95138 t: 408 754 2491 f: 408 754 2521 www.stryker.com
Stryker®
Endoscopy
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Device Name
| Proprietary Name: | Stryker Scope Holder |
|---|---|
| Common and Usual Name: | Endoscope Holder |
| Classification Name: | Laparoscope, General & Plastic Surgery, Endoscope and/or Accessories |
This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of the SMDA 1990.
The Stryker Scope Holder is substantially equivalent in terms of safety and effectiveness to currently marketed devices, including the Kronner Low Profile Scope Holder (K000663).
The Stryker Scope Holder is a new product developed by Stryker Scope Holder is an endoscopic accessory, composed of aluminum, stainless steel, PVC and PEEK.
The Stryker Scope Holder is indicated for use in arthroscopic, nasal, abdominal and laparoscopic surgical procedures, including laparoscopic general surgery, and endoscopic surgery. The device is intended to hold endoscopes steady in a desired position during the previously mentioned procedures. In addition, the device allows for the rapid repositioning of these endoscopes, laparoscopes and accessories during these procedures.
The Stryker Scope Holder conforms to the following voluntary safety and performance standards: IEC 60601-1 Medical electrical equipment - Part 1: General requirements for safety, IEC 60601-2-18 Medical electrical equipment - Part 2: Particular requirements for the safety of endoscopic equipment, IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests, IEC 60601-1-4 Collateral Standard: Programmable Electrical Medical Equipment, UL 60601-1 Medical Electrical Equipment, Part 1: General Requirements for Safety, and EN 554 Sterilization of medical devices Validation and routine control of sterlization by moist heat. In addition, the nitrogen tank will be a DOT 39 non-refillable compressed gas tank. The nitrogen used (ID # UN1066) is an identified material on the Hazardous Materials Table in DOT 49 CFR 172.101 and will adhere to the specified shipping requirements.
There are no significant technological or performance differences between the Stryker Scope Holder and the identified predicate device (Kronner Low Profile Scope Holder (K000663), nor are there any new questions raised regarding safety or effectiveness, therefore, the Stryker Scope Holder is substantially equivalent to the identified predicate devices and surgery systems.
eunk cox
Regulatory I ffairs Representative
April 11 2006
Date:
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Stryker Endoscopy c/o Ms. Crystal Ong Regulatory Affairs Representative 5900 Optical Court San Jose, California 95138
APR 2 7 2006
Re: K060085
Trade/Device Name: Stryker Scope Holder Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: April 6, 2006 Received: April 12, 2006
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. Iisting 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
2
Page 2 - Ms. Kathleen Burns
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. 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 contact the Office of Compliance 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.
Sor Mark N. Melkerson
Director
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Kobco8sΓ
510(k) Number: K060085 Device Name: Stryker Scope Holder
Indications for Use:
The Stryker Scope Holder is indicated for use in arthroscopic, nasal, abdominal and laparoscopic surgical procedures, including laparoscopic general surgery, thoracic surgery, and endoscopic surgery. The device is intended to hold endoscopes steady in a desired position during the previously mentioned procedures. In addition, the device allows for the rapid repositioning of these endoscopes, laparoscopes and accessories during these procedures.
Prescription Use (Per 21 CFR 801 Subpart D)
OR
Over-The-Counter-Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-( ff) Division of General, M. storative, and Neurological De ... es
510(k) Number K061185
Stryker Scope Holder 510(k) Submission 3 of 12