(106 days)
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.
The Stryker Scope Holder is an endoscopic accessory, composed of aluminum, stainless steel, PVC and PEEK.
The provided text describes a 510(k) summary for the Stryker Scope Holder, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study proving a device meets specific performance criteria in the way a clinical trial for a novel AI algorithm would.
Therefore, many of the requested categories for acceptance criteria and study details are not directly applicable to this document. The information provided is primarily related to regulatory approval based on demonstrating equivalence, not a performance study against predefined benchmarks.
Here's how the requested information maps to the provided text, along with an explanation for categories that are not applicable:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety and Effectiveness Equivalence: Substantially equivalent in terms of safety and effectiveness to currently marketed devices. | Substantially Equivalent: The Stryker Scope Holder is substantially equivalent in terms of safety and effectiveness to the Kronner Low Profile Scope Holder (K000663). No new questions raised regarding safety or effectiveness. |
| Compliance with Voluntary Standards: Adherence to specified safety and performance standards. | Conforms to Standards: IEC 60601-1, IEC 60601-2-18, IEC 60601-1-2, IEC 60601-1-4, UL 60601-1, EN 554. Nitrogen tank (UN1066) adheres to DOT 49 CFR 172.101 shipping requirements. |
| Intended Use: Device performs as intended to hold and reposition endoscopes during various surgical procedures. | Indicated Use: Intended to hold endoscopes steady and allow rapid repositioning in arthroscopic, nasal, abdominal, laparoscopic, general, and endoscopic surgical procedures. |
| Technological/Performance Differences: No significant differences compared to the predicate device. | No Significant Differences: There are no significant technological or performance differences between the Stryker Scope Holder and the identified predicate device. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not Applicable. This document describes a 510(k) submission, which relies on demonstrating substantial equivalence to a predicate device, not on a performance study with a test set of data. Clinical data from human subjects or retrospective/prospective studies are not mentioned or required for this type of submission for this device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not Applicable. Ground truth, in the context of expert consensus, is not relevant to this 510(k) submission. There is no mention of a test set requiring expert adjudication.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. No test set or expert adjudication method is mentioned or required for this 510(k) submission.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This document describes a physical medical device (scope holder), not an AI-powered diagnostic or assistive technology that would involve human readers or MRMC studies.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a physical tool, not an algorithm. Therefore, "standalone" performance in the context of AI algorithms is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable. For this 510(k) submission, "ground truth" as it relates to establishing the accuracy of a diagnostic or predictive algorithm is not applicable. The primary "truth" being established is that the device is substantially equivalent to a legally marketed predicate and is safe and effective for its intended use. This is achieved through engineering assessment, comparison to standards, and comparison to the predicate device, not through clinical ground truth data in the usual sense.
8. The sample size for the training set
- Not Applicable. This document describes a physical medical device, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set for a machine learning model, the establishment of ground truth for such a set is not applicable.
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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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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
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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)
2
(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
§ 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.