The WalterLorenz Surgical Assist Arm Scope Holder is a manually operated surgical device intended to hold scopes (such as endoscopes, arthroscopes, etc) and accessories during general diagnostic procedures. The device is also intended to hold endoscopes during diagnostic and therapeutic neurologic procedures.
The WalterLorenz Surgical Assist Arm Scope Holder is a manually operated surgical instrument intended to hold scopes (such as endoscopes, etc) in a desired position during diagnostic, therapeutic, and surgical procedures (including neurologic procedures). The holder is manufactured from Stainless Steel and functions by the user manually tightening or loosening a knob, which opens and closes around a surgical scope. The device is intended to attach to the WalterLorenz Surgical Assist Arm, which is a Class 1, table-mounted, electromechanical holding arm that has many general surgical functions in addition to scope holding; it can also be used for instrument holding, retraction, and positioning.
This document is a 510(k) premarket notification for a medical device called the "WalterLorenz Surgical Assist Arm Scope Holder." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving effectiveness through clinical trials. As such, the document explicitly states that "Clinical testing was not necessary for the determination of substantial equivalence."
Therefore, the following information, typically found in studies proving device effectiveness, is not applicable to this 510(k) submission:
- A table of acceptance criteria and the reported device performance: This submission relies on substantial equivalence to predicate devices based on non-clinical performance data and similar indications for use, not on specific performance metrics against pre-defined acceptance criteria from a clinical study.
- Sample size used for the test set and the data provenance: Clinical testing was not performed; hence, there is no test set or related data provenance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there was no test set requiring ground truth establishment.
- Adjudication method for the test set: Not applicable as there was no test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: This device is a mechanical surgical assist arm, not an AI-powered diagnostic or assistive tool, so an MRMC study is not relevant.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable as this is a mechanical device, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable as there were no clinical studies generating such data.
- The sample size for the training set: Not applicable as this is a mechanical device, not an AI/ML algorithm.
- How the ground truth for the training set was established: Not applicable as this is a mechanical device, not an AI/ML algorithm.
However, the document does contain information about non-clinical performance data and acceptance criteria in a broader sense related to safety and effectiveness for substantial equivalence:
Acceptance Criteria and Device Performance (Non-Clinical):
The submission states: "Non-clinical testing met all established acceptance criteria." While the specific acceptance criteria and detailed performance metrics are not explicitly presented in this summary document, the FDA's clearance implies that the sponsor provided sufficient non-clinical data to demonstrate that the device performs as intended and is as safe and effective as the predicate devices. The non-clinical tests would typically address aspects like:
- Mechanical Integrity/Durability: Ability to securely hold scopes and accessories, withstand repeated use, and resist forces encountered during surgical procedures.
- Compatibility: Ability to attach to the WalterLorenz Surgical Assist Arm and hold a range of scope diameters.
- Sterilization Effectiveness: Validation that the recommended sterilization method (steam sterilization) is effective for the reusable device.
- Material Biocompatibility: Assurance that the stainless steel material is suitable for medical devices and does not pose undue risks.
Key Information from the Document:
- Device Name: WalterLorenz Surgical Assist Arm Scope Holder
- Indications for Use: The device is a manually operated surgical device intended to hold scopes (such as endoscopes, arthroscopes, etc.) and accessories during general diagnostic and therapeutic procedures, including neurologic procedures.
- Predicate Devices:
- Similarities to Predicate Devices (basis for substantial equivalence):
- Similar indications for use.
- Similar range of scope diameters accepted.
- Identical sterility (provided non-sterile, to be steam sterilized by end-user).
- Similar material (Stainless Steel).
- Non-Clinical Performance Data: "Non-clinical testing met all established acceptance criteria." (Specific details of these tests and criteria are not in this summary, but would have been submitted to the FDA).
- Clinical Performance Data: "Clinical testing was not necessary for the determination of substantial equivalence."
- Training Set (for AI/ML): Not applicable for this mechanical device.
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June 5, 2019
Biomet Microfixation Lauren Jasper Regulatory Affairs Project Manager 1520 Tradeport Drive Jacksonville, Florida 32218
Re: K190576
Trade/Device Name: WalterLorenz Surgical Assist Arm Scope Holder Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: March 4, 2019 Received: March 6, 2019
Dear Lauren Jasper:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
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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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Jennifer R. Stevenson Acting Division Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K190576
Device Name
WalterLorenz Sugical Assist Arm Scope Holder
Indications for Use (Describe)
The WalterLorenz Surgical Assist Arm Scope Holder is a manually operated surgical device intended to hold scopes (such as endoscopes, arthroscopes, etc) and accessories during general diagnostic procedures. The device is also intended to hold endoscopes during diagnostic and therapeutic neurologic procedures.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary - K190576
Prepared June 3, 2019
| Submitter: | Biomet Microfixation |
|---|---|
| 1520 Tradeport Drive | |
| Jacksonville, FL 32218 |
- Contact: Lauren Jasper, Regulatory Affairs Project Manager lauren.jasper@zimmerbiomet.com Telephone: (904) 741-9259 Fax: (904) 741-9425
Device Name: WalterLorenz Surgical Assist Arm Scope Holder
Common or Usual Name: Scope Holder
Classification Name: Endoscope and Accessories
Primary Device Classification:
| Product Code | ClassificationName | DeviceClassification | RegulationNumber | Regulation Description |
|---|---|---|---|---|
| OCV | EndoscopeHolder | 2 | 876.1500 | Endoscope and Accessories |
Secondary Device Classification:
| Product Code | Classification Name | Device Classification | Regulation Number | Regulation Description |
|---|---|---|---|---|
| GCJ | Laparoscope,General &PlasticSurgery | 2 | 876.1500 | Endoscope and Accessories |
Indications for Use: The WalterLorenz Surgical Assist Arm Scope Holder is a manually operated surgical device intended to hold scopes (such as endoscopes, etc) and accessories during general diagnostic and therapeutic procedures. The device is also intended to hold endoscopes during diagnostic and therapeutic neurologic procedures.
Device Description: The WalterLorenz Surgical Assist Arm Scope Holder is a manually operated surgical instrument intended to hold scopes (such as endoscopes, etc) in a desired position during diagnostic, therapeutic, and surgical procedures (including neurologic procedures). The holder is manufactured from Stainless Steel and functions by the user manually tightening or
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K190576
loosening a knob, which opens and closes around a surgical scope. The device is intended to attach to the WalterLorenz Surgical Assist Arm, which is a Class 1, table-mounted, electromechanical holding arm that has many general surgical functions in addition to scope holding; it can also be used for instrument holding, retraction, and positioning.
Predicate Devices:
Primary Predicate: K990334, KSEA (Karl Storz) Endoscope Holder Secondary Predicate: K070509, Fisso Holding Arm
The similarities of the subject device to the predicate devices are as follows:
- The indications for use are similar to that of the predicate devices.
- The range of scope diameters accepted by the scope holder is similar to that of the predicate devices.
- The sterility of the subject device is identical to that of the predicate devices.
- The material of the subject device is similar to that of the predicate devices.
Non-Clinical Performance Data: Non-clinical testing met all established acceptance criteria.
Clinical Performance Data: Clinical testing was not necessary for the determination of substantial equivalence.
Sterilization Information: The reusable scope holder is provided non-sterile to be sterilized by the end user using steam sterilization.
Substantial Equivalence: The proposed device has similar indications for use as the predicate devices. The submission demonstrates that (1) any differences in technological characteristics of the predicates do not raise any new questions of safety and (2) the proposed device is at least as safe and effective as the predicates. It is concluded that the information included in this summary supports substantial equivalence.
§ 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.