(126 days)
The Armand Endoscope Holder is intended for use by surgeons for holding rigid and flexible endoscopes with diameters from 14.6mm to 15.8mm during diagnostic and therapeutic procedures.
The Armand Endoscope Holder is a manually operated surgical device. It is composed of surgical grade stainless steel and anodized aluminum. The holder consists of a table clamp, adjustable stainless steel rods, and an endoscope clamp. The endoscope clamp is designed to hold endoscopes in diameter from 14.6mm to 15.8mm. The device uses a single knob clamp assembly to hold the endoscope and a single knob to tighten and lock the stainless steel rods into the desired position.
The provided 510(k) submission (K050051) for the Armand Endoscope Holder does not contain information about acceptance criteria or a study demonstrating the device meets such criteria in the way typically expected for performance claims in medical imaging or diagnostic AI devices.
This submission is for a manually operated surgical device (an endoscope holder). Its equivalence is based on its technological characteristics (materials, description, application, and function) to predicate devices, not on performance metrics derived from a clinical or analytical study with ground truth and statistical analysis.
Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, experts, adjudication, MRMC, standalone performance, and ground truth establishment cannot be found in this document because they are not relevant to the type of device and the pathway chosen (substantial equivalence based on technological characteristics).
Here's why and what can be extracted:
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated as performance metrics. The underlying acceptance criterion for this type of device is "substantial equivalence" to predicate devices in materials and function.
- Reported Device Performance: The document only describes the device's physical attributes and intended function (holding endoscopes of a specific diameter). It doesn't report performance metrics like accuracy, sensitivity, or specificity, as these are not applicable to an endoscope holder.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable. There was no "test set" in the context of performance evaluation for this device. The evaluation was based on a comparison of design and intended use specifications to predicate devices.
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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. No ground truth establishment was performed, as it's not relevant for a mechanical device like an endoscope holder.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No test set requiring adjudication.
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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 device is a mechanical endoscope holder, not an AI or imaging device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a mechanical endoscope holder, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. No ground truth used.
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The sample size for the training set:
- Not applicable. No training set was used.
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How the ground truth for the training set was established:
- Not applicable. No ground truth for a training set.
Summary based on the provided document:
The K050051 submission for the Armand Endoscope Holder is a 510(k) premarket notification for a Class II medical device. The basis for substantial equivalence is a comparison of its technological characteristics and intended use to legally marketed predicate devices, the Neuroview® Instrument Holder (K992006) and the KSEA Endoscope Holder (K990334).
The relevant "acceptance criteria" here are that the device's design, materials (surgical grade stainless steel and anodized aluminum), and function (holding rigid and flexible endoscopes from 14.6mm to 15.8mm in diameter) are sufficiently similar to the predicates to ensure safety and effectiveness for its intended use. The "study" proving this is implicitly the comparison described in the "Technological Characteristics" and "Substantial Equivalence" sections, affirming its similarity to previously cleared devices.
No performance study, clinical trial, or AI-specific evaluation was conducted or required for this type of device and regulatory pathway.
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MAY 1 6 2005
510(K) SUMMARY
| Submitter: | KLS-Martin, L.P.11239-1 St. Johns Industrial Parkway SouthJacksonville, FL 32246Phone: 904-641-7746Fax: 904-641-7378 |
|---|---|
| Contact Person: | Jennifer DamatoDirector RA/QA |
| Date of Summary: | 31 December 2004 |
| Device Name: | Armand Endoscope Holder |
| Trade Name: | Endoscope Holder |
| Common Name: | Endoscope Holder |
| Classification Name and Number: | Endoscope and/or accessories (CFR 876.1500) |
| Regulatory Class: | Class II |
| Predicate Devices: | Neuroview ® Instrument Holder (Model 300-33) (K992006)KSEA Endoscope Holder (K990334) |
| Intended Use: | The Armand Endoscope Holder is intended for use by surgeons for holding rigid and flexible endoscopes with diameters from 14.6mm to 15.8mm during diagnostic and therapeutic procedures. |
| Device Description: | The Armand Endoscope Holder is a manually |
The Armand Endoscope Holder is a manually operated surgical device. It is composed of surgical grade stainless steel and anodized aluminum. The holder consists of a table clamp, adjustable stainless steel rods, and an endoscope clamp. The endoscope clamp is designed to hold endoscopes in diameter from 14.6mm to 15.8mm. The device uses a single knob clamp assembly to hold the endoscope and a single knob to tighten and lock the stainless steel rods into the desired position.
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Technological Characteristics:
Similarities to Predicate
The Armand Endoscope Holder is similar in materials and description to the Neuroview ® Instrument Holder (Model 300-33) (K992006) and the KSEA Endoscope Holder (K990334)
Substantial Equivalence:
The Armand Endoscope Holder is substantially equivalent in application and function to the Neuroview ® Instrument Holder (Model 300-33) (K992006) and the KSEA Endoscope Holder (K990334).
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized depiction of three human figures in profile, arranged in a row. The figures are black and are connected to each other. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 6 2005
Ms. Jennifer Damato Director RA/QA KLS Martin, L.P P.O. Box 50249 Jacksonville, Florida 32250-0249
Re: K050051
Trade/Device Name: Armand Endoscope Holder Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: April 22, 2005 Received: April 25, 2005
Dear Ms. Damato:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for asc stated in the encreativent of the enactment date of the Medical Device Amendments, or to commerce pror to May 20, 1978, in accordance with the provisions of the Federal Food, Drug, de rices that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, aterere, mans 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 it may be saojoer to back as a submit and 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 r lease be action and i termination that your device complies with other requirements of the Act that I Dri has intatutes and regulations administered by other Federal agencies. You must or any I ederal statuated and equirements, including, but not limited to: registration and listing (2 l CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI IT an 6077, adoling (21 OS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality by Bections (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 – Ms. Jennifer Damato
This letter will allow you to begin marketing your device as described in your Section 510(k) I ins letter will anow you to oegin maning of substantial equivalence of your device to a legally prematics notification. "The PDF Intentig esfication 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 Jour acon 2011 - 11:51 Also, please note the regulation entitled, a Comaci the Office of Compulance in (21 the Part 807.97). You may obtain Misoranuing by reference to prenessonsibilities under the Act from the Division of Small other general International and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, Internet and Octises http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Deviccs Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number (if known): K050051
Device Name: Armand Endoscope Holder
Indications for Use:
The Armand Endoscope Holder is intended for use by surgeons to hold rigid and flexible endoscopes from 14.6mm to 15.8mm in diameter during diagnostic and therapeutic procedures.
AND/OR Prescription Use × (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
§ 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.