(126 days)
Not Found
No
The description details a manually operated mechanical device with no mention of software, data processing, or AI/ML terms.
No.
The device is an endoscope holder, which is a tool used by surgeons to hold endoscopes during procedures, rather than directly providing therapy itself. Its function is to assist in procedures, some of which may be therapeutic, but the device itself is not a therapeutic device.
No
The device is described as an endoscope holder used during diagnostic and therapeutic procedures, but it does not perform the diagnostic function itself; it merely holds the endoscope that might be used for diagnosis.
No
The device description explicitly states it is composed of surgical grade stainless steel and anodized aluminum, and describes physical components like a table clamp, rods, and an endoscope clamp. This indicates it is a physical hardware device, not software only.
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.
- Device Function: The Armand Endoscope Holder is a surgical device used to physically hold endoscopes during procedures. It does not perform any tests on biological samples.
- Intended Use: The intended use clearly states it's for "holding rigid and flexible endoscopes... during diagnostic and therapeutic procedures." This describes a physical support function, not a diagnostic test.
Therefore, the Armand Endoscope Holder falls under the category of a surgical instrument or accessory, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
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.
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
surgeons
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): 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.
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.
Not Found
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).
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
MAY 1 6 2005
510(K) SUMMARY
| Submitter: | KLS-Martin, L.P.
11239-1 St. Johns Industrial Parkway South
Jacksonville, FL 32246
Phone: 904-641-7746
Fax: 904-641-7378 |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jennifer Damato
Director 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.
3
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
4
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)