(40 days)
No
The device description and intended use clearly describe a simple mechanical holder for endoscopes, with no mention of any computational or analytical capabilities that would involve AI/ML.
No
The device is an accessory designed to hold an endoscope and prevent fogging, not to treat or diagnose a medical condition. Its function is purely supportive to other medical equipment.
No
The device is an accessory designed to hold endoscopes above a warm solution to prevent fogging or wetting, not to diagnose medical conditions.
No
The device description clearly states it is a physical holder manufactured from thermoplastic polyester resins, designed to hold an endoscope. It is a hardware device, not software.
Based on the provided information, the ORS 6000 Endoscope Holder is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to hold an endoscope above a warm solution to prevent fogging or wetting of the eyepiece. This is a mechanical function related to the use of an endoscope during a medical procedure, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a physical holder made of plastic. It does not mention any components or functions related to analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The ORS 6000 Endoscope Holder is an accessory for a medical device (endoscope) used in a clinical setting, but its function is purely mechanical and supportive, not diagnostic.
N/A
Intended Use / Indications for Use
The ORS 6000 Endoscope Holder is a single use disposable device as an accessory for ORS Solution Warmers. The ORS 6000 Endoscope Holder is designed to hold optical end of various endoscopes above the warm solution to prevent fogging or wetting of the scope eyepiece.
Product codes
KOG
Device Description
The ORS 6000 Endoscope Holder (figures 1) is designed to prevent fogging or wetting of the scope eyepiece by providing a hold for the scope, which keeps it above the water line of the warm solutions.
The ORS 6000 Endoscope Holder is manufactured from GE VALOX thermoplastic polyester resins. The ORS Endoscope Holder is a single use disposable device. The ORS 6000 Endoscope Holder is used with ORS-2000 Solution Warmer K921633 and ORS-2000LD Solution Warmer K021289.
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)
Karl Storz KSEA Endoscope Holder K990334
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
SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
- Submitters Identification: 1.
O.R. Solutions, Inc. 3901 Centerview Drive, Suite L Chantilly, Virginia 20151
Date of Summary June 17, 2005
-
- Device Name: ORS 6000 Endoscope Holder
-
- Classification Name: Warmer, Irrigation, Solution, Accessory
-
- Predicate Devices: Karl Storz KSEA Endoscope Holder K990334
-
- Description
The ORS 6000 Endoscope Holder (figures 1) is designed to prevent fogging or wetting of the scope eyepiece by providing a hold for the scope, which keeps it above the water line of the warm solutions.
The ORS 6000 Endoscope Holder is manufactured from GE VALOX thermoplastic polyester resins. The ORS Endoscope Holder is a single use disposable device. The ORS 6000 Endoscope Holder is used with ORS-2000 Solution Warmer K921633 and ORS-2000LD Solution Warmer K021289.
-
- Indications for Use
The ORS 6000 Endoscope Holder is a single use disposable device as an accessory for ORS Solution Warmers. The ORS 6000 Endoscope Holder is designed to hold optical end of various endoscopes above the warm solution to prevent fogging or wetting of the scope eyepiece.
- Indications for Use
-
- Biocompatibility
Cytotoxicity Test Systemic Injection Test Intracutaneous Injection Tests Dermal Sensitization
- Biocompatibility
1
8. Substantial Equivalence
| Parameters | ORS 6000 | Storz |
|---|---|---|
| 510(k) Number | K990334 | |
| Intended Use: | The ORS 6000 Endoscope | |
| Holder is a single use | ||
| disposable device as an | ||
| accessory for ORS Solution | ||
| Warmers. The ORS 6000 | ||
| Endoscope Holder is | ||
| designed to hold optical end | ||
| of various endoscopes | ||
| above the warm solution to | ||
| prevent fogging or wetting | ||
| of the scope eyepiece. | The KSEA Endoscope | |
| Holder is intended for use | ||
| by qualified surgeons for | ||
| holding rigid and flexible | ||
| endoscopes during | ||
| diagnostic and therapeutic | ||
| neurologic procedures. | ||
| Material Choice | Thermoplastic polyester | |
| resins | Stainless Steel and | |
| Anodized Aluminum | ||
| Meets Biocompatibility | ||
| Standards | Yes | Yes |
| Reusable/Disposable | Disposable | Reusable |
The ORS 6000 Endoscope Holder does not raise any new issue concerning safety The ORD 0000 Endooope Storz and ORS 6000 product meet biocompatibility and circoll reness. Doth the beensimilar purpose(s), which is holding an endoscope during a procedure.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a human figure with outstretched arms, representing health and well-being.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 3 0 2005
O.R. Solutions, Inc. c/o Mr. E. J. Smith Smith Associates PO Box 4341 Crofton, Maryland 21114
Re: K051979
Trade/Device Name: ORS Endoscope Holder Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: KOG Dated: May 17, 2005 Received: August 3, 2005
Dear Mr. Smith:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your 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 r ou may) aters 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 11 Jour at 110 is exactional 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 or any I 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 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.
3
Page 2- Mr. E. J. Smith
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter with anow you to ocgin maing of substantial equivalence of your device to a legally prematication: The PDF Interessification 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 ucate specific advice for your acc (240) 276-0115. Also, please note the regulation entitled, Colliact the Orition of Company of Comparket notification" (21CFR Part 807.97). You may obtain Misolanding by reference to pronessionsibilities under the Act from the Division of Small other general 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,
Barbara Bruchin
for
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): _ KOS1979
Device Name: ORS Endoscope Holder
Indications for Use:
The ORS 6000 Endoscope Holder is a single use disposable device as an accessory for The ORS 6000 Endoscope Holder is a single ass captolder is designed to hold the optical OKS Solution Walners. The Ord 6000 Enevent fogging or wetting of the scope eyepiece.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Page1of_1
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbare Buen
(Division Sign-Off)
Division of General. Restorative,
and Neurological Devices
510(k) Number. K051979