(63 days)
No
The device description and intended use clearly describe a mechanical instrument holder with no mention of software, algorithms, or any capabilities that would suggest AI/ML. The focus is on its physical properties and ability to maintain position.
No
The device is described as an instrument holder for endoscopes and primarily serves to hold other instruments in place during procedures, rather than directly providing a therapeutic effect itself.
No
The device is an instrument holder for endoscopes and does not directly perform diagnostic functions itself. It facilitates diagnostic and therapeutic procedures by holding an endoscope, but it is not a diagnostic device.
No
The device description explicitly details a physical, reusable stainless steel accessory with mechanical components (rail clamp, rods, toggle clamps, instrument clamp). It is designed to hold a physical endoscope. There is no mention of software as a component or function of the device.
No, 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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Neuroview Instrument Holder is a mechanical device designed to hold an endoscope in a specific position during surgical procedures. It does not analyze biological samples or provide diagnostic information based on such analysis.
- Intended Use: The intended use clearly states it's for "holding Neuro Navigational Neuroview Endoscopes in a desired position over the patient during diagnostic and therapeutic procedures." This describes a surgical support function, not an in vitro diagnostic test.
- Device Description: The description details its mechanical components and function in holding an instrument. There is no mention of analyzing samples or providing diagnostic results.
The device is an accessory used in a surgical setting to facilitate procedures that may be diagnostic or therapeutic, but the device itself is not performing the diagnostic function.
N/A
Intended Use / Indications for Use
Neuroview® Instrument Holder (Model: 300-33) is intended for use in holding Neuro Navigational Neuroview Endoscopes in a desired position over the patient during diagnostic and therapeutic procedures.
Product codes
OCV, GCJ
Device Description
The Neuroview Instrument Holder, Model 300-33, is a reusable, stainless steel accessory used to hold currently marketed Neuro Navigational Endoscopes. The holder consists of a rail clamp, adjustable stainless steel rods, toggle clamps, and an instrument clamp.
This Instrument Holder, as well as the predicate devices, includes a one-piece design that is completely stable when used to position an instrument. The arms contain adjustable stainless steel clamps and holders that will adapt to any operating room table and hold any Neuro Navigational Endoscope. The holder can be positioned over the patient and locked into place to facilitate accurate Endoscope manipulation and instrument passage. The Instrument Holder, as well as the predicates accessory devices, is sold non-sterile and autoclavable for rapid operating room preparation.
This Instrument Holder is intended to hold the Neuroview Endoscope in place. It has no direct contact with the patient. The only important performance aspect of the Instrument Holder is that it maintains its position once it has been positioned and tightened in place.
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
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Key Metrics
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Predicate Device(s)
Reference Device(s)
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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
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circle's perimeter. The eagle design is composed of three parallel lines that create a sense of movement and depth.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Integra NeuroCare LLC Ms. Nancy A. Mathewson, Esq. Manager, Regulatory Affairs 5955 Pacific Center Boulevard San Diego, CA. 92121
JUL 2 7 2015
Re: K992006 Trade/Device Name: Neuroview® Instrument Holder (Model 300-33) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCV, GCJ Dated (Date on orig SE ltr): June 14, 1999 Received (Date on orig SE ltr): June 15, 1999
Dear Ms. Mathewson,
This letter corrects our substantially equivalent letter of August 17, 1999.
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, 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
1
Page 2 -
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
-t- - . . - - -
INDICATIONS FOR USE
Indications
510(k) Number:
K 992006
Device Name: Neuroview® Instrument Holder (Model: 300-33)
Indications for Use:
Neuroview® Instrument Holder (Model: 300-33) is intended for use in holding Neuro Navigational Neuroview Endoscopes in a desired position over the patient during diagnostic and therapeutic procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109 Or
Over-the-Counter Use _
Optional Format 1-2-96)
Thunell S. Reymore for J20
(Division Sign-Off) Division of General 510(k) Number .
11
3
AUG 17 1999
TEGRA NEUROCARE
5955 Pacific Center Boulerard . San Dicgo. CA 92121-4309 . (858) 455-1115 . Fax: (850) 455-8290
Summary of Safety and Effectiveness Page 1 of 2
K 99200$
"NEUROVIEW® INSTRUMENT HOLDER (MODEL 300-33)"
SUMMARY OF SAFETY AND EFFECTIVENESS
Submitter's name and address:
Integra NeuroCarc LLC 5955 Pacific Center Blvd. San Diego, CA 92121-4309
Contact person and telephone number:
Nancy A. Mathewson Manager Regulatory Affairs (858) 455-1115 X 185
Manufacturing Facility:
Integra NeuroCare LLC 5955 Pacific Center Blvd. San Diego, CA 92121-4309
Establishment Registration Number: 2023988
Date Summary was prepared: June 11, 1999
Name of the device:
Neuroview@ Instrument Holder (Model 300-33) Proprietary Name: Endoscope Holder Common Name: Neurological Endoscope (21 CFR 882.1480) Classification Name:
Substantial Equivalence: The Neuroview@ Instrument Holder (Model 300-33) is substantially equivalent to the following currently marketed instruments or endoscope holders:
- KSEA Endoscope Holder (K990334) ●
- Codman Rigid and Steerable Endoscope Holders (K945572) 0
- Leonard Arm-Support Arm-Endoscope Accessory (K951854) .
4
Device Description: The Neuroview Instrument Holder, Model 300-33, is a reusable, stainless steel accessory used to hold currently marketed Neuro Navigational Endoscopes. The holder consists of a rail clamp, adjustable stainless steel rods, toggle clamps, and an instrument clamp.
This Instrument Holder, as well as the predicate devices, includes a one-piece design that is completely stable when used to position an instrument. The arms contain adjustable stainless steel clamps and holders that will adapt to any operating room table and hold any Neuro Navigational Endoscope. The holder can be positioned over the patient and locked into place to facilitate accurate Endoscope manipulation and instrument passage. The Instrument Holder, as well as the predicates accessory devices, is sold non-sterile and autoclavable for rapid operating room preparation.
This Instrument Holder is intended to hold the Neuroview Endoscope in place. It has no direct contact with the patient. The only important performance aspect of the Instrument Holder is that it maintains its position once it has been positioned and tightened in place.
Statement of intended use: The Neuroview® Instrument Holder (Model 300-33) is intended for use in holding Neuro Navigational Neuroview Endoscopes in a desired position over the patient during diagnostic and therapeutic procedures.
Comparison of technological characteristics to predicate devices: A feature comparison chart between Neuroview Instrument Holder (Model 300-33) and the currently marketed predicates KSEA Endoscope Holder, Codman® Rigid and Steerable Endoscope Holders and Leonard Arm-Support Arm-Endoscope Accessory is presented in Table 1.
Safety
None of the Neuroview Instrument Holder (Model 300-33) components have patient, blood, and/or fluid contact. The Instrument Holder is composed of stainless steel materials that are widely used in other instrument and scope holders.
| Parameter | Neuroview Instrument Holder (300-33) | KSEA Endoscope Holder | Codman Rigid and Steerable Endoscope Holders | Leonard Arm-Support Arm-Endoscopic Accessory |
|---|---|---|---|---|
| Manufacturer | Integra NeuroCare LLC | Karl Storz Endoscopey-America, Inc., | Johnson & Johnson Professionals, Inc | Leonard Medical, Inc |
| Intended Use | Rigidly Affix Endoscopes | Rigidly Affix Endoscopes | Rigidly Affix Endoscopes | Rigidly Affix Endoscopes |
| Materials | Stainless Steel | Stainless Steel and Anodized Aluminum | Stainless Steel and Silicone Rubber | Stainless Steel |
| Means of Mounting | Table Mounted | Table Mounted | Table Mounted | Table Mounted |
| Adjustable | Yes | Yes | Yes | Yes |
| Possible to sterilize | Yes | Yes | Yes | Yes |
Table 1: Substantial Equivalence Comparison Chart