(63 days)
Not Found
No
The summary describes a standard endoscope and accessories with no mention of AI/ML, image processing, or performance metrics typically associated with AI/ML devices.
No
This device is described as an endoscope used for viewing interior body cavities, which is a diagnostic function, not a therapeutic one.
No
The device is described as an endoscope used for viewing interior cavities. While viewing can assist in diagnosis, the device itself is a tool for visualization, not for generating a diagnosis. Its function is descriptive (to show), not interpretive (to diagnose).
No
The device description explicitly mentions a "semi-rigid fiberscope" and an "Accessory Pack comprised of a solid obturator (dilator) and an Introducer (Cannula)," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "viewing an interior cavity of the human body through either a natural opening or incision." This describes a device used for direct visualization within the body, which is a characteristic of an endoscope, not an IVD.
- Device Description: The description clearly identifies the device as a "semi-rigid fiberscope" and mentions accessories like an obturator and introducer, all of which are components of endoscopic systems used for internal examination.
- Lack of IVD Characteristics: There is no mention of the device being used to examine samples (like blood, urine, tissue) outside of the body to diagnose a condition. IVDs are designed for testing biological samples in vitro (in glass, or outside the living organism).
Therefore, this device is an endoscope used for direct visualization within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This device is to be used by a physician for viewing an interior cavity of the human body through either a natural opening or incision.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
The NovaCyte Micro endoscope is a semi-rigid fiberscope intended for limited reuse (not to exceed 10 procedures) and is provided non-sterile. The NovaCyte Micro endoscope must be sterilized prior to use. Refer to the Handling, Cleaning and Sterilization instructions. The NovaCyte Accessory Pack is comprised of a solid obturator (dilator) and an Introducer (Cannula). It is intended for single use and is provided sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
interior cavity of the human body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
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
Image /page/0/Picture/0 description: The image shows a logo with the text "CYTYC" underneath it. The logo is a stylized letter "C" inside of a circle. The letter "C" is made up of horizontal lines.
MAY 16 2005
K050650
510(K) -- Premarket Notification
NovaCyte™ Microendoscope and Accessories
SUMMARY OF SAFETY AND EFFECTIVENESS
Trade Name:
Cytyc Surgical Products NovaCyte™ Microendoscope and Accessories
Manufacturer Information:
Cytyc Surgical Products 1047 Elwell Court Palo Alto, CA 94303
Contact: Jim Talbot Phone: (650) 335-2639 Fax: (650) 335-2638 E-Mail: jim.talbot@cytyc.com
Establishment Registration Number: 3003407659 (copy page 10)
FDA Device Classification:
| Standard Product Nomenclature: | Laparoscope, General & Plastic Surgery |
|---|---|
| Device Description: | Endoscope and Accessories |
| Medical Specialty: | General & Plastic Surgery |
| Product Code: | GCJ |
| Device Class: | II |
| 510(K) Exempt? | No |
| Regulation Number: | 876.1500 |
Intended Use and Product Description:
The NovaCyte™ Microendoscope will be labeled for the intended use of:
This device is to be used by a physician for viewing an interior cavity of the human body through either a natural opening or incision.
The NovaCyte Micro endoscope is a semi-rigid fiberscope intended for limited reuse (not to exceed 10 procedures) and is provided non-sterile. The NovaCyte Micro endoscope must be sterilized prior to use. Refer to the Handling, Cleaning and Sterilization instructions. The NovaCyte Accessory Pack is comprised of a solid obturator (dilator) and an Introducer (Cannula). It is intended for single use and is provided sterile.
Substantial Equivalence/Predicate Device:
Establishment of equivalence is based on similarities of intended use, design, and materials, physical characteristics and geometry between the Cytyc Surgical NovaCyte Microendoscope and the Acueity Microendoscope (Viaduct) (K011189) and the Davlite Microendoscope (K020310) among other marketed visualization products.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an abstract eagle design with three stylized lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.
MAY 1 6 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jim Talbot Director, Quality and Regulatory Affairs Cytyc Surgical Products 1047 Elwell Court Palo Alto, California 94303
Re: K050650
Trade/Device Name: NovaCyte™ Microendoscope and Accessories Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: April 25, 2005 Received: April 25, 2005
Dear Mr. Talbot:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt 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 use stated in the encreases) 7 the enactment date of the Medical Device Amendments, or to conniner of Prier to Prie) 2011-12-11 accordance with the provisions of the Federal Food, Drug, de nees mat hat e occh ithat do not require approval of a premarket approval application (PMA). and Cosment For (110) that the device, subject to the general controls provisions of the Act. The r ou may, mererere, maxis of the Act include requirements for annual registration, listing of general voltarons provincities, 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 of subject to back 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 r lease of actived that I be mination that your device complies with other requirements of the Act that I Dri has Intact and regulations administered by other Federal agencies. You must or uny I edetar states as requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI K ratt 607); adoling (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.
2
Page 2 – Mr. Jim Talbot
This letter will allow you to begin marketing your device as described in your Section 510(k) I his ictici will anow you to ough finding of substantial equivalence of your device to a legally promatics notification: "The starsification 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 your as (240) 276-0115 . Also, please note the regulation entitled, Comacit inc Office of Compullion in (21 the Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on your response at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Signature
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(K) - Premarket Notification
Image /page/3/Picture/1 description: The image shows a logo with the text "CYTYC" underneath. The logo is a circular shape with horizontal lines inside, resembling a globe or planet. The text is in a simple, sans-serif font and is centered below the circular graphic.
NovaCyte™ Microendoscope and Accessories 50650
Indications for Use
510(k) Number : K050650
Device Name: NovaCyte™ Microendoscope and Accessories
Indications for Use:
This device is to be used by a physician for viewing an interior cavity of the human body through either a natural opening or incision.
ﺒ
Prescription Use: Yes (Part 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use: No (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
signature
storative
Cytyc Surgical Products, 1047 Elwell Ct. Palo Alto, CA 94303