NOVACYTE MICROENDOSCOPE AND ACCESSORIES, MODELS NC1000;NCAM1000

K050650 · Cytyc Surgical Products · GCJ · May 16, 2005 · Gastroenterology, Urology

Device Facts

• Record ID: K050650
• Device Name: NOVACYTE MICROENDOSCOPE AND ACCESSORIES, MODELS NC1000;NCAM1000
• Applicant: Cytyc Surgical Products
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: May 16, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended 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.

Device Story

NovaCyte Microendoscope is a semi-rigid fiberscope used by physicians for visualization of interior human body cavities via natural openings or incisions. Device is provided non-sterile and requires sterilization prior to use; limited to 10 reuse cycles. Accessory pack includes a solid obturator (dilator) and an introducer (cannula), both provided sterile for single use. Device functions as a standard endoscope to assist clinical visualization; output is viewed directly by the physician to inform diagnostic or surgical decision-making.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and material similarities to predicate devices.

Technological Characteristics

Semi-rigid fiberscope; includes solid obturator and introducer cannula. Materials and geometry are consistent with predicate microendoscopes. Requires sterilization prior to use.

Indications for Use

Indicated for use by physicians to visualize interior human body cavities via natural openings or incisions.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Acueity Microendoscope (Viaduct) (K011189)
• Davlite Microendoscope (K020310)

Submission Summary (Full Text)

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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: [phone] Fax: [phone] E-Mail: [e-mail]

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.

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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.

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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 [phone] . 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 [phone] or [phone] 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

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510(K) - Premarket Notification

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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