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.

AI/ML Overview

This response is based on the provided text, which is a 510(k) premarket notification. 510(k) submissions typically focus on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical studies with detailed acceptance criteria and performance metrics as might be found in a PMA.

Therefore, many of the requested data points (e.g., specific acceptance criteria for performance, sample sizes for test/training sets, expert qualifications, MRMC studies) are not provided in this type of document. The document primarily focuses on technical specifications, intended use, and comparison to predicate devices to establish safety and effectiveness.

Here's an analysis based on the available information:

Acceptance Criteria and Study for NovaCyte™ Microendoscope and Accessories

The provided document, a 510(k) premarket notification, focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against pre-defined acceptance criteria through a standalone clinical study. Therefore, formal "acceptance criteria" in the sense of specific performance thresholds for a clinical outcome are not explicitly stated in this document.

The "study" conducted to meet the requirements of the 510(k) process is a comparison of the NovaCyte™ Microendoscope and Accessories to established predicate devices (Acueity Microendoscope (K011189) and Davlite Microendoscope (K020310)). The premise is that if the new device is substantially equivalent in intended use, design, materials, physical characteristics, and geometry, it is considered as safe and effective as the predicate devices, which are already legally marketed.

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, explicit acceptance criteria in terms of specific performance metrics (like accuracy, sensitivity, specificity) for clinical outcomes are not detailed in this 510(k) submission.

Instead, the "acceptance criteria" for a 510(k) are implicitly met by demonstrating substantial equivalence to predicate devices. The "reported device performance" is largely inferred from its similarity to the predicate devices and its ability to perform its intended function of "viewing an interior cavity of the human body."

Criterion Type	Acceptance Criteria (Implicit from 510(k) Submission)	Reported Device Performance (Inferred from Submission)
Intended Use	The intended use of the NovaCyte™ Microendoscope and Accessories must be the same as or very similar to the predicate devices.	Match: "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." This matches the general intended use of endoscopes and is substantially equivalent to the predicates.
Technological Characteristics	The design, materials, physical characteristics, and geometry of the NovaCyte™ Microendoscope and Accessories must be substantially equivalent to the predicate devices, not raising new questions of safety or effectiveness. This includes mechanical properties, optical performance (e.g., field of view, resolution – though not quantified in this summary), and compatibility with accessories.	Demonstrated by Comparison: The submission states, "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." Specific technical data would be in the full submission, but the conclusion is that these characteristics are substantially equivalent. Key characteristics mentioned: semi-rigid fiberscope, limited reuse (not to exceed 10 procedures), non-sterile (must be sterilized), accessory pack (obturator, introducer) for single use and sterile.
Safety & Effectiveness	The device must not raise new questions of safety or effectiveness compared to the predicate devices. This implies satisfactory biocompatibility, structural integrity, and appropriate sterilization methods.	Inferred from Equivalence: By demonstrating substantial equivalence in design, materials, and intended use, the device is deemed to have a similar safety and effectiveness profile to the legally marketed predicate devices. The document highlights the need for sterilization prior to use for the main device and states the accessories are sterile and single-use, indicating consideration for infection control.

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size: This 510(k) summary does not report a specific "test set" sample size in the context of a clinical performance study with human subjects. The device comparison is primarily a technical and design comparison to predicate devices, not a clinical trial.
Data Provenance: Not applicable in the context of a clinical study test set here. The data provenance relevant to the 510(k) includes the technical specifications and design features of the NovaCyte device and its predicate devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Number of Experts & Qualifications: Not applicable. The 510(k) process for this device did not involve establishing ground truth through expert consensus on a clinical test set. The regulatory review process involves FDA experts evaluating the submission.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable as there was no clinical test set with associated ground truth to adjudicate.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No, the provided summary does not indicate that an MRMC comparative effectiveness study was performed. Such studies are generally not required for 510(k) submissions unless there are significant new questions of effectiveness.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Standalone Study: Not applicable. This device is a microendoscope, a hardware device for direct visual viewing by a physician (human-in-the-loop). There is no "algorithm only" component.

7. Type of Ground Truth Used

Type of Ground Truth: Not applicable in the context of clinical performance data. The "ground truth" for the 510(k) submission relates to the established safety and effectiveness of the predicate devices based on their prior marketing and regulatory clearance.

8. Sample Size for the Training Set

Sample Size: Not applicable. This is a hardware device; there is no "training set" in the machine learning sense. The design and manufacturing process would involve internal testing and validation, but not a "training set" for an algorithm.

9. How the Ground Truth for the Training Set Was Established

Ground Truth Establishment: Not applicable, as there is no training set for an algorithm.

Summary

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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: (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.

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 (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

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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

Regulation Number and Section

§ 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.