The THD N-Ano Anoscopes, are intended for physician use to examine the anal sphincter, anus, rectum to perform various diagnostic and therapeutic procedures.

Device Description

The disposable, not sterile THD N-ano anoscope is a disposable, not sterile anoscope with an integrated LED light source. The device is designed for the examination o the anal sphincter, anus, rectum to perform various diagnostic and therapeutic procedures. The light source is integrated on the handle. Differently than predicate devices (Family of THD disposable Anoscopes, Proctoscopes, Rectoscopes and Light-scope - K103647) disposable, not sterile THD N-ano Anoscope does not have any accessory and is available only "not sterile"

AI/ML Overview

The provided text describes a 510(k) summary for the THD N-ANO ANOSCOPE, which is a medical device. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria for device performance in a clinical or diagnostic setting. Therefore, most of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth establishment is not present in the provided text.

The document highlights modifications made to the THD N-ANO ANOSCOPE compared to its predicate device (THD S.p.A. Family of THD disposable Anoscopes, Proctoscopes, Rectoscopes and Light-scope, K103647). The review process involves design control activities, risk analysis, and a declaration of conformity, aiming to ensure that the modifications do not adversely affect the safety and performance of the device.

Here's a breakdown of the information that can be extracted or deduced from your input:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for device performance in terms of diagnostic accuracy or clinical outcomes. Instead, the "acceptance criteria" are implied to be substantial equivalence to the predicate device, meaning the modified device performs as safely and effectively as the original device.

The reported "performance" relates to the design and materials of the device, rather than diagnostic metrics.

Acceptance Criteria (Implied)	Reported Device "Performance" (Design Changes)
Safety and Performance Equivalence to Predicate Device (K103647)	- Handle modified to lodge LED light source circuit components (LED circuit itself unchanged).- LED light source block eliminated (due to handle modification).- Cover of LED light source circuit made of ABS Terluran (vs. ABS Lustran in predicate).- Dimensions are "not more critical than dimensions of predicate devices" (Length: 105mm vs. 90mm/130mm, Diameter: 21.7mm vs. 22.1mm/26.1mm/15.1mm).- White polypropylene tip on introducer eliminated.
Intended Use Equivalence	The THD N-Ano Anoscope is indicated for the same intended use: "to examine the anal sphincter, anus, rectum to perform various diagnostic and therapeutic procedures."
Materials Equivalence	Manufactured with the same materials and the same process as the predicate family of devices.

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

Not applicable. The document does not describe a test set or clinical study to evaluate diagnostic performance. The evaluation is focused on engineering and design changes and their impact on substantial equivalence.

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

Not applicable. No ground truth for a test set is established in this document as it's not a clinical performance study.

4. Adjudication Method for the Test Set

Not applicable. No test set or expert adjudication is described for clinical performance evaluation.

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

No. The document does not mention any MRMC study or an assessment of human reader improvement with or without AI assistance. This device is a physical instrument, not an AI or diagnostic software.

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

No. This is not an algorithm or AI-driven device, so a standalone performance study in that context is not relevant.

7. Type of Ground Truth Used

Not applicable in the context of diagnostic performance. The "ground truth" here is the predicate device and its established safety and efficacy, to which the modified device is compared through design and material analysis.

8. Sample Size for the Training Set

Not applicable. No training set is mentioned as this is not an AI or machine learning device.

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

Not applicable.

Summary of the Document's Focus:

This 510(k) summary is for a medical device (anoscope) where the manufacturer is seeking FDA clearance based on substantial equivalence to a previously cleared predicate device. The changes described are primarily related to mechanical design (handle, LED light source integration, dimensions) and material of a component. The "study" referenced implicitly is the design control process, risk analysis, and material compatibility assessment to demonstrate that these modifications do not alter the fundamental safety or effectiveness of the device compared to the predicate. It is not a clinical trial evaluating diagnostic accuracy or a performance study of AI.

Summary

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THD N-ANO ANOSCOPE

K133687 · page 1 of 3

510(k) Summary for the

DEC 1 1 2013

Family of disposable THD N-ano anoscope

This 510(k) Summary is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.

2.1. General Information Submitter:

THD S.p.A. Via dell'Industria. 1 42015 - Correggio (RE) Italy

Establishment Registration Number: 3006680097

Contact Person:

Guido Bonapace ISEMED srl Via A. Altobelli Bonetti 3/A 40026 Imola (BO) Italy Mob.phone: +39-335-5378686 Telephone: +39-0542 683803 Fax: +39-0542 698456 Email: regulatory@isemed.eu

Summary Preparation Date:

2.2. Names
Device Name: Classification Name: Product Code: Regulation number:

October 29, 2013

THD N-ano anoscope Endoscope and accessories FER/GCP 876.1500

2.3. Predicate Devices

This Special 510(k) is related to the device modifications of the following devices:

Applicant	Device name	510(k) Number
THD S.p.A.	Family of THD disposable Anoscopes,Proctoscopes, Rectoscopes and Light-scope	K103647

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K133687 page 2 of 3

The THD N-ano anoscope and its predicate device are indicated for the same intended use and have the same technological characteristics. Both families include the anoscopes and similar devices manufactured with the same materials and the same process.

The differences between the families are that:

The handle of THD N-ano anoscope is modified in order to lodge all the . components of LED light source circuit (even though the LED light source circuit is not modified respect to predicate devices)
As a consequence of the point above the LED light source block, used in predicate o devices to lodge all the components of LED light source circuit, is eliminated
The cover of the LED light source circuit of THD N-Ano anoscope is made of . ABS Terluran, while the LED light source block of predicate devices is made of ABS Lustran.
The THD N-Ano has similar dimensions than its predicate devices, but this . doesn't include any change on safety and performances of the device, since the THD N-Ano measures are not more critical than dimensions of predicate devices. In fact length of THD N-ano anoscope is 105 mm, longer than an anoscope (which is 90 mm) but shorter than proctoscope (which is 130 mm)., while diameter is 21,7 mm, which is tighter than a Medium Anoscope/proctoscope (which is 22.1 mm. but there are also Large Anoscopes/proctoscopes with a diameter of 26,1 mm) and larger than a Pediatric - small size anoscope (which is 15.1 mm)
The white polypropylene tip on the introducer, used in predicate devices is . eliminated.

2.4. Device Description

The disposable, not sterile THD N-ano anoscope is a disposable, not sterile anoscope with an integrated LED light source.

The device is designed for the examination o the anal sphincter, anus, rectum to perform various diagnostic and therapeutic procedures.

The light source is integrated on the handle.

Differently than predicate devices (Family of THD disposable Anoscopes, Proctoscopes, Rectoscopes and Light-scope - K103647) disposable, not sterile THD N-ano Anoscope does not have any accessory and is available only "not sterile"

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2.5. Indications for Use

The THD N-Ano Anoscope, is intended for physician use to examine the anal sphincter, anus, rectum to perform various diagnostic and therapeutic procedures.

The Indications for Use of THD N-Ano Anoscope have not been modified with respect to the previous submission (Family of THD disposable Anoscopes, Proctoscopes, Rectoscopes and Light-scope K 103647).

2.6. Design Control Activities

As listed in chapter 2.3 the differences between THD N-Ano anoscpe and its predicate devices are:

. The handle of THD N-ano anoscope is modified in order to lodge all the components of LED light source circuit (even though the LED Light source is not modified respect to predicate devices)
As a consequence of the point above the LED light source block, used in predicate . devices to lodge all the components of LED light source circuit, is eliminated
The cover of the LED light source circuit of THD N-Ano anoscope is made of . ABS Terluran, while the LED light source block of predicate devices is made of ABS Lustran.
The THD N-Ano has similar dimensions than its predicate devices, but this o doesn't include any change on safety and performances of the device, since the THD N-Ano measures are not more critical than dimensions of predicate devices. In fact length of THD N-ano Anoscope is 105 mm, longer than an anoscope (which is 90 mm) but shorter than proctoscope (which is 130 mm)., while diameter is 21,7 mm, which is tighter than a Medium Anoscope/proctoscope (which is 22,1 mm, but there are also Large Anoscopes/proctoscopes with a diameter of 26,1 mm) and larger than a Pediatric - small size anoscope (which is 15.1 mm)
The white polypropylene tip on the introducer, used in predicate devices is ● eliminated.

The summary about design review is described in the Annex 4.1. The summary about design review activity(Annex 4.1 - summary design review) relates the modification introduced with the risk analysis assessment (Annex 4.2 - Hazard analysis table).

The risk analysis method used to assess the impact of the modifications is described in the Annex 4.3 - Risk management plan.

A declaration of conformity with design controls is included in annex 1.1

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and three bars below the eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 11. 2013

THD S.p.A. % Guido Bonapace Isemed S.R.L. Via A. Altobelli Bonetti, 3/A Imola (BO), Italy 40026

Re: K133687

Trade/Device Name: THD N-Ano Anoscope Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FER, GCP Dated: October 29, 2013 Received: December 2, 2013

Dear Guido Bonapace,

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 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

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Page 2 - Guido Bonapace

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 tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYowIndustry/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 vours.

Herbert P.Lerner -S

for

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

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THD S.p.A. SPECIAL 510(K) NOTIFICATION THD N-ANO ANOSCOPE

Indications for Use

510(k) Number (if known): K133687

Device Name: THD N-Ano Anoscope

Indications for Use:

The THD N-Ano Anoscopes, are intended for physician use to examine the anal sphincter, anus, rectum to perform various diagnostic and therapeutic procedures.

Prescription Use ਮ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

ートメイドデジタルアイデント (1) 17,5 × 4,2,111,5,3,6,1,1,1,5,3,6,1,1,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,

Concurrence of CDRH, Office of Device Evaluation (ODE)

Herbert P. Lerner -5
2013.12.11 16:37:51 -05'00'

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.