The THD Bandy is used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or ring placed around the hemorrhoid base. The THD Bandy is to be used for exclusive use by medical personnel trained in a proctology procedures.

Device Description

The THD Bandy is an hemorthoidal ligator intended for pinching off hemorrhoidal nodule. The device is to be used in combination with a suction device, mounted on the basis of the THD Bandy. The THD Bandy consists of a ligation unit, a pusher and a cone. The ligation unit consists of a cylindrical housing connected with a trigger for the release of the elastic band or of the ligature. The hemorrhoidal nodule, trapped on the distal portion of the device, receive an elastic ring or a ligature in order to cut off the blood flow. The pusher and the cylindrical cone are provided in order to assist in the loading of the bands.

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of device performance metrics (e.g., sensitivity, specificity, accuracy) or comparative effectiveness. The available documents are a 510(k) summary and the FDA's clearance letter for the THD Bandy hemorrhoidal ligator.

Instead, the documents indicate that the device (THD Bandy) was determined to be "substantially equivalent" to predicate devices based on similarities in intended use, design characteristics, materials, and labeling information. The performance data section refers to compliance with international standards for biocompatibility (ISO 10993-1:2003), graphical symbols in labeling (CEN EN 980:1996+A1:1999+A2:2001), and risk management (ISO 14971:2007). These are general safety and procedural standards, not performance criteria for diagnostic or clinical effectiveness as one might expect for a study proving device performance in the sense of AI/reader studies.

Therefore, I cannot populate the requested table or provide information for points 2 through 9 based on the provided text. The device's "performance" in this context refers to its adherence to established safety and quality standards, and its equivalence to legally marketed predicate devices, rather than a clinical performance study with defined metrics.

Here's a breakdown of what can be extracted or deduced from the provided documents:

#	Information Requested	Details from Document
1	Table of acceptance criteria and reported device performance	Acceptance Criteria (Implied by Substantial Equivalence to Predicate Devices and Standards Compliance): The device should have: - Same intended use as predicate devices. - Similar design characteristics to predicate devices. - Similar materials to predicate devices. - Compliant labeling information. - Adherence to biocompatibility standards (ISO 10993-1:2003). - Adherence to graphical symbol standards for labeling (CEN EN 980:1996+A1:1999+A2:2001). - Adherence to risk management standards (ISO 14971:2007). Reported Device Performance (from K093497): - "The THD Bandy is substantially equivalent to the predicate devices." - "The intended use of THD Bandy is the same as Sapimed LEM (K070881)." - "Both THD Bandy and Sapimed LEM (K070881) are manufacture in plastic material, are designed with similar dimensions and are single use devices." - "The THD Bandy is equivalent to the Sapimed LEM (K070881) and to the Haemoband Multi Ligator Device (K091519) and to the THD Disposable Anoscope/Proctoscope (K080132) concerning the labeling information." - The device has "been developed and tested according to the following international standards": ISO 10993-1:2003, CEN EN 980:1996+A1:1999+A2:2001, ISO 14971:2007.
2	Sample size used for the test set and data provenance	Not applicable. No "test set" in the context of clinical performance data is mentioned. The submission focuses on substantial equivalence and compliance with general standards.
3	Number of experts used to establish ground truth and qualifications	Not applicable. No clinical ground truth establishment or expert review process (outside of FDA's regulatory review) is described in relation to performance data.
4	Adjudication method for the test set	Not applicable. No test set requiring adjudication is mentioned.
5	MRMC comparative effectiveness study and effect size	Not applicable. No MRMC study or AI assistance is mentioned. This device is a mechanical ligator, not an AI or diagnostic tool.
6	Standalone (algorithm only) performance study	Not applicable. This is a medical device, not an algorithm.
7	Type of ground truth used	Not applicable in the context of clinical performance metrics. The "ground truth" for substantial equivalence is the characteristics of the predicate devices and the relevant international standards.
8	Sample size for the training set	Not applicable. No training set for an algorithm is mentioned.
9	How ground truth for training set was established	Not applicable. No training set for an algorithm is mentioned.

Summary

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THD S.p.A. 510(K) Notification

093497
page 1 of 2

THD Bandy

FDA CDRH DMC

1 1 5,20102010 Received

510(k) Summary for the THD Bandy

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:

Contact Person:

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

Guido Bonapace ISEMED srl Via Borgo Santa Cristina 12 40026 Imola (BO) Italy Mob.phone: +39-335-5378686 Telephone: +39-051-6527315 Fax: +39-0542 698456 Email: gbonapace@isemed.eu

Summary Preparation Date:

October 27, 2009

2.2. Names

Device Name: Classification Name: Product Code: Regulation number:

THD Bandy Hemorrhoidal ligator FHN 876.4400

2.3. Predicate Devices

The THD Bandy is substantially equivalent to the following devices:

Applicant	Device name	510(k) Number
Sapimed S.p.A.	LEM	K070881
Haemoband SurgicalLTD	Haemoband Multi Ligator	K091519
THD S.p.A.	THD DisposableAnoscope/Proctoscope	K080132

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THD S.p.A. 510(K) Notification

K093497
page 2 of 2

THD Bandy

The THD Bandy is substantial equivalent to the predicate devices. The design characteristics are similar to the Sapimed model number A.5650 (LEM model for use with suction - K070881). The intended use of THD Bandy is the same as Sapimed LEM (K070881).

Both THD Bandy and Sapimed LEM (K070881) are manufacture in plastic material, are designed with similar dimensions and are single use devices. The THD Bandy is equivalent to the Sapimed LEM (K070881) and to the Haemoband Multi Ligator Device (K091519) and to the THD Disposable Anoscope/Proctoscope (K080132) concerning the labeling information.

2.4. Device Description

2.5. Indications for Use

The THD Bandy is used to cut off the blood flow to hemorrhoidal tissue by means of a elastic band or a ligature placed around the hemorrhoid base.

The THD Bandy is to be used for exclusive use by medical personnel trained in proctology procedures.

2.6. Performance Data

Performance characteristics of device are equivalent to the Predicate Devices. The THD Bandy has been developed and tested according to the following international standards:

V ISO 10993-1:2003, Biological evaluation of medical devices Part 1: Evaluation and testing. (Biocompatibility) - FDA Recognition Number 2-વેજ
V CEN EN 980:1996+A1:1999+A2:2001, Graphical Symbols for Use in the Labelling of Medical Devices. - FDA Recognition Number 5-32
V ISO 14971:2007, Medical devices Application of risk management to medical devices. (General) - FDA Recognition Number 5-40

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure with outstretched arms. The symbol is composed of three thick, curved lines that converge at the bottom.

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

THD S.p.A c/o Mr. Guido Bonapace President and Regulatory Consultant ISEMED S.r.l. Via Borgo Santa Cristina 12 Imola, BO ITALY 40026

JUL 1 3 2010.

Re: K093497

Trade/Device Name: THD Bandy Regulation Number: 21 CFR §876.4400 Regulation Name: Hemorrhoidal ligator Regulatory Class: II Product Code: FHN Dated: July 5, 2010 Received: July 7, 2010

Dear Mr. 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related

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adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Janine M. Morris

Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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THD S.p.A. 510(K) Notification

THD Bandy

JUL 1 5 2010

Indications for Use

510(k) Number (if known): K093497

Device Name:

THD Bandy

Indications for Use:

The THD Bandy is used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or ring placed around the hemorrhoid base.

The THD Bandy is to be used for exclusive use by medical personnel trained in a proctology procedures.

Prescription Use X (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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
---------------------	--

Division of Reproductive, Abdominal, and
Radiological Devices

510(k) Number	K093497
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Regulation Number and Section

§ 876.4400 Hemorrhoidal ligator.

(a)
Identification. A hemorrhoidal ligator is a device used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or band placed around the hemorrhoid.(b)
Classification. Class II (special controls). Except for a hemostatic metal clip intended for use in the gastrointestinal tract, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.