The THD Slide Doppler guided proctoscope is a system for the surgical treatment of the hemorrhoids of second and third degree. It is based on Transanal Hemorrhoidal Dearterialization technique guided by a Doppler probe. The Doppler system, placed inside the THD Evolution Doppler device, is used to detect the terminal branch of the superior hemorrhoid artery, in order to perform ligation with a THD Slide proctoscope, sutures and a needle holder included in the THD Slide Kit.

The THD Slide is to be used by physicians in hospitals, clinics, and physician's offices by prescription or doctor's orders.

Device Description

The THD Slide consists of the THD Evolution Doppler device and the THD Slide Kit. The THD Evolution Doppler is an 8 MHz continuous wave (CW) Doppler detector with loudspeaker and a power light source. The THD Evolution Doppler is used with dedicated accessories (Doppler transducer, optical fibers and pneumatic foot pedal), in order to facilitate surgical operation. The THD Kit is a sterilized surgical kit comprised of a proctoscope, a needle holder, a knot tightener and sutures.

AI/ML Overview

The provided text describes a 510(k) summary for the THD Slide, a medical device. This summary primarily focuses on regulatory approval based on substantial equivalence to a predicate device and acoustic emission testing. It does not contain the detailed information typically found in a study demonstrating clinical performance or meeting specific acceptance criteria in the way a clinical trial or algorithm validation study would.

Therefore, many of the requested sections below cannot be fully populated from the provided document.

Here's an analysis based on the available information:

Acceptance Criteria and Device Performance Study for THD Slide

The THD Slide's acceptance criteria primarily revolve around its substantial equivalence to a predicate device and meeting safety standards related to acoustic emissions, rather than specific clinical performance metrics. The study mentioned is limited to acoustic output measurements.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Substantial Equivalence	Device is substantially equivalent to legally marketed predicate devices (K07081).	The THD Slide is considered substantially equivalent to the predicate device K07081.
Acoustic Emissions	Acoustic emissions (MI, Ispta3, Beam Area, Wo) must be below upper limits recommended by FDA guidance "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" (September 30, 1997).	Mean Values:MI: 0.027Ispta3: 232 mW/cm²Beam Area: 3.063 mm²Wo: 15.633 mWMax Values:MI: 0.032Ispta3: 322 mW/cm²Beam Area: 3.880 mm²Wo: 18.500 mWThese reported values are stated to be below the recommended upper limits.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not applicable in the context of clinical performance data. For acoustic emissions, the 'test set' would refer to the measurements taken on the device itself. The document does not specify how many individual measurements were taken or if multiple devices were tested; it provides mean, standard deviation, and max values, implying multiple measurements.
Data Provenance: The acoustic emission data would have been generated internally by the manufacturer (THD S.p.A.) as part of product testing to demonstrate compliance with standards. The country of origin for the device manufacturer is Italy.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable as the 'ground truth' here relates to objective physical measurements (acoustic output) rather than expert interpretation of clinical data. Compliance with acoustic output limits is typically determined by specialized engineers and equipment.

4. Adjudication method for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations (e.g., in reading medical images). For acoustic emissions, measurements are objective and compared against pre-defined regulatory limits.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This is not an AI/algorithm-based device in the sense of image interpretation or diagnostic assistance. It's an ultrasonic Doppler device used for guiding a surgical procedure. Therefore, an MRMC study or AI assistance evaluation is irrelevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. This device is not an algorithm that operates in a standalone manner. It is a physical medical device (Doppler probe and surgical kit) used by physicians to guide a surgical procedure.

7. The type of ground truth used

For the acoustic emissions, the "ground truth" is adherence to established regulatory limits and standards for ultrasonic output, measured by calibrated equipment.
For substantial equivalence, the "ground truth" is a regulatory determination made by the FDA based on comparison to an already cleared predicate device (K07081) regarding indications for use, technological characteristics, and safety/effectiveness. There is no clinical "ground truth" such as pathology or outcomes data presented in this specific 510(k) summary.

8. The sample size for the training set

Not applicable. This device is not an AI/machine learning model and therefore does not have a "training set."

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this device.

Summary

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K081429

JUL 3 0 2008

510(k) Summary for the THD Slide

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, 142015 - Correggio (RE)Italy
Contact Person in Italy:	Guido BonapaceISEMED srlVia Borgo Santa Cristina 1240026 Imola (BO)ItalyMob.phone: +39-335-5378686Telephone: +39-051-6527315Fax: +39-051-6284344Email: gbonapace@isemed.eu
Contact Person:	Maureen O'ConnellO'Connell Regulatory Consultants, Inc.5 Timber LaneNorth Reading, MA 01864Telephone: 978-207-1245Fax: 978-824-2541Email: Maureen@OConnellRegulatory.com
Summary Preparation Date:	May 16, 2008
2.2. Names
Device Name:	THD Slide
Classification Name:	Nonfetal Ultrasonic monitor
Product Code:	JAF
Regulation number:	892.1540

2.3. Predicate Devices

The THD Slide is substantially equivalent to the following device:

Applicant	Device name	510/1Numner
CD1Carlos Carder Comparis Comparis Comparis Comparis Comparis Comparis Comparis Comparis Comparis Comments Comments of Comments of Children Comments of Children Comments of Chilدار الاتCompany of Class	TTT TTand the same of the control and the company of	K07081

CONFIDENTIAL

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2.4. Device Description

2.5. Indications for Use

The THD Slide is to be used by physicians in hospitals, clinics, and physician's offices by prescription or doctor's orders.

THD Ev.doppler ProbeId.	MI	Ispta3(mW/cm²)	Beam Area(mm²)	Wo(mW)
Mean value:	0.027	232	3.063	15.633
Standard Dev.:	0.0042	78	0.724	2.676
Max Value	0.032	322	3.880	18.500

2.6. Performance Data

Performance data was submitted which shows that the acoustic emissions for the THD Slide are below the upper limits recommended by the guidance "Information for Manufacturers Secking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" September 30, 1997.

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DEPARTMENT OF HEALTH & HUMAN SERVICES • USA

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

THD Spa % O'Connell Regulatory Consultants, Inc. Ms. Maureen O'Connell President 5 Timber Lane North Reading, Massachusetts 01864

JUL 30 2008

Re: K081429 Trade/Device Name: THD Slide Regulation Number: 21 CFR 892.1540 Regulation Name: Nonfetal ultrasonic monitor Regulatory Class: II Product Code: JAF Dated: May 16, 2008 Received: May 21, 2008

Dear Ms. O'Connell:

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.

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 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); good manufacturing practice requirements as set

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Page 2 - Ms. Maureen O'Connell

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark M. Millman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K 081429

Device Name: THD Slide Comment

Indications for Use:

The THD Slide is to be used by physicians in hospitals, clinics, and physician's offices by prescription or doctor's orders.

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 General, Restorative, and Neurological Devices

CONFIDENTIAL	Page 18
510(k) Number	K08 1429

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Appendix F

Diagnostic Ultrasound Indications for Use Form

Fill out one form for each ultrasound system and each transducer.

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application	A	CWD
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal		X
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletal Superficial
Other (specify)N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:	THD Slide includes THD Evolution Doppler device with 8MHz Doppler probe

510(k) Numb

CONI

. .

Regulation Number and Section

§ 892.1540 Nonfetal ultrasonic monitor.

(a)
Identification. A nonfetal ultrasonic monitor is a device that projects a continuous high-frequency sound wave into body tissue other than a fetus to determine frequency changes (doppler shift) in the reflected wave and is intended for use in the investigation of nonfetal blood flow and other nonfetal body tissues in motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.