(70 days)
K07081
Not Found
No
The description focuses on a standard Doppler system and surgical instruments, with no mention of AI or ML capabilities.
Yes
The device is described as a "system for the surgical treatment of the hemorrhoids" and explicitly states that it is used to "perform ligation," indicating a direct medical intervention for a condition.
No
The device is described as a system for the surgical treatment of hemorrhoids, and its Doppler system is used to detect the artery for ligation, not for diagnosis. While it uses Doppler technology, its stated purpose and application are interventional, not diagnostic.
No
The device description explicitly states that the system consists of both the "THD Evolution Doppler device" (hardware) and the "THD Slide Kit" (surgical instruments), indicating it is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the surgical treatment of hemorrhoids using a Doppler-guided technique to ligate arteries. This is a surgical procedure performed on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The device consists of a Doppler system and surgical instruments (proctoscope, needle holder, sutures). These are tools used during a surgical intervention.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The Doppler is used for real-time guidance during surgery, not for in vitro diagnosis.
IVD devices are designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
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.
Product codes
JAF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Doppler ultrasound (continuous wave)
Anatomical Site
Rectum (Transrectal)
Superior hemorrhoid artery
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians in hospitals, clinics, and physician's offices.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" September 30, 1997.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K07081
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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, 1 | |
| 42015 - Correggio (RE) | |
| Italy | |
| Contact Person in Italy: | Guido Bonapace |
| ISEMED srl | |
| Via Borgo Santa Cristina 12 | |
| 40026 Imola (BO) | |
| Italy | |
| Mob.phone: +39-335-5378686 | |
| Telephone: +39-051-6527315 | |
| Fax: +39-051-6284344 | |
| Email: gbonapace@isemed.eu | |
| Contact Person: | Maureen O'Connell |
| O'Connell Regulatory Consultants, Inc. | |
| 5 Timber Lane | |
| North Reading, MA 01864 | |
| Telephone: 978-207-1245 | |
| Fax: 978-824-2541 | |
| Email: 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 | 510/1
Numner |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|-----------------|
| CD1
Carlos Carder Comparis Comparis Comparis Comparis Comparis Comparis Comparis Comparis Comparis Comments Comments of Comments of Children Comments of Children Comments of Chil
دار الات
Company of Class | TTT TT
and the same of the control and the company of | K07081 |
CONFIDENTIAL
1
2.4. 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.
2.5. Indications for Use
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.
| THD Ev.
doppler Probe
Id. | 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.
2
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
3
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
4
Indications for Use
510(k) Number (if known): K 081429
Device Name: THD Slide Comment
Indications for Use:
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.
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 |
5
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 | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(specify) | Other
(specify) |
|-----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| 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-skeletal
Conventional | | | | | | | | | | |
| 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
:
. .