(85 days)
Not Found
No
The summary does not mention AI, ML, deep learning, or any related concepts. The device description focuses on standard ultrasound and ligation technology.
Yes
The device is intended for detecting hemorrhoidal arteries, manually ligating them, and carrying out mucopexy of hemorrhoidal prolapse, which are therapeutic interventions.
Yes
The device "detecting hemorrhoidal arteries" is a diagnostic function, as it identifies a condition.
No
The device description explicitly states that the system includes physical components that come into contact with the patient (RAR Probes, Sleeve, Wi-3 Arm, Wi-3 Fixation Nut) and is a Bluetooth-enabled, pulsed Doppler, ultrasound system, indicating hardware components beyond just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Wi-3 HAL-RAR System is a surgical device that uses ultrasound to locate hemorrhoidal arteries and then facilitates their ligation and potential mucopexy. It is used during a surgical procedure on the patient's body, not on a sample taken from the body.
- Intended Use: The intended use clearly describes a surgical procedure involving the detection and treatment of hemorrhoidal issues within the patient's body.
- Device Description: The description details components that come into direct contact with the patient's tissue and skin during the procedure.
- Lack of Sample Analysis: There is no mention of analyzing any biological samples from the patient.
Therefore, based on the provided information, the Wi-3 HAL-RAR System is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Wi-3 HAL-RAR System is a Bluetooth-enabled, pulsed Doppler, ultrasound system intended to be used for detecting hemorrhoidal arteries, manually ligating these arteries, and subsequently carrying out a mucopexy of hemorrhoidal prolapse if necessary.
Product codes (comma separated list FDA assigned to the subject device)
FHN, IYN
Device Description
The Wi-3 HAL-RAR System is a Bluetooth-enabled, pulsed Doppler, ultrasound system intended to be used for detecting hemorrhoidal arteries, manually ligating these arteries, and subsequently carrying out a mucopexy of hemorrhoidal prolapse if necessary. "HAL" is an acronym referring to "Hemorrhoidal Arteries Ligation", and "RAR" is an acronym referring to "Recto Anal Repair." The Wi-3 HAL-RAR System is designed for use in a surgical suite or operating room.
The Wi-3 HAL-RAR System includes components that come in contact with the patient during use. The RAR Probes (made of acrylic-based multipolymer) and Sleeve (PBT) are external communicating devices having limited contact duration (
§ 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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 12, 2015
Agency for Medical Innovations GmbH % Dr. Allison C. Komiyama, Ph. D., R.A.C. AcKnowledge Regulatory Strategies 2834 Hawthorn Street San Diego, California 92104
Re: K150718
Trade/Device Name: Wi-3 HAL-RAR System Regulation Number: 21 CFR 876.4400 Regulation Name: Hemorrhoidal ligator Regulatory Class: Class II Product Code: FHN, IYN Dated: March 18, 2015 Received: March 19, 2015
Dear Dr. Komiyama:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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 yours.
Jennifer R. Stevenson -S
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K150718
Device Name Wi-3 HAL-RAR System
Indications for Use (Describe)
The Wi-3 HAL-RAR System is a Bluetooth-enabled, pulsed Doppler, ultrasound system intended to be used for detecting hemorrhoidal arteries, manually ligating these arteries, and subsequently carrying out a mucopexy of hemorrhoidal prolapse if necessary.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/1 description: The image shows the text "K150718 Page 1 of 3" at the top. Below that is a large blue logo that says "A.M.I.". The logo has a small registered trademark symbol next to the I.
510(k) Summary K150718
DATE PREPARED
March 18, 2015
MANUFACTURER AND 510(k) OWNER
Agency for Medical Innovations GmbH Im Letten 1, 6800 Feldkirch, Vorarlberg, Austria +43 5522 90505-0 Telephone: Fax: +43 5522 90505-4006 Official Contact: Stefanie Hoellger, Quality Assurance & Regulatory Affairs
REPRESENTATIVE/CONSULTANT
Allison C. Komiyama, Ph.D., R.A.C. AcKnowledge Regulatory Strategies Telephone: akomiyama@acknowledge-rs.com Email:
PROPRIETARY NAME OF SUBJECT DEVICE
Wi-3 HAL-RAR System
COMMON NAME
Hemorrhoidal ligator
DEVICE CLASSIFICATION
Hemorrhoidal ligator (21 CFR 876.4400, Product Code FHN, Class II) Ultrasonic pulsed Doppler imaging system (21 CFR 892.1550, Product Code IYN, Class II)
INDICATIONS FOR USE
The Wi-3 HAL-RAR System is a Bluetooth-enabled, pulsed Doppler, ultrasound system intended to be used for detecting hemorrhoidal arteries, manually ligating these arteries, and subsequently carrying out a mucopexy of hemorrhoidal prolapse if necessary.
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Image /page/4/Picture/0 description: The image shows the logo for A.M.I. in blue. Above the logo, the text "K151532 Page 2 of 3" is visible. The logo is in a bold, sans-serif font and has a modern, corporate look.
DEVICE DESCRIPTION
The Wi-3 HAL-RAR System is a Bluetooth-enabled, pulsed Doppler, ultrasound system intended to be used for detecting hemorrhoidal arteries, manually ligating these arteries, and subsequently carrying out a mucopexy of hemorrhoidal prolapse if necessary. "HAL" is an acronym referring to "Hemorrhoidal Arteries Ligation", and "RAR" is an acronym referring to "Recto Anal Repair." The Wi-3 HAL-RAR System is designed for use in a surgical suite or operating room.
The Wi-3 HAL-RAR System includes components that come in contact with the patient during use. The RAR Probes (made of acrylic-based multipolymer) and Sleeve (PBT) are external communicating devices having limited contact duration (