MEDCHANNEL HTS SYSTEM

K061831 · Medchannel, LLC · IYN · Aug 7, 2006 · Radiology

Device Facts

• Record ID: K061831
• Device Name: MEDCHANNEL HTS SYSTEM
• Applicant: Medchannel, LLC
• Product Code: IYN · Radiology
• Decision Date: Aug 7, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The HTS System is an adjunctive audio vessel landmarking aid for use during hemorrhoidal artery treatment. It is not recommended for fetal or ophthalmic use.

Device Story

The MedChannel HTS System is an ultrasonic pulsed Doppler device used as an adjunctive audio aid for hemorrhoidal artery treatment. The device utilizes a transducer to detect blood flow within vessels; it converts detected flow into audible Doppler sounds. The clinician positions the transducer over the target area; the presence of audio signals indicates the location of a hemorrhoidal artery. Cessation of these sounds confirms successful vessel ligation. The system includes disposable, single-use accessories for manual ligation. It is intended for use by healthcare professionals in a clinical setting to assist in identifying and treating hemorrhoidal arteries, potentially improving the precision of the ligation procedure.

Clinical Evidence

Bench testing only. The device complies with FDA Quality Systems Regulation (21 CFR 820), ISO 10993-1 for biological evaluation, and NEMA UD 2-2004 for acoustic output measurement. No clinical trial data was required for this 510(k) clearance.

Technological Characteristics

Ultrasonic pulsed Doppler system (Class II, Product Code IYN). Features a single transducer. Acoustic output values are below maximum pre-amendment intensities for peripheral vessel applications. Complies with IEC 60601 (safety) and NEMA UD 2-2004 (acoustic output). Sterilization via ethylene oxide or moist heat.

Indications for Use

Indicated for use as an adjunctive audio vessel landmarking aid during hemorrhoidal artery treatment. Not for fetal or ophthalmic use.

Regulatory Classification

Identification

An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Submission Summary (Full Text)

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Kobi831

### 510(k) Summary of Safety and Effectiveness MedChannel HTS System & Accessories

AUG - 7 2006

#### Company Name

MedChannel, LLC 250 Dorchester Avenue Boston, MA 02127

#### Official Contact

Frederick Tobia Regulatory Consultant

#### Device Name

| Proprietary Name: | MedChannel HTS System |
|-------------------------|--------------------------------------------------------|
| Classification Name(s): | Ultrasonic Pulsed Doppler System |
| Classification Code(s): | IYN |
| Classification: | Ultrasonic Pulsed Doppler Systems are Class II Devices |

#### Predicate Devices used for Substantial Equivalence

| -------------------- | <br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 1<br> |

#### Intended Use & Indications

The HTS System is an adjunctive audio vessel landmatking aid for use during hemorrhoidal artery treatment. It is not recommended for fetal or ophthalmic use ..

#### Description

The HTS System is an adjunctive audio vessel landmarking aid for use during hemorrhoidal artery treatment. It is not recommended for fetal or ophthalmic use. Doppler audio sounds are heard when the transducer is positioned directly over a hemorrhoidal artery. Cessation of Doppler sounds occurs when ligation of the identified vessel has been completed successfully.

Acoustic output values for this transducer are lower than the maximum pre-amendment intensities specified for "Peripheral Vessel" and "Fetal Imaging and Other" applications. There is only one transducer available with this system.

The System includes disposable/single use accessories which can be used to perform the manual ligation of the hemorrhoidal arteries.

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# Summary of Standards Achieved

| 21 CFR § 820 | FDA Quality Systems Regulation |
|--------------|--------------------------------------------------------------------------------------------------------------------------------|
| ISO 10993:1 | Biological evaluation of medical devices -- Part 1: Evaluation and testing |
| AAMI 11135 | Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization |
| AAMI 11134 | Sterilization of health care products - Requirements for validation and routine<br>control-industrial moist heat sterilization |
| IEC 60601 | Medical Electrical Equipment - Part 1: General Requirements for Safety |
| UD 2-2004 | Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment<br>(NEMA) |

## Summary

In summary, the MedChannel HTS System is substantially equivalent to legally marketed devices. Quality System Controls assure the device is substantially equivalent to the predicate devices with respect to its performance, safety, and effectiveness.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The text is in all caps and is smaller than the caduceus symbol.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

AUG - 7 2006

MedChannel, LLC % Mr. Frederick Tobia Regulatory Consultant 55 Worcester Street, #3 BOSTON MA 02118

Re: K061831

Trade/Device Name: MedChannel HTS System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN Dated: June 27, 2006 Received: June 29, 2006

Dear Mr. Tobia:

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 (Premarket Approval), 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.

Image /page/2/Picture/10 description: The image shows a circular logo with the letters "FDA" in bold at the center. Above the letters, the years "1906-2006" are printed. Below the letters, the word "Centennial" is written in cursive. Three stars are placed below the word "Centennial". The text "...in the service of the nation..." is printed around the circle.

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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 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.

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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone]

or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page __ 1_ of __ 1

长061831 દ્વાર 510(k) Number (if known):

Device Name:

MedChannel HTS System

Indications for Use:

The HTS System is an adjunctive audio vessel landmarking aid for use during hemorrhoidal artery treatment. It is not recommended for fetal or ophthalmic use.

Prescription Use: X (Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David R. Syverson
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number

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# Med Channel HTS S

Diagnostic Ultrasound Indications for Use Form Kobic

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:

| | | | | | | Mode of Operation | | | | |
|----------------------------------|---|---|---|-----|-----|-------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | P | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

N

Additional Comments:__________________________________________________________________________________________________________________________________________________________

V

(PLEASE DC NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Ovin

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device 510(k) Number _

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