(40 days)
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.
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.
The provided text is a 510(k) summary for the MedChannel HTS System. It primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to relevant standards rather than presenting a performance study with acceptance criteria in the way one might find for an AI/ML device.
Here's an analysis of the document regarding acceptance criteria and study information, addressing the points you requested:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table of acceptance criteria for a specific performance study of the MedChannel HTS System itself, nor does it report specific device performance metrics in numerical fashion against such criteria.
Instead, the "Summary of Standards Achieved" section lists regulatory and quality standards that the device complies with, implying that meeting these standards constitutes "acceptance." These are predominantly related to safety, manufacturing quality, and general medical device characteristics.
| Acceptance Criteria (Standards Met) | Reported Device Performance |
|---|---|
| 21 CFR § 820 (FDA Quality Systems Regulation) | Assured through Quality System Controls |
| ISO 10993:1 (Biological evaluation of medical devices -- Part 1: Evaluation and testing) | Not explicitly detailed for the HTS System, but implied compliance. |
| AAMI 11135 (Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization) | Not explicitly detailed, but implied compliance for accessories. |
| AAMI 11134 (Sterilization of health care products - Requirements for validation and routine control-industrial moist heat sterilization) | Not explicitly detailed, but implied compliance for accessories. |
| IEC 60601 (Medical Electrical Equipment - Part 1: General Requirements for Safety) | Compliance with general safety requirements. |
| UD 2-2004 (Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment (NEMA)) | Acoustic output values are lower than maximum pre-amendment intensities for relevant applications. |
The "substantially equivalent" determination is the primary "acceptance criterion" met by this 510(k) submission.
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a specific performance test set with a sample size or data provenance (e.g., country of origin, retrospective/prospective clinical data) for the MedChannel HTS System. The submission relies on demonstrating substantial equivalence to already marketed predicate devices and compliance with general safety and performance standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not present in the document, as there is no described performance study involving a test set and ground truth established by experts.
4. Adjudication Method for the Test Set
Since no specific test set or performance study is described, there is no information on an adjudication method.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No MRMC comparative effectiveness study is mentioned or described in this 510(k) summary. The device, an "adjunctive audio vessel landmarking aid" using Doppler sounds, is not an AI/ML diagnostic interpretation system that would typically undergo such a study to compare human readers with and without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
The MedChannel HTS System is described as an "adjunctive audio vessel landmarking aid." Its function is to provide real-time audio feedback to a human surgeon during a procedure. It is inherently a "human-in-the-loop" device. Therefore, a "standalone algorithm only" performance study, as typically understood for AI devices, would not be applicable and is not mentioned. Its performance is tied to its utility in aiding a human operator.
7. The Type of Ground Truth Used
Given the nature of the device and the content of the 510(k) summary, explicit "ground truth" (like pathology or outcomes data) for a specific performance study of the HTS system itself is not discussed. The ground truth for its intended use would be the actual presence and successful ligation of hemorrhoidal arteries, which is confirmed clinically during the procedure, but this is not referred to as a "ground truth" in the context of a study within this document. The submission focuses on the device's technical specifications and safety profile, arguing its substantial equivalence to other devices, which implies its ability to contribute to successful outcomes.
8. The Sample Size for the Training Set
The document does not describe a training set or its sample size. This type of submission does not involve machine learning algorithms that require training data.
9. How the Ground Truth for the Training Set Was Established
Since no training set is discussed, there is no information on how its ground truth would be established.
In summary:
This 510(k) summary for the MedChannel HTS System is a traditional submission focused on demonstrating substantial equivalence to predicate devices and adherence to recognized safety and quality standards (e.g., ISO, AAMI, IEC, NEMA). It pre-dates the common requirements for detailed performance studies with acceptance criteria, test sets, ground truth establishment, and AI/ML specific evaluations (like MRMC or standalone performance) that are now typical for modern AI-powered medical devices. The "acceptance" of this device is based on its compliance with these foundational standards and its similarity to existing, legally marketed ultrasound devices.
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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
| -------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|---|
| 1 |
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 routinecontrol-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(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 (800) 638-2041 or (240) 276-3150
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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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 | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(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-skeletalConventional | ||||||||||
| 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 _
Page 119
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
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.(b)
Classification. Class II.